Prasugrel versus clopidogrel for acute coronary syndromes without revascularization

Matthew T. Roe, Paul W. Armstrong, Keith A A Fox, Harvey D. White, Dorairaj Prabhakaran, Shaun G. Goodman, Jan H. Cornel, Deepak L. Bhatt, Peter Clemmensen, Felipe Martinez, Diego Ardissino, Jose C. Nicolau, William E. Boden, Paul A. Gurbel, Witold Ruzyllo, Anthony J. Dalby, Darren K. McGuire, Jose L. Leiva-Pons, Alexander Parkhomenko, Shmuel GottliebGracita O. Topacio, Christian Hamm, Gregory Pavlides, Assen R. Goudev, Ali Oto, Chuen Den Tseng, B. Merkely, Vladimir Gasparovic, Ramon Corbalan, Mircea Cintezǎ, R. Craig McLendon, Kenneth J. Winters, Eileen B. Brown, Yuliya Lokhnygina, Philip E. Aylward, Kurt Huber, Judith S. Hochman, E. Magnus Ohman

Research output: Contribution to journalArticle

538 Citations (Scopus)

Abstract

BACKGROUND: The effect of intensified platelet inhibition for patients with unstable angina or myocardial infarction without ST-segment elevation who do not undergo revascularization has not been delineated. METHODS: In this double-blind, randomized trial, in a primary analysis involving 7243 patients under the age of 75 years receiving aspirin, we evaluated up to 30 months of treatment with prasugrel (10 mg daily) versus clopidogrel (75 mg daily). In a secondary analysis involving 2083 patients 75 years of age or older, we evaluated 5 mg of prasugrel versus 75 mg of clopidogrel. RESULTS: At a median follow-up of 17 months, the primary end point of death from cardiovascular causes, myocardial infarction, or stroke among patients under the age of 75 years occurred in 13.9% of the prasugrel group and 16.0% of the clopidogrel group (hazard ratio in the prasugrel group, 0.91; 95% confidence interval [CI], 0.79 to 1.05; P = 0.21). Similar results were observed in the overall population. The prespecified analysis of multiple recurrent ischemic events (all components of the primary end point) suggested a lower risk for prasugrel among patients under the age of 75 years (hazard ratio, 0.85; 95% CI, 0.72 to 1.00; P = 0.04). Rates of severe and intracranial bleeding were similar in the two groups in all age groups. There was no significant between-group difference in the frequency of nonhemorrhagic serious adverse events, except for a higher frequency of heart failure in the clopidogrel group. CONCLUSIONS: Among patients with unstable angina or myocardial infarction without ST-segment elevation, prasugrel did not significantly reduce the frequency of the primary end point, as compared with clopidogrel, and similar risks of bleeding were observed. (Funded by Eli Lilly and Daiichi Sankyo; TRILOGY ACS ClinicalTrials.gov number, NCT00699998.)

Original languageEnglish
Pages (from-to)1297-1309
Number of pages13
JournalNew England Journal of Medicine
Volume367
Issue number14
DOIs
Publication statusPublished - Oct 4 2012

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clopidogrel
Acute Coronary Syndrome
Unstable Angina
Confidence Intervals
Hemorrhage
Aspirin
Prasugrel Hydrochloride
Cause of Death
Blood Platelets
Heart Failure
Age Groups
Stroke
Myocardial Infarction

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Roe, M. T., Armstrong, P. W., Fox, K. A. A., White, H. D., Prabhakaran, D., Goodman, S. G., ... Ohman, E. M. (2012). Prasugrel versus clopidogrel for acute coronary syndromes without revascularization. New England Journal of Medicine, 367(14), 1297-1309. https://doi.org/10.1056/NEJMoa1205512

Prasugrel versus clopidogrel for acute coronary syndromes without revascularization. / Roe, Matthew T.; Armstrong, Paul W.; Fox, Keith A A; White, Harvey D.; Prabhakaran, Dorairaj; Goodman, Shaun G.; Cornel, Jan H.; Bhatt, Deepak L.; Clemmensen, Peter; Martinez, Felipe; Ardissino, Diego; Nicolau, Jose C.; Boden, William E.; Gurbel, Paul A.; Ruzyllo, Witold; Dalby, Anthony J.; McGuire, Darren K.; Leiva-Pons, Jose L.; Parkhomenko, Alexander; Gottlieb, Shmuel; Topacio, Gracita O.; Hamm, Christian; Pavlides, Gregory; Goudev, Assen R.; Oto, Ali; Tseng, Chuen Den; Merkely, B.; Gasparovic, Vladimir; Corbalan, Ramon; Cintezǎ, Mircea; McLendon, R. Craig; Winters, Kenneth J.; Brown, Eileen B.; Lokhnygina, Yuliya; Aylward, Philip E.; Huber, Kurt; Hochman, Judith S.; Ohman, E. Magnus.

