Long-Term Results After Drug-Eluting Versus Bare-Metal Stent Implantation in Saphenous Vein Grafts: Randomized Controlled Trial
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Long-Term Results After Drug-Eluting Versus Bare-Metal Stent Implantation in Saphenous Vein Grafts : Randomized Controlled Trial. / Fahrni, Gregor; Farah, Ahmed; Engstrøm, Thomas; Galatius, Søren; Eberli, Franz; Rickenbacher, Peter; Conen, David; Mueller, Christian; Pfister, Otmar; Twerenbold, Raphael; Coslovsky, Michael; Cattaneo, Marco; Kaiser, Christoph; Mangner, Norman; Schuler, Gerhard; Pfisterer, Matthias; Möbius-Winkler, Sven; Jeger, Raban V; BASKET‐SAVAGE‐Investigators*.
I: Journal of the American Heart Association, Bind 9, Nr. 20, e017434, 2020.Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › fagfællebedømt
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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.clinicaltrials.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.clinicaltrials.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 -
ID: 261234375