Long-term clinical results of bioresorbable absorb scaffolds using the PSP-technique in patients with and without diabetes

ObjectivesWe 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. BackgroundAbsorb 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. MethodsIn 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 >12mm. 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. ResultsDoCE 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. ConclusionsPatients 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.