Randomized Pilot Study to Compare DCB-Based versus DST-Based Strategies for the Treatment of True or Complex Coronary Bifurcation Lesions.

Background: Dual stenting technique (DST) is still mandatory for some true bifurcation lesions (BLs), but drug-coated balloon (DCB) alone may offer a new optional treatment with the potential benefits of fewer implants. However, procedural safety presents a concern when using DCB-only to treat true BLs. This study sought to explore the safety and efficacy of the DCB-only strategy for the treatment of true BLs. Methods: Sixty patients with TBLs were randomly assigned to be treated by a DCB-based strategy or DST-based strategy. All patients received angiographic follow-up scheduled after one-year and staged clinical follow-up. The primary endpoint was the one-year late lumen loss (LLL) and cumulative major cardiac adverse events (MACEs) composed of cardiac death (CD), target vessel myocardial infarction (TVMI), target lesion thrombosis (TVT), or target vessel/lesion revascularization (TLR/TVR). The secondary endpoint was the one-year minimal lumen diameter (MLD), diameter stenosis percentage (DSP) or binary restenosis (BRS), and each MACE component. Results: The baseline clinical and lesioncharacteristics were comparable with similar proportions (20.0% vs. 23.3%, p = 1.000) of the complex BLs between the two groups. At the one-year follow-up, LLL was significantly lower in the DCB-based group (main-vessel: 0.05 ± 0.24 mm vs. 0.25 ± 0.35 mm, p = 0.013; side-branch: -0.02 ± 0.19 mm vs. 0.11 ± 0.15 mm, p = 0.005). MLD, DSP and TLR/TVR were comparable between the groups. The one-year cumulative MACE, all driven by TLR/TVR (6.7% vs. 13.3%, p = 0.667), was low and similar without CD, TVMI or TVT in both groups. Conclusions: Compared to the DST strategy, the DCB-based strategy may be safe and effective in treatment of the selected true BLs. Clinical Trial Registration: Clinical registration number is ChiCTR1900024914. [ABSTRACT FROM AUTHOR]

Copyright of Reviews in Cardiovascular Medicine is the property of IMR Press and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)