OBJECTIVES: We evaluated clinical results up to 36 months after implantation of Absorb BVS using PSP-technique and compared the outcome of patients with and without diabetes mellitus. BACKGROUND: Absorb II demonstrated that interventional treatment of coronary artery disease with bioresorbable vascular scaffolds (BVS) without proper PSP-technique (pre-dilation, proper sizing, and post-dilation) is associated with an increased thrombotic risk, even in simple lesions. METHODS: In this prospective study 319 patients with 420 lesions were enrolled and treated with the Absorb BVS. Pre-dilation was mandatory and post-dilation with a high-pressure balloon was performed in patients with a scaffold length >12 mm. Patients were clinically followed up to 3 years. Primary outcome measure was the device-oriented endpoint (DoCE) defined as cardiac death, myocardial infarction not clearly related to a non-target vessel and target lesion revascularization. RESULTS: DoCE was 5.0%, 7.1%, and 10.0% after 12, 24, and 36 months for the total population. Rate of scaffold thrombosis was 0.5%, 0.8%, and 1.4% after 12, 24, and 36 months. Rate of DoCE was higher in the diabetic subgroup with 9.1%, 12.6%, and 12.9% after 12, 24, and 36 months compared with 4.0% (P = 0.13), 5.6% (P = 0.05), and 9.9% (P = 0.20) in patients without diabetes mellitus. CONCLUSIONS: Patients treated with the Absorb BVS using the PSP-technique show good results up to 3 years with a low rate of scaffold thrombosis. Patients suffering from diabetes mellitus have an increased rate of DoCE compared with non-diabetic patients. CLINICAL TRIAL REGISTRATION: clinicaltrials.gov_NCT02162056.
OBJECTIVES: We evaluated clinical results up to 36 months after implantation of Absorb BVS using PSP-technique and compared the outcome of patients with and without diabetes mellitus. BACKGROUND: Absorb II demonstrated that interventional treatment of coronary artery disease with bioresorbable vascular scaffolds (BVS) without proper PSP-technique (pre-dilation, proper sizing, and post-dilation) is associated with an increased thrombotic risk, even in simple lesions. METHODS: In this prospective study 319 patients with 420 lesions were enrolled and treated with the Absorb BVS. Pre-dilation was mandatory and post-dilation with a high-pressure balloon was performed in patients with a scaffold length >12 mm. Patients were clinically followed up to 3 years. Primary outcome measure was the device-oriented endpoint (DoCE) defined as cardiac death, myocardial infarction not clearly related to a non-target vessel and target lesion revascularization. RESULTS:DoCE was 5.0%, 7.1%, and 10.0% after 12, 24, and 36 months for the total population. Rate of scaffold thrombosis was 0.5%, 0.8%, and 1.4% after 12, 24, and 36 months. Rate of DoCE was higher in the diabetic subgroup with 9.1%, 12.6%, and 12.9% after 12, 24, and 36 months compared with 4.0% (P = 0.13), 5.6% (P = 0.05), and 9.9% (P = 0.20) in patients without diabetes mellitus. CONCLUSIONS:Patients treated with the Absorb BVS using the PSP-technique show good results up to 3 years with a low rate of scaffold thrombosis. Patients suffering from diabetes mellitus have an increased rate of DoCE compared with non-diabeticpatients. CLINICAL TRIAL REGISTRATION: clinicaltrials.gov_NCT02162056.
Authors: Mateusz P Jeżewski; Michał J Kubisa; Ceren Eyileten; Salvatore De Rosa; Günter Christ; Maciej Lesiak; Ciro Indolfi; Aurel Toma; Jolanta M Siller-Matula; Marek Postuła Journal: J Clin Med Date: 2019-12-07 Impact factor: 4.241
Authors: Cordula M Felix; Victor J van den Berg; Sanne E Hoeks; Jiang Ming Fam; Mattie Lenzen; Eric Boersma; Peter C Smits; Patrick W Serruys; Yoshinobu Onuma; Robert Jan M van Geuns Journal: PLoS One Date: 2018-05-09 Impact factor: 3.240