Two-year results and subgroup analyses of the PEPCAD China in-stent restenosis trial: A prospective, multicenter, randomized trial for the treatment of drug-eluting stent in-stent restenosis

Catheterization and Cardiovascular Interventions : Official Journal of the Society for Cardiac Angiography & Interventions
Bo XuPEPCAD China ISR investigators

Abstract

The PEPCAD China ISR trial investigated the safety and efficacy of paclitaxel-coated balloon (PCB) angioplasty in an Asian patient population with coronary drug-eluting stent in-stent restenosis (DES-ISR). A total of 220 patients with coronary DES-ISR were treated with PCB angioplasty or with paclitaxel-eluting stents (PES). This randomized (1:1), single-blind prospective multicenter trial in a Chinese population used 9-month in-segment late lumen loss (LLL) as the primary endpoint. Secondary endpoints included the 24-month clinical event rates. Both treatment groups were similar in terms of patient, lesion, or procedural characteristics. After the 12-month follow-up evaluation, additional clinical events only occurred in the PES study group. The combined rate of all-cause mortality and myocardial infarction (MI) in the PCB group was significantly lower than that in the PES group (3.7% vs. 11.8%, P = 0.03). Additional subgroup analyses of 9-month in-segment LLL and 2-year target lesion failure in patients with diabetes, small vessels, diffuse ISR, and stent margin restenosis did not show more favorable results for one specific treatment group. The 2-year follow-up demonstrated sustained long-term clinical efficacy for both devi...Continue Reading

References

May 2, 2007·Circulation·Donald E CutlipUNKNOWN Academic Research Consortium
Feb 26, 2011·JACC. Cardiovascular Interventions·Seiji HabaraMitsuru Yoshino
Jun 15, 2013·Catheterization and Cardiovascular Interventions : Official Journal of the Society for Cardiac Angiography & Interventions·Mohammad AlmallaRainer Hoffmann
Jul 4, 2015·Journal of the American College of Cardiology·Seiji HabaraKazuaki Mitsudo
Jul 4, 2015·Journal of the American College of Cardiology·Fernando AlfonsoUNKNOWN RIBS IV Study Investigators (under auspices of Interventional Cardiology Working Group of Spanish Society of Cardiology)

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Citations

Jun 29, 2017·Catheterization and Cardiovascular Interventions : Official Journal of the Society for Cardiac Angiography & Interventions·Stephen W WaldoEhrin J Armstrong
Jul 19, 2018·Catheterization and Cardiovascular Interventions : Official Journal of the Society for Cardiac Angiography & Interventions·Leos PlevaOta Hlinomaz
Jan 11, 2020·Expert Opinion on Drug Delivery·Thomas NestelbergerRaban Jeger
Nov 13, 2019·Catheterization and Cardiovascular Interventions : Official Journal of the Society for Cardiac Angiography & Interventions·Yangbo XiJianmin Xiao
Jan 23, 2019·EuroIntervention : Journal of EuroPCR in Collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology·Franz-Josef NeumannMichael O Zembala
Aug 31, 2018·European Heart Journal·Franz-Josef NeumannUNKNOWN ESC Scientific Document Group
Aug 31, 2018·European Journal of Cardio-thoracic Surgery : Official Journal of the European Association for Cardio-thoracic Surgery·Miguel Sousa-UvaUNKNOWN ESC Scientific Document Group
Aug 28, 2017·EuroIntervention : Journal of EuroPCR in Collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology·Fernando Alfonso, Bruno Scheller
Nov 7, 2019·Future Cardiology·Dario BuccheriBernardo Cortese
Mar 7, 2020·Journal of the American College of Cardiology·Bruno SchellerFelix Mahfoud
Aug 12, 2021·Deutsches Ärzteblatt International·Helen UllrichTommaso Gori

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