A magdy when 2 pci after mi


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presentation on thrombolysis and primary PCI indication after STEMI

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  • Review recent influences/randomized clinical trials (RCTs) in reperfusion that have impacted the guidelines and that this will be reviewed in-depth during this session: Superiority of PPCI over fibrinolysis if Door-to-Balloon completed in a timely fashion (Keeley & Grines, European STEMI Guidelines 2003 heralded PPCI as the preferred method of reperfusion) Plain old balloon angioplasty (POBA) has become almost extinct in the states. The most commonly used PPCI in the US- Stents + GP IIb-IIIa Inhibitor Drug eluting stents (DES) in STEMI is on the horizon Finally, acknowledgement that Time Matters in PPCI. Zwolle group, CADDILAC data, Nallamathou and Bates (graph on Door- to- Balloon minus Door-to- Needle), etc. Recommendations for time to reperfusion for PPCI (time from first medical contact-to-balloon; door-to-balloon) have been lowered to within 90 minutes Phase III studies on GP IIb-IIIa + ½ dose TNK-tPA, ½ dose rPA as well as Enoxaparin + full dose TNK-tPA have been published and reviewed. Studies with other antithrombins (including, ASSENT-3 ASSENT-3+, HERO-2). Awaiting EXTRACT (ENOX vs UFH with any lytic). To date, nothing Phase III scheduled with Bivalrudin and newer fibrinolytics. Recent predominantly European STEMI trials influence the guidelines Prehospital received a Phase IIa rating-explored in TIMI 19, CAPTIM, ASSENT-3 + European Transfer Trials (PRAGUE experience, DANAMI-2) and their transferability to the US system is in question; Guidelines emphasize ‘Prehospital Destination Protocols’.
  • “ The mortality benefit associated with primary percutaneous coronary intervention in ST-segment elevation myocardial infarction may be lost if door-to-balloon time is delayed by > 1 hour as compared with fibrinolytic therapy door-to-needle time. Interventional cardiology laboratories endeavoring to achieve the benefits of primary percutaneous coronary intervention seen in randomized clinical trials should aim to match their short door-to-balloon times”. (pg. 824) Legend key (pg.825) Absolute risk reduction in 4- to 6-week mortality rates with primary PCI as a function of PCI-related time delay. Circle sizes reflect the sample size of the individual study. Values > 0 represent benefit and values < 0 represent harm. Solid line , weighted meta-regression .   Nallamothu BK, Bates ER. Am J Cardiol. 2003;92:824-6
  • A magdy when 2 pci after mi

    1. 1. PCI after MI, When ? Ahmed Magdy, MD, FACC, FSCAI National Heart Institute, Cairo
    2. 2. Optimizing Reperfusion for STEMI <ul><li>Rapid delivery of reperfusion therapy is essential whether PPCI or thrombolytics </li></ul><ul><li>Each of these reperfusion methods has its merits and shortcomings. </li></ul><ul><li>The ideal reperfusion strategy would deliver rapid, complete and sustained reperfusion with normalization of micro-vascular flow. </li></ul>
    3. 3. Assessing Reperfusion Options for Patients with STEMI 1 <ul><li>STEP 1: Assess time from symptom onset, risk of STEMI , risk of thrombolysis , time for transport to PCI lab </li></ul><ul><li>STEP 2: Determine whether fibrinolysis or invasive strategy is preferred* </li></ul>* If presentation is <3 hours from onset and no delay to an invasive strategy, there is no preference for either strategy JACC 44: 671, 2004 Fibrinolysis preferred if: Invasive strategy preferred if: <ul><li>Early presentation (<3 hours) </li></ul><ul><li>Invasive strategy not an option </li></ul><ul><li>Delay to invasive strategy </li></ul><ul><li>Skilled PCI lab with surgical backup available </li></ul><ul><li>High risk (i.e. cardiogenic shock) </li></ul><ul><li>Contraindications to fibrinolysis </li></ul><ul><li>Late presentation (>3 hours) </li></ul><ul><li>Diagnosis of STEMI is in doubt </li></ul>
    4. 4. Patients Transported by EMS After Calling 9-1-1 Onset of STEMI Symptoms Call 911 Call Fast 9-1-1 EMS Dispatch <ul><li>EMS on-scene </li></ul><ul><li>Encourage 12-lead ECG </li></ul><ul><li>Consider prehospital fibrinolytic if capable and EMS-to-needle < 30 min </li></ul>EMS Triage Plan Not PCI Capable Hospital PCI Capable Hospital Interhospital Transfer Hospital Fibrinolysis: Door-to-needle within<30 min EMS transport:EMS to Balloon within 90 min Patient self-transport: Hospital Door-to-Balloon within 90 min EMS transport EMS on scene Within 8 min Dispatch 1 min Patient 5 min after Symptom onset Goals Total ischemic time: Within 120 min * * Golden hour = First 60 min Adapted from Panel A Figure 1 Antman et al. JACC 2004;44:676 .
