Comparison of Prasugrel and Ticagrelor in the Treatment of Acute Myocardial Infarction - PRAGUE-18

Jan 22, 2018
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Author/Summarized by Author:
Anthony A. Bavry, MD, MPH, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Date Presented:
11/14/2017
Date Published:
11/14/2017
Date Updated:
01/22/2018
Original Posted Date:
08/30/2016
References

Contribution To Literature:

The PRAGUE-18 trial showed similar efficacy for either prasugrel or ticagrelor during primary PCI.

Description:

The goal of the trial was to evaluate treatment with prasugrel versus ticagrelor among patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI).

Study Design

  • Randomized
  • Parallel

Patients with STEMI undergoing primary PCI were randomized to prasugrel (n = 634) versus ticagrelor (n = 596).

  • Total number of enrollees: 1,230 (the trial was stopped early due to futility)
  • Duration of follow-up: 30 days; 1 year
  • Mean patient age: 62 years
  • Percentage female: 23%
  • Percentage diabetics: 20%

Inclusion criteria:

  • Patients with STEMI undergoing primary PCI
  • Patients with very high risk non-STEMI undergoing emergent PCI

Exclusion criteria:

  • History of stroke
  • Serious bleeding within the last 6 months
  • Indication for anticoagulation therapy
  • Administration of clopidogrel ≥300 mg before randomization
  • >75 years of age and <60 kg
  • Severe liver disease
  • Current use of a strong CYP3A4 inhibitor

Other salient features/characteristics:

  • 5.2% enrolled as a very high risk non-STEMI

Principal Findings:

The primary outcome, incidence of death, reinfarction, urgent target vessel revascularization, stroke, serious bleeding requiring transfusion, or prolonged hospitalization at 7 days, occurred in 4.0% of the prasugrel group versus 4.1% of the ticagrelor group (p = 0.94).

Secondary outcomes:

  • Cardiovascular death, nonfatal MI, or stroke at 30 days: 2.7% versus 2.5% (p = 0.86), respectively, for prasugrel versus ticagrelor
  • TIMI major bleeding at 30 days: 0.6% versus 0.7% (p = 0.85), respectively, for prasugrel versus ticagrelor
  • Cardiovascular death, nonfatal MI, or stroke at 1 year: 6.6% versus 5.7% (p = 0.50), respectively, for prasugrel versus ticagrelor

Interpretation:

Among patients with STEMI undergoing primary PCI, similar efficacy and bleeding was observed for either prasugrel or ticagrelor. Similar ischemic events were noted at 7 days and 1 year. Among such patients, the use of either agent is acceptable.

References:

Motovska Z, Hlinomaz O, Kala P, et al., on behalf of the PRAGUE-18 Study Group. 1-Year Outcomes of Patients Undergoing Primary Angioplasty for Myocardial Infarction Treated With Prasugrel Versus Ticagrelor. J Am Coll Cardiol 2018;71:371-81.

Editorial Comment: Chatzizisis YS, Stefanadis C. Clash of Oral P2Y12 Receptor Inhibitors in Acute Coronary Syndromes. J Am Coll Cardiol 2018;71:382-5.

Presented by Dr. Zuzana Motovska at the American Heart Association Annual Scientific Sessions (AHA 2017), Anaheim, CA, November 14, 2017.

Motovska Z, Hlinomaz O, Miklik R, et al., on behalf of the PRAGUE-18 Study Group. Prasugrel Versus Ticagrelor in Patients With Acute Myocardial Infarction Treated With Primary Percutaneous Coronary Intervention: Multicenter Randomized PRAGUE-18 Study. Circulation 2016;134:1603-12.

Presented by Dr. Petr Widimsky at the European Society of Cardiology Congress, Rome, Italy, August 30, 2016.

Keywords: AHA Annual Scientific Sessions, AHA17, Acute Coronary Syndrome, Hemorrhage, Medical Futility, Myocardial Infarction, Myocardial Revascularization, Percutaneous Coronary Intervention, Secondary Prevention, Stroke, ESC Congress


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