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Rivaroxaban plus aspirin increases major bleeding in patients with chronic CAD, PAD

23 Sep 2019
For nearly 100 years, aspirin has been a common drug used for pain relief and fever treatment.

Patients with chronic coronary (CAD) or peripheral artery disease (PAD) treated with the combination of rivaroxaban and aspirin are at greater risk of bleeding than those treated with aspirin alone, according to a study. Major bleeding usually occurs during the first year of treatment, arises in the gastrointestinal (GI) tract and can be managed using conventional supportive therapies.

“In contrast, the reduction in cardiovascular death, stroke or myocardial infarction continued to accrue after the first year, suggesting accumulating net clinical benefit over time,” the researchers said.

A total of 27,395 patients (mean age, 68 years; 22 percent women) were enrolled in this study, of whom 18,278 were randomly assigned to the combination of rivaroxaban and aspirin or to aspirin alone. Mean follow-up was 23 months.

The combination treatment compared with aspirin alone led to an increase in modified International Society on Thrombosis and Hemostasis (ISTH) major bleeding (3.1 percent vs 1.9 percent; hazard ratio [HR], 1.70, 95 percent CI, 1.40–2.05; p<0.001), ISTH major bleeding (2.3 percent vs 1.3 percent; HR, 1.78, 1.41–2.23; p<0.0001) and minor bleeding (9.2 percent vs 5.5 percent; HR, 1.70, 1.52–1.90; p<0.0001). [J Am Coll Cardiol 2019;74:1519-1528]

The need for any red cell transfusion also increased with the combination of rivaroxaban and aspirin compared with aspirin alone (1.0 percent vs 0.5 percent; HR, 1.97, 1.37–2.83; p=0.0002).

Most major bleeding events were from the GI tract (1.5 percent vs 0.7 percent; HR, 2.15, 1.60–2.89; p<0.001), had mild or moderate intensity, and occurred predominantly during the first year after randomization. The most common sites of major GI bleeding were as follows: stomach, duodenum, colon and rectum. About a third were from an unknown GI site. Additionally, patients who had major bleeding received platelets, clotting factors or other haemostatic agents.

Information on the use of investigations for GI bleeding were not collected, but it is likely that “most unknown bleeding among those who underwent investigation was from pathology in the small bowel, including mass lesions, inflammation, or vascular abnormalities not detected on routine upper or lower GI tract endoscopic examination,” the researchers said. [Gastroenterol Clin N Am 2005;34:679-698]

The early excess bleeding could be explained by the revelation of underlying pathology with more intensive antithrombotic therapy, they noted. “Once this pathology is unmasked, rates of bleeding are similar by treatment group because treatment does not affect the rate of the development of new pathology, which is similar in both groups.”

Early bleeding has also been reported in trials of warfarin, antiplatelet therapy with combination of aspirin and clopidogrel, or aspirin alone, according to the researchers. [Lancet 1996;348:423-428; J Am Coll Cardiol 2007;49:1982-1988; Lancet 2012;379:1602-1612]

“Future studies should explore whether the combination of rivaroxaban plus aspirin for secondary prevention of CV disease can be extended to patients at high risk of bleeding, such as those with a history of bleeding or with end-stage kidney disease,” they added.

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Most Read Articles
Stephen Padilla, 03 Aug 2018
It appears that the two-dose AS04-adjuvanted HPV-16/18 vaccine (AS04-HPV-16/18v) is the most cost-effective choice for lowering the burden of cervical cancer through universal mass vaccination for 12-year-old girls in Singapore from the perspective of the healthcare payer (MOH Singapore), according to a recent study.
25 Apr 2020
The human papillomavirus (HPV) DNA vaccine (GX-188E) is effective against HPV type 16/18–associated cervical intraepithelial neoplasia (CIN) 3, according to the results of a phase II trial.
Audrey Abella, 02 Jul 2020
The highly selective SGLT2 inhibitor bexagliflozin demonstrated significant efficacy and safety in controlling hyperglycaemia, weight, and blood pressure (BP) in patients with type 2 diabetes (T2D) who were at high risk of cardiovascular (CV) events, results of the BEST** trial have shown.
18 Jul 2019
In the treatment of patients with human papillomavirus-positive oropharyngeal squamous cell carcinoma (HPV+ OPSCC), de-escalating dose and volume of radiotherapy (RT) or chemoradiotherapy (CRT) based on response to induction chemotherapy appears to positively affect oncologic outcomes and reduce toxicity, according to data from the phase II OPTIMA trial.