"I was amazed at how quiet my heart was," says Currier, a 69-year-old resident of Springfield. But the benefits of the treatment, called catheter ablation, didn't last. Soon her heartbeat became erratic again, forcing her to ask: What should I do?So I found it interesting that while the above article alluded to, but did not mention by name, the multi-center, prospectively randomized pivotal trial ongoing now called the CABANA trial (Catheter ABlation versus ANtiarrhythmic drug therapy for Atrial fibrillation). So far, only 46 patients of nearly 3000 patients needed to complete the study have been enrolled. It is anticipated that over 140 centers around the world will participate.
That's the dilemma facing more than 2.2 million Americans who have atrial fibrillation, the most common heart arrhythmia and one of the most vexing to control. While treatments ranging from medication to surgery are proliferating -- and often are marketed aggressively by hospitals -- no one can say with certainty which will work best for any individual patient. And each treatment has side effects, some of them serious.
"We don't have great evidence to help patients and doctors make a fundamental choice among the treatment options, which differ dramatically," says Steven Pearson, president of the Institute for Clinical and Economic Review, which evaluates medical treatments and is affiliated with Harvard Medical School.
That makes A-fib, as it's commonly called, a top candidate for comparative effectiveness research, say Pearson and other experts. Congress set aside $1.1 billion last year for this type of research, which involves head-to-head testing of drugs and treatments to determine which work best, and for which types of patients. Advocates say such research will improve health care and help get costs under control.
More information about A-fib therapies, for instance, would allow doctors to customize treatment for specific patients, says Harold Sox, a prominent internist who headed an Institute of Medicine committee advising Congress on how to spend the comparative effectiveness research funds. The committee issued a report recommending that atrial fibrillation should be a top candidate for such funding when it is given out by the government in the coming months.
Yet despite the widespread prevalence of atrial fibrillation, the study has been slow to enroll. We should ask ourselves "why?"
Let me count he ways.
First, is the public and referring doctors are not aware of the study and the pivotal trial is just getting underway. (This morning's article should help a bit.)
But there are other issues...
... like the media and other doctors' pre-conceived understanding of the procedure - "I-hear-that-ablation-stuff-is 90-98% effective, so just go in there and get your afib ablated and you'll be fixed" attitude. Patients have seen the glowing early results of catheter ablation, touted by some early on with "85 percent" success rates (which, quite frankly, are hogwash, unless we count people who continue to take antiarrhythmic drugs following their ablation - hardly a comparison of the two approaches).
But other early trials that only looked only at the time to first afib recurrence have had glowing press coverage as well, potentially biasing recruitment efforts for the CABANA trial.
Finally, there's the complexity of recruiting patients. Patient's usually prefer a "guick-fix" and many might be less inclined to participate in the CABANA trial's five-year duration. Also, gathering the vast quantities of information required for such a comprehensive evaluation of these two widely-disparate treatment approaches involves numerous medication, heart rhythm, and patient evaluations throughout the study's course. When one tries to capture every single warfarin medication adjustment or palpitation on event recorder, the manpower needs and time required to complete such a "comparative effectiveness research" trial in the era of manpower constraints being imposed on hospital systems limits enthusiasm for conducting such large trials. Are we to assume doctors who are already taxed with ever-growing clinical responsibilities can easily pick up the slack? That's why centers with higher research nurse-to-doctor ratios will be the centers most likely to recruit faster.
Which leads other less well-endowed medical centers to wonder if the results of these types of trials will really reflect "real-world" clinical medicine.
But when you don't have much else to go on, and the money for research is increasingly showered on large health care systems, it might be the best we can do as a country. What this might mean to smaller, more rural health care delivery as the government applies the results of this trial across the nation remains to be seen.
Disclaimer: I am the principle investigator for CABANA trial at our institution and yes, we have one research nurse dedicated to this trial.