PINNACLE-AF Registry Suggests Slow Uptake of New Anticoagulants

August 17, 2012

August 16, 2012 (Washington, DC) — Preliminary data from the PINNACLE registry focusing on patients with atrial fibrillation (AF) suggest that just under half of patients with AF are treated with anticoagulants [1]. Interestingly, of patients in the registry who received oral anticoagulation, 87.4% were treated with warfarin in 2011 while just 12.6% were prescribed one of the two newly available oral anticoagulants.

"We were a little bit surprised," said Dr William Oetgen (Georgetown University, Washington, DC) in reference to the relatively high number of patients who remained on warfarin. "The efficacy and the safety of the novel oral anticoagulants, the two of them that are on the market, are better than Coumadin. The ease of administration is much better than Coumadin. . . . On balance, the drugs seem to be a therapeutic advancement, but the uptake has been slower than we thought it would be."

The PINNACLE-AF registry is part of the American College of Cardiology (ACC) National Cardiovascular Data Registry (NCDR) and is designed to determine how the next generation of anticoagulants is being used in clinical practice. Like PINNACLE, which is the largest cardiovascular outpatient database in the US, the PINNACLE-AF registry is focused on improving quality of care and clinical outcomes in patients with AF. As reported previously by heartwire , treatment of AF patients has altered dramatically in recent years with the emergence and approval of the direct thrombin inhibitor dabigatran (Pradaxa, Boehringer Ingelheim) and the oral factor Xa inhibitor rivaroxaban (Xarelto, Bayer/Johnson & Johnson).

To date, 121 000 unique AF patients are included in the registry. Of these, 50% were treated with anticoagulants in 2011. To heartwire , Oetgen, the senior vice president of science and quality at the ACC, said this number is in line with a previous analysis of AF patients treated in the PINNACLE registry. In that report, 55.1% of patients were treated with anticoagulation. In addition, the 50% anticoagulation rate is in line with other studies that assessed performance measures in patients with cardiovascular disease. For example, during the 1990s, the initial level of treating MI patients with beta blockers was approximately 45%.

"We're just starting to measure [anticoagulation rates], and there has not been time for dissemination of knowledge or for raising awareness among physicians and patients," said Oetgen. Regarding the 12.6% uptake of new oral anticoagulants, he added that physicians can be slow to change treatment patterns and are skeptical of new drugs, particularly in a therapeutic area that is fraught with danger such as AF.

"You can overdo anticoagulation and the patient gets into trouble," Oetgen told heartwire . "You can underdo it and the patient can get into trouble, too. There is a natural hesitancy. The other thing is that there have been a rash of press reports about untoward effects, or bad results, such as bleeds, probably in the range of what would be expected, but they've gotten a huge amount of press. So there's a little bit of a fear factor there."

Bristol-Myers Squibb and Pfizer provide financial support for the PINNACLE-AF registry.

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