David Dai

Contemporary mortality risk prediction for percutaneous coronary intervention: results from 588,398 procedures in the National Cardiovascular Data Registry.

OBJECTIVES We sought to create contemporary models for predicting mortality risk following percutaneous coronary intervention (PCI). BACKGROUND There is a need to identify PCI risk factors and accurately quantify procedural risks to facilitate comparative effectiveness research, provider comparisons, and informed patient decision making. METHODS Data from 181,775 procedures performed from January 2004 to March 2006 were used to develop risk models based on pre-procedural and/or angiographic factors using logistic regression. These models were independently evaluated in 2 validation cohorts: contemporary (n = 121,183, January 2004 to March 2006) and prospective (n = 285,440, March 2006 to March 2007). RESULTS Overall, PCI in-hospital mortality was 1.27%, ranging from 0.65% in elective PCI to 4.81% in ST-segment elevation myocardial infarction patients. Multiple pre-procedural clinical factors were significantly associated with in-hospital mortality. Angiographic variables provided only modest incremental information to pre-procedural risk assessments. The overall National Cardiovascular Data Registry (NCDR) model, as well as a simplified NCDR risk score (based on 8 key pre-procedure factors), had excellent discrimination (c-index: 0.93 and 0.91, respectively). Discrimination and calibration of both risk tools were retained among specific patient subgroups, in the validation samples, and when used to estimate 30-day mortality rates among Medicare patients. CONCLUSIONS Risks for early mortality following PCI can be accurately predicted in contemporary practice. Incorporation of such risk tools should facilitate research, clinical decisions, and policy applications.

Treatments, trends, and outcomes of acute myocardial infarction and percutaneous coronary intervention.

Coronary artery disease remains a major public health problem in the U.S. as many Americans experience an acute myocardial infarction (MI) and/or undergo percutaneous coronary intervention (PCI) each year. Given the attendant risks of mortality and morbidity, acute MI remains a principal focus of

Clinical Outcomes at 1 Year Following Transcatheter Aortic Valve Replacement

IMPORTANCE Introducing new medical devices into routine practice raises concerns because patients and outcomes may differ from those in randomized trials. OBJECTIVE To update the previous report of 30-day outcomes and present 1-year outcomes following transcatheter aortic valve replacement (TAVR) in the United States. DESIGN, SETTING, AND PARTICIPANTS Data from the Society of Thoracic Surgeons/American College of Cardiology (STS/ACC) Transcatheter Valve Therapies Registry were linked with patient-specific Centers for Medicare & Medicaid Services (CMS) administrative claims data. At 299 US hospitals, 12 182 patients linked with CMS data underwent TAVR procedures performed from November 2011 through June 30, 2013, and the end of the follow-up period was June 30, 2014. EXPOSURE Transcatheter aortic valve replacement. MAIN OUTCOMES AND MEASURES One-year outcomes including mortality, stroke, and rehospitalization were evaluated using multivariate modeling. RESULTS The median age of patients was 84 years and 52% were women, with a median STS Predicted Risk of Operative Mortality (STS PROM) score of 7.1%. Following the TAVR procedure, 59.8% were discharged to home and the 30-day mortality was 7.0% (95% CI, 6.5%-7.4%) (n = 847 deaths). In the first year after TAVR, patients were alive and out of the hospital for a median of 353 days (interquartile range, 312-359 days); 24.4% (n = 2074) of survivors were rehospitalized once and 12.5% (n = 1525) were rehospitalized twice. By 1 year, the overall mortality rate was 23.7% (95% CI, 22.8%-24.5%) (n = 2450 deaths), the stroke rate was 4.1% (95% CI, 3.7%-4.5%) (n = 455 stroke events), and the rate of the composite outcome of mortality and stroke was 26.0% (25.1%-26.8%) (n = 2719 events). Characteristics significantly associated with 1-year mortality included advanced age (hazard ratio [HR] for ≥95 vs <75 years, 1.61 [95% CI, 1.24-2.09]; HR for 85-94 years vs <75 years, 1.35 [95% CI, 1.18-1.55]; and HR for 75-84 years vs <75 years, 1.23 [95% CI, 1.08-1.41]), male sex (HR, 1.21; 95% CI, 1.12-1.31), end-stage renal disease (HR, 1.66; 95% CI, 1.41-1.95), severe chronic obstructive pulmonary disease (HR, 1.39; 95% CI, 1.25-1.55), nontransfemoral access (HR, 1.37; 95% CI, 1.27-1.48), STS PROM score greater than 15% vs less than 8% (HR, 1.82; 95% CI, 1.60-2.06), and preoperative atrial fibrillation/flutter (HR, 1.37; 95% CI, 1.27-1.48). Compared with men, women had a higher risk of stroke (HR, 1.40; 95% CI, 1.15-1.71). CONCLUSIONS AND RELEVANCE Among patients undergoing TAVR in US clinical practice, at 1-year follow-up, overall mortality was 23.7%, the stroke rate was 4.1%, and the rate of the composite outcome of death and stroke was 26.0%. These findings should be helpful in discussions with patients undergoing TAVR.

