Oral medication regimen for pulmonary embolism effective at preventing venous thromboembolism, causes fewer major bleeds

mdCurrent Conference Report: American College of Cardiology’s 61st Annual Scientific Session & Expo

A new study looking at an all-oral medication regimen for treating pulmonary embolism (PE) finds it as effective as starting with injectable enoxaparin and then switching to warfarin. The one-agent regimen would permit most of the treatment for PE to take place outside of the hospital.

Key Point: Rivaroxaban appears to be just as effective as and more convenient than enoxaparin followed by warfarin in treating pulmonary embolism. The oral agent also is associated with less major bleeding, especially in older patients.

The study results were presented at the 61st annual scientific session of the American College of Cardiology, held in Chicago, Illinois, United States, followed by publication in the New England Journal of Medicine. In the open-label trial, a novel oral rivaroxaban regimen proved noninferior to standard therapy in preventing the recurrence of[s2If !is_user_logged_in()]…

[/s2If][s2If is_user_logged_in()] venous thromboembolism (VTE) in patients with primary PE while causing less major bleeding, said the study’s lead investigator Harry R. Büller, MD, professor of vascular medicine, Academic Medical Center, Amsterdam, The Netherlands.

“This study was undertaken that there is increasing awareness that VTE or PE actually could be treated outside the hospital,” Büller said. “Maybe the patient needs to be in the hospital for 1 day to be observed, but it is not necessary to have these patients in the hospital for 5 to 10 days as has been the practice. Therefore, we wanted to make this regimen very simple.”

Oral rivaroxaban was tested in a regimen of 15 mg twice daily for 21 days followed by 20 mg once daily. It was compared with enoxaparin twice daily for at least 5 days plus a vitamin K antagonist (warfarin or acenocoumarol) in 4,833 patients with objectively confirmed PE with or without deep vein thrombosis (DVT).

The primary end point—first recurrence of symptomatic VTE—occurred in  2.1% in the rivaroxaban group and 1.8% in the enoxaparin/vitamin K antagonist group, which met the criterion for noninferiority of efficacy (the maximum allowed hazard ratio [HR] was 1.31, the actual HR was 1.12).

The principal safety outcome—major or nonmajor clinically relevant bleeding—occurred with similar frequency in the 2 arms (10.3% in patients randomized to rivaroxaban and 11.4% in those randomized to enoxaparin/vitamin K antagonist). The frequency of major bleeding events, however, was reduced by half in the rivaroxaban group compared with the enoxaparin/vitamin K antagonist group.

Patients older than 75 years were the main benefactors of the rivaroxaban regimen. There were 23 major bleeds in the group randomized to enoxaparin/vitamin K antagonist vs 5 randomized to rivaroxaban.

VTE at one time was considered to be a rare occurrence in Asia, but an institutional-based retrospective analysis published in 2009 found that was no longer the case in India (European Journal of Vascular & Endovascular Surgery, April 2009). The study, which spanned 9 years, found that general surgical operations were the most common cause of postoperative DVT. The incidence of VTE was 17.46 per 10,000 admissions, with malignancy (31%) the most common predisposing factor, followed by postoperative status (30%). PE was diagnosed in 14.9% of the study patients, and mortality in those with confirmed PE was 13.5%.

Source: The EINSTEIN-PE investigators. Oral rivaroxaban for the treatment of symptomatic pulmonary embolism. N Engl J Med. 2012;366:1287-1297.

Lee AD, Stephen E, Agarwal S, et al. Venous thrombo-embolism in India. European Journal of Vascular & Endovascular Surgery. 2009;37:482-485.

Access the original journal information here:
http://www.nejm.org/doi/full/10.1056/NEJMoa1113572?query=cardiology
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