STREAM-2: Half-Dose Tenecteplase or Primary Percutaneous Coronary Intervention in Older Patients With ST-Segment-Elevation Myocardial Infarction: A Randomized, Open-Label Trial.

Autor:	Van de Werf F; Department of Cardiovascular Sciences, KU Leuven, Belgium (F.V.d.W., K.V., P.S.)., Ristić AD; Department of Cardiology, University Clinical Center of Serbia, University of Belgrade, Serbia (A.D.R)., Averkov OV; Pirogov Russian National Research Medical University and City Clinical Hospital #15, Moscow, Russian Federation (O.V.A.)., Arias-Mendoza A; Coronary Care Unit, National Institute of Cardiology, Mexico City, Mexico (A.A.-M.)., Lambert Y; Centre Hospitalier de Versailles, SAMU 78 and Mobile Intensive Care Unit, France (Y.L.)., Kerr Saraiva JF; Cardiology Discipline, Pontifical Catholic University of Campinas School of Medicine, Brazil (J.F.K.S.)., Sepulveda P; Pontifica Universidad Católica de Chile, Santiago (P.S.)., Rosell-Ortiz F; Servicio de Urgencias y Emergencias 061 de La Rioja, Spain (F.R.-O.)., French JK; School of Medicine, University of New South Wales, Sydney, Department of Cardiology, Liverpool Hospital, Sydney, School of Medicine, Western Sydney University, New South Wales, Australia (J.K.F.)., Musić LB; Cardiology Clinic, University Clinical Center of Montenegro, University of Podgorica, Medical Faculty (L.B.M.)., Vandenberghe K; Department of Cardiovascular Sciences, KU Leuven, Belgium (F.V.d.W., K.V., P.S.)., Bogaerts K; Interuniversity Institute for Biostatistics and statistical Bioinformatics (I-BioStat), KU Leuven, Leuven and University Hasselt, Belgium (K.B.)., Westerhout CM; The Canadian Virtual Coordinating Centre for Global Collaborative Cardiovascular Research {Canadian VIGOUR Centre}, University of Alberta, Edmonton (C.M.W., K.R.B., R.C.W., P.W.A.)., Pagès A; Boehringer Ingelheim GmbH, Ingelheim am Rhein, Germany (A.P.)., Danays T; TDC, Aix en Provence, France (T.D.)., Bainey KR; The Canadian Virtual Coordinating Centre for Global Collaborative Cardiovascular Research {Canadian VIGOUR Centre}, University of Alberta, Edmonton (C.M.W., K.R.B., R.C.W., P.W.A.)., Sinnaeve P; Department of Cardiovascular Sciences, KU Leuven, Belgium (F.V.d.W., K.V., P.S.)., Goldstein P; Emergency Department and SAMU, Lille University Hospital, France (P.G.)., Welsh RC; The Canadian Virtual Coordinating Centre for Global Collaborative Cardiovascular Research {Canadian VIGOUR Centre}, University of Alberta, Edmonton (C.M.W., K.R.B., R.C.W., P.W.A.)., Armstrong PW; The Canadian Virtual Coordinating Centre for Global Collaborative Cardiovascular Research {Canadian VIGOUR Centre}, University of Alberta, Edmonton (C.M.W., K.R.B., R.C.W., P.W.A.).
Jazyk:	angličtina
Zdroj:	Circulation [Circulation] 2023 Aug 29; Vol. 148 (9), pp. 753-764. Date of Electronic Publication: 2023 Jul 13.
