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Guidelines stemi.2009 focused update_final.acc.aha
 

Guidelines stemi.2009 focused update_final.acc.aha

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  • Evolution of Guidelines for Management of Patients with AMI The first guideline published by the ACC/AHA described the management of patients with acute myocardial infarction (AMI). The subsequent three documents were the Agency for Healthcare and Quality/National Heart, Lung and Blood Institute sponsored guideline on management of unstable angina (UA), the revised/updated ACC/AHA guideline on AMI, and the revised/updated ACC/AHA guideline on unstable angina/non-ST segment myocardial infarction (UA/NSTEMI), and the revised/updated ACC/AHA guideline on STEMI. The present guideline is a update of the management of patients presenting with ST segment elevation myocardial infarction (STEMI) and percutaneous coronary intervention (PCI). The names of the chairs of the writing committees for each of the guidelines are shown at the bottom of each box. Rev, Revised; Upd, Update
  • Overall incidence of ACS in the U.S has decreased from 2004 to 2006 (reported in the 2007 and 2009 Heart Disease & Stroke Statistics), from 1.57 million to 1.37 million, respectively.
  • Grum meta-analysis Fig 2. Forest plot of ORs of 30 day mortality. Size of data markers are proportional to the weight of each study in the meta-analysis. The study by Danzi et al had no events in either arm & is, thus, not represented in the forest plot.
  • FINESSE design
  • *Bolus 25 μ g/kg & 0.15 μ g/kg/min infusion
  • 1 yr survival: patients with primary PCI: Tirofiban group significantly greater survival at 1 yr. (p=0.007, RR=0.44 (0.24-0.81)) Death at 1 yr. in primary PCI group: Tirofiban (2.4%) vs. Placebo (5.5%) - DATA REPORTED BUT NOT PUBLISHED
  • BRAVE 3 design
  • † The optimum LD of clopidogrel has not been established. Randomized trials establishing its efficacy and providing data on bleeding risks used a LD of 300 mg orally followed by a daily oral dose of 75 mg. Higher oral LDs such as 600 mg or more than 900 mg of clopidogrel more rapidly inhibit platelet aggregation and achieve a higher absolute level of inhibition of platelet aggregation, but the additive clinical efficacy and safety of higher oral LDs have not been rigorously established. The necessity for giving a LD of clopidogrel prior to PCI is driven by the pharmacokinetics of clopidogrel where several hours are required to achieve desired levels of platelet inhibition.
  • Do not use prasugrel in patients with active pathological bleeding or a history of TIA or stroke. In patients ≥ 75 years of age, prasugrel is generally not recommended, because of the increased risk of fatal and intracranial bleeding and uncertain benefit, except in high-risk situations (patients with diabetes or a history of prior MI) where its effect appears to be greater and its use may be considered. Do not start prasugrel in patients likely to undergo urgent CABG. Additional risk factors for bleeding include: body weight < 60 kg; propensity to bleed; concomitant use of medications that increase the risk of bleeding ( e.g. , warfarin, heparin, fibrinolytic therapy, chronic use of non-steroidal anti-inflammatory drugs [NSAIDS]).
  • Patients were candidates for the trial if they were moderate-high risk, had an acute coronary syndrome, and there was a plan to perform PCI. A sample size of 13, 600 was considered necessary to provide at least 90 % power to test the primary hypothesis All patients were to receive ASA. Randomization was stratified by UA/NSTEMI vs STEMI DB study drug therapy consisted either of - standard dosing with clopidogrel with a LD of 300 mg and MD of 75 mg - OR prasugrel with a LD of 60 mg and MD of 10 mg DB study drug was to be given for a median of at least 12 months with a minimum of 6 mos and maximum of 15 months The primary composite EP was CV death, MI, or Stroke through the end of the study Key secondary EPs are listed here and among these was Stent thrombosis Key safety Eps included: TIMI major (non CABG) bleeds, and life-threatening bleeds Two key substudies are evaluating pharmacokinetics and genomics
  • This slide depicts the balance of efficacy and safety observed in the trial. At the top is shown the significant reduction in the primary endpoint as presented a few moments ago. The number needed to treat to prevent one event was 46 At the bottom is the rate of TIMI major non CABG bleeds--a key safety endpoint-- which was 2.4% with prasugrel and 1.8% with clopidogrel—a 0.6% Absolute risk increase. The excess of 35 major bleeds with prasugrel corresponded to an HR of 1.32 and P value of 0.03 . The number of subjects who would need to be treated to result in one excess major bleed (NNH) was 167.
  • The beneficial effect of prasugrel on the primary end point was consistent across key prespecified major subgroups. Notable observations include: A significant benefit in both the UA/NSTEMI and STEMI cohorts There was a consistent reduction in events with prasugrel in men and women, pts with and without diabetes, those treated with either a BMS or DES whether or not a GPI was administered and regardless of the degree of renal function All P values in tests for interaction for the subgroups described were negative. Not depicted on the slide are the data showing a reduction in events with prasugrel regardless of the timing of the LD
  • To evaluate the impact of the LD and MD of prasugrel we performed a landmark analysis of events through 3 days, and from 3 days to the end of the study. As you can see PRASUGREL REDUCED THE PRIMARY ENDPOINT by 18% through 3 days and by 20% from 3 days to the end of the study suggesting that there was a significant benefit of prasugrel compared clopidogrel during both the LD and MD phases of treatment.
  • More details of the bleeding events are shown on this slide. The TIMI major non CABG bleed data are shown in the pair of bar graphs on the left, showing the increase in events with prasugrel Life threatening bleeding--another key safety EP ( defined as requiring a 4 unit txn, fluid or inotropic support, surgical intervention, or an ICH) occurred in 0.9 % of clopidogrel and 1.4% of prasugrel subjects—a 0.5% ARI with prasugrel, associated with a P value of 0.01 Subcategories of life threatening bleeding are shown to the right. Fatal bleeding occurred in 0.1% of pts with clopidogrel and was increased to 0.4% of patients with prasugrel—a 0.3% Absolute risk increase associated with a P value of 0.002. There was no difference in ICH overall in the trial—occurring in 0.3% of pts in both groups. Of note, in the subgroup of 518 patients with a history of prior stroke or TIA, no ICH’s occurred with clopidogrel while 6 occurred with prasugrel—a significant difference at the 0.02 level.
  • ‡ Clopidogrel LD post fibrinolytic therapy: for patients given fibrin- and non-fibrin-specific lytic undergoing PCI within 24 hrs, 300 mg; for patients given fibrin-specific lytic undergoing PCI after more than 24 hrs, 300-600 mg; for patients given non-fibrin-specific lytic undergoing PCI between 24-48 hrs, 300 mg; for patients given non-fibrin-specific lytic undergoing PCI after 48 hrs, 300-600 mg.
  • † For post-PCI patients receiving a stent (BMS or DES), a daily maintenance dose should be given for at least 12 months and up to 15 months unless the risk of bleeding outweighs the anticipated net benefit afforded by a thienopyridine. §Patients weighing < 60 kg have an increased exposure to the active metabolite of prasugrel and an increased risk of bleeding on a 10 mg once daily maintenance dose. Consider lowering the maintenance dose to 5 mg in patients < 60 kg. The effectiveness and safety of the 5 mg dose have not been prospectively studied. For post-PCI patients receiving a stent (BMS or DES), a daily maintenance dose should be given for at least 12 months and up to 15 months unless the risk of bleeding outweighs the anticipated net benefit afforded by a thienopyridine. Do not use prasugrel in patients with active pathological bleeding or a history of TIA or stroke. In patients ≥ 75 years of age, prasugrel is generally not recommended, because of the increased risk of fatal and intracranial bleeding and uncertain benefit, except in high-risk situations (patients with diabetes or a history of prior MI) where its effect appears to be greater and its use may be considered. Do not start prasugrel in patients likely to undergo urgent CABG. When possible, discontinue prasugrel at least 7 days prior to any surgery. Additional risk factors for bleeding include: body weight < 60 kg; propensity to bleed; concomitant use of medications that increase the risk of bleeding (e.g., warfarin, heparin, fibrinolytic therapy, chronic use of non-steroidal anti-inflammatory drugs [NSAIDS]).
  • With provisional abciximab or double-bolus eptifibatide. After coronary arteriography, a second round of randomization was performed, with eligible patients to receive a paclitaxel-eluding stent or a bare metal stent (not shown)- this randomization remains blinded.
  • P values based on log rank test. Event rates represent kaplan meier estimates.
  • P values based on log rank test. Event rates represent Kaplan-Meier estimates. 1-yr difference= 5.8% vs. 9.2%, p=0.001
  • High risk based on definitions used in CARESS-IN-AMI and TRANSFER-AMI
  • High risk features in CARESS-IN-AMI: extensive ST elevation, new onset LBBB, previous MI, Killip class >2, or LVEF < 35%
  • High risk features in CARESS-IN-AMI: extensive ST elevation, new onset LBBB, previous MI, Killip class >2, or LVEF < 35%
  • High risk features in TRANSFER-AMI were: greater than or equal to 2 mm ST-segment elevation in 2 anterior leads, systolic BP100 beats per minute, Killip Class II-III, > 2 mm of ST-segment depression in the anterior leads, > 1 mm of ST-elevation in right-sided lead V4 indicative of right ventricular involvement for inferior MIs; anterior MI alone with > 2 mm ST-elevation in 2 or more leads also qualified.
  • High risk features in TRANSFER-AMI were: greater than or equal to 2 mm ST-segment elevation in 2 anterior leads, systolic BP100 beats per minute, Killip Class II-III, > 2 mm of ST-segment depression in the anterior leads, > 1 mm of ST-elevation in right-sided lead V4 indicative of right ventricular involvement for inferior MIs; anterior MI alone with > 2 mm ST-elevation in 2 or more leads also qualified.
