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- W3140147149 abstract "<h3>Background</h3> Outcome data after extended long-term follow-up of patients with coronary artery disease treated with drug-eluting stents (DES) in randomized clinical trials is scant. <h3>Objective</h3> Performance differences between devices may be expected to emerge over time depending on whether stenting is done with polymer-free or durable polymer DES. We assessed the 10-year outcomes of patients enrolled in the ISAR-TEST 5 trial. <h3>Methods</h3> 3002 patients were randomized to treatment with either polymer-free sirolimus- and probucol-eluting stents (PF-SES) (n=2002) or durable polymer zotarolimus-eluting stents (DP-ZES) (n=1000). The primary endpoint was the composite of cardiac death, target vessel-related myocardial infarction or target lesion revascularisation (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 revascularisation, individual components of the composite endpoints, and definite or probable stent thrombosis. <h3>Results</h3> 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 PF-SES and DP-ZES, (DOCE: 43.8% versus 43.0%, respectively, hazard ratio = 1.01, 95% CI, 0.89–1.14; P=0.90), (POCE: 66.2% versus 67.7%, respectively, hazard ratio = 0.94, 95%CI, 0.86–1.04; 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, 0.46–1.54], P=0.58). <h3>Conclusion</h3> 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." @default.
- W3140147149 created "2021-04-13" @default.
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- W3140147149 date "2020-09-30" @default.
- W3140147149 modified "2023-09-25" @default.
- W3140147149 title "11 Ten-year clinical outcomes from a randomized trial of polymer-free versus durable polymer drug-eluting stents ten-year results of the intracoronary stenting and angiographic results: test efficacy of sirolimus- and probucol- and zotarolimus- eluting stents (ISAR-test 5) trial" @default.
- W3140147149 doi "https://doi.org/10.1136/heartjnl-2020-ics.11" @default.
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