Prevalence and association of the Wellens' sign with coronary artery disease in an ethnically diverse urban population.

BACKGROUND: Wellens' sign is considered to be an ominous sign indicative of underlying significant proximal left anterior descending artery stenosis. We sought to identify the prevalence of the Wellens' pattern in a large ethnically diverse urban population and assess its association with the presence and extent of coronary artery disease. METHODS: We utilized the MUSE ECG database of Montefiore Medical Center, an academic tertiary health care system, to identify ECGs from 2012 to 2019 exhibiting a Wellens' pattern. From a dataset of 1.76 million tracings, six screening diagnosis codes were selected to approximate the Wellens' pattern. These codes were used to generate a cohort of ECGs for manual review by a board certified cardiologist to determine if a Wellens' pattern was present. RESULTS: Of 1,756,742 ECGs performed on 433,218 patients from 2012 to 2019; after initial screening 2186 ECGs were identified for manual review. Of these, 448 (0.1%) patients were confirmed to have a Wellens' pattern. 229 patients underwent cardiac catheterization, while 219 patients were managed medically. No statistical difference was seen in the occurrence of Wellens' Type A and B pattern across the ethnic groups after multivariate analysis. Women were more likely to have Type B Wellens' compared to men (OR 2.40 (1.58, 3.62) P < 0.0001). 80 (35%) patients had single vessel LAD disease of which 22 (10%) had proximal, 40 (17%) had mid, 4 (1%) had distal stenosis, while diffuse LAD disease was seen in 14 (6%) patients. Two vessel disease was seen in 46 (20%) patients with a Wellens' pattern, and triple vessel disease was seen in 23 (10%) patients. Of note, 71 (31%) patients had either normal or nonobstructive coronary disease despite exhibiting a Wellens' pattern ECG. CONCLUSION: Wellens' sign is a rare electrocardiographic pattern which when seen in a patient with an appropriate clinical presentation, suggests but is not definitive for the presence of significant coronary disease, often but not exclusively in an LAD distribution. We found no statistical difference in the occurrence of Wellens' sign among different racial/ethnic groups. Patients with a Wellens' pattern may have critical lesions at a variety of LAD sites as well as in multiple vessels. As such, the interventionalist needs to be prepared for these uncertainties at the time of cardiac catheterization.

Rosiglitazone and outcomes for patients with diabetes mellitus and coronary artery disease in the Bypass Angioplasty Revascularization Investigation 2 Diabetes (BARI 2D) trial.

BACKGROUND: Rosiglitazone improves glycemic control for patients with type 2 diabetes mellitus, but there remains controversy regarding an observed association with cardiovascular hazard. The cardiovascular effects of rosiglitazone for patients with coronary artery disease remain unknown. METHODS AND RESULTS: To examine any association between rosiglitazone use and cardiovascular events among patients with diabetes mellitus and coronary artery disease, we analyzed events among 2368 patients with type 2 diabetes mellitus and coronary artery disease in the Bypass Angioplasty Revascularization Investigation 2 Diabetes (BARI 2D) trial. Total mortality, composite death, myocardial infarction, and stroke, and the individual incidence of death, myocardial infarction, stroke, congestive heart failure, and fractures, were compared during 4.5 years of follow-up among patients treated with rosiglitazone versus patients not receiving a thiazolidinedione by use of Cox proportional hazards and Kaplan-Meier analyses that included propensity matching. After multivariable adjustment, among patients treated with rosiglitazone, mortality was similar (hazard ratio [HR], 0.83; 95% confidence interval [CI], 0.58-1.18), whereas there was a lower incidence of composite death, myocardial infarction, and stroke (HR, 0.72; 95% CI, 0.55-0.93) and stroke (HR, 0.36; 95% CI, 0.16-0.86) and a higher incidence of fractures (HR, 1.62; 95% CI, 1.05-2.51); the incidence of myocardial infarction (HR, 0.77; 95% CI, 0.54-1.10) and congestive heart failure (HR, 1.22; 95% CI, 0.84-1.82) did not differ significantly. Among propensity-matched patients, rates of major ischemic cardiovascular events and congestive heart failure were not significantly different. CONCLUSIONS: Among patients with type 2 diabetes mellitus and coronary artery disease in the BARI 2D trial, neither on-treatment nor propensity-matched analysis supported an association of rosiglitazone treatment with an increase in major ischemic cardiovascular events. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00006305.

Prediction of length of stay following elective percutaneous coronary intervention.