Lipid levels in patients hospitalized with coronary artery disease: an analysis of 136,905 hospitalizations in Get With The Guidelines

BACKGROUND Lipid levels among contemporary patients hospitalized with coronary artery disease (CAD) have not been well studied. This study aimed to analyze admission lipid levels in a broad contemporary population of patients hospitalized with CAD. METHODS The Get With The Guidelines database was analyzed for CAD hospitalizations from 2000 to 2006 with documented lipid levels in the first 24 hours of admission. Patients were divided into low-density lipoprotein cholesterol (LDL), high-density lipoprotein cholesterol (HDL), and triglyceride categories. Factors associated with LDL and HDL levels were assessed along with temporal trends. RESULTS Of 231,986 hospitalizations from 541 hospitals, admission lipid levels were documented in 136,905 (59.0%). Mean lipid levels were LDL 104.9 +/- 39.8, HDL 39.7 +/- 13.2, and triglyceride 161 +/- 128 mg/dL. Low-density lipoprotein cholesterol <70 mg/dL was observed in 17.6% and ideal levels (LDL <70 with HDL > or =60 mg/dL) in only 1.4%. High-density lipoprotein cholesterol was <40 mg/dL in 54.6% of patients. Before admission, only 28,944 (21.1%) patients were receiving lipid-lowering medications. Predictors for higher LDL included female gender, no diabetes, history of hyperlipidemia, no prior lipid-lowering medications, and presenting with acute coronary syndrome. Both LDL and HDL levels declined over time (P < .0001). CONCLUSIONS In a large cohort of patients hospitalized with CAD, almost half have admission LDL levels <100 mg/dL. More than half the patients have admission HDL levels <40 mg/dL, whereas <10% have HDL > or =60 mg/dL. These findings may provide further support for recent guideline revisions with even lower LDL goals and for developing effective treatments to raise HDL.

Risk Score for In-Hospital Ischemic Stroke Mortality Derived and Validated Within the Get With The Guidelines–Stroke Program

Background— There are few validated models for prediction of in-hospital mortality after ischemic stroke. We used Get With the Guidelines–Stroke Program data to derive and validate prediction models for a patients risk of in-hospital ischemic stroke mortality. Methods and Results— Between October 2001 and December 2007, there were 1036 hospitals that contributed 274 988 ischemic stroke patients to this study. The sample was randomly divided into a derivation (60%) and validation (40%) sample. Logistic regression was used to determine the independent predictors of mortality and to assign point scores for a prediction model. We also separately derived and validated a model in the 109 187 patients (39.7%) with a National Institutes of Health Stroke Scale (NIHSS) score recorded. Model discrimination was quantified by calculating the C statistic from the validation sample. In-hospital mortality was 5.5% overall and 5.2% in the subset in which NIHSS score was recorded. Characteristics associated with in-hospital mortality were age, arrival mode (eg, via ambulance versus other mode), history of atrial fibrillation, previous stroke, previous myocardial infarction, carotid stenosis, diabetes mellitus, peripheral vascular disease, hypertension, history of dyslipidemia, current smoking, and weekend or night admission. The C statistic was 0.72 in the overall validation sample and 0.85 in the model that included NIHSS score. A model with NIHSS score alone provided nearly as good discrimination (C statistic 0.83). Plots of observed versus predicted mortality showed excellent model calibration in the validation sample. Conclusions— The Get With the Guidelines–Stroke risk model provides clinicians with a well-validated, practical bedside tool for mortality risk stratification. The NIHSS score provides substantial incremental information on a patients short-term mortality risk and is the strongest predictor of mortality.

