Department of Cardiology and Angiology, Hannover Medical School, Hannover, Germany.
EuroIntervention. 2019 Jul 20;15(4):e382-e388. doi: 10.4244/EIJ-D-18-00261.
The aim of this study was to investigate the use of a drug-coated balloon (DCB) in daily clinical practice and provide further evidence on the safety and efficacy of paclitaxel-coated balloon treatment using urea as an inert excipient.
Between December 2013 and December 2015, 757 patients treated for coronary lesions with the IN.PACT Falcon balloon were enrolled in this prospective real-world all-comers registry. The primary outcome was the clinically driven target lesion revascularisation (TLR) rate at 12 months. The secondary outcome was major adverse cardiac events (MACE) defined as cardiac death, myocardial infarction, TLR and target vessel revascularisation (TVR). Out of 805 lesions, 43.1% were de novo, and 53.2% drug-eluting stent (DES) or bare metal stent (BMS) in-stent restenosis (ISR). TLR at 12 months was 6.2% and TVR 8.3%. MACE occurred in 9.7% of patients with a composite of cardiac death in 0.8% and myocardial infarction in 2.7% plus TLR/TVR. Subgroup analysis confirmed a TLR rate of 7.5% for ISR (2.1% BMS and 9.5% DES) and 4.9% for de novo lesions.
The IN.PACT Falcon urea-based paclitaxel-coated balloon is safe and efficient in de novo and ISR lesions with low rates of TLR/TVR. The high proportion of treatment of de novo lesions indicates that a DCB-only strategy is nowadays common.
本研究旨在调查药物涂层球囊（DCB）在日常临床实践中的应用，并提供使用尿素作为惰性赋形剂的紫杉醇涂层球囊治疗的安全性和有效性的进一步证据。
2013 年 12 月至 2015 年 12 月，757 例接受 IN.PACT Falcon 球囊治疗的冠状动脉病变患者被纳入本前瞻性真实世界所有患者登记研究。主要终点为 12 个月时临床驱动的靶病变血运重建（TLR）率。次要终点为主要不良心脏事件（MACE），定义为心脏死亡、心肌梗死、TLR 和靶血管血运重建（TVR）。在 805 个病变中，43.1%为初发型，53.2%为药物洗脱支架（DES）或裸金属支架（BMS）支架内再狭窄（ISR）。12 个月时 TLR 为 6.2%，TVR 为 8.3%。9.7%的患者发生 MACE，其中包括 0.8%的心脏死亡和 2.7%的心肌梗死加上 TLR/TVR。亚组分析证实，ISR 的 TLR 率为 7.5%（BMS 为 2.1%，DES 为 9.5%），初发型病变的 TLR 率为 4.9%。
IN.PACT Falcon 尿素基紫杉醇涂层球囊在初发型和 ISR 病变中安全有效，TLR/TVR 发生率低。初发型病变治疗比例较高表明，目前 DCB 治疗策略较为常见。