    5. 6. Gersh, B. J. et al. JAMA 2005;293:979-986. 1)Time is myocardium 2)Infarct size is outcome Relationship Between Duration of Symptoms of MI Before Reperfusion Therapy, Mortality Reduction, and Extent of Myocardial Salvage Modified by collaterals,ischemic preconditioning,myocardial oxygen uptake, other vessels
    6. 7. Gersh, B. J. et al. JAMA 2005;293:979-986. 1)Time is myocardium 2)Infarct size is outcome Relationship Between Duration of Symptoms of MI Before Reperfusion Therapy, Mortality Reduction, and Extent of Myocardial Salvage Modified by collaterals,ischemic preconditioning,myocardial oxygen uptake, other vessels Symptom onset to hosp Arrival 2 hr Thrombolysis given, 2 ½ hr Symptom onset to balloon 3 ½ hr Thrombolysis induced reperfusion 3 ½ hr
    7. 8. Importance of Rapid Time to Treatment With Fibrinolysis in STEMI Time from onset of symptoms to treatment (hours) Absolute % difference in mortality at 35 days 3.5%  2.5%  1.8%   1.6%  0.5%  0.0 1.0 3.0 2.0 4.0 0 – 1 2 – 3 4 – 6 7 – 12 12 – 24 The Fibrinolytics Therapy Trialists’ collaborative group. Lancet . 1994; 343:311.
    8. 9. PCI In-hospital Mortality vs Door to Balloon Time Door to Balloon Time (hours) In-hosp Death Rate 0-1.4 1.5-1.9 2.0-2.9 >3.0 N= 2,322 Brodie BR, JACC 47, 2006 N=384 N=493 N=750 N=673
    9. 13. Recent Influences of Practice Salvage is Time Dependant <ul><li>Superiority of PPCI over fibrinolysis if Door-to-Balloon completed in a timely fashion </li></ul><ul><li>Acknowledgement that Time Matters in PPCI </li></ul><ul><ul><li>Recommendations for time to reperfusion updated </li></ul></ul>
    10. 14. Mortality rates with primary PCI as a function of PCI-related time delay Circle sizes = sample size of the individual study. Solid line = weighted meta-regression . 62 min Benefit Favors PCI Harm Favors Lysis For Every 10 min delay to PCI: 1% reduction in mortality difference towards lytics P = 0.006 0 20 40 60 80 100 PCI-Related Time Delay (door-to-balloon - door to needle) Absolute Risk Difference in Death (%) -5 0 5 10 15 Nallamothu BK, Bates ER. Am J Cardiol. 2003;92:824-6
    11. 15. Causes of Time Waste <ul><li>Many patients are not educated, may wait clinic hours </li></ul><ul><li>Bias of Initial diagnosis </li></ul><ul><li>Long rush hours, difficult transport </li></ul><ul><li>Availability of beds in CCU </li></ul><ul><li>Availability of cath labs, ready staff and experienced doctors </li></ul><ul><li>Cost of intervention </li></ul>
    12. 17. Thrombolytics are Frequently Used During Off Hours
    13. 18. PCI post thrombolysis in STEMI <ul><li>Prehospital TL + immediate transfer </li></ul><ul><li>Rescue PCI for failed TL </li></ul><ul><li>Immediate post-lysis </li></ul><ul><li>« facilitated PCI  » </li></ul><ul><li><24h post lysis ESC PCI GL 05 </li></ul><ul><li>Delayed PCI before discharge </li></ul>
