Half-Dose Tenecteplase or Primary Percutaneous Coronary Intervention in Older Patients With ST-Elevation Myocardial Infarction: STREAM-2 1-Year Mortality Follow-Up

Abstract

on behalf of the STREAM-2 Investigators D elays in achieving reperfusion with either fibrinoly-sis or primary percutaneous coronary intervention (PPCI) are associated with excess mortality. ST-elevation myocardial infarction guidelines recommend a pharmacoinvasive (PI) treatment strategy if timely PPCI is unavailable. 1,2 However, PI treatment with full-dose tenecteplase is associated with an increased risk of intracranial hemorrhage in older patients. 3 In STREAM-2 (Strategic Reperfusion in Elderly Patients Early After Myocardial Infarction [URL: https://clinicaltrials.gov; Unique identifier: NCT02777580]), we tested a half-dose, tenecteplase-based PI strategy in patients ≥60 years with ST-elevation myocardial infarction, presenting <3 hours of symptom onset and unable to undergo PPCI <1 hour. Because of similar angiographic and clinical 30-day outcomes-except for an excess of intracra-nial bleedings in the PI arm, in part because of protocol violations including excessive anticoagulation 4-we performed a prespecified exploratory analysis of mortality and cardiac rehospitalization rates at 1 year. As previously reported, institutional review boards approved STREAM-2 (n=604) and informed consent was obtained. 3,4 After 2 years from the time of the publication , requests for STREAM-2 trial data will be considered by the executive committee provided that the data are requested in writing by qualified researchers with an outline of proposed objectives that address any potential conflicts of interest. Data sharing will be accompanied by an expectation that any outcomes will be shared with the STREAM-2 executive committee, which reserves the right to review any proposed publication of the work. Patients were randomized (2:1) to either a PI strategy or PPCI. Patients assigned to PI treatment received half-dose, weight-adjusted bolus tenecteplase, 150 to 325 mg aspirin, 300 mg clopidogrel, and subcutane-ous enoxaparin 0.75 mg/kg, with patients ≤75 years receiving an additional IV dose of 30 mg. Depending on successful reperfusion 60 to 90 minutes after bolus tenecteplase, coronary angiography was undertaken 6 to 24 hours after randomization. All-cause and cardiac mortality were estimated using Kaplan−Meier curves. Cardiac rehospitalizations ≤1 year were calculated using competing risk methodology. In a prespecified per-protocol analysis, 31 patients (24 PI; 9 PPCI) were excluded. One-year vital statuses for 399 of 401 (99.5%) patients in the PI arm and 201 of 203 (99.0%) patients in the PPCI arms were available. The mean age was 70±8 years, and 27% were ≥75 years of age. The median time from symptom onset to start of reperfusion was relatively short in both arms, and 80 minutes shorter in the PI versus PPCI arm (Figure [A]). The median delay between