Warfarin Benefits Extended To Patients with Chronic Kidney Disease Reply

Anticoagulation is a cornerstone of therapy for atrial fibrillation because it lowers the heightened risk for stroke in this population. People with chronic kidney disease are also at increased risk for stroke, but the benefits of anticoagulation are less clear in this group, and anticoagulation is used less often in AF patients who have CKD. Now, a large observational study offers some reassurance that anticoagulation in AF patients with CKD may be beneficial.

Researchers in Sweden analyzed data from more than 24,000 survivors of acute myocardial infarction who had AF….

Click here to read the full post on Forbes.

 

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FDA Plans New Safety Assessment Of Dabigatran (Pradaxa) Reply

Since the approval of dabigatran (Pradaxa, Boehringer Ingelheim) in Europe in 2008 and in the US in 2010 there have been persistent and lingering concerns about the drug’s safety. Now the FDA plans to perform a large new assessment of the drug compared to warfarin.

n December 30 the FDA posted a request for public comment on a proposed protocol of the study, which it describes as “a one-time assessment of selected safety outcomes in adults with atrial fibrillation who are new users of dabigatran or warfarin.”

Click here to read the full post on Forbes.

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Disappointing Results with Dabigatran for Mechanical Valves 1

Despite being more durable than bioprosthetic valves, mechanical heart valves are often not chosen because of the requirement for lifelong anticoagulant therapy. It has been hoped that the newer generation of oral anticoagulants might eventually replace warfarin, making anticoagulation more tolerable and better accepted, since these agents don’t require continuous monitoring and have much fewer serious interactions with other drugs and food. So far, however, there has been no convincing demonstration that the the newer agents are as safe and effective as warfarin for this indication.

RE-ALIGN was a phase 2 dose-validation study of dabigatran in patients with mechanical heart valves. Results of the trial were presented at the European Society of Cardiology meeting in Amsterdam and published simultaneously in the New England Journal of Medicine.  Patients in the trial were randomized to dabigatran or warfarin.

After 252 patients had been randomized, the trial was stopped early due to an increase in thromboembolic and bleeding events in the dabigatran group:

Click here to read the full post on Forbes.

Encouraging 4 Year Results For Watchman Device In AF Patients Reply

Encouraging long-term results from the PROTECT AF trial comparing the Watchman left atrial appendage closure device to warfarin in atrial fibrillation patients were presented yesterday at the Heart Rhythm Society meeting in Denver.

Previously, the main results of the trial, published in the Lancet, demonstrated that the Watchman was noninferior to warfarin, but the total number of events in the trial was small. In addition, there were more safety problems, as might be expected, in the early days after implantation. The FDA required the company to perform a confirmatory trial. That trial, PREVAIL, has been the subject of considerable controversy. Now, long term followup of PROTECT AF may help better understand the risks and benefits of the device.

Vivek Reddy presented 4 year followup results from PROTECT AF. The primary efficacy endpoint– the combined rate of all stroke, cardiovascular or unexplained death and systemic embolism– occurred in  2.3% of the device group versus 3.8% of the warfarin group (RR 0.60, CI 0.41-1.05).

Click here to read the full story on Forbes.

 

 

 

Bruise Control: Continued Warfarin Beats Heparin Bridging During Device Implantation 1

Many patients receiving an ICD or a pacemaker are already receiving oral anticoagulants. Current guidelines recommend replacement of the oral anticoagulant with the temporary use of heparin as a bridging strategy. Now a new study, BRUISE CONTROL (Bridge or Continue Coumadin for Device Surgery Randomized Controlled Trial), offers convincing evidence that this strategy is not beneficial and, in fact, results in an increase in device-pocket hematoma. Results of the trial were presented today at the Heart Rhythm Society meeting in Denver and published simultaneously in the New England Journal of Medicine.

A group of mostly Canadian investigators randomized 681 patients undergoing ICD or pacemaker implantation with an annual risk for thromboembolic events greater than 5% to either heparin bridging or continued warfarin. The trial was terminated early after a prespecified interim analysis by the data and safety monitoring board. The primary outcome — clinically significant device-pocket hematoma, which the investigators defined as a hematoma that led to prolonged hospitalization, interruption of anticoagulation, or hematoma evacuation — was significantly reduced in the continued-warfarin group, as were all three components of the endpoint:

Primary outcome: 3.5% with continued warfarin versus 16% with heparin bridging (RR 0.19, CI 0.10-0.36, p<0.001).

