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
| 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 |
| Downloads |
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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.
