PRAMI clinical trial (for STEMI intervention)

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  • 1. PRAMI Trial Abdelkader Almanfi, MD, MRCP-UK Texas Heart Institute Journal club 11/04/2013
  • 2. Disclosure I have nothing to disclose except that I am getting free lunches, books, dinners and courses from countless number of companies. But for sure, No cash money or checks involved (yet)
  • 3. Original Article Randomized Trial of Preventive Angioplasty in Myocardial Infarction David S. Wald, M.D., Joan K. Morris, Ph.D., Nicholas J. Wald, F.R.S., Alexander J. Chase, M.B., B.S., Ph.D., Richard J. Edwards, M.D., Liam O. Hughes, M.D., Colin Berry, M.B., Ch.B., Ph.D., Keith G. Oldroyd, M.D., for the PRAMI Investigators N Engl J Med Volume 369(12):1115-1123 September 19, 2013
  • 4. Study Overview • Patients with acute STEMI were randomly assigned to undergo infarct-vessel-only PCI or preventive PCI (PCI to noninfarct arteries with stenoses). • The rate of the primary outcome of cardiac death, myocardial infarction, or refractory angina was lower with preventive PCI.
  • 5. Enrollment and Follow-up. Wald DS et al. N Engl J Med 2013;369:1115-1123
  • 6. Kaplan–Meier Curves for the Primary Outcome. Wald DS et al. N Engl J Med 2013;369:1115-1123
  • 7. Characteristics of the Patients at Baseline. Wald DS et al. N Engl J Med 2013;369:1115-1123
  • 8. Details Regarding PCI and Medical Therapy at Discharge. Wald DS et al. N Engl J Med 2013;369:1115-1123
  • 9. Prespecified Clinical Outcomes. Wald DS et al. N Engl J Med 2013;369:1115-1123
  • 10. Conclusions • In patients with STEMI and multi-vessel coronary artery disease undergoing infarctartery PCI, preventive PCI in non-infarct coronary arteries with major stenoses significantly reduced the risk of adverse cardiovascular events, as compared with PCI limited to the infarct artery.
  • 11. Critics about the study: - Sample size is small -Larger number of patients were inferior infarcts - EF was not reported in the study
  • 12. What does the guidelines say about PCI in STEMI and how the question of noninfarct artery PCI was addressed in 2013 guidelines ?
  • 13. Primary PCI in STEMI I IIa IIb III Primary PCI should be performed in patients with STEMI and ischemic symptoms of less than 12 hours’ duration. I IIa IIb III Primary PCI should be performed in patients with STEMI and ischemic symptoms of less than 12 hours’ duration who have contraindications to fibrinolytic therapy, irrespective of the time delay from FMC. I IIa IIb III Primary PCI should be performed in patients with STEMI and cardiogenic shock or acute severe HF, irrespective of time delay from MI onset.
  • 14. Primary PCI in STEMI I IIa IIb III Primary PCI is reasonable in patients with STEMI if there is clinical and/or ECG evidence of ongoing ischemia between 12 and 24 hours after symptom onset. I IIa IIb Harm III PCI should not be performed in a noninfarct artery at the time of primary PCI in patients with STEMI who are hemodynamically stable
  • 15. Primary PCI in STEMI
  • 16. PCI of a Noninfarct Artery Before Hospital Discharge: Recommendations CLASS I 1. PCI is indicated in a noninfarct artery at a time separate from primary PCI in patients who have spontaneous symptoms of myocardial ischemia. (Level of Evidence: C) CLASS IIa 1. PCI is reasonable in a noninfarct artery at a time separate from primary PCI in patients with intermediate- or high-risk findings on noninvasive testing. (Level of Evidence: B)
  • 17. Multivessel coronary artery disease is present in 40% to 65% of patients presenting with STEMI who undergo primary PCI and is associated with adverse prognosis. Studies of staged PCI of noninfarct arteries have been nonrandomized in design and have varied with regard to the timing of PCI and duration of follow-up. These variations have contributed to the disparate findings reported, although there seems to be a clear trend toward lower rates of adverse outcomes when primary PCI is limited to the infarct artery and PCI of a noninfarct artery is undertaken in staged fashion at a later time.
  • 18. The largest of these observational studies compared 538 patients undergoing staged multivessel PCI within 60 days of primary PCI with propensity-matched individuals who had culprit-vessel PCI alone. Multivessel PCI was associated with lower mortality rate at 1 year (1.3% versus 3.3%; p0.04). A none significant trend toward a lower mortality rate at 1 year was observed in the subset of 258 patients who underwent staged PCI during the initial hospitalization for STEMI.