Click here to read the full story on Forbes.

 

Registry Study Offers Reassurance About Safety And Efficacy Of Dabigatran Reply

As the first new oral anticoagulant since warfarin, dabigatran (Pradaxa, Boehringer-Ingelheim) has been subject to intense concerns over its safety and efficacy in a real-world population. Last November an FDA investigation found no indication that bleeding rates for dabigatran were any higher than bleeding rates for warfarin. A new study from Scandinavia, published in the Journal of the American College of Cardiology (see note at bottom of story), provides more real-world information that helps to confirm the safety and efficacy of the new drug.

Using data from the Danish Registry of Medicinal Product Statistics, researchers compared 4978 patients treated with dabigatran to 8936 matched patients who received warfarin. They found similar rates of stroke or systemic embolism and major bleeding with dabigatran and warfarin. In addition, mortality, intracranial bleeding, pulmonary embolism,and myocardial infarction were significantly lower in the dabigatran-treated group.

Here are the adjusted hazard ratios (and 95% confidence intervals) for dabigatran 110 mg and 150 mg, respectively, compared with warfarin:

  • Stroke: 0.73 (0.53 -1.00), 1.18 (0.85 – 1.64)
  • Systemic embolism: 0.60 (0.19 – 1.60), 1.00 (0.26 – 3.35)
  • Death: 0.79 (0.65 – 0.95), 0.57 (0.40 – 0.80)
  • MI: 0.30 (0.18 – 0.49), 0.40 (0.21 – 0.70)
  • Pulmonary embolism: 0.33 (0.12 – 0.74), 0.24 (0.06 – 0.72)
  • Intracranial bleeding: 0.24 (0.08 – 0.56), 0.08 (0.01 – 0.40)
  • Major bleeding: 0.82 (0.59 -1.12), 0.77 (0.51 – 1.13)

The authors concluded that ”previous concerns about an excess of bleeding events or myocardial infarction amongst dabigatran treated patients were not evident in this propensity-matched comparison against warfarin in a large post-approval registry study.” However, they noted one limitation of their study: The Danish AF patients included in the study were at lower risk and had a lower event rate than the patients studied in the pivotal RE-LY randomized trial of dabigatran.

Note to readers: This study is now available on Science Direct and the manuscript has been posted on CardioSource. Due to technical problems the article will be published online in the Journal of the American College of Cardiology website on Wednesday, April 10.

 

FDA Officials Calm Concerns Over Excessive Bleeding With Dabigatran 1

Concerns over excessive bleeding complications with dabigatran (Pradaxa, Boehringer Ingelheim) as compared with warfarin are most likely due to the heightened sensitivity and vigilance that can accompany a new drug, according to FDA officials in a perspective published online in the New England Journal of Medicine.

“We believe that the large number of reported cases of bleeding associated with dabigatran provides a salient example of stimulated reporting,” write Mary Ross Southworth, Marsha Reichman, and Ellis Unger. “In this case, such reporting provided a distorted estimate of the comparative bleeding rates associated with dabigatran and warfarin in clinical practice.”

Click here to read the full story on Forbes.

 

New Studies Examine Prolonged Anticoagulation For VTE Recurrence Reply

Three studies published in the New England Journal of Medicine provide important new information about the risks and benefits of extended prophylaxis using two of the new oral anticoagulants in patients who have had venous thromboembolism (VTE).

In an accompanying editorial, Jean Connors writes that “deciding how to balance the risks and benefits of extended anticoagulation is difficult” in patients with unprovoked VTE, since the risk of recurrent VTE may reach 40% at 5 years. Patients at low-to-moderate risk of recurrence may benefit from aspirin, which “may be safer than the newer agents,” though “it appears to have less efficacy in reducing recurrent events.” For patients at higher risk, “the new targeted anticoagulants are attractive alternatives to warfarin. The finding that a low prophylactic dose of apixaban has the same efficacy as the full therapeutic dose, with no increased risk of major bleeding, may tip the risk-to-benefit ratio in favor of extended treatment for this patient population. The wide therapeutic window of this agent enables use of a lower dose that retains great efficacy with no or only a minimal increase in bleeding.”

Click here to read the entire post in Forbes.

