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
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 i...
Source: BMJ Open - Category: General Medicine Authors: Gao, X.-F., Ge, Z., Kan, J., Kong, X.-Q., Wang, Y., Qiu, C.-G., Tresukosol, D., He, Y.-Q., Wu, Q., Li, J.-F., Yuan, H.-T., Shen, C., Chen, X., Munawar, M., Hanif, B., Santoso, T., Shin, E.-S., Sheiban, I., Ye, F., Zhang, J.-J., Chen, S.-L., On behalf of t Tags: Open access, Cardiovascular medicine Source Type: research
More News: Angioplasty | Baloon Angioplasty | Cardiology | Cardiovascular | Conferences | General Medicine | Heart | Heart Attack | Medical Ethics | Stroke | Study | Thrombosis