佐他莫司洗脱支架与西罗莫司洗脱支架治疗原发性冠状动脉疾病患者的比较：一项随机对照试验。
Comparison of zotarolimus-eluting and sirolimus-eluting stents in patients with native coronary artery disease: a randomized controlled trial.
作者信息
Kandzari David E, Leon Martin B, Popma Jeffrey J, Fitzgerald Peter J, O'Shaughnessy Charles, Ball Michael W, Turco Mark, Applegate Robert J, Gurbel Paul A, Midei Mark G, Badre Sejal S, Mauri Laura, Thompson Kweli P, LeNarz LeRoy A, Kuntz Richard E
机构信息
Duke Clinical Research Institute, Durham, North Carolina 27705, USA.
出版信息
J Am Coll Cardiol. 2006 Dec 19;48(12):2440-7. doi: 10.1016/j.jacc.2006.08.035. Epub 2006 Nov 28.
OBJECTIVES
This trial examined the relative clinical efficacy, angiographic outcomes, and safety of zotarolimus-eluting coronary stents (ZES) with a phosphorylcholine polymer versus sirolimus-eluting stents (SES).
BACKGROUND
Whether a cobalt-based alloy stent coated with the novel antiproliferative agent, zotarolimus, and a phosphorylcholine polymer may provide similar angiographic and clinical benefit compared with SES is undetermined.
METHODS
A prospective, multicenter, 3:1 randomized trial was conducted to evaluate the safety and efficacy of ZES (n = 323) relative to SES (n = 113) in 436 patients undergoing elective percutaneous revascularization of de novo native coronary lesions with reference vessel diameters between 2.5 mm and 3.5 mm and lesion length > or =14 mm and < or =27 mm. The primary end point was 8-month angiographic in-segment late lumen loss.
RESULTS
Angiographic in-segment late lumen loss was significantly higher among patients treated with ZES compared with SES (0.34 +/- 0.44 mm vs. 0.13 +/- 0.32 mm, respectively; p < 0.001). In-hospital major adverse cardiac events were significantly lower among patients treated with ZES (0.6% vs. 3.5%, p = 0.04). In-segment binary angiographic restenosis was also higher in the ZES cohort (11.7% vs. 4.3%, p = 0.04). Total (clinically and non-clinically driven) target lesion revascularization rates at 9 months were 9.8% and 3.5% for the ZES and SES groups, respectively (p = 0.04). However, neither clinically driven target lesion revascularization (6.3% zotarolimus vs. 3.5% sirolimus, p = 0.34) nor target vessel failure (12.0% zotarolimus vs. 11.5% sirolimus, p = 1.0) differed significantly.
CONCLUSIONS
Compared with SES, treatment with a phosphorylcholine polymer-based ZES is associated with significantly higher late lumen loss and binary restenosis at 8-month angiographic follow-up. (The Endeavor III CR; http://clinicaltrials.gov/ct/show/NCT00265668?order=1?).
目的
本试验比较了含磷酸胆碱聚合物的佐他莫司洗脱冠状动脉支架（ZES）与西罗莫司洗脱支架（SES）的相对临床疗效、血管造影结果及安全性。
背景
涂有新型抗增殖药物佐他莫司及磷酸胆碱聚合物的钴基合金支架与SES相比，是否能带来相似的血管造影及临床益处尚不确定。
方法
进行了一项前瞻性、多中心、3:1随机试验，以评估ZES（n = 323）相对于SES（n = 113）在436例行择期经皮冠状动脉血管重建术的患者中的安全性和有效性，这些患者的冠状动脉原发病变参考血管直径在2.5毫米至3.5毫米之间，病变长度≥14毫米且≤27毫米。主要终点为8个月时血管造影测定的节段内晚期管腔丢失。
结果
与SES组相比，ZES组患者的血管造影节段内晚期管腔丢失显著更高（分别为0.34±0.44毫米和0.13±0.32毫米；p < 0.001）。ZES组患者的院内主要不良心脏事件显著更低（0.6%对3.5%，p = 0.04）。ZES组的节段内二元血管造影再狭窄率也更高（11.7%对4.3%，p = 0.04）。ZES组和SES组9个月时总的（临床和非临床驱动的）靶病变血管重建率分别为9.8%和3.5%（p = 0.04）。然而，临床驱动的靶病变血管重建率（佐他莫司组为6.3%，西罗莫司组为3.5%，p = 0.34）和靶血管失败率（佐他莫司组为12.0%，西罗莫司组为11.5%，p = 1.0）均无显著差异。
结论
与SES相比，在8个月的血管造影随访中，含磷酸胆碱聚合物的ZES治疗与显著更高的晚期管腔丢失和二元再狭窄相关。（Endeavor III CR；http://clinicaltrials.gov/ct/show/NCT00265668?order=1?）
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