There have been published risk stratification approaches to predict complications following percutaneous coronary interventions (PCI). However, a formal assessment of such approaches with respect to predicting length of stay (LOS) is lacking. Therefore, we sought to assess the performance of, an easy-to-use, tree-structured prognostic classification model in predicting LOS among patients with elective PCI. The study is based on the New York State PCI database. The model was developed on data for 1999-2000, consisting of 67,766 procedures. Validation was carried out, with respect to LOS, using data for 2001-2002, consisting of 79,545 procedures. The risk groups identified by the model exhibited a strong progressively increasing relative risk pattern of longer LOS. The predicted average LOS ranged from 3 to 9 days. The performance of this model was comparable to other published risk scores. In conclusion, the tree-structured prognostic classification is a model which can be easily applied to aid practitioners early on in their decision process regarding the need for extra resources required for the management of more complicated patients following PCI, or to justify to payors the extra costs required for the management of patients who have required extended observation and care after PCI.

Improving primary percutaneous coronary intervention performance in an urban minority population using a quality improvement approach.

It has been well established that there are racial and ethnic disparities in cardiovascular care. Quality improvement initiatives have been recommended to proactively address these disparities. An initiative was implemented to improve timeliness of and access to primary percutaneous coronary intervention (PCI) procedures among myocardial infarction patients at an academic medical center serving a predominantly minority population. The effort was part of a national quality improvement collaborative focused on improving cardiovascular care for Hispanic/Latino and African American/ black populations. The proportion of primary PCI procedures performed within 90 minutes improved significantly from 17% in the first quarter of 2006 to 93% in the fourth quarter of 2008 (P < .001). There were no significant differences in the frequency with which Hispanic/Latino or African American/black patients received primary PCI therapy in comparison to nonmembers of these groups. Quality improvement techniques can improve the quality of and access to acute cardiovascular care for minority populations.

A simple prognostic classification model for postprocedural complications after percutaneous coronary intervention for acute myocardial infarction (from the New York State percutaneous coronary intervention database).

Previous postprocedural complications risk scores have shown very good performance. However, the need for real-time risk score computation makes their implementation in an emergency situation challenging. Therefore, we developed an easy-to-use prognostic classification model for postprocedural complications after early percutaneous coronary intervention for acute myocardial infarction. The model was developed on the New York State percutaneous coronary intervention database for 1999 to 2000 (consisting of 5,385 procedures) and was validated using the subsequent 2001 to 2002 database (consisting of 7,414 procedures). Tree-structured prognostic classification identified 4 key presenting features: cardiogenic shock, congestive heart failure, age, and diabetes. In the validation database, the model identified patient groups with postprocedural complications rates ranging from 1.0% to 22.8%, >22-fold increased risk. The performance of this model was similar to the Mayo Clinic and another recently published risk scores with a discrimination capacity of 78% (95% confidence interval, 75%, 80%). In conclusion, patients undergoing percutaneous coronary intervention for acute myocardial infarction can be readily stratified into distinct prognostic classes using the tree-structured model.

Effect of physician volume on the relationship between hospital volume and mortality during primary angioplasty.

OBJECTIVES: We sought to examine the combined effect of hospital and physician volume of primary percutaneous coronary intervention (PCI) on in-hospital mortality. BACKGROUND: An inverse relationship between volume and outcome has been observed for both hospitals and physicians after primary PCI for acute myocardial infarction. METHODS: Using the New York State PCI registry, we examined yearly hospital volume, physician volume, and risk-adjusted mortality in 7,321 patients undergoing primary PCI for acute myocardial infarction. Risk-adjusted mortality rates for high-volume hospitals (>50 cases/year) and high-volume physicians (>10 cases/year) were compared with their respective low-volume counterparts. RESULTS: Primary PCI by high-volume hospitals (odds ratio [OR]: 0.58; 95% confidence interval [CI]: 0.38 to 0.88) and high-volume physicians (OR: 0.66; 95% CI: 0.48 to 0.92) was associated with lower odds of mortality. Furthermore, there was a significant interaction between hospital and physician volume on adjusted mortality (p = 0.02). Although unadjusted mortality was lower when primary PCI was performed by high-volume physicians in high-volume hospitals compared with low-volume physicians in low-volume hospitals (3.2% vs. 6.7%, p = 0.03), the risk-adjusted mortality rate was not statistically significant (3.8% vs. 8.4%, p = 0.09). In low-volume hospitals, the average risk-adjusted mortality rate for low-volume physicians was 8.4% versus 4.8% for high-volume physicians (OR: 1.44; 95% CI: 0.68 to 3.03). However, in high-volume hospitals, the risk-adjusted mortality rate for high-volume physicians was 3.8% versus 6.5% for low-volume physicians (OR: 0.58; 95% CI: 0.39 to 0.86). CONCLUSIONS: During primary PCI, physician experience significantly modifies the hospital volume-outcome relationship. Therefore, policymakers need to consider physician experience when developing strategies to improve access to primary PCI.

