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Cited by 14Antiplatelet Therapy and Cardiovascular DiseasesCoronary Interventions and DiagnosticsAcute Myocardial Infarction Research

Safety and efficacy of prasugrel compared with clopidogrel in different regions of the world

Ruff, Christian T., Giugliano, Robert P., Antman, Elliott M., Murphy, Sabina A., Lotan, Chaim, Heuer, Herbertus, Merkely, Bela, Baracioli, Luciano +4 more·2012·International Journal of Cardiology
DOI 10.1016/j.ijcard.2010.10.040
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Abstract

Background Among patients with acute coronary syndrome (ACS), demographics, procedural characteristics and adjunctive medications differ globally. We examined whether there were differential effects of prasugrel compared with clopidogrel in the multinational TRITON-TIMI 38 study.Methods We divided the enrollment into 5 pre-specified geographic regions. Patients were randomized to prasugrel or clopidogrel without regard to country of enrollment. End points are expressed as Kaplan-Meier failure estimates through 15 months. Heterogeneity was evaluated using Cox proportional hazards model. Additional sensitivity analyses were performed by dividing countries into categories based on the Human Development Index (HDI), which is a composite measure of social and economic development.Results 13,608 patients were enrolled. Clinical characteristics including age, comorbidities, ACS presentation, stent types, and adjunctive medications differed broadly among regions. Despite these differences, no regional heterogeneity was observed with prasugrel compared to clopidogrel in the reduction of ischemic events (HR range: 0.76-0.87, p(interaction)>0.10 for each) and stent thrombosis (HR range: 0.34-0.72, p(interaction)>0.10 for each) or in the increased rate of non-CABG TIMI major bleeding (HR range: 1.16-1.76, p(interaction)>0.10 for each). There was a consistent trend in net clinical benefit (all cause death/MI/stroke/non-CABG TIMI major bleeding) favoring prasugrel (HR range: 0.81-0.97, p(interaction)>0.10 for each). Consistent results were also observed regarding the safety and efficacy of prasugrel compared with clopidogrel in both developed and developing countries.Conclusions Despite differences in patient demographics, procedural techniques and adjunctive medications, consistent reduction in ischemic events and increased bleeding were seen with prasugrel compared with clopidogrel throughout the world.

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  • International trials of various pharmacotherapies have sometimes found discordant results in patients enrolled in the United States than seen in overall trial results.

    “International trials of various pharmacotherapies have sometimes found discordant results in patients enrolled in the United States than seen in overall trial results.19–32”

    From REDUCE-IT USA: Results From the 3146 Patients Randomized in the United States (2020) · cites this paper as [24]

  • The reasons for discordant US results range from low numbers of patients enrolled in the United States to potential differences in background medical management or in patient risk profiles.

    “The reasons range from low numbers of patients enrolled in the United States to potential differences in background medical management or in patient risk profiles.”

    From REDUCE-IT USA: Results From the 3146 Patients Randomized in the United States (2020) · cites this paper as [24]

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Authors
Ruff, C. T., Giugliano, R. P., Antman, E. M., Murphy, S. A., Lotan, C., Heuer, H., Merkely, B., Baracioli, L., Schersten, F., Seabro-Gomes, R., Braunwald, E., & Wiviott, S. D.
Affiliations
  • Brigham and Women's Hospital (US)
  • Hadassah Medical Center (IL)
  • St.-Johannes-Hospital Dortmund (DE)
  • Instituto do Coração (PT)
Corresponding author
Ruff, Christian T.
ORCID
Venue
International Journal of Cardiology
Publisher
Elsevier BV
Published
2012-03
Volume
155
Issue
3
Pages
424-429
ISSN
0167-5273 (ISSN-L)
DOI
10.1016/j.ijcard.2010.10.040
OpenAlex
W2038039359
Cited by
14
References
41
Citations by year
2025: 1 · 2019: 2 · 2016: 3 · 2015: 1 · 2014: 2 · 2013: 1 · 2012: 3
FWCI
1.10
Type
journal article
Language
en
Open access
closed
Licence
www.elsevier.com/tdm/userlicense/1.0/ (tdm)
Locations
  • International Journal of Cardiology (publishedVersion)
  • PubMed (publishedVersion)
Topics
  • Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Antiplatelet Therapy and Cardiovascular Diseases
  • Health Sciences › Medicine › Surgery › Coronary Interventions and Diagnostics
  • Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Acute Myocardial Infarction Research
Keywords
prasugrel, clopidogrel, acute coronary syndrome, TRITON-TIMI 38, stent thrombosis, ischemic events, regional heterogeneity, Human Development Index, developing countries, antiplatelet therapy, percutaneous coronary intervention
MeSH terms
Prasugrel Hydrochloride, Clopidogrel, Cause of Death, Dose-Response Relationship, Drug, Electrocardiography, Female, Follow-Up Studies, Humans, Male, Middle Aged, Piperazines, Retrospective Studies, Thiophenes, Ticlopidine, Global Health, Incidence, Treatment Outcome, Acute Coronary Syndrome, Purinergic P2Y Receptor Antagonists

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