The open-artery hypothesis postulates that late opening of an infarct-related artery

after myocardial infarction will improve clinical outcomes. We evaluated the quality-

of-life and economic outcomes associated with the use of this strategy.

We compared percutaneous coronary intervention (PCI) plus stenting with medical

therapy alone in high-risk patients in stable condition who had a totally occluded

infarct-related artery 3 to 28 days after myocardial infarction. In 951 patients (44%

of those eligible), we assessed quality of life by means of a battery of tests that included

two principal outcome measures, the Duke Activity Status Index (DASI) (which measures

cardiac physical function on a scale from 0 to 58, with higher scores indicating

better function) and the Medical Outcomes Study 36-Item Short-Form Mental

Health Inventory 5 (which measures psychological well-being). Structured quality-oflife

interviews were performed at baseline and at 4, 12, and 24 months. Costs of treatment

were assessed for 458 of 469 patients in the United States (98%), and 2-year

cost-effectiveness was estimated.

At 4 months, the medical-therapy group, as compared with the PCI group, had a clinically

marginal decrease of 3.4 points in the DASI score (P = 0.007). At 1 and 2 years,

the differences were smaller. No significant differences in psychological well-being

were observed. For the 469 patients in the United States, cumulative 2-year costs were

approximately $7,000 higher in the PCI group (P<0.001), and the quality-adjusted survival

was marginally longer in the medical-therapy group.

PCI was associated with a marginal advantage in cardiac physical function at 4 months

but not thereafter. At 2 years, medical therapy remained significantly less expensive

than routine PCI and was associated with marginally longer quality-adjusted survival.

(ClinicalTrials.gov number, NCT00004562.)