Drug-Eluting vs Bare-Metal Stents in Primary Angioplasty: A Pooled Patient-Level Meta-Analysis of Randomized Trials

Study Questions:

What is the long-term safety and effectiveness of drug-eluting stents (DES) compared with bare-metal stents (BMS) in patients undergoing primary percutaneous coronary intervention (PCI) for ST-segment elevation myocardial infarction (STEMI)?

Methods:

Formal searches of electronic databases (MEDLINE and CENTRAL) and scientific session presentations from January 2000 to June 2011 were performed. The authors examined all completed randomized trials of DES for STEMI and extracted individual patient data. The primary endpoint for the present study was mortality, whereas secondary endpoints were reinfarction, target-vessel revascularization (TVR), and stent thrombosis (definite or probable according to Academic Research Consortium [ARC] definitions) at long-term follow-up. Kaplan-Meier survival curves are presented with event rates reported as estimated probabilities.

Results:

Individual patient data were obtained from 11 of 13 trials identified, including a total of 6,298 patients (3,980 [63.2%] randomized to DES [99% sirolimus-eluting or paclitaxel-eluting stents] and 2,318 [36.8%] randomized to BMS). At long-term follow-up (mean [standard deviation], 1,201 [440] days), DES implantation significantly reduced the occurrence of TVR (12.7% vs. 20.1%; hazard ratio, 0.57; 95% confidence interval, 0.50-0.66; p < 0.001; p value for heterogeneity, 0.20), without any significant difference in terms of mortality, reinfarction, and stent thrombosis. However, DES implantation was associated with an increased risk of very late stent thrombosis and reinfarction.

Conclusions:

The authors concluded that among patients with STEMI undergoing primary PCI, DES compared with BMS is associated with a significant reduction in TVR at long-term follow-up.

Perspective:

This study reports that among patients with STEMI undergoing primary PCI, DES compared with BMS, siromimus-eluting stents, and paclitaxel-eluting stents are associated with significant and sustained reductions in TVR, without significant differences in stent thrombosis, reinfarction, or death. Reductions in TVR were noted with DES in both the early and very late periods. However, there was a significantly higher occurrence of very late reinfarction and stent thrombosis with these DES compared with BMS. Despite this, there were no significant differences in overall or very late mortality, with the point estimate favoring DES in all periods. DES should be the preferred stent for STEMI PCI as long as the patient is able to comply with prolonged dual antiplatelet therapy.

Clinical Topics: Invasive Cardiovascular Angiography and Intervention, Noninvasive Imaging, Interventions and Imaging, Angiography, Nuclear Imaging

Keywords: Paclitaxel, Myocardial Infarction, Coronary Angiography, Thrombosis, Drug-Eluting Stents, Cardiovascular Diseases, Confidence Intervals, Sirolimus, Angioplasty, Balloon, Coronary, Stents, Percutaneous Coronary Intervention, MEDLINE


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