Multifaceted Intervention to Improve P2Y12 Inhibitor Adherence After Percutaneous Coronary Intervention: A Stepped Wedge Trial.

Background P2Y12 inhibitor medications are critical following percutaneous coronary intervention (PCI); however, adherence remains suboptimal. Our objective was to assess the effectiveness of a multifaceted intervention to improve P2Y12 inhibitor adherence following PCI. Methods and Results This was a modified stepped wedge trial of 52 eligible hospitals, of which 15 were randomly selected and agreed to participate (29 hospitals declined, and 8 eligible hospitals were not contacted). At each intervention hospital, patient recruitment occurred for 6 months and enrolled patients were followed up for 1 year after PCI. Three control groups were used: patients at intervention hospitals undergoing PCI (1) before the intervention period (preintervention); (2) after the intervention period (postintervention); or (3) at the 8 hospitals not contacted (concurrent controls). The intervention consisted of 4 components: (1) P2Y12 inhibitor delivered to patients' bedside after PCI; (2) education on importance of P2Y12 inhibitors; (3) automated reminder telephone calls to refill medication; and (4) outreach to patients if they delayed refilling P2Y12 inhibitor. The primary outcomes were as follows: (1) proportion of patients with delays filling P2Y12 inhibitor at hospital discharge and (2) proportion of patients who were adherent in the year after PCI using pharmacy refill data. Primary analysis compared intervention with preintervention control patients. There were 1377 (intent-to-treat) potentially eligible patients, of whom 803 (per protocol) were approached at intervention sites versus 5910 preintervention, 2807 postintervention, and 4736 concurrent control patients. In the intent-to-treat analysis, intervention patients were less likely to delay filling P2Y12 at hospital discharge (-3.4%; 98.3% CI, -1.2% to -5.6%) and more likely to be adherent to P2Y12 (4.1%; 98.3% CI, 1.0%-7.1%) at 1 year, but had more clinical events (3.2%; 98.3% CI, 2.3%-4.1%) driven by repeated PCI compared with preintervention patients. In post hoc analysis looking at myocardial infarction, stroke, and death, intervention patients had lower event rates compared with preintervention patients (-1.7%; 98.3% CI, -2.3% to -1.1%). Conclusions A 4-component intervention targeting P2Y12 inhibitor adherence was difficult to implement. The intervention produced mixed results. It improved P2Y12 adherence, but there was also an increase in repeat PCI. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT01609842.

Impact of Operator Volumes and Experience on Outcomes After Percutaneous Coronary Intervention: Insights From the Veterans Affairs Clinical Assessment, Reporting and Tracking (CART) Program.

BACKGROUND: Recent analyses of the volume-outcome relationship for percutaneous coronary intervention (PCI) have suggested a less robust association than previously reported. It is unknown if novel factors such as lifetime operator experience influence this relationship. OBJECTIVES: To assess the relationship between annual volumes and outcomes for PCI and determine whether lifetime operator experience modulates the association. METHODS: Annual PCI volumes for facilities and operators within the Veterans Affairs Healthcare System and their relationship with 30-day mortality following PCI were described. The influence of operator lifetime experience on the volume-outcome relationship was assessed. Hierarchical logistic regression was used to adjust for patient and procedural factors. RESULTS: 57,608 PCIs performed from 2013 to 2018 by 382 operators and 63 institutions were analyzed. Operator annualized PCI volume averaged 47.6 (standard deviation [SD] 49.1) and site annualized volume averaged 189.2 (SD 105.2). Median operator experience was 9.0 years (interquartile range [IQR] 4.0-15.0). There was no independent relationship between operator annual volume, institutional volume, or operator lifetime experience with 30-day mortality (p > 0.10). However, the interaction between operator volume and lifetime experience was associated with a marginal decrease in mortality (odds ratio [OR] 0.9998, 95% CI 0.9996-0.9999). CONCLUSIONS: There were no significant associations between facility or operator-level procedural volume and 30-day mortality following PCI in a nationally integrated healthcare system. There was a marginal association between the interaction of operator lifetime experience, operator annual volume, and 30-day mortality that is unlikely to be clinically relevant, though does suggest an opportunity to explore novel factors that may influence the volume-outcome relationship.

