Stephan Moll, MD writes… Apixaban (Eliquis®) was approved by the FDA this week (Aug 21, 2014) for the treatment of DVT and PE. The approval covers (a) acute DVT/PE management and (b) prevention of recurrent DVT/PE. Read the rest of this entry »
Beth Waldron, Clot Connect program director writes…
Background: Anticoagulant and anti-platelet drugs increase bleeding risk. Patients taking these drugs are typically advised to avoid activities which might cause increased bleeding, bruising or trauma.
Acupuncture involves the insertion of thin needles through the skin at strategic points along the body. These needles are very thin, much smaller than the hypodermic needles used for phlebotomy and injections.(Ref 1) Because the needles used are so small, very little bleeding occurs with acupuncture. (2)
- A 2014 published study on the safety of acupuncture for patients taking anticoagulant or anti-platelet medications found no reports of major bleeding.(3) Minor ‘microbleeding’—defined as bleeding which stopped within 30 seconds—occurred in only slightly more patients taking an anticoagulant (4.8%) than patients not on an anticoagulant (3.0%). Patients taking an anti-platelet medication had very little bleeding (0.9%).
- There was also no significant difference in the amount of bruising which occurred from acupuncture between those taking an anticoagulant (2.0%) or an anti-platelet (1.6%) and those who took neither (1.3%).
- An earlier study of acupuncture among hospitalized patients taking warfarin, also found very little bleeding and that a higher INR value did not predict a higher risk of bleeding–bleeding incidence after acupuncture were no different among patients with a low INR (14.6%) and those with a high INR (14.3%). (4)
Summary: Acupuncture appears to be safe for the patient on an anticoagulant or anti-platelet medication. However as a precaution, patients should inform their acupuncture provider in advance of the procedure of their medications so they can be alert and prepared.
1. UpToDate http://www.uptodate.com/contents/acupuncture
2. “A Guide to Integrative Oncology” University of Washington http://depts.washington.edu/integonc/patients/spc/acupuncture.shtml
3. Kim et al. The safety of acupuncture treatments for patients taking warfarin or antiplatelet medications: A retrospective chart review study European Journal of Integrative Medicine, May 17, 2014. http://www.sciencedirect.com/science/article/pii/S1876382014000626
4. Miller et al. Acupuncture treatment for hospitalized patients on anticoagulant therapy—a safety study BMC Complementary and Alternative Medicine 2012 (Suppl 1) p 107
Stephan Moll, MD writes… Interesting study: Are commercial airline pilots at increased risk of venous thromboembolism (VTE) [ref 1]? One might think so, as air travel is an established, although only weak, risk factor for VTE [ref 2,3]. This study found, however, that the risk of VTE is NOT increased in airline pilots. Read the rest of this entry »
Stephan Moll, MD writes… Our medical center (University of North Carolina Hospitals, Chapel Hill) has put together an “Emergent Anticoagulation Reversal Guideline” for our local use as a practical, clinical how-to document (PDF here). Since not every medical institution has coagulation expertise available, we are making this guideline available through Clot Connect. Colleagues are welcome to take the document, modify it, and apply it to their institution.
Disclosures: I have been a consultant for CSL Behring and Janssen.
Last updated: June 9th, 2014
Beth Waldron, Clot Connect Program Director writes….
The physical consequences of thromboembolism (VTE) [=deep vein thrombosis DVT and pulmonary embolism PE] have been extensively reported in the medical literature. Less documented has been the emotional impact of VTE on patients. This lack of formal study is notable given the extensive research on the psychological impact of other sudden, potentially life-threatening cardiovascular events (heart attack, stroke) which has provided clear evidence that such illnesses can result in significant psychological morbidity and contribute to adverse health outcomes. Read the rest of this entry »
Stephan Moll, MD writes… Today the FDA approved Pradaxa (dabigatran) for the treatment of venous thromboembolism, based on the phase 3 RECOVER and RECOVER II trials. The dose is 150 mg twice daily for patients with a GFR > 30 ml/min. Due to the design of the RECOVER and RECOVER II trials, the drug is approved to be used in the patient with acute DVT or PE only AFTER 5-10 days of a parenteral anticoagulant have been given – not immediately from day zero onwards. The full package insert is here. The press release from Boehringer-Ingelheim is here. The FDA approval status of the four big new oral anticoagulants for the various indications is summarized in this table.
