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Patient-Level Analysis of Bare-Metal Stents vs. Drug-Eluting Stents - Patient-Level Analysis of Bare-Metal Stents vs. Drug-Eluting Stents - Presented at TCT 2006
Description:
The goal of the study was to evaluate stent thrombosis among patients undergoing percutaneous coronary intervention (PCI) with bare-metal stents (BMS) compared with drug-eluting stents (DES).
Study Design
Study Design:
Drug/Procedures Used:
Data were drawn from nine randomized trials of BMS compared with DES. Patient-level data were obtained from the device companies who sponsored the trials. Endpoints evaluated were stent thrombosis, death, Q-wave myocardial infarction (MI), and the composite of death or Q-wave MI. Trials included in the meta-analysis were RAVEL, SIRIUS, ESIRIUS, and C-SIRIUS (sirolimus-eluting stents [SES]; n = 878 for SES and n = 870 for BMS) and TAXUS I, II, IV, V, and VI (paclitaxel-eluting stents [PES]; n = 1,755 for PES and n = 1,758 for BMS).
Principal Findings:
Among the SES trials, total stent thrombosis occurred in 1.2% of SES patients and 0.6% of BMS patients (relative risk [RR] 2.0, p = 0.20). Late stent thrombosis (occurring ≥1 year) was significantly higher with SES versus BMS (0.6% vs. 0%, p = 0.025). Among the PES trials, total stent thrombosis occurred in 1.3% of PES patients and 0.9% of BMS patients (RR 1.44, p = 0.30). Late stent thrombosis (occurring ≥1 year) was significantly higher with PES versus BMS (0.7% vs. 0.2%, p = 0.028).
Total mortality was reported in 6.7% of SES patients compared with 5.3% of BMS patients (RR 1.27, p = 0.23) and 6.1% of PES patients compared with 6.6% of BMS patients (RR 0.94, p = 0.68). Cardiac death was reported in 3.5% of SES patients compared with 2.7% of BMS patients (RR 1.26, p = 0.40) and 2.4% of PES patients compared with 3.0% of BMS patients (RR 0.86, p = 0.51); for noncardiac death, the rates were 3.3% of SES patients compared with 2.7% of BMS patients (RR 1.27, p = 0.40) and 3.8% of PES patients compared with 3.7% of BMS patients (RR 1.01, p = 0.98). Death or Q-wave MI was reported in 8.2% of SES patients compared with 6.4% of BMS patients (RR 1.30, p = 0.14) and 7.3% of PES patients compared with 7.5% of BMS patients (RR 0.99, p = 0.93).
Interpretation:
Among patients undergoing PCI for de novo coronary lesions, DES were associated with significantly higher rates of late stent thrombosis but no excess in mortality compared with BMS in this patient-level analysis of nine trials of the PES and SES.
Death or Q-wave MI did not differ between PES versus BMS or SES versus BMS in the present analysis, unlike a recent meta-analysis presented at the European Society of Cardiology (ESC) meeting that showed higher rates of death or Q-wave MI with SES. Additionally, data in the present study are unlike another meta-analysis of 17 randomized trials by Nordmann et al., in which noncardiac death was significantly higher with SES than BMS by 2 years (odds ratio [OR] 2.74, 95% confidence interval [CI] 1.22-6.13). Unlike the prior meta-analysis that included all 17 trials that had been published or presented to date, the present analysis included only nine trials. Given the large number of patients treated with DES annually (estimated at ~1 million per year), even a small excess in stent thrombosis with DES can have large, long-term clinical implications.
References:
Stone GW, Moses JW, Ellis SG, et al. Safety and efficacy of sirolimus- and paclitaxel-eluting coronary stents. N Engl J Med 2007;356:998-1008.
Presented by Drs. Gregg W. Stone and Marty Leon at the Transcatheter Cardiovascular Therapeutics meeting (TCT 2006), Washington, DC, October 2006.
Keywords: Odds Ratio, Myocardial Infarction, Neoplasms, Angina, Stable, Drug-Eluting Stents, Death, Sudden, Sirolimus, Angioplasty, Balloon, Coronary, Thienopyridines, Paclitaxel, Taxus, Public Health, Biomarkers, Confidence Intervals, Coronary Thrombosis, Risk Assessment, Troponin
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