BackgroundWe 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.Methods262 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.ResultsAt 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.ConclusionsIn 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).

中文翻译：

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两种不同涂层策略的紫杉醇涂层球囊治疗药物洗脱冠状动脉支架再狭窄的长期疗效和安全性比较


背景我们之前表明，在 12 个月时的血管造影和临床终点方面，与正常剂量碘普罗胺赋形剂 (SeQuent Please PCB) 相比，含有柠檬酸盐赋形剂 (Agent PCB) 的低剂量紫杉醇涂层球囊 (PCB) 具有非劣效性。 PCB 剂的长期临床疗效和安全性尚未确定。方法 262 名患者（323 个 DES-ISR 病变）被纳入本研究，并在 ISAR-DESIRE 3a 试验中使用 PCB 剂（125 名患者，151 个病变）或在随机 ISAR-DESIRE 3 试验中使用 SeQuent Please PCB（137 名患者，172 个病变），以类似的纳入标准和排除标准作为历史对照组。随访期延长至7年。该分析的有效性和安全性终点是 7 年时的靶病灶血运重建 (TLR)、死亡、心肌梗死 (MI) 和靶病灶血栓形成 (TLT)。 结果 7 年时，206 名患者 (78.6%) 存活。 TLR 风险（风险比 [HR]：1.29，95% 置信区间 [CI]：0.87-1.90；p = 0.205）、死亡（HR：1.38，95% CI：0.82-2.35；p = 0.227）、MI Agent PCB 和 SeQuent PCB 之间的（HR：1.10，95% CI：0.39–3.15；p = 0.852）和 TLT（HR：2.18，95% CI：0.20–24.10；p = 0.523）具有可比性。多变量分析显示两种 PCB 装置之间的 TLR、死亡和 MI 风险相当。 结论 在使用 Agent PCB 和 SeQuent Please PCB 进行血管成形术接受 DES-ISR 治疗的患者中，7 年时 TLR 没有统计学上的显着差异。有必要进行标准化病灶准备和长期随访的随机试验，以进一步评估两种设备的比较疗效。 （ClinicalTrials.gov 标识符：NCT02367495）。