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Long-Term Results After Drug-Eluting Versus Bare-Metal Stent Implantation in Saphenous Vein Grafts: Randomized Controlled Trial

Fahrni, Gregor and Farah, Ahmed and Engstrøm, Thomas and Galatius, Søren and Eberli, Franz and Rickenbacher, Peter and Conen, David and Mueller, Christian and Pfister, Otmar and Twerenbold, Raphael and Coslovsky, Michael and Cattaneo, Marco and Kaiser, Christoph and Mangner, Norman and Schuler, Gerhard and Pfisterer, Matthias and Möbius-Winkler, Sven and Jeger, Raban V. and Basket‐Savage‐Investigators*, . (2020) Long-Term Results After Drug-Eluting Versus Bare-Metal Stent Implantation in Saphenous Vein Grafts: Randomized Controlled Trial. Journal of the American Heart Association Cardiovascular and Cerebrovascular , 9 (20). e017434.

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Abstract

Background Efficacy data on drug-eluting stents (DES) versus bare-metal stents (BMS) in saphenous vein grafts are controversial. We aimed to compare DES with BMS among patients undergoing saphenous vein grafts intervention regarding long-term outcome. Methods and Results In this multinational trial, patients were randomized to paclitaxel-eluting or BMS. The primary end point was major adverse cardiac events (cardiac death, nonfatal myocardial infarction, and target-vessel revascularization at 1 year. Secondary end points included major adverse cardiac events and its individual components at 5-year follow-up. One hundred seventy-three patients were included in the trial (89 DES versus 84 BMS). One-year major adverse cardiac event rates were lower in DES compared with BMS (2.2% versus 16.0%, hazard ratio, 0.14; 95% CI, 0.03-0.64,; P; =0.01), which was mainly driven by a reduction of subsequent myocardial infarctions and need for target-vessel revascularization. Five-year major adverse cardiac event rates remained lower in the DES compared with the BMS arm (35.5% versus 56.1%, hazard ratio, 0.40; 95% CI, 0.23-0.68,; P; <0.001). A landmark-analysis from 1 to 5 years revealed a persistent benefit of DES over BMS (hazard ratio, 0.33; 95% CI, 0.13-0.74,; P; =0.007) in terms of target-vessel revascularization. More patients in the BMS group underwent multiple target-vessel revascularization procedures throughout the study period compared with the DES group (DES 1.1% [n=1] versus BMS 9.5% [n=8],; P; =0.013). Enrollment was stopped before the target sample size of 240 patients was reached. Conclusions In this randomized controlled trial with prospective long-term follow-up of up to 5 years, DES showed a better efficacy than BMS with sustained benefits over time. DES may be the preferred strategy in this patient population. Registration URL: https://www.clini​caltr​ials.gov; Unique identifier: NCT00595647.
Faculties and Departments:03 Faculty of Medicine > Bereich Medizinische Fächer (Klinik) > Kardiologie
03 Faculty of Medicine > Departement Klinische Forschung > Bereich Medizinische Fächer (Klinik) > Kardiologie
03 Faculty of Medicine > Bereich Medizinische Fächer (Klinik) > Kardiologie > Klinische Outcomeforschung Kardiologie (Müller)
03 Faculty of Medicine > Departement Klinische Forschung > Bereich Medizinische Fächer (Klinik) > Kardiologie > Klinische Outcomeforschung Kardiologie (Müller)
UniBasel Contributors:Fahrni, Gregor and Conen, David and Müller, Christian and Pfister, Otmar and Twerenbold, Raphael and Coslovsky, Michael and Kaiser, Christoph A. and Jeger, Raban
Item Type:Article, refereed
Article Subtype:Research Article
Publisher:American Heart Association
ISSN:2047-9980
Note:Publication type according to Uni Basel Research Database: Journal article
Language:English
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Last Modified:15 Mar 2022 13:31
Deposited On:15 Mar 2022 13:31

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