Loh Joshua P, Stella Pieter R, Sangiorgi Giuseppe, Silber Sigmund, Stahnke Stefanie, von Strandmann Rembert Pogge, Torguson Rebecca, Waksman Ron
Interventional Cardiology, MedStar Washington Hospital Center, Washington DC, USA.
Department of Cardiology, University Medical Center Utrecht, Utrecht, The Netherlands.
Cardiovasc Revasc Med. 2014 Jan;15(1):23-8. doi: 10.1016/j.carrev.2013.08.011.
To analyze the effect of paclitaxel-coated balloon (PCB) treatment on patients with drug-eluting stent (DES) restenosis.
In the Valentines I trial, treatment of coronary in-stent restenosis was effective and safe with the second-generation DIOR® PCB.
Valentines I prospectively enrolled 250 patients with in-stent restenosis (ISR); 76 patients (30.4%) had restenosis of a previous paclitaxel or limus DES. Patients underwent balloon angioplasty followed by PCB treatment. Clinical outcomes of patients with paclitaxel-eluting DES restenosis (n=34; 41 lesions) and limus-eluting (sirolimus, everolimus and zotarolimus) DES restenosis (n=42; 43 lesions) treated with DIOR® PCB were compared.
Baseline characteristics were similar. There were more diffuse lesions >20mm treated in paclitaxel- compared to limus-eluting DES restenosis (50% vs. 26.8%, p=0.032). Number of PCB used per patient (1.08±0.31 overall), mean PCB diameter (2.99±0.42mm overall), mean PCB length (24.4±11.9mm overall), and bailout stenting (2.4% vs. 4.7%) were similar (p=NS). At mean follow-up of 231±43days, major adverse cardiac events was 0% vs. 23.8% in paclitaxel- vs. limus-eluting DES restenosis (p=0.002), driven mainly by less target vessel revascularization (0% vs. 21.4%, p=0.004). Target lesion revascularization was 0% vs. 16.7% for paclitaxel- vs. limus-eluting DES restenosis (p=0.015).
In Valentines I, PCB use was more effective in patients with paclitaxel DES restenosis compared to limus DES restenosis, achieving better mid-term clinical outcomes. This suggests the efficacy of localized paclitaxel delivery to overcome paclitaxel resistance but not limus resistance due to different mechanisms of DES failure.
分析紫杉醇涂层球囊（PCB）治疗药物洗脱支架（DES）再狭窄患者的效果。
在情人节I试验中，第二代DIOR® PCB治疗冠状动脉支架内再狭窄有效且安全。
情人节I前瞻性纳入250例支架内再狭窄（ISR）患者；76例（30.4%）曾有紫杉醇或雷帕霉素DES再狭窄。患者接受球囊血管成形术，随后进行PCB治疗。比较使用DIOR® PCB治疗的紫杉醇洗脱DES再狭窄患者（n = 34；41处病变）和雷帕霉素洗脱（西罗莫司、依维莫司和佐他莫司）DES再狭窄患者（n = 42；43处病变）的临床结局。
基线特征相似。与雷帕霉素洗脱DES再狭窄相比，紫杉醇洗脱DES再狭窄中治疗的弥漫性病变>20mm更多（50%对26.8%，p = 0.032）。每位患者使用的PCB数量（总体为1.08±0.31）、平均PCB直径（总体为2.99±0.42mm）、平均PCB长度（总体为24.4±11.9mm）和补救性支架置入（2.4%对4.7%）相似（p = 无显著差异）。在平均231±43天的随访中，紫杉醇洗脱DES再狭窄与雷帕霉素洗脱DES再狭窄的主要不良心脏事件分别为0%和23.8%（p = 0.002），主要是由于靶血管再血管化较少（0%对21.4%，p = 0.004）。紫杉醇洗脱DES再狭窄与雷帕霉素洗脱DES再狭窄的靶病变再血管化分别为0%和16.7%（p = 0.015）。
在情人节I试验中，与雷帕霉素DES再狭窄患者相比，PCB治疗紫杉醇DES再狭窄患者更有效，可实现更好的中期临床结局。这表明局部递送紫杉醇可有效克服紫杉醇耐药，但由于DES失败机制不同，无法克服雷帕霉素耐药。