The New England Journal of Medicine

 

 

 

Two Experts Help Sort Out The New Generation Of Anticoagulants Reply

Don’t miss this very practical discussion about the new generation of anticoagulants and the short term loan costs to cover them over on CardioExchange. Here are a few excerpts.

Christian Thomas Ruff:

I believe the addition of the 3 currently approved novel anticoagulants (dabigatran, rivaroxaban, and apixaban) will eventually translate into a greater proportion of eligible patients being treated; it certainly has in my practice…

Although I think it is important to continue to develop reversal agents for the novel anticoagulants, I don’t think the lack of such an agent is sufficient reason to avoid using a novel anticoagulant.

I think that price is one of the most important factors that has hindered uptake of the novel agents. Although these drugs may well be “cost-effective” in complicated analyses that focused on the costs and benefits to society at large, it is the out of pocket expense for the drugs that really matters to patients…

Andrew E. Epstein:

 It is highly unlikely that a direct comparison of the new anticoagulants will ever be done. Thus, we will have to choose between one or another based on pharmacokinetics, convenience, and perhaps formulary availability. Substudy analyses are also important…

I am concerned that although the elderly often have the most to gain from the new anticoagulants, they are also the patients at greatest risk for bleeding, especially if renal function is labile with drugs cleared by the kidneys. For such patients, warfarin should be considered.

Longer Warfarin Therapy After Bioprosthetic Aortic Valve Replacement May Be Beneficial Reply

Three months of warfarin is the usual standard of care following bioprosthetic aortic valve replacement (AVR),  although the supporting evidence base for this practice is limited. Now a large new registry study published in JAMA suggests that more prolonged warfarin therapy may be beneficial.

Danish researchers identified 4,075 patients who underwent bioprosthetic AVR. As expected, warfarin treatment between 30 and 90 days after AVR was associated with significant reductions in stroke, thromboembolic events and cardiovascular deaths compared with patients not taking warfarin. The benefits continued between 3 and 6 months, though the reduction in stroke was no longer statistically significant. The authors calculated that for every 23  patients not being treated with warfarin between 3 and 6 months, there was one additional cardiovascular death, at a cost of 1 bleeding complication requiring hospital admission for every 74 patients.

“With no randomized trials to guide the length of warfarin treatment, our results call for a review of guidelines in the field to consider an extension of the treatment to 6 months after surgery, especially in patients with an increased risk of cardiovascular death,” the authors wrote.

In an accompanying editorial, Shamir Mehta and Jeffrey Weitz write that, despite the limitations of an observational study, the results support a change in clinical practice in favor of prolonged warfarin therapy for as long as 6 months. They observe that the trial does not provide information about the possible role for the newer oral anticoagulants or about the role of adjunctive aspirin.

Here is the press release from JAMA:

Anticoagulation Treatment For Longer Than Three Months After Aortic Valve Replacement Associated With Decreased Risk of Cardiovascular Death

 CHICAGO – Although current guidelines recommend 3 months of anticoagulation treatment after bioprosthetic aortic valve replacement surgery, a study that included more than 4,000 patients found that patients who had warfarin therapy continued between 3 and 6 months after surgery had a lower rate of cardiovascular death, according to a study in the November 28 issue of JAMA.

“Biological prostheses are preferred to mechanical valves for aortic valve replacement (AVR) surgery in elderly patients older than 65 years because of shorter life expectancy and lack of a need to use anticoagulation treatment in the long-term. Especially in these patients, the tradeoff between thromboembolic complications due to the valve implant and bleeding events as adverse effects from anticoagulation therapy must be balanced. Nevertheless, appropriate duration of anticoagulation treatment postoperatively is yet to be established because the risk of complications when the treatment is discontinued is unknown,” according to background information in the article. The current recommendation of 3 months of warfarin treatment after bioprosthetic AVR surgery is primarily based on results from 1 retrospective study with a limited number of events.

Charlotte Merie, M.D., of the Copenhagen University Hospital Gentofte, Copenhagen, Denmark and colleagues investigated whether discontinuation of warfarin treatment within prespecified periods after bioprosthetic AVR surgery was associated with increased risk of thromboembolic complications, cardiovascular death, and bleeding incidents. Through a search in the Danish National Patient Registry, 4,075 patients were identified who had bioprosthetic AVR surgery performed between January 1997 and December 2009. The researchers determined the incidence rate ratios (IRRs) of strokes, thromboembolic events, cardiovascular deaths, and bleeding incidents by discontinuing warfarin as opposed to continued treatment at 30 to 89 days, 90 to 179 days, 180 to 364 days, 365 to 729 days, and at least 730 days after surgery. Average age of the patients was 75 years; 41 percent were women.

