Monday, November 5, 2007

AHA - 2007: Study compares cost, health outcomes in clearing coronary blockages

Study compares cost, health outcomes in clearing coronary blockages

Late-Breaking Clinical Trials News Release 12

ORLANDO, Nov. 5 – In a follow-up analysis of a major clinical study presented last year, researchers found that percutaneous coronary intervention (PCI) with stenting at 3-28 days after a heart attack was not an economically efficient way to improve health outcomes in people with coronary blockage, according to late-breaking clinical trial results announced at the American Heart Association’s Scientific Sessions 2007.

The Occluded Artery Trial (OAT) was an NHLBI-funded prospective, randomized, multicenter trial comparing late PCI (at 3 to 28 days) with medical therapy alone in 2,166 heart attack patients with a totally blocked major heart artery. Patients were eligible for OAT if they had not received effective therapy (early PCI or clot-buster medicine) to open the blocked artery within the first 12 hours after symptom onset.

“The overall goal of this study was to compare cost and quality of life outcomes in patients randomized to the two arms of OAT,” said Daniel Mark, M.D., substudy lead author and professor of medicine and director of outcomes research at Duke Clinical Research Institute in Durham, N.C.

Patients received either state-of-the art medical therapy alone (which included daily aspirin, beta-blockers, ACE inhibitors and cholesterol-lowering drugs) or medical therapy plus PCI with stenting. Patients’ median age was 59 years, 83 percent were Caucasian, and 78 percent were male. All patients were considered high-risk but stable and without evidence of severe ischemia.

Researchers obtained quality of life data from 951 OAT patients at the start of the study, then again during follow-up interviews at four months, one year and two years after enrollment. They also collected medical resource-use data (all OAT patients) and detailed healthcare costs data (U.S. patients only) out to two years. All comparisons were done according to the principal of intention-to-treat., so patients assigned to medical treatment were analyzed as belonging to that group, even if they later crossed over and had a PCI.

Two principal quality of life outcomes were compared: PCI was associated with a clinically significant benefit in physical functioning (what patients are able to do) at four months, but this benefit was not sustained at one year or beyond. There were no significant effects on psychological well being. Of the secondary quality of life outcomes, PCI was associated with a modestly lower level of heart pains (angina) at four months and one year but these benefits also diminished over time.

In the 469 U.S. OAT patients, 30-day costs (hospital + physician) were about $10,000 higher in the PCI arm than the medical arm. At the end of two years, the cost difference had narrowed somewhat to $7,000. In cost effectiveness analysis, PCI had higher costs and worse health outcomes than medicine.

“This analysis showed that in OAT eligible patients, a strategy of routine late (3-28 day) PCI was substantially more expensive than optimal medical therapy alone when the results were examined over a two year period and the small symptom benefits provided were insufficient to make PCI an economically attractive strategy,” Mark said.

Support for this substudy was provided by Boston Scientific (Argentina), Cordis, Eli Lilly and Guidant.

Statements and conclusions of study authors that are presented at American Heart Association scientific meetings are solely those of the study authors and do not necessarily reflect association policy or position. The American Heart Association makes no representation or warranty as to their accuracy or reliability.

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