Klinik für Innere Medizin, III, Universitätsklinikum des Saarlandes, Homburg/Saar, Germany.
JACC Cardiovasc Interv. 2012 Mar;5(3):323-30. doi: 10.1016/j.jcin.2012.01.008.
This study presents long-term clinical follow-up, including binary restenosis rate and major adverse cardiovascular events, of the PACCOCATH-ISR (Treatment of In-Stent Restenosis by Paclitaxel Coated PTCA Balloons) I and II trial.
The PACCOCATH-ISR trial was a first-in-human study with a drug-coated balloon catheter and the first study for the treatment of coronary ISR with a drug-coated balloon. So, far no long-term follow-up data have been presented.
This study enrolled 108 patients in a randomized, double-blinded multicenter trial on the efficacy and safety of a paclitaxel-coated balloon (3 μg/mm(2) balloon surface; PACCOCATH [Bayer AG, Germany]) compared with an uncoated balloon. The main inclusion criteria were a diameter stenosis of ≥ 70% and <30-mm length with a vessel diameter of 2.5 to 3.5 mm. The primary endpoint was angiographic late lumen loss in-segment after 6 months. Combined antiplatelet therapy was continued only for 1 month followed by treatment with aspirin alone.
During a follow-up of 5.4 ± 1.2 years, the clinical event rate was significantly reduced in patients treated with the drug-coated balloon (major adverse cardiovascular events: 59.3% vs. 27.8%, p = 0.009), which was mainly driven by the reduction of target lesion revascularization from 38.9% to 9.3% (p = 0.004).
Treatment of coronary ISR with paclitaxel-coated balloon catheters is safe and persistently reduces repeat revascularization during long-term follow-up. The initial results were sustained over the 5-year period. (Treatment of In-Stent Restenosis by Paclitaxel Coated PTCA Balloons [PACCOCATH ISR I]; NCT00106587. Treatment of In-Stent Restenosis by Paclitaxel Coated PTCA Balloons [PACCOCATH ISR II]; NCT00409981).
本研究呈现 PACCOCATH-ISR（紫杉醇涂层 PTCA 球囊治疗支架内再狭窄）I 期和 II 期临床试验的长期临床随访结果，包括二元再狭窄率和主要不良心血管事件。
PACCOCATH-ISR 试验是首例应用药物涂层球囊导管的人体研究，也是首例应用药物涂层球囊治疗冠状动脉支架内再狭窄的研究。到目前为止，尚无长期随访数据。
本研究纳入了 108 例在一项随机、双盲、多中心试验中接受紫杉醇涂层球囊（涂层面积为 3μg/mm²；PACCOCATH[拜耳公司，德国]）与非涂层球囊治疗的有效性和安全性评估的患者。主要纳入标准为血管直径为 2.5 至 3.5mm 时，直径狭窄率≥70%且<30mm 长度。主要终点为 6 个月时节段内的血管造影晚期管腔丢失。双联抗血小板治疗仅持续 1 个月，之后单独使用阿司匹林治疗。
在 5.4±1.2 年的随访期间，药物涂层球囊治疗组的临床事件发生率显著降低（主要不良心血管事件：59.3%比 27.8%，p=0.009），这主要归因于靶病变血运重建率从 38.9%降至 9.3%（p=0.004）。
应用紫杉醇涂层球囊导管治疗冠状动脉支架内再狭窄是安全的，在长期随访中持续降低重复血运重建。初始结果在 5 年期间得到维持。[紫杉醇涂层 PTCA 球囊治疗支架内再狭窄（PACCOCATH ISR I）；NCT00106587. 紫杉醇涂层 PTCA 球囊治疗支架内再狭窄（PACCOCATH ISR II）；NCT00409981]。
