Prasugrel vs. Ticagrelor in Patients With Acute MI Treated With Primary PCI - PRAGUE-18

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
  • 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

Interpretation:

Among patients with STEMI undergoing primary PCI, similar efficacy and bleeding was observed for either prasugrel or ticagrelor. Among such patients, the use of either agent is acceptable.

References:

Motovska Z, Hlinomaz O, Miklik R, et al. Prasugrel Versus Ticagrelor in Patients With Acute Myocardial Infarction Treated With Primary Percutaneous Coronary Intervention: Multicenter Randomized PRAGUE-18 Study. Circulation 2016;Aug 30:[Epub ahead of print].

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

Clinical Topics: Acute Coronary Syndromes, Cardiac Surgery, Invasive Cardiovascular Angiography and Intervention, Prevention, Aortic Surgery, Cardiac Surgery and Arrhythmias, Interventions and ACS

Keywords: Acute Coronary Syndrome, Hemorrhage, Medical Futility, Myocardial Infarction, Myocardial Revascularization, Percutaneous Coronary Intervention, Secondary Prevention, Stroke, ESC Congress


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