Cangrelor, Tirofiban, and Chewed or Standard Prasugrel Regimens in Patients With ST-Segment-Elevation Myocardial Infarction: Primary Results of the FABOLUS-FASTER Trial
Standard administration of newer oral P2Y inhibitors, including prasugrel or ticagrelor, provides suboptimal early inhibition of platelet aggregation (IPA) in patients with ST-segment-elevation myocardial infarction undergoing primary percutaneous coronary intervention. We aimed to investigate the e...
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| Published in: | Circulation (New York, N.Y.) Vol. 142; no. 5; p. 441 |
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| Main Authors: | , , , , , , , , , , , , , , , , |
| Format: | Journal Article |
| Language: | English |
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04.08.2020
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| ISSN: | 1524-4539, 1524-4539 |
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| Abstract | Standard administration of newer oral P2Y
inhibitors, including prasugrel or ticagrelor, provides suboptimal early inhibition of platelet aggregation (IPA) in patients with ST-segment-elevation myocardial infarction undergoing primary percutaneous coronary intervention. We aimed to investigate the effects of cangrelor, tirofiban, and prasugrel, administered as chewed or integral loading dose, on IPA in patients undergoing primary percutaneous coronary intervention.
The FABOLUS-FASTER trial (Facilitation Through Aggrastat or Cangrelor Bolus and Infusion Over Prasugrel: A Multicenter Randomized Open-Label Trial in Patients with ST-Elevation Myocardial Infarction Referred for Primary Percutaneous Intervention) is an investigator-initiated, multicenter, open-label, randomized study. A total of 122 P2Y
-naive patients with ST-segment-elevation myocardial infarction were randomly allocated (1:1:1) to cangrelor (n=40), tirofiban (n=40) (both administered as bolus and 2-hour infusion followed by 60 mg of prasugrel), or 60-mg loading dose of prasugrel (n=42). The latter group underwent an immediate 1:1 subrandomization to chewed (n=21) or integral (n=21) tablets administration. The trial was powered to test 3 hypotheses (noninferiority of cangrelor compared with tirofiban using a noninferiority margin of 9%, superiority of both tirofiban and cangrelor compared with chewed prasugrel, and superiority of chewed prasugrel as compared with integral prasugrel, each with α=0.016 for the primary end point, which was 30-minute IPA at light transmittance aggregometry in response to 20 μmol/L adenosine diphosphate.
At 30 minutes, cangrelor did not satisfy noninferiority compared with tirofiban, which yielded superior IPA over cangrelor (95.0±8.9 versus 34.1±22.5;
<0.001). Cangrelor or tirofiban were both superior to chewed prasugrel (IPA, 10.5±11.0;
<0.001 for both comparisons), which did not provide higher IPA over integral prasugrel (6.3±11.4;
=0.47), despite yielding higher prasugrel active metabolite concentration (ng/mL; 62.3±82.6 versus 17.1±43.5;
=0.016).
Cangrelor provided inferior IPA compared with tirofiban; both treatments yielded greater IPA compared with chewed prasugrel, which led to higher active metabolite concentration but not greater IPA compared with integral prasugrel. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02978040; URL: https://www.clinicaltrialsregister.eu; EudraCT 2017-001065-24. |
|---|---|
| AbstractList | Standard administration of newer oral P2Y
inhibitors, including prasugrel or ticagrelor, provides suboptimal early inhibition of platelet aggregation (IPA) in patients with ST-segment-elevation myocardial infarction undergoing primary percutaneous coronary intervention. We aimed to investigate the effects of cangrelor, tirofiban, and prasugrel, administered as chewed or integral loading dose, on IPA in patients undergoing primary percutaneous coronary intervention.