Completeness of revascularization for multivessel coronary artery disease and its effect on one-year outcome: a report from the NHLBI Dynamic Registry.

When percutaneous coronary intervention (PCI) is performed in patients with multivessel coronary disease, a targeted revascularization (TR) of diseased vessels is performed more often than complete revascularization (CR). We compared baseline characteristics and 1-year outcomes of patients undergoing TR by operator choice (n = 1,091), TR because CR was unachievable (n = 375), and CR (n = 315) in the National Heart, Lung, and Blood Institute (NHLBI) Dynamic Registry. Patients receiving TR because CR was unachievable were older, had more comorbidities, worse ejection fraction, less often received 2b/3a inhibitors and stents, and less frequently achieved complete angiographic success than either patients receiving TR by choice or CR. Despite these considerable differences, cumulative rates of 1-year mortality, the need for repeat PCI, or coronary bypass surgery were similar in patients who received CR, TR by choice, or TR because CR was unachievable. In multivariable models, after adjustment for clinical characteristics and propensity to receive CR, the hazard ratio for CR versus TR was 1.10 (95% CI: 0.58-2.10) for 1-year mortality; 0.89 (0.60-1.32) for repeat PCI, and 0.92 (0.66-1.29) for repeat PCI or coronary bypass surgery. In conclusion, despite the presence of more unfavorable characteristics, patients undergoing TR demonstrate 1-year outcomes equivalent to those having CR, supporting its continued use in selected patients.

Tree-structured risk stratification of in-hospital mortality after percutaneous coronary intervention for acute myocardial infarction: a report from the New York State percutaneous coronary intervention database.

BACKGROUND: Previous risk scores have shown excellent performance. However, the need for real-time risk score computation makes their implementation in an emergent situation challenging. A more simplified approach can provide practitioners with a practical bedside risk stratification tool. METHODS: We developed an easy-to-use tree-structured risk stratification model for patients undergoing early percutaneous coronary intervention (PCI) for acute myocardial infarction. The model was developed on the New York State PCI database for 1999 to 2000 (consisting of 5385 procedures) and was validated using the subsequent 2001 to 2002 database (consisting of 7414 procedures). RESULTS: Tree-structured modeling identified 3 key presenting features: cardiogenic shock, congestive heart failure, and age. In the validation data set, this risk stratification model identified patient groups with in-hospital mortality ranging from 0.5% to 20.6%, more than a 20-fold increased risk. The performance of this model was similar to the Mayo Clinic Risk Score with a discriminative capacity of 82% (95% confidence interval, 79%-84%) versus 80% (95% confidence interval, 77%-82%), respectively. CONCLUSION: Patients undergoing PCI for acute myocardial infarction can be readily stratified into risk categories using the tree-structured model. This provides practicing cardiologists with an internally validated and easy-to-use scheme for in-hospital mortality risk stratification.

Persistent sex difference in hospital outcome following percutaneous coronary intervention: results from the New York State reporting system.

BACKGROUND: Although sex-related differences in early outcomes have been observed in young women following acute myocardial infarction (AMI) and coronary bypass surgery, evidence for similar differences following percutaneous coronary intervention (PCI) is lacking. METHODS: Using the 1999 to 2002 New York State PCI reporting system, we identified 11,162 men and 2,561 women aged 50 years or younger undergoing a first PCI procedure. In-hospital outcomes were compared by gender after multivariable adjustment for baseline, clinical and procedural characteristics. RESULTS: Young women undergoing an initial PCI procedure were more likely to belong to racial or ethnic minorities and exhibit more comorbidities than young men. However, they had better ejection fraction (52.9% +/- 11.3 vs. 51.9 +/- 11; p = 0.0002) and presented more often with single-vessel disease (75% vs. 67%; p < 0.0001). Despite women receiving glycoprotein IIb/IIIa inhibitors (58.6% vs. 65.1%; p < 0.0001) and stents (92.5% vs. 94.9%; p < 0.0001) less often, procedural success was achieved equally (97% vs. 96%). Young women experienced higher rates of in-hospital mortality (0.70% vs. 0.22%; p < 0.0001), and vascular damage (0.82% vs. 0.24%; p < 0.0001) compared to men. In multivariable analysis, female sex independently predicted in-hospital mortality (OR 4.0, 95% CI: 1.9 to 8.1) after adjustment for urgency of PCI, clinical and procedural characteristics. CONCLUSION: A gender-based difference in early survival exists in young women undergoing a first PCI procedure. Further investigation into the mechanism of this higher risk is warranted.

