Polymer-free drug-eluting stents showed no measurable differences in clinical outcomes or stent thrombosis compared to durable polymer stents at 10-year follow-up.
RCT
Do polymer-free drug-eluting stents improve 10-year outcomes compared to durable polymer drug-eluting stents in patients requiring coronary stenting?
At 10-year follow-up, polymer-free DES showed comparable outcomes and stent thrombosis rates to durable polymer DES, with high overall adverse event rates in both groups.
BACKGROUND: Outcome data after extended long-term follow-up of patients with coronary artery disease treated with drug-eluting stents (DES) in randomized clinical trials are scant. OBJECTIVES: Performance differences among devices may be expected to emerge over time depending on whether stenting is done with polymer-free or durable polymer DES. This study 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. METHODS: A total of 3,002 patients 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). Additional endpoints of interest were the patient-oriented composite endpoint (POCE), including all-cause death, any myocardial infarction, or any revascularization; individual components of the composite endpoints; and definite or probable stent thrombosis. RESULTS: The median age of the patients at randomization was 67.8 years. 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; 95% confidence interval CI: 0.89 to 1.14; p = 0.90; POCE: 66.2% vs. 67.7%, respectively; hazard ratio: 0.94; 95% CI: 0.86 to 1.04; p = 0.22). 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; 95% CI: 0.46 to 1.54; p = 0.58). CONCLUSIONS: 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. (Test Efficacy of Sirolimus- and Probucol-Eluting Versus Zotarolimus-Eluting Stents ISAR-TEST-5; NCT00598533).
“In the end, we didn't see any difference between this polymer-free technology and the permanent-polymer device at all. On the one hand, that's quite disappointing because there was no additional benefit, but on the other hand it also means that with these new-generation drug-eluting stents, the polymer-free drug-eluting stent does have the same safety and efficacy as a current benchmark stent, which is good news.”
Kufner et al. (Wed,) conducted a rct in Coronary artery disease requiring stenting. Polymer-free drug-eluting stents (sirolimus- and probucol-eluting) vs. Durable polymer drug-eluting stents (zotarolimus-eluting) was evaluated on Clinical outcomes and stent thrombosis. Polymer-free drug-eluting stents showed no measurable differences in clinical outcomes or stent thrombosis compared to durable polymer stents at 10-year follow-up.