V Auffret1, J Berland2, P Barragan3, M Waliszewski4, L Bonello5, N Delarche6, A Furber7, F Albert8, D Carrié9, H Eltchaninoff10, M Pansieri11, M Schneeberger12, C Piot13, P Marcollet14, M Bedossa15. 1. CHU Rennes, Service de Cardiologie et Maladies Vasculaires, Rennes, F-35000, France; INSERM, U1099, Rennes, F-35000, France; Université de Rennes 1, LTSI, Rennes, F-35000, France. 2. Clinique Saint Hilaire Rouen, Service de Cardiologie, F-76000, France. 3. Polyclinique Les Fleurs Ollioules, Service de Cardiologie, F-83190, France. 4. Medical Scientific Affairs, B. Braun Melsungen AG, Germany. 5. Département de Cardiologie Centre Hospitalo, Universitaire Nord, Marseille, F-13915, France. 6. Centre Hospitalier de Pau, Service de Cardiologie, F-64000, France. 7. Centre Hospitalier Universitaire Angers, Service de Cardiologie, F-49100, France. 8. Centre Hospitalier de Chartres, Service de Cardiologie, F-28018, France. 9. CHU de Toulouse, Service de Cardiologie, F-31059, France. 10. CHU de Rouen, Service de Cardiologie, F-76000, France. 11. Centre Hospitalier Avignon, Service de Cardiologie, F-84000, France. 12. Hôpital Albert Schweitzer, Colmar, Service de Cardiologie, F-68024, France. 13. CHU de Montpellier, Service de Cardiologie, F-34090, France. 14. Centre Hospitalier de Bourges, Service de Cardiologie, F-18000, France. 15. CHU Rennes, Service de Cardiologie et Maladies Vasculaires, Rennes, F-35000, France; INSERM, U1099, Rennes, F-35000, France; Université de Rennes 1, LTSI, Rennes, F-35000, France. Electronic address: marc.bedossa@chu-rennes.fr.
Abstract
BACKGROUND: Data about paclitaxel-eluting balloon (PCB) angioplasty to treat drug-eluting stents (DES) in-stent restenosis (ISR) were mainly collected in selected patient populations in the setting of randomized trials. The main goal of this prospective registry was to confirm the positive findings of these studies in an unselected population in clinical practice. METHODS: Consecutive patients with DES-ISR treated by PCB angioplasty were recruited in this prospective real-world registry. The primary endpoint was clinically driven target-lesion revascularization (TLR) at 9 months. Secondary endpoints included acute technical success, in-hospital outcomes, 9-month major adverse cardiac events (MACE) a composite of death, myocardial infarction (MI) and TLR and the occurrence of target vessel revascularization. RESULTS: A total of 206 patients (67.7 ± 10.2 years, 80.6% male, 41.3% diabetics) with 210 lesions were recruited. Unstable coronary artery disease was present in 55.3% of patients. The time from DES implantation to DES-ISR was 3.0 ± 2.4 years. Quantitative analyses revealed that patterns of treated DES-ISR were focal in 55.7% and diffuse in 44.3%. The reference diameter was 2.76 ± 0.64 mm. The 9-month follow-up rate was 90.8% (187/206). At 9 months, the TLR rate was 7.0% (13/187) whereas the rates for MACE, MI and cardiac death were 10.7% (20/187), 4.8% (9/187) and 2.1% (4/187) respectively. Results were consistent in patients with paclitaxel and non-paclitaxel-eluting stents (PES) ISR. CONCLUSION: This large prospective registry demonstrated acceptable rates of TLR and MACE at 9 months after treatment of DES-ISR by PCB angioplasty. PCB angioplasty was equally effective in patients with PES-ISR and non PES-ISR.
BACKGROUND: Data about paclitaxel-eluting balloon (PCB) angioplasty to treat drug-eluting stents (DES) in-stent restenosis (ISR) were mainly collected in selected patient populations in the setting of randomized trials. The main goal of this prospective registry was to confirm the positive findings of these studies in an unselected population in clinical practice. METHODS: Consecutive patients with DES-ISR treated by PCB angioplasty were recruited in this prospective real-world registry. The primary endpoint was clinically driven target-lesion revascularization (TLR) at 9 months. Secondary endpoints included acute technical success, in-hospital outcomes, 9-month major adverse cardiac events (MACE) a composite of death, myocardial infarction (MI) and TLR and the occurrence of target vessel revascularization. RESULTS: A total of 206 patients (67.7 ± 10.2 years, 80.6% male, 41.3% diabetics) with 210 lesions were recruited. Unstable coronary artery disease was present in 55.3% of patients. The time from DES implantation to DES-ISR was 3.0 ± 2.4 years. Quantitative analyses revealed that patterns of treated DES-ISR were focal in 55.7% and diffuse in 44.3%. The reference diameter was 2.76 ± 0.64 mm. The 9-month follow-up rate was 90.8% (187/206). At 9 months, the TLR rate was 7.0% (13/187) whereas the rates for MACE, MI and cardiac death were 10.7% (20/187), 4.8% (9/187) and 2.1% (4/187) respectively. Results were consistent in patients with paclitaxel and non-paclitaxel-eluting stents (PES) ISR. CONCLUSION: This large prospective registry demonstrated acceptable rates of TLR and MACE at 9 months after treatment of DES-ISR by PCB angioplasty. PCB angioplasty was equally effective in patients with PES-ISR and non PES-ISR.