Disclosures: I have been a consultant for Boehringer-Ingelheim, Daiichi, and Janssen.
Last updated: April 7th, 2014
Stephan Moll, MD writes… A recent NEJM study (ref 1) examined whether the risk for thrombosis in women persists beyond the first 6 weeks after delivery. It found that an increased risk persists for at least 3 months after delivery, although the absolute risk was low after the first 6 weeks. This is of clinical relevance, as the post-partum period has traditionally often been defined as the 6 weeks after delivery and, if post-partum anticoagulation prophylaxis is considered, it is typically given for 6 weeks only (ACOG – ref 2). Read the rest of this entry »
Stephan Moll, MD writes… This week (Feb 18th, 2014) a guidance document on the prevention and management of catheter-associated upper extremity (brachial, axillary, subclavian, and brachiocephalic veins) and neck (internal jugular) DVT was published by the International Society for Thrombosis and Haemostasis (ISTH) [ref 1]. The authors acknowledge that optimal long-term management of catheter-associated DVT has not been established. The key recommendations: Read the rest of this entry »
Stephan Moll, MD writes… No reversal agent (antidote, neutralizing drug) is presently clinically available if (a) major bleeding occurs or (b) urgent reversal for emergent surgery is needed in patients on one of the new oral anticoagulants (apixaban = Eliquis; dabigatran = Pradaxa; edoxaban = Savaysa; rivaroxaban = Xarelto). At least three drugs are in development, but all are at least 2 years away from being clinically available, should they prove to be beneficial.
- ANDEXANET (PRT064445)
- What is it? Recombinant, modified factor Xa molecule that is being developed as a direct reversal agent (antidote) for patients receiving a Factor Xa inhibitor who suffer a major bleeding episode or who require emergency surgery. It sort-of sops up the anti-Xa anticoagulant, making a patients own factor Xa available again to participate in the coagulation process.
- What anticoagulant drugs might it reverse? Apixaban, edoxaban, rivaroxaban.
- Clinical trial status: A phase 2 healthy volunteer study is ongoing to evaluate the ability of Andexanet to reverse the effects of several anticoagulant drugs on laboratory tests (NCT01758432).
- What is it? It is a humanized antibody fragment directed against dabigatran; generated from mouse monoclonal antibody against dabigatran; humanized and reduced to a FAb fragment.
- What anticoagulant drugs might it reverse? Dabigatran.
- Clinical trial status: (a) A phase 3 study of patients on dabigatran with major bleeding or needing emergency surgery is in the planning stages and will likely start in 2014. (b) A phase 1 study to determine the effect of idarucizumab on coagulation tests in dabigatran-treated healthy volunteers has been completed (NCT01688830), another two are ongoing (NCT01955720; NCT02028780).
- What is it? This is a synthetic small molecule (D-arginine compound) which appears to have broad activity against various new oral anticoagulants (dabigatran, rivaroxaban, apixaban and edoxaban) and other anticoagulants (heparins).
- What anticoagulant drugs might it reverse? Apixaban, edoxaban, rivaroxaban, dabigatran, heparin, LMWH.
- Clinical trial status: This drug has not yet been used in humans. It has been shown to have activity in rat bleeding models [Laulicht B et al. Small molecule antidote for anticoagulants [abstract];Circulation 2012; 126:A11395].
Conflict of interest: None.
Last updated: Feb 20th, 2014
Stephan Moll, MD writes… LMWH (low molecular weight heparin) is the preferred anticoagulant in the pregnant patient. LMWH and warfarin are safe in the woman who is beast-feeding.
Rivaroxaban (Xarelto), dabigatran (Pradaxa) and apixaban (Eliquis) should not be used during pregnancy or while breastfeeding.