  • Death & reinfarction not different between groups at 6 months
  • (GUSTO=Global Use of Strategies to Open Occluded Coronary Arteries)
  • May be useful in STEMI patients with short ischemic times and large clot burdens
  • † For example, small vessels, long lesions, or diabetes mellitus. This recommendation applies to primary and nonprimary PCI patients with STEMI.
  • Meta-analysis of randomized trials comparing isosmolar iodixanol with LOCM. 16 trials in 2 763 patients. Subanalyses showed variations in relative renal safety by specific LOCM: A reduction in CIN was observed when iodixanol was compared with ioxaglate, the only ionic LOCM, (RR 0.58, CI 0.37 to 0.92, P= 0.02) and with iohexol, a nonionic LOCM, (RR 0.19 to 0.38, P <0.01), but no difference was noted in comparisons of iodixanol with iomeprol, iopamidol, iopromide, or ioversal.
  • Meta-Analysis: 25 trials in 3,260 patients. Older trends in CIN favoring iodixanol are not significant; summary RR 0.80; CI 0.61 to1.04; p=0.10
  • A pooled comparison of iodixanol with all nonionic LOCM other than iohexal indicated equivalent safety (RR 0.97; CI 0.72 to 1.32 p=0.86)
  • Tonino et al. FAME . N Engl J Med. 2009;360;213-224…. Adapted with permission from Fearon W. Exclusions: Left main disease or previous bypass surgery ST-elevation MI with creatine kinase >1000 U/L within the last 5 days Cardiogenic shock Life expectancy <2 years Contraindication to drug-eluting stents Pregnant patients Extremely tortuous or calcified coronary arteries
  • *Stenting for unprotected left main coronary artery (uLMCA) disease is relatively more favorable for patients with isolated LMCA lesions or LMCA plus single vessel disease, for patients with ostial or mid-LMCA lesions, and for patients with factors (such as severe lung disease, prior thoracic surgery, or poor bypass graft targets) that would make CABG high risk or unlikely to be successful. Conversely, CABG for uLMCA may be relatively more favorable for patients with LMCA plus multi-vessel disease, distal/bifurcation LMCA lesions, or low surgical risk with good chance of technical success.
  • Deleted Recommendation
  • Appendix 6
  • *Immediate catheterization/angiography is recommended for unstable patients.
  • Mehta SR, Granger CB, Boden WE, et al. Early versus delayed invasive intervention in acute coronary syndromes. N Engl J Med. 2009;360:2165-75 *Further exclusion criteria in supplemental appendix in NEJM
  • Kaplan–Meier Cumulative Risk of the Primary and Secondary Outcome at 6 Months. Panel A shows the cumulative risk of the composite primary outcome of death, MI, or stroke in the early-intervention group, as compared with the delayed-intervention group, with a nonsignificant between-group difference (P = 0.15) Trial underpowered- Subgroup analysis (high-risk subset) of this overall negative trial was not robust and must be viewed cautiously Mehta SR, Granger CB, Boden WE, et al. Early versus delayed invasive intervention in acute coronary syndromes. N Engl J Med. 2009;360:2165-75
  • Kaplan–Meier Cumulative Risk of the Primary and Secondary Outcome at 6 Months. Panel B shows the risk of the composite secondary outcome of death, MI, or refractory ischemia, with a significant between-group difference (P = 0.002). Trial underpowered- Subgroup analysis (high-risk subset) of this overall negative trial was not robust and must be viewed cautiously Mehta SR, Granger CB, Boden WE, et al. Early versus delayed invasive intervention in acute coronary syndromes. N Engl J Med. 2009;360:2165-75
  • Appendix 4 This list is in alphabetical order and is not meant to indicate a particular therapy preference. This drug table does not make recommendations for combinations of listed drugs. It is only meant to indicate approved dosages if a drug is chosen for a given situation.
  • Appendix 4 † The optimum LD of clopidogrel has not been established. Randomized trials establishing its efficacy and providing data on bleeding risks used an LD of 300 mg orally followed by a daily oral dose of 75 mg. Higher oral LDs such as 600 mg or more than 900 mg of clopidogrel more rapidly inhibit platelet aggregation and achieve a higher absolute level of inhibition of platelet aggregation, but the additive clinical efficacy and safety of higher oral LD have not been rigorously established. For post-PCI patients receiving a DES, a daily MD should be given for at least 12 months unless the risk of bleeding outweighs the anticipated net benefit afforded by a thienopyridine. For post-PCI patients receiving a BMS, an MD should be given for a minimum of 1 month and ideally up to 12 months (unless the risk of bleeding outweighs the anticipated net benefit afforded by a thienopyridine; then it should be given for a minimum of 2 weeks). The necessity for giving an LD of clopidogrel before PCI is driven by the pharmacokinetics of clopidogrel, for which a period of several hours is required to achieve desired levels of platelet inhibition. Patients who have a reduced-function CYP2C19 allele have significantly lower levels of the active metabolite of clopidogrel, diminished platelet inhibition, and a higher rate of MACE, including stent thrombosis. In STEMI patients taking clopidogrel for whom CABG is planned and can be delayed, it is reasonable to discontinue the clopidogrel to allow for dissipation of the antiplatelet effect, unless the urgency for revascularization and/or the net benefit of clopidogrel outweighs the potential risks of excess bleeding. Clopidogrel LD after fibrinolytic therapy: For patients given fibrin- and non–fibrin-specific thrombolytic drugs who are undergoing PCI within 24 hours, 300 mg; for patients given a fibrin-specific thrombolytic undergoing PCI after more than 24 hours, 300 to 600 mg; for patients given a non–fibrin-specific thrombolytic undergoing PCI between 24 and 48 hours, 300 mg; for patients given a non–fibrin-specific thrombolytic undergoing PCI after 48 hours, 300 to 600 mg.
  • ‡ Patients weighing <60 kg, propensity to bleed, concomitant use of medications that increase the risk of bleeding (eg, warfarin, heparin, fibrinolytic therapy, or chronic use of nonsteroidal anti-inflammatory drugs).
  • This list is in alphabetical order and is not meant to indicate a particular therapy preference. This drug table does not make recommendations for combinations of listed drugs. It is only meant to indicate approved dosages if a drug is chosen for a given situation.

Guidelines stemi.2009 focused update_final.acc.aha Guidelines stemi.2009 focused update_final.acc.aha Presentation Transcript

  • ACC/AHA 2009 STEMI/PCI Guidelines Focused Update Based on the ACC/AHA Guidelines for the Management of Patients With ST-Elevation Myocardial Infarction (STEMI) and the ACC/AHA/SCAI Guidelines on Percutaneous Coronary Intervention (PCI): A Report of the ACC/AHA Task Force on Practice Guidelines
    • This slide set was adapted from the 2009 Focused Update of the ACC/AHA Guidelines for Management of Patients With ST-Elevation Myocardial Infarction and the ACC/AHA/SCAI Guidelines on Percutaneous Coronary Intervention ( Journal of the American College of Cardiology published ahead of print on November 18, 2009, available at: http://content.onlinejacc.org/cgi/content/full/j.jacc.2009.10.015 )
    • This is an update of both the STEMI and PCI 2007 focused updates & their respective 2004 & 2005 guidelines.
    • The full-text guidelines are also available on the Web sites:
    • ACC ( www.acc.org ) and,
    • AHA ( www.americanheart.org )
  • Elliott M. Antman, MD, FACC, FAHA* Eric R. Bates, MD, FACC, FAHA Donald E. Casey, Jr., MD, MPH, MBA Lee A. Green, MD, MPH Judith S. Hochman, MD, FACC, FAHA Frederick G. Kushner, MD, FACC, FAHA, FSCAI , Co-Chair Mary Hand, MSPH, RN, FAHA, Co-Chair Harlan M. Krumholz, MD, FACC, FAHA Joseph P. Ornato, MD, FACC, FAHA David L. Pearle, MD, FACC, FAHA Michael A. Sloan, MD, MS, FACC, FAHA Sidney C. Smith, Jr., MD, FACC, FAHA *2004 Writing Committee Chair ‡ SCAI Representatives Slide Set Editor Frederick G. Kushner, MD, FACC, FAHA, FSCAI Special Thanks to The 2009 STEMI Guidelines Focused Update Writing Committee Members and The 2009 PCI Guidelines Focused Update Writing Committee Members Sidney C. Smith, Jr., MD, FACC, FAHA, Chair Spencer B. King, III, MD, MACC, FSCAI, Co-Chair Jeffrey L. Anderson, MD, FACC, FAHA* Douglass A. Morrison, MD, PhD, FACC, FSCAI ‡ Steven R. Bailey, MD, FACC, FSCAI ‡ Eric D. Peterson, MD, MPH, FACC James E. Blankenship, Jr., MD, FACC,FSCAI ‡ Patrick L. Whitlow, MD, FACC, FAHA Alice K. Jacobs, MD, FACC David O. Williams, MD, FACC, FAHA, FSCAI ‡
  • 1990 1992 1994 1996 1998 2000 2002 2004 2007 Evolution of Guidelines for ACS 2009 2009 Upd ACC/AHA STEMI/PCI F. Kushner 1990 ACC/AHA AMI R. Gunnar 1994 AHCPR/NHLBI UA E. Braunwald 1996 1999 Rev Upd ACC/AHA AMI T. Ryan 2004 2007 Rev Upd ACC/AHA STEMI E. Antman 2000 2002 2007 Rev Upd Rev ACC/AHA UA/NSTEMI E. Braunwald; J. Anderson
  • Hospitalizations in the U.S. Due to Acute Coronary Syndromes (ACS) Acute Coronary Syndromes* 1.57 Million Hospital Admissions - ACS UA/NSTEMI † STEMI 1.24 million Admissions per year .33 million Admissions per year Heart Disease and Stroke Statistics – 2007 Update. Circulation 2007; 115:69-171. *Primary and secondary diagnoses. †About 0.57 million NSTEMI and 0.67 million UA.
