Drug-eluting versus bare-metal stents in saphenous vein graft lesions (ISAR-CABG): A randomised controlled superiority trial

Julinda Mehilli, Jürgen Pache, Mohamed Abdel-Wahab, Stefanie Schulz, Robert A. Byrne, Klaus Tiroch, Jörg Hausleiter, Melchior Seyfarth, Ilka Ott, Tareq Ibrahim, Massimiliano Fusaro, Karl Ludwig Laugwitz, Steffen Massberg, Franz Josef Neumann, Gert Richardt, Albert Schömig, Adnan Kastrati

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168 Scopus citations

Abstract

Background Comparative assessment of clinical outcomes after use of drug-eluting stents versus bare-metal stents for treatment of aortocoronary saphenous vein graft lesions has not been undertaken in large randomised trials. We aimed to undertake a comparison in a randomised trial powered for clinical endpoints. Methods In this randomised superiority trial, patients with de-novo saphenous vein graft lesions were assigned by computer-generated sequence (1:1:1:3) to receive either drug-eluting stents (one of three types: permanent-polymer paclitaxel-eluting stents, permanent-polymer sirolimus-eluting stents, or biodegradable-polymer sirolimus-eluting stents) or bare-metal stents. Randomisation took place immediately after crossing of the lesion with a guidewire, and was stratifi ed for each participating centre. Investigators assessing data were masked to treatment allocation; patients were not masked to allocation. The primary endpoint was the combined incidence of death, myocardial infarction, and target lesion revascularisation at 1 year. Analysis was by intention to treat. This trial is registered at ClinicalTrials.gov, number NCT00611910. Findings 610 patients were allocated to treatment groups (303 drug-eluting stent, 307 bare-metal stent). Drug-eluting stents reduced the incidence of the primary endpoint compared with bare-metal stents (44 [15%] vs 66 [22%] patients; hazard ratio [HR] 0•64, 95% CI 0•44-0•94; p=0•02). Target lesion revascularisation rate was reduced by drug-eluting stents (19 [7%] vs 37 [13%] patients; HR 0•49, 95% CI 0•28-0•86; p=0•01). No signifi cant diff erences were seen between drug-eluting stents and bare-metal stents regarding all-cause mortality (15 [5%] vs 14 [5%] patients; HR 1•08, 95% CI 0•52-2•24; p=0•83), myocardial infarction (12 [4%] vs 18 [6%]; HR 0•66, 95% CI 0•32-1•37; p=0•27), or defi nite or probable stent thrombosis (2 [1%] in both groups; HR 1•00, 95% CI 0•14-7•10; p=0•99). Interpretation In patients undergoing percutaneous coronary intervention for de-novo saphenous vein graft lesions, drug-eluting stents are the preferred treatment option because they reduce the risk of adverse events compared with bare-metal stents. Funding Deutsches Herzzentrum.

Original languageEnglish
Pages (from-to)1071-1078
Number of pages8
JournalThe Lancet
Volume378
Issue number9796
DOIs
StatePublished - 17 Sep 2011

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