Rationale and design for comparison of non-compliant balloon with drug-coating balloon angioplasty for side branch after provisional stenting for patients with true coronary bifurcation lesions: a prospective, multicentre and randomised DCB-BIF trial

Xiao-Fei Gao, Zhen Ge, Jing Kan, Xiang-Quan Kong, Yan Wang, Chun-Guang Qiu, Damras Tresukosol, Yu-Quan He, Qiang Wu, Ji-Fu Li, Hai-Tao Yuan, Chengxing Shen, Xiang Chen, Muhammad Munawar, Bashir Hanif, Teguh Santoso, Eun-Seok Shin, Imad Sheiban, Fei Ye, Jun-Jie Zhang, Shao-Liang Chen, DCB-BIF investigators, Xiao-Fei Gao, Zhen Ge, Jing Kan, Xiang-Quan Kong, Yan Wang, Chun-Guang Qiu, Damras Tresukosol, Yu-Quan He, Qiang Wu, Ji-Fu Li, Hai-Tao Yuan, Chengxing Shen, Xiang Chen, Muhammad Munawar, Bashir Hanif, Teguh Santoso, Eun-Seok Shin, Imad Sheiban, Fei Ye, Jun-Jie Zhang, Shao-Liang Chen, DCB-BIF investigators

Abstract

Introduction: Provisional stenting using drug-eluting stent is effective for simple coronary bifurcation lesions. Kissing balloon inflation using conventional non-compliant balloon is the primary treatment of side branch (SB) after main vessel (MV) stenting. Drug-coating balloon (DCB) is reported to be associated with less frequent clinical events in in-stent restenosis and small vessel disease. The importance of DCB in bifurcation treatment is understudied. Accordingly, this trial is designed to investigate the superiority of DCB to non-compliant balloon angioplasty for SB after provisional stenting in patients with true coronary bifurcation lesions.

Methods and analysis: The DCB-BIF trial is a prospective, multicentre, randomised, superiority trial including 784 patients with true coronary bifurcation lesions. Patients will be randomised in a 1:1 fashion to receive either DCB or non-compliant balloon angioplasty if SB diameter stenosis >70% after MV stenting. The primary endpoint is the composite of major adverse cardiac event at the 1-year follow-up, including cardiac death, myocardial infarction (MI) or clinically driven target lesion revascularisation. The major secondary endpoints include all-cause death, periprocedural MI, spontaneous MI, clinically driven target vessel revascularisation, in-stent restenosis, stroke and individual component of the primary endpoint. The safety endpoint is the risk of stent thrombosis.

Ethics and dissemination: The study protocol and informed consent have been reviewed and approved by the Institutional Review Board of all participating centres. The written informed consent for participation in the trial will be obtained from all participants. The results of this study will be published in a peer-reviewed journal and disseminated at conferences.

Trial registration number: NCT04242134.

Keywords: coronary heart disease; coronary intervention; ischaemic heart disease.

Conflict of interest statement

Competing interests: None declared.

© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
Study flow chart. DCB, drug-coated balloon; DS, diameter stenosis; MACE, major adverse cardiac event; NC, non-compliant; NCB: non-compliant balloon; POT, proximal optimisation technique; SB, side branch; TIMI, thrombolysis and thrombin inhibition in myocardial infarction.

