冠状动脉裸金属支架植入术后口服雷帕霉素预防再狭窄：阿根廷口服雷帕霉素前瞻性随机研究（ORAR II）

Oral rapamycin after coronary bare-metal stent implantation to prevent restenosis: the Prospective, Randomized Oral Rapamycin in Argentina (ORAR II) Study.

作者信息

Rodriguez Alfredo E, Granada Juan F, Rodriguez-Alemparte Máximo, Vigo Cesar F, Delgado Juan, Fernandez-Pereira Carlos, Pocovi Antonio, Rodriguez-Granillo Alfredo M, Schulz Daryl, Raizner Albert E, Palacios Igor, O'Neill William, Kaluza Grzegorz L, Stone Gregg

机构信息

Otamendi Hospital, Buenos Aires, Argentina.

出版信息

J Am Coll Cardiol. 2006 Apr 18;47(8):1522-9. doi: 10.1016/j.jacc.2005.12.052. Epub 2006 Mar 29.

DOI:10.1016/j.jacc.2005.12.052

PMID:16630986

Abstract

OBJECTIVES

The purpose of this study was to assess the role of oral rapamycin in decreased restenosis after bare metal stent implantation.

BACKGROUND

Small observational studies suggest that the administration of oral rapamycin reduces angiographic restenosis after bare metal stent implantation.

METHODS

Between September 2003 and September 2004, 100 patients were randomized to either oral rapamycin (6-mg loading dose given 2.7 h before intervention followed by 3 mg/day for 14 days) plus diltiazem 180 mg/day or no therapy after the implantation of a coronary bare metal stent design. The primary study end point was incidence of angiographic binary restenosis and late loss at nine months. The secondary end points were target lesion revascularization, target vessel revascularization, and incidence of major adverse cardiovascular events at 1 year.

RESULTS

Angiographic follow-up was completed in 87% of patients. In the rapamycin group, the drug was well tolerated (26% minor side effects) and was maintained in 96% of patients. At 9 months, the in-segment binary restenosis was reduced by 72% (11.6% rapamycin vs. 42.8% no-therapy group, p = 0.001) and the in-stent binary restenosis was reduced by 65% (12% rapamycin vs. 34.6% no-therapy group, p = 0.009). The in-segment late loss was also significantly reduced with oral therapy (0.66 vs. 1.13 mm, respectively; 43% reduction, p < 0.001). At 1 year, patients in the oral rapamycin group also showed a significantly lower incidence of target vessel revascularization (8.3% vs. 38%, respectively, p < 0.001), target lesion revascularization (7.6% vs. 37.2%, respectively, p < 0.001), and major adverse cardiovascular events (20% vs. 44%, respectively, p = 0.018).

CONCLUSIONS

This randomized, controlled, and unblinded study showed that the administration of oral rapamycin during 14 days after stent implantation significantly reduces angiographic and clinical parameters of restenosis.

摘要

目的

本研究旨在评估口服雷帕霉素在降低裸金属支架植入术后再狭窄中的作用。

背景

小型观察性研究表明，口服雷帕霉素可降低裸金属支架植入术后的血管造影再狭窄。

方法

在2003年9月至2004年9月期间，100例患者被随机分为两组，一组接受口服雷帕霉素（干预前2.7小时给予6毫克负荷剂量，随后14天每天给予3毫克）加地尔硫卓180毫克/天，另一组在植入冠状动脉裸金属支架后不接受治疗。主要研究终点是9个月时血管造影二元再狭窄的发生率和晚期管腔丢失。次要终点是靶病变血管重建、靶血管血管重建以及1年时主要不良心血管事件的发生率。

结果

87%的患者完成了血管造影随访。在雷帕霉素组中，药物耐受性良好（26%有轻微副作用），96%的患者持续用药。9个月时，节段内二元再狭窄降低了72%（雷帕霉素组为11.6%，未治疗组为42.8%，p = 0.001），支架内二元再狭窄降低了65%（雷帕霉素组为12%，未治疗组为34.6%，p = 0.009）。口服治疗后节段内晚期管腔丢失也显著降低（分别为0.66毫米和1.13毫米；降低43%，p < 0.001）。1年时，口服雷帕霉素组患者的靶血管血管重建发生率（分别为8.3%和38%，p < 0.001）、靶病变血管重建发生率（分别为7.6%和37.2%，p < 0.001）以及主要不良心血管事件发生率（分别为20%和44%，p = 0.018）也显著较低。