Zalunfiban at First Medical Contact for ST-Elevation Myocardial
Infarction

J 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

URL

Označené pro přenos do RIV

Ano

Organizační jednotka

Lékařská fakulta

Klíčová slova anglicky

ST-elevation myocardial infarction; zalunfiban; first medical contact; antiplatelet therapy; early pharmacologic intervention

Štítky

14110211

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.

Citovat

@article{2558048,
   author = {van't Hof, A W J and Gibson, C M and Rikken, S A O F and Januzzi, J L and Granger, C B and van Beurden, A. and Rasoul, S. and Ruiters, L. and Vainer, J. and Verburg, A. and Arslan, F. and Jukema, J W and Durieux, M. and Polad, J. and van Vliet, R. and van den Branden, B J L and Magro, M. and Remkes, W. and Beelen, J. and Hermanides, R. and Tolsma, R. and Gosselink, M. and Vinereanu, D. and Chioncel, V. and van de Hoef, T P and Boomars, R. and Arkenbout, K E and van Houwelingen, G K and Hengstman, G. and Hvan de Wetering, H. and Pisters, R. and Kala, Petr and Merkely, B. and Ecollan, P. and Lapostolle, F. and Giugliano, R P and Welsh, R C and Levy, M. and AriasandMendoza, A. and Baron, N. and Cociorva, D. and Wittes, J. and Unger, E F and Coller, B S and ten Berg, J M and Montalescot, G.},
   article_location = {WALTHAM},
   article_number = {1},
   doi = {https://doi.org/10.1056/EVIDoa2500268},
   keywords = {ST-elevation myocardial infarction; zalunfiban; first medical contact; antiplatelet therapy; early pharmacologic intervention},
   language = {eng},
   issn = {2766-5526},
   journal = {NEJM EVIDENCE},
   title = {Zalunfiban at First Medical Contact for ST-Elevation Myocardial Infarction},
   url = {https://evidence.nejm.org/doi/10.1056/EVIDoa2500268},
   volume = {5},
   year = {2025}
}

TY  - JOUR
ID  - 2558048
AU  - van't Hof, A W J - Gibson, C M - Rikken, S A O F - Januzzi, J L - Granger, C B - van Beurden, A. - Rasoul, S. - Ruiters, L. - Vainer, J. - Verburg, A. - Arslan, F. - Jukema, J W - Durieux, M. - Polad, J. - van Vliet, R. - van den Branden, B J L - Magro, M. - Remkes, W. - Beelen, J. - Hermanides, R. - Tolsma, R. - Gosselink, M. - Vinereanu, D. - Chioncel, V. - van de Hoef, T P - Boomars, R. - Arkenbout, K E - van Houwelingen, G K - Hengstman, G. - Hvan de Wetering, H. - Pisters, R. - Kala, Petr - Merkely, B. - Ecollan, P. - Lapostolle, F. - Giugliano, R P - Welsh, R C - Levy, M. - Arias-Mendoza, A. - Baron, N. - Cociorva, D. - Wittes, J. - Unger, E F - Coller, B S - ten Berg, J M - Montalescot, G.
PY  - 2025
TI  - Zalunfiban at First Medical Contact for ST-Elevation Myocardial Infarction
JF  - NEJM EVIDENCE
VL  - 5
IS  - 1
SP  - 1-10
EP  - 1-10
PB  - MASSACHUSETTS MEDICAL SOC
SN  - 27665526
KW  - ST-elevation myocardial infarction
KW  - zalunfiban
KW  - first medical contact
KW  - antiplatelet therapy
KW  - early pharmacologic intervention
UR  - https://evidence.nejm.org/doi/10.1056/EVIDoa2500268
N2  - 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.
ER  -

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