比较依维莫司洗脱支架与西罗莫司洗脱和紫杉醇洗脱支架：通过血管内超声体积分析评估内膜增生和血管变化。
Comparison of zotarolimus-eluting stents with sirolimus-eluting and paclitaxel-eluting stents: intimal hyperplasia and vascular changes assessed by volumetric intravascular ultrasound analysis.
机构信息
Department of Cardiology, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea.
出版信息
Circ Cardiovasc Interv. 2011 Apr 1;4(2):139-45. doi: 10.1161/CIRCINTERVENTIONS.110.957936. Epub 2011 Mar 1.
BACKGROUND
As a substudy of the large, randomized ZEST (Comparison of the Efficacy and Safety of Zotarolimus-Eluting Stent with Sirolimus-Eluting and PacliTaxel-Eluting Stent for Coronary Lesions) trial comparing first- and second-generation drug-eluting stents, we evaluated intimal hyperplasia (IH) and vascular changes using volumetric intravascular ultrasound analysis.
METHODS AND RESULTS
Complete angiographic and volumetric intravascular ultrasound data immediately after stenting and at 9-month follow-up were available in 162 patients with 183 lesions: 61 sirolimus-eluting stents (SES), 64 paclitaxel-eluting stents (PES), and 58 zotarolimus-eluting stents (ZES). External elastic membrane, stent, lumen, and peristent plaque volumes (external elastic membrane minus stent) were normalized by stent length. Percent IH volumes were calculated as [IH volume/stent volume]×100, %. Reduction of minimal luminal area) was greater in PES than SES (-1.4±1.5 mm(2) versus -0.7±0.9 mm(2), P=0.003), whereas minimal luminal area change in ZES was not significantly different from SES (-1.2±1.0 mm(2) versus -0.7±0.9 mm(2), P=0.055). Percent IH volume was less in SES compared with PES (9.8±6.0% versus 17.5±11.2%, P=0.002) or with ZES (9.8±6.0% versus 18.2±7.6%, P=0.005). Comparing ZES versus PES, there were no significant differences in %IH volume (17.5±11.2% versus 18.2±7.6%, P=0.779) or changes in normalized lumen volume (-1.2±1.3 mm(2) versus -1.1±0.8 mm(2), P=0.452). Late stent malapposition was identified in 8 (13%) SES and 2 (3%) PES but in no ZES (P=0.050). Angiographic restenosis was detected in 6 lesions (3 PES and 3 ZES).
CONCLUSIONS
The degree of neointimal growth in ZES was similar to that in PES but less than that in SES. ZES had no late stent malappositions.
CLINICAL TRIAL REGISTRATION
URL: http://www.clinicaltrials.gov. Unique identifier: NCT00418067.
背景
作为大型随机 ZEST（比较雷帕霉素洗脱支架与西罗莫司洗脱和紫杉醇洗脱支架治疗冠状动脉病变的疗效和安全性）试验的一个亚组研究，我们使用血管内超声体积分析评估了内膜增生（IH）和血管变化。
方法和结果
162 例 183 处病变的患者具有完整的血管造影和血管内超声体积数据，包括即刻支架置入后和 9 个月随访：61 个西罗莫司洗脱支架（SES），64 个紫杉醇洗脱支架（PES）和 58 个佐他莫司洗脱支架（ZES）。通过支架长度对外部弹性膜、支架、管腔和持续斑块体积（外部弹性膜减去支架）进行归一化。通过计算 IH 体积/支架体积×100%来计算 IH 体积百分比。PES 组的最小管腔面积减少程度大于 SES 组（-1.4±1.5mm²与-0.7±0.9mm²，P=0.003），而 ZES 组的最小管腔面积变化与 SES 组无显著差异（-1.2±1.0mm²与-0.7±0.9mm²，P=0.055）。SES 组的 IH 体积百分比与 PES 组（9.8±6.0%与 17.5±11.2%，P=0.002）或 ZES 组（9.8±6.0%与 18.2±7.6%，P=0.005）相比均较小。与 PES 组相比，ZES 组的 IH 体积百分比（17.5±11.2%与 18.2±7.6%，P=0.779）或管腔体积归一化变化（-1.2±1.3mm²与-1.1±0.8mm²，P=0.452）无显著差异。SES 中有 8 例（13%）和 PES 中有 2 例（3%）发现晚期支架贴壁不良，但 ZES 中没有（P=0.050）。血管造影再狭窄在 6 个病变中检测到（3 个 PES 和 3 个 ZES）。
结论
ZES 的新生内膜生长程度与 PES 相似，但小于 SES。ZES 无晚期支架贴壁不良。
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