A drug-eluting Balloon for the trEatment of coronarY bifurcatiON lesions in the side branch: a prospective multicenter ranDomized (BEYOND) clinical trial in China.
10.1097/CM9.0000000000000743
- Author:
Quan-Min JING
1
;
Xin ZHAO
1
;
Ya-Ling HAN
1
;
Ling-Ling GAO
2
;
Yang ZHENG
3
;
Zhan-Quan LI
4
;
Ping YANG
5
;
Hong-Liang CONG
6
;
Chuan-Yu GAO
7
;
Tie-Min JIANG
8
;
Hui LI
9
;
Jun-Xia LI
10
;
Dong-Mei WANG
11
;
Geng WANG
1
;
Zhan-Chun CONG
1
;
Zhong ZHANG
12
Author Information
1. Department of Cardiology, General Hospital of Northern Theater Command, Shenyang, Liaoning 110016, China.
2. Peking University Clinical Research Institute, Beijing 100191, China.
3. Department of Cardiology, The First Bethune Hospital of Jilin University, Changchun, Jilin 130021, China.
4. Department of Cardiology, The People's Hospital of Liaoning Province, Shenyang, Liaoning 110016, China.
5. Department of Cardiology, China-Japan Union Hospital of Jilin University, Changchun, Jilin 130033, China.
6. Department of Cardiology, Tianjin Chest Hospital, Tianjin 300051, China.
7. Department of Cardiology, Henan Provincial People's Hospital, Zhengzhou, Henan 450008, China.
8. Department of Cardiology, Affiliated Hospital of Logistics University of People's Armed Police Force, Tianjin 300163, China.
9. Department of Cardiology, Daqing Oilfield General Hospital, Daqing, Heilongjiang 163001, China.
10. Department of Cardiology, The Seventh Medical Center of People's Liberation Army General Hospital, Beijing 100125, China.
11. Department of Cardiology, Bethune International Peace Hospital, Shijiazhuang, Hebei 050082, China.
12. Department of Cardiology, The 306th Hospital of People's Liberation Army, Beijing 100101, China.
- Publication Type:Journal Article
- From:
Chinese Medical Journal
2020;133(8):899-908
- CountryChina
- Language:English
-
Abstract:
BACKGROUND:Treatment of coronary bifurcation lesions remains challenging; a simple strategy has been preferred as of late, but the disadvantage is ostium stenosis or even occlusion of the side branch (SB). Only a few single-center studies investigating the combination of a drug-eluting stent in the main branch followed by a drug-eluting balloon in the SB have been reported. This prospective, multicenter, randomized study aimed to investigate the safety and efficacy of a paclitaxel-eluting balloon (PEB) compared with regular balloon angioplasty (BA) in the treatment of non-left main coronary artery bifurcation lesions.
METHODS:Between December 2014 and November 2015, a total of 222 consecutive patients with bifurcation lesions were enrolled in this study at ten Chinese centers. Patients were randomly allocated at a 1:1 ratio to a PEB group (n = 113) and a BA group (n = 109). The primary efficacy endpoint was angiographic target lesion stenosis at 9 months. Secondary efficacy and safety endpoints included target lesion revascularization, target vessel revascularization, target lesion failure, major adverse cardiac and cerebral events (MACCEs), all-cause death, cardiac death, non-fatal myocardial infarction, and thrombosis in target lesions. The main analyses performed in this clinical trial included case shedding analysis, base-value equilibrium analysis, effectiveness analysis, and safety analysis. SAS version 9.4 was used for the statistical analyses.
RESULTS:At the 9-month angiographic follow-up, the difference in the primary efficacy endpoint of target lesion stenosis between the PEB (28.7% ± 18.7%) and BA groups (40.0% ± 19.0%) was -11.3% (95% confidence interval: -16.3% to -6.3%, Psuperiority <0.0001) in the intention-to-treat analysis, and similar results were recorded in the per-protocol analysis, demonstrating the superiority of PEB to BA. Late lumen loss was significantly lower in the PEB group than in the BA group (-0.06 ± 0.32 vs. 0.18 ± 0.34 mm, P < 0.0001). For intention-to-treat, there were no significant differences between PEB and BA in the 9-month percentages of MACCEs (0.9% vs. 3.7%, P = 0.16) or non-fatal myocardial infarctions (0 vs. 0.9%, P = 0.49). There were no clinical events of target lesion revascularization, target vessel revascularization, target lesion failure, all-cause death, cardiac death or target lesion thrombosis in either group.
CONCLUSIONS:In de novo non-left main coronary artery bifurcations treated with provisional T stenting, SB dilation with the PEB group demonstrated better angiographic results than treatment with regular BA at the 9-month follow-up in terms of reduced target lesion stenosis.
TRIAL REGISTRATION:ClinicalTrials.gov, NCT02325817; https://clinicaltrials.gov.
