{"id":6979,"date":"2011-03-18T14:06:06","date_gmt":"2011-03-18T18:06:06","guid":{"rendered":"http:\/\/blogs.nejm.org\/cardioexchange\/?p=6979"},"modified":"2011-07-19T17:45:11","modified_gmt":"2011-07-19T21:45:11","slug":"dabigatran-dialog-two-experts-answer-our-questions-and-yours","status":"publish","type":"post","link":"https:\/\/blogs.nejm.org\/cardioexchange\/2011\/03\/18\/dabigatran-dialog-two-experts-answer-our-questions-and-yours\/","title":{"rendered":"Dabigatran Dialogue: Two Experts Answer Our Questions and Yours"},"content":{"rendered":"

In a series of blog posts on CardioExchange, Samuel Goldhaber<\/a>, Director of the Venous Thromboembolism Research Group in the Cardiovascular Division at Brigham and Women\u2019s Hospital, has been guiding us on best practices around dabigatran. Recently, he teamed up with Elaine Hylek<\/a>, Director of the Thrombosis and Anticoagulation Service at Boston University School of Medicine, for a live interview on the topic. An edited transcript is below, and the podcast is available as well.<\/p>\n

Click to Listen<\/a><\/p>\n

Q: Are there patients that you definitely would or would not put on dabigatran?<\/strong><\/p>\n

SG:<\/strong> For patients with new-onset atrial fibrillation and a CHADS2<\/sub> score \u22652, where anticoagulation is unequivocally recommended, dabigatran is my default choice, barring end-stage renal disease with a creatinine clearance <15. For patients who are already on warfarin and doing fine, I see no reason to rock the boat.<\/p>\n

EH:<\/strong> Every patient should be informed about exciting and new advances in the field. That said, this drug does require some changes, compared to what patients are accustomed to with warfarin. For example, dabigatran is a twice-daily drug, it does not require monitoring, and there may need to be some education around fluctuating renal status. Also, the drug loses its potency when it is removed from the original bottle, so patients should not<\/em> remove the tablets to place into a pill organizer or pill box.<\/p>\n

Q: Let\u2019s shift to some cases now. If a 70-year-old woman with hypertension, prior heart failure, and no other major issues is newly diagnosed with chronic atrial fibrillation in your office, how would you counsel her regarding warfarin versus dabigatran? <\/strong><\/p>\n

SG: <\/strong>I would discuss both drugs with her, but I would tell her that dabigatran (150 mg twice daily) is my preferred choice based on a rigorous, pivotal clinical trial (RE-LY<\/a>). In that study, patients who took dabigatran (150 mg twice daily) had a 30% lower risk for stroke and a 60% lower risk for intracranial bleeding than those who took warfarin. I would emphasize the importance of adherence to dabigatran and note that it should always be taken with food.<\/p>\n

EH: <\/strong>I agree with Sam and would also counsel her about the slightly higher risk for GI bleeding with dabigatran versus warfarin.<\/p>\n

Q: There\u2019s no clear test of adherence to dabigatran. If a patient reports being on this drug consistently for at least 4 weeks prior to cardioversion, would you consider it safe to cardiovert without transesophageal echocardiogram to rule out intracardiac clot?<\/strong><\/p>\n

SG: <\/strong>Performing a TEE and not detecting an intracardiac thrombus does not give the patient immunity against stroke during the cardioversion procedure and can, in fact, lead to a false sense of security. My preference is always to give the patient anticoagulation for 4 weeks prior to cardioversion rather than do a TEE\/cardioversion. I have always told my patients receiving anticoagulation that the risk for stroke during cardioversion is about 1 in 1000. However, a posthoc analysis of the RE-LY trial<\/a> was just published, showing that, regardless of whether you give dabigatran at 150 mg twice a day or warfarin, the rate of stroke within 30 days after cardioversion is, to me, amazingly high: 3 to 6 events in every 1000 patients cardioverted. Based on that information, I am certainly going to change the conversation I have with my patients about the risks of cardioversion.<\/p>\n

EH: <\/strong>The RE-LY trial clearly demonstrated that dabigatran is a potent anticoagulant, but some clinicians may be uncomfortable with the lack of monitoring and thus may be hesitant to trust the drug\u2019s effects. My sense is that if you have put someone on dabigatran for 4 weeks before a cardioversion, then you believe in the medication, you believe in the mechanism and in the coagulation pathway, and you believe in the results of the RE-LY trial. To then subject the patient to a procedure like a TEE is not necessarily sound. If the patient is absolutely certain they have taken the medication, then you have done all you can to prevent stroke in this setting.<\/p>\n

Q: How would you recommend managing patients on dabigatran before and after noncardiovascular surgical procedures?<\/strong><\/p>\n

SG: <\/strong>Unless the patient is at very high risk for a stroke or bleeding event, I simply omit the dabigatran dose the afternoon or evening before the procedure and then omit both doses on the day of.<\/p>\n

EH: <\/strong>The package insert also provides details about specific procedures for which you would want to hold dabigatran for longer \u2014 for example, those that require absolute hemostasis. Obviously, it would behoove the surgeon and proceduralist to consult that resource.<\/p>\n

Q: Given the dangers of not being in the therapeutic range because of nonadherence, do you think that more-intensive or more-frequent counseling will be required for patients taking dabigatran, and if so, what sort of initial counseling and frequency of follow-up would you recommend? <\/strong><\/p>\n

EH:<\/strong> Patients who alternate or skip doses of dabigatran won\u2019t have the same buffer as they would on warfarin, because warfarin tends to remain in circulation for upwards of 36 to 40 hours. I would follow patients closely as they transition to dabigatran, especially if they have been on warfarin \u2014 at a minimum, I would see them once or twice in the first month and then maybe every 3 months for the next 6 months or so.<\/p>\n

SG: <\/strong>We need the same type of collaborative engagement with patients on dabigatran as we have for patients on clopidogrel after coronary artery stent placement. Every clinician taking care of the patient \u2014 whether it be a cardiologist, primary care doctor, physician\u2019s assistant, or nurse \u2014 needs to reminds him or her to take the dabigatran.<\/p>\n

For more of our coverage on dabigatran, check out the Dabigatran Resource Round-Up<\/a>.<\/em><\/p>\n","protected":false},"excerpt":{"rendered":"

In a series of blog posts on CardioExchange, Samuel Goldhaber, Director of the Venous Thromboembolism Research Group in the Cardiovascular Division at Brigham and Women\u2019s Hospital, has been guiding us on best practices around dabigatran. Recently, he teamed up with Elaine Hylek, Director of the Thrombosis and Anticoagulation Service at Boston University School of Medicine, […]<\/p>\n","protected":false},"author":494,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[495,1],"tags":[492,341,339],"class_list":["post-6979","post","type-post","status-publish","format-standard","hentry","category-anticoagulation-2","category-general","tag-anticoagulation","tag-atrial-fibrillation","tag-dabigatran"],"_links":{"self":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/6979","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/users\/494"}],"replies":[{"embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/comments?post=6979"}],"version-history":[{"count":0,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/6979\/revisions"}],"wp:attachment":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/media?parent=6979"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/categories?post=6979"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/tags?post=6979"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}