Extra six weeks of anti-clotting remedy reduces additional clot threat after distal DVT

Giving the anti-clotting drug rivaroxaban to sufferers for 12 weeks as a substitute of the same old six after a blood clot within the decrease leg reduces the danger of additional clots growing as much as two years after remedy, finds a trial revealed by The BMJ as we speak.

What’s extra, the extra six weeks of remedy didn’t end in elevated bleeding threat, a typical facet impact of anti-clotting medication.

Rivaroxaban is an anticoagulant drug. It is given to folks at a excessive threat of getting harmful blood clots to assist their blood clot (thicken) extra slowly.

Anticoagulation is understood to forestall additional clots growing in sufferers who’ve already had a blood clot of their leg, together with these with remoted distal deep vein thrombosis (DVT). However docs are nonetheless unsure whether or not all sufferers with distal DVT ought to obtain anticoagulation, and for the way lengthy.

To deal with this uncertainty, researchers got down to examine two completely different remedy durations of rivaroxaban in 402 adults (common age 65; 58% girls) recognized with remoted distal DVT at 28 specialist outpatient clinics throughout Italy.

Not one of the individuals had been pregnant or breastfeeding, had lively most cancers, kidney or liver issues, at excessive threat of bleeding, or unable to obtain anticoagulant remedy as a result of an underlying situation.

After receiving normal dose rivaroxaban for six weeks, individuals who had not developed any clotting or bleeding issues had been randomly assigned to obtain both rivaroxaban 20 mg or placebo as soon as each day for an extra six weeks.

Contributors had been assessed for brand spanking new clots or critical bleeding at three weeks, six weeks, three months, and 24 months, and had been suggested to hunt medical recommendation if new indicators or signs that probably recommended recurrent occasions occurred.

The outcomes present that after randomization, 23 (11%) sufferers within the rivaroxaban group and 39 (19%) within the placebo group developed an additional clot, both within the decrease leg (remoted or recurrent distal DVT), the higher leg (proximal DVT), or the lung (pulmonary embolism).

Recurrent remoted distal DVT occurred in 16 (8%) sufferers within the rivaroxaban group and 31 (15%) within the placebo group, whereas proximal DVT or pulmonary embolism occurred in 7 (3%) sufferers within the rivaroxaban group and eight (4%) within the placebo group.

No main bleeding occasions occurred in the course of the two-year research interval, and the researchers estimate that, for each 13 sufferers receiving further rivaroxaban, one blood clot can be prevented.

The researchers level to some limitations, comparable to being unable to succeed in the perfect pattern dimension of over 1000 sufferers owing to sluggish enrolment and the onset of the covid-19 pandemic, they usually cannot rule out the chance that analysis of remoted and recurrent distal DVT could have been overestimated.

Nonetheless, this was a well-designed trial and outcomes had been constant amongst sufferers with different kinds of clots, for instance within the higher arm, suggesting that the findings are sturdy.

As such, the researchers conclude: “Rivaroxaban administered for 3 months successfully and safely reduces the danger of recurrent venous thromboembolism in contrast with rivaroxaban administered for six weeks in sufferers with remoted distal DVT.”

These findings don’t apply to sufferers with most cancers related DVT and shouldn’t be extrapolated to different anticoagulant therapies, they add. “Extra investigation remains to be wanted to establish low threat sufferers who could not require anticoagulant remedy.”

Journal reference:

Ageno, W., et al. (2022) Rivaroxaban remedy for six weeks versus three months in sufferers with symptomatic remoted distal deep vein thrombosis: randomised managed trial. The BMJ. doi.org/10.1136/bmj-2022-072623.

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