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10-Year outcomes from a randomized trial of polymer-free versus durable polymer drug-eluting coronary stents

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posted on 26.05.2021, 15:33 by Sebastian Kufner, Maximilian Ernst, Salvatore Cassese, Michael Joner, Katharina Mayer, Roisin Colleran, Tobias Koppara, Erion Xhepa, Tobias Koch, Jens Wiebe, Tareq Ibrahim, Massimiliano Fusaro, Karl-Ludwig Laugwitz, Heribert Schunkert, Adnan Kastrati, Robert Byrne, ISAR-TEST-5 Investigators

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).

Funding

Bavarian Research Foundation (BFS-ISAR Aktenzeichen AZ: 504/02 and BFS-DES Aktenzeichen AZ: 668/05)

European Union under the Seventh Frame Work Programme (FP7 PRESTIGE 260309)

History

Comments

The original article is available at https://www.sciencedirect.com

Published Citation

Kufner S, Ernst M, Cassese S, Joner M, Mayer K, Colleran R, Koppara T, Xhepa E, Koch T, Wiebe J, Ibrahim T, Fusaro M, Laugwitz KL, Schunkert H, Kastrati A, Byrne RA; ISAR-TEST-5 Investigators. 10-Year outcomes from a randomized trial of polymer-free versus durable polymer drug-eluting coronary stents. J Am Coll Cardiol. 2020;76(2):146-158.

Publication Date

6 July 2020

PubMed ID

32646563

Department/Unit

  • School of Pharmacy and Biomolecular Sciences

Research Area

  • Vascular Biology

Publisher

Elsevier

Version

  • Published Version (Version of Record)