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Abstract Background We previously showed non‐inferiority of a low‐dose paclitaxel‐coated balloon (PCB) with citrate excipient (Agent PCB) as compared to normal‐dose iopromide excipient (SeQuent Please PCB) in terms of angiographic and clinical endpoints at 12 months. The long‐term clinical efficacy and safety of Agent PCB is not defined. Methods 262 patients (323 DES‐ISR lesions) were enrolled in this study and treated with either Agent PCB (125 patients, 151 lesions) in the ISAR‐DESIRE 3a trial or with SeQuent Please PCB (137 patients, 172 lesions) in the setting of the randomized ISAR‐DESIRE 3 trial with similar in‐ and exclusion criteria serving as historical control arm. The follow‐up period was extended to 7 years. The efficacy and safety endpoints of this analysis were target‐lesion revascularization (TLR), death, myocardial infarction (MI) and target lesion thrombosis (TLT) at 7 years. Results At 7 years, 206 patients (78.6%) were alive. The risks of TLR (hazard ratio HR: 1.29, 95% confidence interval CI: 0.87–1.90; p = 0.205), death (HR: 1.38, 95% CI: 0.82‐2.35; p = 0.227), MI (HR: 1.10, 95% CI: 0.39–3.15; p = 0.852) and TLT (HR: 2.18, 95% CI: 0.20–24.10; p = 0.523) were comparable between Agent PCB and SeQuent PCB. Multivariate analysis showed comparable risks of TLR, death and MI between both PCB devices. Conclusions In patients treated for DES‐ISR by angioplasty with Agent PCB and SeQuent Please PCB, there was no statistically significant difference in TLR at 7 years. Randomized trials with standardized lesion preparation and long‐term follow‐up are warranted to further evaluate comparative efficacy of both devices. (ClinicalTrials. gov Identifier: NCT02367495).
Koch et al. (Wed,) studied this question.