References

    1. Burzotta F, Lassen JF, Louvard Y, et al. . European bifurcation Club white paper on stenting techniques for patients with bifurcated coronary artery lesions. Catheter Cardiovasc Interv 2020;96:1067–79. 10.1002/ccd.29071
    1. Zhang J-J, Ye F, Xu K, et al. . Multicentre, randomized comparison of two-stent and provisional stenting techniques in patients with complex coronary bifurcation lesions: the definition II trial. Eur Heart J 2020;41:2523–36. 10.1093/eurheartj/ehaa543
    1. Chen S-L, Sheiban I, Xu B, et al. . Impact of the complexity of biFurcation lesIons treated with drug-eluting steNts: the definition study (definitions and impact of complEx biFurcation lesIons on clinical outcomes after percutaNeous coronary intervention using drug-eluting steNts). JACC Cardiovasc Interv 2014;7:1266–76. 10.1016/j.jcin.2014.04.026
    1. Loh PH, Lassen JF, Jepson N, et al. . Asia Pacific consensus document on coronary bifurcation interventions. EuroIntervention 2020;16:e706–14. 10.4244/EIJ-D-19-00977
    1. Neumann F-J, Sousa-Uva M, Ahlsson A, et al. . 2018 ESC/EACTS guidelines on myocardial revascularization. Eur Heart J 2019;40:87–165. 10.1093/eurheartj/ehy394
    1. Yerasi C, Case BC, Forrestal BJ, et al. . Drug-Coated Balloon for De Novo Coronary Artery Disease: JACC State-of-the-Art Review. J Am Coll Cardiol 2020;75:1061–73. 10.1016/j.jacc.2019.12.046
    1. Chen Y, Gao L, Qin Q, et al. . Comparison of 2 different Drug-Coated balloons in in-stent restenosis: the restore ISR China randomized trial. JACC Cardiovasc Interv 2018;11:2368–77. 10.1016/j.jcin.2018.09.010
    1. Giacoppo D, Alfonso F, Xu B, et al. . Paclitaxel-Coated balloon angioplasty vs. drug-eluting stenting for the treatment of coronary in-stent restenosis: a comprehensive, collaborative, individual patient data meta-analysis of 10 randomized clinical trials (Daedalus study). Eur Heart J 2020;41:3715–28. 10.1093/eurheartj/ehz594
    1. Tang Y, Qiao S, Su X, et al. . Drug-Coated balloon versus drug-eluting stent for small-vessel disease: the restore SVD China randomized trial. JACC Cardiovasc Interv 2018;11:2381–92. 10.1016/j.jcin.2018.09.009
    1. Jeger RV, Farah A, Ohlow M-A, et al. . Long-Term efficacy and safety of drug-coated balloons versus drug-eluting stents for small coronary artery disease (BASKET-SMALL 2): 3-year follow-up of a randomised, non-inferiority trial. Lancet 2020;396:1504–10. 10.1016/S0140-6736(20)32173-5
    1. Berland J, Lefèvre T, Brenot P, et al. . DANUBIO - a new drug-eluting balloon for the treatment of side branches in bifurcation lesions: six-month angiographic follow-up results of the DEBSIDE trial. EuroIntervention 2015;11:868–76. 10.4244/EIJV11I8A177
    1. Mathey DG, Wendig I, Boxberger M, et al. . Treatment of bifurcation lesions with a drug-eluting balloon: the PEPCAD V (paclitaxel Eluting PTCA balloon in coronary artery disease) trial. EuroIntervention 2011;7 Suppl K:K61–5. 10.4244/EIJV7SKA11
    1. Worthley S, Hendriks R, Worthley M, et al. . Paclitaxel-Eluting balloon and everolimus-eluting stent for provisional stenting of coronary bifurcations: 12-month results of the multicenter BIOLUX-I study. Cardiovasc Revasc Med 2015;16:413–7. 10.1016/j.carrev.2015.07.009
    1. Chen S-L, Santoso T, Zhang J-J, et al. . A randomized clinical study comparing double kissing crush with provisional stenting for treatment of coronary bifurcation lesions: results from the DKCRUSH-II (double kissing crush versus provisional stenting technique for treatment of coronary bifurcation lesions) trial. J Am Coll Cardiol 2011;57:914–20. 10.1016/j.jacc.2010.10.023
    1. Chen S-L, Zhang J-J, Han Y, et al. . Double Kissing Crush Versus Provisional Stenting for Left Main Distal Bifurcation Lesions: DKCRUSH-V Randomized Trial. J Am Coll Cardiol 2017;70:2605–17. 10.1016/j.jacc.2017.09.1066
    1. Jing Q-M, Zhao X, Han Y-L, et al. . A drug-eluting balloon for the trEatment of coronarY bifurcatiON lesions in the side branch: a prospective multicenter ranDomized (beyond) clinical trial in China. Chin Med J 2020;133:899–908. 10.1097/CM9.0000000000000743
    1. Colombo A, Bramucci E, Saccà S, et al. . Randomized study of the crush technique versus provisional side-branch stenting in true coronary bifurcations: the cactus (coronary bifurcations: application of the crushing technique using sirolimus-eluting stents) study. Circulation 2009;119:71–8. 10.1161/CIRCULATIONAHA.108.808402
    1. Hildick-Smith D, de Belder AJ, Cooter N, et al. . Randomized trial of simple versus complex drug-eluting stenting for bifurcation lesions: the British bifurcation coronary study: old, new, and evolving strategies. Circulation 2010;121:1235–43. 10.1161/CIRCULATIONAHA.109.888297
    1. Steigen TK, Maeng M, Wiseth R, et al. . Randomized study on simple versus complex stenting of coronary artery bifurcation lesions: the Nordic bifurcation study. Circulation 2006;114:1955–61. 10.1161/CIRCULATIONAHA.106.664920
    1. Dou K, Zhang D, Pan H, et al. . Active SB-P Versus Conventional Approach to the Protection of High-Risk Side Branches: The CIT-RESOLVE Trial. JACC Cardiovasc Interv 2020;13:1112–22. 10.1016/j.jcin.2020.01.233
    1. Niemelä M, Kervinen K, Erglis A, et al. . Randomized comparison of final kissing balloon dilatation versus no final kissing balloon dilatation in patients with coronary bifurcation lesions treated with main vessel stenting: the Nordic-Baltic bifurcation study III. Circulation 2011;123:79–86. 10.1161/CIRCULATIONAHA.110.966879
    1. Pan M, Medina A, Suárez de Lezo J, et al. . Coronary bifurcation lesions treated with simple approach (from the Cordoba & Las Palmas [CORPAL] Kiss Trial). Am J Cardiol 2011;107:1460–5. 10.1016/j.amjcard.2011.01.022
    1. Sawaya FJ, Lefèvre T, Chevalier B, et al. . Contemporary Approach to Coronary Bifurcation Lesion Treatment. JACC Cardiovasc Interv 2016;9:1861–78. 10.1016/j.jcin.2016.06.056
    1. Chen X, Li X, Zhang J-J, et al. . 3-Year outcomes of the DKCRUSH-V trial comparing DK crush with provisional stenting for left main bifurcation lesions. JACC Cardiovasc Interv 2019;12:1927–37. 10.1016/j.jcin.2019.04.056

Source: PubMed

Sponsorer og samarbeidspartnere

Medisinsk tilstand

Legemiddelintervensjoner

3
Abonnere