《冠状动脉旁路移植手术(CORONARY ARTERY BYPASS GRAFT SURGERY) CABG后抗血小板治疗》

  • 来源专题:心血管疾病防治
  • 编译者: 张燕舞
  • 发布时间:2018-05-22
  • 冠状动脉旁路移植手术(CABG)后给予长期阿司匹林预防大隐静脉移植物闭塞并减少心血管不良事件的发生率。 有人认为加入有效的P2Y12受体阻断剂如替格瑞洛可能会进一步改善预后。 在DACAB试验中,接受CABG的500名患者在术后24小时内被随机分配为替格瑞洛加阿司匹林,单用替格瑞洛或单用阿司匹林。 通过心血管成像确定的主要终点,一年的隐静脉移植通畅分别发生在三组静脉移植物中约89%,83%和77%。 虽然替卡格雷与阿司匹林的添加统计学上比单独使用阿司匹林更有效,但我们不推荐使用它,并担心增加出血风险的可能性,并等待临床结果的临床试验结果。

    Importance The effect of ticagrelor with or without aspirin on saphenous vein graft patency in patients undergoing coronary artery bypass grafting (CABG) is unknown.

    Objective To compare the effect of ticagrelor + aspirin or ticagrelor alone vs aspirin alone on saphenous vein graft patency 1 year after CABG.

    Design, Setting, and Participants Randomized, multicenter, open-label, clinical trial among 6 tertiary hospitals in China. Eligible patients were aged 18 to 80 years with indications for elective CABG. Patients requiring urgent revascularization, concomitant cardiac surgery, dual antiplatelet or vitamin K antagonist therapy post-CABG, and who were at risk of serious bleeding were excluded. From July 2014 until November 2015, 1256 patients were identified and 500 were enrolled. Follow-up was completed in January 2017.

    Interventions Patients were randomized (1:1:1) to start ticagrelor (90 mg twice daily) + aspirin (100 mg once daily) (n = 168), ticagrelor (90 mg twice daily) (n = 166), or aspirin (100 mg once daily) (n = 166) within 24 hours post-CABG. Neither patients nor treating physicians were blinded to allocation.

    Main Outcomes and Measures Primary outcome was saphenous vein graft patency 1 year after CABG (FitzGibbon grade A) adjudicated independently by a committee blinded to allocation. Saphenous vein graft patency was assessed by multislice computed tomographic angiography or coronary angiography.

    Results Among 500 randomized patients (mean age, 63.6 years; women, 91 [18.2%]), 461 (92.2%) completed the trial. Saphenous vein graft patency rates 1 year post-CABG were 88.7% (432 of 487 vein grafts) with ticagrelor + aspirin; 82.8% (404 of 488 vein grafts) with ticagrelor alone; and 76.5% (371 of 485 vein grafts) with aspirin alone. The difference between ticagrelor + aspirin vs aspirin alone was statistically significant (12.2% [95% CI, 5.2% to 19.2%]; P < .001), whereas the difference between ticagrelor alone vs aspirin alone was not statistically significant (6.3% [95% CI, -1.1% to 13.7%]; P = .10). Five major bleeding episodes occurred during 1 year of follow-up (3 with ticagrelor + aspirin; 2 with ticagrelor alone).

    Conclusions and Relevance Among patients undergoing elective CABG with saphenous vein grafting, ticagrelor + aspirin significantly increased graft patency after 1 year vs aspirin alone; there was no significant difference between ticagrelor alone and aspirin alone. Further research with more patients is needed to assess comparative bleeding risks.Trial Registration clinicaltrials.gov Identifier: NCT02201771.

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  • 《PCI后冠状动脉病变与多支血管病变的CABG死亡率》

