Central Adjudication Identified Additional and Prognostically Important Myocardial Infarctions in Patients Undergoing Percutaneous Coronary Intervention.
Central Adjudication Identified Additional and Prognostically Important Myocardial Infarctions in Patients Undergoing Percutaneous Coronary Intervention.
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中央裁决在接受经皮冠状动脉介入治疗的患者中发现了额外的且具有重要预后意义的心肌梗死
DOI：
10.1161/circinterventions.118.007342
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发表时间：
2019
期刊：
影响因子：
--
通讯作者：
Mahaffey KW
中科院分区：
文献类型：
--
作者：
Olivier CB;Bhatt DL;Leonardi S;Stone GW;Gibson CM;Steg PG;Hamm CW;Wilson MD;Mangum S;Price MJ;Prats J;White HD;Lopes RD;Harrington RA;Mahaffey KW
背景在CHAMPION PHOENIX试验中，坎格雷洛降低了48小时内死亡、心肌梗死（MI）、缺血驱动的血运重建或支架血栓形成的主要复合终点。本研究的目的是探讨事件裁定的影响和MI的临床事件委员会（CEC）或现场调查（SI）报告的预后重要性。方法和结果数据从CHAMPION PHOENIX试验的患者进行择期或非择期经皮冠状动脉介入治疗进行了分析。CEC使用预定义的标准、识别疑似事件的计算机算法和审查生物标志物变化的半对数图系统识别和裁定MI。使用基线特征对30天死亡进行建模。在10942名患者中，（4.2%）例患者在CEC确定的48小时内至少发生1起MI（坎格雷洛207例[3.8%];氯吡格雷255例[4.7%];比值比[OR] 0.80; 95%CI，0.67-0.97; P=0.022），SI报告了143例患者在48小时内至少发生1次MI（60例[1.1%]坎格雷洛; 83例[1.5%]氯吡格雷; OR，0.72; 95%CI，0.52-1.01;P=0.053）。在CEC确定的462例MI中，92例（20%）由SI报告，370例（80%）未报告。在SI报告的143例MI中，51例（36%）未经CEC证实。所有类别均与30天死亡的校正风险增加相关（CEC：OR，5.35; 95% CI，2.56-11.2;P<0.001; SI：9.08 [4.01-20.5];P<0.001; CEC和SI：10.9 [3.23-36.6];P<0.001; CEC而非SI：4.69 [1.94-11.3]; P<0.001; SI但不是CEC：15.4 [5.26-44.9];P<0.001）.结论在接受经皮冠状动脉介入治疗的患者中，CEC程序识别的MI是SI报告的3倍。与氯吡格雷相比，坎格雷洛显著降低了CEC确定的MI，SI报告的MI相对风险降低在定性上相似。CEC确定的MI或SI报告的MI与30天死亡恶化独立相关。中心裁定确定了其他具有重要临床意义的事件。临床试验注册URL：https://www.clinicaltrials.gov。唯一标识符：NCT 01156571。
BackgroundIn the CHAMPION PHOENIX trial, cangrelor reduced the primary composite end point of death, myocardial infarction (MI), ischemia-driven revascularization, or stent thrombosis at 48 hours. This study aimed to explore the impact of event adjudication and the prognostic importance of MI reported by a clinical events committee (CEC) or site investigators (SIs).Methods and ResultsData from the CHAMPION PHOENIX trial of patients undergoing elective or nonelective percutaneous coronary intervention were analyzed. A CEC systematically identified and adjudicated MI using predefined criteria, a computer algorithm to identify suspected events, and semilogarithmic plots to review biomarker changes. Thirty-day death was modeled using baseline characteristics. Of 10 942 patients, 462 (4.2%) patients had at least 1 MI by 48 hours identified by the CEC (207 [3.8%] cangrelor; 255 [4.7%] clopidogrel; odds ratio [OR] 0.80; 95% CI, 0.67–0.97;P=0.022), and 143 patients had at least 1 MI by 48 hours reported by the SI (60 [1.1%] cangrelor; 83 [1.5%] clopidogrel; OR, 0.72; 95% CI, 0.52–1.01;P=0.053). Of the 462 MIs identified by the CEC, 92 (20%) were reported by SI, and 370 (80%) were not. Of the 143 MI reported by the SI, 51 (36%) were not confirmed by CEC. All categories were associated with an increased adjusted risk for 30-day death (CEC: OR, 5.35; 95% CI, 2.56–11.2;P<0.001; SI: 9.08 [4.01–20.5];P<0.001; CEC and SI: 10.9 [3.23–36.6];P<0.001; CEC but not SI: 4.69 [1.94–11.3];P<0.001; SI but not CEC: 15.4 [5.26–44.9];P<0.001).ConclusionsIn patients undergoing percutaneous coronary intervention, CEC procedures identified 3 times as many MIs as the SI reported. Compared with clopidogrel, cangrelor significantly reduced MIs identified by the CEC with a qualitatively similar relative risk reduction in MIs reported by the SI. MIs identified by CEC or reported by SI were independently associated with worse 30-day death. Central adjudication identified additional, prognostically important events.Clinical Trial RegistrationURL: https://www.clinicaltrials.gov. Unique identifier: NCT01156571.
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