Prasugrel versus clopidogrel for patients with unstable angina or non-ST-segment elevation myocardial infarction with or without angiography: A secondary, prespecified analysis of the TRILOGY ACS trial

Stephen D. Wiviott, Harvey D. White, E. Magnus Ohman, Keith A.A. Fox, Paul W. Armstrong, Dorairaj Prabhakaran, Gail Hafley, Yuliya Lokhnygina, William E. Boden, Christian Hamm, Peter Clemmensen, Jose C. Nicolau, Alberto Menozzi, Witold Ruzyllo, Petr Widimsky, Ali Oto, Jose Leiva-Pons, Gregory Pavlides, Kenneth J. Winters, Matthew T. RoeDeepak L. Bhatt

Research output: Contribution to journalArticle

80 Citations (Scopus)

Abstract

Background Treatment with prasugrel and aspirin improves outcomes compared with clopidogrel and aspirin for patients with acute coronary syndrome who have had angiography and percutaneous coronary intervention; however, no clear benefit has been shown for patients managed first with drugs only. We assessed outcomes from the TRILOGY ACS trial based on whether or not patients had coronary angiography before treatment was chosen. Methods TRILOGY ACS (ClinicalTrials.gov number NCT00699998) was a randomised controlled trial, done at more than 800 sites worldwide. Patients with non-ST-elevation acute coronary syndrome who were selected for management with revascularisation were randomly assigned to clopidogrel or prasugrel. The primary endpoint was cardiovascular death, myocardial infarction, or stroke at 30 months. In the present analysis we assessed differences in the primary endpoint by angiography status and whether the effects of treatment on the primary endpoint differed between patients who had angiography before enrolment and those who had not. Findings 7243 patients younger than 75 years were included in the TRILOGY ACS primary analysis. 3085 (43%) had angiography at baseline, 4158 (57%) had not. Fewer patients who had angiography reached the primary endpoint at 30 months compared with those who did not have angiography, according to Kaplan-Meier analysis (281/3085 [12·8%] vs 480/4158 [16·5%], adjusted hazard ratio [HR] 0·63, 95% CI 0·53-0·75; p<0·0001). The proportion of patients who reached the primary endpoint was lower in the prasugrel group than in the clopidogrel group for those who had angiography (122/1524 [10·7%] vs 159/1561 [14·9%], HR 0·77, 95% CI 0·61-0·98; p=0·032) but did not differ between groups in patients who did not have angiography (242/2096 [16·3%] vs 238/2062 [16·7%], HR 1·01, 0·84-1·20; p=0·94; p interaction=0·08). Overall, TIMI major bleeding and GUSTO severe bleeding were rare. Bleeding outcomes tended to be higher with prasugrel but did not differ significantly between treatment groups in either angiography cohort. Interpretation Among patients who had angiography who took prasugrel there were fewer cardiovascular deaths, myocardial infarctions, or strokes than in those who took clopidogrel. This result needs to be corroborated, but it is consistent with previous trials of more versus less intensive antiplatelet treatment. When angiography is done for acute coronary syndrome and anatomic coronary disease confirmed, the benefits and risks of intensive antiplatelet treatment exist whether the patient is treated with drugs or percutaneous coronary intervention.

Original languageEnglish (US)
Pages (from-to)605-613
Number of pages9
JournalThe Lancet
Volume382
Issue number9892
DOIs
StatePublished - Jan 1 2013

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clopidogrel
Unstable Angina
Angiography
Acute Coronary Syndrome
Percutaneous Coronary Intervention
Hemorrhage
Aspirin
Non-ST Elevated Myocardial Infarction
Prasugrel Hydrochloride
Therapeutics
Stroke
Myocardial Infarction

ASJC Scopus subject areas

  • Medicine(all)

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Prasugrel versus clopidogrel for patients with unstable angina or non-ST-segment elevation myocardial infarction with or without angiography : A secondary, prespecified analysis of the TRILOGY ACS trial. / Wiviott, Stephen D.; White, Harvey D.; Ohman, E. Magnus; Fox, Keith A.A.; Armstrong, Paul W.; Prabhakaran, Dorairaj; Hafley, Gail; Lokhnygina, Yuliya; Boden, William E.; Hamm, Christian; Clemmensen, Peter; Nicolau, Jose C.; Menozzi, Alberto; Ruzyllo, Witold; Widimsky, Petr; Oto, Ali; Leiva-Pons, Jose; Pavlides, Gregory; Winters, Kenneth J.; Roe, Matthew T.; Bhatt, Deepak L.

In: The Lancet, Vol. 382, No. 9892, 01.01.2013, p. 605-613.

