DES Reduce Repeat Revascularization in Saphenous Vein Grafts

April 4, 2011 (New Orleans, Louisiana) — Drug-eluting stents (DES) reduced repeat revascularization compared with bare-metal stents in saphenous vein grafts (SVGs) in the Is Drug-Eluting Stenting Associated With Improved Results in Coronary Artery Bypass Grafts (ISAR CABG) trial [1].

Dr Julinda Mehilli (Technische Universität Munich, Germany) presented results of the 610-patient, four-center trial this morning at the American College of Cardiology 2011 Scientific Sessions. In the trial, patients with at least one lesion in a previously implanted saphenous vein bypass graft were randomized to receive a drug-eluting stent or a bare-metal stent. Patients in the DES group received a paclitaxel-eluting, sirolimus-eluting, or bioabsorbable polymer sirolimus-eluting stent.

Mehilli characterized the patients in the study as "high risk." About 85% of the patients were male, with an average age of 71.5 years. The average age of the SVGs was 13 years, just over half of the patients had a previous MI, and over one-third had diabetes.

At one-year postintervention, the DES group had a 35% lower incidence of the primary end point--a composite of death, MI, and target lesion revascularization--than patients treated with a bare-metal stent (16.5% vs 22.1%, p=0.028). The difference was almost entirely driven by the reduction of target lesion revascularization (7.2% vs 12.9%, p=0.020). There were no statistically significant differences in the individual rates of death or MI.

There was only one confirmed stent thrombosis in the DES patients and zero in the bare-metal stent patients. There were no significant differences in outcomes with the different types of DES. The investigators are planning further subgroup analysis on the types of SVGs treated and concomitant drug therapy, she said.

ISAR-CABG trial was designed to compare DES and bare-metal stents in SVGs with a large enough study population to provide information on clinical end points, Mehilli explained. Although many interventionalists already use DES in SVGs, most drug-eluting-stent trials have excluded SVGs, and the only two previous randomized trials of comparing DES and bare-metal stents in SVGs were very small and produced conflicting mortality results, she said. The Death and Events at Long-term Follow-up Analysis: Extended Duration of RRISC (DELAYED RRISC) showed worse mortality with sirolimus-eluting stents than with bare-metal stents in 75 patients with SVG disease. However, recently published results of the 88-patient Stenting of Saphenous Vein Grafts (SOS) trial found that paclitaxel-eluting stents reduced revascularization compared with bare-metal stents with no difference in mortality over a median follow-up of 35 months [1].

Mehilli disclosed that she has earned lecture fees from Abbott Vascular.