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

• Published in: The Lancet (British edition) Vol. 378; no. 9796; pp. 1071 - 1078
• Main Authors: Mehilli, Julinda, Prof, Pache, Jürgen, MD, Abdel-Wahab, Mohamed, MD, Schulz, Stefanie, MD, Byrne, Robert A, MB BCh, Tiroch, Klaus, MD, Hausleiter, Jörg, MD, Seyfarth, Melchior, Prof, Ott, Ilka, MD, Ibrahim, Tareq, MD, Fusaro, Massimiliano, MD, Laugwitz, Karl-Ludwig, Prof, Massberg, Steffen, Prof, Neumann, Franz-Josef, Prof, Richardt, Gert, Prof, Schömig, Albert, Prof, Kastrati, Adnan, MD
• Format: Journal Article
• Language: English
• Published: Kidlington Elsevier Ltd 17.09.2011; Elsevier; Elsevier Limited
• Subjects: Absorbable Implants; Acute coronary syndromes; Aged; Angioplasty, Balloon, Coronary; Biodegradation; Biological and medical sciences; Blood clots; Coronary Artery Bypass; Coronary vessels; Data collection; death; Design; Drug-Eluting Stents - adverse effects; Female; General aspects; Graft Occlusion, Vascular - surgery; Humans; Internal Medicine; Intervention; Lesions; Male; Medical imaging; Medical sciences; Metals; Mortality; Myocardial infarction; Paclitaxel; patients; Polymers; Radiotherapy. Instrumental treatment. Physiotherapy. Reeducation. Rehabilitation, orthophony, crenotherapy. Diet therapy and various other treatments (general aspects); risk; Risk reduction; saphenous vein; Saphenous Vein - pathology; Saphenous Vein - surgery; Saphenous Vein - transplantation; Side effects; Sirolimus; Stents; Stents - adverse effects; Thromboembolism; thrombosis; Veins & arteries; Medicine; Saphenous vein; Instrumentation therapy; Clinical trial; Graft; Lesion; Metal; Drug eluting stent; Randomized controlled trial; Comparative study
• ISSN: 0140-6736; 1474-547X
• DOI: 10.1016/S0140-6736(11)61255-5

Summary 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 stratified 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 significant differences 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 definite 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.