Clinical Outcomes for Sirolimus-Eluting Stents and Polymer-Coated Paclitaxel-Eluting Stents in Daily Practice

• Published in: Journal of the American College of Cardiology 2006-10, Vol.48 (7), p.1312-1318
• Main Authors: Saia, Francesco, Piovaccari, Giancarlo, Manari, Antonio, Santarelli, Andrea, Benassi, Alberto, Aurier, Enrico, Sangiorgio, Pietro, Tarantino, Fabio, Geraci, Giuseppe, Vecchi, Giuseppe, Guastaroba, Paolo, Grilli, Roberto, Marzocchi, Antonio
• Format: Article
• Language: English
• ISSN: 0735-1097; 1558-3597
• DOI: 10.1016/j.jacc.2006.03.063

Clinical Outcomes for Sirolimus-Eluting Stents and Polymer-Coated Paclitaxel-Eluting Stents in Daily Practice: Results From a Large Multicenter Registry Francesco Saia, Giancarlo Piovaccari, Antonio Manari, Andrea Santarelli, Alberto Benassi, Enrico Aurier, Pietro Sangiorgio, Fabio Tarantino, Giuseppe Geraci, Giuseppe Vecchi, Paolo Guastaroba, Roberto Grilli, Antonio Marzocchi We compared the clinical outcome of sirolimus-eluting stents (SES) and polymer-coated paclitaxel-eluting stents (PES) in a real-world scenario. Overall, 1,676 consecutive patients with de novo coronary lesions treated with SES (n = 992) or PES (n = 684) were enrolled in a prospective multicenter registry. A considerable number of patients presented complex clinical, angiographic, and procedural characteristics. At 1-year follow-up, SES utilization reduced the risk of adverse events by 44% and the risk of new revascularizations by 55% compared to PES. This study suggests better clinical outcome of SES compared to PES in the treatment of real-world high-complex patients. We compared the clinical outcome of sirolimus-eluting stents (SES) and paclitaxel-eluting stents (PES) in a real-world scenario. In selected patients, SES has been associated with lower late luminal loss than PES. Whether this emerging biological difference could translate into different clinical efficacy in daily practice is presently unknown. This analysis included 1,676 consecutive patients with de novo coronary lesions treated solely with drug-eluting stents (SES = 992; PES = 684). All patients were enrolled in a dynamic prospective registry comprising 13 hospitals. We assessed the cumulative incidence of major adverse cardiac events (MACE), defined as death, myocardial infarction (MI), and target vessel revascularization (TVR) during follow-up. Overall, 29% of the patients had diabetes, 23% had prior MI, and 9% had poor left ventricular function. ST-segment elevation MI was diagnosed at admission in 12%. Multivessel intervention was performed in 16%. At 1-year follow-up, SES was associated with a reduced incidence of MACE (9.2% SES vs. 14.1% PES; p = 0.007) and TVR (5.0% SES vs. 10.0% PES; p = 0.0008) compared to PES. A propensity analysis with many clinical and angiographic variables was carried out to adjust for baseline differences. In this analysis, SES was associated with a 44% risk reduction of MACE (hazard ratio 0.56, 95% confidence interval 0.39 to 0.78) and a 55% reduction of TVR (hazard ratio 0.45, 95% c