Research output: Contribution to journalArticle

Wiviott, SD, White, HD, Ohman, EM, Fox, KAA, Armstrong, PW, Prabhakaran, D, Hafley, G, Lokhnygina, Y, Boden, WE, Hamm, C, Clemmensen, P, Nicolau, JC, Menozzi, A, Ruzyllo, W, Widimsky, P, Oto, A, Leiva-Pons, J, Pavlides, G, Winters, KJ, Roe, MT & Bhatt, DL 2013, 'Prasugrel versus clopidogrel for patients with unstable angina or non-ST-segment elevation myocardial infarction with or without angiography: A secondary, prespecified analysis of the TRILOGY ACS trial', The Lancet, vol. 382, no. 9892, pp. 605-613. https://doi.org/10.1016/S0140-6736(13)61451-8
Wiviott, Stephen D. ; White, Harvey D. ; Ohman, E. Magnus ; Fox, Keith A.A. ; Armstrong, Paul W. ; Prabhakaran, Dorairaj ; Hafley, Gail ; Lokhnygina, Yuliya ; Boden, William E. ; Hamm, Christian ; Clemmensen, Peter ; Nicolau, Jose C. ; Menozzi, Alberto ; Ruzyllo, Witold ; Widimsky, Petr ; Oto, Ali ; Leiva-Pons, Jose ; Pavlides, Gregory ; Winters, Kenneth J. ; Roe, Matthew T. ; Bhatt, Deepak L. / Prasugrel versus clopidogrel for patients with unstable angina or non-ST-segment elevation myocardial infarction with or without angiography : A secondary, prespecified analysis of the TRILOGY ACS trial. In: The Lancet. 2013 ; Vol. 382, No. 9892. pp. 605-613.
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abstract = "Background Treatment with prasugrel and aspirin improves outcomes compared with clopidogrel and aspirin for patients with acute coronary syndrome who have had angiography and percutaneous coronary intervention; however, no clear benefit has been shown for patients managed first with drugs only. We assessed outcomes from the TRILOGY ACS trial based on whether or not patients had coronary angiography before treatment was chosen. Methods TRILOGY ACS (ClinicalTrials.gov number NCT00699998) was a randomised controlled trial, done at more than 800 sites worldwide. Patients with non-ST-elevation acute coronary syndrome who were selected for management with revascularisation were randomly assigned to clopidogrel or prasugrel. The primary endpoint was cardiovascular death, myocardial infarction, or stroke at 30 months. In the present analysis we assessed differences in the primary endpoint by angiography status and whether the effects of treatment on the primary endpoint differed between patients who had angiography before enrolment and those who had not. Findings 7243 patients younger than 75 years were included in the TRILOGY ACS primary analysis. 3085 (43{\%}) had angiography at baseline, 4158 (57{\%}) had not. Fewer patients who had angiography reached the primary endpoint at 30 months compared with those who did not have angiography, according to Kaplan-Meier analysis (281/3085 [12·8{\%}] vs 480/4158 [16·5{\%}], adjusted hazard ratio [HR] 0·63, 95{\%} CI 0·53-0·75; p<0·0001). The proportion of patients who reached the primary endpoint was lower in the prasugrel group than in the clopidogrel group for those who had angiography (122/1524 [10·7{\%}] vs 159/1561 [14·9{\%}], HR 0·77, 95{\%} CI 0·61-0·98; p=0·032) but did not differ between groups in patients who did not have angiography (242/2096 [16·3{\%}] vs 238/2062 [16·7{\%}], HR 1·01, 0·84-1·20; p=0·94; p interaction=0·08). Overall, TIMI major bleeding and GUSTO severe bleeding were rare. Bleeding outcomes tended to be higher with prasugrel but did not differ significantly between treatment groups in either angiography cohort. Interpretation Among patients who had angiography who took prasugrel there were fewer cardiovascular deaths, myocardial infarctions, or strokes than in those who took clopidogrel. This result needs to be corroborated, but it is consistent with previous trials of more versus less intensive antiplatelet treatment. When angiography is done for acute coronary syndrome and anatomic coronary disease confirmed, the benefits and risks of intensive antiplatelet treatment exist whether the patient is treated with drugs or percutaneous coronary intervention.",
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TY - JOUR

T1 - Prasugrel versus clopidogrel for patients with unstable angina or non-ST-segment elevation myocardial infarction with or without angiography

T2 - A secondary, prespecified analysis of the TRILOGY ACS trial

AU - Wiviott, Stephen D.

AU - White, Harvey D.

AU - Ohman, E. Magnus

AU - Fox, Keith A.A.

AU - Armstrong, Paul W.

AU - Prabhakaran, Dorairaj

AU - Hafley, Gail

AU - Lokhnygina, Yuliya

AU - Boden, William E.

AU - Hamm, Christian

AU - Clemmensen, Peter

AU - Nicolau, Jose C.

AU - Menozzi, Alberto

AU - Ruzyllo, Witold

AU - Widimsky, Petr

AU - Oto, Ali

AU - Leiva-Pons, Jose

AU - Pavlides, Gregory

AU - Winters, Kenneth J.

AU - Roe, Matthew T.

