Long-Term Effect of Ultrathin-Strut Versus Thin-Strut Drug-Eluting Stents in Patients With Small Vessel Coronary Artery Disease Undergoing Percutaneous Coronary Intervention: A Subgroup Analysis of the BIOSCIENCE Randomized Trial.

Iglesias, Juan F; Heg, Dierik Hans; Roffi, Marco; Tüller, David; Noble, Stéphane; Muller, Olivier; Moarof, Igal; Cook, Stéphane; Weilenmann, Daniel; Kaiser, Christoph; Cuculi, Florim; Häner, Jonas; Jüni, Peter; Windecker, Stephan; Pilgrim, Thomas (2019). Long-Term Effect of Ultrathin-Strut Versus Thin-Strut Drug-Eluting Stents in Patients With Small Vessel Coronary Artery Disease Undergoing Percutaneous Coronary Intervention: A Subgroup Analysis of the BIOSCIENCE Randomized Trial. Circulation: Cardiovascular interventions, 12(8), e008024. Lippincott Williams & Wilkins 10.1161/CIRCINTERVENTIONS.119.008024

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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.

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