Merging the properties of a sirolimus coated balloon with those of a bioresorbable polymer sirolimus eluting stent to address the "diabetes issue" Results from the En-Abl multicenter registry

Luca Testa, Sameer Dani, Dewang Desai, Rashmit Pandya, Pritesh Parekh, Nirav Bhalani, Arvind Sharma, Chirag Seth, Mainish Doshi, Prakash Sojitra, Poonam Chodvadiya, Gopee Dutta, Francesco Bedogni

Research output: Contribution to journalArticle


BACKGROUND: Patients with diabetes mellitus (DM) have poorer outcomes after percutaneous coronary intervention than patients without diabetes. The Abluminus DES+™ drug-eluting stent (DES) features a novel technology of fusion coating of PLLA bioresorbable polymer on both the abluminal surface of the stent and exposed parts of the balloon. The aim of this study was to evaluate the efficacy/safety profile of the Abluminus DES+ in an all-comers population with minimal exclusion criteria and with a specific focus on diabetic patients. METHODS: Multicenter, prospective, all-comers registry performed in 31 centers in India. Patients were analyzed according to the diagnosis of DM and insulin dependency (ID or Non ID): non-DM (1256 patients), NIDDM (498 patients), IDDM (99 patients). The primary endpoint was a composite of device-oriented major adverse cardiac events (MACE): Cardiac death, target vessel-related myocardial infarction (MI), and ischemia-driven target lesion revascularization (TLR)/target vessel revascularization (TVR) at 1 year. Stent thrombosis (ST) at any time point was also recorded. RESULTS: The MACE rate at 1 year in the overall population was 2.3% and it was mainly driven by a 1.57% rate of TLR/TVR. Although patients with IDDM showed slightly higher figures for MACE (non-DM 2.3%, NIDDM 2.8%, IDDM 4%, P=0.09), as well as for single end-points, none of them reached statistical significance. The rate of ST was 0.56%, 0.4%, 1% for non-DM, NIDDM and IDDM group, respectively (P=0.6). CONCLUSIONS: The performance of the Abluminus DES+ is consistent among patients with or without diabetes, regardless the insulin dependency.

Original languageEnglish
Pages (from-to)536-542
Number of pages7
JournalMinerva Cardioangiologica
Issue number5
Publication statusPublished - Oct 1 2018



  • Coronary artery disease
  • Diabetes mellitus
  • Drug-eluting stent
  • Percutaneous coronary intervention

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this