Long-Term Outcomes Following Drug-Eluting Balloons Versus Thin-Strut Drug-Eluting Stents for Treatment of In-Stent Restenosis (DEB-Dragon-Registry)

• Published in: Circulation. Cardiovascular interventions Vol. 14; no. 9; p. e010868
• Main Authors: Wańha, Wojciech, Bil, Jacek, Januszek, Rafał, Gilis-Malinowska, Natasza, Figatowski, Tomasz, Milewski, Marek, Pawlik, Artur, Staszczak, Bartłomiej, Wybraniec, Maciej, Tomasiewicz, Brunon, Kübler, Piotr, Kuliczkowski, Wiktor, Walczak, Tomasz, Hrymniak, Bruno, Desperak, Piotr, Mielczarek, Maksymilian, Ciecwierz, Dariusz, Niezgoda, Piotr, Wolny, Rafał, Chudzik, Magdalena, Kuźma, Łukasz, Kralisz, Paweł, Kedhi, Elvin, D’Ascenzo, Fabrizio, Hudziak, Damian, Kowalówka, Adam, Smolka, Grzegorz, Reczuch, Krzysztof, Gruchała, Marcin, Kubica, Jacek, Gil, Robert J., Dobrzycki, Sławomir, Dudek, Dariusz, Bartuś, Stanisław, Gąsior, Mariusz, Ochała, Andrzej, Witkowski, Adam, Jaguszewski, Miłosz, Wojakowski, Wojciech
• Format: Journal Article
• Language: English
• Published: 01.09.2021
• ISSN: 1941-7640; 1941-7632
• DOI: 10.1161/CIRCINTERVENTIONS.121.010868

Background: Data regarding the use of percutaneous coronary intervention with drug-eluting balloons (DEB) versus thin-strut drug-eluting stents (thin-DES) for treating DES in-stent restenosis in everyday clinical practice is scarce. Our goal was to evaluate the efficacy and safety profile of DEB versus thin-DES in DES in-stent restenosis. Methods: Consecutive patients with DES in-stent restenosis who underwent percutaneous coronary intervention between 2008 and 2019 entered the multicenter DEB-DRAGON Registry with a follow-up of 3 years. Patients who received DEB at the index procedure (n=557, 49.9%) were compared with those who received thin-DES (n=560, 50.1%). Results: Analysis of the unmatched cohort revealed lower rates of target lesion revascularization (9.1% versus 13.6%; hazard ratio [HR], 0.58 [95% CI, 0.41–0.83], P =0.003), target vessel revascularization (11.8% versus 16.7%; HR, 0.62 [95% CI, 0.45–0.84], P =0.003) and device-oriented composite end point, defined as a composite of cardiac death, target lesion revascularization, and target vessel myocardial infarction (12.7% versus 16.0%; HR, 0.69 [95% CI, 0.50–0.94], P =0.018) in the thin-DES group compared with the DEB group. The incidence of cardiac death, target vessel-myocardial infarction, and myocardial infarction were similar in both groups. However, after propensity score matching, there were no significant differences in target lesion revascularization (11.2% versus 11.2%; HR, 0.91 [95% CI, 0.55–1.51], P =0.707), target vessel revascularization (13.4% versus 14.2%; HR, 0.86 [95% CI, 0.55–1.36], P =0.523), and device-oriented composite end point (14.2% versus 14.2%; HR, 0.91 [95% CI, 0.58–1.42], P =0.667) between the thin-DES and DEB group, respectively. Conclusions: This analysis of a real-life registry revealed similar long-term outcomes of thin-DES and DEB in DES in-stent restenosis regarding target lesion revascularization, myocardial infarction, cardiac death, and device-oriented composite end point. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT04415216.