Polymer-free stents no better than durable-polymer stents in long run
Germany: Polymer-free versus durable polymer drug-eluting stent (DES) yielded no measurable differences at 10 years in patients with coronary artery disease (CAD), show results from ISAR-TEST-5 trial. The study, published in the Journal of the American College of Cardiology, found the incidence of stent thrombosis to be low and comparable in both the groups. Also, long-term adverse outcomes were similar for both groups.
There is a limited outcome data after extended long-term follow-up of patients with coronary artery disease treated with drug-eluting stents (DES) in CAD patients treated with DES in randomized clinical trials. Stenting done with polymer-free or durable polymer DES may yield performance differences that may emerge over time. Sebastian Kufner, Deutsches Herzzentrum München, Technische Universität München, Munich, Germany, and colleagues assessed the 10-year outcomes of patients enrolled in the ISAR-TEST-5 (Test Efficacy of Sirolimus- and Probucol-Eluting Versus Zotarolimus-Eluting Stents) trial.
3,002 patients (median age 67.8 years) were randomized to treatment with either polymer-free sirolimus- and probucol-eluting stents (n = 2,002) or durable polymer zotarolimus-eluting stents (n = 1,000)
The primary endpoint was the composite of cardiac death, target vessel-related myocardial infarction, or target lesion revascularization (a device-oriented composite endpoint [DOCE]).
Key findings of the study include:
- At 10 years, 63.9% of patients were alive.
- The rates of DOCE and POCE were high in both groups with no difference in the incidence between polymer-free sirolimus- and probucol-eluting stents and durable polymer zotarolimus-eluting stents (DOCE: 43.8% vs. 43.0%, respectively; hazard ratio: 1.01; POCE: 66.2% vs. 67.7%, respectively; hazard ratio: 0.94).
- The rates of the individual components of the composite endpoints were comparable in both groups.
- The incidence of definite/probable stent thrombosis over 10 years was low and comparable in both groups (1.6% vs. 1.9%; hazard ratio: 0.85).
"At 10 years, there were no measurable differences in outcomes between patients treated with polymer-free versus durable polymer DES. The incidence of stent thrombosis was low and comparable in both groups. High overall adverse clinical event rates were observed during extended follow-up," concluded the authors.
The study, "10-Year Outcomes From a Randomized Trial of Polymer-Free Versus Durable Polymer Drug-Eluting Coronary Stents," was published in the Journal of the American College of Cardiology.