Drug-Eluting Versus Bare-Metal Stents in Saphenous Vein Graft Lesions (ISAR-CABG): A Randomised Controlled Superiority Trial
What is the comparative efficacy of drug-eluting stents (DES) and bare-metal stents (BMS) in patients with de-novo saphenous vein graft lesions?
In this randomized superiority trial, patients with de-novo saphenous vein graft lesions were assigned by computer-generated sequence (1:1:1:3) to receive either DES (one of three types: permanent-polymer paclitaxel-eluting stents, permanent-polymer sirolimus-eluting stents, or biodegradable-polymer sirolimus-eluting stents) or BMS. Randomization took place immediately after crossing of the lesion with a guidewire, and was stratified for each participating center. 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 revascularization (TLR) at 1 year. Analysis was by intention to treat. Hazard ratios (HRs), confidence intervals (CIs), and p values were calculated from univariate Cox proportional hazards models.
A total of 610 patients were allocated to treatment groups (303 DES, 307 BMS). DES reduced the incidence of the primary endpoint compared with BMS (44 [15%] vs. 66 [22%] patients; hazard ratio [HR], 0.64; 95% CI, 0.44-0.94; p = 0.02). TLR rate was reduced by DES (19 [7%] vs. 37 [13%] patients; HR, 0.49; 95% CI, 0.28-0.86; p = 0.01). No significant differences were seen between DES and BMS 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).
The authors concluded that in patients undergoing percutaneous coronary intervention for de-novo saphenous vein graft lesions, DES are the preferred treatment option because they reduce the risk of adverse events compared with BMS.
In this multicenter randomized trial, the incidence of the primary composite endpoint of death, myocardial infarction, and TLR was lower with DES than with BMS when used in saphenous vein graft lesions. This benefit was primarily due to the significant reduction of TLR by DES. The results of this trial suggest that DES might be as useful for treatment of saphenous vein graft failures as they are for lesions of native coronary vessels, and should be the preferred treatment option. Some previously published data have suggested an erosion of the antirestenotic effect of DES at long-term follow-up when used to treat saphenous vein graft lesions, and additional studies with longer-term follow-up are indicated to ascertain the durability of the benefit of DES when used for vein graft lesions.
Keywords: Incidence, Myocardial Infarction, Follow-Up Studies, Drug-Eluting Stents, Polymers, Saphenous Vein, Coronary Vessels, Coronary Artery Bypass, Stents, Percutaneous Coronary Intervention
< Back to Listings