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Low-Dose Aspirin and CV Events in Patients with T2D

Circulation; ePub 2016 Nov 15; Saito, et al

Publish date:

The risk of cardiovascular (CV) events in patients with type 2 diabetes (T2D) was not affected by low-dose aspirin, but there was increased risk for gastrointestional bleeding, a recent study found. The randomized trial examined whether low-dose aspirin affected CV events in 2,539 patients with T2D and without pre-existing CVD. Patients were randomly allocated to receive aspirin (81 mg or 100 mg daily, aspirin group), or no aspirin (no-aspirin group). Researchers found:

  • Median follow-up period was 10.3 years; 1,621(64%) patients were followed throughout the study, and 2,160 (85%) patients retained their original allocation.
  • Low-dose aspirin did not reduce CV events in the per-protocol cohort (HR, 1.14); multivariable model adjusted for age, sex, glycemic control, kidney function, smoking status, hypertension, and dyslipidemia showed similar results.
  • Sensitivity analyses on the intention-to-treat cohort yielded consistent results (HR, 1.01).
  • Gastrointestional bleeding occurred in 25 (2%) patients in the aspirin group and 12 (0.9%) in the no-aspirin group.

Citation:

Saito Y, Okada S, Ogawa H, et al. Low-dose aspirin for primary prevention of cardiovascular events in patients with type 2 diabetes: 10-year follow-up of a randomized controlled trial. [Published online ahead of print November 15, 2016]. Circulation. doi:10.1161/CIRCULATIONAHA.116.025760.

Commentary:

This study adds to the conflicting evidence of whether or not aspirin is protective against the development of CV events. Though this study did not show a beneficial result, other studies have and the current American Diabetes Association’s standards of care for patients with diabetes recommends, “Consider aspirin therapy (75 to 162 mg/day) as a primary prevention strategy in those with type 1 or type 2 diabetes who are at increased cardiovascular risk (10% or greater 10-year CVD risk).1” The current USPSTF recommendations for the general population are2:

  • Initiating low-dose aspirin use for the primary prevention of cardiovascular disease (CVD) and colorectal cancer (CRC) in adults aged 50 to 59 years who have a 10% or greater 10-year CVD risk, are not at increased risk for bleeding.
  • The decision to initiate low-dose aspirin use for the primary prevention of CVD and CRC in adults aged 60 to 69 years who have a 10% or greater 10-year CVD risk should be an individual one.
  • The current evidence is insufficient to assess the balance of benefits and harms of initiating aspirin use for the primary prevention of CVD and CRC in adults younger than 50 years or older than 70.

This is an area where no single primary prevention study has shown a significant positive result, but the recommendations are based on pooled studies. The current study, in a homogeneous population, will add to the evidence, if not the uncertainty, around this issue. —Neil Skolnik, MD

  1. Cardiovascular disease and risk management – American Diabetes Association Standards of Care. Diabetes Care. 2016;39(Suppl. 1):S60–S71. doi:10.2337/dc16-S011.
  2. US Preventive Services Task Force. Aspirin use to prevent cardiovascular disease and colorectal cancer: Preventive medication. https://www.uspreventiveservicestaskforce.org/Page/Document/RecommendationStatementFinal/aspirin-to-prevent-cardiovascular-disease-and-cancer. Accessed November 28, 2016.

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