Rationale and design of a prospective, open-label, randomized, multicentric clinical trial on the role of drug-coated balloons for bifurcation coronary lesions: the PRO-DAVID study

From Top Italian Scientists Journal
Published
January 14, 2024
Title
Rationale and design of a prospective, open-label, randomized, multicentric clinical trial on the role of drug-coated balloons for bifurcation coronary lesions: the PRO-DAVID study
Authors
Đeiti Prvulović, Bernardo Cortese
DOI
10.62684/EHOA4798
Keywords
DCB; coronary bifurcations; study design
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Đeiti Prvulović(a), Bernardo Cortese(b,c)

(a) Clinical Hospital Center Rijeka, Rijeka, Croatia

(b) Fondazione Ricerca e Innovazione Cardiovascolare, Milano, Italy

(c) DCB Academy, Milano, Italy

Correspondence to: Bernardo Cortese, MD, FESC, Cardiovascular Research Group, Fondazione Ricerca e Innovazione Cardiovascolare, Milano, Italy. Via E. Ponti 49, Milano, Italy. bcortese@gmail.com - Running head: DCB use for coronary bifurcations.

Abstract

Background

Coronary bifurcation lesions (CBL) are associated with impaired outcome. The role of drug-coated balloons (DCB) in this setting has been only investigated in small studies so far.

Aim

We here describe the design of PRO-DAVID study, aiming at investigating the clinical outcomes of a “provisional DCB” versus a "standard" approach (provisional or upfront two stent techniques) for the treatment of complex CBL.

Methods and results

The PRO-DAVID trial is a prospective, open-label, randomized, multicentric clinical trial of the interventions with true CBL (Medina 1,0,1; 1,1,1; 0,1,1) of unprotected left main (LM), and non-left main (non-LM) CBL with affected significant side branche (SB). The study hypothesis is that a “provisional DCB approach” with PCI using first DCB in SB after optimal predilatation and then DES implantation in the main vessel will be non-inferior to standard bifurcation-PCI as per EBC recommendations. The calculated sample size is 602 patients in total, and allocation is 1:1. The primary study endpoint is a composite of cardiac death, target vessel MI, or clinically-driven target lesion revascularization (TLR) at 12 months, and patients will be followed up for up to 3 years.

Implications

CBL management with stents only is associated with impaired outcome, and some preliminary data on the performance of DCB show their safety and efficacy in this setting. PRO DAVID study is an adequately powered randomized trial with clinical endpoints aimed to test DCB use in true CBL.

Declarations

Acknowledgments

None.

Conflict of Interest

The Authors declare that there is no conflict of interest.

Funding

None.

Running head

DCB use for coronary bifurcations.

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