The FABOLUS-FASTER trial (Facilitation Through Aggrastat or Cangrelor Bolus and Infusion Over Prasugrel: A Multicenter Randomized Open-Label Trial in Patients with ST-Elevation Myocardial Infarction Referred for Primary Percutaneous Intervention) is an investigator-initiated, multicenter, open-label, randomized study. A total of 122 P2Y
-naive patients with ST-segment-elevation myocardial infarction were randomly allocated (1:1:1) to cangrelor (n=40), tirofiban (n=40) (both administered as bolus and 2-hour infusion followed by 60 mg of prasugrel), or 60-mg loading dose of prasugrel (n=42). The latter group underwent an immediate 1:1 subrandomization to chewed (n=21) or integral (n=21) tablets administration. The trial was powered to test 3 hypotheses (noninferiority of cangrelor compared with tirofiban using a noninferiority margin of 9%, superiority of both tirofiban and cangrelor compared with chewed prasugrel, and superiority of chewed prasugrel as compared with integral prasugrel, each with α=0.016 for the primary end point, which was 30-minute IPA at light transmittance aggregometry in response to 20 μmol/L adenosine diphosphate.
At 30 minutes, cangrelor did not satisfy noninferiority compared with tirofiban, which yielded superior IPA over cangrelor (95.0±8.9 versus 34.1±22.5;
<0.001). Cangrelor or tirofiban were both superior to chewed prasugrel (IPA, 10.5±11.0;
<0.001 for both comparisons), which did not provide higher IPA over integral prasugrel (6.3±11.4;
=0.47), despite yielding higher prasugrel active metabolite concentration (ng/mL; 62.3±82.6 versus 17.1±43.5;
=0.016).
Cangrelor provided inferior IPA compared with tirofiban; both treatments yielded greater IPA compared with chewed prasugrel, which led to higher active metabolite concentration but not greater IPA compared with integral prasugrel. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02978040; URL: https://www.clinicaltrialsregister.eu; EudraCT 2017-001065-24. Standard administration of newer oral P2Y12 inhibitors, including prasugrel or ticagrelor, provides suboptimal early inhibition of platelet aggregation (IPA) in patients with ST-segment-elevation myocardial infarction undergoing primary percutaneous coronary intervention. We aimed to investigate the effects of cangrelor, tirofiban, and prasugrel, administered as chewed or integral loading dose, on IPA in patients undergoing primary percutaneous coronary intervention.BACKGROUNDStandard administration of newer oral P2Y12 inhibitors, including prasugrel or ticagrelor, provides suboptimal early inhibition of platelet aggregation (IPA) in patients with ST-segment-elevation myocardial infarction undergoing primary percutaneous coronary intervention. We aimed to investigate the effects of cangrelor, tirofiban, and prasugrel, administered as chewed or integral loading dose, on IPA in patients undergoing primary percutaneous coronary intervention.The FABOLUS-FASTER trial (Facilitation Through Aggrastat or Cangrelor Bolus and Infusion Over Prasugrel: A Multicenter Randomized Open-Label Trial in Patients with ST-Elevation Myocardial Infarction Referred for Primary Percutaneous Intervention) is an investigator-initiated, multicenter, open-label, randomized study. A total of 122 P2Y12-naive patients with ST-segment-elevation myocardial infarction were randomly allocated (1:1:1) to cangrelor (n=40), tirofiban (n=40) (both administered as bolus and 2-hour infusion followed by 60 mg of prasugrel), or 60-mg loading dose of prasugrel (n=42). The latter group underwent an immediate 1:1 subrandomization to chewed (n=21) or integral (n=21) tablets administration. The trial was powered to test 3 hypotheses (noninferiority of cangrelor compared with tirofiban using a noninferiority margin of 9%, superiority of both tirofiban and cangrelor compared with chewed prasugrel, and superiority of chewed prasugrel as compared with integral prasugrel, each with α=0.016 for the primary end point, which was 30-minute IPA at light transmittance aggregometry in response to 20 μmol/L adenosine diphosphate.METHODSThe FABOLUS-FASTER trial (Facilitation Through Aggrastat or