  • Descriptive Epidemiology of STEMI Heart Disease and Stroke Statistics – 2009 Update. Circulation 2009; 119:e21-e181. *Primary and secondary diagnoses . †About 0.57 million NSTEMI and 0.54 million UA. The percentage of ACS or MI with ST elevation varies in different registries/databases Registry % of MI which are STEMI National Registry of Myocardial Infarction (NRMI-4) 29% AHA Get with the Guidelines 32% Global Registry of Acute Coronary Events (GRACE) 38%
  • Applying Classification of Recommendations and Level of Evidence Class I Benefit >>> Risk Procedure/ Treatment SHOULD be performed/ administered Class IIa Benefit >> Risk Additional studies with focused objectives needed IT IS REASONABLE to perform procedure/administer treatment Class IIb Benefit ≥ Risk Additional studies with broad objectives needed; Additional registry data would be helpful Procedure/Treatment MAY BE CONSIDERED Class III Risk ≥ Benefit No additional studies needed Procedure/Treatment should NOT be performed/administered SINCE IT IS NOT HELPFUL AND MAY BE HARMFUL should is recommended is indicated is useful/effective/ beneficial is reasonable can be useful/effective/ beneficial is probably recommended or indicated may/might be considered may/might be reasonable usefulness/effectiveness is unknown /unclear/uncertain or not well established is not recommended is not indicated should not is not useful/effective/beneficial may be harmful
  • Applying Classification of Recommendations and Level of Evidence Class III Risk ≥ Benefit No additional studies needed Procedure/Treatment should NOT be performed/administered SINCE IT IS NOT HELPFUL AND MAY BE HARMFUL Class IIb Benefit ≥ Risk Additional studies with broad objectives needed; Additional registry data would be helpful Procedure/Treatment MAY BE CONSIDERED Class IIa Benefit >> Risk Additional studies with focused objectives needed IT IS REASONABLE to perform procedure/administer treatment Class I Benefit >>> Risk Procedure/ Treatment SHOULD be performed/ administered Level C: Very limited populations evaluated. Only consensus opinion of experts, case studies, or standard-of-care. Level B: Limited populations evaluated. Data derived from a single randomized trial or non-randomized studies Level A: Multiple populations evaluated; Data derived from multiple randomized clinical trials or meta-analyses
    • Recommendations for the Use of Glycoprotein IIb/IIIa Receptor Antagonists in STEMI
  • It is reasonable to start treatment with glycoprotein IIb/IIIa receptor antagonists at the time of primary PCI (with or without stenting) in selected patients with STEMI: abciximab tirofiban and eptifibatide Use of Glycoprotein IIb/IIIa Receptor Antagonists in STEMI I I I IIa IIa IIa IIb IIb IIb III III III I I I IIa IIa IIa IIb IIb IIb III III III I I I IIa IIa IIa IIb IIb IIb III III III IIa IIa IIa IIb IIb IIb III III III B I I I IIa IIa IIa IIb IIb IIb III III III I I I IIa IIa IIa IIb IIb IIb III III III I I I IIa IIa IIa IIb IIb IIb III III III IIa IIa IIa IIb IIb IIb III III III A Modified Recommendation
  • Use of Glycoprotein IIb/IIIa Receptor Antagonists in STEMI Grum et al. Small Molecule GP IIb/IIIa Inhibitors primary PCI. Circ Cardiovas Intervent. 2009;2:230-2236. 0.1 0.2 0.5 1 2 5 Favors SM GPI Favors Abciximab OR and 95% CI of 30-day Mortality Study Name Year Statistics p-value Dead/Total SM GPI Abciximab Valgimigli 2005 0.667 (0.11-4.09) 0.661 2/87 3/88 EVA-AMI 2007 1.017 (0.36-2.86) 0.974 8/226 7/201 MULTISTRATEGY 2008 0.438 (0.13-1.44) 0.173 4/372 9/372 FATA 2008 1.367 (0.43-4.35) 0.596 7/351 5/341 0.843 (0.46-1.55) 0.584
  • Use of Glycoprotein IIb/IIIa Receptor Antagonists in STEMI The usefulness of glycoprotein IIb/IIIa receptor antagonists (as part of a preparatory pharmacologic strategy for patients with STEMI prior to arrival in the cardiac catheterization laboratory for angiography and PCI) is uncertain. I I I IIa IIa IIa IIb IIb IIb III III III I I I IIa IIa IIa IIb IIb IIb III III III I I I IIa IIa IIa IIb IIb IIb III III III IIa IIa IIa IIb IIb IIb III III III B Modified Recommendation
  • FINESSE : Study design Ellis et al. N Eng J Med. 2008;358:2205-2217. Treatment Pre-PCI treatment with ½ -dose lytic plus abciximab, pre-PCI abciximab alone, and abciximab at time of PCI Inclusion Suspected acute MI (ST change or LBBB) within 6 h of symptom onset Exclusion Low risk (<60 yo, localized inferior infarct) high risk for bleeding 1 ° OUTCOMES Death, VF after 48 hours, shock, CHF within 90 days
  • Ellis et al. N Eng J Med. 2008;358:2205-2217
  • OnTIME 2 : Study design Acute myocardial infarction diagnosed in ambulance or referral center ASA+600 mg Clopidogrel Angiogram Tirofiban * Placebo Transportation PCI centre Angiogram Tirofiban provisional Tirofiban cont’d PCI van’t Hof et al. Lancet 2008;372:537-46 .
  • OnTIME 2 : endpoints
    • Primary
    • Residual ST segment deviation (>3mm) 1 hour after PCI
    • Key Clinical Secondary
    • Combined occurrence of death, recurrent MI, urgent TVR or thrombotic bailout at 30 days follow-up
    • Safety (major bleeding)
    • Death at 1 year follow-up
  • On-TIME 2: Results van’t Hof et al. Lancet 2008;372:537-46 Residual ST Deviation after PCI p=0.003 3.6 ± 4.6mm 4.8± 6.3mm
  • On-TIME 2 : Results van’t Hof et al. Lancet 2008;372:537-46 . Event-free Survival at 30 days Clinical outcome Placebo tirofiban P-value Death/recurrent MI or urgent TVR 39/477 (8.2%) 33/473 (7.0%) 0.485
  • BRAVE 3 : Study design
    • TREATMENT : pre-PCI treatment with clopidogrel (600 mg), followed by abciximab vs. placebo
    • INCLUSION: s uspected acute MI (ST change or LBBB) within 24 h of symptom onset
    • EXCLUSION: high risk for bleeding, prior stroke,shock,
    • trauma, thrombolytics, hypertension,
    • relevant hematologic deviations
    • 1 ° OUTCOMES: infarct size, death, stroke, urgent
    • revascularization of affected artery
    Mehilli et al. Circ . 2009;119:1933-1940
  • Effects of Abciximab Mehilli et al. Circ . 2009;119:1933-1940 No significant difference in infarct size or major bleeding P= 0.47 P= 0.40
    • Recommendations for the use of Thienopyridines
    • Loading doses for Thienopyridines in Patients with Acute Coronary Syndromes (STEMI and UA/NSTEMI)
  • Recommendations for the use of Thienopyridines A loading dose of thienopyridine is recommended for STEMI patients for whom PCI is planned. Regimens should be one of the following: Clopidogrel at least 300 mg to 600mg† should be given as early as possible before or at the time of primary or non-primary PCI. MODIFIED Recommendation I I I IIa IIa IIa IIb IIb IIb III III III I I I IIa IIa IIa IIb IIb IIb III III III I I I IIa IIa IIa IIb IIb IIb III III III IIa IIa IIa IIb IIb IIb III III III C
    • The optimal loading dose of clopidogrel has not been established
    • Randomized clinical trials using >300mg of clopidogrel as a loading dose for PCI in STEMI or UA/NSTEMI have not rigorously established superior safety or efficacy
    • Clopidogrel is a prodrug which must undergo hepatic conversion to its active metabolite for platelet inhibition, a process taking several hours.
