Angiographic and 5-Year Clinical Follow-Up After Implantation of Drug-Eluting Stents with Biodegradable Coating in Patients at High Risk of Restenosis : The PAINT Randomized Trial

Background: Biodegradable polymers were developed to reduce the hypersensitivity reaction associated to durable polymers found with the first generation drug-eluting stents, while maintaining antiproliferative efficacy and increasing safety. This study evaluated the 9-month angiographic follow-up and long-term clinical outcomes of biodegradable polymer-coated drug-eluting stents compared with identical platform metallic stents in patients with high-risk for restenosis. Methods: Patients with a reference diameter ≤ 2.5 mm, lesion length ≥ 15 mm, diabetes, or a combination of these characteristics were selected from the population of the PAINT trial. These patients were previously randomized and allocated for percutaneous coronary intervention with either a sirolimus-eluting biodegradable polymer-coated stent, a paclitaxel-eluting biodegradable polymer-coated stent, or an identical metallic platform stent, at a ratio of 2:2:1. Results: One hundred and seventy-eight patients were treated with biodegradable polymer-coated drug-eluting stents (n = 142) or bare metal stents (n = 36). At the 9-month angiographic follow-up, biodegradable polymercoated drug-eluting stents had lower rates of late loss (0.40 ± 0.42 mm vs. 0.90 ± 0.47 mm; p < 0.01) and binary restenosis (7.4% vs. 25%; p < 0.01). In the 5-year clinical follow-up, the group with biodegradable polymer-coated drug-eluting stents had lower rates of the composite endpoint of cardiac death, myocardial infarction, and target vessel revascularization (16.2% vs. 38.0%; p = 0.03), especially due to the reduction of target vessel revascularization (9.9% vs. 36.1%; p < 0.01). Total death, cardiac death and myocardial infarction were not different among groups. Probable or definitive stent thrombosis 1 Instituto do Coração, Hospital das Clínicas, Universidade de São Paulo, São Paulo, SP, Brazil. 2 Hospital Universitário Cassiano Antonio de Moraes, Vitória, ES, Brazil. 3 Hospital Santa Marcelina, São Paulo, SP, Brazil. 4 Natal Hospital Center, Natal, RN, Brazil. 5 Hospital Meridional, Vitória, ES, Brazil. 6 Escola Paulista de Medicina, Universidade Federal de São Paulo, São Paulo, SP, Brazil. 7 Hospital Universitário Walter Cantídio, Fortaleza, CE, Brazil. 8 Hospital São Lucas, Pontifícia Universidade Católica do Rio Grande do Sul, Porto Alegre, RS, Brazil. 9 Rede D’Or de Hospitais, Rio de Janeiro, RJ, Brazil. 10 Hospital Biocor, Belo Horizonte, MG, Brazil. 11 Hospital São Camilo, São Paulo, SP, Brazil. Corresponding Author: Pedro A. Lemos. Avenida Dr. Enéas de Carvalho Aguiar, 44, bloco I, 3o andar, Hemodinâmica − Cerqueira César − CEP: 05403-000 − São Paulo (SP), Brazil E-mail: pedro.lemos@incor.usp.br Received on: 09/08/2014 • Accepted on: 11/15/2014 Original Article