Rates of cardiac death, myocardial infarction (MI), or target lesion revascularization (TLR) in patients with acute ST-elevation MI (STEMI) who were treated with paclitaxel-eluting stents (PES) were similar in those who were treated with bare-metal stents (BMS) at 5 years. However, there was a trend toward a higher rate of late stent thrombosis (30 days to 5 years) after treatment with PES. Maarten A. Vink, MD, OLVG Hospital, Amsterdam, The Netherlands, presented findings from the 5-year clinical follow-up of the PASSION (Paclitaxel-Eluting Stent versus Bare-Metal Stent in Acute ST-Elevation Myocardial Infarction) Trial.

Many current guidelines do not consistently support the use of DES in primary percutaneous coronary intervention (PCI) for STEMI due to the lack of long-term outcome trial data. The prospective, randomized, singleblind PASSION trial set out to address the concern of late and very late stent thrombosis that is related to DES use over a 5-year follow-up period. It is the first large-scale randomized study that compared PES with BMS in an exclusively STEMI population.

PASSION included 619 consecutive patients with STEMI who were eligible for primary PCI with stenting. In the interest of focusing on a real-world population, trial exclusion was limited to cardiogenic shock prior to randomization, failed fibrinolysis, expected mortality of <6 months, and mechanical ventilation at presentation. Clinical follow-up occurred at 6, 12, 24, and 60 months. Routine angiographic follow-up was not performed. Patients were randomized to receive either PES (n=310) or BMS (n=309), and all patients received concomitant clopidogrel (300-mg loading dose followed by 75 mg daily for ≥6 months) and aspirin (100- to 500-mgmg loading dose followed by 80 to 100 mg daily indefinitely) postprocedure. GP IIb/IIIa receptor blockers were administered at the discretion of the treating physician, as were thrombus aspiration and direct stenting. The groups were well matched at baseline. The mean age was 61 years, and follow-up of all patients was obtained at 5 years.

The primary endpoint was the composite of death, reinfarction, or TLR (within 5 mm of stent edges) at 5 years. The secondary endpoints included major adverse cardiac events (MACE) at 5 years, individual components of MACE, and stent thrombosis. There was no significant difference in the occurrence of the composite primary endpoint at 5 years, nor was there any difference in the individual components (cardiac death, recurrent MI, or TLR) of the primary endpoint between the two groups. Additionally, there was no significant difference in the occurrence of individual MACE between the two groups. However, there was a slightly higher risk of very late stent thrombosis (1 to 5 years) that was associated with PES (2.5% for PES vs 0.7% for BMS). The rate of definite stent thrombosis at 5 years was 2-fold higher in the PES group (HR, 1.98; 95% CI, 0.67 to 5.79; p=0.20).

Results from the PASSION trial indicate that the long-term risk of cardiac death, MI, or TLR is similar for PES and BMS. The risk of late stent thrombosis is increased slightly with PES, and this risk appears to persist over time. Therefore, clinicians may want to consider the risk versus benefit of PES when choosing a treatment strategy for patients with acute STEMI.