Intensive oral antiplatelet therapy for reduction of ischaemic events including stent thrombosis in patients with acute coronary syndromes treated with percutaneous coronary intervention and stenting in the TRITON-TIMI 38 trial: a subanalysis of a randomised trial

Stephen D. Wiviott, Eugene Braunwald, Carolyn H. McCabe, Ivan Horvath, Matyas Keltai, Jean Paul R Herrman, Frans Van de Werf, William E. Downey, Benjamin M. Scirica, Sabina A. Murphy, Elliott M. Antman

Research output: Article

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Abstract

Background: Intracoronary stenting can improve procedural success and reduce restenosis compared with balloon angioplasty in patients with acute coronary syndromes, but can also increase the rate of thrombotic complications including stent thrombosis. The TRITON-TIMI 38 trial has shown that prasugrel-a novel, potent thienopyridine-can reduce ischaemic events compared with standard clopidogrel therapy. We assessed the rate, outcomes, and prevention of ischaemic events in patients treated with prasugrel or clopidogrel with stents in the TRITON-TIMI 38 study. Methods: Patients with moderate-risk to high-risk acute coronary syndromes were included in our analysis if they had received at least one coronary stent at the time of the index procedure following randomisation in TRITON-TIMI 38, and were further subdivided by type of stent received. Patients were randomly assigned in a 1 to 1 fashion to receive a loading dose of study drug (prasugrel 60 mg or clopidogrel 300 mg) as soon as possible after randomisation, followed by daily maintenance therapy (prasugrel 10 mg or clopidogrel 75 mg). All patients were to receive aspirin therapy. Treatment was to be continued for a minimum of 6 months and a maximum of 15 months. Randomisation was not stratified by stents used or stent type. The primary endpoint was the composite of cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke. Stent thrombosis was assessed using Academic Research Consortium definitions, and analysis was by intention to treat. TRITON-TIMI 38 is registered with ClinicalTrials.gov, number NCT00097591. Findings: 12 844 patients received at least one coronary stent; 5743 received only drug-eluting stents, and 6461 received only bare-metal stents. Prasugrel compared with clopidogrel reduced the primary endpoint (9·7 vs 11·9%, HR 0·81, p=0·0001) in the stented cohort, in patients with only drug-eluting stents (9·0 vs 11·1%, HR 0·82, p=0·019), and in patients with only bare-metal stents (10·0 vs 12·2%, HR 0·80, p=0·003). Stent thrombosis was associated with death or myocardial infarction in 89% (186/210) of patients. Stent thrombosis was reduced with prasugrel overall (1·13 vs 2·35%, HR 0·48, p

Original languageEnglish
Pages (from-to)1353-1363
Number of pages11
JournalThe Lancet
Volume371
Issue number9621
DOIs
Publication statusPublished - 2008

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Percutaneous Coronary Intervention
Acute Coronary Syndrome
clopidogrel
Stents
Thrombosis
Therapeutics
Random Allocation
Drug-Eluting Stents
Metals
Myocardial Infarction
Intention to Treat Analysis
Balloon Angioplasty
Aspirin
Prasugrel Hydrochloride
Stroke

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Intensive oral antiplatelet therapy for reduction of ischaemic events including stent thrombosis in patients with acute coronary syndromes treated with percutaneous coronary intervention and stenting in the TRITON-TIMI 38 trial : a subanalysis of a randomised trial. / Wiviott, Stephen D.; Braunwald, Eugene; McCabe, Carolyn H.; Horvath, Ivan; Keltai, Matyas; Herrman, Jean Paul R; Van de Werf, Frans; Downey, William E.; Scirica, Benjamin M.; Murphy, Sabina A.; Antman, Elliott M.

In: The Lancet, Vol. 371, No. 9621, 2008, p. 1353-1363.

Research output: Article

Wiviott, Stephen D. ; Braunwald, Eugene ; McCabe, Carolyn H. ; Horvath, Ivan ; Keltai, Matyas ; Herrman, Jean Paul R ; Van de Werf, Frans ; Downey, William E. ; Scirica, Benjamin M. ; Murphy, Sabina A. ; Antman, Elliott M. / Intensive oral antiplatelet therapy for reduction of ischaemic events including stent thrombosis in patients with acute coronary syndromes treated with percutaneous coronary intervention and stenting in the TRITON-TIMI 38 trial : a subanalysis of a randomised trial. In: The Lancet. 2008 ; Vol. 371, No. 9621. pp. 1353-1363.
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abstract = "Background: Intracoronary stenting can improve procedural success and reduce restenosis compared with balloon angioplasty in patients with acute coronary syndromes, but can also increase the rate of thrombotic complications including stent thrombosis. The TRITON-TIMI 38 trial has shown that prasugrel-a novel, potent thienopyridine-can reduce ischaemic events compared with standard clopidogrel therapy. We assessed the rate, outcomes, and prevention of ischaemic events in patients treated with prasugrel or clopidogrel with stents in the TRITON-TIMI 38 study. Methods: Patients with moderate-risk to high-risk acute coronary syndromes were included in our analysis if they had received at least one coronary stent at the time of the index procedure following randomisation in TRITON-TIMI 38, and were further subdivided by type of stent received. Patients were randomly assigned in a 1 to 1 fashion to receive a loading dose of study drug (prasugrel 60 mg or clopidogrel 300 mg) as soon as possible after randomisation, followed by daily maintenance therapy (prasugrel 10 mg or clopidogrel 75 mg). All patients were to receive aspirin therapy. Treatment was to be continued for a minimum of 6 months and a maximum of 15 months. Randomisation was not stratified by stents used or stent type. The primary endpoint was the composite of cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke. Stent thrombosis was assessed using Academic Research Consortium definitions, and analysis was by intention to treat. TRITON-TIMI 38 is registered with ClinicalTrials.gov, number NCT00097591. Findings: 12 844 patients received at least one coronary stent; 5743 received only drug-eluting stents, and 6461 received only bare-metal stents. Prasugrel compared with clopidogrel reduced the primary endpoint (9·7 vs 11·9{\%}, HR 0·81, p=0·0001) in the stented cohort, in patients with only drug-eluting stents (9·0 vs 11·1{\%}, HR 0·82, p=0·019), and in patients with only bare-metal stents (10·0 vs 12·2{\%}, HR 0·80, p=0·003). Stent thrombosis was associated with death or myocardial infarction in 89{\%} (186/210) of patients. Stent thrombosis was reduced with prasugrel overall (1·13 vs 2·35{\%}, HR 0·48, p",
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T1 - Intensive oral antiplatelet therapy for reduction of ischaemic events including stent thrombosis in patients with acute coronary syndromes treated with percutaneous coronary intervention and stenting in the TRITON-TIMI 38 trial

