Three-year clinical outcomes from patients in the international GARFIELD-VTE registry confirm that the highest incidence of recurrent VTE events and bleeding occurs in the first 12 months after a VTE diagnosis.
The findings, published in Thrombosis Research [link here], highlight the clinical importance of providing optimal treatment soon after diagnosis.
The 36-month data comes from 10,679 patients with objectively confirmed VTE enrolled in the registry between May 2014 and January 2017 from 415 sites across 28 countries.
Most patients had DVT alone (61.6%) while 38.4% had PE with or without concomitant DVT.
The study, co-authored by Associate Professor Harry Gibbs, Medical Director of the Vascular Laboratory at Alfred Hospital, said 98.2% of patients received anticoagulation with or without other modalities of therapy.
The proportion of patients receiving anticoagulation therapy decreased over time from baseline to 87.5% at 3 months, 73.1% at 6 months, 54.3% at 12 months and 41.9% at 36 months.
“After 12-months, over half of all patients remaining on anticoagulation therapy were receiving a direct oral anticoagulant (DOAC) (12 months: 52.9%, 24 months: 54.8%, 36 months: 56.1%), with a smaller proportion receiving a vitamin K antagonist (VKA) (12 months: 32.4%, 24 months: 31.3%, 36 months: 30.2%),” the study said.
It found the rate of all-cause mortality was higher in the first month of treatment than in the subsequent 11 months and higher in the first year of follow-up than in the second and third years.
The rate of all-cause mortality was highest in patients treated with parenteral therapy (PAR) versus oral anticoagulants (OAC) and no OAC (12.09 versus 2.91 and 7.43 per 100 person-years, respectively).
Cancer was the leading cause of death at 1-month (42%),12-months (53%), and 36-months (48.6%).
Recurrent VTE was highest in patients treated with no OAC compared to those treated with OAC and PAR (6.26 vs 3.25 and 4.3 per 100-person-years, respectively).
“Patients treated with OAC had the lowest rate per 100 person-years of major bleeding compared to PAR and no OAC (1.17 versus 2.67 and 2.16 per 100-person-years, respectively).”
The most common sites of major bleeding were the upper and lower GI tract.
“Patients treated with OAC had the lowest rate per 100 person-years of stroke/TIA (0.54), MI (0.45), DVT (2,28), and PE events (1.15) compared to patients treated with PAR (0.74, 0.61, 3.09, and 1.46, respectively) and no OAC (2.34,1.89, 4.67, and 1.67, respectively).”
The study authors said the highest incidence of all-cause mortality, recurrent VTE and major bleeding was in the first 12 months, particularly the first month after diagnosis.
The rates of new cancer, stroke/TIA and MI were also higher at 12 months than at 24 or 36 months, consistent with previous reports.
“The high rates of death, recurrent VTE and bleeding in the first year after VTE diagnosis, particularly in the first month, highlights the importance of swift and effective VTE treatment in newly diagnosed patients,” they concluded.
“When comparing outcomes of difference treatments, the low event rates of mortality, major bleeding, and recurrent VTE seen in patients treated with OAC versus PAR and no OAC further supports their long-term safety in a real-word setting.”