title: Impact of optimal medical therapy with or without percutaneous coronary intervention on long-term cardiovascular end points in patients with stable coronary artery disease (from the COURAGE Trial).
abstract: The main results of the Clinical Outcomes Utilizing Revascularization and Aggressive DruG Evaluation (COURAGE) trial revealed no significant differences in the primary end point of all-cause mortality or nonfatal myocardial infarction [MI] or major secondary end points (composites of death/MI/stroke; hospitalization for acute coronary syndromes [ACSs]) during a median 4.6-year follow-up in 2,287 patients with stable coronary artery disease randomized to optimal medical therapy (OMT) with or without percutaneous coronary intervention (PCI). We sought to assess the impact of PCI when added to OMT on major prespecified tertiary cardiovascular outcomes (time to first event), namely cardiac death and composites of cardiac death/MI, cardiac death/MI/hospitalization for ACS, cardiac death/MI/stroke, MI/stroke, or cardiac death/MI/ACS/stroke, during study follow-up. There were no significant differences between treatment arms for the composite of cardiac death or MI (15% in PCI + OMT group vs 14.2% in OMT group, hazard ratio 1.07, 95% confidence interval 0.86 to 1.33, p = 0.62) or in any of the major prespecified composite cardiovascular events during long-term follow-up, even after excluding periprocedural MI as an outcome of interest. Overall, cause-specific cardiovascular outcomes paralleled closely the primary and secondary composite outcomes of the trial as a whole. In conclusion, compared with an initial management strategy of OMT alone, addition of PCI did not decrease the incidence of major cardiovascular outcomes including cardiac death or the composite of cardiac death/MI/ACS/stroke in patients with stable coronary artery disease.
authors: VA Western New York Health Care System, Buffalo General Hospital, and the University at Buffalo, Buffalo, NY, USA. wboden@kaleidahealth.org
authors: William E
authors: WE
authors: Boden
authors: Robert A
authors: RA
authors: O'Rourke
authors: Koon K
authors: KK
authors: Teo
authors: David J
authors: DJ
authors: Maron
authors: Pamela M
authors: PM
authors: Hartigan
authors: Steven P
authors: SP
authors: Sedlis
authors: Marcin
authors: M
authors: Dada
authors: Mohammed
authors: M
authors: Labedi
authors: John A
authors: JA
authors: Spertus
authors: William J
authors: WJ
authors: Kostuk
authors: Daniel S
authors: DS
authors: Berman
authors: Leslee J
authors: LJ
authors: Shaw
authors: Bernard R
authors: BR
authors: Chaitman
authors: G B John
authors: GB
authors: Mancini
authors: William S
authors: WS
authors: Weintraub
mesh_terms: D015906:Angioplasty, Balloon, Coronary; D016001:Confidence Intervals; D003324:Coronary Artery Disease / Q000188:drug therapy* / Q000401:mortality / Q000628:therapy*; D023381:Endpoint Determination; D006801:Humans; D015994:Incidence; D053208:Kaplan-Meier Estimate; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome