PRAMI Shows Preventive PCI Reduces MI Risk by 65%

September 2, 2013—The European Society of Cardiology (ESC) announced that Principal Investigator David Wald, MD, presented results from the PRAMI study (Preventive Angioplasty in Myocardial Infarction), which found that preventive percutaneous coronary intervention (PCI) in addition to infarct-only PCI resulted in a 65% risk reduction in adverse cardiovascular events. The study was presented at the ESC Congress 2013, held August 31 to September 4 in Amsterdam, the Netherlands. They were published online ahead of print in in the New England Journal of Medicine (2013;369:1115–1123). 

In the ESC press release, Dr. Wald commented, “The results of this trial are new. They help resolve a clinical dilemma which regularly confronts doctors who treat patients with a heart attack. The initial costs of preventive PCI are higher, but there will be reduced costs thereafter, with a reduced need for subsequent hospital admissions, cardiac investigations, and revascularization procedures.”

Dr. Wald advised that current guidelines recommend infarct-artery PCI for ST-segment elevation myocardial infarction (STEMI) patients, not preventive PCI in other partially blocked vessels. This is because the evidence in favor of preventive PCI is lacking, which has led to variations in practice.

As summarized by the ESC announcement, the PRAMI trial sought to guide practice in this area. Its primary endpoint was a composite of cardiac deaths, non-fatal MI or refractory angina. The study recruited 465 patients from five acute cardiaccenters in the United Kingdom. All were STEMI patients having infarct-artery PCI who, after completion of the procedure, were randomly assigned to either preventive PCI (n = 234) or no further PCI (n = 231).

Patients were considered for eligibility during catheterization. They were deemed eligible if the infarct artery had been treated successfully and there was stenosis of 50% or more in one or more coronary arteries, other than the infarct artery, and the stenosis was deemed treatable by PCI. Staged PCI in patients with angina was discouraged.

The Data Monitoring Committee stopped the trial early when a planned interim analysis showed a clear benefit in favor of preventive PCI.

After a mean follow-up of 23 months, results showed the primary outcome occurred in 21 patients assigned to preventive PCI and in 53 patients assigned to no preventive PCI, an absolute risk reduction of 14 per 100 patients in the preventive PCI group (hazard ratio, 0.35; P < .001) and a relative risk reduction of 65%.

The relative risk reduction was similar (64%) even when the analyses were limited to cardiac death and non-fatal MI—in which case, the primary outcome occurred in 11 of those patients assigned to preventive PCI and in 27 assigned to no preventive PCI.

“The results of this trial show that in this situation, preventive PCI reduces the risk of cardiac death, a subsequent myocardial infarction, or angina resistant to medical therapy by about two-thirds,” concluded Dr. Wald.