Minerva Cardiology and Angiology 2021 Apr 07

DOI: 10.23736/S2724-5683.20.05413-4

Copyright © 2020 EDIZIONI MINERVA MEDICA

language: English

Targeting "diabetic" coronary stenosis merging the properties of sirolimus coated balloon with sirolimus eluting stent

Luca TESTA ¹ ✉, Matteo CASENGHI ¹, Antonio POPOLO RUBBIO ¹, Sameer DANI ², Devang DESAI ³, Rashmit PANDYA ², Pritesh PAREKH ⁴, Nirav BHALANI ⁵, Arvind SHARMA ⁵, Chirag SETH ⁵, Francesco BEDOGNI ¹

¹ Department of Cardiology, IRCCS Policlinico S. Donato, Milan, Italy; ² Life Care Institute of Medical Sciences & Research & Apollo Hospitals, Ahmedabad, Gujarat, India; ³ Mahavir Hospitals, Surat, Gujarat, India; ⁴ Care Hospitals, Surat, Gujarat, India; ⁵ Rhythm Heart Institute, Baroda, Gujarat, India

BACKGROUND: Patients with diabetes mellitus (DM) represents a challenging subset of population as they experience worse outcomes after percutaneous coronary intervention than patients without diabetes. We evaluated the 2-year efficacy and safety profile of the Abluminus DES+ in patients with diabetes within the population enrolled in the large multicenter en-ABL e-registry.
METHODS: Multicenter, prospective, all-comers registry performed in 31 centers in India. We analyze patients according to the diagnosis of DM and insulin dependency (ID or Non-ID): non-DM (1.641 patients), NIDDM (721 patients), IDDM (138 patients). The primary endpoint was a composite of device-oriented major adverse cardiac events (MACE): cardiac death, target vesselrelated myocardial infarction (MI), and ischemia-driven target lesion revascularization (TLR)/ target vessel revascularization (TVR) at 2-year. Stent thrombosis (ST) at any time point was also recorded.
RESULTS: The MACE rate at 2-year follow-up was 3.0 %in the overall population with DM patients showing a higher rate of primary endpoint compared to non-DM (4.4 % vs 2.4 %, p=0.025). Rate of cardiac death was actually low and consistent between the 2 groups (1.7 % vs 0.9 %, p=0.100). At 2-year, the rate of ST was 0.9 % in DM patients versus 0.5 % in non-DM, p=0.213.
CONCLUSIONS: At 2-year, the Abluminus DES+ technology that merges the features of a sirolimus coated balloon with those of a bioresorbable polymer drug eluting stent appears to be safe and effective. This safety/efficacy profile was consistent in patients with or without DM.

KEY WORDS: Diabetes mellitus; Sirolimus Eluting stent; Biodegradable polymer; Insulin dependent diabetes mellitus; Stent thrombosis