Overall, 361 patients (8.9 percent) experienced a stroke, 615 (15.1 percent) had a thromboembolic event, and 364 (8.9 percent) encountered a bleeding incident after the date of surgery. During the observation period, 1,156 patients (28.4 percent) died, with 879 (76.0 percent) of these deaths related to cardiovascular disease. The IRRs for patients not treated with warfarin compared with those treated with warfarin were 2.46 for stroke; 2.93 for thromboembolic events; 2.32 for bleeding incidents; and 7.61for cardiovascular deaths within 30 to 89 days after surgery; and 3.51 for cardiovascular deaths within 90 to 179 days after surgery.

“Our study demonstrates that discontinuing warfarin therapy within the first 3 months after surgery is associated with a significant increase in the risk of stroke, thromboembolic complications, and cardiovascular death. The novelty of our study is the finding that discontinuing warfarin therapy within 90 to 179 days after surgery is associated with a significant increase in the risk of cardiovascular death,” the authors write.

“International guidelines on anticoagulation after a bioprosthetic AVR have been written with limited data on the appropriate duration of warfarin treatment after surgery. Consequently, our study challenges current guidelines on the duration of antithrombotic treatment after AVR surgery with biological valves by presenting results suggesting that these patients will gain from an additional 3 months of warfarin treatment in terms of reduced cardiovascular death without risking a significant increase in bleeding events.”

(JAMA. 2012;308(20):2097-2107)

Editor’s Note: This work was supported by the Research Fund of the Department of Cardiology at Copenhagen University Hospital Gentofte, Gentofte, Denmark. Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, etc.

ASPIRE: Aspirin An Attractive Alternative After First VTE Reply

It is unclear what the best approach is for the long-term treatment of people who have had a first unprovoked episode of venous thromboembolism (VTE). Although warfarin is effective at preventing a recurrence, it is inconvenient and raises the risk for bleeding. Newer anticoagulants have not been tested or approved for this population.

The ASPIRE (Aspirin to Prevent Recurrent Venous Thromboembolism) trial randomized 822 patients who had finished an initial course of anticoagulant therapy after a first unprovoked case of VTE to either aspirin (100 mg daily) or placebo for 4 years. Although the reduction in the rate for recurrent VTE with aspirin did not reach statistical significance, there were significant reductions in secondary outcomes of clinical events:

26% reduction in the yearly rate of VTE recurrence (primary endpoint):

  • 6.5% for placebo and 4.8% for aspirin (HR 0.74, CI 0.52-1.05, p=0.09)

34% reduction in the yearly rate of major vascular events (VTE, MI, stroke, or CV death):

  • 8.0% versus 5.2% (HR 0.66, CI 0.48-0.92, p=0.01)

33% reduction in the yearly rate of VTE, MI, stroke, major bleeding, or all-cause mortality (net clinical benefit):

  • 9.0% versus 6.0% (HR 0.67, CI 0.49-0.91, p=0.01)

The ASPIRE investigators calculated that for every 1000 patients treated for 1 year, aspirin would prevent 17 episodes of VTE and 28 major thrombotic events, at a cost of 5 nonfatal bleeding episodes.

Reporting in the New England Journal of Medicine, the investigators write that although aspirin is “substantially less effective than warfarin,” it is “an attractive alternative because it is simple and inexpensive and its safety profile is well documented.”

In an accompanying editorial, Theodore Warkentin combined the ASPIRE results with findings from the recent WARFASA trial and calculated that aspirin results in a 32% reduction in the rate of recurrent VTE and a 34% reduction in the rate of major vascular events. He concludes that aspirin is “a reasonable option” for patients who wish to stop anticoagulation:

Aspirin is inexpensive, does not require monitoring (in contrast to warfarin), and does not accumulate in patients with renal insufficiency (in contrast to dabigatran and rivaroxaban); in addition, if major bleeding occurs or the patient requires urgent surgery, the antiplatelet effects of aspirin can be reversed…”