    Recommendations for the use of Thienopyridines
  • Recommendations for the use of Thienopyridines Prasugrel 60 mg should be given as soon as possible for primary PCI. MODIFIED Recommendation I I I IIa IIa IIa IIb IIb IIb III III III I I I IIa IIa IIa IIb IIb IIb III III III I I I IIa IIa IIa IIb IIb IIb III III III IIa IIa IIa IIb IIb IIb III III III B
  • TRITON-TIMI 38: Study Design Double-blind ACS (STEMI or UA/NSTEMI) & Planned PCI ASA PRASUGREL 60 mg LD/ 10 mg MD CLOPIDOGREL 300 mg LD/ 75 mg MD 1 o endpoint: CV death, MI, Stroke 2 o endpoints: CV death, MI, Stroke, Rehosp-Rec Isch CV death, MI, UTVR Stent Thrombosis (ARC definite/prob.) Safety endpoints: TIMI major bleeds, Life-threatening bleeds Key Substudies: Pharmacokinetic, Genomic Median duration of therapy - 12 months N= 13,600 Wiviott SD et al AHJ 152: 627,2006 Adapted with permission from E.Antman
  • 0 5 10 15 0 30 60 90 180 270 360 450 HR 0.81 (0.73-0.90) P=0.0004 Prasugrel Clopidogrel Days Endpoint (%) 12.1 9.9 HR 1.32 (1.03-1.68) P=0.03 Prasugrel Clopidogrel 1.8 2.4 138 events 35 events Balance of Efficacy and Safety CV Death / MI / Stroke TIMI Major NonCABG Bleeds NNT = 46 NNH = 167 Adapted with permission from Wiviott SD et al NEJM 357:2007 TRITON : Results
  • B OVERALL No GPI GPI DES BMS DM No DM > 75 65-74 <65 Female Male STEMI UA/NSTEMI 0.5 1 2 Prasugrel Better Clopidogrel Better HR Age Reduction in risk (%) 18 21 12 25 14 6 14 30 20 18 21 16 19 21 P inter = NS CV Death, MI, Stroke Major Subgroups CrCl > 60 CrCl < 60 14 20 Wiviott SD et al NEJM 357: 2001, 2007 TRITON TIMI-38
  • 0 2 4 6 8 0 1 2 3 1 0 30 60 90 180 270 360 450 HR 0.82 P=0.01 HR 0.80 P=0.003 5.6 4.7 6.9 5.6 Days Primary Endpoint (%) Prasugrel Clopidogrel Prasugrel Clopidogrel Loading Dose Maintenance Dose Timing of Benefit (Landmark Analysis - 3 days) Adapted with permission from Antman EM JACC 2008. TRITON TIMI-38
  • Diabetic Subgroup 0 2 4 6 8 10 12 14 16 18 0 30 60 90 180 270 360 450 HR 0.70 P<0.001 Days Endpoint (%) CV Death / MI / Stroke TIMI Major NonCABG Bleeds NNT = 21 N=3146 17.0 12.2 Prasugrel Clopidogrel Prasugrel Clopidogrel 2.6 2.5 Wiviott SD et al Circulation 2008.Adapted with permission from Antman EM. TRITON TIMI-38
  • 0 5 10 15 0 30 60 90 180 270 360 450 Percent (%) Days From Randomization 9.5% 6.5% HR 0.68 (0.54-0.87) P=0.002 12.4% 10.0% HR 0.79 (0.65-0.97) P=0.02 Clopidogrel Prasugrel NNT = 42 CV Death / MI / Stroke TIMI Major NonCABG Bleeds Clopidogrel Prasugrel 2.4 2.1 STEMI Cohort N=3534 Montalescot et al Lancet 2008.Adapted with permission from Antman EM. TRITON TIMI-38
  • Stent Thrombosis (ARC Definite + Probable) 0 1 2 3 0 30 60 90 180 270 360 450 HR 0.48 P <0.0001 Prasugrel Clopidogrel 2.4 (142) NNT= 77 1.1 (68) Days Endpoint (%) Any Stent at Index PCI N= 12,844 Adapted with permission from Wiviott SD et al Lancet 2008 Significant reductions both with BMS, DES Significant reductions in early and late stent thromboses TRITON TIMI-38
  • % Events ARD 0.6% HR 1.32 P=0.03 NNH=167 Clopidogrel Prasugrel ARD 0.5% HR 1.52 P=0.01 ARD 0.2% P=0.23 ARD 0% P=0.74 ARD 0.3% P=0.002 ICH in Pts w Prior Stroke/TIA (N=518) Clop 0 (0) % Pras 6 (2.3)% (P=0.02) Wiviott SD et al NEJM 357: 2001, 2007. Adapted with permission from Antman EM. TRITON TIMI-38: Bleeding Events Safety Cohort (N=13,457)
  • Recommendations for the use of Thienopyridines For STEMI patients undergoing non-primary PCI, the following regimens are recommended:
    • … and has been given clopidogrel, it should be continued as the thienopyridine of choice.
    • … without a thienopyridine, a loading dose of 300-600 ‡ mg of clopidogrel should be given as the thienopyridine of choice.
    • If the patient did not receive fibrinolytic therapy…
    • c. …either a loading dose of 300-600 mg of clopidogrel should be given or, once the coronary anatomy is known and PCI is planned, a loading dose of 60 mg of prasugrel should be given promptly and no later than 1 hour after the PCI.
    If the patient has received fibrinolytic therapy… I I I IIa IIa IIa IIb IIb IIb III III III I I I IIa IIa IIa IIb IIb IIb III III III I I I IIa IIa IIa IIb IIb IIb III III III IIa IIa IIa IIb IIb IIb III III III C I I I IIa IIa IIa IIb IIb IIb III III III I I I IIa IIa IIa IIb IIb IIb III III III I I I IIa IIa IIa IIb IIb IIb III III III IIa IIa IIa IIb IIb IIb III III III B MODIFIED Rec
    • The duration of Thienopyridine therapy
  • Thienopyridines The duration of thienopyridine therapy should be as follows:
    • In patients receiving a stent (BMS or DES)
    • during PCI for ACS, clopidogrel 75 mg daily †
    • or prasugrel 10 mg § daily should be given
    • for at least 12 months;
    • If the risk of morbidity from bleeding
    • outweighs the anticipated benefit afforded
    • by thienopyridine therapy, earlier
    • discontinuation should be considered.
    MODIFIED Recommendation I I I IIa IIa IIa IIb IIb IIb III III III I I I IIa IIa IIa IIb IIb IIb III III III I I I IIa IIa IIa IIb IIb IIb III III III IIa IIa IIa IIb IIb IIb III III III C I I I IIa IIa IIa IIb IIb IIb III III III I I I IIa IIa IIa IIb IIb IIb III III III I I I IIa IIa IIa IIb IIb IIb III III III IIa IIa IIa IIb IIb IIb III III III B
  • Thienopyridines In patients taking a thienopyridine in whom coronary artery bypass surgery (CABG) is planned and can be delayed, it is recommended that the drug be discontinued to allow for dissipation of the antiplatelet effect. The period of withdrawal should be at least 5 days in patients receiving clopidogrel and at least 7 days in patients receiving prasugrel , … unless the need for revascularization and/or the net benefit of the thienopyridine outweighs the potential risks of excess bleeding. I I I IIa IIa IIa IIb IIb IIb III III III I I I IIa IIa IIa IIb IIb IIb III III III I I I IIa IIa IIa IIb IIb IIb III III III IIa IIa IIa IIb IIb IIb III III III C MODIFIED Recommendation (prasugrel added) I I I IIa IIa IIa IIb IIb IIb III III III I I I IIa IIa IIa IIb IIb IIb III III III I I I IIa IIa IIa IIb IIb IIb III III III IIa IIa IIa IIb IIb IIb III III III C I I I IIa IIa IIa IIb IIb IIb III III III I I I IIa IIa IIa IIb IIb IIb III III III I I I IIa IIa IIa IIb IIb IIb III III III IIa IIa IIa IIb IIb IIb III III III C I I I IIa IIa IIa IIb IIb IIb III III III I I I IIa IIa IIa IIb IIb IIb III III III I I I IIa IIa IIa IIb IIb IIb III III III IIa IIa IIa IIb IIb IIb III III III B
  • Thienopyridines Continuation of clopidogrel or prasugrel beyond 15 months may be considered in patients undergoing drug-eluting stent placement MODIFIED Recommendation I I I IIa IIa IIa IIb IIb IIb III III III I I I IIa IIa IIa IIb IIb IIb III III III I I I IIa IIa IIa IIb IIb IIb III III III IIa IIa IIa IIb IIb IIb III III III C
  • Thienopyridines In STEMI patients with a prior history of stroke and transient ischemic attack for whom primary PCI is planned, prasugrel is not recommended as part of a dual antiplatelet therapy regimen NEW Recommendation I I I IIa IIa IIa IIb IIb IIb III III III I I I IIa IIa IIa IIb IIb IIb III III III I I I IIa IIa IIa IIb IIb IIb III III III IIa IIa IIa IIb IIb IIb III III III C
    • Recommendations for
    • Use of Parenteral Anticoagulants in Patients with STEMI
  • Use of Parenteral Anticoagulants in STEMI
    • For prior treatment with UFH, additional boluses of UFH should be administered as needed to maintain therapeutic activated clotting time levels, taking into account whether GP IIb/IIIa receptor antagonists have been administered
    For patients proceeding to primary PCI, who have been treated with ASA and a thienopyridine, recommended supportive anticoagulant regimens include: Modified Recommendation I I I IIa IIa IIa IIb IIb IIb III III III I I I IIa IIa IIa IIb IIb IIb III III III I I I IIa IIa IIa IIb IIb IIb III III III IIa IIa IIa IIb IIb IIb III III III C
  • Use of Parenteral Anticoagulants in STEMI (cont.) b. Bivalirudin is useful as support for primary PCI with or without prior treatment with heparin. For patients proceeding to primary PCI, who have been treated with ASA and a thienopyridine, recommended supportive anticoagulant regimens include: Modified Recommendation I I I IIa IIa IIa IIb IIb IIb III III III I I I IIa IIa IIa IIb IIb IIb III III III I I I IIa IIa IIa IIb IIb IIb III III III IIa IIa IIa IIb IIb IIb III III III B
    • Bilvalirudin added as an acceptable anticoagulant for primary PCI
    • Unfractionated heparin (UFH) administration guided by:
      • Therapeutic activated clotting time (ACT) levels
      • Prior administration of GP IIb/IIIa receptor antagonists
    • Enoxaparin and fondaparinux unchanged from 2007 STEMI Focused Update
    Use of Parenteral Anticoagulants in STEMI Patients Proceeding to Primary PCI: Modified Class I Recommendations
  • HORIZONS-AMI : Design Stone et al. N Eng J Med. 2008;358:2218-30. Emergency angiography Emergency angiography
    • Endpoints : Composite of net adverse clinical events (NACE)
    • Included major bleeding plus MACE (a composite of CVD death, reinfarction, target-vessel revascularization for ischemia, and stroke within 30 days )
    3602 patients with STEMI & symptom onset ≤ 12 hours randomized 1800 received bivalirudin alone * 1802 received heparin + GP IIb/IIIa inhibitor Principal management strategy Primary PCI, 1678 (93.2%) Deferred PCI, 5 (0.3%) CABG, 23 (1.3%) Medical management, 94 (5.2%) Principal Management Strategy Primary PCI, 1662 (92.2%) Deferred PCI, 3 (0.2%) CABG, 40 (2.2%) Medical Management, 97 (5.4%)
  • HORIZONS-AMI : Time-to-Event Curves through 30 days: Net Adverse Clinical Events Treatment with bivalirudin alone compared with UFH + GP IIb/IIIa Inhibitors resulted in reduced 30-day rates of net adverse clinical events [HR=0.75, (0.62-0.92); p=0.006] Stone et al. N Eng J Med. 2008;358:2218-30.
