A HYbrid APproach Evaluating a DRug-Coated Balloon in Combination With a New-Generation Drug-Eluting Stent in the Treatment of De Novo Diffuse Coronary Artery Disease: The HYPER Pilot Study.

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.