Low-dose rivaroxaban reduces thromboembolic events in HF


Barry H. Greenberg

Barry H. Greenberg

CHICAGO — In a post hoc analysis of the COMMANDER HF trial, treatment with low-dose rivaroxaban reduced risk for thromboembolic events in patients with worsening of chronic HF, reduced ejection fraction, CAD and sinus rhythm.

“However, confirmation of these results by a prospective trial is required in order to establish a role for low-dose rivaroxaban in treating HF patients,” Barry H. Greenberg, MD, director of the Advanced Heart Failure Treatment Program and professor of medicine at UC San Diego Health, who presented the new post hoc analysis data, said during a presentation at the American Heart Association Scientific Sessions.

Overall, 14.3% of this population experienced a thromboembolic event during a median follow-up of 19.6 months. The predefined composite endpoint for this post hoc analysis — MI, ischemic stroke, sudden/unwitnessed death, pulmonary embolism or symptomatic deep vein thrombosis — occurred in 13.1% of patients assigned rivaroxaban (Xarelto, Bayer/Janssen) compared with 15.5% assigned placebo (HR = 0.83; 95% CI, 0.72-0.96).

Low-dose rivaroxaban also reduced risk for MI and ischemic stroke, when examined separately from the composite outcome. MI occurred in 3.9% of the rivaroxaban group vs. 4.7% of the placebo group (HR = 0.83; 95% CI, 0.63-1.08) and ischemic stroke in 1.6% vs. 2.5%, respectively (HR = 0.64; 95% CI, 0.43-0.95). The results also showed reduction in risk for sudden/unwitnessed death (7.6% vs. 8.5%; HR = 0.88; 95% CI, 0.73-1.07) and symptomatic DVT (0.2% vs. 0.3%; HR = 0.71; 95% CI, 0.23-2.24). Risk for PE, which occurred in a small number of patients, was similar at 0.4% in both treatment groups (HR = 1.24; 95% CI, 0.51-2.99).

“These findings support the possibility that low-dose rivaroxaban may reduce the risk of thromboembolic events in HF patients,” Greenberg said.

Findings in context

Previous research from the ATLAS ACS 2-TIMI 51 and COMPASS trials showed benefit of rivaroxaban 2.5 mg twice daily in addition to antiplatelet agents for reduction in risk for CV death, MI and stroke. Although ATLAS ACS 2-TIMI 51 focused on patients with MI and unstable angina and COMPASS focused on those with stable coronary and/or peripheral disease, both trials also included patients with HF, Greenberg said.

As previously reported by Cardiology Today , in the overall COMMANDER HF trial, results of which were presented at the European Society of Cardiology Congress in Munich, low-dose rivaroxaban failed to improve the primary outcome or the secondary efficacy outcome of CV mortality and HF hospitalization. The primary outcome was driven by mortality, a large proportion of which was due to worsening HF, Greenberg said during a presentation. Testing for homogeneity between the three components of the primary outcome suggested that risk varied, and there were numerical advantages of rivaroxaban vs. placebo for MI and stroke.

“The findings [of the overall COMMANDER HF trial] suggest that the … primary composite [endpoint] was driven by events that were not influenced by rivaroxaban 2.5 mg twice daily,” he said. “Therefore, we postulated that low-dose rivaroxaban would be superior to placebo in reducing the risk of thromboembolic events in this population.”

Freek W.A. Verheugt, MD, professor of cardiology at the Heart-Lung Centre of the University Medical Centre in Nijmegen, the Netherlands, and chair of cardiology at Onze Lieve Vrouwe Gasthuis in Amsterdam, discussed findings of the post hoc analysis during a presentation at the AHA Scientific Sessions.

“Although COMMANDER HF did not meet its primary endpoint, oral anticoagulation did prevent ischemic endpoints — stroke and MI,” Verheugt said. “This underscores the long-term benefit of oral anticoagulation in chronic ischemic heart disease, as found in the old post-MI trials with vitamin K antagonists, and in modern times in the COMPASS and COMMANDER HF trials.”

Greenberg noted several limitations of the trial, including the post hoc analysis design and nonadjudicated endpoints. Additionally, this trial enrolled patients with reduced EF and the effect of rivaroxaban on thromboembolic events in the HF with reduced EF population is unknown, Greenberg said. – by Katie Kalvaitis

Reference:

Greenberg BH, et al. LBS.05 – Late Breaking Clinical Trials: Hot News in HF. Presented at: American Heart Association Scientific Sessions; Nov. 10-12, 2018; Chicago.

Disclosures: The COMMANDER HF study was supported by Janssen. Greenberg reports he received research support from Janssen, serves on speakers bureaus for Otsuka and has consulted for Bayer, Cellular Dynamics, Ionis, Mesoblast, Novartis and Zensun. Verheugt reports he receives research support or is a principal investigator for Bayer HealthCare, Boehringer Ingelheim, Eli Lilly and Roche; is a consultant for Bayer HealthCare, Daiichi Sankyo, Eli Lilly and Merck; receives honoraria from Bayer HealthCare, Daiichi Sankyo, Eli Lilly and Merck; and is on the data safety monitoring boards for the ENTRUST AF-PCI, ENVISAGE TAVI-AF and FRAIL trials.

Barry H. Greenberg

Barry H. Greenberg

CHICAGO — In a post hoc analysis of the COMMANDER HF trial, treatment with low-dose rivaroxaban reduced risk for thromboembolic events in patients with worsening of chronic HF, reduced ejection fraction, CAD and sinus rhythm.

“However, confirmation of these results by a prospective trial is required in order to establish a role for low-dose rivaroxaban in treating HF patients,” Barry H. Greenberg, MD, director of the Advanced Heart Failure Treatment Program and professor of medicine at UC San Diego Health, who presented the new post hoc analysis data, said during a presentation at the American Heart Association Scientific Sessions.

