Risk Prediction Tool for Assessing the Probability of Death or Myocardial Infarction in Patients With Stable Coronary Artery Disease.

Several risk scores in acute coronary syndromes are available, but few models exist for stable coronary artery disease to guide decision-making and prognosis. A multivariate model was developed using 23 baseline candidate variables from the Clinical Outcomes Utilizing Revascularization and Aggressive Drug Therapy EvaluationTrial (n = 2,287 patients). Discrimination of the model was evaluated by the concordance c-index. The procedure was validated using 100 random half samples. We identified 9 independent predictors of death or myocardial infarction (MI) during a 5-year follow-up. The following predictors and points contributing to the risk score were: heart failure (3), number of diseased coronary arteries (1 for each vessel), diabetes (1), age (1 for each 15 years ≥ age 45), previous revascularization (1), current smoking (1), female (1), previous MI (1), and high-density lipoprotein cholesterol (1: 31 to 40 mg/dL; 2: <30 mg/dL). The risk tool had a potential range from 0 to 15, corresponding to 5-year event rates of 5.8% to 56%. C-indices ranged from 0.67 for the full data set to 0.62 for the validating subsamples. Respective observed versus predicted 5-year event rates for 3 predefined risk strata revealed: 30% had a low-risk score of 0 to 3 (9.3% vs 9.3%, or 1.9%/year); 59% had an intermediate-risk score of 4-6 (18.0% vs 18.1%, or 3.6%/year); and 11% had a high-risk score of 7-11 (36% vs 36.5%, or 7.2%/year). This stable coronary artery disease risk score permitted a prognostic assessment of 5-year probability of death or MI with an approximate 4-fold range in event rates from the lowest (9.3%) to the highest (36%) terciles, thus enabling better clinical practice decisions that allow physicians to tailor the intensity of treatment to the level of risk.

Lifestyle, Glycosylated Hemoglobin A1c, and Survival Among Patients With Stable Ischemic Heart Disease and Diabetes.

BACKGROUND: The importance of glycosylated hemoglobin A1c (A1c) control as part of comprehensive risk factor management in patients with stable ischemic heart disease (SIHD) and diabetes mellitus (DM) is controversial. OBJECTIVES: The purpose of this study was to determine whether a greater number of controlled risk factors at 1 year, including A1c, affects survival in patients with DM and SIHD. METHODS: Of 690 patients with DM followed in the COURAGE (Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation) trial, 592 (86%) had complete ascertainment of 7 pre-specified risk factors at baseline and after 1 year: systolic blood pressure, low-density lipoprotein cholesterol, nonsmoking, physical activity, diet adherence, body mass index, and A1c. The primary outcome measure was mortality beyond 1 year after randomization. RESULTS: During a mean follow-up of 7.0 ± 4.2 years beyond 1 year after randomization, 186 subjects died (31.4% overall, 4.5%/year). The greater the number of risk factors controlled at 1 year, the higher the probability of survival (unadjusted log rank p = 0.002). Compared with 0 to 1 controlled risk factors, attaining 3 to 7 goals predicted progressively lower mortality (hazard ratio for control of 6 or 7 risk factors was 0.13; 95% confidence interval: 0.05 to 0.40). Importantly, only 10.3% of subjects achieved control of 6 or 7 risk factors. In multivariate analysis, the strongest predictors of improved survival were no smoking, regular physical activity, dietary adherence, and A1c <7%. CONCLUSIONS: In this high-risk subset of SIHD patients with DM, the number of controlled risk factors, particularly lifestyle behaviors and A1c, were associated with improved survival. (Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation; NCT00007657).

Healthy Behavior, Risk Factor Control, and Survival in the COURAGE Trial.

BACKGROUND: Individual risk factor control improves survival in patients with stable ischemic heart disease (SIHD). It is uncertain if multiple risk factor control further extends survival. OBJECTIVES: This study determined whether a greater number of risk factors at goal predicted improved survival in SIHD patients. METHODS: Of 2,287 participants in the COURAGE (Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation) trial, 2,102 (92%) had complete ascertainment of 6 pre-specified risk factors: systolic blood pressure, low-density lipoprotein cholesterol, smoking, physical activity, diet, and body mass index. Participants received interventions to control these risk factors. The outcome measure was mortality. RESULTS: During a mean follow-up of 6.8 years, 473 (22.5%) subjects died. In univariate analysis, the greater the number of risk factors controlled, the higher the probability of survival (unadjusted log rank: p < 0.001). In multivariate analysis, the strongest predictors at 1 year of improved survival were being a nonsmoker, regular physical activity, having a systolic blood pressure <130 mm Hg, and following the American Heart Association Step 2 diet. Baseline risk factor values and evidence-based medications did not independently predict survival once risk factor control at 1 year was included in the model. Having 4 to 6 risk factors compared with 0 to 1 risk factor at goal predicted lower mortality (hazard ratios for 4 and 6 controlled risk factors: 0.64; 95% confidence interval: 0.41 to 0.98, and 0.27; 95% confidence interval: 0.09 to 0.79, respectively). CONCLUSIONS: The greater the number of risk factors in control, the higher the probability of survival in patients with SIHD. More effective strategies are needed to achieve comprehensive risk factor control, including healthy behaviors. (Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation [COURAGE]; NCT00007657).

