Drug-eluting vs bare-metal stents in primary angioplasty: a pooled patient-level meta-analysis of randomized trials

• Published in: Archives of internal medicine (1960) Vol. 172; no. 8; p. 611
• Main Authors: De Luca, Giuseppe, Dirksen, Maurits T, Spaulding, Christian, Kelbaek, Henning, Schalij, Martin, Thuesen, Leif, van der Hoeven, Bas, Vink, Marteen A, Kaiser, Christoph, Musto, Carmine, Chechi, Tania, Spaziani, Gaia, Díaz de la Llera, Luis Salvador, Pasceri, Vincenzo, Di Lorenzo, Emilio, Violini, Roberto, Cortese, Giuliana, Suryapranata, Harry, Stone, Gregg W
• Format: Journal Article
• Language: English
• Published: United States 23.04.2012
• Subjects: Angioplasty, Balloon, Coronary - methods; Drug-Eluting Stents - adverse effects; Heart Conduction System - physiopathology; Humans; Incidence; Myocardial Infarction - epidemiology; Myocardial Infarction - etiology; Myocardial Infarction - mortality; Myocardial Infarction - physiopathology; Myocardial Infarction - surgery; Myocardial Infarction - therapy; Myocardial Revascularization - statistics & numerical data; Odds Ratio; Paclitaxel - adverse effects; Proportional Hazards Models; Randomized Controlled Trials as Topic; Recurrence; Risk Factors; Sirolimus - adverse effects; Stents - adverse effects; Thrombosis - chemically induced; Thrombosis - epidemiology; Thrombosis - etiology; Time Factors
• ISSN: 1538-3679
• DOI: 10.1001/archinternmed.2012.758

Concerns have emerged regarding a higher risk of stent thrombosis after drug-eluting stent (DES) implantation, especially in the setting of ST-segment elevation myocardial infarction (STEMI). Our objective was to perform a meta-analysis using individual patient data to evaluate the long-term safety and effectiveness of DES compared with bare-metal stents (BMS) in patients undergoing primary percutaneous coronary intervention for STEMI. Formal searches of electronic databases (MEDLINE and CENTRAL) and scientific session presentations from January 2000 to June 2011. We examined all completed randomized trials of DES for STEMI. Individual patient data. Individual patient data were obtained from 11 of 13 trials identified, including a total of 6298 patients (3980 [63.2%] randomized to DES [99% sirolimus-eluting or paclitaxel-eluting stents] and 2318 [36.8%] randomized to BMS). At long-term follow-up (mean [SD], 1201 [440] days), DES implantation significantly reduced the occurrence of target-vessel revascularization (12.7% vs 20.1%; hazard ratio [95% CI], 0.57 [0.50-0.66]; P < .001, P value for heterogeneity, .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. The present pooled patient-level meta-analysis demonstrates that among patients with STEMI undergoing primary percutaneous coronary intervention, sirolimus-eluting and paclitaxel-eluting stents compared with BMS are associated with a significant reduction in target-vessel revascularization at long-term follow-up. Although there were no differences in cumulative mortality, reinfarction, or stent thrombosis, the incidence of very late reinfarction and stent thrombosis was increased with these DES.