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March 29, 2025
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Key takeaways:
Acute left ventricular thrombus occurs in about 3% of all patients with STEMI.
Rivaroxaban demonstrated similar efficacy and safety to warfarin for resolution of left ventricular thrombus after heart attack.
CHICAGO — In the RIVAWAR trial, patients hospitalized for a heart attack who were treated with rivaroxaban for left ventricular thrombus had comparable outcomes at 3 months to patients treated with warfarin.
At 3 months of follow-up, efficacy and safety of rivaroxaban was similar to warfarin for resolution of left ventricular thrombus (LVT). Moreover, there were no excess deaths, strokes or major bleeds.
Acute left ventricular thrombus occurs in about 3% of all patients with STEMI. Image: Adobe Stock
“These findings support rivaroxaban as a viable alternative to warfarin, offering predictable dosing and eliminating the need for routine INR monitoring in patients with post-MI left ventricular thrombus,” Jehangir Ali Shah, MBBS, associate professor at the National Institute of Cardiovascular Diseases (NICVD) in Karachi, Pakistan, said during a press conference at the American College of Cardiology Scientific Session.
Acute LVT, which is associated with risk for embolic events and death, occurs in about 3% of all patients with STEMI and 9% of patients with anterior STEMI, according to Shah. The recommended first-line therapy is warfarin, but it requires frequent blood tests and it interacts with many foods and other medications. Direct oral anticoagulants have advantages over warfarin and are increasingly used in patients with acute LVT, Shah said here.
RIVAWAR was an open-label, randomized controlled trial designed to evaluate efficacy and safety of rivaroxaban compared with warfarin for patients with acute LVT after MI. The study was conducted at the NICVD.
The researchers randomly assigned 261 patients to rivaroxaban or warfarin for 3 months. The intervention period included 1 month of dual antiplatelet therapy followed by single antiplatelet therapy for 8 weeks along with the oral anticoagulant. Guideline-directed medical therapy for LV dysfunction was also started. Echocardiography was performed at 1 month and again at 3 months, Shah said during the press conference.
More than three-quarters of patients (79.3%) were men and the mean age was 54.5 years. Ninety percent of patients had a STEMI, and PCI was performed in 85%. About 94% had LV ejection fraction of 35% or less.
At 1 month, LVT resolution occurred in 20.1% of patients assigned rivaroxaban compared with 8.3% assigned warfarin (OR = 2.41; 95% CI, 1.05-2.46; P = .017), according to results presented here. At 3 months, the clot resolution rate was 95.8% in the rivaroxaban group compared with 96.6% in the warfarin group (OR = 0.98; 95% CI, 0.74-1.29; P = .88), Shah said.
Jehangir Ali Shah
“In patients with post-MI LVT, rivaroxaban demonstrated similar efficacy to warfarin in resolution of LVT at 3 months’ follow-up, with complete resolution of more than 95% of patients in both groups,” Shah said.
In addition, Shah said, “there was no evidence of excess harm in terms of mortality, stroke or bleeding.”
All-cause mortality was similar at 3.5% in the rivaroxaban group vs. 3.3% in the warfarin group (P > .999), ischemic stroke in 3.5% vs. 1.1% (P = .428) and major bleeding in 2.3% vs. 1.1% (P = .662).
During a discussion of the results, Anna E. Bortnick, MD, PhD, MSc, FACC, associate director of structural and valvular heart disease at Montefiore Einstein and chair-elect of the ACC Interventional Council, said the RIVAWAR trial answers the “burning question” of how to manage patients with LVT after MI.
“What we haven’t had until now is an answer about whether or not we can use the direct oral anticoagulants and be confident that we’re going to get a great result for the patient — if that little clot is going to dissolve — as well as if we were using the gold standard, which is warfarin. Warfarin is more difficult for patients and physicians to use, as compared to rivaroxaban, which is kind of a ‘pop-and-go’ strategy. Now we have a bit more evidence to support the idea of using rivaroxaban.
“What [was demonstrated] here is … a great result at 1 month, in terms of dissolving the clot. And we see with warfarin, it’s OK out to 3 months — that’s fine, we can use either strategy — but we can be confident about using that pop-and-go strategy with the direct oral anticoagulant rivaroxaban,” Bortnick said.
There are several limitations of the RIVAWAR trial, including its single-center and open-label design. Follow-up also ended after 3 months due to a lack of funding, according to information in an ACC press release.
Reference:
Perspective
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This was a very interesting and exciting study. LVT is a major problem after MI, especially anterior STEMI. Although it’s not common, it is very difficult to manage and treat some patients, because you have to give them anticoagulation.Up until now, the data have been mixed on how successful anticoagulation is in this population, and whether or not a direct oral anticoagulant would be as successful as warfarin. RIVAWAR was a well-designed study comparing rivaroxaban, a DOAC, with warfarin for patients with LVT after MI. It is hard to do a study in this space, so kudos to the authors for taking it on. One key takeaway is that anticoagulation is effective. More than 95% of patients had resolution of their LV thrombus within 12 weeks, which is reassuring. Another is that rivaroxaban was just as effective as warfarin, which I was surprised about. In studies in atrial fibrillation and other spaces, there is some suggestion that at least when it comes to treatment of thrombotic events, the DOAC might be at a slight disadvantage to warfarin. So it is reassuring that here, it was as effective as warfarin. And rivaroxaban has a better safety profile, can be taken once per day and does not require monitoring based on international normalized ratio. From a patient perspective, this is a big win. This real-world, pragmatic study has direct clinical implications. DOACs are as safe and effective as warfarin and are more convenient. That is useful information in and of itself. I had been of the mindset that if you had LVT, you should be anticoagulated with warfarin. But now, I feel better about giving a DOAC, because this is the only randomized controlled trial in this space. This could change practice.
Grant Reed, MD, MSc, FACC, FSCAI
Interventional Cardiologist
Program Director, Interventional Cardiology Fellowship
Robert and Suzanne Tomsich Department of Cardiovascular Medicine
Sydell and Arnold Miller Family Heart, Vascular & Thoracic Institute
Cleveland Clinic
Disclosures: Reed reports no relevant financial disclosures.
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Sources/DisclosuresCollapse
Source:
Shah J, et al. Late-breaking clinical trials II. Presented at: American College of Cardiology Scientific Session; March 29-31, 2025; Chicago (hybrid meeting).
Disclosures:
Bortnick is chair-elect of the ACC Interventional Council; she reports receiving consultant fees/honoraria from Getinge and Zoll, unrestricted educational grant(s) to her institution from Zoll and research/research grants from Amgen. Shah reports no relevant financial disclosures.
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