    14. 19. PCI post thrombolysis in STEMI: <ul><li>Prehospital TL + immediate transfer </li></ul><ul><li>Rescue PCI for failed TL </li></ul><ul><li>Immediate post-lysis </li></ul><ul><li>« facilitated PCI  » </li></ul><ul><li><24h post lysis ESC PCI GL 05 </li></ul><ul><li>Delayed PCI before discharge </li></ul>CAPTIM RESCUE, REACT PACT PRAGUE GRACIA 2 ASSENT-4 FINESSE SIAM III GRACIA 1 CAPITAL AMI WEST CARESS « Open artery hypothesis » OAT SWISSI II
    15. 20. <ul><li>Following successful thrombolytic therapy, patients should undergo early angiography and PCI of their IRA </li></ul>PCI post thrombolysis in STEMI: <ul><li>Defined: more than 50% reduction in ST elevation in 60 to 90 min post TL Rx </li></ul><ul><li>Defined: less than 24hours post TL Rx </li></ul>
    16. 21. PCI post thrombolysis in STEMI: RATIONALE <ul><li>Risk of reocclusion high </li></ul><ul><li>2. Early angiographic risk stratification </li></ul><ul><li>3. High likelihood of residual complex stenosis despite successful TL Rx </li></ul>
    17. 23. Rescue PCI
    18. 25. Impact of TIMI Flow Pre-PCI on Infarct Size
    19. 26. Facilitated Angioplasty
    20. 33. Primary, secondary and bleeding end points in FINESSE End points Primary PCI (%) Abciximab +PCI%) (abcixima/ reteplase) -facilitated PCI (%) p, combined+ PCI vs primary PCI p, combin +PCIvs abciximab-facilitate Primary end point* 10.7 10.5 9.8 NS NS All-cause mortality 4.5 5.5 5.2 NS NS Complications of MI 8.9 7.5 7.4 NS NS Death 4.5 5.5 5.2 NS NS TIMI major bleeding 2.6 4.1 4.8 0.025 NS TIMI minor bleeding 4.3 6.0 9.7 <0.001 0.006
    21. 36. (Earlier ) Delayed PCI
    22. 37. OAT Occluded Artery Trial
    23. 38. OAT Occluded Artery Trial
    24. 39. Disadvantages of OAT
    25. 50. Comments on CARESS <ul><li>Again use of potent antiplatelet agent (abciximab), platelets inactivated at time of PCI, (In ASSENT IV < 10% use!!) </li></ul><ul><li>Bleeding reassuring as pts > 75yo excluded </li></ul><ul><li>Median time from TL Rx to PCI 212 min </li></ul>
    26. 51. Post-Lysis PCI studies GRACIA-1 SIAM III CAPITAL MI CARESS P=0.001 P=0.0008 P=0.04 P=0.001 N=1436
    27. 53. T rial of R outine AN gioplasty and S tenting after F ibrinolysis to E nhance R eperfusion in A cute M yocardial I nfarction The TRANSFER-AMI trial Warren J. Cantor, David Fitchett, Bjug Borgundvaag, Michael Heffernan, Eric A. Cohen, Laurie J. Morrison, John Ducas, Anatoly Langer, Shamir Mehta, Charles Lazzam, Brian Schwartz, Vladimir Dzavik, Amparo Casanova, Paramjit Singh, Shaun G. Goodman on behalf of the TRANSFER-AMI Investigators
    28. 54. Background <ul><li>Treatment delays can reduce or eliminate benefits of primary PCI </li></ul><ul><li>STEMI pts presenting to non-PCI centres often cannot undergo primary PCI in timely manner, and therefore receive thrombolysis </li></ul><ul><li>The role and optimal timing of routine early PCI after fibrinolysis remains controversial </li></ul>
    29. 55. Objective <ul><li>To compare: </li></ul><ul><li>Pharmacoinvasive strategy (transfer to PCI centre for routine early PCI within 6 hrs) with </li></ul><ul><li>Standard treatment (early transfer only for failed reperfusion, otherwise cath > 24 hrs) </li></ul><ul><li>for high-risk STEMI patients receiving thromboysis at non-PCI centres . </li></ul>
