Effectiveness of Paclitaxel-Eluting Stents in Complex Clinical Patients - Insights From the TAXUS Japan Postmarket Surveillance Study -

BACKGROUND: The TAXUS Japan Postmarket Surveillance Study (TAXUS-PMS) enrolled patients receiving percutaneous coronary intervention in real-world clinical practice. This analysis focuses on outcomes in the overall patient population and in a subgroup of diabetic patients. METHODS AND RESULTS: Between July 2007 and December 2008, 2,132 patients (with 2,504 lesions) were consecutively enrolled at 56 sites in Japan. One-year outcomes were analyzed. The prevalence of patients with diabetes was 44% (21% of diabetics were insulin-treated) and 5.5% of patients were receiving ongoing hemodialysis. The majority of patients received paclitaxel-eluting stents (PES) for `off-label' indications (68.2%). The rate of major adverse cardiovascular events (cardiac death, myocardial infarction, and target vessel revascularization (TVR)) at 1 year was 8.2%, driven mainly by TVR (6.9%). No differences in TVR, late loss or restenosis rates were found between diabetic and non-diabetic patients; outcomes in insulin- compared with oral hypoglycemic-treated diabetic patients, were similar. Multiple stent implantation and ostial lesion location were independent predictors for both major adverse cardiac events (MACE) and target lesion revascularization (TLR). Hemodialysis was an independent predictor for MACE but not TLR whereas in-stent restenosis was an independent predictor for TLR. CONCLUSIONS: TAXUS-PMS demonstrated a consistent, positive effect of PES in complex clinical cases. PES diminished the increased risk of clinical restenosis in diabetic patients, leading to a similar low risk of cardiac events in diabetic and non-diabetic patients.