Salvatore Cassese1, Bo Xu2, Seiji Habara3, Harald Rittger4, Robert A Byrne5, Matthias Waliszewski6, María José Pérez-Vizcayno7, Runlin Gao2, Adnan Kastrati8, Fernando Alfonso9. 1. Klinik für Herz- und Kreislauferkrankungen, Deutsches Herzzentrum München, Technische Universität München, München, Germany. Electronic address: cassese@dhm.mhn.de. 2. National Center for Cardiovascular Diseases, Fu Wai Hospital, Beijing, China. 3. Department of Cardiology, Kurashiki Central Hospital, Okayama, Japan. 4. Medizinische Klinik I, Klinikum Fürth, Fürth, Germany. 5. Klinik für Herz- und Kreislauferkrankungen, Deutsches Herzzentrum München, Technische Universität München, München, Germany. 6. Medical Scientific Affairs, B. Braun Vascular Systems, Berlin, Germany. 7. Fundación Interhospitalaria de Investigación Cardiovascular, Hospital Universitario Clínico San Carlos, Madrid, Spain. 8. Klinik für Herz- und Kreislauferkrankungen, Deutsches Herzzentrum München, Technische Universität München, München, Germany; German Centre for Cardiovascular Research (Deutsche Zentrum für Herz-Kreislauf-Forschung, DZHK), partner site Munich Heart Alliance, München, Germany. 9. Servicio de Cardiología, Hospital Universitario de La Princesa, Madrid, Spain.
Abstract
INTRODUCTION AND OBJECTIVES: The incidence and predictors of recurrent restenosis after drug-coated balloon (DCB) angioplasty for drug-eluting stent (DES) restenosis remain poorly studied. We sought to evaluate the incidence and predictors of recurrent restenosis among participants in randomized controlled trials receiving DCB angioplasty for DES restenosis. METHODS: The clinical and lesion data of individuals enrolled in 6 randomized controlled trials of DCB angioplasty for DES restenosis were pooled. All patients included in this report were assigned to receive paclitaxel-coated balloon angioplasty with the SeQuent Please DCB (B Braun, Melsungen, Germany). The current analysis focused on participants with available follow-up angiography at 6 to 9 months. The incidence of recurrent restenosis, defined as diameter restenosis ≥ 50% in the in-segment area at follow-up angiography, and its clinical and angiographic predictors were evaluated. RESULTS: A total of 546 patients were combined in a single dataset. Angiographic follow-up at 6 to 9 months was available for 484 patients (88.6%) with 518 treated lesions. Recurrent restenosis was detected in 101 (20.8%) patients. On multivariable analysis, lesion length (OR, 1.58; 95%CI, 1.10-2.26; P=.012 for 5mm increase) and vessel size (OR, 1.42; 95%, 1.12-1.79; P=.003 for 0.5mm reduction) were independently associated with recurrent restenosis. CONCLUSIONS: In the largest cohort to date of individuals with angiographic surveillance after DCB angioplasty for DES restenosis, we demonstrated that recurrent restenosis occurs in approximately 1 out of 5 patients. Predictors of recurrent restenosis are increased lesion length and small vessel size.
INTRODUCTION AND OBJECTIVES: The incidence and predictors of recurrent restenosis after drug-coated balloon (DCB) angioplasty for drug-eluting stent (DES) restenosis remain poorly studied. We sought to evaluate the incidence and predictors of recurrent restenosis among participants in randomized controlled trials receiving DCB angioplasty for DES restenosis. METHODS: The clinical and lesion data of individuals enrolled in 6 randomized controlled trials of DCB angioplasty for DES restenosis were pooled. All patients included in this report were assigned to receive paclitaxel-coated balloon angioplasty with the SeQuent Please DCB (B Braun, Melsungen, Germany). The current analysis focused on participants with available follow-up angiography at 6 to 9 months. The incidence of recurrent restenosis, defined as diameter restenosis ≥ 50% in the in-segment area at follow-up angiography, and its clinical and angiographic predictors were evaluated. RESULTS: A total of 546 patients were combined in a single dataset. Angiographic follow-up at 6 to 9 months was available for 484 patients (88.6%) with 518 treated lesions. Recurrent restenosis was detected in 101 (20.8%) patients. On multivariable analysis, lesion length (OR, 1.58; 95%CI, 1.10-2.26; P=.012 for 5mm increase) and vessel size (OR, 1.42; 95%, 1.12-1.79; P=.003 for 0.5mm reduction) were independently associated with recurrent restenosis. CONCLUSIONS: In the largest cohort to date of individuals with angiographic surveillance after DCB angioplasty for DES restenosis, we demonstrated that recurrent restenosis occurs in approximately 1 out of 5 patients. Predictors of recurrent restenosis are increased lesion length and small vessel size.
Authors: Monika Colombo; Yong He; Anna Corti; Diego Gallo; Stefano Casarin; Jared M Rozowsky; Francesco Migliavacca; Scott Berceli; Claudio Chiastra Journal: Sci Rep Date: 2021-01-15 Impact factor: 4.379