PASSION Follow-Up Data Compare PES and BMS to Treat STEMI at 5 Years

January 19, 2011—Results from a 5-year follow-up study of the PASSION (Paclitaxel-Eluting Versus Conventional Stent in Myocardial Infarction With ST-Segment Elevation) trial were published by Maarten A. Vink, MD, et al in the Journal of the American College of Cardiology: Cardiovascular Interventions (2011;4:24–29).

According to the investigators, the background of the study is that the use of drug-eluting stents is still controversial in primary percutaneous coronary intervention for acute ST-segment elevation myocardial infarction (STEMI). In several randomized controlled trials of drug-eluting stents compared with bare-metal stents (BMS), short-term follow-up showed a reduction in target lesion revascularization (TLR), but no differences in the rates of cardiac death or recurrent myocardial infarction. Also, the occurrence of very late stent thrombosis continues to be of major concern; therefore, long-term follow-up results are needed.

In the present analysis of paclitaxel-eluting stents (PES) compared with BMS in percutaneous coronary intervention for STEMI, the investigators found that there was no significant difference in major adverse cardiac events and no difference in the incidence of definite or probable stent thrombosis; however, very late stent thrombosis was almost exclusively seen after the use of PES.

In the PASSION trial, 619 patients presenting with STEMI were randomly assigned to PES or BMS. The primary endpoint was the composite of cardiac death, recurrent myocardial infarction, or TLR.

The investigators reported that at 5 years, the occurrence of the primary endpoint was comparable for PES and BMS (18.6% vs 21.8%; hazard ratio, 0.82; 95% confidence interval, 0.58–1.18; P = .28). The incidence of definite or probable stent thrombosis was 4.2% in the PES group and 3.4% in the BMS group (hazard ratio, 1.19; 95% confidence interval, 0.51–276; P = .68).