Overall, 14.3% of this population experienced a thromboembolic event during a median follow-up of 19.6 months. The predefined composite endpoint for this post hoc analysis — MI, ischemic stroke, sudden/unwitnessed death, pulmonary embolism or symptomatic deep vein thrombosis — occurred in 13.1% of patients assigned rivaroxaban (Xarelto, Bayer/Janssen) compared with 15.5% assigned placebo (HR = 0.83; 95% CI, 0.72-0.96).

Low-dose rivaroxaban also reduced risk for MI and ischemic stroke, when examined separately from the composite outcome. MI occurred in 3.9% of the rivaroxaban group vs. 4.7% of the placebo group (HR = 0.83; 95% CI, 0.63-1.08) and ischemic stroke in 1.6% vs. 2.5%, respectively (HR = 0.64; 95% CI, 0.43-0.95). The results also showed reduction in risk for sudden/unwitnessed death (7.6% vs. 8.5%; HR = 0.88; 95% CI, 0.73-1.07) and symptomatic DVT (0.2% vs. 0.3%; HR = 0.71; 95% CI, 0.23-2.24). Risk for PE, which occurred in a small number of patients, was similar at 0.4% in both treatment groups (HR = 1.24; 95% CI, 0.51-2.99).

“These findings support the possibility that low-dose rivaroxaban may reduce the risk of thromboembolic events in HF patients,” Greenberg said.

Findings in context

Previous research from the ATLAS ACS 2-TIMI 51 and COMPASS trials showed benefit of rivaroxaban 2.5 mg twice daily in addition to antiplatelet agents for reduction in risk for CV death, MI and stroke. Although ATLAS ACS 2-TIMI 51 focused on patients with MI and unstable angina and COMPASS focused on those with stable coronary and/or peripheral disease, both trials also included patients with HF, Greenberg said.

As previously reported by Cardiology Today , in the overall COMMANDER HF trial, results of which were presented at the European Society of Cardiology Congress in Munich, low-dose rivaroxaban failed to improve the primary outcome or the secondary efficacy outcome of CV mortality and HF hospitalization. The primary outcome was driven by mortality, a large proportion of which was due to worsening HF, Greenberg said during a presentation. Testing for homogeneity between the three components of the primary outcome suggested that risk varied, and there were numerical advantages of rivaroxaban vs. placebo for MI and stroke.

PAGE BREAK

“The findings [of the overall COMMANDER HF trial] suggest that the … primary composite [endpoint] was driven by events that were not influenced by rivaroxaban 2.5 mg twice daily,” he said. “Therefore, we postulated that low-dose rivaroxaban would be superior to placebo in reducing the risk of thromboembolic events in this population.”

Freek W.A. Verheugt, MD, professor of cardiology at the Heart-Lung Centre of the University Medical Centre in Nijmegen, the Netherlands, and chair of cardiology at Onze Lieve Vrouwe Gasthuis in Amsterdam, discussed findings of the post hoc analysis during a presentation at the AHA Scientific Sessions.

“Although COMMANDER HF did not meet its primary endpoint, oral anticoagulation did prevent ischemic endpoints — stroke and MI,” Verheugt said. “This underscores the long-term benefit of oral anticoagulation in chronic ischemic heart disease, as found in the old post-MI trials with vitamin K antagonists, and in modern times in the COMPASS and COMMANDER HF trials.”

Greenberg noted several limitations of the trial, including the post hoc analysis design and nonadjudicated endpoints. Additionally, this trial enrolled patients with reduced EF and the effect of rivaroxaban on thromboembolic events in the HF with reduced EF population is unknown, Greenberg said. – by Katie Kalvaitis

Reference:

Greenberg BH, et al. LBS.05 – Late Breaking Clinical Trials: Hot News in HF. Presented at: American Heart Association Scientific Sessions; Nov. 10-12, 2018; Chicago.

Disclosures: The COMMANDER HF study was supported by Janssen. Greenberg reports he received research support from Janssen, serves on speakers bureaus for Otsuka and has consulted for Bayer, Cellular Dynamics, Ionis, Mesoblast, Novartis and Zensun. Verheugt reports he receives research support or is a principal investigator for Bayer HealthCare, Boehringer Ingelheim, Eli Lilly and Roche; is a consultant for Bayer HealthCare, Daiichi Sankyo, Eli Lilly and Merck; receives honoraria from Bayer HealthCare, Daiichi Sankyo, Eli Lilly and Merck; and is on the data safety monitoring boards for the ENTRUST AF-PCI, ENVISAGE TAVI-AF and FRAIL trials.

Let’s block ads! (Why?)


Source link

What's Your Reaction?

Cry Cry
0
Cry
Cute Cute
0
Cute
Damn Damn
0
Damn
Dislike Dislike
0
Dislike
Like Like
0
Like
Lol Lol
0
Lol
Love Love
0
Love
Win Win
0
Win
WTF WTF
0
WTF

Comments 0

Your email address will not be published. Required fields are marked *

You may also like

More From: Event

DON'T MISS

Choose A Format
Personality quiz
Series of questions that intends to reveal something about the personality
Trivia quiz
Series of questions with right and wrong answers that intends to check knowledge
Poll
Voting to make decisions or determine opinions
Story
Formatted Text with Embeds and Visuals
List
The Classic Internet Listicles
Countdown
The Classic Internet Countdowns
Open List
Submit your own item and vote up for the best submission
Ranked List
Upvote or downvote to decide the best list item
Meme
Upload your own images to make custom memes
Video
Youtube, Vimeo or Vine Embeds
Audio
Soundcloud or Mixcloud Embeds
Image
Photo or GIF
Gif
GIF format