T2 - a subanalysis of a randomised trial

AU - Wiviott, Stephen D.

AU - Braunwald, Eugene

AU - McCabe, Carolyn H.

AU - Horvath, Ivan

AU - Keltai, Matyas

AU - Herrman, Jean Paul R

AU - Van de Werf, Frans

AU - Downey, William E.

AU - Scirica, Benjamin M.

AU - Murphy, Sabina A.

AU - Antman, Elliott M.

PY - 2008

Y1 - 2008

N2 - Background: Intracoronary stenting can improve procedural success and reduce restenosis compared with balloon angioplasty in patients with acute coronary syndromes, but can also increase the rate of thrombotic complications including stent thrombosis. The TRITON-TIMI 38 trial has shown that prasugrel-a novel, potent thienopyridine-can reduce ischaemic events compared with standard clopidogrel therapy. We assessed the rate, outcomes, and prevention of ischaemic events in patients treated with prasugrel or clopidogrel with stents in the TRITON-TIMI 38 study. Methods: Patients with moderate-risk to high-risk acute coronary syndromes were included in our analysis if they had received at least one coronary stent at the time of the index procedure following randomisation in TRITON-TIMI 38, and were further subdivided by type of stent received. Patients were randomly assigned in a 1 to 1 fashion to receive a loading dose of study drug (prasugrel 60 mg or clopidogrel 300 mg) as soon as possible after randomisation, followed by daily maintenance therapy (prasugrel 10 mg or clopidogrel 75 mg). All patients were to receive aspirin therapy. Treatment was to be continued for a minimum of 6 months and a maximum of 15 months. Randomisation was not stratified by stents used or stent type. The primary endpoint was the composite of cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke. Stent thrombosis was assessed using Academic Research Consortium definitions, and analysis was by intention to treat. TRITON-TIMI 38 is registered with ClinicalTrials.gov, number NCT00097591. Findings: 12 844 patients received at least one coronary stent; 5743 received only drug-eluting stents, and 6461 received only bare-metal stents. Prasugrel compared with clopidogrel reduced the primary endpoint (9·7 vs 11·9%, HR 0·81, p=0·0001) in the stented cohort, in patients with only drug-eluting stents (9·0 vs 11·1%, HR 0·82, p=0·019), and in patients with only bare-metal stents (10·0 vs 12·2%, HR 0·80, p=0·003). Stent thrombosis was associated with death or myocardial infarction in 89% (186/210) of patients. Stent thrombosis was reduced with prasugrel overall (1·13 vs 2·35%, HR 0·48, p

AB - Background: Intracoronary stenting can improve procedural success and reduce restenosis compared with balloon angioplasty in patients with acute coronary syndromes, but can also increase the rate of thrombotic complications including stent thrombosis. The TRITON-TIMI 38 trial has shown that prasugrel-a novel, potent thienopyridine-can reduce ischaemic events compared with standard clopidogrel therapy. We assessed the rate, outcomes, and prevention of ischaemic events in patients treated with prasugrel or clopidogrel with stents in the TRITON-TIMI 38 study. Methods: Patients with moderate-risk to high-risk acute coronary syndromes were included in our analysis if they had received at least one coronary stent at the time of the index procedure following randomisation in TRITON-TIMI 38, and were further subdivided by type of stent received. Patients were randomly assigned in a 1 to 1 fashion to receive a loading dose of study drug (prasugrel 60 mg or clopidogrel 300 mg) as soon as possible after randomisation, followed by daily maintenance therapy (prasugrel 10 mg or clopidogrel 75 mg). All patients were to receive aspirin therapy. Treatment was to be continued for a minimum of 6 months and a maximum of 15 months. Randomisation was not stratified by stents used or stent type. The primary endpoint was the composite of cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke. Stent thrombosis was assessed using Academic Research Consortium definitions, and analysis was by intention to treat. TRITON-TIMI 38 is registered with ClinicalTrials.gov, number NCT00097591. Findings: 12 844 patients received at least one coronary stent; 5743 received only drug-eluting stents, and 6461 received only bare-metal stents. Prasugrel compared with clopidogrel reduced the primary endpoint (9·7 vs 11·9%, HR 0·81, p=0·0001) in the stented cohort, in patients with only drug-eluting stents (9·0 vs 11·1%, HR 0·82, p=0·019), and in patients with only bare-metal stents (10·0 vs 12·2%, HR 0·80, p=0·003). Stent thrombosis was associated with death or myocardial infarction in 89% (186/210) of patients. Stent thrombosis was reduced with prasugrel overall (1·13 vs 2·35%, HR 0·48, p

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