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

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.