Effectiveness of glycoprotein IIb/IIIa inhibitor use during primary coronary angioplasty: results of propensity analysis using the New York State Percutaneous Coronary Intervention Reporting System.

Patients undergoing primary angioplasty in clinical practice experience a higher risk for adverse events than those enrolled in clinical trials. Whether glycoprotein (GP) IIb/IIIa inhibitor use during primary angioplasty is both safe and effective in real life is unknown. Therefore, we examined the pattern of GP IIb/IIIa use and its effectiveness in a large population-based cohort of 7,321 patients who underwent primary angioplasty in New York State. Propensity analysis was used to account for the nonrandomized use of GP IIb/IIIa inhibitors. Overall, 78.5% of patients who underwent primary angioplasty received GP IIb/IIIa inhibitors. In-hospital mortality was significantly lower with GP IIb/IIIa use (3% vs 6.2%, p <0.0001) after adjustment for both propensity score (odds ratio 0.57, 95% confidence interval 0.44 to 0.74, p <0.0001) and the combination of propensity score and clinical characteristics (odds ratio 0.63, 95% confidence interval 0.45 to 0.88, p = 0.006). Patients with older age and higher Mayo Clinic Risk Score (MCRS) received GP IIb/IIIa inhibitors less often. However, stratified analysis of patients with low to moderate risk (MCRS <12) versus high risk (>or=12) demonstrated that GP IIb/IIIa use lowered risk of mortality both in low- to moderate-risk (1.39% vs 3.23%, p <0.0001) and high-risk patients (16.15% vs 22.41%, p = 0.03). In conclusion, adjunct GP IIb/IIIa inhibitor use during primary angioplasty is effective and associated with improved in-hospital survival rates.

Specimen processing time and measurement of total insulin-like growth factor-I (IGF-I), free IGF-I, and IGF binding protein-3 (IGFBP-3).

BACKGROUND: An increasing number of epidemiologic studies are investigating the relationship between serum levels of insulin-like growth factor-I (IGF-I) and IGF binding proteins (IGFBPs) and risk of cancer, cardiovascular disease, and other diseases. However, little is known regarding the effects of blood specimen processing time on measured levels of total and free IGF-I, and on IGFBP-3, the major binding protein. DESIGN: Two serum separation tubes were collected from each of 12 subjects. One tube was centrifuged as soon as possible following blood collection (a mean of 47 min; range=30-80 min), and serum aliquots were placed into -70 degrees C storage either shortly after centrifugation, or following 2, 4, 10, or 24 h at ambient temperature (measured from the time of blood draw). The second serum separation tube was maintained at ambient temperature for 24h before centrifugation and freezing. Total IGF-I, free IGF-I, and IGFBP-3 levels were determined using commercial enzyme linked immunosorbent assays (ELISAs) commonly employed in epidemiologic studies. The effects of time until centrifugation and freezing on seroassay results were evaluated using generalized estimating equation (GEE) linear regression models and Spearman correlation. RESULTS: Total IGF-I and IGFBP-3 levels did not vary significantly with the amount of time at ambient temperature following centrifugation, even up to 24 h, in blood specimens that were centrifuged soon after collection (all pchi2). However, free IGF-I levels increased significantly with increasing time intervals between centrifugation and freezing in these same specimens (ptrend <0.001). Total IGF-I/IGFBP-3 molar ratio, a crude measure of free IGF-I levels, showed no clear association. In blood specimens that were not centrifuged for 24h, total IGF-I, free IGF-I, and IGFBP-3 were each significantly elevated (each pchi2) compared with results in blood specimens that were centrifuged and frozen soon after collection, whereas the total IGF-I/IGFBP-3 molar ratio was decreased pchi2. Nonetheless, all total IGF-I, free IGF-I, IGFBP-3, and total IGF-I/IGBFBP-3 molar ratio values altered by delays in processing were highly correlated with the values in specimens processed as soon as possible (all Spearman rank correlation coefficients 0.84). CONCLUSIONS: Total IGF-I and IGFBP-3 can be fairly stably measured in serum with commonly used commercial assays regardless of the interval between blood collection and freezing, up to at least 24 h, as long as centrifugation and serum aliquoting take place shortly after blood collection. Free IGF-I levels, however, increase steadily with the time interval until freezing, even if serum separation has been completed soon after blood collection. Because the altered serum values are highly correlated with the referent values, analysis of total IGF-I, free IGF-I, IGFBP-3, and total IGF-I/IGFBP-3 molar ratio data by quartile might help mitigate concerns regarding the effects of delays in processing time.

