Patients with chronic coronary artery disease ( CAD ) or peripheral artery disease ( PAD ) and history of heart failure ( HF ) are at high risk for major adverse cardiovascular events ( MACE ).
Researchers have explored the effects of Rivaroxaban ( Xarelto ) with or without Aspirin ( Acetylsalicylic acid ) in these patients.
The COMPASS trial randomized 27,395 participants with chronic CAD or PAD to Rivaroxaban 2.5 mg twice daily plus Aspirin 100 mg daily, Rivaroxaban 5 mg twice daily alone, or Aspirin 100 mg alone.
Patients with NYHA class III or IV HF or left ventricular ejection fraction ( EF ) less than 30% were excluded.
The primary MACE outcome comprised cardiovascular death, stroke, or myocardial infarction, and the primary safety outcome was major bleeding using modified ISTH criteria. Investigators recorded a history of heart failure and ejection fraction at baseline, if available.
Researchers have examined the effects of Rivaroxaban on MACE and major bleeding in patients with or without a history of heart failure and an ejection fraction less than or gretaer than or equal to 40% at baseline.
Of the 5902 participants ( 22% ) with a history of heart failure, 4971 ( 84% ) had ejection fraction recorded at baseline and 12% had ejection fraction less than 40%.
Rivaroxaban and Aspirin had similar relative MACE reduction compared with Aspirin in participants with heart failure ( 5.5% versus 7.9%; hazard ratio, HR=0.68, 95% CI 0.53-0.86 ) and those without heart failure ( 3.8% vs 4.7%, HR=0.79, 95% CI 0.68-0.93, p for interaction 0.28 ) but larger absolute risk reduction ( ARR ) in those with heart failure ( HF ARR 2.4%, NNT=42 no HF ARR 1.0%, NNT=103 ).
The primary MACE outcome was not statistically different between those with ejection fraction less than 40% [ HR=0.88, 95% CI 0.55-1.42 ) and greater than or equal to 40% ( HR=0.81, 95% CI: 0.67-0.98 ), p for interaction 0.36 ].
The excess hazard for major bleeding was not different in participants with heart failure ( 2.5% vs 1.8%, HR=1.36, 95% CI 0.88-2.09 ) compared to those without heart failure ( 3.3% vs 1.9%, HR=1.79, 95% CI 1.45-2.21, p for interaction 0.26 ).
There were no significant differences in the primary outcomes with Rivaroxaban alone.
In conclusion, in patients with chronic CAD or PAD and a history of mild or moderate heart failure, combination Rivaroxaban and Aspirin compared with Aspirin alone produces similar relative but larger absolute benefits compared with those without heart failure. ( Xagena )
Branch KR et al, Circulation 2019; Epub ahead of print