  • HORIZONS-AMI : Time-to-Event Curves through 30 days: Major Bleeding HR=0.59 (0.45-0.76); p<0.0001 * 40% less bleeding in Bivalirudin group at 30 days Stone et al. N Eng J Med. 2008;358:2218-30.
  • HORIZONS-AMI : Results (cont.)
    • There was a statistically significant 1% increase in stent thrombosis (n=17) within the first 24 hours with bivalirudin, but no subsequent difference (1.3% versus 0.3%, p<0.001)
  • HORIZONS-AMI : Results (cont.)
    • Treatment with bivalirudin compared with UFH plus GP IIb/IIa inhibitors resulted in significantly lower:
      • 30-day death rates from cardiac causes (1.8% vs. 2.9%; RR 0.62; 95% CI 0.40 to 0.95; p=.03), &
      • 30-day death from all causes (2.1% vs. 3.1%; RR 0.66; 95% CI 0.44 to 1.00; p=0.047)
    • At one year, MACE rates were identical, but there was a decrease in all-cause mortality
    • with bivalirudin (3.4% versus 4.8%, p=0.03).
  • HORIZONS-AMI : Limitations
    • Open-label design
    • Administration of UFH before randomization in 66% of patients in the bivalirudin arm and 76% of patients in the UFH plus GP IIb/IIIa receptor antagonist arm
    • Only 615 patients received bivalirudin monotherapy and only 60% of patients in the trial received a 600 mg clopidogrel loading dose
  • HORIZONS-AMI : Other Preliminary Data (cont.)
    • A preliminary report suggested that the use of bivalirudin alone (p=0.005) & a lower loading dose of clopidogrel (300 mg vs. 600 mg; p=0.01) were independent predictors of acute & subacute stent thrombosis rates, respectively
    • p-values for secondary end points may not have been adjusted for multiple looks
    • Dangas et a., Predictors of Stent Thrombosis After Primary Angioplasty in Acute Myocardial Infarction: The HORIZONS AMI Trial (http://www.cardiosource.com/rapidnewssummaries/summary.asp?SumID=406)
  • Recommendations for triage and transfer for Percutaneous Coronary Intervention for Patients with STEMI
  • Recommendations for Triage and Transfer for PCI (for STEMI)
    • Each community should develop a STEMI system of care following the standards developed for Mission Lifeline including:
    • Ongoing multidisciplinary team meetings with EMS, non-PCI-capable hospitals (STEMI Referral Centers), & PCI-capable hospitals (STEMI Receiving Centers)
    I I I IIa IIa IIa IIb IIb IIb III III III I I I IIa IIa IIa IIb IIb IIb III III III I I I IIa IIa IIa IIb IIb IIb III III III IIa IIa IIa IIb IIb IIb III III III C NEW Recommendation
  • Recommendations for Triage and Transfer for PCI (for STEMI) (cont.)
    • STEMI system of care standards in communities should also include:
    • Process for prehospital identification & activation
    • Destination protocols to STEMI Receiving Centers
    • Transfer protocols for patients who arrive at STEMI Referral Centers and are primary PCI candidates, and/or are fibrinolytic ineligible and/or in cardiogenic shock
    I I I IIa IIa IIa IIb IIb IIb III III III I I I IIa IIa IIa IIb IIb IIb III III III I I I IIa IIa IIa IIb IIb IIb III III III IIa IIa IIa IIb IIb IIb III III III C NEW Recommendation
  • Recommendations for Triage and Transfer for PCI (for STEMI) (cont.) It is reasonable to transfer high risk patients who receive fibrinolytic therapy as primary reperfusion therapy at a non-PCI capable facility to a PCI-capable facility as soon as possible where either PCI can be performed when needed or as a pharmacoinvasive strategy. NEW Recommendation I I I IIa IIa IIa IIb IIb IIb III III III I I I IIa IIa IIa IIb IIb IIb III III III I I I IIa IIa IIa IIb IIb IIb III III III IIa IIa IIa IIb IIb IIb III III III B
  • Recommendations for Triage and Transfer for PCI (for STEMI) (cont.) Consideration should be given to initiating a preparatory antithrombotic (anticoagulant plus antiplatelet) regimen prior to and during patient transfer to the catheterization laboratory. NEW Recommendation I I I IIa IIa IIa IIb IIb IIb III III III I I I IIa IIa IIa IIb IIb IIb III III III I I I IIa IIa IIa IIb IIb IIb III III III IIa IIa IIa IIb IIb IIb III III III B
  • Recommendations for Triage and Transfer for PCI (for STEMI) (cont.) Patients who are not high risk who receive fibrinolytic therapy as primary reperfusion therapy at a non-PCI capable facility may be considered for transfer to a PCI-capable facility as soon as possible where either PCI can be performed when needed or as a pharmacoinvasive strategy. Modified Recommendation I I I IIa IIa IIa IIb IIb IIb III III III I I I IIa IIa IIa IIb IIb IIb III III III I I I IIa IIa IIa IIb IIb IIb III III III IIa IIa IIa IIb IIb IIb III III III C
  • Triage and Transfer for PCI: STEMI Patients Who Are Candidates for Reperfusion
    • Terms “facilitated PCI” and “rescue PCI” no longer used for the recommendations in this update
    • Contemporary therapeutic choices leading to reperfusion for pts with STEMI can be described without these potentially misleading labels
  • Triage and Transfer for PCI: STEMI Patients Who Are Candidates for Reperfusion
    • 2009 STEMI Focused Update new trials:
      • Combined Abciximab REteplase Stent Study in Acute Myocardial Infarction (CARESS-in-AMI)
      • Trial of Routine ANgioplasty and Stenting after Fibrinolysis to Enhance Reperfusion in Acute Myocardial Infarction trial (TRANSFER-AMI)
  • CARESS-IN-AMI: Design
    • 600 STEMI pts < 75 years old with > 1 high risk feature initially treated at non-PCI hospitals with half-dose reteplase, abciximab, heparin, and ASA within 12 hours of symptom onset
    • All pts randomized to immediate transfer for PCI or to standard treatment with transfer for rescue PCI if needed
    Di Mario et al. Lancet 2008;371.
  • CARESS-IN-AMI: Study Flow Chart 600 STEMI ASA 300-500 mg IV Reteplase 5 U+5 U at 30 min UFH 40 u/kg (max 3000 per u) ->7 u/kg/h Abciximab 0.25 mg/kg bolus ->0.125 μ g/kg/min for 12 h to a maximum 10 μ g/min 299 assigned to immediate PCI 1 consent not valid 297 received reteplase 289 transferred for immediate PCI 255 received PCI 301 assigned to standard care/rescue PCI 1 consent withdrawn 298 received reteplase 107 transferred for rescue PCI 91 received PCI Di Mario et al. Lancet 2008;371.
  • CARESS-IN-AMI: Design
    • Designed to address optimum treatment in pts for whom primary PCI not readily available
    • Not a trial of facilitated angioplasty opposed to primary angioplasty
    • Comparison between the general application of a combined pharmaco-invasive approach and the standard fibrinolysis plus selective rescue PCI approach in pts who do not qualify for primary angioplasty
    Di Mario et al. Lancet 2008;371.
  • Recommendations for Triage and Transfer for PCI: *High Risk Definition
    • Defined in CARESS-in-AMI as STEMI patients with one or more high-risk features:
      • extensive ST-segment elevation
      • new-onset left bundle branch block
      • previous MI
      • Killip class >2, or
      • left ventricular ejection fraction < 35% for inferior MIs;
    • Anterior MI alone with 2 mm or more
    • ST-elevation in 2 or more leads qualifies
    Di Mario et al. Lancet 2008;371.
  • CARESS-IN-AMI: Study Results
    • PCI was performed in 85.6% of patients in the immediate PCI group & rescue PCI was performed in 30.3% of the standard treatment/transfer for rescue PCI group.
    • There was a shorter median fibrinolytic therapy-to-PCI center transfer time in the immediate vs. rescue PCI groups (110 min vs 180 min, p<0.0001).
    Di Mario et al. Lancet 2008;371.
  • CARESS-IN-AMI: Primary Outcome primary outcome (composite of all cause mortality, reinfarction, & refractory MI within 30 days) occurred significantly less often in the immediate PCI group vs. standard care/rescue PCI group 10.7% 4.4% HR=0.40 (0.21-0.76) Di Mario et al. Lancet 2008;371.