Contemporary Clinical and Coronary Anatomic Risk Model for 30-Day Mortality After Percutaneous Coronary Intervention.

BACKGROUND: Percutaneous coronary intervention (PCI) procedures are increasing in clinical and anatomic complexity, likely increasing the calculated risk of mortality. There is need for a real-time risk prediction tool that includes clinical and coronary anatomic information that is integrated into the electronic medical record system. METHODS: We assessed 70 503 PCIs performed in 73 Veterans Affairs hospitals from 2008 to 2019. We used regression and machine-learning strategies to develop a prediction model for 30-day mortality following PCI. We assessed model performance with and without inclusion of the Veterans Affairs SYNTAX score (Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery), an assessment of anatomic complexity. Finally, the discriminatory ability of the Veterans Affairs model was compared with the CathPCI mortality model. RESULTS: The overall 30-day morality rate was 1.7%. The final model included 14 variables. Presentation status (salvage, emergent, urgent), ST-segment-elevation myocardial infarction, cardiogenic shock, age, congestive heart failure, prior valve disease, chronic kidney disease, chronic lung disease, atrial fibrillation, elevated international normalized ratio, and the Veterans Affairs SYNTAX score were all associated with increased risk of death, while increasing body mass index, hemoglobin level, and prior coronary artery bypass graft surgery were associated with lower risk of death. C-index for the development cohort was 0.93 (95% CI, 0.92-0.94) and for the 2019 validation cohort and the site validation cohort was 0.87 (95% CI, 0.83-0.92) and 0.86 (95% CI, 0.83-0.89), respectively. The positive likelihood ratio of predicting a mortality event in the top decile was 2.87% more accurate than the CathPCI mortality model. Inclusion of anatomic information in the model resulted in significant improvement in model performance (likelihood ratio test P<0.01). CONCLUSIONS: This contemporary risk model accurately predicts 30-day post-PCI mortality using a combination of clinical and anatomic variables. This can be immediately implemented into clinical practice to promote personalized informed consent discussions and appropriate preparation for high-risk PCI cases.

Comparison of Patients With Nonobstructive Coronary Artery Disease With Versus Without Myocardial Infarction (from the VA Clinical Assessment Reporting and Tracking [CART] Program).

Comparisons of the outcomes of patients with myocardial infarction with nonobstructive coronary artery disease (MINOCA) and patients with nonobstructive coronary artery disease (CAD) without myocardial infarction (MI) are limited. Here we compare the outcomes of patients with MINOCA and patients with nonobstructive CAD without MI and assess the influence of medical therapy on outcomes in these patients. Veterans who underwent coronary angiography between 2008 to 2017 with nonobstructive CAD were divided into those with or without pre-procedural troponin elevation. Patients with prior revascularization, heart failure, or who presented with cardiogenic shock, STEMI, or unstable angina were excluded. After propensity matching, outcomes were compared between groups. The primary outcome was major adverse cardiovascular events (MACE: mortality, myocardial infarction, and revascularization) within one year: 3,924 patients with nonobstructive CAD and a troponin obtained prior to angiography were identified (n=1,986 with elevated troponin) and restricted to 1,904 patients after propensity-matching. There was a significantly higher risk of MACE among troponin-positive patients compared with those with a negative troponin (HR 2.37; 95% CI, 1.67 to 3.34). Statin (HR 0.32; 95% CI, 0.22 to 0.49) and ACE inhibitor (HR 0.49; 95% CI, 0.32 to 0.75) therapy after angiography was associated with decreased MACE, while P2Y12 inhibitor, calcium-channel and beta-blocker therapy were not associated with outcomes. In conclusion, Veterans with MINOCA are at increased risk for MACE compared with those with nonobstructive CAD and negative troponin at the time of angiography. Specific medications were associated with a reduction in MACE, suggesting an opportunity to explore novel approaches for secondary prevention in this population.

Development and Implementation of an In-Hospital Bleeding Risk Model for Percutaneous Coronary Intervention.