Cangrelor Bolus and Infusion Over Prasugrel: A Multicenter Randomized Open-Label Trial in Patients with ST-Elevation Myocardial Infarction Referred for Primary Percutaneous Intervention) is an investigator-initiated, multicenter, open-label, randomized study. A total of 122 P2Y12-naive patients with ST-segment-elevation myocardial infarction were randomly allocated (1:1:1) to cangrelor (n=40), tirofiban (n=40) (both administered as bolus and 2-hour infusion followed by 60 mg of prasugrel), or 60-mg loading dose of prasugrel (n=42). The latter group underwent an immediate 1:1 subrandomization to chewed (n=21) or integral (n=21) tablets administration. The trial was powered to test 3 hypotheses (noninferiority of cangrelor compared with tirofiban using a noninferiority margin of 9%, superiority of both tirofiban and cangrelor compared with chewed prasugrel, and superiority of chewed prasugrel as compared with integral prasugrel, each with α=0.016 for the primary end point, which was 30-minute IPA at light transmittance aggregometry in response to 20 μmol/L adenosine diphosphate.At 30 minutes, cangrelor did not satisfy noninferiority compared with tirofiban, which yielded superior IPA over cangrelor (95.0±8.9 versus 34.1±22.5; P<0.001). Cangrelor or tirofiban were both superior to chewed prasugrel (IPA, 10.5±11.0; P<0.001 for both comparisons), which did not provide higher IPA over integral prasugrel (6.3±11.4; P=0.47), despite yielding higher prasugrel active metabolite concentration (ng/mL; 62.3±82.6 versus 17.1±43.5; P=0.016).RESULTSAt 30 minutes, cangrelor did not satisfy noninferiority compared with tirofiban, which yielded superior IPA over cangrelor (95.0±8.9 versus 34.1±22.5; P<0.001). Cangrelor or tirofiban were both superior to chewed prasugrel (IPA, 10.5±11.0; P<0.001 for both comparisons), which did not provide higher IPA over integral prasugrel (6.3±11.4; P=0.47), despite yielding higher prasugrel active metabolite concentration (ng/mL; 62.3±82.6 versus 17.1±43.5; P=0.016).Cangrelor provided inferior IPA compared with tirofiban; both treatments yielded greater IPA compared with chewed prasugrel, which led to higher active metabolite concentration but not greater IPA compared with integral prasugrel. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02978040; URL: https://www.clinicaltrialsregister.eu; EudraCT 2017-001065-24.CONCLUSIONSCangrelor provided inferior IPA compared with tirofiban; both treatments yielded greater IPA compared with chewed prasugrel, which led to higher active metabolite concentration but not greater IPA compared with integral prasugrel. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02978040; URL: https://www.clinicaltrialsregister.eu; EudraCT 2017-001065-24. |
| Author | Heg, Dik Esposito, Giovanni Windecker, Stephan Gragnano, Felice Gargiulo, Giuseppe Campo, Gianluca Piccolo, Raffaele Leonardi, Sergio Tebaldi, Matteo Vranckx, Pascal Cirillo, Plinio Manavifar, Negar Hunziker, Lukas Nagler, Michael Avvedimento, Marisa Minuz, Pietro Valgimigli, Marco |
| Author_xml | – sequence: 1 givenname: Giuseppe surname: Gargiulo fullname: Gargiulo, Giuseppe organization: Department of Advanced Biomedical Sciences, Federico II University of Naples, Italy (G.G., G.E., M.A., R.P., P.C.) – sequence: 2 givenname: Giovanni surname: Esposito fullname: Esposito, Giovanni organization: Department of Advanced Biomedical Sciences, Federico II University of Naples, Italy (G.G., G.E., M.A., R.P., P.C.) – sequence: 3 givenname: Marisa surname: Avvedimento fullname: Avvedimento, Marisa organization: Department of Advanced Biomedical Sciences, Federico II University of Naples, Italy (G.G., G.E., M.A., R.P., P.C.) – sequence: 4 givenname: Michael surname: Nagler fullname: Nagler, Michael organization: University Institute of Clinical Chemistry, Inselspital (M.N.), University of Bern, Switzerland – sequence: 5 givenname: Pietro surname: Minuz fullname: Minuz, Pietro organization: Department of Medicine, Unit of General Medicine for the Study and Treatment of Hypertensive Disease, University of Verona, Policlinico GB Rossi, Italy (P.M.) – sequence: 6 