Cervinka Pavel, Costa Marco A, Angiolillo Dominick J, Spacek Radim, Bystron Marian, Kvasnák Martin, Veselka Josef, Nanda Hitesh, Futamatsu Hideki, Futamatsu Kino
Division of cardiology, Masaryk hospital Ustí nad Labem, Czech Republic.
Catheter Cardiovasc Interv. 2006 Jun;67(6):846-51. doi: 10.1002/ccd.20755.
The aim of this study was to assess neointimal hyperplasia following sirolimus-eluting (SES) and paclitaxel-eluting stents (PES) implantation in a patients with complex coronary disease.
Between January to December 2004, 70 patients were enrolled in this study (SES = 37; PES = 33. The primary objective was to assess the efficacy of SES and PES on neointimal proliferation inhibition in patients with complex coronary lesions by volumetric 3D intravascular ultrasound (IVUS) assessment at six-month follow-up.
Baseline clinical, demographic or angiographic characteristics were well balanced in both groups. All procedures as well as hospitalisation were uneventful. The percentage of B2/C lesions in our study was > 90% in both groups. The IVUS-assessed in-stent mean neointimal hyperplasia volume was significantly lower in lesions treated with SES compared to PES (4.1 +/- 11 mm3 vs. 17.4 +/- 23 mm3, p < 0.002) at 6 month follow-up. No difference in both MACE (3.0 versus 6.0%, p = NS) and restenosis (5.4 versus 9.1%, p = NS) were found. The in-segment late loss at six month was 0.26 mm in the SES and 0.48 mm in the PES group (p = NS).
The present study showed reduced neointimal proliferation after sirolimuseluting as compared to paclitaxel-eluting stents in patients with complex coronary artery disease. Both SES and PES were associated with low rate of angiographic restenosis or major adverse cardiovascular events.
本研究的目的是评估西罗莫司洗脱支架(SES)和紫杉醇洗脱支架(PES)植入复杂冠状动脉疾病患者后新生内膜增生情况。
2004年1月至12月期间,70例患者纳入本研究(SES组37例;PES组33例)。主要目的是通过三维血管内超声(IVUS)在6个月随访时评估SES和PES对复杂冠状动脉病变患者新生内膜增殖抑制的疗效。
两组患者的基线临床、人口统计学或血管造影特征均衡良好。所有手术及住院过程均顺利。本研究中两组B2/C病变的比例均>90%。在6个月随访时,SES治疗的病变中,IVUS评估的支架内平均新生内膜增生体积显著低于PES组(4.1±11mm³对17.4±23mm³,p<0.002)。主要不良心血管事件(MACE)(3.0%对6.0%,p=无统计学意义)和再狭窄(5.4%对9.1%,p=无统计学意义)在两组中均无差异。SES组6个月时节段内晚期管腔丢失为0.26mm,PES组为0.48mm(p=无统计学意义)。
本研究表明,在复杂冠状动脉疾病患者中,与紫杉醇洗脱支架相比,西罗莫司洗脱支架后新生内膜增殖减少。SES和PES均与血管造影再狭窄率或主要不良心血管事件发生率较低相关。