A drug-eluting Balloon for the trEatment of coronarY bifurcatiON lesions in the side branch : a prospective multicenter ranDomized (BEYOND) clinical trial in China
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.
Medienart: |
E-Artikel |
---|
Erscheinungsjahr: |
2020 |
---|---|
Erschienen: |
2020 |
Enthalten in: |
Zur Gesamtaufnahme - volume:133 |
---|---|
Enthalten in: |
Chinese medical journal - 133(2020), 8 vom: 20. Apr., Seite 899-908 |
Sprache: |
Englisch |
---|
Beteiligte Personen: |
Jing, Quan-Min [VerfasserIn] |
---|
Links: |
---|
Themen: |
Journal Article |
---|
Anmerkungen: |
Date Completed 01.02.2021 Date Revised 01.02.2021 published: Print ClinicalTrials.gov: NCT02325817 Citation Status MEDLINE |
---|
doi: |
10.1097/CM9.0000000000000743 |
---|
funding: |
|
---|---|
Förderinstitution / Projekttitel: |
|
PPN (Katalog-ID): |
NLM308506898 |
---|
LEADER | 01000naa a22002652 4500 | ||
---|---|---|---|
001 | NLM308506898 | ||
003 | DE-627 | ||
005 | 20231225131858.0 | ||
007 | cr uuu---uuuuu | ||
008 | 231225s2020 xx |||||o 00| ||eng c | ||
024 | 7 | |a 10.1097/CM9.0000000000000743 |2 doi | |
028 | 5 | 2 | |a pubmed24n1028.xml |
035 | |a (DE-627)NLM308506898 | ||
035 | |a (NLM)32265425 | ||
040 | |a DE-627 |b ger |c DE-627 |e rakwb | ||
041 | |a eng | ||
100 | 1 | |a Jing, Quan-Min |e verfasserin |4 aut | |
245 | 1 | 2 | |a A drug-eluting Balloon for the trEatment of coronarY bifurcatiON lesions in the side branch |b a prospective multicenter ranDomized (BEYOND) clinical trial in China |
264 | 1 | |c 2020 | |
336 | |a Text |b txt |2 rdacontent | ||
337 | |a ƒaComputermedien |b c |2 rdamedia | ||
338 | |a ƒa Online-Ressource |b cr |2 rdacarrier | ||
500 | |a Date Completed 01.02.2021 | ||
500 | |a Date Revised 01.02.2021 | ||
500 | |a published: Print | ||
500 | |a ClinicalTrials.gov: NCT02325817 | ||
500 | |a Citation Status MEDLINE | ||
520 | |a 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 | ||
520 | |a 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 | ||
520 | |a 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 | ||
520 | |a 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 | ||
520 | |a TRIAL REGISTRATION: ClinicalTrials.gov, NCT02325817; https://clinicaltrials.gov | ||
650 | 4 | |a Journal Article | |
650 | 4 | |a Multicenter Study | |
650 | 4 | |a Randomized Controlled Trial | |
650 | 7 | |a Paclitaxel |2 NLM | |
650 | 7 | |a P88XT4IS4D |2 NLM | |
700 | 1 | |a Zhao, Xin |e verfasserin |4 aut | |
700 | 1 | |a Han, Ya-Ling |e verfasserin |4 aut | |
700 | 1 | |a Gao, Ling-Ling |e verfasserin |4 aut | |
700 | 1 | |a Zheng, Yang |e verfasserin |4 aut | |
700 | 1 | |a Li, Zhan-Quan |e verfasserin |4 aut | |
700 | 1 | |a Yang, Ping |e verfasserin |4 aut | |
700 | 1 | |a Cong, Hong-Liang |e verfasserin |4 aut | |
700 | 1 | |a Gao, Chuan-Yu |e verfasserin |4 aut | |
700 | 1 | |a Jiang, Tie-Min |e verfasserin |4 aut | |
700 | 1 | |a Li, Hui |e verfasserin |4 aut | |
700 | 1 | |a Li, Jun-Xia |e verfasserin |4 aut | |
700 | 1 | |a Wang, Dong-Mei |e verfasserin |4 aut | |
700 | 1 | |a Wang, Geng |e verfasserin |4 aut | |
700 | 1 | |a Cong, Zhan-Chun |e verfasserin |4 aut | |
700 | 1 | |a Zhang, Zhong |e verfasserin |4 aut | |
773 | 0 | 8 | |i Enthalten in |t Chinese medical journal |d 1979 |g 133(2020), 8 vom: 20. Apr., Seite 899-908 |w (DE-627)NLM000002755 |x 2542-5641 |7 nnns |
773 | 1 | 8 | |g volume:133 |g year:2020 |g number:8 |g day:20 |g month:04 |g pages:899-908 |
856 | 4 | 0 | |u http://dx.doi.org/10.1097/CM9.0000000000000743 |3 Volltext |
912 | |a GBV_USEFLAG_A | ||
912 | |a GBV_NLM | ||
951 | |a AR | ||
952 | |d 133 |j 2020 |e 8 |b 20 |c 04 |h 899-908 |