PRAMI Trial – Review

PRAMI Trial – Review


Preventive Angioplasty in Myocardial Infarction Trial (PRAMI) was conducted at five centres in the United Kingdom between 2008 and 2013. The study enrolled 465 patients with acute ST elevation myocardial infarction (STEMI) including 3 with left bundle branch block. Patients undergoing infarct related artery or culprit artery percutaneous intervention were randomized to either preventive PCI or no preventive PCI [1]. After primary PCI, subsequent PCI was recommended only for refractory angina with objective evidence of myocardial ischemia. Primary outcome measure in the PRAMI trial was a composite of death from cardiac causes, non fatal myocardial infarction or refractory angina. Patients with cardiogenic shock, previous coronary artery bypass graft (CABG) or candidates for CABG and those with only an additional chronic total occlusion were excluded from the study.

The trial was stopped prematurely by the data and safety monitoring committee as conclusive evidence was obtained. Primary outcome occurred in 21 patients in the preventive PCI group and 53 patients in the no preventive PCI group, during a mean follow up of 23 months. The study authors concluded that in STEMI patients with multivessel coronary artery disease, preventive PCI in non infarct coronary arteries with major stenosis significantly reduced the risk of adverse cardiovascular events.

It may be noted that as per study protocol, there was no option for a staged PCI for the non infarct related arteries in the study. Repeat PCI was only driven by refractory angina with objective evidence of myocardial ischemia. The analysis was on intention to treat basis. There was an absolute reduction of 14% and relative reduction of 65% in the primary outcome measures of the trial. The results of as treated analysis were similar to those of intention to treat analysis in this study.

Another prior study had evaluated staged PCI option in addition to culprit vessel PCI and immediate multivessel PCI. That study had lesser number of patients (263) and concluded that culprit vessel only PCI had the highest rate of long term major adverse cardiovascular events (MACE). Patients scheduled for staged PCI had MACE rates similar to those undergoing simultaneous PCI of non infarct related artery [2].

A systematic review of multi vessel versus culprit vessel only revascularization in STEMI with multivessel coronary artery disease has been published [3]. They noted that multivessel disease may be present in about half of patients with STEMI. This meta-analysis included 10 randomized controlled trials representing 7,030 patients. There was no significant difference in the all cause mortality between the two study groups. There was lower risk for cardiovascular mortality and repeat revascularization with multivessel PCI. Major bleeding, stroke and contrast induced nephropathy were not significantly different between the two groups. Multivessel PCI was associated with a 31% lower risk of re-infarction with no significant difference in all cause mortality. But this does not apply to those in cardiogenic shock as CULPRIT-SHOCK trial had shown increased mortality with multivessel PCI [4].

References

  1. Wald DS, Morris JK, Wald NJ, Chase AJ, Edwards RJ, Hughes LO, Berry C, Oldroyd KG; PRAMI Investigators. Randomized trial of preventive angioplasty in myocardial infarction. N Engl J Med. 2013 Sep 19;369(12):1115-23.
  2. Politi L, Sgura F, Rossi R, Monopoli D, Guerri E, Leuzzi C, Bursi F, Sangiorgi GM, Modena MG. A randomised trial of target-vessel versus multi-vessel revascularisation in ST-elevation myocardial infarction: major adverse cardiac events during long-term follow-up. Heart. 2010 May;96(9):662-7.
  3. Atti V, Gwon Y, Narayanan MA, Garcia S, Sandoval Y, Brilakis ES, Basir MB, Turagam MK, Khandelwal A, Mena-Hurtado C, Mamas MA, Abbott JD, Bhatt DL, Velagapudi P. Multivessel Versus Culprit-Only Revascularization in STEMI and Multivessel Coronary Artery Disease: Meta-Analysis of Randomized Trials. JACC Cardiovasc Interv. 2020 Jul 13;13(13):1571-1582.
  4. Thiele H, Akin I, Sandri M, Fuernau G, de Waha S, Meyer-Saraei R, Nordbeck P, Geisler T, Landmesser U, Skurk C, Fach A, Lapp H, Piek JJ, Noc M, Goslar T, Felix SB, Maier LS, Stepinska J, Oldroyd K, Serpytis P, Montalescot G, Barthelemy O, Huber K, Windecker S, Savonitto S, Torremante P, Vrints C, Schneider S, Desch S, Zeymer U; CULPRIT-SHOCK Investigators. PCI Strategies in Patients with Acute Myocardial Infarction and Cardiogenic Shock. N Engl J Med. 2017 Dec 21;377(25):2419-2432.
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