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Meta-analyses of incomplete trial datasets: unreliable and potentially misleading
  1. Victor Serebruany1,
  2. Nikita Lomakin2,
  3. Thomas Marciniak3
  1. 1 Division of Neurology, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA
  2. 2 Department of Intensive Cardiology, Central Clinical Hospital of the Administrative Affairs of the President of the Russian Federation, Moscow, Russian
  3. 3 Physician, Bethany Beach, Delaware, USA
  1. Correspondence to Dr Victor Serebruany, Johns Hopkins University School of Medicine, Division of Neurology, Stroke Unit, 7600 Osler Drive, Suite 307, Towson 21204, Maryland, USA; heartdrug{at}

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While clopidogrel remains the dominant oral antiplatelet agent (OAA), newer P2Y12 platelet inhibitors such as prasugrel or ticagrelor are expanding for postacute coronary syndrome indications. However, reliable randomised data among these three OAA are lacking, and thus, the comparative outcomes remain unclear. Even less is known regarding special patient subsets dichotomised by age, gender, comorbidities and concomitant medications. Therefore, data from carefully designed and properly implemented meta-analyses may provide critical, but yet missing evidence. Moreover, yielding specific advantages or risks of certain OAA for various clinical scenarios represent an urgent, unmet and unsolved need with regard to the choice of agents, duration of treatment and potential dose/regimen adjustment. The lack of large, randomised clinical trials that are adequately powered to compare the various OAA and designed to specifically assess the impact of gender, the absence of standardised efficacy and safety data and the overly optimistic publications that have been based on post hoc subanalyses of the primary mega-trials have tended to exaggerate the clinical benefits and minimise risks of the newer agents.

Lately, both prasugrel and ticagrelor suffer from array of secondary subset publications claiming superiority although the quality of such data are usually poor, while their interpretation is somewhat biased. Finally, triaging patients by any variable in general, and gender in particular is problematic due …

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  • Contributors Contributors VS and NL initially outlined a sketch of the text. TM provided the final draft. All authors contributed to critical review, revisions and agreed to the final version.

  • Competing interests None declared.

  • Provenance and peer review Commissioned; internally peer reviewed.

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