In: New England Journal of Medicine, Vol. 367, No. 14, 04.10.2012, p. 1297-1309.

Research output: Contribution to journalArticle

Roe, MT, Armstrong, PW, Fox, KAA, White, HD, Prabhakaran, D, Goodman, SG, Cornel, JH, Bhatt, DL, Clemmensen, P, Martinez, F, Ardissino, D, Nicolau, JC, Boden, WE, Gurbel, PA, Ruzyllo, W, Dalby, AJ, McGuire, DK, Leiva-Pons, JL, Parkhomenko, A, Gottlieb, S, Topacio, GO, Hamm, C, Pavlides, G, Goudev, AR, Oto, A, Tseng, CD, Merkely, B, Gasparovic, V, Corbalan, R, Cintezǎ, M, McLendon, RC, Winters, KJ, Brown, EB, Lokhnygina, Y, Aylward, PE, Huber, K, Hochman, JS & Ohman, EM 2012, 'Prasugrel versus clopidogrel for acute coronary syndromes without revascularization', New England Journal of Medicine, vol. 367, no. 14, pp. 1297-1309. https://doi.org/10.1056/NEJMoa1205512
Roe MT, Armstrong PW, Fox KAA, White HD, Prabhakaran D, Goodman SG et al. Prasugrel versus clopidogrel for acute coronary syndromes without revascularization. New England Journal of Medicine. 2012 Oct 4;367(14):1297-1309. https://doi.org/10.1056/NEJMoa1205512
Roe, Matthew T. ; Armstrong, Paul W. ; Fox, Keith A A ; White, Harvey D. ; Prabhakaran, Dorairaj ; Goodman, Shaun G. ; Cornel, Jan H. ; Bhatt, Deepak L. ; Clemmensen, Peter ; Martinez, Felipe ; Ardissino, Diego ; Nicolau, Jose C. ; Boden, William E. ; Gurbel, Paul A. ; Ruzyllo, Witold ; Dalby, Anthony J. ; McGuire, Darren K. ; Leiva-Pons, Jose L. ; Parkhomenko, Alexander ; Gottlieb, Shmuel ; Topacio, Gracita O. ; Hamm, Christian ; Pavlides, Gregory ; Goudev, Assen R. ; Oto, Ali ; Tseng, Chuen Den ; Merkely, B. ; Gasparovic, Vladimir ; Corbalan, Ramon ; Cintezǎ, Mircea ; McLendon, R. Craig ; Winters, Kenneth J. ; Brown, Eileen B. ; Lokhnygina, Yuliya ; Aylward, Philip E. ; Huber, Kurt ; Hochman, Judith S. ; Ohman, E. Magnus. / Prasugrel versus clopidogrel for acute coronary syndromes without revascularization. In: New England Journal of Medicine. 2012 ; Vol. 367, No. 14. pp. 1297-1309.
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abstract = "BACKGROUND: The effect of intensified platelet inhibition for patients with unstable angina or myocardial infarction without ST-segment elevation who do not undergo revascularization has not been delineated. METHODS: In this double-blind, randomized trial, in a primary analysis involving 7243 patients under the age of 75 years receiving aspirin, we evaluated up to 30 months of treatment with prasugrel (10 mg daily) versus clopidogrel (75 mg daily). In a secondary analysis involving 2083 patients 75 years of age or older, we evaluated 5 mg of prasugrel versus 75 mg of clopidogrel. RESULTS: At a median follow-up of 17 months, the primary end point of death from cardiovascular causes, myocardial infarction, or stroke among patients under the age of 75 years occurred in 13.9{\%} of the prasugrel group and 16.0{\%} of the clopidogrel group (hazard ratio in the prasugrel group, 0.91; 95{\%} confidence interval [CI], 0.79 to 1.05; P = 0.21). Similar results were observed in the overall population. The prespecified analysis of multiple recurrent ischemic events (all components of the primary end point) suggested a lower risk for prasugrel among patients under the age of 75 years (hazard ratio, 0.85; 95{\%} CI, 0.72 to 1.00; P = 0.04). Rates of severe and intracranial bleeding were similar in the two groups in all age groups. There was no significant between-group difference in the frequency of nonhemorrhagic serious adverse events, except for a higher frequency of heart failure in the clopidogrel group. CONCLUSIONS: Among patients with unstable angina or myocardial infarction without ST-segment elevation, prasugrel did not significantly reduce the frequency of the primary end point, as compared with clopidogrel, and similar risks of bleeding were observed. (Funded by Eli Lilly and Daiichi Sankyo; TRILOGY ACS ClinicalTrials.gov number, NCT00699998.)",
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T1 - Prasugrel versus clopidogrel for acute coronary syndromes without revascularization

AU - Roe, Matthew T.

AU - Armstrong, Paul W.

AU - Fox, Keith A A

AU - White, Harvey D.

