Comparison of Characteristics and Outcomes of Veterans With Stable Ischemic Heart Disease Enrolled in the COURAGE Trial Versus the Veterans Affairs Clinical Assessment, Reporting, and Tracking Program.

Randomized clinical trials have not demonstrated a survival benefit with percutaneous coronary intervention in stable ischemic heart disease (SIHD). We evaluated the generalizability of the COURAGE (Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation) trial findings to the broader population of veterans with SIHD. Veterans who underwent coronary angiography between 2005 and 2013 for SIHD were identified from the Veterans Affairs Clinical Assessment, Reporting and Tracking Program (VA CART). Patient-level comparisons were made between patients from VA CART who met the eligibility criteria for COURAGE and veterans enrolled in COURAGE between 1999 and 2004. All-cause mortality over long-term follow-up was assessed using Cox proportional hazards models. COURAGE-eligible patients from VA CART (n = 59,758) were older, had a higher body mass index, a greater prevalence of co-morbidities, but fewer diseased vessels on index coronary angiography, and were less likely to be on optimal medical therapy at baseline and on 1-year follow-up compared with VA COURAGE participants (n = 968). Patients from VA CART (median follow-up 6.5 years) had higher all-cause mortality (adjusted hazard ratio [aHR] 1.98 [1.61 to 2.43]) than participants from VA COURAGE (median follow-up: 4.6 years). Risks of mortality were greater in the 56.4% patients from CART who were medically managed (aHR 1.94 [1.49 to 2.53]) and in the 43.6% who underwent percutaneous coronary intervention (aHR 1.99 [1.45 to 2.74]), compared with their respective VA COURAGE arms. In conclusion, in this noncontemporaneous patient-level analysis, veterans in the randomized COURAGE trial had more favorable outcomes than the population of veterans with SIHD at large.

Patterns and outcomes of invasive management of type 2 myocardial infarction in the United States.

BACKGROUND: Type 2 myocardial infarction (MI) occurs due to a mismatch in myocardial oxygen supply and demand without unstable coronary artery disease. We sought to identify patterns, predictors and outcomes of invasive management of type 2 MI in the USA. METHODS: Adults aged ≥18 years hospitalized with type 2 MI were identified in a cross-sectional study from the 2018 National Inpatient Sample. Invasive management was defined as invasive coronary angiography or revascularization. Patient, hospital and geographic characteristics associated with invasive management were identified by multivariable logistic regression. Propensity-matched cohorts were generated to evaluate associations between invasive vs. conservative management and mortality. RESULTS: We identified 268 850 admissions with type 2 MI in 2018. Type 2 MI patients had a high burden of comorbidities and were commonly admitted with diagnoses of circulatory (39.7%), infectious (23.1%) or respiratory (10.8%) illness. Only 11.2% of type 2 MI were managed invasively, of which 17.9% underwent coronary revascularization. Odds of invasive management were higher with commercial insurance [adjusted OR (aOR) 1.39; 95% confidence interval (CI), 1.27-1.52] and lower with Medicaid (aOR 0.86; 95% CI, 0.76-0.96) vs. Medicare. Significant heterogeneity in invasive management of type 2 MI was observed by geographic region (range 7.2-13.8%), independent of patient and hospital factors. Invasive management was associated with lower in-hospital mortality than conservative management overall (3.9 vs. 9.1%; P < 0.001) and in propensity-matched analyses (OR, 0.70; 95% CI, 0.59-0.84). CONCLUSION: Invasive management of type 2 MI varies by insurance status and geography, highlighting uncertainty regarding optimal management and potential disparities in clinical care.

Sex-Based Differences in Outcomes With Percutaneous Transcatheter Repair of Mitral Regurgitation With the MitraClip System: Transcatheter Valve Therapy Registry From 2011 to 2017.

