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

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].).

The natural history of moderate aortic stenosis in a veteran population.

OBJECTIVE: Our objective was to evaluate the natural history of moderate aortic stenosis in veterans--a unique patient population with significant comorbidities. METHODS: We retrospectively reviewed the records of all patients who underwent echocardiography at a single veterans affairs hospital during 2006. We identified consecutive patients who had moderate aortic stenosis as indicated by a mean transaortic gradient of 25 to 40 mm Hg, peak aortic jet velocity of 3 to 4 m/s, or aortic valve area of 1.0 to 1.5 cm(2). The primary end point was defined as survival without aortic valve replacement. RESULTS: Of the 104 patients (mean age, 74 ± 10 years), 49% had diabetes, 21% had peripheral vascular disease, 21% were current smokers, 18% had chronic obstructive pulmonary disease, 60% had coronary artery disease, 89% had hypertension, and 31% had a body mass index of 30 kg/m(2) or more. Mean ejection fraction was 49% ± 12%. During the mean follow-up period of 22 months (range, 1-67 months), 30% of patients underwent aortic valve replacement--26% for symptomatic severe aortic stenosis and 4% concomitantly with coronary artery bypass grafting as the primary indicated operation--and 61% died. Event-free survivals were 48%, 24%, and 15% at 1, 3, and 5 years, respectively. CONCLUSIONS: Our cohort of military veteran patients had significant comorbidities. Event-free survival for such patients who have moderate aortic stenosis is significantly lower than previously reported data suggest. Within this unique group of patients, identifying factors that accelerate the progression of moderate aortic stenosis would help surgeons select patients who may benefit from early aortic valve replacement for moderate aortic stenosis.

Severe aortic stenosis in a veteran population: treatment considerations and survival.

BACKGROUND: We examined factors affecting the choice of surgical versus medical treatment of severe aortic stenosis and evaluated associated patient survival. METHODS: We retrospectively reviewed data from all patients diagnosed with severe aortic stenosis at a Veterans Affairs medical facility between January 1997 and April 2008. RESULTS: Of 345 patients with severe aortic stenosis, 260 (75%) underwent surgical evaluation, and 205 (59%) underwent aortic valve replacement (AVR). The patient's decision to decline surgical referral or AVR (n = 47) and severe comorbidities (n = 34) were the top two reasons for medical treatment rather than AVR. The AVR group was younger (69.5 +/- 9.6 years versus 75.7 +/- 8.6 years; p < 0.001) and had a higher prevalence of symptoms (96% versus 71%; p < 0.001) than the medical group. The medical group had a lower cardiac ejection fraction (0.42 +/- 0.15 versus 0.50 +/- 0.12; p < 0.001) and was less likely to be independent in activities of daily living (64% versus 74%). The AVR group had higher survival rates than the medical patients at 1 year (92% versus 65%), 3 years (85% versus 29%), and 5 years (73% versus 16%; log-rank test p < 0.0001). Valve replacement was independently associated with decreased mortality (hazard ratio, 0.17; 95% confidence interval, 0.10 to 0.27; p < 0.0001). CONCLUSIONS: The management of severe aortic stenosis in veterans is sometimes limited to medical evaluation and treatment. Surgeons should be involved in the complex process of risk assessment, to select patients with severe aortic stenosis who would benefit from the survival advantage associated with AVR.

Intensive multifactorial intervention for stable coronary artery disease: optimal medical therapy in the COURAGE (Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation) trial.

OBJECTIVES: This paper describes the medical therapy used in the COURAGE (Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation) trial and its effect on risk factors. BACKGROUND: Most cardiovascular clinical trials test a single intervention. The COURAGE trial tested multiple lifestyle and pharmacologic interventions (optimal medical therapy) with or without percutaneous coronary intervention in patients with stable coronary disease. METHODS: All patients, regardless of treatment assignment, received equivalent lifestyle and pharmacologic interventions for secondary prevention. Most medications were provided at no cost. Therapy was administered by nurse case managers according to protocols designed to achieve predefined lifestyle and risk factor goals. RESULTS: The patients (n = 2,287) were followed for 4.6 years. There were no significant differences between treatment groups in proportion of patients achieving therapeutic goals. The proportion of smokers decreased from 23% to 19% (p = 0.025), those who reported <7% of calories from saturated fat increased from 46% to 80% (p < 0.001), and those who walked >or=150 min/week increased from 58% to 66% (p < 0.001). Body mass index increased from 28.8 +/- 0.13 kg/m(2) to 29.3 +/- 0.23 kg/m(2) (p < 0.001). Appropriate medication use increased from pre-randomization to 5 years as follows: antiplatelets 87% to 96%; beta-blockers 69% to 85%; renin-angiotensin-aldosterone system inhibitors 46% to 72%; and statins 64% to 93%. Systolic blood pressure decreased from a median of 131 +/- 0.49 mm Hg to 123 +/- 0.88 mm Hg. Low-density lipoprotein cholesterol decreased from a median of 101 +/- 0.83 mg/dl to 72 +/- 0.88 mg/dl. CONCLUSIONS: Secondary prevention was applied equally and intensively to both treatment groups in the COURAGE trial by nurse case managers with treatment protocols and resulted in significant improvement in risk factors. Optimal medical therapy in the COURAGE trial provides an effective model for secondary prevention among patients with chronic coronary disease. (Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation; NCT00007657).

Papillary fibroelastoma of the aortic valve: operative approaches upon incidental discovery.

Papillary fibroelastomas are the most common benign neoplasms of the cardiac valvular structures, and they are being recognized more frequently because of higher-resolution imaging technology. Papillary fibroelastomas are associated with substantial complications that are secondary to systemic embolism. Incidentally discovered papillary fibroelastomas are treated on the basis of their size, mobility, and associated comorbidities and symptoms. Surgical resection should be offered to all patients who have symptoms and to asymptomatic patients who have pedunculated lesions or tumors larger than 1 cm in diameter. Valve-sparing excision produces good long-term results in most instances.Herein, we present the case of a patient who was scheduled for elective myocardial revascularization and in whom an aortic valve papillary fibroelastoma was discovered incidentally during routine intraoperative transesophageal echocardiography. The timely recognition of this asymptomatic tumor enabled a modified operative approach: the patient underwent myocardial revascularization with concomitant valve-sparing resection of the tumor. We discuss the pathophysiology of fibroelastomas of the aortic valve and operative approaches to the management of these tumors when they are discovered incidentally.