2025
Zalunfiban at First Medical Contact for ST-Elevation Myocardial Infarction
VAN'T HOF, A W J; C M GIBSON; S A O F RIKKEN; J L JANUZZI; C B GRANGER et al.Základní údaje
Originální název
Zalunfiban at First Medical Contact for ST-Elevation Myocardial Infarction
Autoři
VAN'T HOF, A W J; C M GIBSON; S A O F RIKKEN; J L JANUZZI; C B GRANGER; A. VAN BEURDEN; S. RASOUL; L. RUITERS; J. VAINER; A. VERBURG; F. ARSLAN; J W JUKEMA; M. DURIEUX; J. POLAD; R. VAN VLIET; B J L VAN DEN BRANDEN; M. MAGRO; W. REMKES; J. BEELEN; R. HERMANIDES; R. TOLSMA; M. GOSSELINK; D. VINEREANU; V. CHIONCEL; T P VAN DE HOEF; R. BOOMARS; K E ARKENBOUT; G K VAN HOUWELINGEN; G. HENGSTMAN; H. HVAN DE WETERING; R. PISTERS; Petr KALA; B. MERKELY; P. ECOLLAN; F. LAPOSTOLLE; R P GIUGLIANO; R C WELSH; M. LEVY; A. ARIAS-MENDOZA; N. BARON; D. COCIORVA; J. WITTES; E F UNGER; B S COLLER; J M TEN BERG a G. MONTALESCOT
Vydání
NEJM EVIDENCE, WALTHAM, MASSACHUSETTS MEDICAL SOC, 2025, 2766-5526
Další údaje
Jazyk
angličtina
Typ výsledku
Článek v odborném periodiku
Obor
30201 Cardiac and Cardiovascular systems
Stát vydavatele
Spojené státy
Utajení
není předmětem státního či obchodního tajemství
Odkazy
Označené pro přenos do RIV
Ano
Kód RIV
RIV/00216224:14110/25:00143850
Organizační jednotka
Lékařská fakulta
UT WoS
EID Scopus
Klíčová slova anglicky
ST-elevation myocardial infarction; zalunfiban; first medical contact; antiplatelet therapy; early pharmacologic intervention
Štítky
Příznaky
Mezinárodní význam, Recenzováno
Změněno: 3. 3. 2026 12:53, Mgr. Tereza Miškechová
Anotace
V originále
Background Zalunfiban is a glycoprotein IIb/IIIa (integrin alpha IIb beta 3) inhibitor designed for subcutaneous administration on first medical contact with patients with suspected ST-segment elevation myocardial infarction (STEMI). Methods An international, double-blind, placebo-controlled trial randomly assigned patients with STEMI in a 1:1:1 ratio to receive a single subcutaneous injection of zalunfiban (0.11 mg/kg or 0.13 mg/kg) or placebo. The primary efficacy end point was a hierarchical proportional odds model ranking seven end points from worst to best: all-cause death, stroke, recurrent myocardial infarction, acute stent thrombosis, new-onset or rehospitalization for heart failure, larger infarct size, or no end point through 30 days. The primary safety end point was the occurrence of severe or life-threatening bleeding as per the global use of strategies to open occluded coronary arteries (GUSTO) criteria. Results The trial randomly assigned 2467 patients (853 to zalunfiban 0.11 mg/kg, 818 to zalunfiban 0.13 mg/kg, and 796 to placebo). The primary efficacy end point was significantly improved by zalunfiban (adjusted odds ratio 0.79; 95% confidence interval, 0.65 to 0.98; P=0.028). GUSTO severe bleeding was similar between those who received zalunfiban versus placebo (1.2% vs. 0.8%; P=0.40), but GUSTO mild to moderate bleeding was increased (6.4% vs. 2.5%; P<0.001). Angiography showed faster coronary blood flow with zalunfiban versus placebo (corrected frame count of the infarct-related artery 109 [interquartile range 35 to 176] vs. 176 [interquartile range 40 to 176]; P=0.012). Conclusions In patients with STEMI, zalunfiban administered at first medical contact significantly improved preintervention infarct-related patency and reduced the likelihood of a worse 30-day multicomponent hierarchical clinical end point. Zalunfiban was not associated with increased severe or life-threatening bleeding but was associated with increased mild to moderate bleeding.