BACKGROUND: Women have a higher rate of adverse events after mitral valve surgery. We sought to evaluate whether outcomes after transcatheter edge-to-edge repair intervention by sex have similar trends to mitral valve surgery. METHODS: The primary outcome was 1-year major adverse events defined as a composite of all-cause mortality, stroke, and any bleeding in the overall study cohort. Patients who underwent transcatheter edge-to-edge repair for mitral regurgitation with the MitraClip system in the Society of Thoracic Surgery/American College of Cardiology Transcatheter Valve Therapy registry were evaluated. Linked administrative claims from the Centers for Medicare and Medicaid Services were used to evaluate 1-year clinical outcomes. Associations between sex and outcomes were evaluated using a multivariable logistic regression model for in-hospital outcomes and Cox model for 1-year outcomes. RESULTS: From November 2013 to March 2017, 5295 patients, 47.6% (n=2523) of whom were female, underwent transcatheter edge-to-edge repair. Females were less likely to have >1 clip implanted (P<0.001) and had a lower adjusted odds ratio of device success (adjusted odds ratio, 0.78 [95% CI, 0.67-0.90]), driven by lower odds of residual mitral gradient <5 mm Hg (adjusted odds ratio, 0.54 [CI, 0.46-0.63]) when compared with males. At 1-year follow-up, the primary outcome did not differ by sex. Female sex was associated with lower adjusted 1-year risk of all-cause mortality (adjusted hazard ratio, 0.80 [CI, 0.68-0.94]), but the adjusted 1-year risk of stroke and any bleeding did not differ by sex. CONCLUSIONS: No difference in composite outcome of all-cause mortality, stroke, and any bleeding was observed between females and males. Adjusted 1-year all-cause mortality was lower in females compared with males.

Cost of coronary syndrome treated with percutaneous coronary intervention and 30-day unplanned readmission in the United States.

OBJECTIVES: This study aimed to examine the cost of coronary syndrome treated with percutaneous coronary intervention (PCI) and 30-day unplanned readmissions. BACKGROUND: There is limited understanding of the hospital cost of index PCI and 30-day unplanned readmissions. METHODS: Patients undergoing PCI between 2010 and 2014 in the U.S. Nationwide Readmission Database were included. The primary outcome was total cost defined by cost of index PCI and first unplanned readmission within 30 days. RESULTS: This analysis included 2,294,244 patients who underwent PCI, and the mean cost was $23,541 ± $20,730 (~$10.8 billion/year). There was a modest increase in cost over the study years of 17.5%. Of the 9.4% with an unplanned readmission within 30 days, the mean total cost was $35,333 ± 24,230 versus $22,323 ± 19,941 for those not readmitted. The variables most strongly associated with the highest quartile of cost were heart failure (adjusted odds ratio (aOR) 25.60 [95% CI 21.59-30.35]), need for circulatory support (aOR 11.62 [10.13-13.32]), periprocedural coronary artery bypass graft (CABG, aOR 585.08 [357.85-956.58]), and readmission within 30 days (aOR 24.49 [22.40-26.77]). An acute kidney injury (AKI; 8.5%), major bleed (0.8%), vascular injury (0.8%), or need for periprodedural CABG (1.4%) had an average increased cost of $21,935; $30,898; $27,875; and $43,005, respectively, compared to PCI without adverse outcome. CONCLUSIONS: The annual 30-day hospital cost of PCI is approximately $10.8 billion, and the costs associated with in-hospital adverse events, particularly the need for AKI and periprocedural CABG, were significant.

The IMPact on Revascularization Outcomes of intraVascular ultrasound-guided treatment of complex lesions and Economic impact (IMPROVE) trial: Study design and rationale.