The Mayo Clinic Risk Score predicts in-hospital mortality following primary angioplasty.

BACKGROUND: The Mayo Clinic Risk Score (MCRS) is a validated numeric score that predicts outcome following primary percutaneous coronary intervention (PCI). PURPOSE: We evaluated the ability of MCRS to risk stratify patients undergoing primary angioplasty. METHODS: Patients undergoing primary angioplasty within 6 hours of the onset of chest pain in the New York State percutaneous coronary intervention reporting system (n = 3,005) had their MCRS calculated using predictive variables: age, presence of cardiogenic shock, renal failure, class III-IV congestive heart failure, left main coronary disease and multivessel coronary disease. All patients were presumed to have intra-coronary thrombus and undergoing an urgent/emergent procedure. Based on the MCRS, patients were classified into five risk categories: very low-risk (MCRS < 5), low risk (6-8), moderate (9-11), high (12-14) and very high risk (15-25). RESULTS: The mean age of the study population was 62 years, 70% were male; stents were used in 89% and glycoprotein IIb/IIIa antagonists in 72%. The prevalence of cardiogenic shock, multivessel disease and left main disease was higher in patients with MCRS > 12. Overall in-hospital mortality following primary angioplasty was 4.7%; it was 0% in the very low-risk category, 0.9% in the low-risk category, 3.2% in the moderate-risk category, 10.7% in the high-risk category, and 25.1% in the very high-risk category (p < 0.0001). The higher-risk MCRS category predicted increased risk even when 317 (10.5%) patients with cardiogenic shock were excluded from the analysis. The overall c-statistic for the prediction of in-hospital mortality by MCRS was 0.85. CONCLUSION: Increasing MCRS predicts in-hospital mortality following primary angioplasty.

Physicians' perceptions of the effect of nonclinical factors on coronary revascularization.

The main objective of this study was to determine if physicians perceive that extracardiac or nonclinical factors such as patients' financial status, lifestyle, or trust in the physician impact coronary revascularization decisions. A self-administered questionnaire was developed and mailed to a random sample of 1200 family physicians, internists, cardiologists, and cardiothoracic surgeons who were active members of well-respected medical organizations in the United States. Survey questions were rated on a 4- and 5-point Likert scale to determine whether physicians perceive that nonclinical factors impede or facilitate coronary revascularization, respectively. The survey response rate was 70%. Family physicians were most likely to perceive that unhealthy lifestyle (51%), financial barriers (48%), and lack of social support (31%) probably or definitely precluded revascularization. White physicians (52%) were more likely to perceive that distrust in the physician affected revascularization, compared with black (33%), Hispanic (38%) and Asian (40%) physicians. Mean responses regarding how often (1 = rarely to 5 = most of the time) nonclinical factors facilitate revascularization revealed that women and Hispanic physicians were more likely to perceive male patients had easier access to the procedure (mean response, 2.8 for women versus 2.1 for men; 2.8 for Hispanics versus 2.4 for blacks and 2.1 for whites). Physicians perceived that nonclinical factors influence decision making for coronary revascularization. What needs to be further explored is whether such factors affect actual patient outcomes or contribute to disparities in the utilization of cardiac interventions.

Elevated levels of Factor XI are associated with cardiovascular disease in women.

Coronary artery disease (CAD) continues to be the most frequent cause of death among women in the United States. Although elevated levels of clotting factors have been associated with CAD, few of these studies have been performed in women. Elevated levels of Factor XI have previously been associated with venous thrombosis, but little is known about its effect on arterial thrombosis. We selected women referred for cardiac catheterization who were found to have either normal coronaries or evidence of severe CAD and compared levels of homocysteine, anticardiolipin IgG/IgM antibodies, fibrinogen, platelet count, Factor VII, Factor VIII and Factor XI. Women with severe CAD had significantly higher levels of Factor XI than those without CAD (128% vs. 82%, p<0.04). Statistical adjustment for age, diabetes, hypertension, total cholesterol (TC), current smoking, or BMI had no effect on the independent association between CAD status and Factor XI. Factor XI was higher in women with total cholesterol levels >6.18 mmol/l (>239 mg/dl) compared with normocholesteremic women and was also higher in the upper tertile of age, but even when adjusted for these, the association remained significant. This initial study suggests that Factor XI may be an important parameter in arterial as well as venous thrombosis.