Saw Jacqueline, Wong Graham C, Mayo John, Bernstein Victoria, Mancini G B John, Ye Jian, Skarsgard Peter, Starovoytov Andrew, Cairns John
Divisions of Cardiology, Vancouver General Hospital & St Paul's Hospital, University of British Columbia, Vancouver, British Columbia, Canada.
Divisions of Radiology, Vancouver General Hospital & St Paul's Hospital, University of British Columbia, Vancouver, British Columbia, Canada.
Heart. 2016 May 15;102(10):763-9. doi: 10.1136/heartjnl-2015-308691. Epub 2016 Feb 18.
Ticagrelor was shown to reduce mortality in patients who underwent coronary artery bypass grafting (CABG), but its effect on graft patency is unknown.
We performed a prospective, randomised, double-blind, placebo-controlled trial, comparing ticagrelor 90 mg twice daily versus placebo for 3 months added to aspirin 81 mg/day, following isolated CABG. Aspirin was started within 12 h, and study medication within 72 h after CABG. Primary outcome was graft occlusion on CT angiography (CTA) performed 3 months post CABG. Patients were followed to 12 months for death, myocardial infarction, stroke, repeat revascularisation and bleeding.
The study was terminated prematurely after randomising 70 patients between September 2011 and August 2014 because of slow recruitment. CTA was performed in 56 patients who completed >1 month of study drug. Graft occlusion occurred in 7/25 (28.0%) patients on ticagrelor and 17/31 (48.3%) on placebo, p=0.044. Of 207 analysable grafts, graft occlusion occurred in 9/87 (10.3%) with ticagrelor and 22/120 (18.3%) with placebo, p=0.112. Graft occlusion or stenosis ≥50% occurred in 10/87 (11.5%) ticagrelor vs 32/120 (26.7%) placebo, p=0.007. There was no major bleeding, but minor bleeding was higher with ticagrelor (31.4% vs 2.9%, p=0.003). In univariate analysis, ticagrelor use reduced graft occlusion (OR 0.32, 95% CI 0.10 to 0.97, p=0.047), which remained significant on multivariable analysis (OR 0.25, 95% CI 0.073 to 0.873, p=0.03).
Ticagrelor added to aspirin after CABG reduced the proportion of patients with graft occlusion, and was a significant univariate and multivariable predictor of graft occlusion. These results are hypothesis-generating and should be confirmed in larger studies.
NCT01373411: Results.
替格瑞洛已被证明可降低接受冠状动脉旁路移植术(CABG)患者的死亡率,但其对移植血管通畅性的影响尚不清楚。
我们进行了一项前瞻性、随机、双盲、安慰剂对照试验,比较在接受单纯CABG术后,每天两次服用90毫克替格瑞洛加每天81毫克阿司匹林与安慰剂,持续3个月。阿司匹林在术后12小时内开始服用,研究药物在CABG术后72小时内开始服用。主要结局是CABG术后3个月进行CT血管造影(CTA)时的移植血管闭塞情况。对患者随访至12个月,观察死亡、心肌梗死、中风、再次血管重建和出血情况。
由于入组缓慢,该研究在2011年9月至2014年8月间随机纳入70例患者后提前终止。56例完成>1个月研究药物治疗的患者进行了CTA检查。替格瑞洛组25例患者中有7例(28.0%)发生移植血管闭塞,安慰剂组31例患者中有17例(48.3%)发生移植血管闭塞,p = 0.044。在207条可分析的移植血管中,替格瑞洛组87条中有9条(10.3%)发生移植血管闭塞,安慰剂组120条中有22条(18.3%)发生移植血管闭塞,p = 0.112。替格瑞洛组87条中有10条(11.5%)发生移植血管闭塞或狭窄≥50%,安慰剂组120条中有32条(26.7%)发生移植血管闭塞或狭窄≥50%,p = 0.007。未发生大出血,但替格瑞洛组的小出血发生率更高(31.4%对2.9%,p = 0.003)。在单变量分析中,使用替格瑞洛可降低移植血管闭塞的发生率(OR 0.32,95%CI 0.10至0.97,p = 0.047),在多变量分析中这一结果仍具有显著性(OR 0.25,95%CI 0.073至0.873,p = 0.03)。
CABG术后在阿司匹林基础上加用替格瑞洛可降低移植血管闭塞患者的比例,并且是移植血管闭塞的显著单变量和多变量预测因素。这些结果只是初步的,需要在更大规模的研究中得到证实。
NCT01373411:结果