  • CARESS-IN-AMI: Study Results
    • No significant differences in the rates of major bleeding at 30 days (3.4% versus 2.3%, p=0.47) or stroke (0.7% versus 1.3%, p=0.50) between groups
    Di Mario et al. Lancet 2008;371.
  • CARESS-IN-AMI: Implications
    • High-risk STEMI patients treated at non-PCI hospitals with a preparatory pharmacologic strategy of half-dose fibrinolytic therapy, abciximab, heparin, & ASA have improved outcomes when transferred immediately to a PCI facility rather than continuing medical therapy with transfer for rescue PCI only if there is evidence of failed reperfusion.
  • TRANSFER-AMI
    • Study of pharmacoinvasive strategy in 1059 patients with STEMI presenting to non-PCI-capable hospitals within 12 hrs of symptom onset & with ≥ 1 high-risk feature
    Cantor et al. N Eng J Med 2009;360:26.
  • Recommendations for Triage and Transfer for PCI: *High Risk Definition
    • Defined in TRANSFER-AMI as > 2 mm ST-segment elevation in 2 anterior leads or ST elevation at least 1 mm in inferior leads with at least one of the following:
      • systolic blood pressure <100 mm Hg
      • heart rate >100 beats per minute
      • Killip Class II-III
      • > 2 mm of ST-segment depression in the anterior leads
      • > 1mm of ST elevation in right-sided lead V4 indicative of right ventricular involvement
    Cantor et al. N Eng J Med 2009;360:26.
  • TRANSFER-AMI--Design
    • All patients were treated with fibrinolytic therapy and randomized to:
      • a pharmaco-invasive strategy (immediate transfer for PCI within 6 hours of fibrinolytic therapy) or to
      • standard treatment after fibrinolytic therapy (included rescue PCI as required for ongoing chest pain and less than 50% resolution of ST-elevation at 60-90 minutes or hemodynamic instability).
    Cantor et al. N Eng J Med 2009;360:26.
  • TRANSFER-AMI--Design (cont.)
    • Standard treatment patients who did not require rescue PCI remained at the initial hospital for at least 24 hours and coronary angiography within the first 2 weeks encouraged.
    • All patients received standard-dose tenecteplase (TNK), ASA, and either UFH or enoxaparin.
    Cantor et al. N Eng J Med 2009;360:26.
  • TRANSFER-AMI--Design (cont.)
    • Clopidogrel loading (300 mg for patients < 75 years of age, and 75 mg > 75 years of age) strongly encouraged in all study patients
    • GP IIb/IIIa receptor antagonists administered at the PCI-capable hospitals according to institutions’ standard practice
    Cantor et al. N Eng J Med 2009;360:26.
  • TRANSFER-AMI: Results Procedures Cantor et al. N Engl J Med 2009;360:26. Pharmaco-invasive vs. Standard Treatment Median time to TNK administration from symptom onset Approximately 2 hrs in both groups Median time from TNK to catheterization 2.8 hrs vs. 32.5 hrs Coronary angiography 98.5% vs. 88.7% PCI performed 84.9% vs. 67.4%
  • TRANSFER-AMI: Efficacy Kaplan Meier Curves for Primary Endpoint 17.2% 11.0% primary end point: composite of death, reinfarction, recurrent ischemia, new or worsening CHF, or shock within 30 days pharmaco-invasive group=11.0% vs. standard treatment group=17.2% RR= 0.64, 95 CI% (0.47-0.87) Cumulative Incidence Days p=0.004 Cantor et al. N Engl J Med 2009;360:26
  • TRANSFER-AMI--Safety Results
    • Incidence of TIMI major and minor bleeding and GUSTO moderate and severe bleeding was not different between groups
    • There was higher incidence of GUSTO mild bleeding in the pharmaco-invasive group (13.0% compared to 9.0% in the standard treatment group, p=0.036).
    Cantor et al. N Eng J M 2009;360:26.
  • TRANSFER-AMI Study Conclusion
    • Following treatment with fibrinolytic therapy in high risk STEMI pts presenting to hospitals without PCI-capability, transfer to a PCI center to undergo coronary angiography and PCI should be initiated immediately without waiting to determine whether reperfusion has occurred.
    Cantor et al. N Eng J M 2009;360:26.
  • Pathway: Triage and Transfer for PCI (in STEMI) 2009 STEMI Focused Update. Appendix 5 STEMI patient who is a candidate for reperfusion Initially seen at a PCI capable facility Initially seen at a non-PCI capable facility Send to Cath Lab for primary PCI (Class I, LOE:A) Transfer for primary PCI (Class I, LOE:A) Initial Treatment with fibrinolytic therapy (Class 1, LOE:A) Prep antithrombotic (anticoagulant plus antiplatelet) regimen Diagnostic angio Medical therapy only PCI CABG NOT HIGH RISK Transfer to a PCI facility may be considered (Class IIb, LOE:C), especially if ischemic symptoms persist and failure to reperfuse is suspected HIGH RISK Transfer to a PCI facility is reasonable for early diagnostic angio & possible PCI or CABG (Class IIa, LOE:B), High-risk patients as defined by 2007 STEMI Focused Update should undergo cath (Class 1: LOE B) At PCI facility, evaluate for timing of diagnostic angio
  • Pathway: Triage and Transfer for PCI (in STEMI)
    • Those presenting to a non-PCI-capable facility should be triaged to fibrinolytic therapy or immediate transfer for PCI .
    • Decision depends on multiple clinical observations that allow judgment of:
      • mortality risk of the STEMI
      • risk of fibrinolytic therapy
      • duration of the symptoms when first seen
      • time required for transport to a PCI-capable facility
    2009 STEMI Focused Update. Appendix 5
  • Pathway: Triage and Transfer for PCI (in STEMI) —(cont.)
    • If primary PCI is chosen, the patient will be transferred for PCI.
    • If fibrinolytic therapy is chosen, the patient will receive the agent(s) and a judgment as to whether the patient is high risk or not will be determined.
    2009 STEMI Focused Update. Appendix 4
  • Pathway: Triage and Transfer for PCI (in STEMI) —(cont.)
    • If high risk, the patient should receive appropriate antithrombotic therapy and be moved immediately to a PCI-capable facility for diagnostic catheterization and consideration of PCI.
    2009 STEMI Focused Update. Appendix 5
  • Pathway: Triage and Transfer for PCI (in STEMI) —(cont.)
    • If not high risk, the patient may be moved to a PCI-capable facility after receiving antithrombotic therapy, or observed in the initial facility
    2009 STEMI Focused Update. Appendix 5
  • Pathway: Triage and Transfer for PCI (in STEMI) —(cont.)
    • Patients best suited for transfer for PCI are STEMI pts:
      • Presenting with high-risk features
      • High bleeding risk from fibrinolytic therapy
      • Late presenters-->4 hrs after onset of symptoms
    • Decision to transfer is a judgment made considering the time required for transport and the capabilities of the receiving hospital
    2009 STEMI Focused Update. Appendix 5
  • Pathway: Triage and Transfer for PCI (in STEMI) —(cont.)
    • STEMI pts best suited for fibrinolytic therapy are those presenting early after symptom onset with low bleeding risk
    • After fibrinolytic therapy, if not high risk, transfer to a PCI-capable facility may be considered, especially if symptoms persist and failure to reperfuse is suspected. 
    2009 STEMI Focused Update. Appendix 5
  • Triage and Transfer for PCI (in STEMI)
    • The duration of symptoms should continue to serve as a modulating factor in selecting a reperfusion strategy for STEMI patients.
    • While patients at high risk (e.g., CHF, shock, contraindications to fibrinolytic therapy) are best served with timely PCI, inordinate delays between the time from symptom onset and effective reperfusion with PCI may prove deleterious, especially among the majority of STEMI patients at relatively low risk.
    2009 STEMI Focused Update. Appendix 5
  • Triage and Transfer for PCI (in STEMI)
    • Each community and each facility in that community should have an agreed-upon plan for how STEMI patients are to be treated, including:
      • which hospitals should receive STEMI patients from EMS units capable of obtaining diagnostic ECGs
      • management at the initial receiving hospital, and
      • written criteria & agreements for expeditious transfer of patients from non-PCI-capable to PCI-capable facilities
    2009 STEMI Focused Update. Appendix 5
  • Triage and Transfer for PCI (in STEMI)
    • Need for the development of regional systems of STEMI care through stakeholder efforts to evaluate ACS care using:
      • standardized performance & quality improvement measures, (e.g., endorsed by the ACC, AHA, Joint Commission, Centers for Medicare and Medicaid Services)
      • standardized quality-of-care data registries designed to track and measure outcomes, complications and adherence to evidence-based processes of care
        • NCDR ACTION Registry ®
        • American Heart Association “Get With the Guidelines”
  • Triage and Transfer for PCI (in STEMI)
    • American Heart Association’s Mission Lifeline is an initiative to encourage closer cooperation and trust amongst prehospital care providers, and cardiac care professionals.
