Tag Archives: atrial fibrillation

Encouraging 4 Year Results For Watchman Device In AF Patients Reply

by • Heart Rhythms, Interventional Cardiology & Surgery, Policy & Ethics • Tags: , , , , ,

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).

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Click here to read the full story on Forbes.

 

 

 

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Following An Embargo Break PREVAIL Trial Won’t Be Presented At ACC 2

by • Heart Rhythms, Interventional Cardiology & Surgery, People, Places & Events, Policy & Ethics • Tags: , , , , , ,

UPDATED–The already complicated story behind the PREVAIL trial, which was designed to confirm the safety and efficacy of the Watchman left atrial appendage closure device, just got even more complicated. This morning, after the trial’s sponsor, Boston Scientific, prematurely distributed to investors a press release summarizing the results of the trial, the ACC announced that the scheduled presentation of the results at the main opening session of the meeting would not take place.

 

By way of background, last week the trial’s sponsor, Boston Scientific, first announced that the  principal investigator of the trial, David Holmes, would only “present the acute procedural safety results” from the trial. Then the company reversed itself two days later and announced that Holmes would present all three co-primary endpoints.

Holmes intended presentation this morning at the ACC in San Francisco makes clear why there was so much confusion. (The slides from his presentation have been made available to the media.) Although the trial results appear largely positive, the trial missed one of its three primary endpoints, and experts will likely spend a lot of time and energy trying to interpret the results.

Click here to read the full story on Forbes.

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Rivaroxaban Effective In Medically Ill Patients But At High Bleeding Cost Reply

by • Heart Rhythms, Prevention, Epidemiology & Outcomes • Tags: , , , , ,

The recent arrival of novel oral anticoagulants has provided important new options for venous thromboembolism (VTE) treatment and prevention. New indications for these drugs have been granted for patients with atrial fibrillation and following orthopedic surgery. But an additional indication, for acutely ill medical patients at risk for VTE, does not appear likely in the near future, as a new trial published in the New England Journal of Medicine shows that one of these novel drugs, though effective at preventing VTE, also resulted in a significant increase in bleeding risk.

In the Multicenter, Randomized, Parallel Group Efficacy and Safety Study for the Prevention of Venous Thromboembolism in Hospitalized Acutely Ill Medical Patients Comparing Rivaroxaban with Enoxaparin (MAGELLAN), first presented at the American College of Cardiology meeting in 2011, more than 8,000 medically ill patients were randomized to subcutaneous enoxaparin for 1o days or oral rivaroxaban for 35 days.

Click here to read the full post in Forbes.

Small Study Suggests Yoga May Benefit AF Patients Reply

by • Uncategorized • Tags: , , ,

A small study published online in the Journal of the American College of Cardiology suggests that yoga may benefit people who have atrial fibrillation. The study, which the authors describe as “a small, proof-of-concept study,” is the first of its kind. The findings raise the possibility that yoga may reduce AF symptoms and arrhythmia burden. Other physiological and quality of life benefits were also observed. But, the authors caution, large randomized trials will be required to confirm the finding.

 

Click here to read the full post on Forbes.

 

A yoga class.

 

Trials Of Niacin And Atrial Fibrillation Device Will Headline American College Of Cardiology Program Reply

by • Heart Failure, Heart Rhythms, Interventional Cardiology & Surgery, MI/ACS, People, Places & Events • Tags: , , , , ,

Two big trials will highlight this year’s American College of Cardiology meeting in March in San Francisco. First is the PREVAIL trial testing Boston Scientific‘s long-anticipated Watchman left atrial appendage closure device for stroke prevention in patients with atrial fibrillation. Second is  the detailed presentation of the controversial failed HPS2-THRIVE trial of extended-release niacin and laropiprant.

Read my complete story on Forbes, along with a list of the late-breakers. 

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Two Experts Help Sort Out The New Generation Of Anticoagulants Reply

by • Uncategorized • Tags: , , , , , , , , ,

Don’t miss this very practical discussion about the new generation of anticoagulants 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.

FDA Approves Eliquis (Apixaban) For Stroke Prevention In AF 2

by • Heart Rhythms, Policy & Ethics • Tags: , , , , , , ,

The FDA has finally approved apixaban (Eliquis, Bristol Myers Squibb and Pfizer) to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation. The action comes after the widely-anticipated drug had been plagued by delays at the FDA but well before the PDUFA deadline of March 17, 2013. Eliquis is the latest member of the new generation of oral anticoagulants, which also includes dabigatran (Pradaxa, Boehringer Ingelheim) and rivaroxaban (Xarelto, Johnson & Johnson).

The FDA said that apixaban should not be taken by patients with prosthetic heart valves or by patients with AF caused by a heart valve problem. (Recently the FDA added a contraindication to the dabigatran label against using the drug in patients with mechanical heart valves.) The FDA said that the most serious risk associated with apixaban, as with other anticoagulants, is bleeding, including life-threatening and fatal bleeding. Patients taking apixaban will receive a patient Medication Guide. The FDA is advising health care professionals to counsel patients about the signs of symptoms of possible bleeding.

The FDA approval was based largely on the results of the highly positive ARISTOTLE trial which found that apixaban was superior to warfarin in AF patients. The FDA will likely allow BMS and Pfizer to claim that apixaban is superior to warfarin, as the press release states that “patients taking Eliquis had fewer strokes than those who took warfarin.”