Patterns and Intensity of Medical Therapy in Patients Undergoing Percutaneous Coronary Intervention

CONTEXT The Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation (COURAGE) study, which provided optimal medical therapy (OMT) to all patients and demonstrated no incremental advantage of percutaneous coronary intervention (PCI) on outcomes other than angina-related quality of life in stable coronary artery disease (CAD), suggests that a trial of OMT is warranted before PCI. It is unknown to what degree OMT is applied before PCI in routine practice or whether its use increased after the COURAGE trial. OBJECTIVE To examine the use of OMT in patients with stable angina undergoing PCI before and after the publication of the COURAGE trial. DESIGN, SETTING, AND PARTICIPANTS An observational study of patients with stable CAD undergoing PCI in the National Cardiovascular Data Registry between September 1, 2005, and June 30, 2009. Analysis compared use of OMT, both before PCI and at the time of discharge, before and after the publication of the COURAGE trial. Optimal medical therapy was defined as either being prescribed or having a documented contraindication to all medicines (antiplatelet agent, β-blocker, and statin). MAIN OUTCOME MEASURES Rates of OMT before PCI and at discharge (following PCI) between the 2 study periods. RESULTS Among all 467,211 patients (173,416 before [37.1%] and 293,795 after [62.9%] the COURAGE trial) meeting study criteria, OMT was used in 206,569 patients (44.2%; 95% confidence interval [CI], 44.1%-44.4%) before PCI and in 303,864 patients (65.0%; 95% CI, 64.9%-65.2%) at discharge following PCI (P < .001). Before PCI, OMT was applied in 75,381 patients (43.5%; 95% CI, 43.2%-43.7%) before the COURAGE trial and in 131,188 patients (44.7%; 95% CI, 44.5%-44.8%) after the COURAGE trial (P < .001). The use of OMT at discharge following PCI before and after the COURAGE trial was 63.5% (95% CI, 63.3%-63.7%) and 66.0% (95% CI, 65.8%-66.1%), respectively (P < .001). CONCLUSION Among patients with stable CAD undergoing PCI, less than half were receiving OMT before PCI and approximately two-thirds were receiving OMT at discharge following PCI, with relatively little change in these practice patterns after publication of the COURAGE trial.

Racial and Ethnic Differences in the Treatment of Acute Myocardial Infarction Findings From the Get With The Guidelines–Coronary Artery Disease Program

Background— Racial/ethnic differences in cardiovascular care have been well documented. We sought to determine whether racial/ethnic differences in evidence-based acute myocardial infarction care persist among hospitals participating in a national quality improvement program. Methods and Results— We analyzed 142 593 acute myocardial infarction patients (121 528 whites, 10 882 blacks, and 10 183 Hispanics) at 443 hospitals participating in the Get With the Guidelines-Coronary Artery Disease (GWTG-CAD) program between January 2002 and June 2007. We examined individual and overall composite rates of defect-free care, defined as the proportion of patients receiving all eligible performance measures. In addition, we examined temporal trends in use of performance measures according to race/ethnicity by calendar quarter. Overall, individual performance measure use was high, ranging from 78% for use of angiotensin-converting enzyme inhibitors to 96% for use of aspirin at discharge. Use of each of these improved significantly over the 5 years of study. Overall, defect-free care was 80.9% for whites, 79.5% for Hispanics (adjusted odds ratio versus whites 1.00, 95% confidence interval 0.94 to 1.06, P=0.94), and 77.7% for blacks (adjusted odds ratio versus whites 0.93, 95% confidence interval 0.87 to 0.98, P=0.01). A significant gap in defect-free care was observed for blacks mostly during the first half of the study, which was no longer present during the remainder of the study. Overall, progressive improvements in defect-free care were observed regardless of race/ethnic groups. Conclusions— Among hospitals engaged in a national quality monitoring and improvement program, evidence-based care for acute myocardial infarction appeared to improve over time for patients irrespective of race/ethnicity, and differences in care by race/ethnicity care were reduced or eliminated.

Clinical Effectiveness of Coronary Stents in Elderly Persons: Results From 262,700 Medicare Patients in the American College of Cardiology―National Cardiovascular Data Registry

OBJECTIVES The aim of this study was to compare outcomes in older individuals receiving drug-eluting stents (DES) and bare-metal stents (BMS). BACKGROUND Comparative effectiveness of DES relative to BMS remains unclear. METHODS Outcomes were evaluated in 262,700 patients from 650 National Cardiovascular Data Registry sites during 2004 to 2006 with procedural registry data linked to Medicare claims for follow-up. Outcomes including death, myocardial infarction (MI), revascularization, major bleeding, stroke, death or MI, death or MI or revascularization, and death or MI or stroke were compared with estimated cumulative incidence rates with inverse probability weighted estimators and Cox proportional hazards ratios. RESULTS The DES were implanted in 217,675 patients and BMS were implanted in 45,025. At 30 months, DES patients had lower unadjusted rates of death (12.9% vs. 17.9%), MI (7.3 of 100 patients vs. 10.0 of 100 patients), and revascularization (23.0 of 100 patients vs. 24.5 of 100 patients) with no difference in stroke or bleeding. After adjustment, DES patients had lower rates of death (13.5% vs. 16.5%, hazard ratio [HR]: 0.75, 95% confidence interval [CI]: 0.72 to 0.79, p < 0.001) and MI (7.5 of 100 patients vs. 8.9 of 100 patients, HR: 0.77, 95% CI: 0.72 to 0.81, p < 0.001), with minimal difference in revascularization (23.5 of 100 patients vs. 23.4 of 100 patients; HR: 0.91, 95% CI: 0.87 to 0.96), stroke (3.1 of 100 patients vs. 2.7 of 100 patients, HR: 0.97, 95% CI: 0.88 to 1.07), or bleeding (3.4 of 100 patients vs. 3.6 of 100 patients, HR: 0.91, 95% CI: 0.84 to 1.00). The DES survival benefit was observed in all subgroups analyzed and persisted throughout 30 months of follow-up. CONCLUSIONS In this largest ever real-world study, patients receiving DES had significantly better clinical outcomes than their BMS counterparts, without an associated increase in bleeding or stroke, throughout 30 months of follow-up and across all pre-specified subgroups.

