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PVSS24. Bleeding Increases the Risk for Major Ischemic Events in Patients with Peripheral Arterial Disease Using Antithrombotic Treatments

Eline S. van Hattum, Ale Algra, Bert C. Eikelboom, James A. Lawson, Frans L. Moll, Marco J.D. Tangelder.
University Medical Center Utrecht, Utrecht, The Netherlands.

OBJECTIVES: To study if bleeding was associated with the subsequent occurrence of ischemic events in patients with peripheral arterial disease (PAD) receiving antithrombotic therapy.

METHODS: All patients from the Dutch BOA (Bypass and Oral anticoagulants or Aspirin) Study, a multicenter randomized trial, comparing oral anticoagulants with aspirin after infrainguinal bypass surgery were included. Bleeding was defined as all non-fatal bleedings requiring hospital admission, excluding intraocular and direct postoperative bleedings. The primary outcome event was the composite of non-fatal myocardial infarction, non-fatal ischemic stroke, and death from cardiovascular causes. Univariable and multivariable Cox regression analyses were performed to identify independent risk factors for bleeding. These independent risk factors were entered in a multivariable Cox regression model to calculate the adjusted hazard ratio (HR) for ischemic events in patients with bleeding versus no bleeding.

RESULTS: From 1995 until 1998, a total of 2650 patients were included and followed for a mean period of 21 months. In total 137 non-fatal bleedings occurred. The primary outcome event occurred in 317 patients, of which 35 events were preceded by a bleeding. Independent risk factors for bleeding were age (HR 1.1; 95%CI 1.03-1.08) and oral anticoagulants (HR 1.9; 95%CI 1.31-2.65). Bleeding was associated with a nearly threefold increased risk of subsequent ischemic events (HR 2.8; 95%CI 2.00-4.08; figure).

CONCLUSIONS: In patients with PAD bleeding was strongly associated with major vascular complications. Without compromising the benefits of antithrombotic therapies, these findings call for cautiousness regarding the risks of bleeding. Further research in pooled trial databases is ongoing.

Figure 1.

Kaplan-Meier Curves of the Cumulative Percentage of the Primary Outcome Between Patients with and Without Bleeding.