CLINICAL NEWS
were not reported):
• major bleeding: 0.28% for rivaroxaban
vs. 0.15% for placebo (HR=1.88; 95% CI
0.84-4.23)
• nonmajor clinically relevant bleeding:
1.42% vs. 0.85% (HR=1.66; 95% CI
1.17-2.35)
• other bleeding: 0.90% vs. 0.57%
(HR=1.59; 95% CI 1.03-12.44)
“The observation that there appeared to be
no effect with rivaroxaban on VTE-related
death raises the question of whether the
TABLE 2.
definition used in the trial (which included
sudden and unexplained death) was specific
enough to capture true thrombotic-related
causes of death,” Dr. Spyropoulos noted.
“These differences in risk suggest that the
number needed to treat to prevent one
symptomatic VTE is 430 while the number
needed to harm to cause one major bleed is
856, suggesting a [net] populational health
benefit of rivaroxaban in approximately 25 to
30 percent of medically ill patients that fit the
criteria for this study.”
The authors listed the difficulty of defin-
ing VTE-related mortality as a potential
limitation of the study, as well as the possible
underdosing of patients with moderate renal
impairment who received rivaroxaban at 7.5
mg once-daily.
According to Dr. Spyropoulos, additional
research should work toward more accurately
identifying mortality “caused by thrombotic
mechanisms and should focus on the patients
who are at highest risk of thrombosis that may
benefit from anticoagulant prophylaxis,” he
added.
The corresponding authors report financial
relationships with Janssen, which also sup-
ported the study. ●
REFERENCE
Spyropoulos AC, Ageno W, Albers GW, et al. Rivaroxaban for
thromboprophylaxis after hospitalization for medical illness. N Engl J Med.
2018;379:1118-27.
Efficacy Outcomes During 45-Day Treatment Period
Rivaroxaban (n=6,007) Placebo (n=6,012) Hazard Ratio (95% CI)
50 (0.83%) 66 (1.10%) 0.76 (0.52–1.09)*
43 (0.72%) 46 (0.77%) 0.93 (0.62–1.42)
Primary efficacy outcome
Symptomatic VTE or VTE-related death
Secondary efficacy outcomes
VTE-related death
Symptomatic VTE 11 (0.18%) 25 (0.42%) 0.44 (0.22–0.89)
Symptomatic VTE or death from any cause 78 (1.30%) 107 (1.78%) 0.73 (0.54–0.97)
Symptomatic VTE, myocardial infarction, nonhemorrhagic stroke, or cardiovascular death 94 (1.56%) 120 (2.00%) 0.78 (0.60–1.02)
Death from any cause 71 (1.18%) 89 (1.48%) 0.80 (0.58–1.09)
VTE = venous thromboembolism; *p=0.14
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