Discharge to a Skilled Nursing Facility and Subsequent Clinical Outcomes Among Older Patients Hospitalized for Heart Failure

Background— Heart failure (HF) is the leading cause of hospitalization among older Americans. Subsequent discharge to skilled nursing facilities (SNF) is not well described. Methods and Results— We performed an observational analysis of Medicare beneficiaries ≥65 years of age, discharged alive to SNF or home after ≥3-day hospitalization for HF in 2005 and 2006 within the Get With The Guidelines–HF Program. Among 15 459 patients from 149 hospitals, 24.1% were discharged to an SNF, 22.3% to home with home health service, and 53.6% to home with self-care. SNF use varied significantly among hospitals (median, 10.2% versus 33.9% in low versus high tertiles), with rates highest in the Northeast. Patient factors associated with discharge to SNF included longer length of stay, advanced age, female sex, hypotension, higher ejection fraction, absence of ischemic heart disease, and a variety of comorbidities. Performance measures were modestly lower for patients discharged to SNF. Unadjusted absolute event rates were higher at 30 days (death, 14.4% versus 4.1%; rehospitalization, 27.0% versus 23.5%) and 1 year (death, 53.5% versus 29.1%; rehospitalization, 76.1% versus 72.2%) after discharge to SNF versus home, respectively (P<0.0001 for all). After adjustment for measured patient characteristics, discharge to SNF remained associated with increased death (hazard ratio, 1.76; 95% confidence interval, 1.66 to 1.87) and rehospitalization (hazard ratio, 1.08; 95% confidence interval, 1.03 to 1.14). Conclusions— Discharge to SNF is common among Medicare patients hospitalized for HF, and these patients face substantial risk for adverse events, with more than half dead within 1 year. These findings highlight the need to better characterize this unique patient population and understand the SNF care they receive.

Prevalence and predictors of nonobstructive coronary artery disease identified with coronary angiography in contemporary clinical practice

BACKGROUND Guidelines recommend noninvasive tests (NITs) to risk stratify and identify patients with higher likelihood of coronary artery disease (CAD) prior to elective coronary angiography. However, a high percentage of patients are found to have nonobstructive CAD. We aimed to understand the relationship between patient characteristics, NIT findings, and the likelihood of nonobstructive CAD. METHODS Patients undergoing elective catheterization without history of CAD were identified from 1,128 hospitals in National Cardiovascular Data Registrys CathPCI Registry between July 2009 and December 2011. Noninvasive tests included stress electrocardiogram, stress echocardiogram, stress radionuclide, stress cardiac magnetic resonance, and computed tomographic angiography. Patient demographics, risk factors, symptoms, and NIT results were correlated with the presence of nonobstructive CAD, defined as all native coronary stenoses <50%. RESULTS Of 661,063 patients undergoing elective angiography, 386,003 (58.4%) had nonobstructive CAD. Preprocedure NIT was performed in 64% of patients; 51.9% were reported to be abnormal, but only 9% had high-risk findings. Independent factors associated with nonobstructive CAD were younger age, female sex, atypical chest pain, and a low-risk NIT. Patients with high-risk findings on NIT were more likely to have obstructive CAD (adjusted odds ratio 3.03 [2.86-3.22]). Noninvasive test findings had minimal incremental value beyond clinical factors for predicting obstructive disease (C index = 0.75 for clinical factors vs 0.74 for NIT findings). CONCLUSION In current practice, about two-thirds of patients undergo NIT prior to elective cardiac catheterization, yet most patients have nonobstructive CAD. The weak correlation between most NIT results and the likelihood of obstructive CAD provides further impetus for improving preangiography assessment of likelihood of disease.