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Glycoprotein IIb/IIIa inhibitors in acute myocardial infarction and angiographic microvascular obstruction: the REVERSE-FLOW trial
European Heart Journal ( IF 37.6 ) Pub Date : 2024-09-01 , DOI: 10.1093/eurheartj/ehae587 Ingo Eitel 1, 2 , Roza Saraei 1, 2 , Dominik Jurczyk 1, 2 , Andreas Fach 3 , Rainer Hambrecht 3 , Harm Wienbergen 3 , Christian Frerker 1 , Tobias Schmidt 1 , Abdelhakim Allali 1 , Alexander Joost 1 , Christoph Marquetand 1 , Thomas Kurz 1 , Philip Haaf 4 , Gregor Fahrni 4 , Christian Mueller 4 , Steffen Desch 5 , Holger Thiele 5 , Thomas Stiermaier 1, 2
European Heart Journal ( IF 37.6 ) Pub Date : 2024-09-01 , DOI: 10.1093/eurheartj/ehae587 Ingo Eitel 1, 2 , Roza Saraei 1, 2 , Dominik Jurczyk 1, 2 , Andreas Fach 3 , Rainer Hambrecht 3 , Harm Wienbergen 3 , Christian Frerker 1 , Tobias Schmidt 1 , Abdelhakim Allali 1 , Alexander Joost 1 , Christoph Marquetand 1 , Thomas Kurz 1 , Philip Haaf 4 , Gregor Fahrni 4 , Christian Mueller 4 , Steffen Desch 5 , Holger Thiele 5 , Thomas Stiermaier 1, 2
Affiliation
Background and Aims Glycoprotein (GP) IIb/IIIa inhibitors are recommended in acute myocardial infarction (AMI) for bailout treatment in case of angiographic microvascular obstruction (MVO), also termed no-reflow phenomenon, after percutaneous coronary intervention (PCI) with, however, lacking evidence (class IIa, level C). Methods The investigator-initiated, international, multicentre REVERSE-FLOW trial randomized 120 patients with AMI and thrombolysis in myocardial infarction flow grade ≤ 2 after primary PCI to optimal medical therapy with or without GP IIb/IIIa inhibitor. The primary endpoint was infarct size [percentage of left ventricular (LV) mass assessed by cardiac magnetic resonance (CMR). Secondary endpoints included CMR-derived MVO and 30-day adverse clinical events. The trial is registered with ClinicalTrials.gov: NCT02739711. Results The population was predominantly male (76.7%) with a median age of 66 years and ST-elevation myocardial infarction in 73.3% of patients. Clinical and angiographic characteristics were well balanced between the cohorts. Patients in the treatment group (n = 62) received eptifibatide (n = 41) or tirofiban (n = 21). Infarct size assessed by CMR imaging was similar in both study groups [25.4% of LV mass (%LV) vs. 25.2%LV; P = .386]. However, the number of patients with evidence of CMR-derived MVO (74.5% vs. 92.2%; P = .017) and the extent of MVO (2.1%LV vs. 3.4%LV; P = .025) were significantly reduced in the GP IIb/IIIa inhibitor group compared with controls. Thirty-day outcome showed an increased bleeding risk after GP IIb/IIIa inhibitor administration restricted to non–life-threatening bleedings (22.6% vs. 6.9%; P = .016) without differences in all-cause mortality (4.8% vs. 3.4%; P = .703). Conclusions Bailout GP IIb/IIIa inhibition in AMI patients with angiographic MVO failed to reduce the primary endpoint infarct size but decreased CMR-derived MVO and led to an increase in non-fatal bleeding events.