Intravascular ultrasound (IVUS)-guided percutaneous coronary intervention (PCI) has been shown in clinical trials, registries, and meta-analyses to reduce recurrent major adverse cardiovascular events after PCI. However, IVUS utilization remains low. An increasing number of high-risk or complex coronary artery lesions are treated with PCI, and we hypothesize that the impact of IVUS in guiding treatment of these complex lesions will be of increased importance in reducing major adverse cardiovascular events while remaining cost-effective. The "IMPact on Revascularization Outcomes of intraVascular ultrasound-guided treatment of complex lesions and Economic impact" trial (registered on clinicaltrials.gov: NCT04221815) is a multicenter, international, clinical trial randomizing subjects to IVUS-guided versus angiography-guided PCI in a 1:1 ratio. Patients undergoing PCI involving a complex lesion are eligible for enrollment. Complex lesion is defined as involving at least 1 of the following characteristics: chronic total occlusion, in-stent restenosis, severe coronary artery calcification, long lesion (≥28 mm), or bifurcation lesion. The clinical investigation will be conducted at approximately 120 centers in North America and Europe, enrolling approximately 2,500 to 3,100 randomized subjects with an adaptive design. The primary clinical end point is the rate of target vessel failure at 12 months, defined as the composite of cardiac death, target vessel-related myocardial infarction, and ischemia-driven target vessel revascularization. The co-primary imaging end point is the final post-PCI minimum stent area assessed by IVUS. The primary objective of this study is to assess the impact of IVUS guidance on the PCI treatment of complex lesions.

Relative Costs of Surgical and Transcatheter Aortic Valve Replacement and Medical Therapy.

BACKGROUND: The number of patients treated for aortic valve disease in the United States is increasing rapidly. Transcatheter aortic valve replacement (TAVR) is supplanting surgical aortic valve replacement (SAVR) and medical therapy (MT). The economic implications of these trends are unknown. Therefore, we undertook to determine the costs, inpatient days, and number of admissions associated with treating aortic valve disease with SAVR, TAVR, or MT. METHODS: Using the Nationwide Readmissions Database, we identified patients with aortic valve disease admitted 2012 to 2016 for SAVR, TAVR, and disease symptoms (congestive heart failure, unstable angina, non-ST-elevation myocardial infarction, syncope). Patients not undergoing SAVR or TAVR were classified as receiving MT. Beginning with the index admission, we estimated inpatient costs, days, and admissions over 6 months. RESULTS: Among 190 563 patients with aortic valve disease, the average aggregate 6-month inpatient costs were $59 743 for SAVR, $64 395 for TAVR, and $23 460 for MT. Mean index admission was longer for SAVR (10.0 days) than for TAVR (7.0 day) or MT (5.3 days), but the average number of unplanned readmission inpatient days was 2.0 for SAVR, 3.0 for TAVR, and 4.3 for MT; the average number of total admissions was 1.3 for SAVR, 1.5 for TAVR, and 1.7 for MT (P<0.01 for all). TAVR index admission costs decreased over time to become similar to SAVR costs by 2016. CONCLUSIONS: Aggregate costs were higher for TAVR than SAVR and were significantly more expensive than MT alone. However, TAVR costs decreased over time while SAVR and MT costs remained unchanged.

Timing and Causes of Unplanned Readmissions After Percutaneous Coronary Intervention: Insights From the Nationwide Readmission Database.

OBJECTIVES: The aim of this study was to describe the rates and causes of unplanned readmissions at different time periods following percutaneous coronary intervention (PCI). BACKGROUND: The rates and causes of readmission at different time periods after PCI remain incompletely elucidated. METHODS: Patients undergoing PCI between 2010 and 2014 in the U.S. Nationwide Readmission Database were evaluated for the rates, causes, predictors, and costs of unplanned readmission between 0 and 7 days, 8 and 30 days, 31 and 90 days, and 91 and 180 days after index discharge. RESULTS: This analysis included 2,412,000 patients; 2.5% were readmitted between 0 and 7 days, 7.6% between 8 and 30 days, 8.9% between 31 and 90 days, and 8.0% between 91 and 180 days (cumulative rates 2.5%, 9.9%, 18.0%, and 24.8%, respectively). The majority of readmissions during each time period were due to noncardiac causes (53.1% to 59.6%). Nonspecific chest pain was the most common identifiable noncardiac cause for readmission during each time period (14.2% to 22.7% of noncardiac readmissions). Coronary artery disease including angina was the most common cardiac cause for readmission during each time period (37.4% to 39.3% of cardiac readmissions). The second most common cardiac cause for readmission was acute myocardial infarction between 0 and 7 days (27.6% of cardiac readmissions) and heart failure during all subsequent time periods (22.2% to 23.7% of cardiac readmissions). CONCLUSIONS: Approximately 25% of patients following PCI have unplanned readmissions within 6 months. Causes of readmission depend on the timing at which they are assessed, with noncardiovascular causes becoming more important at longer time points.

