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

Christian T. Ruff, Robert P. Giugliano, Elliott M. Antman, Sabina A. Murphy, Chaim Lotan, Herbertus Heuer, B. Merkely, Luciano Baracioli, Fredrik Schersten, Ricardo Seabro-Gomes, Eugene Braunwald, Stephen D. Wiviott

Research output: Contribution to journalArticle

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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.

Original languageEnglish
Pages (from-to)424-429
Number of pages6
JournalInternational Journal of Cardiology
Volume155
Issue number3
DOIs
Publication statusPublished - Mar 22 2012

Fingerprint

clopidogrel
Safety
Acute Coronary Syndrome
Hemorrhage
Stents
Demography
Economic Development
Kaplan-Meier Estimate
Human Development
Proportional Hazards Models
Developed Countries
Developing Countries
Prasugrel Hydrochloride
Comorbidity
Cause of Death
Thrombosis
Stroke

Keywords

  • Clopidogrel
  • HDI
  • Prasugrel
  • Regional differences
  • TRITON-TIMI 38

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

Ruff, C. T., Giugliano, R. P., Antman, E. M., Murphy, S. A., Lotan, C., Heuer, H., ... Wiviott, S. D. (2012). Safety and efficacy of prasugrel compared with clopidogrel in different regions of the world. International Journal of Cardiology, 155(3), 424-429. https://doi.org/10.1016/j.ijcard.2010.10.040

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, B.; Baracioli, Luciano; Schersten, Fredrik; Seabro-Gomes, Ricardo; Braunwald, Eugene; Wiviott, Stephen D.

In: International Journal of Cardiology, Vol. 155, No. 3, 22.03.2012, p. 424-429.

Research output: Contribution to journalArticle

Ruff, CT, Giugliano, RP, Antman, EM, Murphy, SA, Lotan, C, Heuer, H, Merkely, B, Baracioli, L, Schersten, F, Seabro-Gomes, R, Braunwald, E & Wiviott, SD 2012, 'Safety and efficacy of prasugrel compared with clopidogrel in different regions of the world', International Journal of Cardiology, vol. 155, no. 3, pp. 424-429. https://doi.org/10.1016/j.ijcard.2010.10.040
Ruff, Christian T. ; Giugliano, Robert P. ; Antman, Elliott M. ; Murphy, Sabina A. ; Lotan, Chaim ; Heuer, Herbertus ; Merkely, B. ; Baracioli, Luciano ; Schersten, Fredrik ; Seabro-Gomes, Ricardo ; Braunwald, Eugene ; Wiviott, Stephen D. / Safety and efficacy of prasugrel compared with clopidogrel in different regions of the world. In: International Journal of Cardiology. 2012 ; Vol. 155, No. 3. pp. 424-429.
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