Full Title: Incidence of Major Adverse Cardiovascular and/or Limb Events among Patients Using Aspirin for Secondary Prevention Volume 3 - Issue 2

Nicholas J Leeper¹, Windsor Ting², Akshay Kharat³, Brian Murphy⁴, Jeffrey S Berger⁵, Alex Simpson⁶ and Ariel Berger⁴*

• ¹Stanford University Medical School, California, USA
• ²Mount Sinai Health System, New York, USA
• ³Real World Value & Evidence, Cardiovascular, Janssen Scientific Affairs LLC, Titusville, NJ, US
• ⁴Real-World Evidence, Evidera, Waltham, MA, USA
• ⁵Center for the Prevention of Cardiovascular Disease, New York University School of Medicine, New York, USA
• ⁶Real-World Evidence, Evidera, Hammersmith, London, UK

Received:September 22, 2020;   Published: October 01, 2020

Corresponding author: Ariel Berger Evidera, Real-World Evidence, Evidera, Waltham, MA, USA

DOI: 10.32474/ACR.2020.03.000158

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Abstract

Background: Low-dose aspirin (ASA) is often used for secondary prevention of major adverse cardiovascular events (MACE) and/or major adverse limb events (MALE) in chronic coronary artery disease (CAD) or peripheral artery disease (PAD). The COMPASS trial demonstrated that adding rivaroxaban to low-dose ASA significantly decreased relative risk of these events. However, its absolute impact will depend on real-world effectiveness of ASA monotherapy, as clinical trials differ from clinical practice.

Objectives: To examine real-world rates of MACE and MALE among patients receiving ASA as secondary prevention.

Methods: We used a large US claims database linked to electronic medical records to identify patients with chronic CAD/PAD who were using ASA for secondary prevention. We then assessed occurrence of MACE and MALE from date chronic CAD/PAD was established to earliest of death, disenrollment, or end of study.

Results: A total of 1,285 patients met selection criteria (mean age: 69.6 years; 60.7% male). Over a mean follow-up of 2.3 years, 16.0% experienced MACE or MALE (7.8 events per 100 person-years). Patients were more likely to experience events than the “ASAonly” COMPASS arm, including MACE (11.7% vs. 5.6% in patients with CAD; 14.0% vs. 6.9% in patients with PAD) and MALE (e.g., critical limb ischemia: 12.9% vs. 1.0% in PAD).

Conclusions: Real-world risk of MACE/MALE among patients using ASA as secondary prevention are substantially higher than that reported in the COMPASS trial. Further study is needed to determine whether emerging secondary prevention strategies have greater absolute impact on real-world clinical outcomes than those observed in clinical trials.

Keywords:Coronary Artery Disease; Peripheral Artery Disease; Secondary Prevention; Aspirin; Myocardial Infarction; Risk

Abbreviations: ASA: Aspirin; CAD: coronary artery disease; CCI: Charlson Comorbidity Index; CLI: critical limb ischemia: CPT-4: Current Procedural Terminology, Fourth Edition; CV: cardiovascular; DVT deep-vein thrombosis; ED: emergency department; EMR: electronic medical records; FDA: Food and Drug Administration; ICD-9-CM: International Classification of Diseases, Ninth Revision, Clinical Modification; MACE major adverse cardiovascular events; MALE: major adverse limb events; MI: myocardial infarction; OTC: over-the-counter; PAD: peripheral artery disease; PE: pulmonary embolism; PYs: person-years; SD: standard deviations

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