The assessment of thrombotic markers utilizing ionic versus non-ionic contrast during coronary angiography and intervention trial.

OBJECTIVE: To determine how two different types of iodinated contrast media (CM), low-osmolar ionic dimer ioxaglate (Hexabrix) and iso-osmolar non-ionic dimer iodixanol (Visipaque), affect multiple indices of hemostasis. BACKGROUND: In vitro models demonstrate differential effects of ionic and non-ionic CM on markers of hemostasis. METHODS: This blinded endpoint trial randomized 100 patients to ioxaglate or iodixanol. The primary endpoint was change in endogenous thrombin potential (ETP) following diagnostic angiography. Secondary endpoints included change in markers of fibrinolysis [tissue plasminogen activator (tPA) and plasminogen activator inhibitor 1 (PAI-1)] and platelet aggregation following diagnostic angiography and percutaneous coronary intervention (PCI) with bivalirudin. Data are presented as median [interquartile range]. RESULTS: ETP significantly decreased after diagnostic angiography in both ioxaglate (baseline 1810 nM*minute [1540-2089] to post-angiography 649 nM*minute [314-1347], p < 0.001) and iodixanol groups (baseline 1682 nM*minute [1534-2147] to post-angiography 681 nM*minute [229-1237], p < 0.001), but the decrease was not different between CM (p = 0.70). There was a significant increase in ETP during PCI (n = 45), despite the use of bivalirudin, suggesting a prothrombotic effect of PCI (post-angiography 764 nM*minute [286-1283] to post-PCI 1081 nM*minute [668-1552], p = 0.02). There were no significant differential effects on tPA, PAI-1, and markers of platelet activity. CONCLUSION: There were no significant differential effects between ioxaglate and iodixanol. Both CM led to significant reductions in thrombin generation and no significant effects on fibrinolytic activity or platelet activity, thereby contributing to a favorable antithrombotic milieu. © 2016 Wiley Periodicals, Inc.

Mean platelet volume and long-term mortality in patients undergoing percutaneous coronary intervention.

Increased platelet activity is associated with adverse cardiovascular events. The mean platelet volume (MPV) correlates with platelet activity; however, the relation between the MPV and long-term mortality in patients undergoing percutaneous coronary intervention (PCI) is not well established. Furthermore, the role of change in the MPV over time has not been previously evaluated. We evaluated the MPV at baseline, 30 days, 60 days, 90 days, 1 year, 2 years, and 3 years after the procedure in 1,512 patients who underwent PCI. The speed of change in the MPV was estimated using the slope of linear regression. Mortality was determined by query of the Social Security Death Index. During a median of 8.7 years, mortality was 49.3% after PCI. No significant difference was seen in mortality when stratified by MPV quartile (first quartile, 50.1%; second quartile, 47.7%; third quartile, 51.3%; fourth quartile, 48.3%; p = 0.74). For the 839 patients with available data to determine a change in the MPV over time after PCI, mortality was 49.1% and was significantly greater in patients with an increase (52.9%) than in those with a decrease (44.2%) or no change (49.1%) in the MPV over time (p <0.0001). In conclusion, no association was found between the baseline MPV and long-term mortality in patients undergoing PCI. However, increased mortality was found when the MPV increased over time after PCI. Monitoring the MPV after coronary revascularization might play a role in risk stratification.