givenname: Gianluca surname: Campo fullname: Campo, Gianluca organization: Maria Cecilia Hospital, GVM Care and Research, Cotignola, Italy (G.C.) – sequence: 7 givenname: Felice surname: Gragnano fullname: Gragnano, Felice organization: Department of Translational Medical Sciences, University of Campania "Luigi Vanvitelli," Naples, Italy (F.G.) – sequence: 8 givenname: Negar surname: Manavifar fullname: Manavifar, Negar organization: Department of Cardiology (G.G., F.G., N.M., L.H., S.W., M.V.), University of Bern, Switzerland – sequence: 9 givenname: Raffaele surname: Piccolo fullname: Piccolo, Raffaele organization: Department of Advanced Biomedical Sciences, Federico II University of Naples, Italy (G.G., G.E., M.A., R.P., P.C.) – sequence: 10 givenname: Matteo surname: Tebaldi fullname: Tebaldi, Matteo organization: Cardiology Unit, Azienda Ospedaliera Universitaria di Ferrara, Italy (G.C., M.T.) – sequence: 11 givenname: Plinio surname: Cirillo fullname: Cirillo, Plinio organization: Department of Advanced Biomedical Sciences, Federico II University of Naples, Italy (G.G., G.E., M.A., R.P., P.C.) – sequence: 12 givenname: Lukas surname: Hunziker fullname: Hunziker, Lukas organization: Department of Cardiology (G.G., F.G., N.M., L.H., S.W., M.V.), University of Bern, Switzerland – sequence: 13 givenname: Pascal surname: Vranckx fullname: Vranckx, Pascal organization: Department of Cardiology and Intensive Care Medicine, Jessa Ziekenhuis, Faculty of Medicine and Life Sciences at the Hasselt University, Belgium (P.V.) – sequence: 14 givenname: Sergio surname: Leonardi fullname: Leonardi, Sergio organization: University of Pavia and Fondazione IRCCS Policlinico S Matteo, Italy (S.L.) – sequence: 15 givenname: Dik surname: Heg fullname: Heg, Dik organization: Bern University Hospital, and Clinical Trials Unit, CTU Bern (D.H.), University of Bern, Switzerland – sequence: 16 givenname: Stephan surname: Windecker fullname: Windecker, Stephan organization: Department of Cardiology (G.G., F.G., N.M., L.H., S.W., M.V.), University of Bern, Switzerland – sequence: 17 givenname: Marco surname: Valgimigli fullname: Valgimigli, Marco organization: Department of Cardiology (G.G., F.G., N.M., L.H., S.W., M.V.), University of Bern, Switzerland |
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| Snippet | Standard administration of newer oral P2Y
inhibitors, including prasugrel or ticagrelor, provides suboptimal early inhibition of platelet aggregation (IPA) in... Standard administration of newer oral P2Y12 inhibitors, including prasugrel or ticagrelor, provides suboptimal early inhibition of platelet aggregation (IPA)... |
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| SubjectTerms | Adenosine Diphosphate - pharmacology Adenosine Monophosphate - administration & dosage Adenosine Monophosphate - analogs & derivatives Adenosine Monophosphate - blood Adenosine Monophosphate - pharmacology Adenosine Monophosphate - therapeutic use Administration, Oral Aged Aged, 80 and over Area Under Curve Aspirin - therapeutic use Cardiac Catheterization Comorbidity Female Heart - physiopathology Humans Infusions, Intravenous Male Mastication Middle Aged Percutaneous Coronary Intervention Platelet Aggregation - drug effects Polypharmacy Prasugrel Hydrochloride - administration & dosage Prasugrel Hydrochloride - blood Prasugrel Hydrochloride - pharmacology Prasugrel Hydrochloride - therapeutic use Proportional Hazards Models Purinergic P2Y Receptor Antagonists - administration & dosage Purinergic P2Y Receptor Antagonists - blood Purinergic P2Y Receptor Antagonists - pharmacology Purinergic P2Y Receptor Antagonists - therapeutic use ST Elevation Myocardial Infarction - drug therapy ST Elevation Myocardial Infarction - therapy Tablets Tirofiban - administration & dosage Tirofiban - blood Tirofiban - pharmacology Tirofiban - therapeutic use Treatment Outcome |
| Title | Cangrelor, Tirofiban, and Chewed or Standard Prasugrel Regimens in Patients With ST-Segment-Elevation Myocardial Infarction: Primary Results of the FABOLUS-FASTER Trial |
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