Abstract | OBJECTIVES: To assess feasibility, safety and efficacy of hybrid approach, consisting in a combination of modern drug-eluting stent (DES) and drug-eluting balloon (DCB), for treatment of de-novo diffuse coronary artery disease (CAD). BACKGROUNDS: Contemporary DES are associated with a persistent risk of major cardiovascular events, due to in- stent thrombosis and restenosis. The hybrid approach, reducing the permanent metallic cage length, is supposed to mitigate the risk of device-related adverse events, especially in diffuse CAD. METHODS: This is a prospective, non-randomized, observational, multicenter study intended to obtain data from 100 consecutive patients affected by de-novo diffuse CAD undergoing percutaneous coronary intervention with a hybrid approach, consisting in the combined use of DES and DCB in contiguous coronary segments. The study is recorded in ClinicalTrials.gov with the identifier: NCT03939468. RESULTS: The primary endpoint is a device oriented composite end-point (DOCE) of cardiac death, target vessel myocardial infarction (TV-MI) and ischemia-driven target lesion revascularization (ID-TLR) in DES- and/or DCB-treated segment. DOCE will be assessed at 12-months follow-up. CONCLUSIONS: This will be the first study investigating the feasibility, safety and efficacy of hybrid DES/DCB approach for the treatment of de-novo diffuse CAD. Here we describe the rationale and the design of the study.
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Authors | Alfonso Ielasi, Andrea Buono, Mariano Pellicano, Delio Tedeschi, Marco Loffi, Michael Donahue, Damiano Regazzoli, Giuseppe De Angelis, Giambattista Danzi, Bernhard Reimers, Maurizio Tespili |
Journal | Cardiovascular revascularization medicine : including molecular interventions
(Cardiovasc Revasc Med)
Vol. 28
Pg. 14-19
(07 2021)
ISSN: 1878-0938 [Electronic] United States |
PMID | 32933874
(Publication Type: Clinical Trial, Journal Article, Multicenter Study, Observational Study)
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Copyright | Copyright © 2020 Elsevier Inc. All rights reserved. |
Chemical References |
- Pharmaceutical Preparations
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Topics |
- Coronary Artery Disease
(diagnostic imaging, therapy)
- Coronary Restenosis
(diagnostic imaging, etiology)
- Drug-Eluting Stents
- Humans
- Percutaneous Coronary Intervention
(adverse effects)
- Pharmaceutical Preparations
- Pilot Projects
- Prospective Studies
- Prosthesis Design
- Treatment Outcome
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