Jailed Balloon Technique Is Superior to Jailed Wire Technique in Reducing the Rate of Side Branch Occlusion: Subgroup Analysis of the Conventional Versus Intentional StraTegy in Patients With High Risk PrEdiction of Side Branch OccLusion in Coronary Bifurcation InterVEntion Trial

Abstract

Objective: Jailed balloon technique (JBT) is an active side branch (SB) protection strategy and is considered to be superior to the jailed wire technique (JWT) in reducing SB occlusion. However, no randomized trials have proved that. We aim to investigate whether JBT could decrease the SB occlusion rate.

Methods: Conventional versus Intentional straTegy in patients with high Risk prEdiction of Side branch OccLusion in coronary bifurcation interVEntion (CIT-RESOLVE) (NCT02644434, registered on December 31, 2015) (https://clinicaltrials.gov) is a randomized trial that assessed the effects of different strategies on SB occlusion rate in patients with a high risk of SB occlusion. The present subgroup analysis enrolled bifurcation lesions (2 mm ≤ reference vessel diameter of SB < 2.5 mm) with Visual estimation for Risk prEdiction of Side branch OccLusion in coronary bifurcation intervention (V-RESOLVE) score ≥ 12 points. The primary endpoint is SB occlusion. One-year clinical events were compared.

Results: A total of 284 subjects at 16 sites were randomly assigned to the JBT group (n = 143) or the JWT group (n = 141). The rate of SB occlusion (9.1 vs. 19.9%, p = 0.02) and periprocedural myocardial infarction (defined by WHO, 7 vs. 14.9%, p = 0.03) is significantly lower in the JBT group than in the JWT group. The JBT and JWT groups showed no significant differences in cardiac death (0.7 vs. 0.7%, p = 1), myocardial infarction (MI, 6.3 vs. 7.1%, p = 0.79), target lesion revascularization (TLR, 1.4 vs. 2.1%, p = 0.68), and major cardiac adverse events (MACE, a composite of all-cause death, MI, or TLR, 8.4 vs. 10.6%, p = 0.52) during a 1-year follow-up.

Conclusion: In patients with a high risk of SB occlusion (V-RESOLVE score ≥ 12 points), JBT is superior to JWT in reducing SB occlusion. However, no significant differences were detected in 1-year MACE.

Keywords: coronary bifurcation lesions; jailed balloon technique; jailed wire technique; major adverse cardiac event (MACE); side branch occlusion.

Conflict of interest statement

The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Copyright © 2022 Zhang, Zhao, Gao, Xu, Wang, Liu, Yin, Feng, Zhu, Wang, Zhao, Yang, Gao, Xu and Dou.

Figures

FIGURE 1

Study population. From December 2016 to April 2019, a total of 335 subjects were randomly assigned to the active strategy group (n = 168) or conventional strategy group (n = 167). Among them, 143 patients in the active strategy group have an SB with 2 mm ≤ RVD < 2.5 mm and were assigned to JBT accordingly, while 141 patients in the conventional strategy group have an SB with 2 mm ≤ RVD < 2.5 mm and were assigned to JWT. For the ATS, 140 patients underwent the JBT strategy and 138 patients underwent the JWT strategy. IC, informed content; JBT, jailed balloon technique; JWT, jailed wire technique; ITT, intention to treat; ATS, as treated set.

FIGURE 2

The incidence of the primary endpoint [side branch (SB) occlusion] and its 2 components [TIMI (thrombolysis in myocardial infarction) flow grade decrease and absence of blood flow] between the SB protection jailed balloon technique (JBT) group and jailed wire technique (JWT) group. CI, confidence interval.

FIGURE 3

MACE-free survival rate at 1 year. The rate was 91.6% in the JBT group, and it was 89.4% in the JWT group (p = 0.52). MACE: major adverse cardiac event; JBT: jailed balloon technique; JWT: jailed wire technique.