A Polylactide Bioresorbable Scaffold Eluting Everolimus for Treatment of Coronary Stenosis: 5-Year Follow-Up.

Serruys, Patrick W; Ormiston, John; van Geuns, Robert-Jan; de Bruyne, Bernard; Dudek, Dariusz; Christiansen, Evald; Chevalier, Bernard; Smits, Pieter; McClean, Dougal; Koolen, Jacques; Windecker, Stephan; Whitbourn, Robert; Meredith, Ian; Wasungu, Luc; Ediebah, Divine; Veldhof, Susan; Onuma, Yoshinobu (2016). A Polylactide Bioresorbable Scaffold Eluting Everolimus for Treatment of Coronary Stenosis: 5-Year Follow-Up. Journal of the American College of Cardiology, 67(7), pp. 766-776. Elsevier 10.1016/j.jacc.2015.11.060

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BACKGROUND

Long-term benefits of coronary stenosis treatment with an everolimus-eluting bioresorbable scaffold are unknown.

OBJECTIVES

This study sought to evaluate clinical and imaging outcomes 5 years after bioresorbable scaffold implantation.

METHODS

In the ABSORB multicenter, single-arm trial, 45 (B1) and 56 patients (B2) underwent coronary angiography, intravascular ultrasound (IVUS), and optical coherence tomography (OCT) at different times. At 5 years, 53 patients without target lesion revascularization underwent final imaging.

RESULTS

Between 6 months/1 year and 5 years, angiographic luminal late loss remained unchanged (B1: 0.14 ± 19 mm vs. 0.13 ± 0.33 mm; p = 0.7953; B2: 0.23 ± 0.28 mm vs. 0.18 ± 0.32 mm; p = 0.5685). When patients with a target lesion revascularization were included, luminal late loss was 0.15 ± 0.20 mm versus 0.15 ± 0.24 mm (p = 0.8275) for B1 and 0.30 ± 0.37 mm versus 0.32 ± 0.48 mm (p = 0.8204) for B2. At 5 years, in-scaffold and -segment binary restenosis was 7.8% (5 of 64) and 12.5% (8 of 64). On IVUS, the minimum lumen area of B1 decreased from 5.23 ± 0.97 mm(2) at 6 months to 4.89 ± 1.81 mm(2) at 5 years (p = 0.04), but remained unchanged in B2 (4.95 ± 0.91 mm(2) at 1 year to 4.84 ± 1.28 mm(2) at 5 years; p = 0.5). At 5 years, struts were no longer discernable by OCT and IVUS. On OCT, the minimum lumen area in B1 decreased from 4.51 ± 1.28 mm(2) at 6 months to 3.65 ± 1.39 mm(2) at 5 years (p = 0.01), but remained unchanged in B2, 4.35 ± 1.09 mm(2) at 1 year and 4.12 ± 1.38 mm(2) at 5 years (p = 0.24). Overall, the 5-year major adverse cardiac event rate was 11.0%, without any scaffold thrombosis.

CONCLUSIONS

At 5 years, bioresorbable scaffold implantation in a simple stenotic lesion resulted in stable lumen dimensions and low restenosis and major adverse cardiac event rates. (ABSORB Clinical Investigation, Cohort B [ABSORB B]; NCT00856856).

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