Efficacy and Safety of a Pharmaco-Invasive Strategy With Half-Dose Alteplase Versus Primary Angioplasty in ST-Segment–Elevation Myocardial Infarction

• DOI: 10.1161/circulationaha.117.030582
• Publication Date: 2017-08-28T00:10:43Z
• Authors: Jun Pu; Song Ding; Heng Ge; Yaling Han; Jinchen Guo; Rong Lin; Xi Su; Heng Zhang; Lianglong Chen; Ben He
• Keywords: TIMI; Clinical endpoint; Cardiac catheterization; Fibrinolytic agent

Timely primary percutaneous coronary intervention (PPCI) cannot be offered to all patients with ST-segment-elevation myocardial infarction (STEMI). Pharmaco-invasive (PhI) strategy has been proposed as a valuable alternative for eligible STEMI. We conducted randomized study compare the efficacy and safety of PhI half-dose fibrinolytic regimen versus PPCI in STEMI.The EARLY-MYO trial (Early Routine Catheterization After Alteplase Fibrinolysis Versus Primary PCI Acute ST-Segment-Elevation Myocardial Infarction) was an investigator-initiated, prospective, multicenter, randomized, noninferiority comparing alteplase STEMI 18 75 years age presenting ≤6 hours after symptom onset but expected PCI-related delay. The end point complete epicardial reperfusion PCI, defined thrombolysis flow grade 3, perfusion ST-segment resolution ≥70%. also measured infarct size left ventricular ejection fraction cardiac magnetic resonance recorded 30-day clinical outcomes.A total 344 from 7 centers were (n=171) or (n=173). noninferior (and even superior) (34.2% 22.8%, Pnoninferiority<0.05, Psuperiority=0.022), no significant differences frequency individual components combined point: 3 (91.3% 89.2%, P=0.580), (65.8% 62.9%, P=0.730), ≥70% (50.9% 45.5%, P=0.377). Infarct (23.3%±11.3% 25.8%±13.7%, P=0.101) (52.2%±11.0% 51.4%±12.0%, P=0.562) similar both groups. No occurred rates death (0.6% 1.2%, P=1.0), reinfarction 0.6%, heart failure (13.5% 16.2%, P=0.545), major bleeding events 0%, P=0.497), intracranial hemorrhage (0% 0%), minor (26.9% 11.0%, P<0.001) observed more often group.For delay, timely offers when compared PPCI. Adequately powered trials this assess outcomes are warranted.URL: https://www.clinicaltrials.gov. Unique identifier: NCT01930682.