title: Outcomes in patients with ST-segment elevation acute myocardial infarction treated with clopidogrel versus prasugrel (from the INFUSE-AMI trial).
abstract: Prasugrel is more potent than clopidogrel, but it is not known whether this translates into clinical benefit in patients undergoing primary percutaneous coronary intervention (PCI) with bivalirudin for ST elevation myocardial infarction. In the Intracoronary Abciximab and Aspiration Thrombectomy in Patients With Large Anterior Myocardial Infarction trial, 452 patients with anterior STEMI undergoing primary PCI with bivalirudin were randomized to intralesional abciximab or placebo and to thrombus aspiration or no aspiration. Clopidogrel or prasugrel were administered at physician discretion. The primary end point was infarct size at 30 days by cardiac magnetic resonance imaging. Clinical events at 30 days and 1 year were independently adjudicated. Propensity score was used to adjust for nonrandom allocation of the drugs. Prasugrel and clopidogrel were administered to 155 patients (34.3%) and 297 patients (65.7%), respectively. Patients receiving prasugrel were younger with higher left ventricular ejection fraction and greater use of drug-eluting stents. Prasugrel-treated patients had higher rates of procedural success (94% vs 89%, p = 0.03), Thrombolysis In Myocardial Infarction (TIMI) 3 flow (95% vs 90%, p = 0.06), and lower corrected TIMI frame counts (21 ± 6 vs 23 ± 11, p = 0.008). At 30 days, infarct size was marginally lower in the prasugrel group (median [interquartile range] = 16.4% [6.5 to 20.0] vs 17.6% [8.1 to 25.7], p = 0.06). At 1 year, prasugrel group had significantly fewer deaths (1.3% vs 8.3%, p = 0.004) and fewer episodes of severe heart failure (2.0% vs 7.7%, p = 0.02). These findings persisted after propensity score adjustment. There were no significant differences in major bleeding. Stent thrombosis was 0% versus 2.5%, respectively, p = 0.054. We conclude that prasugrel was associated with improved efficacy and similar safety compared with clopidogrel in patients undergoing primary PCI with bivalirudin.
authors.affiliation: The Cardiovascular Research Foundation, New York, New York; Department of Medicine, New York Methodist Hospital, Brooklyn, New York. Electronic address: sjb9005@nyp.org.
authors.forename: Sorin J
authors.initials: SJ
authors.lastname: Brener
authors.affiliation: Department of Medicine, University of Glasgow, Glasgow, United Kingdom.
authors.forename: Keith G
authors.initials: KG
authors.lastname: Oldroyd
authors.affiliation: The Cardiovascular Research Foundation, New York, New York.
authors.forename: Akiko
authors.initials: A
authors.lastname: Maehara
authors.affiliation: Department of Medicine, Manchester Heart Centre, Manchester, United Kingdom.
authors.forename: Magdi
authors.initials: M
authors.lastname: El-Omar
authors.affiliation: Department of Medicine, Amper Kliniken, Munich, Germany.
authors.forename: Bernhard
authors.initials: B
authors.lastname: Witzenbichler
authors.affiliation: The Cardiovascular Research Foundation, New York, New York.
authors.forename: Ke
authors.initials: K
authors.lastname: Xu
authors.affiliation: The Cardiovascular Research Foundation, New York, New York; Department of Medicine, Mount Sinai Hospital, New York, New York.
authors.forename: Roxana
authors.initials: R
authors.lastname: Mehran
authors.affiliation: Department of Medicine, Beth Israel Deaconess Medical Center, Boston, Massachusetts.
authors.forename: C Michael
authors.initials: CM
authors.lastname: Gibson
authors.affiliation: The Cardiovascular Research Foundation, New York, New York; Department of Medicine, Columbia University Medical Center, New York, New York.
authors.forename: Gregg W
authors.initials: GW
authors.lastname: Stone
mesh_terms: D000991:Antithrombins / Q000627:therapeutic use; D000077144:Clopidogrel; D017023:Coronary Angiography; D004562:Electrocardiography; D005260:Female; D006629:Hirudins; D006801:Humans; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000188:drug therapy* / Q000503:physiopathology / Q000601:surgery; D010446:Peptide Fragments / Q000627:therapeutic use; D062645:Percutaneous Coronary Intervention; D010879:Piperazines / Q000627:therapeutic use*; D010975:Platelet Aggregation Inhibitors / Q000627:therapeutic use*; D000068799:Prasugrel Hydrochloride; D058921:Purinergic P2Y Receptor Antagonists / Q000627:therapeutic use*; D011994:Recombinant Proteins / Q000627:therapeutic use; D013876:Thiophenes / Q000627:therapeutic use*; D013988:Ticlopidine / Q000031:analogs & derivatives* / Q000627:therapeutic use; D016896:Treatment Outcome
chemical_list: D000991:Antithrombins; D006629:Hirudins; D010446:Peptide Fragments; D010879:Piperazines; D010975:Platelet Aggregation Inhibitors; D058921:Purinergic P2Y Receptor Antagonists; D011994:Recombinant Proteins; D013876:Thiophenes; D000077144:Clopidogrel; D000068799:Prasugrel Hydrochloride; D013988:Ticlopidine; C074619:bivalirudin