5-Year Follow-Up After Primary Percutaneous Coronary Intervention With a Paclitaxel-Eluting Stent Versus a Bare-Metal Stent in Acute ST-Segment Elevation Myocardial Infarction: A Follow-Up Study of the PASSION (Paclitaxel-Eluting Versus Conventional Stent in Myocardial Infarction With ST-Segment Elevation) Trial

Study Questions:

What are the long-term outcomes of the PASSION (Paclitaxel-Eluting Versus Conventional Stent in Myocardial Infarction With ST-Segment Elevation) trial?

Methods:

The investigators randomly assigned 619 patients presenting with ST-segment elevation myocardial infarction (STEMI) to a paclitaxel-eluting stent (PES) or a similar bare-metal stent (BMS). The primary endpoint was the composite of cardiac death, recurrent MI, or target lesion revascularization (TLR). They performed clinical follow-up at 5 years. Hazard ratios (HRs) with 95% confidence intervals (CIs) were calculated with Cox proportional-hazards models with treatment allocation as the only variable.

Results:

At 5 years, the occurrence of the composite of cardiac death, recurrent MI, or TLR was comparable at 18.6% versus 21.8% in PES and BMS, respectively (HR, 0.82; 95% CI, 0.58-1.18; p = 0.28). The incidence of definite or probable stent thrombosis was 12 (4.2%) in the PES group and 10 (3.4%) in the BMS group (HR, 1.19; 95% CI, 0.51-276; p = 0.68).

Conclusions:

The authors concluded that with PES compared with BMS in primary percutaneous coronary intervention (PCI) for STEMI, there were no significant differences in major adverse cardiac events (MACE).

Perspective:

The 5-year clinical follow-up of this prospective, randomized trial of DES in STEMI observed no significant difference in the occurrence of MACE and TLR in PES compared with BMS. Also, up to 5 years of follow-up, there were no differences in the occurrence of definite or probable stent thrombosis, although there might be a higher incidence of (very) late stent thrombosis using PES. It should be noted that the large (HORIZONS-AMI) trial had demonstrated that implantation of PES for primary PCI, as compared with BMS, significantly reduced angiographic evidence of restenosis and recurrent ischemia, necessitating repeat revascularization procedures. The present analysis provides additional long-term efficacy and safety data on DES in primary PCI, but the possibility of a higher risk of very late stent thrombosis in PES needs to be evaluated in further clinical studies.

Clinical Topics: Invasive Cardiovascular Angiography and Intervention

Keywords: Paclitaxel, Incidence, Myocardial Infarction, Follow-Up Studies, Thrombosis, Stents, Percutaneous Coronary Intervention


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