Optimal medical therapy with or without percutaneous coronary intervention to reduce ischemic burden: results from the Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation (COURAGE) trial nuclear substudy.

BACKGROUND: Extent and severity of myocardial ischemia are determinants of risk for patients with coronary artery disease, and ischemia reduction is an important therapeutic goal. The Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation (COURAGE) nuclear substudy compared the effectiveness of percutaneous coronary intervention (PCI) for ischemia reduction added to optimal medical therapy (OMT) with the use of myocardial perfusion single photon emission computed tomography (MPS). METHODS AND RESULTS: Of the 2287 COURAGE patients, 314 were enrolled in this substudy of serial rest/stress MPS performed before treatment and 6 to 18 months (mean=374+/-50 days) after randomization using paired exercise (n=84) or vasodilator stress (n=230). A blinded core laboratory analyzed quantitative MPS measures of percent ischemic myocardium. Moderate to severe ischemia encumbered > or = 10% myocardium. The primary end point was > or = 5% reduction in ischemic myocardium at follow-up. Treatment groups had similar baseline characteristics. At follow-up, the reduction in ischemic myocardium was greater with PCI+OMT (-2.7%; 95% confidence interval, -1.7%, -3.8%) than with OMT (-0.5%; 95% confidence interval, -1.6%, 0.6%; P<0.0001). More PCI+OMT patients exhibited significant ischemia reduction (33% versus 19%; P=0.0004), especially patients with moderate to severe pretreatment ischemia (78% versus 52%; P=0.007). Patients with ischemia reduction had lower unadjusted risk for death or myocardial infarction (P=0.037 [risk-adjusted P=0.26]), particularly if baseline ischemia was moderate to severe (P=0.001 [risk-adjusted P=0.08]). Death or myocardial infarction rates ranged from 0% to 39% for patients with no residual ischemia to > or = 10% residual ischemia on follow-up MPS (P=0.002 [risk-adjusted P=0.09]). CONCLUSIONS: In COURAGE patients who underwent serial MPS, adding PCI to OMT resulted in greater reduction in ischemia compared with OMT alone. Our findings suggest a treatment target of > or = 5% ischemia reduction with OMT with or without coronary revascularization.

Evaluation of patients with severe symptomatic aortic stenosis who do not undergo aortic valve replacement: the potential role of subjectively overestimated operative risk.

BACKGROUND: Some patients with severe symptomatic aortic stenosis (AS) do not undergo aortic valve replacement (AVR) despite demonstrated symptomatic and survival advantages and despite unequivocal guideline recommendations for surgical evaluation. METHODS AND RESULTS: In 3 large tertiary care institutions (university, Veterans Affairs, and private practice) in Washtenaw County, Mich, patients were identified with unrefuted echocardiography/Doppler evidence of severe AS during calendar year 2005. Medical records were retrospectively reviewed for symptoms, referral for AVR, calculated operative risk for AVR, and rationale as to why patients did not undergo valve replacement. Of 369 patients with severe AS, 191 (52%) did not undergo AVR. Of these, 126 (66%, 34% of total) had symptoms consistent with AS. The most common reasons cited for absent intervention were comorbidities with high operative risk (61 patients [48%]), patent refusal (24 patients [19%]), and symptoms unrelated to AS (24 patients [19%]). Operated patients had a lower Society of Thoracic Surgery-calculated perioperative mortality risk than unoperated patients (1.8% [interquartile range, 1.0 to 3.0%] versus 2.7% [interquartile range, 1.6 to 5.5%], P<0.001). However, 28 (24%) of 126 unoperated symptomatic patients had a calculated perioperative risk less than the median risk for patients who underwent AVR. Only 57 (30%) of 191 unoperated patients were evaluated by a cardiac surgeon. There were similar rates of intervention across practice settings, and similar rates of unoperated patients despite symptoms and low operative risk. CONCLUSIONS: One third of patients with severe AS are symptomatic but do not undergo AVR, with similar findings in multiple practice environments. For most unoperated patients, objectively calculated operative risks did not appear prohibitive. Despite this, a minority of unoperated patients were referred for surgical consultation. Some patients with severe symptomatic AS may be inappropriately denied access to potentially life-saving therapy.