A Non-inferiority, Randomized Clinical Trial Comparing Paclitaxel-Coated Balloon Versus New-Generation Drug-Eluting Stents on Angiographic Outcomes for Coronary De Novo Lesions

Overview

Journal Cardiovasc Drugs Ther

Specialties Cardiology & Vascular Diseases
Pharmacology

Date 2021 Mar 13

PMID 33713211

Citations 16

Authors

Xue Yu

Xinyue Wang

Fusui Ji

Wenduo Zhang

Chenguang Yang

Feng Xu

Fang Wang

Affiliations

Soon will be listed here.

Abstract

Background: Drug-coated balloon (DCB) has been proved efficacy for coronary small vessel disease, but data regarding outcomes of DCB in common de novo lesions (including reference vessel diameter more than 3.0mm) compared with new-generation drug-eluting stent (DES) are lacking. We hypothesized that a DCB-only strategy for coronary de novo lesions would be non-inferior to DES treatment on angiographic outcomes.

Methods: In this randomized controlled trial, we compared the effect of DCB with DES on late lumen loss (LLL) at 9-month angiographic follow-up and 12-month major adverse cardiac events (MACEs), including death, non-fatal myocardial infarction, target lesion revascularization (TLR), and target vessel revascularization (TVR).

Results: From July 2017 to July 2018, 288 consecutive patients with reference vessel diameter (RVD) between 2.25 and 4.0mm were screened. After proper pre-dilation, 170 patients were enrolled and randomized to the DCB and the DES groups at 1:1 ratio. Seven patients withdrew the consent forms during hospital stay (1 in DCB group, 6 in DES group). Two patients in DCB group underwent bailout stenting due to severe dissection after DCB release. The primary endpoint of 9-month LLL was -0.19±0.49mm with the DCB versus 0.03±0.64mm with the DES. The one-sided 97.5% upper confidence limit of the difference was -0.04mm, achieving non-inferiority of the DCB compared with the DES (P=0.019). The 12-month cumulative MACE rate was similar in the DCB and DES groups (2.44% vs. 6.33%, P=0.226).

Conclusions: In this prospective study, the DCB only strategy for de novo lesion was non-inferior to the new-generation DES in terms of 9-month late lumen loss.

Citing Articles

Drug-Coated Balloons versus Drug-Eluting Stents for the Treatment of De Novo Coronary Artery Disease: A Meta-Analysis of Randomized Controlled Trials.

Niu J, Wang K, Wang W, Liu Y, Yang J, Sun Y Rev Cardiovasc Med. 2025; 25(12):446.

PMID: 39742237 PMC: 11683689. DOI: 10.31083/j.rcm2512446.

Stent, balloon and hybrid in PCI: could the whole be greater than the sum of its parts?.

Lim P Br J Cardiol. 2024; 30(4):37.

PMID: 39247419 PMC: 11376257. DOI: 10.5837/bjc.2023.037.

Clinical Updates in Coronary Artery Disease: A Comprehensive Review.

Bottardi A, Prado G, Lunardi M, Fezzi S, Pesarini G, Tavella D J Clin Med. 2024; 13(16).

PMID: 39200741 PMC: 11354290. DOI: 10.3390/jcm13164600.

Drug-coated balloon versus drug-eluting stent for treating de novo large vessel coronary artery disease: a systematic review and meta-analysis of 13 studies involving 2888 patients.

Caminiti R, Vizzari G, Ielasi A, Vetta G, Parlavecchio A, Della Rocca D Clin Res Cardiol. 2024; .

PMID: 38958753 DOI: 10.1007/s00392-024-02481-8.

A New Frontier for Drug-Coated Balloons: Treatment of "De Novo" Stenosis in Large Vessel Coronary Artery Disease.

Sciahbasi A, Mazza T, Pidone C, Samperi S, Cittadini E, Granatelli A J Clin Med. 2024; 13(5).

PMID: 38592181 PMC: 10931954. DOI: 10.3390/jcm13051320.

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