022 Paclitaxel Eluting Stent use in everyday practice and impact of diabetes mellitus on safety and efficacy at 3 years

Abstract

ObjectivesWe sought to assess the efficacy and safety of the PES used in everyday practice in diabetic patients (DP) with single or multiple vessel disease compared to non-diabetic patients (NDP) over at least 3 years. Safety concerns about PES have been raised, particularly when used in less highly selected patients than those included in randomized trials and especially among DP.MethodsThe EVASTENT-Tax study is a multicenter matched cohort registry of 502 patients (pts) revascularised exclusively with paclitaxel stents (Taxus®). For each DP included a NDP patient was subsequently included. Patients were followed for at least 3 years (follow-up at 1 yr 98%, at ≥3 yrs 92%). The safety primary end point was a composite of cardiac death and nonfatal myocardial infarction (with or without stent thrombosis, according to Academic Research Consortium definitions), and for efficacy target lesion revascularisation (TLR). Target vessel revascularisation excluding TLR (TVR) and non TVR were also assessed.ResultsWe included 502 patients (mean age 70 years) presenting with ACS (52%) or a stable condition (48%), but not acute MI, of who 233 were diabetic and 381 (76%) were male. During follow-up 30 pts (6%) died, with cardiac death in 12 pts (2.4%). Nonfatal myocardial infarction occurred in 12 pts (2%). Stent thrombosis was noted in 15 pts (3%): 4 definite (3 acute), 6 probable (1 sub-acute), and 5 possible; 4 acute or sub acute, 4 late and 7 very late ST. At 3-years, the safety endpoint rate was significantly higher in diabetic than in non-diabetic patients (8% vs.1%, p≤0.001), whereas TLR was not significantly different.ConclusionsIn everyday practice the PES has a good efficacy with comparable clinical parameters for restenosis in DP and NDP at 3 years. PES are clinically safe, however the risk of paclitaxel stent thrombosis, including very late ST, is higher for DP