FDA Investigation Finds No Excess Bleeding Risk For Dabigatran 1

In its latest assessment of a highly controversial issue, the FDA has found no indication that bleeding rates for dabigatran (Pradaxa, Boehringer-Ingelheim) are any higher than the bleeding rates for warfarin. The FDA investigation was in response to the large number of post-marketing reports of bleeding in people taking dabigatran. Click here to for the full FDA statement. Here is the first paragraph of the statement:

The U.S. Food and Drug Administration (FDA) has evaluated new information about the risk of serious bleeding associated with use of the anticoagulants (blood thinners) dabigatran (Pradaxa) and warfarin (Coumadin, Jantoven, and generics). Following the approval of Pradaxa, FDA received a large number of post-marketing reports of bleeding among Pradaxa users.  As a result, FDA investigated the actual rates of gastrointestinal bleeding (occurring in the stomach and intestines) and intracranial hemorrhage (a type of bleeding in the brain) for new users of Pradaxa compared to new users of warfarin.  This assessment was done using insurance claims and administrative data from FDA’s Mini-Sentinel pilot of the Sentinel Initiative. The results of this Mini-Sentinel assessment indicate that bleeding rates associated with new use of Pradaxa do not appear to be higher than bleeding rates associated with new use of warfarin, which is consistent with observations from the large clinical trial used to approve Pradaxa (the RE-LY trial).1 (see Data Summary). FDA is continuing to evaluate multiple sources of data in the ongoing safety review of this issue.

High Rate Of Warfarin Discontinuation Observed In Study Reply

One of the many potential problems with warfarin-based anticoagulant therapy is the poor rate of adherence and persistence among patients who are prescribed the drug. Now a new observational study published in Archives of Internal Medicine raises the possibility that the problem may be even worse than many may have previously suspected, as discontinuation rates in clinical trials appear to be much lower than in the real world.

Tara Gomes and colleagues analyzed data from more than 125,000 new users of warfarin in Ontario, Canada and found very high rates of discontinuation over time:

  • 8.9% never filled a second prescription
  • 31.8% discontinued warfarin within 1 year
  • 43.2% discontinued warfarin with 2 years
  • 61.3% discontinued warfarin within 5 years

People at higher risk for stroke, as assessed by the CHADS2 score, were more likely to continue taking warfarin over the course of the study.

In an invited commentary, Whitney Maxwell and Charles Bennett write that the results are consistent with previous observational studies but that warfarin discontinuation can be appropriate and is often initiated by the physician. “Appropriateness of anticoagulation discontinuation is perhaps a more important outcome to evaluate rather than absolute discontinuation rates,” they write. An additional plausible explanation for the study finding is that few patients in Canada were treated at anticoagulation clinics.

Maxwell and Bennett write that any potential problem with anticoagulation discontinuation is not limited to warfarin. In the RE-LY trial, they note, more patients discontinued therapy in the dabigatran arm than in the warfarin arm, and a similar trend was observed with rivaroxaban in ROCKET AF.

Growing Popularity Of Dabigatran Leads To Increased Complications 1

Since its approval in the United States in October 2010 dabigatran (Pradaxa) has been prescribed 3.2 million times to more than 600,000 patients with nonvalvular atrial fibrillation (AF), according to its manufacturer, Boehringer Ingelheim. The company also announced that, based on the pivotal RE-LY trial, the “Clinical Studies” section of the drug’s prescribing information now includes the statement that 150 mg twice daily of dabigatran “was superior in reducing ischemic and hemorrhagic strokes relative to warfarin.”

But the news about dabigatran is not entirely upbeat. According to new data compiled by QuarterWatch (PDF), in 2011 the FDA received more safety reports about dabigatran than any other drug. The data are not entirely unexpected, since the bleeding complications of dabigatran are well known and physicians are more likely to report adverse events associated with new drugs. The drug that dabigatran was designed to replace, warfarin (Coumadin), was the second most reported drug, and has been high on the FDA list for many years.

Dabigatran was the subject of  3,781 serious adverse events reported to the FDA in 2011. This included 542 patient deaths and 2,367 hemorrhages. Warfarin  was the subject of  1,106 serious adverse events, including 72 deaths.

QuarterWatch noted that the difference between the two anticoagulants “could be at least partly explained by differences in the reporting rate for an older generic drug with many manufacturers, and a newly launched brand name drug being promoted by a large sales force.” But, according to QuarterWatch:

“What is clear, however, is that the FDA’s system is receiving a strong signal about this safety issue. A large share of dabigatran reports (79%) come from health professionals, suggesting that despite this well-known drug risk the bleeding was unexpected or unusually severe.”

