Efficacy and safety of drug-coated balloon-only technique versus provisional T-stenting with drug-eluting stent in true coronary bifurcation lesions: study protocol for a multi-center, randomized, controlled, noninferiority trial

Abstract

Background: Provisional T-stenting is generally acknowledged for treating coronary bifurcation lesions, but risk of adverse cardiac events is still high. Drug-coated balloon (DCB) has been proved non-inferior and even superior to stent combined with general balloon strategy but the efficacy and safety of using it alone in bifurcation lesions needs further investigation. Hence, this prospective, multi-center, randomized, controlled study was devised to test whether DCB-only technique is non-inferior to provisional T-stenting with drug-eluting stent (DES) for true coronary bifurcation lesions. Methods: A total of 1000 patients with true coronary bifurcation lesions (Medina classes 1.1.1, 1.0.1 or 0.1.1) from 20 research institutes in China who meet the inclusion criteria and satisfy no exclusion criteria will be enrolled in this trial. Subjects will be randomly assigned to the RESTORE^R DCB group or the DES group in a 1:1 ratio. Patients in the DCB group will receive DCB treatment only, while those in the DES group will undergo provisional T-stenting. Coronary angiography will be performed by well-trained operators and participants will take antiplatelet or anticoagulation medication in accordance with the protocol. The first primary endpoint is the target lesion failure (TLF) rate at 12 months postoperatively. The second primary endpoint is clinical net event rates at 12 months postoperatively. The follow-up data will be collected at 1, 6 and 12months and 2 and 3 years postoperatively by phone call or clinic visit. Statistical analysis will test the noninferiority of DCB regarding the first primary endpoint and further test the superiority of DCB concerning the second primary endpoint if the noninferiority is supported. Discussion: This trial is intended to test whether DCB-only technique is non-inferior to provisional T-stenting with DES in true coronary bifurcation lesions, which will provide evidence for strategy selection in treating such patients. Trial registration: NCT04842838 [ClinicalTrials.gov] [registered on April 13, 2021]