    30. 56. PCI Centre Cath Lab Community Hospital Emergency Department Cath / PCI within 6 hrs regardless of reperfusion status Cath and Rescue PCI  GP IIb/IIIa Inhibitor TNK + ASA + Heparin / Enoxaparin + Clopidogrel “ Pharmacoinvasive Strategy” Urgent Transfer to PCI Centre Assess chest pain, ST  resolution at 60-90 minutes after randomization ‘ High Risk’ ST Elevation MI within 12 hours of symptom onset Failed Reperfusion* Successful Reperfusion Elective Cath  PCI > 24 hrs later “ Standard Treatment” * ST segment resolution < 50% & persistent chest pain, or hemodynamic instability Repatriation of stable patients within 24 hrs of PCI Randomization stratified by age (≤75 vs. > 75) and by enrolling site
    31. 57. Procedures Cardiac Cath performed (%) Time- TNK to Cath (hrs) PCI performed (%) Stent used (% of PCI cases) Time- TNK to PCI (hrs) PCI within 6 hrs of TNK (%) PCI within 12 hrs of TNK (%) GP IIb/IIIa inhibitor use (%) Time- TNK to GP IIb/IIIa inhib. (hrs) IABP use (%) CABG performed (%) Standard Treatment (n=508) 82 27 (4, 69) 62 98 18 (4, 73) 38 47 53 11 (4, 63) 6 8 Pharmacoinvasive Strategy (n=522) 97 3 (2, 4) 84 98 4 (3, 5) 89 97 73 4 (3, 5) 7 6 PRELIMINARY
    32. 58. Selected Medications Used ASA 1 st 6 hrs Clopidogrel 1 st 6 hrs * Heparin Enoxaparin Beta Blocker 1 st 6 hrs ASA at discharge Clopidogrel at discharge Beta Blocker at discharge ACE Inhibitor at discharge Lipid Lowering at discharge Standard Treatment (n=508) 97 69 57 55 61 85 73 79 74 80 Pharmacoinvasive Strategy (n=522) 98 87 57 51 55 85 79 81 73 81 * p< 0.05 PRELIMINARY
    33. 59. 0 2 4 6 8 10 12 14 16 18 0 5 10 15 20 25 30 10.6 16.6 Days from Randomization % of Patients n=496 n=508 422 468 415 466 415 463 414 461 414 460 412 457 Primary Endpoint: 30-Day Death, re-MI, CHF, Severe Recurrent Ischemia, Shock PRELIMINARY OR=0.537 (0.368, 0.783); p=0.0013 Standard PCI > 24 hrs (n=496) Invasive < 6 hrs (n=508)
    34. 60. Components of Primary Endpoint Death Reinfarction Recurrent Ischemia Death/MI/Ischemia New / worsening CHF Cardiogenic Shock Standard Treatment (n=498) 3.6 6.0 2.2 11.7 5.2 2.6 Pharmacoinvasive Strategy (n=512) 3.7 3.3 0.2 6.5 2.9 4.5 P-Value 0.94 0.044 0.019 0.004 0.069 0.11 PRELIMINARY
    35. 61. Safety Endpoints - Bleeding Intracranial hemorrhage TIMI scale Major Major (non-CABG-related) GUSTO scale Moderate Severe Severe (non-CABG-related) Transfusions Standard Treatment (n=498) 1.2 4.6 3.2 2.2 1.4 1.2 5.5 Pharmacoinvasive Strategy (n=512) 0.2 4.3 2.2 3.5 0.6 0.6 7.1 P-Value 0.066 0.88 0.33 0.26 0.22 0.34 0.31 PRELIMINARY
    36. 62. Summary <ul><li>Compared with ‘Standard Treatment’, a ‘Pharmacoinvasive Strategy’ of routine early PCI within 6 hrs after thrombolysis is associated with a 6% absolute (46% relative) reduction in the composite of death, reinfarction, recurrent ischemia, heart failure and shock </li></ul>
