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Hormonal contraceptives don’t appear to increase the risk of recurrence of venous thromboembolism among women taking anticoagulants, according to a report published in Blood.
Clinicians are often reluctant to prescribe hormonal contraceptives for women who develop venous thromboembolism (VTE) because the drugs are known to raise the risk of VTE and are considered to be contraindicated in either active or previous VTE. But effective contraception is necessary for women of childbearing age who are taking anticoagulants, because these drugs cross the placenta and could cause fetal bleeding and other adverse events, wrote Dr. Ida Martinelli of the A. Bianchi Bonomi Hemophilia and Thrombosis Center, Fondazione IRCCS Ca’ Granda-Ospedale Maggiore Policlinico, Milan, and her associates (Blood 2016;127[11]:1417-25).
Adding further to the confusion, World Health Organization guidelines state that estrogen-containing contraceptives confer “an unacceptable health risk” during anticoagulant therapy for VTE, but the International Society on Thrombosis and Haemostasis recommends that women diagnosed with VTE continue oral contraceptive and estrogen-replacement hormonal therapy until they discontinue anticoagulant therapy “because any prothrombotic effect of hormonal therapy is likely to be suppressed by therapeutic-intensity anticoagulation,” the investigators noted.
In the current study, the investigators performed a secondary analysis of data accrued in two large trials evaluating rivaroxaban versus enoxaparin plus vitamin K antagonists, which involved 1,888 women younger than age 60 (mean age, 41 years) who were being treated for acute deep vein thrombosis or acute pulmonary embolism. A total of 402 of these women used hormonal therapy during the 4-year studies.
There were 7 VTE recurrences during hormonal contraceptive use and 38 without hormonal contraceptive use. The incidence densities were 3.7% per year with hormonal therapy and 4.7% per year without it, for a hazard ratio of 0.56.
This indicates that hormonal contraceptive use did not make a clinically important difference in the rate of VTE recurrence. Moreover, these findings were consistent regardless of whether the contraceptives contained estrogen (incidence density, 3.7% per year) or progestin only (incidence density, 3.8% per year), and remained consistent in sensitivity analyses.
“These results challenge the WHO guidelines and instead support the International Society on Thrombosis and Haemostasis recommendations,” the investigators wrote.
“Our finding of similar risks of recurrent VTE for women who did or did not receive hormonal therapy, whether progestin-only or estrogen-containing therapy, supports a treatment selection that incorporates patient preference, including the choice of estrogen-containing contraception,” they added.
The study was funded in part by Bayer Healthcare Pharmaceuticals, which also provided editorial assistance. Dr. Martinelli reported having no relevant financial disclosures; her associates reported ties to numerous industry sources.
Martinelli et al. provide reassurance that women taking anticoagulants for VTE may safely use estrogen- or progestin-containing hormonal therapy, although it is important to note that their conclusions are based on only seven events (four with estrogen-containing and three with progestin-containing drugs).
Another important finding was that excessive uterine bleeding was more than twice as common among women taking rivaroxaban as among those taking enoxaparin plus vitamin K antagonists. Patients should be informed of this when they initiate anticoagulation.
Dr. Sam Schulman is in the division of hematology and thromboembolism at McMaster University, Hamilton, Ont. He reported receiving honoraria from Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, and Daiichi. These comments are adapted from an accompanying editorial (Blood 2016;127[11]:1378-9).
Martinelli et al. provide reassurance that women taking anticoagulants for VTE may safely use estrogen- or progestin-containing hormonal therapy, although it is important to note that their conclusions are based on only seven events (four with estrogen-containing and three with progestin-containing drugs).
Another important finding was that excessive uterine bleeding was more than twice as common among women taking rivaroxaban as among those taking enoxaparin plus vitamin K antagonists. Patients should be informed of this when they initiate anticoagulation.
Dr. Sam Schulman is in the division of hematology and thromboembolism at McMaster University, Hamilton, Ont. He reported receiving honoraria from Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, and Daiichi. These comments are adapted from an accompanying editorial (Blood 2016;127[11]:1378-9).
Martinelli et al. provide reassurance that women taking anticoagulants for VTE may safely use estrogen- or progestin-containing hormonal therapy, although it is important to note that their conclusions are based on only seven events (four with estrogen-containing and three with progestin-containing drugs).
Another important finding was that excessive uterine bleeding was more than twice as common among women taking rivaroxaban as among those taking enoxaparin plus vitamin K antagonists. Patients should be informed of this when they initiate anticoagulation.
Dr. Sam Schulman is in the division of hematology and thromboembolism at McMaster University, Hamilton, Ont. He reported receiving honoraria from Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, and Daiichi. These comments are adapted from an accompanying editorial (Blood 2016;127[11]:1378-9).
Hormonal contraceptives don’t appear to increase the risk of recurrence of venous thromboembolism among women taking anticoagulants, according to a report published in Blood.
Clinicians are often reluctant to prescribe hormonal contraceptives for women who develop venous thromboembolism (VTE) because the drugs are known to raise the risk of VTE and are considered to be contraindicated in either active or previous VTE. But effective contraception is necessary for women of childbearing age who are taking anticoagulants, because these drugs cross the placenta and could cause fetal bleeding and other adverse events, wrote Dr. Ida Martinelli of the A. Bianchi Bonomi Hemophilia and Thrombosis Center, Fondazione IRCCS Ca’ Granda-Ospedale Maggiore Policlinico, Milan, and her associates (Blood 2016;127[11]:1417-25).
