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STEPP AMI

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STEPP AMI TRIAL

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STEPP AMI

  1. 1. JOURNAL CLUB Two-year follow-up data from the STEPP-AMI study: A prospective, observational, multicenter study comparing tenecteplase-facilitated PCI versus primary PCI in Indian patients with STEMI i n d i a n h e a r t j o u r n a l 6 8 ( 2 0 1 6 ) 1 6 9 – 1 7 3 DR MALLESWARA RAO
  2. 2. INTRODUCTION
  3. 3. • patients who do reach the hospital early still have to deal with other issues, such asarranging for finances, as most Indian patients pay out-of pocket • introduction of fibrin-specific lytic agents like tenecteplase (TNK) has improved the IRA patency rates significantly. • Rapid fibrinolytic treatment improved the outcomes in patients treated within an hour of symptom onset, with tapering benefits after 3 hrs • fibrinolysis -high rates of reocclusion of IRA • initial bolus lysis followed by early CAG within 3–24 h of fibrinolysis, with an appropriate PCI ='pharmacoinvasive strategy-good alternative especially in a developing country such as India.
  4. 4. PRAGUE-2 • STK vs immediate transport for PCI where the distance between primary hospitals and tertiary PCI centres does not exceed 120 km. • STEMI presenting within 12 h of symptom • thrombolysis administered at the initial receiving hospital (thrombolysis group, n=421) or immediate transport (within 30 min of randomisation) for primary PCI (PCI group, n=429)
  5. 5. PRAGUE-2
  6. 6. Comparison of primary angioplasty and pre- hospital fibrinolysis in acute myocardial infarction (CAPTIM) trial: a 5-year follow-up • primary angioplasty (n = 421)VS pre-hospital fibrinolysis (rt-PA) with immediate transfer to a centre with interventional facilities (n = 419) all-cause mortality at 5 years • 9.7% in the pre-hospital fibrinolysis group • 12.6% in PPCI [ P = 0.18]. patients included within 2 h, 5 year mortality • 5.8% in the pre-hospital fibrinolysis group • 11.1% in PPCI [HR 0.50 ( P = 0.04], Patients included after 2 h, 5 year mortality • 14.5 vs 14.4% [ P = 0.92].
  7. 7. PRESENT STUDY • prospective, observational, multicenter pilot study, • between August 2011 and May 2013 • Study sites, which were capable of performing 24/7 primary PCI, were selected from Tamilnadu ,Karnataka , and Kerala • 200 patients • observational study, the treatment options were chosen entirely by the patient and the attendants • some patients who presented outside the recommended timelines for thrombolysis have received lytic therapy .
  8. 8. AIM • assess the safety, efficacy, and feasibility of a pharmacoinvasive strategy in comparison to primary PCI in STEMI
  9. 9. • primary endpoint • set at 30 days • composite of death, cardiogenic shock, reinfarction, repeat revascularization, and congestive heart failure, and extended to 2 years • Safety end points are bleeding assessed using the TIMI classification at 30 day
  10. 10. • Baseline characteristics were no different between both groups, except more patients in arm B were in killip's class I. • 6.7% (n = 3) patients in arm A had insignificant disease; hence no intervention was performed for them • 100% of patients in arm B required angioplasty and stent implantation. pharmacoinvasive arm (arm 'A') - 45 patients PPCI arm (arm 'B') 155 patients
  11. 11. • Patients in arm A also had better TIMI flow at CAG (TIMI 3 flow in 27.9%), higher radial procedures (76.7%), more IRA patency (82.2%), and less thrombus burden. • In arm 'A', 12.1% -failed thrombolysis.
  12. 12. bleeding outcomes • 2.2% vs. 2.6%, 'p' not significant). • efficacy end points are studied at 30 days, 3 months, 6 months, 1 year, and 2 years-no difference • There is trend of benefit for arm B in the initial few months • Primary endpoint -trend toward benefit in the primary PCI group (11.1% vs.3.9%, p = 0.07, RR = 2.8). • At the end of 2-year follow-up, the initial benefit from PPCI seems to be narrowed as more events have occurred in PPCI group (A-17.8% vs. B-13.6%, p = 0.47, RR = 1.31;). • The additions of events in the primary endpoint of PPCI group are mainly due to death and repeat revascularization
  13. 13. • This may be partly due to the fact that 6.7%of patients in arm A did not require a stent placement due to insignificant disease at the angiogram, which means they are at no risk of stent thrombosis or restenosis. • non-urgent basis on which the angioplasty was performed in arm A may also have influenced the primary endpoint over a period of time, but this fact needs further large studies to provide comprehensive evidence. •
  14. 14. CONCLUSION • fibrinolysis followed by an early coronary angiogram within 3–24 h with PCI, if appropriate, resulted in similar outcomes when compared to primary PCI in patients with STEMI at 2-year follow-up. • pharmacoinvasive strategy where patient and system related delays are inherent
  15. 15. THANKYOU

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