Patient Outcomes And Quality Of Care Are The Focus Of New Journal Edition

Main Category: Cardiovascular / Cardiology
Also Included In: Stroke;  Clinical Trials / Drug Trials;  Hypertension
Article Date: 25 Sep 2008 - 6:00 PST

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A landmark study indicating that angioplasty may not be cost effective for some stable heart disease patients and research indicating individualized consent forms may help patients make better decisions are among topics reported in the debut issue of Circulation: Cardiovascular Quality and Outcomes.

The bi-monthly journal will focus on content that can influence medical practice and health policy, according to editor Harlan Krumholz, M.D., S.M. The publication is the fifth of six new specialty journals that Circulation: Journal of the American Heart Association recently launched. The association is intensifying its scientific publications' focus on research aimed at combating major cardiovascular diseases.

"We are gaining remarkable advances in our ability to understand, prevent and treat cardiovascular disease and stroke, yet there remain vast gaps in effective strategies to preempt, mitigate and cure these conditions," Krumholz said.

He said these gaps often result from a lack of evidence about how best to provide care, prioritize resources and work with - and in the best interests of - patients.

"Circulation: Cardiovascular Quality and Outcomes will focus not just on what we should do, but how best to do it," said Krumholz, who is also professor of medicine and epidemiology at the Yale University School of Medicine and director of the Yale-New Haven Hospital Center for Outcomes Research and Evaluation in New Haven, Conn.

Studies in the inaugural issue focus on important issues including "a landmark article from the COURAGE trial that provides a critical perspective on the value of an initial percutaneous coronary intervention (PCI) strategy for patients with stable coronary disease," Krumholz said.

Here are summaries of four featured reports among articles in the first issue:

• Coronary angioplasty isn't cost effective in patients with chronic artery disease
  
  Angioplasty may add about $10,000 to costs of treatment "without significant gain in life years or quality-adjusted life years," according to a new evaluation of data from the COURAGE trial. Previously, the COURAGE trial compared the effect of balloon angioplasty to reopen clogged heart arteries (percutaneous coronary intervention, or PCI) plus optimal medical therapy versus optimal medical therapy alone. Researchers found that after 4.6 years there was no difference in deaths or heart attacks, although PCI improved patients' quality of life. The study assessed costs of hospitalization and medication for the 2,287 patients randomized between 1999 and 2004 for PCI or medical therapy. Scientists used Framingham study survival data to estimate patients' life expectancy beyond the trial. The incremental cost-effectiveness ratio (ICER) was expressed as cost per life-year and cost per quality-adjusted life-year gained. ICERs varied from $168,000 to $300,000 per life-year of quality-adjusted life-year gained with PCI. There is a reasonable probability that medical therapy alone offers better outcome at lower cost. The costs per patient for significant improvement in angina chest pain frequency, physical limitation and quality of life were $154,580, $112,876 and $124,233, respectively. "The COURAGE trial did not find adding PCI to optimal medical therapy to be a cost-effective initial management strategy for symptomatic, chronic coronary artery disease," the scientists said.
  
  
• Forms that individualize patients' potential risks lead to more informed consent for PCI
  
  Informed consent can be a highly variable communication between patients and their doctors that researchers say often fails to live up to its name. So researchers developed individualize consent forms with patients' specific estimates of risk and outcomes for those undergoing artery-reopening procedures (percutaneous coronary interventions, or PCI), thus enabling them to make decisions that are truly informed. In a study testing the new Web-based system, called Patient Refined Expectation for Deciding Invasive Cardiac Treatment (PREDICT), 142 patients undergoing cardiac catheterization received conventional consent forms and 193 received the PREDICT consent form. The PREDICT group reported higher rates of reading the consent form (72 percent vs. 44 percent); increased perception of shared decision-making (67 percent vs. 45 percent); and decreased anxiety (35 percent vs. 55 percent). Among patients who identified either death or bleeding as a potential complication of their procedure, more in the PREDICT group recalled being informed of the risks than those receiving traditional consent forms (death, 85 percent vs. 62 percent; bleeding, 92 percent vs. 71 percent). Moreover, there was evidence that those patients who would benefit most from new drug-eluting stents received them, while those who might be better treated with traditional bare metal stents were more likely to get those after receiving the PREDICT consent form. Based on this preliminary experience, the scientists conclude, "individualized consent forms with patient-specific risks were associated with improved participation in the consent process, reduced anxiety and better risk recall." The team said PREDICT is "one potential strategy for improving the current practice of obtaining informed consent for PCI." Given the goals set by the Institute of Medicine to transform U.S. healthcare into a more evidence-based, patient-centered process, PREDICT offers a preliminary insight into how this might be accomplished in routine clinical care, researchers said.
  