QuarterWatch notes that the rapid uptake of dabigatran is probably due to its ease of use– no frequent INR tests are required– and the lack of drug interactions. One likely source of complications is the use of the standard 150 mg dose in older patients or those with renal dysfunction. The label now recommends that physicians “assess renal function during therapy as clinically indicated” but QuarterWatch wonders “whether this modest language will lead to safer use.”
Click here to read the Boehringer press release…

Aspirin Found To Prevent Recurrent Venous Thromboembolism 1

Aspirin can help prevent the recurrence of venous thromboembolism (VTE) after discontinuation of anticoagulation therapy, according to results of the WARFASA (the Warfarin and Aspirin) study published in the New England Journal of Medicine.

Following 6 to 18 months of oral anticoagulation, 403 patients with first-time unprovoked VTE were randomized to aspirin (100 mg daily) or placebo for two years. Aspirin therapy resulted in a significant reduction in VTE but did not cause an increase in the risk of bleeding:

  • VTE recurrence: 6.6% per year in the aspirin group versus 11.2% in the placebo group (hazard ratio 0.58, CI 0.36 to 0.93, p=0.02).
  • Major bleeding occurred in one patient in each treatment group.

In an accompanying editorial, Richard Becker writes that the results of WARFASA “are compelling and may signal an important step in the evolution of care” but calls for additional studies to more precisely define the role of aspirin in preventing recurrent VTE. The results of a larger trial, the Aspirin to Prevent Recurrent Venous Thromboembolism (ASPIRE) study, will be reported this year, according to Becker, and, in conjunction with WARFASA, “may provide more reliable evidence of the effect of aspirin in patients with first unprovoked venous thromboembolism.”

WARCEF: No Advantage For Warfarin Over Aspirin In Heart Failure 1

A new study offers “no compelling reason” to use warfarin instead of aspirin in heart failure patients who don’t have atrial fibrillation. In a paper published in the New England Journal of Medicine, Shunichi Homma and members of the Warfarin versus Aspirin in Reduced Cardiac Ejection Fraction (WARCEF) study group report the results of a trial in which 2,305 patients with left ventricular dysfunction were randomized to warfarin or placebo and followed for up to six years.

No significant differences were observed in the primary endpoint (the composite of death, ischemic stroke, or intracerebral hemorrhage) or its individual components. Warfarin was superior to aspirin in reducing the rate of ischemic stroke, but this advantage was offset by an increased incidence of major hemorrhage in the warfarin group.

  • Primary endpoint: 26.4% for warfarin versus 27.5% for aspirin, HR 0.93, CI 0.79-1.10
  • Ischemic stroke: 1.8% versus 3.5%, HR 0.55, CI 0.32-0.96)
  • Major hemorrhage: 5.8% versus 2.7%, OR2.21, CI 1.42-3.47

The authors concluded:

Given the finding that warfarin did not provide an overall benefit and was associated with an increased risk of bleeding, there is no compelling reason to use warfarin rather than aspirin in patients with a reduced LVEF who are in sinus rhythm.

In an accompanying editorial, John Eikelboom and Stuart Connolly agree with the study authors that there is no justification for the “routine clinical use of warfarin in most patients with heart failure” but write that warfarin is still “most likely to benefit” heart failure patients with atrial fibrillation or with a history of cardioembolic stroke or formation of LV thrombus. They leave open the possibility that warfarin may also benefit heart failure patients with underlying coronary artery disease, and recommend that future studies of anticoagulants in heart failure focus on this population.

Study Explores Role of Periprocedural Dabigatran in AF Ablation 1

Updated with a comment from John Mandrola– As dabigatran becomes more widely used in atrial fibrillation (AF) patients, electrophysiologists are now trying to figure out how to handle anticoagulation in patients taking dabigatran (Pradaxa) for whom AF ablation is planned. In a new study published in the Journal of the American College of Cardiology, Dhanunjaya Lakkireddy and colleagues report on a multicenter, observational study of 290 patients who underwent an AF ablation procedure. Half the patients were taking periprocedural dabigatran and half were matched controls taking warfarin.

There were significantly more thromboembolic  and bleeding complications in the dabigatran group than in the warfarin group:
Click to continue reading…