Single-stage hybrid coronary revascularization with long-term follow-up.

OBJECTIVES: Hybrid coronary revascularization, performing a left internal thoracic artery (LITA) to left anterior descending (LAD) bypass followed by percutaneous coronary intervention (PCI) in a non-LAD coronary artery lesion, represents an evolving revascularization strategy. It utilizes the survival benefit of the LITA-to-LAD bypass, while providing complete revascularization with PCI to a non-critical vessel to decrease procedural morbidity. However, quantitative patency results and clinical outcomes remain understudied. The objective of this study was to assess clinical follow-up and graft and stent patency at 6 months and 5 years in a single-stage hybrid revascularization population. METHODS: From 2004 to 2012, a total of 96 patients (64 ± 12 years; 70 males and 26 females) consented to robotic-assisted LITA harvesting and a small left anterior thoracotomy for off-pump coronary artery bypass anastomosis onto the LAD. This was followed immediately by PCI in a non-LAD vessel in the same fluoroscopy-equipped hybrid operating room. Patients underwent a yearly clinical follow-up and a protocol-directed assessment of graft patency via a coronary angiogram at 6 months and cardiac computed tomography (CT) angiography with single-photon emission computed tomography myocardial perfusion scintigraphy (MPS) at 5 years. RESULTS: Successful single-stage hybrid revascularization occurred in 94 of the 96 patients (2 patients required intraoperative conversion to conventional coronary bypass). Six-month protocol coronary angiogram follow-up has been performed in 85 patients. Fitzgibbon Grade A or B LITA-to-LAD patency at 6-month follow-up was 94% in those studied. A total of 105 stents were deployed (89 drug-eluting stents (DES) and 16 bare metal), and at 6-month follow-up in 85 patients, 79 stents were widely patent; 8 had in-stent restenosis, and 2 were completely occluded. To date, 19 patients have undergone 5-year coronary CT angiography and MPS. The LITA-to-LAD anastomosis was patent in 17 of the 19 patients. Of the 19 lesions in which PCI was performed, 17 were widely patent, while 2 circumflex DES were occluded. Five-year clinical outcome demonstrated 91% survival, 94% freedom from angina and 87% freedom from any form of coronary revascularization. CONCLUSIONS: A single-stage hybrid revascularization strategy appears to have acceptable 6-month and angiographic patency results for both LITA-LAD grafts and PCI interventions. Survival, freedom from angina and freedom from revascularization also appear favourable at the 5-year clinical follow-up.

Contrast volume use in manual vs automated contrast injection systems for diagnostic coronary angiography and percutaneous coronary interventions.

BACKGROUND: Contrast-induced nephropathy (CIN) is an important cause of iatrogenic morbidity and mortality. The amount of contrast delivered has a major effect on CIN and is operator-dependent. A few studies suggested that the use of automated contrast injection systems is associated with reduced contrast volume. It is unknown whether this is true when smaller amounts of contrast are used and how this is affected by training. METHODS: Volume of contrast media was measured in 1358 consecutive patients undergoing diagnostic catheterization and percutaneous coronary intervention (PCI) from January 31 to May 31, 2011. Patients were allocated to manual stopcock-manifold contrast injection (1052 patients) or automated contrast injection (306 patients). RESULTS: No significant difference in contrast volume use was found between manual and automated contrast injection systems, respectively: diagnostic catheterization, 72 ± 40 mL vs 96 ± 63 mL (P = 0.08); diagnostic catheterization with left ventricular angiography, 98 ± 40 mL vs 95 ± 35 mL (P = 0.51); PCI, 206 ± 82 mL vs 205 ± 90 mL (P = 0.84); diagnostic catheterization and PCI, 264 ± 83 mL vs 253 ± 93 mL (P = 0.51). No significant difference in CIN incidence, according to contrast injection systems, was found among patients receiving PCI (manual 9.8% vs automated 7.4%, P = 0.43). Using smaller sized catheters during diagnostic procedures was associated with injection of smaller amounts of contrast (P < 0.0001). CONCLUSIONS: The use of automated contrast injection for diagnostic catheterization and PCI is not associated with reduced contrast volume as compared with manual injection. The use of smaller calibre catheters might reduce contrast volume.

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).

Optimal medical therapy with or without percutaneous coronary intervention in older patients with stable coronary disease: a pre-specified subset analysis of the COURAGE (Clinical Outcomes Utilizing Revascularization and Aggressive druG Evaluation) trial.