Click here to download a PDF of the package insert.

Click here to read the FDA press release…

Atrial Fibrillation: Radiofrequency Catheter Ablation And Antiarrhythmic Drug Therapy Compared Reply

by • Heart Rhythms • Tags: , , ,

A trial comparing radiofrequency catheter ablation (RFA) to antiarrhythmic drug therapy (AAD) as initial therapy for atrial fibrillation (AF) found no difference in the overall burden of AF between the groups. But the trial also turned up evidence supporting the use of RFA as an initial treatment strategy in some patients.

In a paper published in the New England Journal of Medicine, European investigators report on 294 patients with paroxysmal AF with no previous use of AADs who were randomized in the MANTRA-PAF (Medical Antiarrhythmic Treatment or Radiofrequency Ablation in Paroxysmal Atrial Fibrillation) trial. Patients– under 70 years of age and with no other major heart disease– were healthier than the general AF population.

The investigators found no significant differences in the cumulative burden of AF or the burden at  3, 6, 12, or 18 months. However, at 2 years the AF burden was significantly reduced in the RFA group compared with the AAD group (90th percentile of AF burden: 9% for RFA versus 18% for AAD, p=0.007). In addition, the percentage of patients with no AF and no symptomatic AF was higher in the RFA group than in the AAD group (85% vs. 71%, p=0.004; 93% vs. 84%, p=0.01, respectively). In the RFA group, there were three cases of cardiac tamponade in addition to one death after a procedure-related stroke. In the AAD group 36% of the patients received supplementary RFA.

The overall results, write the authors, “support the current guidelines recommending antiarrhythmic drugs as first-line treatment in most patients with paroxysmal atrial fibrillation.” However, the positive findings for RFA, as well as the high number of crossovers from AAD to RFA, suggest that “a substantial minority of patients” treated with AAD “may eventually require ablation for adequate rhythm control.”

In an accompanying editorial, William Stevenson and Christine Albert mention the “substantial procedural risks” associated with RFA and warn that the results should not be extrapolated to different patient populations, since the MANTRA-PAF population was younger and healthier than the general AF population. They express hope that the much larger CABANA (Catheter Ablation versus Anti-arrhythmic Drug Therapy for Atrial Fibrillation) trial will provide more definitive evidence about RFA. RFA, they conclude, is ”a reasonable option for patients with symptomatic paroxysmal atrial fibrillation before therapy with an antiarrhythmic drug.”

High Rate Of Warfarin Discontinuation Observed In Study Reply

by • Heart Rhythms, Prevention, Epidemiology & Outcomes • Tags: , , , , ,

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.

Merck Returns To Cardiome All Rights To Atrial Fibrillation Drug Vernakalant Reply

by • Heart Rhythms, People, Places & Events • Tags: , , ,

Merck and Cardiome announced today that Merck was returning to Cardiome all marketing and development rights for the atrial fibrillation (AF) drug vernakalant. An intravenous formulation of vernakalant is marketed in Europe as Brinavess. It has not been approved in the United States, though it received a positive recommendation from the FDA’s Cardiovascular and Renal Drugs Advisory Committee in 2007.

Earlier this year, as reported here, Merck announced that it was ending its involvement in the development of an oral formulation of vernakalant.

During a conference call, Dr. William Hunter, the interim CEO of Cardiome, expressed confidence that the company would go forward with vernakalant. He pointed out that “what constitutes an opportunity for Cardiome is probably very different than what constitutes one for a global corporation the size of Merck.” In a press release, Hunter stated: “Cardiome looks forward to continued advancement of the launch of BRINAVESS IV worldwide and welcomes the opportunity to continue development of vernakalant oral worldwide and vernakalant IV in North America.”

Click here to read the press release from Merck and Cardiome…

In AF, Women Have A Bigger Risk Of Stroke Than Men Reply

by • Heart Rhythms • Tags: , ,

When compared to elderly men with atrial fibrillation, elderly women with AF have a significantly elevated risk for stroke. This increased risk occurs regardless of warfarin use, according to a new study published in JAMA.

Meytal Avgil Tsadok and colleagues reviewed data from Quebec, Canada on more than 80,000 AF patients at least 65 years of age. Much of the increased risk occurred in women over the age of 75.

Overall crude stroke incidence:

  • Women versus men: 2.02 versus 1.61 per 100 person-years, p<0.001

The risk for stroke among women remained elevated after adjustment for baseline risk factors, individual components of the CHADS2 score, and warfarin treatment:

  • Adjusted hazard ratio: 1.14, CI 1.07-1.22, p<0.001

The authors wrote that “women older than 75 years represent the most important target population for stroke prevention in patients with AF, and the effectiveness of novel anticoagulants in this population in real-world practice will need to be closely monitored.”
Click here for the press release from JAMA…

Merck Drops Development of Oral Vernakalant for Atrial Fibrillation Reply

by • Heart Rhythms • Tags: , ,

Merck has discontinued its development of oral vernakalant for the long term prevention of atrial fibrillation (AF) recurrence. Cardiome Pharma, Merck’s partner in the drug, said today that the “decision was based on Merck’s assessment of the regulatory environment and projected development timeline.”

Merck and Cardiome will continue their partnership with the intravenous formulation of vernakalant, Brinavess, which is approved in 37 countries outside the US for the rapid conversion of recent onset AF.
Click here to read the press release from Cardiome…