News:PCI not Cost Effective in the Occluded Artery Trial (OAT)

November 6, 2007 By Alexandra M. Palmer [1]

Orlando, FL: Results from a substudy of the Occluded Artery Trial (OAT) indicate no improvement in death rate, reinfarction, hearth failure, costs, cost-effectiveness or quality of life when patients undergo both percutaneous coronary intervention (PCI) and medical therapy as compared with medical therapy alone. This substudy data was presented by Daniel B. Mark at the American Heart Association 2007 Scientific Sessions.

The OAT trial was a randomized, multicenter study involving 2,166 stable heart attack patients with a completely occluded artery. Inclusion criteria required selecting patients who had not undergone any form of treatment to open the blocked artery within twelve hours of the first symptoms. The objective of the trial was to compare death rate, reinfarction and heart failure in two groups of study participants: those undergoing PCI+ medical therapy and those undergoing just medical therapy. The duration of follow-up was a median of 15.5 days (minimum of 3 and a maximum of 28 days). Results showed that the addition of PCI did nothing more than increase costs.

The OAT substudy introduced new endpoints: quality of life, cost and cost-effectiveness. The 1420 U.S. participants from the original trial made up the substudy population. 951 were randomized to quality of life analysis and 469 to economic assessment. Quality of life was measured by the Duke Activity Status Index (DASI), a patient’s level of physical exertion, and the SF-36 Mental Health Inventory. The duration of clinical follow-up for events was a median of 1 year after enrollment.

No significant difference was observed in quality of life between the PCI+medical therapy arm and the medical therapy alone arm up to at least one year. In addition, the economic analysis showed 30-day medical costs to be close to $10,000 higher (p<0.0001) in the PCI+medical therapy group and close to $7,000 higher after two years. Furthermore, results of the cost effectiveness assessment associated PCI+medical therapy with higher costs and a decreased improvement in health.

Further areas of study include measuring quality of life in both arms after five years.

The fact that this was a substudy and drew upon only U.S. patients from the OAT study limits the broad applicability of the results. These observations pertain to a non-randomized group of population. This substudy extends and supports prior results from OAT which indicate that PCI did not reduce death rates, reinfarction or hearth failure as compared to medical therapy alone.

This substudy was supported by Boston Scientific (Argentina), Cordis, Eli Lilly and Guidant.

View the slides here

References 1. Daniel B Mark, MD, MPH. PCI in the Occluded Artery Trial (OAT): Lots of Bucks, Not Much Bang. As presented at AHA 2007.