TY - JOUR

T1 - Long-Term Results After Drug-Eluting Versus Bare-Metal Stent Implantation in Saphenous Vein Grafts

T2 - Randomized Controlled Trial

AU - Fahrni, Gregor

AU - Farah, Ahmed

AU - Engstrøm, Thomas

AU - Galatius, Søren

AU - Eberli, Franz

AU - Rickenbacher, Peter

AU - Conen, David

AU - Mueller, Christian

AU - Pfister, Otmar

AU - Twerenbold, Raphael

AU - Coslovsky, Michael

AU - Cattaneo, Marco

AU - Kaiser, Christoph

AU - Mangner, Norman

AU - Schuler, Gerhard

AU - Pfisterer, Matthias

AU - Möbius-Winkler, Sven

AU - Jeger, Raban V

AU - BASKET‐SAVAGE‐Investigators

PY - 2020

Y1 - 2020

N2 - 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.

AB - 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.

KW - Aged

KW - Antineoplastic Agents, Phytogenic/therapeutic use

KW - Coronary Artery Bypass/adverse effects

KW - Drug-Eluting Stents/adverse effects

KW - Female

KW - Graft Occlusion, Vascular/diagnosis

KW - Humans

KW - Long Term Adverse Effects/diagnosis

KW - Male

KW - Myocardial Ischemia/diagnosis

KW - Paclitaxel/therapeutic use

KW - Percutaneous Coronary Intervention/instrumentation

KW - Reoperation/methods

KW - Saphenous Vein/transplantation

KW - Stents/adverse effects

KW - Treatment Outcome

KW - Vascular Grafting/instrumentation

U2 - 10.1161/JAHA.120.017434

DO - 10.1161/JAHA.120.017434

M3 - Journal article

C2 - 33032485

VL - 9

JO - Journal of the American Heart Association

JF - Journal of the American Heart Association

SN - 2047-9980

IS - 20

M1 - e017434

ER -