AU - Bhatt, Deepak L.

PY - 2013/1/1

Y1 - 2013/1/1

N2 - Background Treatment with prasugrel and aspirin improves outcomes compared with clopidogrel and aspirin for patients with acute coronary syndrome who have had angiography and percutaneous coronary intervention; however, no clear benefit has been shown for patients managed first with drugs only. We assessed outcomes from the TRILOGY ACS trial based on whether or not patients had coronary angiography before treatment was chosen. Methods TRILOGY ACS (ClinicalTrials.gov number NCT00699998) was a randomised controlled trial, done at more than 800 sites worldwide. Patients with non-ST-elevation acute coronary syndrome who were selected for management with revascularisation were randomly assigned to clopidogrel or prasugrel. The primary endpoint was cardiovascular death, myocardial infarction, or stroke at 30 months. In the present analysis we assessed differences in the primary endpoint by angiography status and whether the effects of treatment on the primary endpoint differed between patients who had angiography before enrolment and those who had not. Findings 7243 patients younger than 75 years were included in the TRILOGY ACS primary analysis. 3085 (43%) had angiography at baseline, 4158 (57%) had not. Fewer patients who had angiography reached the primary endpoint at 30 months compared with those who did not have angiography, according to Kaplan-Meier analysis (281/3085 [12·8%] vs 480/4158 [16·5%], adjusted hazard ratio [HR] 0·63, 95% CI 0·53-0·75; p<0·0001). The proportion of patients who reached the primary endpoint was lower in the prasugrel group than in the clopidogrel group for those who had angiography (122/1524 [10·7%] vs 159/1561 [14·9%], HR 0·77, 95% CI 0·61-0·98; p=0·032) but did not differ between groups in patients who did not have angiography (242/2096 [16·3%] vs 238/2062 [16·7%], HR 1·01, 0·84-1·20; p=0·94; p interaction=0·08). Overall, TIMI major bleeding and GUSTO severe bleeding were rare. Bleeding outcomes tended to be higher with prasugrel but did not differ significantly between treatment groups in either angiography cohort. Interpretation Among patients who had angiography who took prasugrel there were fewer cardiovascular deaths, myocardial infarctions, or strokes than in those who took clopidogrel. This result needs to be corroborated, but it is consistent with previous trials of more versus less intensive antiplatelet treatment. When angiography is done for acute coronary syndrome and anatomic coronary disease confirmed, the benefits and risks of intensive antiplatelet treatment exist whether the patient is treated with drugs or percutaneous coronary intervention.

AB - Background Treatment with prasugrel and aspirin improves outcomes compared with clopidogrel and aspirin for patients with acute coronary syndrome who have had angiography and percutaneous coronary intervention; however, no clear benefit has been shown for patients managed first with drugs only. We assessed outcomes from the TRILOGY ACS trial based on whether or not patients had coronary angiography before treatment was chosen. Methods TRILOGY ACS (ClinicalTrials.gov number NCT00699998) was a randomised controlled trial, done at more than 800 sites worldwide. Patients with non-ST-elevation acute coronary syndrome who were selected for management with revascularisation were randomly assigned to clopidogrel or prasugrel. The primary endpoint was cardiovascular death, myocardial infarction, or stroke at 30 months. In the present analysis we assessed differences in the primary endpoint by angiography status and whether the effects of treatment on the primary endpoint differed between patients who had angiography before enrolment and those who had not. Findings 7243 patients younger than 75 years were included in the TRILOGY ACS primary analysis. 3085 (43%) had angiography at baseline, 4158 (57%) had not. Fewer patients who had angiography reached the primary endpoint at 30 months compared with those who did not have angiography, according to Kaplan-Meier analysis (281/3085 [12·8%] vs 480/4158 [16·5%], adjusted hazard ratio [HR] 0·63, 95% CI 0·53-0·75; p<0·0001). The proportion of patients who reached the primary endpoint was lower in the prasugrel group than in the clopidogrel group for those who had angiography (122/1524 [10·7%] vs 159/1561 [14·9%], HR 0·77, 95% CI 0·61-0·98; p=0·032) but did not differ between groups in patients who did not have angiography (242/2096 [16·3%] vs 238/2062 [16·7%], HR 1·01, 0·84-1·20; p=0·94; p interaction=0·08). Overall, TIMI major bleeding and GUSTO severe bleeding were rare. Bleeding outcomes tended to be higher with prasugrel but did not differ significantly between treatment groups in either angiography cohort. Interpretation Among patients who had angiography who took prasugrel there were fewer cardiovascular deaths, myocardial infarctions, or strokes than in those who took clopidogrel. This result needs to be corroborated, but it is consistent with previous trials of more versus less intensive antiplatelet treatment. When angiography is done for acute coronary syndrome and anatomic coronary disease confirmed, the benefits and risks of intensive antiplatelet treatment exist whether the patient is treated with drugs or percutaneous coronary intervention.

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