Long-Term Effect of Ultrathin-Strut Versus Thin-Strut Drug-Eluting Stents in Patients With Small Vessel Coronary Artery Disease Undergoing Percutaneous Coronary Intervention

Author:

Iglesias Juan F.1,Heg Dik2,Roffi Marco1,Tüller David3,Noble Stéphane1,Muller Olivier4,Moarof Igal5,Cook Stéphane6,Weilenmann Daniel7,Kaiser Christoph8,Cuculi Florim9,Häner Jonas10,Jüni Peter11,Windecker Stephan10,Pilgrim Thomas10

Affiliation:

1. Division of Cardiology, Geneva University Hospitals, Switzerland (J.F.I., M.R., S.N.).

2. Institute of Social and Preventive Medicine and Clinical Trials Unit, Bern University Hospital, Switzerland (D.H.).

3. Department of Cardiology, Triemlispital, Zurich, Switzerland (D.T.).

4. Department of Cardiology, Lausanne University Hospital, Switzerland (O.M.).

5. Department of Cardiology, Kantonsspital Aarau, Switzerland (I.M.).

6. Department of Cardiology, University and Hospital Fribourg, Switzerland (S.C.).

7. Department of Cardiology, Kantonsspital St Gallen, Switzerland (D.W.).

8. Department of Cardiology, Basel University Hospital, Switzerland (C.K.).

9. Department of Cardiology, Kantonsspital Luzern, Switzerland (F.C.).

10. Department of Cardiology, Inselspital, University of Bern, Bern University Hospital, Switzerland (J.H., S.W., T.P.).

11. Applied Health Research Centre, Li Ka Shing Knowledge Institute of St Michael’s Hospital, Department of Medicine and Institute of Health Policy, Management and Evaluation, University of Toronto, Canada (P.J.).

Abstract

Background: Randomized trials evaluating the Orsiro biodegradable polymer sirolimus-eluting stent (BP-SES; 60 and 80 μm strut thickness for stent diameters ≤3 and >3 mm, respectively) did not stratify according to vessel size and failed to specify the impact of ultrathin-strut thickness on long-term clinical outcomes compared with durable polymer everolimus-eluting stents (DP-EES). We sought to assess the long-term effect of ultrathin-strut (60 μm) BP-SES versus thin-strut (81 μm) DP-EES on long-term outcomes in patients undergoing percutaneous coronary revascularization for small vessel disease. Methods: In a subgroup analysis of the randomized, multicenter, noninferiority BIOSCIENCE trial, patients with stable coronary artery disease or acute coronary syndrome randomly assigned to treatment with BP-SES or DP-EES were stratified according to vessel size (≤3 mm versus >3 mm) as a surrogate to compare patients treated with ultrathin-strut versus thin-strut drug-eluting stent. The primary end point was target lesion failure, a composite of cardiac death, target vessel myocardial infarction, and clinically indicated target lesion revascularization, within 5 years. Results: Among 2109 patients, 1234 (59%) were treated for small vessel disease. At 5 years, target lesion failure occurred in 124 patients (cumulative incidence, 22.3%) treated with ultrathin-strut BP-SES and 109 patients (18.3%) treated with thin-strut DP-EES (rate ratio, 1.22; 95% CI, 0.94–1.58; P =0.13). Cumulative incidences of cardiac death, target vessel myocardial infarction, and clinically indicated target lesion revascularization and definite stent thrombosis at 5 years were similar in patients treated with ultrathin-strut BP-SES and thin-strut DP-EES. After adjustment for potential confounders, there was no significant interaction between vessel size and treatment effect of BP-SES versus DP-EES. Conclusions: We found no significant difference in clinical outcomes throughout 5 years between patients with small vessel disease treated with ultrathin-strut BP-SES versus thin-strut DP-EES. Clinical Trial Registration: URL: https://www.clinicaltrials.gov . Unique identifier: NCT01443104.

Publisher

Ovid Technologies (Wolters Kluwer Health)

Subject

Cardiology and Cardiovascular Medicine

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