Bioresorbable Stent Ready for Randomized Evaluation

One-year results of a phase II trial are encouraging, but superiority of a bioresorbable scaffold to current-generation metallic ones will be difficult to demonstrate.

More than 10 years since the first clinical use of a polymer (L-lactide) bioabsorbable stent, phase II evaluation of the latest-generation bioresorbable vascular scaffold is now under way. Investigators for the manufacturer-sponsored trial report the results of planned invasive imaging 12 months after implantation of everolimus-eluting bioresorbable stents in 56 patients with de novo coronary lesions.

Procedural success was high, with no deaths, two myocardial infarctions deemed unrelated to the stents, and two ischemia-driven target-lesion revascularizations. Mean angiographic late lumen loss was 0.27 mm, and the restenosis rate was 3.5%. Some degree of arterial-segment vasodilation was found in 8 of 19 patients assessed with intracoronary …

Reviewing Author

Howard C. Herrmann, MD

Disclosures

Consultant/Advisory BoardAffluent Medical; Artedrone; Caranx; Johnson & Johnson; Medtronic; Prolifagen; Wells Fargo

EquityMicrointerventional Devices, Inc.

RoyaltiesUniversity of Pennsylvania

Grant/Research SupportAbbott Vascular; Edwards Lifesciences; Johnson & Johnson; Medtronic

Editorial BoardsCatheterization and Cardiovascular Interventions; Journal of the American College of Cardiology; Circulation: Cardiovascular Interventions; JACC Cardiovascular Interventions; JACC Case Reports; JSCAI