• DOI:10.1056/NEJMOA070829
• Corpus ID: 37057748

Optimal medical therapy with or without PCI for stable coronary disease.

@article{Boden2007OptimalMT,
  title={Optimal medical therapy with or without PCI for stable coronary disease.},
  author={William E. Boden and Robert A. O'rourke and Koon K Teo and Pamela M. Hartigan and David J. Maron and William J. Kostuk and Merril L. Knudtson and Marcin Dada and Paul Casperson and Crystal L. Harris and Bernard R. Chaitman and Leslee J. Shaw and Gilbert Gosselin and Shah Nawaz and Lawrence M. Title and Gerald T. Gau and Alvin S. Blaustein and David C. Booth and Eric R. Bates and John A. Spertus and Daniel S. Berman and G. B. John Mancini and William S. Weintraub},
  journal={The New England journal of medicine},
  year={2007},
  volume={356 15},
  pages={
          1503-16
        }
}

• W. Boden, R. O'rourke, +20 authors W. Weintraub
• Published 12 April 2007
• Medicine
• The New England journal of medicine

BACKGROUND
In patients with stable coronary artery disease, it remains unclear whether an initial management strategy of percutaneous coronary intervention (PCI) with intensive pharmacologic therapy and lifestyle intervention (optimal medical therapy) is superior to optimal medical therapy alone in reducing the risk of cardiovascular events.

METHODS
We conducted a randomized trial involving 2287 patients who had objective evidence of myocardial ischemia and significant coronary artery disease at 50 U.S. and Canadian centers. Between 1999 and 2004, we assigned 1149 patients to undergo PCI with optimal medical therapy (PCI group) and 1138 to receive optimal medical therapy alone (medical-therapy group). The primary outcome was death from any cause and nonfatal myocardial infarction during a follow-up period of 2.5 to 7.0 years (median, 4.6).

RESULTS
There were 211 primary events in the PCI group and 202 events in the medical-therapy group. The 4.6-year cumulative primary-event rates were 19.0% in the PCI group and 18.5% in the medical-therapy group (hazard ratio for the PCI group, 1.05; 95% confidence interval [CI], 0.87 to 1.27; P=0.62). There were no significant differences between the PCI group and the medical-therapy group in the composite of death, myocardial infarction, and stroke (20.0% vs. 19.5%; hazard ratio, 1.05; 95% CI, 0.87 to 1.27; P=0.62); hospitalization for acute coronary syndrome (12.4% vs. 11.8%; hazard ratio, 1.07; 95% CI, 0.84 to 1.37; P=0.56); or myocardial infarction (13.2% vs. 12.3%; hazard ratio, 1.13; 95% CI, 0.89 to 1.43; P=0.33).

CONCLUSIONS
As an initial management strategy in patients with stable coronary artery disease, PCI did not reduce the risk of death, myocardial infarction, or other major cardiovascular events when added to optimal medical therapy. (ClinicalTrials.gov number, NCT00007657 [ClinicalTrials.gov].).