中文翻译:
糖蛋白 IIb/IIIa 抑制剂治疗急性心肌梗死和血管造影微血管梗阻:REVERSE-FLOW 试验
背景和目的 糖蛋白 (GP) IIb/IIIa 抑制剂被推荐用于急性心肌梗死 (AMI) 的救助治疗,以防经皮冠状动脉介入治疗 (PCI) 后血管造影微血管阻塞 (MVO),也称为无回流现象,但缺乏证据 (IIa 级,C 级)。方法 研究者发起的、国际性的、多中心的 REVERSE-FLOW 试验将 120 例初次 PCI 后心肌梗死血流分级为 ≤ 2 级的 AMI 和溶栓患者随机分配到有或没有 GP IIb/IIIa 抑制剂的最佳药物治疗组。主要终点是梗死面积 [心脏磁共振 (CMR) 评估的左心室 (LV) 质量百分比]。次要终点包括 CMR 衍生的 MVO 和 30 天不良临床事件。试用版已在 ClinicalTrials.gov 注册:NCT02739711。结果 人群以男性为主 (76.7%),中位年龄为 66 岁,73.3% 的患者为 ST 段抬高型心肌梗死。队列之间的临床和血管造影特征平衡良好。治疗组患者 (n = 62) 接受依替巴肽 (n = 41) 或替罗非班 (n = 21)。通过 CMR 成像评估的梗死面积在两个研究组中相似 [25.4% 的 LV 质量 (%LV) 对 25.2%LV;P = .386]。然而,有 CMR 衍生的 MVO 证据的患者人数 (74.5% vs. 92.2%;P = .017) 和 MVO 的范围 (2.1%LV vs. 3.4%LV;P = .025) 与 pH 对照组相比,GP IIb/IIIa 抑制剂组显著降低。30 天结果显示,GP IIb/IIIa 抑制剂给药后出血风险增加,仅限于非危及生命的出血 (22.6% vs. 6.9%;P = .016),全因死亡率无差异 (4.8% vs. 3.4%;P = .703)。 结论 血管造影 MVO 对 AMI 患者进行救助 GP IIb/IIIa 抑制未能减少主要终点梗死面积,但降低了 CMR 衍生的 MVO,并导致非致死性出血事件增加。
更新日期:2024-09-01
中文翻译:
糖蛋白 IIb/IIIa 抑制剂治疗急性心肌梗死和血管造影微血管梗阻:REVERSE-FLOW 试验
背景和目的 糖蛋白 (GP) IIb/IIIa 抑制剂被推荐用于急性心肌梗死 (AMI) 的救助治疗,以防经皮冠状动脉介入治疗 (PCI) 后血管造影微血管阻塞 (MVO),也称为无回流现象,但缺乏证据 (IIa 级,C 级)。方法 研究者发起的、国际性的、多中心的 REVERSE-FLOW 试验将 120 例初次 PCI 后心肌梗死血流分级为 ≤ 2 级的 AMI 和溶栓患者随机分配到有或没有 GP IIb/IIIa 抑制剂的最佳药物治疗组。主要终点是梗死面积 [心脏磁共振 (CMR) 评估的左心室 (LV) 质量百分比]。次要终点包括 CMR 衍生的 MVO 和 30 天不良临床事件。试用版已在 ClinicalTrials.gov 注册:NCT02739711。结果 人群以男性为主 (76.7%),中位年龄为 66 岁,73.3% 的患者为 ST 段抬高型心肌梗死。队列之间的临床和血管造影特征平衡良好。治疗组患者 (n = 62) 接受依替巴肽 (n = 41) 或替罗非班 (n = 21)。通过 CMR 成像评估的梗死面积在两个研究组中相似 [25.4% 的 LV 质量 (%LV) 对 25.2%LV;P = .386]。然而,有 CMR 衍生的 MVO 证据的患者人数 (74.5% vs. 92.2%;P = .017) 和 MVO 的范围 (2.1%LV vs. 3.4%LV;P = .025) 与 pH 对照组相比,GP IIb/IIIa 抑制剂组显著降低。30 天结果显示,GP IIb/IIIa 抑制剂给药后出血风险增加,仅限于非危及生命的出血 (22.6% vs. 6.9%;P = .016),全因死亡率无差异 (4.8% vs. 3.4%;P = .703)。 结论 血管造影 MVO 对 AMI 患者进行救助 GP IIb/IIIa 抑制未能减少主要终点梗死面积,但降低了 CMR 衍生的 MVO,并导致非致死性出血事件增加。