DOI:	10.1161/CIRCULATIONAHA.123.064521
Abstrakt:	Background: ST-segment-elevation myocardial infarction (STEMI) guidelines recommend pharmaco-invasive treatment if timely primary percutaneous coronary intervention (PCI) is unavailable. Full-dose tenecteplase is associated with an increased risk of intracranial hemorrhage in older patients. Whether pharmaco-invasive treatment with half-dose tenecteplase is effective and safe in older patients with STEMI is unknown. Methods: STREAM-2 (Strategic Reperfusion in Elderly Patients Early After Myocardial Infarction) was an investigator-initiated, open-label, randomized, multicenter study. Patients ≥60 years of age with ≥2 mm ST-segment elevation in 2 contiguous leads, unable to undergo primary PCI within 1 hour, were randomly assigned (2:1) to half-dose tenecteplase followed by coronary angiography and PCI (if indicated) 6 to 24 hours after randomization, or to primary PCI. Efficacy end points of primary interest were ST resolution and the 30-day composite of death, shock, heart failure, or reinfarction. Safety assessments included stroke and nonintracranial bleeding. Results: Patients were assigned to pharmaco-invasive treatment (n=401) or primary PCI (n=203). Median times from randomization to tenecteplase or sheath insertion were 10 and 81 minutes, respectively. After last angiography, 85.2% of patients undergoing pharmaco-invasive treatment and 78.4% of patients undergoing primary PCI had ≥50% resolution of ST-segment elevation; their residual median sums of ST deviations were 4.5 versus 5.5 mm, respectively. Thrombolysis In Myocardial Infarction flow grade 3 at last angiography was ≈87% in both groups. The composite clinical end point occurred in 12.8% (51/400) of patients undergoing pharmaco-invasive treatment and 13.3% (27/203) of patients undergoing primary PCI (relative risk, 0.96 [95% CI, 0.62-1.48]). Six intracranial hemorrhages occurred in the pharmaco-invasive arm (1.5%): 3 were protocol violations (excess anticoagulation in 2 and uncontrolled hypertension in 1). No intracranial bleeding occurred in the primary PCI arm. The incidence of major nonintracranial bleeding was low in both groups (<1.5%). Conclusions: Halving the dose of tenecteplase in a pharmaco-invasive strategy in this early-presenting, older STEMI population was associated with electrocardiographic changes that were at least comparable to those after primary PCI. Similar clinical efficacy and angiographic end points occurred in both treatment groups. The risk of intracranial hemorrhage was higher with half-dose tenecteplase than with primary PCI. If timely PCI is unavailable, this pharmaco-invasive strategy is a reasonable alternative, provided that contraindications to fibrinolysis are observed and excess anticoagulation is avoided. Registration: URL: https://www. Clinicaltrials: gov; Unique identifier: NCT02777580. Competing Interests: Disclosures Dr Van de Werf reports institutional grants from Boehringer Ingelheim. Dr Ristić reports grants from Boehringer-Ingelheim and Novartis and travel fees from Astra Zeneca and Pfizer. Dr Arias-Mendoza reports grants from Merck and Novo Nordisk and personal fees from Novartis, Roche, Bayer, Boehringer Ingelheim, and Asofarma. Dr Saraiva received personal fees from Boehringer Ingelheim, Astra Zeneca, Novo Nordisk, Lily, Janssen, Daichii Sankyo, Bayer, Novartis, Nova Quimica Brazil, and Albert Einstein ARO Brazil. Dr Musić reports a grant from Boehringer Ingelheim and travel fees from Astra Zeneca and Pfizer. Dr Westerhout reports consulting fees from Bayer Canada. Dr Pagès is a senior medical advisor of Boehringer Ingelheim. Dr Danays reports consulting fees from Boehringer Ingelheim. Dr Bainey reports personal fees from Bayer, Astra Zeneca, Boehringer Ingelheim, and HLS Therapeutics. Dr Sinnaeve reports consulting fees to his institution (KU Leuven). Dr Welsh reports personal fees and travel fees from Boehringer Ingelheim. Dr Armstrong reports institutional and personal grants from Merck, Bayer, CLS Limited, Eli Lilly, and Boehringer Ingelheim and personal fees from Merck, Boehringer Ingelheim, Bayer, and Novo Nordisk. All other authors report no competing interests.
Databáze:	MEDLINE
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