    • 来源专题:心血管疾病防治
    • 编译者:张燕舞
    • 发布时间:2018-05-22
    • 对于需要血运重建的稳定多支冠状动脉疾病(CAD)患者,经皮冠状动脉介入治疗(PCI)和冠状动脉搭桥手术(CABG)之间的选择可能很困难。 2018年对来自11项比较两种血运重建策略的随机试验的个体患者数据汇总分析显示,多支血管病患者的5年全因死亡率高于PCI。 然而,预先指定的亚组分析发现,没有糖尿病的患者和疾病较轻的患者的CABG没有显着的死亡率益处。 这项荟萃分析提高了我们的舒适度,提供PCI作为无糖尿病或复杂疾病患者的CABG替代方案。 BACKGROUND Numerous randomised trials have compared coronary artery bypass grafting (CABG) with percutaneous coronary intervention (PCI) for patients with coronary artery disease. However, no studies have been powered to detect a difference in mortality between the revascularisation strategies. METHODS We did a systematic review up to July 19, 2017, to identify randomised clinical trials comparing CABG with PCI using stents. Eligible studies included patients with multivessel or left main coronary artery disease who did not present with acute myocardial infarction, did PCI with stents (bare-metal or drug-eluting), and had more than 1 year of follow-up for all-cause mortality. In a collaborative, pooled analysis of individual patient data from the identified trials, we estimated all-cause mortality up to 5 years using Kaplan-Meier analyses and compared PCI with CABG using a random-effects Cox proportional-hazards model stratified by trial. Consistency of treatment effect was explored in subgroup analyses, with subgroups defined according to baseline clinical and anatomical characteristics. FINDINGS We included 11 randomised trials involving 11?518 patients selected by heart teams who were assigned to PCI (n=5753) or to CABG (n=5765). 976 patients died over a mean follow-up of 3·8 years (SD 1·4). Mean Synergy between PCI with Taxus and Cardiac Surgery (SYNTAX) score was 26·0 (SD 9·5), with 1798 (22·1%) of 8138 patients having a SYNTAX score of 33 or higher. 5 year all-cause mortality was 11·2% after PCI and 9·2% after CABG (hazard ratio [HR]1·20, 95% CI 1·06-1·37; p=0·0038). 5 year all-cause mortality was significantly different between the interventions in patients with multivessel disease (11·5% after PCI vs 8·9% after CABG; HR 1·28, 95% CI 1·09-1·49; p=0·0019), including in those with diabetes (15·5% vs 10·0%; 1·48, 1·19-1·84; p=0·0004), but not in those without diabetes (8·7% vs 8·0%; 1·08, 0·86-1·36; p=0·49). SYNTAX score had a significant effect on the difference between the interventions in multivessel disease. 5 year all-cause mortality was similar between the interventions in patients with left main disease (10·7% after PCI vs 10·5% after CABG; 1·07, 0·87-1·33; p=0·52), regardless of diabetes status and SYNTAX score. INTERPRETATION CABG had a mortality benefit over PCI in patients with multivessel disease, particularly those with diabetes and higher coronary complexity. No benefit for CABG over PCI was seen in patients with left main disease.Longer follow-up is needed to better define mortality differences between the revascularisation strategies.
  • 《ACS患者PCI术后抗血小板治疗降低》

    • 来源专题:心血管疾病防治
    • 编译者:张燕舞
    • 发布时间:2018-05-22
    • 在接受经皮冠状动脉介入治疗(PCI)的急性冠脉综合征(ACS)患者中,更有效的抗血小板药物普拉格雷和替卡格雷优于氯吡格雷。虽然他们的使用与缺血事件发生率较低相关,但出血并发症更为常见。为了降低出血风险,基于血小板功能检测结果(PFT)[12],TROPICAL-ACS试验试图确定一组可以转用氯吡格雷的患者。该研究发现,净临床受益(心血管死亡,心肌梗死,中风或出血)的主要终点事件发生率无明显差异,氯吡格雷出血率较低,缺血事件发生率相似。然而,小规模的研究导致缺血事件太少,以致对结果有信心。我们不推荐使用PFT来确定哪些患者可能会从普拉格雷或替卡格雷转换为氯吡格雷。切换的决定应根据具体情况进行。 BACKGROUND Current guidelines recommend potent platelet inhibition with prasugrel or ticagrelor for 12 months after an acute coronary syndrome managed with percutaneous coronary intervention (PCI). However, the greatest anti-ischaemic benefit of potent antiplatelet drugs over the less potent clopidogrel occurs early, while most excess bleeding events arise during chronic treatment. Hence, a stage-adapted treatment with potent platelet inhibition in the acute phase and de-escalation to clopidogrel in the maintenance phase could be an alternative approach. We aimed to investigate the safety and efficacy of early de-escalation of antiplatelet treatment from prasugrel to clopidogrel guided by platelet function testing (PFT). METHODS In this investigator-initiated, randomised, open-label, assessor-blinded, multicentre trial (TROPICAL-ACS) done at 33 sites in Europe, patients were enrolled if they had biomarker-positive acute coronary syndrome with successful PCI and a planned duration of dual antiplatelet treatment of 12 months. Enrolled patients were randomly assigned (1:1) using an internet-based randomisation procedure with a computer-generated block randomisation with stratification across study sites to either standard treatment with prasugrel for 12 months (control group) or a step-down regimen (1 week prasugrel followed by 1 week clopidogrel and PFT-guided maintenance therapy with clopidogrel or prasugrel from day 14 after hospital discharge; guided de-escalation group). The assessors were masked to the treatment allocation. The primary endpoint was net clinical benefit (cardiovascular death, myocardial infarction, stroke or bleeding grade 2 or higher according to Bleeding Academic Research Consortium [BARC]) criteria) 1 year after randomisation (non-inferiority hypothesis; margin of 30%). Analysis was intention to treat. This study is registered with ClinicalTrials.gov, number NCT01959451, and EudraCT, 2013-001636-22. FINDINGS Between Dec 2, 2013, and May 20, 2016, 2610 patients were assigned to study groups; 1304 to the guided de-escalation group and 1306 to the control group. The primary endpoint occurred in 95 patients (7%) in the guided de-escalation group and in 118 patients (9%) in the control group (pnon-inferiority=0·0004; hazard ratio [HR]0·81 [95% CI 0·62-1·06], psuperiority=0·12). Despite early de-escalation, there was no increase in the combined risk of cardiovascular death, myocardial infarction, or stroke in the de-escalation group (32 patients [3%]) versus in the control group (42 patients [3%]; pnon-inferiority=0·0115). There were 64 BARC 2 or higher bleeding events (5%) in the de-escalation group versus 79 events (6%)in the control group (HR 0·82 [95% CI 0·59-1·13]; p=0·23).