Randomized Comparison of Clopidogrel Versus Ticagrelor or Prasugrel in Patients of 70 years or Older With Non-ST-Elevation Acute Coronary Syndrome - POPular AGE

May 04, 2020
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Author/Summarized by Author:
Anthony A. Bavry, MD, MPH, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
ZonMw (Dutch government institution)
Date Presented:
08/31/2019
Date Published:
04/25/2020
Date Updated:
05/04/2020
Original Posted Date:
08/31/2019
References

Contribution To Literature:

The POPular AGE trial showed that clopidogrel was associated with less bleeding and similar ischemic events vs. a more potent P2Y12 inhibitor among the elderly.

Description:

The goal of the trial was to evaluate clopidogrel compared with ticagrelor or prasugrel among patients ≥70 years of age being treated for a non-ST-segment elevation acute coronary syndrome (NSTE-ACS).

Study Design

  • Randomized
  • Parallel
  • Open-label

Patients ≥70 years of age with an NSTE-ACS were randomized to clopidogrel (n = 500) versus ticagrelor or prasugrel (n = 502) for 12 months.

  • Total number of enrollees: 1,002
  • Duration of follow-up: 12 months
  • Mean patient age: 77 years
  • Percentage female: 37%
  • Percentage with diabetes: 29%

Inclusion criteria:

  • Patients ≥70 years of age with an NSTE-ACS

Exclusion criteria:

  • Contraindication to a P2Y12 inhibitor
  • Dual antiplatelet therapy use prior to presentation
  • Indication for major surgery
  • Limited life expectancy (<1 year)

Principal Findings:

The co-primary safety outcome of PLATO major and minor bleeding occurred in 18% of the clopidogrel group compared with 24% of the ticagrelor/prasugrel group (p = 0.018).

The co-primary net clinical benefit outcome of death, myocardial infarction, stroke, or PLATO major and minor bleeding occurred in 27% of the clopidogrel group compared with 32% of the ticagrelor/prasugrel group (p for noninferiority = 0.025).

Secondary outcomes:

  • PLATO major bleeding: 8% of the clopidogrel group compared with 12% of the ticagrelor/prasugrel group (p = 0.11)
  • Fatal bleeding: 0% of the clopidogrel group compared with 1.0% of the ticagrelor/prasugrel group (p = 0.03)
  • Death, myocardial infarction, or stroke: 11% of the clopidogrel group compared with 12% of the ticagrelor/prasugrel group (p = 0.71)
  • Adherence: 78% in the clopidogrel group vs. 53% in the ticagrelor/prasugrel group

Interpretation:

Among elderly patients (≥70 years of age) being treated for an NSTE-ACS, long-term treatment with clopidogrel was associated with less PLATO major/minor bleeding and less fatal bleeding vs. a more potent P2Y12 inhibitor (i.e., ticagrelor or prasugrel). With regard to net clinical benefit, clopidogrel was noninferior compared with a more potent P2Y12 inhibitor. More patients in the potent P2Y12 inhibitor group switched to another agent due to bleeding, need for a novel oral anticoagulant, or dyspnea.

In summary, for elderly patients who require treatment with a P2Y12 inhibitor, long-term use of clopidogrel appears to be reasonable.

References:

Gimbel M, Qaderdan K, Willemsen L, et al. Clopidogrel versus ticagrelor or prasugrel in patients aged 70 years or older with non-ST-elevation acute coronary syndrome (POPular AGE): the randomised, open-label, non-inferiority trial. Lancet 2020;395:1374-81.

Presented by Dr. Marieke E. Gimbel at the European Society of Cardiology Congress, Paris, France, August 31, 2019.

Keywords: ESC Congress, ESC 19, Acute Coronary Syndrome, Adenosine, Anticoagulants, Dyspnea, Geriatrics, Hemorrhage, Myocardial Infarction, Myocardial Ischemia, Stroke, Vascular Diseases


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