AU - Prabhakaran, Dorairaj

AU - Goodman, Shaun G.

AU - Cornel, Jan H.

AU - Bhatt, Deepak L.

AU - Clemmensen, Peter

AU - Martinez, Felipe

AU - Ardissino, Diego

AU - Nicolau, Jose C.

AU - Boden, William E.

AU - Gurbel, Paul A.

AU - Ruzyllo, Witold

AU - Dalby, Anthony J.

AU - McGuire, Darren K.

AU - Leiva-Pons, Jose L.

AU - Parkhomenko, Alexander

AU - Gottlieb, Shmuel

AU - Topacio, Gracita O.

AU - Hamm, Christian

AU - Pavlides, Gregory

AU - Goudev, Assen R.

AU - Oto, Ali

AU - Tseng, Chuen Den

AU - Merkely, B.

AU - Gasparovic, Vladimir

AU - Corbalan, Ramon

AU - Cintezǎ, Mircea

AU - McLendon, R. Craig

AU - Winters, Kenneth J.

AU - Brown, Eileen B.

AU - Lokhnygina, Yuliya

AU - Aylward, Philip E.

AU - Huber, Kurt

AU - Hochman, Judith S.

AU - Ohman, E. Magnus

PY - 2012/10/4

Y1 - 2012/10/4

N2 - BACKGROUND: The effect of intensified platelet inhibition for patients with unstable angina or myocardial infarction without ST-segment elevation who do not undergo revascularization has not been delineated. METHODS: In this double-blind, randomized trial, in a primary analysis involving 7243 patients under the age of 75 years receiving aspirin, we evaluated up to 30 months of treatment with prasugrel (10 mg daily) versus clopidogrel (75 mg daily). In a secondary analysis involving 2083 patients 75 years of age or older, we evaluated 5 mg of prasugrel versus 75 mg of clopidogrel. RESULTS: At a median follow-up of 17 months, the primary end point of death from cardiovascular causes, myocardial infarction, or stroke among patients under the age of 75 years occurred in 13.9% of the prasugrel group and 16.0% of the clopidogrel group (hazard ratio in the prasugrel group, 0.91; 95% confidence interval [CI], 0.79 to 1.05; P = 0.21). Similar results were observed in the overall population. The prespecified analysis of multiple recurrent ischemic events (all components of the primary end point) suggested a lower risk for prasugrel among patients under the age of 75 years (hazard ratio, 0.85; 95% CI, 0.72 to 1.00; P = 0.04). Rates of severe and intracranial bleeding were similar in the two groups in all age groups. There was no significant between-group difference in the frequency of nonhemorrhagic serious adverse events, except for a higher frequency of heart failure in the clopidogrel group. CONCLUSIONS: Among patients with unstable angina or myocardial infarction without ST-segment elevation, prasugrel did not significantly reduce the frequency of the primary end point, as compared with clopidogrel, and similar risks of bleeding were observed. (Funded by Eli Lilly and Daiichi Sankyo; TRILOGY ACS ClinicalTrials.gov number, NCT00699998.)

AB - BACKGROUND: The effect of intensified platelet inhibition for patients with unstable angina or myocardial infarction without ST-segment elevation who do not undergo revascularization has not been delineated. METHODS: In this double-blind, randomized trial, in a primary analysis involving 7243 patients under the age of 75 years receiving aspirin, we evaluated up to 30 months of treatment with prasugrel (10 mg daily) versus clopidogrel (75 mg daily). In a secondary analysis involving 2083 patients 75 years of age or older, we evaluated 5 mg of prasugrel versus 75 mg of clopidogrel. RESULTS: At a median follow-up of 17 months, the primary end point of death from cardiovascular causes, myocardial infarction, or stroke among patients under the age of 75 years occurred in 13.9% of the prasugrel group and 16.0% of the clopidogrel group (hazard ratio in the prasugrel group, 0.91; 95% confidence interval [CI], 0.79 to 1.05; P = 0.21). Similar results were observed in the overall population. The prespecified analysis of multiple recurrent ischemic events (all components of the primary end point) suggested a lower risk for prasugrel among patients under the age of 75 years (hazard ratio, 0.85; 95% CI, 0.72 to 1.00; P = 0.04). Rates of severe and intracranial bleeding were similar in the two groups in all age groups. There was no significant between-group difference in the frequency of nonhemorrhagic serious adverse events, except for a higher frequency of heart failure in the clopidogrel group. CONCLUSIONS: Among patients with unstable angina or myocardial infarction without ST-segment elevation, prasugrel did not significantly reduce the frequency of the primary end point, as compared with clopidogrel, and similar risks of bleeding were observed. (Funded by Eli Lilly and Daiichi Sankyo; TRILOGY ACS ClinicalTrials.gov number, NCT00699998.)

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DO - 10.1056/NEJMoa1205512

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