Adding further to the confusion, World Health Organization guidelines state that estrogen-containing contraceptives confer “an unacceptable health risk” during anticoagulant therapy for VTE, but the International Society on Thrombosis and Haemostasis recommends that women diagnosed with VTE continue oral contraceptive and estrogen-replacement hormonal therapy until they discontinue anticoagulant therapy “because any prothrombotic effect of hormonal therapy is likely to be suppressed by therapeutic-intensity anticoagulation,” the investigators noted.
In the current study, the investigators performed a secondary analysis of data accrued in two large trials evaluating rivaroxaban versus enoxaparin plus vitamin K antagonists, which involved 1,888 women younger than age 60 (mean age, 41 years) who were being treated for acute deep vein thrombosis or acute pulmonary embolism. A total of 402 of these women used hormonal therapy during the 4-year studies.
There were 7 VTE recurrences during hormonal contraceptive use and 38 without hormonal contraceptive use. The incidence densities were 3.7% per year with hormonal therapy and 4.7% per year without it, for a hazard ratio of 0.56.
This indicates that hormonal contraceptive use did not make a clinically important difference in the rate of VTE recurrence. Moreover, these findings were consistent regardless of whether the contraceptives contained estrogen (incidence density, 3.7% per year) or progestin only (incidence density, 3.8% per year), and remained consistent in sensitivity analyses.
“These results challenge the WHO guidelines and instead support the International Society on Thrombosis and Haemostasis recommendations,” the investigators wrote.
“Our finding of similar risks of recurrent VTE for women who did or did not receive hormonal therapy, whether progestin-only or estrogen-containing therapy, supports a treatment selection that incorporates patient preference, including the choice of estrogen-containing contraception,” they added.
The study was funded in part by Bayer Healthcare Pharmaceuticals, which also provided editorial assistance. Dr. Martinelli reported having no relevant financial disclosures; her associates reported ties to numerous industry sources.
Hormonal contraceptives don’t appear to increase the risk of recurrence of venous thromboembolism among women taking anticoagulants, according to a report published in Blood.
Clinicians are often reluctant to prescribe hormonal contraceptives for women who develop venous thromboembolism (VTE) because the drugs are known to raise the risk of VTE and are considered to be contraindicated in either active or previous VTE. But effective contraception is necessary for women of childbearing age who are taking anticoagulants, because these drugs cross the placenta and could cause fetal bleeding and other adverse events, wrote Dr. Ida Martinelli of the A. Bianchi Bonomi Hemophilia and Thrombosis Center, Fondazione IRCCS Ca’ Granda-Ospedale Maggiore Policlinico, Milan, and her associates (Blood 2016;127[11]:1417-25).
Adding further to the confusion, World Health Organization guidelines state that estrogen-containing contraceptives confer “an unacceptable health risk” during anticoagulant therapy for VTE, but the International Society on Thrombosis and Haemostasis recommends that women diagnosed with VTE continue oral contraceptive and estrogen-replacement hormonal therapy until they discontinue anticoagulant therapy “because any prothrombotic effect of hormonal therapy is likely to be suppressed by therapeutic-intensity anticoagulation,” the investigators noted.
In the current study, the investigators performed a secondary analysis of data accrued in two large trials evaluating rivaroxaban versus enoxaparin plus vitamin K antagonists, which involved 1,888 women younger than age 60 (mean age, 41 years) who were being treated for acute deep vein thrombosis or acute pulmonary embolism. A total of 402 of these women used hormonal therapy during the 4-year studies.
There were 7 VTE recurrences during hormonal contraceptive use and 38 without hormonal contraceptive use. The incidence densities were 3.7% per year with hormonal therapy and 4.7% per year without it, for a hazard ratio of 0.56.
This indicates that hormonal contraceptive use did not make a clinically important difference in the rate of VTE recurrence. Moreover, these findings were consistent regardless of whether the contraceptives contained estrogen (incidence density, 3.7% per year) or progestin only (incidence density, 3.8% per year), and remained consistent in sensitivity analyses.
“These results challenge the WHO guidelines and instead support the International Society on Thrombosis and Haemostasis recommendations,” the investigators wrote.
“Our finding of similar risks of recurrent VTE for women who did or did not receive hormonal therapy, whether progestin-only or estrogen-containing therapy, supports a treatment selection that incorporates patient preference, including the choice of estrogen-containing contraception,” they added.
The study was funded in part by Bayer Healthcare Pharmaceuticals, which also provided editorial assistance. Dr. Martinelli reported having no relevant financial disclosures; her associates reported ties to numerous industry sources.
FROM BLOOD
Key clinical point: Hormonal contraceptives don’t appear to affect VTE recurrence among women taking anticoagulants for acute VTE.
Major finding: There were 7 VTE recurrences with hormonal contraception use and 38 without, for incidence densities of 3.7% per year with hormonal use and 4.7% per year without it (HR, 0.56).
Data source: A secondary analysis of data from two open-label randomized trials involving 1,888 women younger than age 60 with acute VTE.
Disclosures: The study was funded in part by Bayer Healthcare Pharmaceuticals, which also provided editorial assistance. Dr. Martinelli reported having no relevant financial disclosures; her associates reported ties to numerous industry sources.