  
• Patients with artery plaques or at risk of disease pose weighty burden of healthcare costs
  
  Atherothrombosis, the clotting process underlying major forms of vascular disease (e.g. heart attack, stroke), is an enormous economic burden on both patients and society. Researchers examined in a population of outpatients at risk of atherothrombosis, what the annual costs associated with the management of risk factors and atherothrombosis-related hospitalizations are, based on data from an international registry of patients with either a history of atherothrombosis or multiple risk factors for the disease. Based on one-year data from 23,974 U.S. outpatients age 45 or older who had a history of symptomatic coronary artery disease (CAD), cerebrovascular disease, peripheral artery disease (PAD), or had three or more risk factors for atherothrombosis, annualized medication costs ranged from $2,401 to $3,481. Average annual hospitalization costs nearly doubled with each additional disease-affected arterial disease site ranging from $1,344 for patients with risk factors only to $8,155 for patients with a history of CAD, cerebrovascular disease and PAD. Among the 14,353 patients with disease involving a single arterial site, average annual hospitalization costs were $2,999 for the 11,063 patients with CAD, $2,010 for the 2,613 patients with cerebrovascular disease, and $3,911 for the 677 patients with PAD. "These results reveal the high economic burden of atherothrombosis-related clinical events and procedures," said the scientists, noting "the especially high economic burden" associated with multi-vessel disease. "An increased focus on primary prevention and more effective secondary prevention could potentially reduce the tremendous economic impact these patients have on the healthcare system."
  
  
• High blood pressure common, but often uncontrolled in the Big Apple
  
  Researchers report that less than half of people with hypertension in New York City have the disease controlled. The study, modeled after a major national survey, included a representative sample of 1,975 New Yorkers age 20 and older. Analyzing data from interviews and examinations done in 2004, the team found that 25.6 percent of adults had hypertension. African Americans had higher prevalence than whites (32.8 percent vs. 21.1 percent), as did Hispanics (26.5 percent vs. 21.1 percent). Among all adults with hypertension, 83 percent were diagnosed, 72.7 percent were treated, but only 47.1 percent had the disease controlled. Among those treated, 64.8 percent had their hypertension controlled. Statistical adjustment for socio-demographic variables showed that among adults with treated hypertension, lack of a routine place of medical care was most strongly associated with poor control. Among non-elderly adults with treated hypertension, blacks had four-fold lower odds than whites of having the disease controlled. The scientists conclude that hypertension in New York City "is common and frequently uncontrolled. Low levels of control are associated with poor access to care. Racial disparities in prevalence and control are evident among non-elderly adults."

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Author disclosures and funding for all studies are available on the individual manuscripts.

Statements and conclusions of study authors that are published in American Heart Association scientific journals are solely those of the study authors and do not necessarily reflect the association's policy or position. The association makes no representation or guarantee as to their accuracy or reliability. The association receives funding primarily from individuals; foundations and corporations (including pharmaceutical, device manufacturers and other companies) also make donations and fund specific association programs and events. The association has strict policies to prevent these relationships from influencing the science content.

NR08-1117 (Circ:Cardiovascular Quality and Outcomes)

Source: Bridgette McNeill
American Heart Association

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