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Generalisability of trials on antithrombotic treatment intensification in patients with cardiovascular disease

Maria C Castelijns1, Steven H J Hageman1, Martin Teraa2

  • 1Department of Vascular Medicine, University Medical Center Utrecht, Utrecht, The Netherlands.

Heart (British Cardiac Society)
|January 5, 2024
PubMed

Insights

Many patients with cardiovascular disease (CVD) are eligible for intensified antithrombotic treatment trials. Adjusted event risks in these patients largely mirror those not eligible, suggesting guideline recommendations are applicable.

Area of Science:

  • Cardiovascular Medicine
  • Clinical Trials
  • Pharmacology

Background:

  • Guideline recommendations for antithrombotic treatment intensification in cardiovascular disease (CVD) are often based on clinical trials.
  • The generalisability of these trial findings to real-world patient populations remains a critical consideration for clinical practice.

Purpose of the Study:

  • To assess the real-world eligibility of patients with coronary artery disease (CAD) and/or peripheral artery disease (PAD) for major antithrombotic treatment trials.
  • To compare baseline characteristics, cardiovascular events, bleeding risk, and mortality between eligible and ineligible patients in a real-world cohort.

Main Methods:

  • Inclusion and exclusion criteria from key trials (COMPASS, CHARISMA, PEGASUS-TIMI, DAPT) were applied to patients in the Utrecht Cardiovascular Cohort-Second Manifestations of Arterial Disease (UCC-SMART) study.
  • Real-world eligibility for intensified antithrombotic treatment was determined.
  • Statistical comparisons of outcomes were performed between eligible and ineligible patient groups.

Main Results:

  • Real-world eligibility varied significantly across trials, ranging from 11% to 94% for CAD and 75% to 90% for PAD patients.
  • COMPASS-eligible CAD patients had higher risks of cardiovascular events, bleeding, and mortality compared to ineligible patients.
  • After adjustment, higher cardiovascular and mortality risks persisted for COMPASS-eligible CAD patients, while CHARISMA- and DAPT-eligible CAD patients showed lower cardiovascular risks.

Conclusions:

  • A substantial proportion of contemporary patients with CVD meet eligibility criteria for intensified antithrombotic treatment trials.
  • Adjusted event risks in eligible real-world patients are mostly similar to those in ineligible patients.
  • Trial-based guideline recommendations for antithrombotic therapy appear largely applicable to the broader CVD patient population.
Abstract

Keywords:
Coronary Artery DiseasePeripheral Vascular Diseases

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