  • 19. Although fractional flow reserve is evaluated infrequently in patients with STEMI, at least 1 study suggests that determination of fractional flow reserve may be useful to assess the hemodynamic significance of potential target lesions in noninfarct arteries. The writing committee encourages research into the benefit of PCI of noninfarct arteries in patients with multivessel disease after successful primary PCI
  • 20. Prognostic Impact of Staged vs. “Onetime” Multivessel PCI in AMI Retrospective analysis of 668 pts from HORIZONS-AMI • One-time multivessel PCI was associated with higher rates of all-cause and cardiac mortality as well as stent thrombosis compared with staged PCI • The mortality advantage was maintained in a subgroup of pts undergoing „truly elective‟ multivessel PCI • In multivariable analysis, staged vs. onetime PCI was an independent predictor of 1-year mortality Implications: Deferred angioplasty of significant nonculprit lesions should be the default strategy for patients undergoing primary PCI. Kornowski R, et al. J Am Coll Cardiol. 2011;58:704-711.
  • 21. Culprit Vessel Only vs. Multivessel and Staged PCI for Multivessel Disease in STEMI Patients Meta-analysis of 4 prospective and 14 retrospective studies (n = 40,280) Staged PCI was associated with lower short- and long-term mortality compared with culprit-vessel-only and multivessel PCI Multivessel PCI was linked to the highest mortality rates at both short- and long-term follow-up The best strategy in pts with cardiogenic shock remains uncertain Implications: In STEMI pts, significant nonculprit lesions should be treated only during staged procedures, a finding that supports guidelines. Vlaar PJ, et al. J Am Coll Cardiol. 2011;58:692-703.
  • 22. Multivessel Coronary Artery Revascularization vs. Culprit-Only Revascularization in STEMI Patients Meta-analysis of 19 studies (n = 61,764), including 2 randomized trials. • Within 30 days, there was no difference between groups for mortality, MI, stroke, and TVR, but multivessel PCI decreased repeat PCI by 44% and MACE by 32% • Over mean follow-up of 2 years, there was no difference between groups for MI, TVR, or stent thrombosis, but multivessel PCI lowered mortality by 33%, repeat PCI by 43%, and MACE by 40% Implications: A large-scale randomized trial is needed to evaluate comparative efficacy between multivessel revascularization and a culprit-only strategy. Bangalore S, et al. Am J Cardiol. 2011;Epub ahead of print.
  • 23. 55 YO male, initial presentation of CAD Anterior STEMI – 6 hours of chest pain  ECG: Ant. ST Elevation with RBBB  100/70, pulse 95, O2Sat =96% BP .T otal LAD • Culprit • >90% Prox. CX • Dominant • 50% Left Main Small (non dominant) RCA
  • 24. 55YO male, initial presentation of CAD Anterior STEMI – 6 hours of chest pain  ECG: Ant. ST Elevation with RBBB  100/70, pulse 95, O2Sat =96% BP What to do? 1. Culprit only (LAD) 2. LAD and CX 3. LAD now and CX later (Staging) • When? 4. Other Small (non dominant) RCA
  • 25. Why to perform non-culprit PCI • Improve hemodynamics – Hypercontraction of non-infarct territory (especially important in patients with cardiogenic shock) • Prevent reinfarction – Vulnerable non-culprit lesion can become culprit (“pan-coronary inflammation”) • Patient is already receiving aggressive antithrombotic therapy – Protected from complications? • Decrease the need for repeat procedures – Associated morbidity and cost
  • 26. Why not to perform nonculprit PCI (1)  Ischemic complications may lead to severe hemodynamic compromise  There is already myocardial dysfunction secondary to the damage from the culprit  There is a risk of ischemic complication in every PCI  Risk is higher in the setting of MI due to the generalized inflammatory condition  Risk of transformation to culprit during hospitalization is extremely low  Patient receiving aggressive adjunct therapy
  • 27. Why not to perform nonculprit PCI (2)  Contrast nephropathy  Increased contrast load in the setting of unknown kidney function in a patient with decreased renal blood flow (due to the infarction)  Non culprit lesion may not be associated with future symptoms/ ischemia  Overestimation of severity at time of acute angiography?
  • 28. US National Cardiovascular Data Registry - STEMI Single vs. Multivessel Procedures during Primary PCI Hospital Mortality Unadjusted Data % death P= 0.01 Guidelines not necessarily supported by literature P< 0.01 Cavender et al. Am J Cardiol 2009
  • 29.  Four prospective and 14 retrospective studies involving 40,280 patients were included  Pairwise comparison among 3 post culprit PCI strategies: 1. Culprit only 2. Staged revascularization 3. Complete revascularization J Am Coll Cardiol 2011;58:692–703
  • 30. Short Term Mortality – Pairwise Meta-Analysis Prospective RCT Registry Prospective and retrospective data lead to different results Suggestive of significant selection bias Combined Culprit Multivessel
  • 31. Conclusions  Retrospective studies are strongly limited by selection bias and prospective randomized studies are small and inconclusive  Staged revascularization emerges as the preferred approach for stable patients  Non-culprit revascularization strategy should be individualized based on patient‟s characteristics
  • 32. Back to the Patient “individualized” decision for this patient:  Stent the non-culprit first to enable safer treatment of the LAD lesion  Limited reserve due to the specific anatomy
  • 33. Final Result
  • 34. Thanks