E-Abstract

JACC

Lots of interesting abstracts and cases were submitted for TCTAP 2024. Below are the accepted ones after a thorough review by our official reviewers. Don¡¯t miss the opportunity to expand your knowledge and interact with authors as well as virtual participants by sharing your opinion in the comment section!

TCTAP A-030

Safety and Efficacy of Paclitaxel-Coated Balloon for the Treatment of Coronary In-Stent Stenosis: 5-Year Results From the PEPCAD China Registry Study

By Cheng Yang, Jie Qian

Presenter

Cheng Yang

Authors

Cheng Yang1, Jie Qian1

Affiliation

Fuwai Hospital, China1
View Study Report
TCTAP A-030
DES/BRS/DCB

Safety and Efficacy of Paclitaxel-Coated Balloon for the Treatment of Coronary In-Stent Stenosis: 5-Year Results From the PEPCAD China Registry Study

Cheng Yang1, Jie Qian1

Fuwai Hospital, China1

Background

The intention of the PEPCAD China Registry was to demonstrate the safety and effectiveness of paclitaxel-coated balloon (PCB) in an Asian patient population with coronary drug-eluting stent in-stent restenosis (DES-ISR).

Methods

The PEPCAD China Registry study was a prospective, multicenter, single-arm study with primary outcome of 12-month target lesion failure (TLF), including cardiac death, target vessel myocardial infarction (TV-MI) and ischemia-driven target lesion revascularization (TLR). Stent thrombosis was defined according to the Academic Research Consortium (ARC) definition. The clinical follow-up was maintained up to 5 years.

Results

A total of 516 patients with DES-ISR were included in this registry study. The 12-month incidence of TLF was 7.59% and the incidence of TLF components were, cardiac death 0.39%, TV-MI 1.95%, and TLR 6.23%. From 12 to 60 months, 1/65 (1.5%) DCB patients experienced a myocardial infarction while neither TLR nor death occurred in any study patient in either group during that period. The 5-year incidence of TLF was 23.08% and the incidence of TLF components were, cardiac death 2.88%, TV-MI 3.21%, and TLR 18.91%. Three (0.96%) definite/probable stent thrombosis was observed at 5-year follow-up.

Conclusion

The low TLF incidence in this study indicates that PCB is safe and effective in the treatment of coronary in-stent stenosis. (Clinical Trial.gov identifier: NCT03624205)