An open-label randomized controlled trial comparing jailed balloon-proximal optimization technique with jailed wire technique in PCI of true bifurcation lesions

Background The jailed balloon technique (JBT) has proven efficacy in preventing side branch (SB) occlusion during provisional stenting of coronary bifurcation lesions. However, the complexity of JBT-based procedures poses challenges, particularly in lesions with multiple at-risk SBs. To address this, we proposed the jailed balloon-proximal optimization technique (JB-POT) as a means to simplify JBT-based provisional stenting. Objective Preliminary data from observational studies have indicated efficacy and safety of JB-POT. This randomized controlled trial aimed to comprehensively evaluate the efficacy and safety of JB-POT versus the conventional jailed wire technique (JWT) in managing true non-left main coronary bifurcation (non-LMB) lesions. Methods We randomized 110 patients with true non-LMB lesions (Medina classification 1,0,1; 1,1,1; or 0,1,1) from 3 centers into two groups: JB-POT (n=55) and JWT (n=55). The primary endpoint was SB occlusion rate after main vessel stenting or POT. Secondary endpoints encompassed incidence of severe proximal stent malapposition, target lesion failure (TLF, a composite of cardiac death, target vessel myocardial infarction, target lesion revascularization) at various time points (peri-operative, and at 1-, 6-, 12-months follow-up), procedural time, contrast volume and stent thrombosis (ST) served as major safety endpoint. Results The rate of SB occlusion (1.8% vs.20%; p = 0.006) , contrast volume (152.2 ± 6.1 vs.180.4 ± 9.8; p = 0.001) and procedure time (66.8 ± 21.1 vs. 80.8 ± 30.4; p = 0.004) are significantly lower in the JB-POT group than in the JWT group. The JB-POT group and JWT group showed no significant differences in incidence of severe proximal SM (5.5% vs. 0, p = 0.242), TLF (0 vs. 9.1%, p = 0.067) and ST (0 vs. 5.5%, p = 0.242), but the significant differences could be found in survival rate-free from TLF (LogRank: p = 0.023) at 12-months follow-up. Conclusion In the current multicenter randomized trial, JB-POT is superior to JWT in reducing SB occlusion during intervention of true non-LMB lesions, and appeared to use less contrast and shorter procedure time, and get better survival rate-free from TLF at 12-months follow-up. Fewer TLF and ST occurred with JB-POT than JWT, although the difference was not statistically significant. Figure Legends: Fig. 1 Schematic presentation of jailed balloon proximal optimization technique (JB-POT) protocol. (A) Both the MV and SB are wired. (B) The MV stent is then deployed with a balloon jailed in the SB. (C)The jailed balloon is dilated at 6–8 atm if SB blood flow is degraded. (D) POT and post-dilation of the distal stent were performed with NC balloons of corresponding sizes. (E) The jailed balloon is retrieved gently and repeat-POT is performed 2 mm away from the SB branching point. (F) Final effects are examined.