    • Recommendations for Intensive Glucose Control in STEMI
  • Intensive Glucose Control in STEMI It is reasonable to use an insulin based regimen to achieve and maintain glucose levels less than 180 mg/dl while avoiding hypoglycemia for patients with STEMI with either a complicated or uncomplicated course NEW Recommendation I I I IIa IIa IIa IIb IIb IIb III III III I I I IIa IIa IIa IIb IIb IIb III III III I I I IIa IIa IIa IIb IIb IIb III III III IIa IIa IIa IIb IIb IIb III III III B
    • Recommendations for Thrombus Aspiration during PCI for STEMI
  • Thrombus Aspiration During PCI for STEMI Aspiration thrombectomy is reasonable for patients undergoing primary PCI NEW Recommendation I I I IIa IIa IIa IIb IIb IIb III III III I I I IIa IIa IIa IIb IIb IIb III III III I I I IIa IIa IIa IIb IIb IIb III III III IIa IIa IIa IIb IIb IIb III III III B
    • Recommendations for the use of stents in STEMI
  • Use of stents in STEMI It is reasonable to use a drug- eluting stent as an alternative to a bare-metal stent for primary PCI in STEMI * Consideration for the use of stents (DES or BMS) in STEMI should include the ability of the patient to comply with prolonged dual antiplatelet therapy, the bleeding risk in patients on chronic oral anticoagulation, and the possibility that the patient may need surgery during the ensuing year NEW Recommendation I I I IIa IIa IIa IIb IIb IIb III III III I I I IIa IIa IIa IIb IIb IIb III III III I I I IIa IIa IIa IIb IIb IIb III III III IIa IIa IIa IIb IIb IIb III III III B
  • Use of stents in STEMI A DES may be considered for clinical and anatomic settings† in which the efficacy/safety profile appears favorable MODIFIED Recommendation I I I IIa IIa IIa IIb IIb IIb III III III I I I IIa IIa IIa IIb IIb IIb III III III I I I IIa IIa IIa IIb IIb IIb III III III IIa IIa IIa IIb IIb IIb III III III B
    • PCI focused update section
    • Recommendations for angiography in patients with chronic kidney disease
  • Angiography in patients with CKD In patients with chronic kidney disease undergoing angiography and who are not on chronic dialysis, either an isosmolar contrast medium or a low molecular weight contrast medium other than ioxaglate or iohexol is indicated MODIFIED Recommendation I I I IIa IIa IIa IIb IIb IIb III III III I I I IIa IIa IIa IIb IIb IIb III III III I I I IIa IIa IIa IIb IIb IIb III III III IIa IIa IIa IIb IIb IIb III III III B I I I IIa IIa IIa IIb IIb IIb III III III I I I IIa IIa IIa IIb IIb IIb III III III I I I IIa IIa IIa IIb IIb IIb III III III IIa IIa IIa IIb IIb IIb III III III A
  • The indications for contrast agents during angiography or PCI in patients with chronic kidney disease are now expanded to include both iso osmolar and low molecular weight agents other than ioxaglate or iohexol
  • Reed M, et al. J Am Coll Cardiol Intv. 2009;2:645-54 Relative renal safety of iodixanol vs. IOCM: Meta-analysis, Reed et al Variations in relative renal safety by specific LOCM
    • Reduction in CIN observed when iodixanol vs. ioxaglate & iohexol
    • No difference in comparisons of iodixanol with iomeprol, iopamidol,
    • iopromide, or ioversol
  • Heinrich MC et al. Radiology. 2009;250:68-86. Trends in CIN favoring iodixanol no longer significant Nephrotoxicity of iodixanol vs. LOCM: Meta Analysis Heinrich et al
  • RR of CIN for comparison of iodixanol with iohexol and RR of CIN for comparison of iodixanol with nonionic LDCM other than iohexol Heinrich MC et al. Radiology. 2009;250:68-86. p=NS, indicates equivalent safety
  • Recommendations for the use of Fractional Flow Reserve
  • Use of FFR Coronary pressure (fractional flow reserve [FFR]) or Doppler velocimetry can be useful to determine whether PCI of a specific coronary lesion is warranted. FFR or Doppler velocimetry can also be useful as an alternative to performing noninvasive functional testing (e.g., when the functional study is absent or ambiguous) to determine whether an intervention is warranted. It is reasonable to use intracoronary physiologic measurements (coronary pressure [FFR]) (Level of Evidence: A) or Doppler velocimetry ( Level of Evidence: C) ) in the assessment of the effects of intermediate coronary stenoses (30% to 70% luminal narrowing) in patients with anginal symptoms. MODIFIED Recommendation I I I IIa IIa IIa IIb IIb IIb III III III I I I IIa IIa IIa IIb IIb IIb III III III I I I IIa IIa IIa IIb IIb IIb III III III IIa IIa IIa IIb IIb IIb III III III A I I I IIa IIa IIa IIb IIb IIb III III III I I I IIa IIa IIa IIb IIb IIb III III III I I I IIa IIa IIa IIb IIb IIb III III III IIa IIa IIa IIb IIb IIb III III III C
  • Use of FFR Routine assessment with intracoronary physiologic measurements such as coronary pressure (FFR) or Doppler ultrasound to assess the severity of angiographic disease in concordant vascular distribution in patients with angina and a positive, unequivocal noninvasive functional study is not recommended. MODIFIED Recommendation I I I IIa IIa IIa IIb IIb IIb III III III I I I IIa IIa IIa IIb IIb IIb III III III I I I IIa IIa IIa IIb IIb IIb III III III IIa IIa IIa IIb IIb IIb III III III C
  • FAME Tonino et al. N Engl J Med. 2009;360;213-224. Adapted with permission from Fearon W. Assessed for Eligibility N=1905 Angiography-guided PCI N=496 FFR-guided PCI N=509 Lost to follow-up N=8 Analyzed N=496 Analyzed N=509 Randomized N=1005 Lost to follow-up N=11 Not eligible N= 900 Left main stenosis N= 157 Extreme coronary tortuosity or calcification N= 217 No informed consent N= 105 Contra-indication for DES N= 86 Participation in other study N= 94 Logistic reasons N= 210 Other reasons N= 31
  • FAME: Results Tonino et al. N Engl J Med. 2009;360:213-224. Adapted with permission from Fearon W. . absolute difference in MACE-free survival Angio-guided 360 days 5.3% 180 days 4.9% 90 days 3.8% 30 days 2.9% FFR-guided
  • FAME
    • Resource utilization (contrast: 272 vs. 302 ml, cost of procedure ($5,332 vs. $6,007) shorter with FFR-guided PCI compared with routine PCI (all p < 0.05)
    • MACE lower at 1 year with FFR (p = 0.02)
    • Incidence of death (p = 0.19), MI (p = 0.07), and CABG or re-PCI (p = 0.08) at 1 year were similar
    % 0 5 15 1.8 3.0 20 Trial design: Patients with multivessel disease were randomized to either routine angiography-guided PCI or fractional flow reserve (FFR)-guided PCI, with stenting of only those lesions with an FFR of ≤0.8. Clinical outcomes were compared at 1 year. Results Conclusions
    • FFR-guided PCI is associated with a lower incidence of MACE compared with angiography-guided PCI in patients with multivessel disease, with a decrease in resource utilization
    • Further studies validating these findings are necessary
    To nino PA, et al. N Engl J Med 2009;360:213-24 5 10 15 20 13.2 18.3 % 0 MACE Death 10 (p = 0.02) FFR-guided PCI (n = 509) Routine PCI (n = 496) (p = 0.19)
  • Recommendations for PCI for Unprotected Left Main Coronary Artery Disease
  • PCI for unprotected left main PCI of the left main coronary artery using stents as an alternative to CABG may be considered in patients with anatomic conditions that are associated with low risk of PCI procedural complications and Clinical conditions that predict an increased risk of adverse surgical outcomes* NEW Recommendation I I I IIa IIa IIa IIb IIb IIb III III III I I I IIa IIa IIa IIb IIb IIb III III III I I I IIa IIa IIa IIb IIb IIb III III III IIa IIa IIa IIb IIb IIb III III III B
  • PCI for unprotected left main It is reasonable that patients undergoing PCI to unprotected left main coronary obstructions be followed up with coronary angiography between 2 and 6 months after PCI. DELETED Recommendation I I I IIa IIa IIa IIb IIb IIb III III III I I I IIa IIa IIa IIb IIb IIb III III III I I I IIa IIa IIa IIb IIb IIb III III III IIa IIa IIa IIb IIb IIb III III III C
  • Outcomes of PCI vs. CABG for Unprotected Left Main Author/ Year (Reference) Type of Study (recruitment years) PCI/ CABG Short-term Results Long-term Results Chieffo 2006 Cohort 2002-2004 107/ 142 In-hospital outcomes for PCI versus CABG: Death: 0% versus 2.1%, P= NS MI: 9.3% versus 26.1%, P= 0.0009 Stroke: 0% versus 2%, P= NS 1-Year adjusted ORs for PCI versus CABG: Death or MI: 0.26;95% CI 0.078–0.597; P= 0.0005 Death, MI, or stroke: 0.385; 95% CI 0.180–0.819; P= 0.01 Revascularization: 4.2; 95% CI 1.486–14.549; P= 0.005 Lee 2006 Cohort 2003-2005 50/ 123 30-Day outcomes for PCI versus CABG: Death: 2% versus 5%; P= NS MI: 0% versus 2%; P= NS Stroke: 0% versus 8%; P= 0.03 Death/MI/stroke/revascularization: 17% versus 2%; P <0.01 1-Year follow-up for PCI versus CABG: Death: 4% versus 15%; P= 0.2 Death, MI, stroke: 4% versus 21%; HR=4.4; 95% CI 1.0–18.6; P= 0.03 Revascularization: 13.3% versus 5.5%; P= 0.2