    37. 63. Summary <ul><li>The pharmacoinvasive strategy is not associated with any increase in transfusions, severe bleeding or intracranial hemorrhage despite high use of GP IIb/IIIa inhibitors during PCI </li></ul><ul><li>In contrast to older trials, routine early PCI after thrombolysis using stents and contemporary pharmacotherapy is safe and effective </li></ul><ul><ul><li>Benefit seen despite high cath/PCI rates in Standard Treatment group (including ~40% rescue PCI) </li></ul></ul>
    38. 64. Conclusions <ul><li>For high-risk STEMI patients receiving thrombolysis at non-PCI centres, urgent transfer and PCI within 6 hours is associated with significantly less ischemic complications and no excess in bleeding </li></ul><ul><li>Transfers to PCI centres should be initiated immediately after thrombolysis without waiting to see whether reperfusion is successful </li></ul><ul><li>Regional systems should be developed to ensure timely transfers of STEMI patients to PCI centres </li></ul>
    39. 65. <ul><li>Results </li></ul><ul><li>Early PCI within 6 hrs after thrombolysis was associated with a 6% absolute reduction in the primary study composite endpoint . Standard 16.6% vs Pharmacoinvasive 10.6% (OR = 0.0013 = 0.537 [.368, 0.783]: p = 0.0013 (Figure) </li></ul><ul><li>Conclusions </li></ul><ul><li>Challenges findings of older studies regarding timing of fibrinolysis and PCI </li></ul><ul><li>Pharmacoinvasive strategy was safe and effective </li></ul><ul><li>Findings provide important information for shaping future guidelines </li></ul>TRANSFER-MI Trial Design: TRANSFER-MI was a randomized study comparing pharmacoinvasive strategy (transfer to PCI center for routine early PCI within 6 hrs) with standard treatment (early transfer only for failed reperfusion) for high-risk STEMI patients receiving thrombolysis at non-PCI centers (N=1,060). The primary endpoint was 30-day composite of death, reinfarction, recurrent Ischemia, CHF, shock. Standard Pharmacoinvasive 30 Day Composite (death, reinfarction, recurrent ischemia, CHF, shock) OR = 0.537 p =0.0013 Kastrani, K et al. Presented at ACC, 2008 @2008, American Heart Association. All rights reserved. % of pts
    40. 66. Interpretation <ul><li>PCI is the default strategy for STEMI patients admitted to centers without PCI facilities who were initially treated with reteplase, heparin and abciximab, transfer for PCI was associated with a reduction in the primary endpoint of death, MI or refractory ischemia at 30 days compared with continued medical management with revascularization only performed for rescue PCI. </li></ul><ul><li>The message from the two studies that primary PCI does not need facilitation (FINESSE) but if already received facilitation by lysis or IIb-IIIa antagonists, immediate PCI rather than rescue PCI is better. </li></ul>
    41. 67. PCI for AMI Strategies
    42. 68. In summary: European GL
    43. 69. Egypt COMBATMI 2010 March 24-26, Cairo Sheraton Hotel
    44. 70. 2010 4 th . Acute Cardiac Care Course EGYPT COMBAT MI 2010 Cairo Sheraton, March 24-26, 2010