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
| Autor: | Nirav Bhalani, Chirag Seth, Francesco Bedogni, Poonam Chodvadiya, Mainish Doshi, Prakash Sojitra, Arvind Sharma, Pritesh Parekh, Luca Testa, Sameer Dani, Gopee Dutta, Dewang Desai, Rashmit Pandya |
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| Rok vydání: | 2018 |
| Předmět: |
Adult
Male medicine.medical_specialty Polymers medicine.medical_treatment Population Myocardial Infarction Myocardial Ischemia India 030204 cardiovascular system & hematology Coronary artery disease 03 medical and health sciences 0302 clinical medicine Percutaneous Coronary Intervention Internal medicine Diabetes mellitus Absorbable Implants medicine Humans 030212 general & internal medicine Myocardial infarction Prospective Studies Registries education Aged Sirolimus education.field_of_study business.industry Percutaneous coronary intervention Stent Drug-Eluting Stents Middle Aged medicine.disease Diabetes Mellitus Type 1 Treatment Outcome Diabetes Mellitus Type 2 Drug-eluting stent Cardiology Female Cardiology and Cardiovascular Medicine business Mace |
| Zdroj: | Minerva cardioangiologica. 66(5) |
| ISSN: | 1827-1618 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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