  • Author/Year (Reference) Type of Study (yrs of recruitment) PCI/ CABG Short-term Results Long-term Results Palmerini 2006 Cohort 2002-2005 157/154 30-Day outcomes for PCI versus CABG: Death: 3.2% versus 4.5%; P= NS MI: 4.5% versus 1.9%; P= NS Revascularization: 0.6% versus 0.6%; P= NS 1- to 2-Year follow-up for PCI and CABG: Death: 13.4% versus 12.3%; 95% CI 0.51–1.77; P= 0.8 MI: 8.3% versus 4.5%; 95% CI 0.21-1.32; P= 0.17 Revascularization: 2.6% versus 25.5%; 95% CI 0.03–0.23; P= 0.0001 Buszman 2008 Randomized 2001-2004 52/53 30-Day outcomes for PCI versus CABG: Death: 0% versus 0% MI: 2% versus 4%; P= NS MACE: 2% versus 14%; 95% CI 0.79-0.99; P= 0.03 1-Year follow-up for PCI versus CABG: Death: 2% versus 8%; P= NSMI: 2% versus 6%; P= NS Revascularization: 30% versus 10%; 95% CI 1.05–1.54; P= 0.01 MACE: 32% versus 26%; 95% CI 0.85–1.38; P= NS
  • Author/Year (Reference) Type of Study (yrs of recruitment) PCI/ CABG Short-term Results Long-term Results Sanmartin 2007 Cohort 2000-2005 96/245 30-Day outcomes for PCI versus CABG: Death: 2.1% versus 6.1%; P= 0.17 Death/MI/stroke/revascularization: 2.1% versus 9.0%; P= 0.03 1 year for PCI vs. CABG: Death: 5.2% versus 8.4%; P= 0.37 MI: 0% versus 1.3%; P= 0.44 Repeat revascularization: 5.2% versus 0.8%; P= 0.02 Death/MI/stroke/revascularization: 10.4% versus 11.4%; P= 0.5 Brener 2008 Cohort with matched CABG controls 1997-2006 At 3 years, outcomes for PCI versus CABG: Death: 20% versus 15%; P= 0.14
  • Author/Year (Reference) Type of Study (yrs of recruitment) PCI/ CABG Short-term Results Long-term Results Seung 2008 Matched Cohort 2000-2006 542/542 At 3 years, HRs for PCI versus CABG: Death: 1.18; HR=1.18; 95% CI 0.77–1.80; P= 0.45 Death/MI/stroke: 1.10; HR=1.10;, 95% CI 0.75–1.62; P= 0.61, Revascularization: 4.76; HR=4.76; 95% CI 2.80–8.11; P <0.001 White 2008 Cohort 2003-2007 120/223 At 30 months, HRs for PCI vs. CABG; Death 1.93; 95% CI 0.89-4.19; p=0.10 Serruys 2009 Randomized 2005-2007 348/357 At 1 year, HRs for PCI versus CABG: Death/MI/CVA/revascularization: 15.8 versus 13.7;, P= 0.44
  • Recommendations for the timing of Angiography and Antiplatelet Therapy in UA/NSTEMI
  • Recommendations for the Timing of Angiography and Antiplatelet Therapy in UA/NSTEMI Patients with definite or likely UA/NSTEMI selected for an invasive approach should receive dual-antiplatelet therapy. Aspirin should be initiated on presentation. Clopidogrel (before or at the time of PCI) ( Level of Evidence: A ) or prasugrel (at the time of PCI) ( Level of Evidence: B ) is recommended as a second antiplatelet agent. NEW Recommendation I I I IIa IIa IIa IIb IIb IIb III III III I I I IIa IIa IIa IIb IIb IIb III III III I I I IIa IIa IIa IIb IIb IIb III III III IIa IIa IIa IIb IIb IIb III III III A I I I IIa IIa IIa IIb IIb IIb III III III I I I IIa IIa IIa IIb IIb IIb III III III I I I IIa IIa IIa IIb IIb IIb III III III IIa IIa IIa IIb IIb IIb III III III B
  • Recommendations for the Timing of Angiography and Antiplatelet Therapy in UA/NSTEMI It is reasonable for initially stabilized high-risk patients with UA/NSTEMI* (GRACE [Global Registry of Acute Coronary Events] risk score > 140) to undergo an early invasive strategy within 12 to 24 hours of admission. For patients not at high risk , an early invasive approach is also reasonable. I I I IIa IIa IIa IIb IIb IIb III III III I I I IIa IIa IIa IIb IIb IIb III III III I I I IIa IIa IIa IIb IIb IIb III III III IIa IIa IIa IIb IIb IIb III III III B NEW Recommendation
  • TIMACS : Study design Mehta et al. N Engl J Med . 2009;360:2165-75 Treatment Routine early intervention (coronary angiography within 24 hours) or delayed (coronary angiography at 36 hours+) Inclusion NSTE-ACS (no ST elevation within 24 hours of symptom onset) & high risk Exclusion Not suitable for revascularization 1 ° OUTCOMES Death, MI, stroke at 6 mo. 2 ° OUTCOMES Refractory ischemia
  • TIMACS : Results Mehta et al. N Engl J Med . 2009;360:2165-75 HR= 0.85 (95% CI, 0.68-1.06) P=0.15 Early intervention significantly improved outcomes in highest risk patients No significant difference in rate of death, new MI or stroke at 6 mo.
  • TIMACS : Results Mehta et al. N Engl J Med . 2009;360:2165-75 Secondary Outcome: Early-intervention group had a 28% reduction in death, MI, or refractory ischemia compared to the delayed-intervention group. HR, 0.72 (0.58-0.89) P=0.003 12.9% 9.5%
  • Dosing Table for Antiplatelet and Anticoagulant Therapy Discussed in This Focused Update to Support PCI in STEMI Drug During PCI Comments ► All patients to receive ASA (162–325 mg) Patient received initial medical treatment (with an anticoag &/or lytic therapy) Patient did not receive initial medical treatment (with an anticoag &/or lytic therapy) Glycoprotein IIb/IIIa receptor antagonists Abciximab Of uncertain benefit LD of 0.25 mg/kg IV bolus MD of 0.125 mcg/kg per minute (maximum 10 mcg/min) ( Class IIa, LOE:A ) ► Continue for up to 12 hrs at the discretion of the physician Eptifibatide Of uncertain benefit LD of 180 mcg/kg IV bolus followed 10 minutes later by second IV bolus of 180 mcg/kg MD of 2.0 mcg/kg per minute, started after first bolus; reduce infusion by 50% in patients with estimated creatinine clearance <50 mL/min ( Class IIa, LOE:B ) ► Double bolus recommended to support PCI in STEMI as the recommended adult dosage of eptifibatide in patients with normal renal function. ► Infusion should be continued for 12-18 hrs at the discretion of the physician. Tirofiban Of uncertain benefit
      • LD of 25 mcg/kg IV bolus
    • MD of IV infusion of 0.1 mcg/kg/min; reduce rate of infusion by 50% in patients with estimated creatinine clearance < 30 mL/min (Class IIa, LOE:B)
    ► Increased dosing over previous recommendation. ► Continue for up to 18 hrs at the discretion of the physician
  • Dosing Table for Antiplatelet and Anticoagulant Therapy Discussed in This Focused Update to Support PCI in STEMI Drug During PCI Comments ► All patients to receive ASA (162–325 mg) Patient received initial medical treatment (with an anticoag &/or fibrinolytic therapy) Patient did not receive initial medical treatment (with an anticoag &/or fibrinolytic therapy) Thienopyridines Clopidogrel † If 600 mg given orally, then no additional treatment A second LD of 300 mg may be given orally to supplement a prior LD of 300 mg ( Class I, LOE:C ) LD 300–600 mg orally MD of 75 mg orally per day ( Class I, LOE: C ) ► optimal LD has not been established ►Dose for patients >75 years old has not been established. ►A recommended duration of therapy exists for all post-PCI patients receiving a BMS or DES. ►Period of withdrawal before surgery should be at least 5 days. Prasugrel No data available LD of 60 mg orally ► There is no clear need for treatment with prasugrel before PCI.
  • Drug During PCI Comments ► All patients to receive ASA (162–325 mg) Patient received initial medical treatment (with an anticoag &/or lytic therapy) Patient did not receive initial medical treatment (with an anticoag &/or lytic therapy) Prasugrel ‡ (cont.) MD of 10 mg orally per day ( Class I, LOE: B ) ► MD of 5 mg orally per day in special circumstances. ► Special dosing for patients <60 kg or >75 years of age. ► There is a recommended duration of therapy for all post-PCI patients receiving a DES. ► Contraindicated for use in patients with prior history of TIA or stroke.
  • Drug During PCI Comments ► All patients to receive ASA (162–325 mg) Patient received initial medical treatment (with an anticoag &/or lytic therapy) Patient did not receive initial medical treatment (with an anticoag &/or lytic therapy) Parental anticoagulants Bivalirudin For patients who have received UFH, wait 30 minutes, then give 0.75 mg/kg bolus, then 1.75 mg/kg per hour infusion ( Class I, LOE: B ) 0.75 mg/kg bolus, 1.75 mg/kg per hour infusion ► Bivalirudin may be used to support PCI & STEMI with or without previously administered UFH with the addition of 600 mg of clopidogrel ►In STEMI patients undergoing PCI who are at high risk of bleeding, bivalirudin anticoagulation is reasonable. UFH IV GP IIb/IIIa planned: target ACT 200–250 seconds.No IV GP IIb/IIIa planned: target ACT 250–300 seconds for HemoTec, 300–350 seconds for Hemochron ( Class I, LOE: C ) IV GP IIb/IIIa planned: 50–70 U/kg bolus to achieve an ACT of 200–250 seconds. No IV GP IIb/IIIa planned: 70–100 U/kg bolus to achieve target ACT of 250–300 seconds for HemoTec, 300–350 seconds for Hemochron ( Class I, LOE:C ) IV GP IIb/IIIa planned: 50–70 U/kg bolus to achieve an ACT of 200–250 seconds. No IV GP IIb/IIIa planned: 70–100 U/kg bolus to achieve target ACT of 250–300 seconds for HemoTec, 300–350 seconds for Hemochron ( Class I, LOE:C )
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