OBJECTIVES: Our aim was to access clinical effectiveness of percutaneous coronary intervention (PCI) when added to optimal medical therapy (OMT) in older patients with stable coronary artery disease (CAD). BACKGROUND: While older patients with CAD are at increased risk for cardiac events compared with younger patients, it is unclear whether PCI may mitigate this risk more effectively than OMT alone or, alternatively, may be associated with more complications. METHODS: We conducted a pre-specified analysis of outcomes in stable CAD patients stratified by age and randomized to PCI+OMT or OMT alone in the COURAGE (Clinical Outcomes Utilizing Revascularization and Aggressive druG Evaluation) trial. RESULTS: A total of 1,381 patients (60%) were <65 years of age (mean 56+/-6 years) and 904 patients (40%) were >or=65 years of age (mean 72+/-5 years). Achieved treatment targets for blood pressure, low-density lipoprotein cholesterol, adherence to diet and exercise, and angina-free status did not differ by age or treatment assignment. Among older patients, there was a 2- to 3-fold higher death rate, but similar rates of myocardial infarction, stroke, and major cardiac events compared with younger patients. The addition of PCI to OMT did not improve or worsen clinical outcomes in patients>or=65 years of age during a median 4.6 year follow-up. CONCLUSIONS: These data support adherence to American College of Cardiology/American Heart Association clinical practice guidelines that advocate OMT as an appropriate initial management strategy, regardless of age. (Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation [COURAGE]; NCT00007657).

Bivalirudin as an anticoagulant for simultaneous integrated coronary artery revascularization - a novel approach to an inherent concern.

BACKGROUND: Simultaneous integrated coronary artery revascularization combines coronary artery bypass surgery and percutaneous coronary intervention into a single procedure. This approach provides immediate, complete and optimal myocardial revascularization in a less invasive manner. Because simultaneous integrated coronary revascularization necessitates two distinct anticoagulation protocols for the surgical and percutaneous aspects of the procedure, combining these anticoagulation protocols carries a bleeding risk. Using a single anticoagulant to facilitate the necessities of both aspects of the integrated approach may alleviate this risk. CASE PRESENTATION: A 45-year-old man with an occluded left anterior descending artery and a moderately stenotic circumflex artery underwent simultaneous integrated coronary revascularization. Bivalirudin was used to achieve anticoagulation for the duration of the procedure. The patient was asymptomatic with excellent patency of both the bypass graft and the stented circumflex artery via angiography at 10 months. CONCLUSION: Bivalirudin can be used to effectively achieve a unified anticoagulation protocol for simultaneous integrated revascularization.

Simultaneous integrated coronary artery revascularization with long-term angiographic follow-up.

OBJECTIVE: Traditionally integrated coronary artery revascularization has been described as a 2-stage procedure. We evaluated the safety and feasibility of 1-stage, simultaneous, hybrid, robotically assisted coronary artery bypass grafting surgery and percutaneous coronary intervention. METHODS: Fifty-eight patients underwent simultaneous, integrated coronary artery revascularization in an operating theater equipped with angiographic equipment. Forty-five patients were men. The mean age was 59 years. All internal thoracic arteries were harvested with robotic assistance. All anastomoses were manually constructed through a small anterior non-rib-spreading incision without cardiopulmonary bypass on the beating heart. Immediately after and within the same operative suite, both angiographic confirmation of graft patency and percutaneous coronary intervention were performed. In 52 patients therapeutic anticoagulation was achieved with the direct thrombin inhibitor bivalirudin. RESULTS: There were no deaths or wound infections. There was 1 perioperative myocardial infarction. One patient had a stroke, and 3 patients required re-exploration for bleeding. The median lengths of intensive care and hospital stay were 1 and 4 days, respectively. All patients were alive and symptom free at follow-up (mean, 20.2 months; range, 1.1-40.8 months). Long-term angiographic follow-up in 54 patients showed 49 (91%) patent grafts (mean, 9.0 months; range, 4.3-40.8 months). There were 7 in-stent restenoses and 2 occluded stents. CONCLUSION: For multivessel coronary artery disease, simultaneous integrated coronary artery revascularization with bivalirudin is safe and feasible. This approach enables complete multivessel revascularization with decreased surgical trauma and postoperative morbidity. Further studies are necessary to better determine patient selection and long-term outcomes.

Concurrent robotic hybrid revascularization using an enhanced operative suite.

Hybrid myocardial revascularization combines coronary surgery with percutaneous intervention as an alternative therapy for ischemic heart disease. The order and sequence of the hybrid approach is not yet clearly defined. We report on the benefits of an enhanced surgical suite equipped with a carbon fiber operating table and digital C-arm for robotic-assisted hybrid revascularization in a single operative sequence. To our knowledge, this is the first reported case of concurrent robotic-assisted hybrid revascularization utilizing an enhanced operative suite.