BACKGROUND: Bleeding is a common complication of percutaneous coronary intervention (PCI) that is associated with worse clinical outcomes and increased costs. Improved pre-procedural bleeding risk prediction could promote strategies that have been shown to reduce post-PCI bleeding, including increased adoption of radial access. METHODS: We studied patients in the Veterans Affairs Clinical Assessment, Reporting, and Tracking (VA CART) program receiving PCI in VA hospitals. Logistic regression was performed to develop a model for major in-hospital bleeding using demographic, clinical, and procedural variables. The discriminatory ability of the model was compared to the existing National Cardiovascular Data Registry (NCDR) CathPCI bleeding risk model. RESULTS: Among 107,451 patients treated from 2008 to 2019, 5218 (4.86%) experienced an in-hospital bleeding event. Twelve variables were associated with bleeding risk. Predictors of bleeding included emergency or salvage status, cardiogenic shock, NSTEMI, Atrial fibrillation, elevated INR, and peripheral vascular disease, while radial access, greater body surface area, and stable or unstable angina were associated with lower risk of bleeding. The developed model had superior discrimination compared with the NCDR CathPCI model (c-index 0.756, 95% CI 0.749-0.764 vs. 0.707, 95% CI 0.700-0.714, p < 0.001), especially among the highest risk patients. A web-based tool has been created to facilitate calculation of bleeding risk using this model at the point of care. CONCLUSION: The VA CART bleeding risk model uses baseline clinical and procedural variables to predict post-PCI in-hospital bleeding events and has improved discrimination compared to other available models in this patient population. Implementation of this model can facilitate risk stratification at the point of care and permit improved risk-adjustment for quality assessment.

The Impact of Performing a 3D Mapping Biopsy Prior to Primary Cryotherapy for the Treatment of Prostate Cancer.

OBJECTIVE: To study the implications of adding a 3D mapping biopsy (3DMB) prior to prostate cryotherapy (PCT) for the treatment of prostate cancer on the following outcomes: recurrence and biochemical failure (BCF), quality of life outcomes, and complication rates. METHODS: A retrospective analysis of patients treated with either targeted focal therapy, or subtotal CT for localized prostate cancer was performed. The cohort was stratified by patients who had only had a transrectal ultrasound-guided biopsy (TRUS) and those who had undergone 1 additional 3DMB before definitive treatment. Pre- and postprocedural Prostate Symptom Score (IPSS) and Sexual Health Inventory for Men (SHIM) surveys were collected. BCF was defined using the Phoenix criteria. Patients with BCF were re-biopsied. Differences in pre/post changes in IPSS and SHIM scores were examined with Mann-Whitney U tests, binary measures with chi-square tests, and pre/post changes in PSA with t tests. A Kaplan-Meier time to BCF and recurrence analysis is presented. RESULTS: A total of 534 patients underwent PCT following TRUS only (n = 331) and TRUS with subsequent 3DMB (n = 203) between March 2007 and June 2016. No differences were observed in IPSS (P = .60) or SHIM scores drop (P = .06) between groups. PSA drop seemed more pronounced in the TRUS only biopsy group compared to the 3DMB, but again without statistical significance (P = .06). Recurrence rate and BCF were lower in the 3DMB group (P <.01). There was a higher rate of short-term complications detected in the TRUS only group (P = .02). CONCLUSION: BCF and local recurrence rates were lower among patients who underwent a confirmatory 3DMB before PCT, most likely due to better risk stratification in these patients. The addition of a 3DMB did not seem to adversely impact either rate of complications or functional outcomes.

Perceptions of Public and Nonpublic Reporting of Interventional Cardiology Outcomes and Its Impact on Practice: Insights From the Veterans Affairs Clinical Assessment, Reporting, and Tracking Program.

Background Physicians have expressed significant mistrust with public reporting of interventional cardiology outcomes. Similar data are not available on alternative reporting structures, including nonpublic quality improvement programs with internally distributed measures of interventional quality. We thus sought to evaluate the perceptions of public and nonpublic reporting of interventional cardiology outcomes and its impact on clinical practice. Methods and Results A standardized survey was distributed to 218 interventional cardiologists in the Veterans Affairs Healthcare System, with responses received from 62 (28%). The majority of respondents (90%) expressed some or a great deal of trust in the analytic methods used to generate reports in a nonpublic quality improvement system within Veterans Affairs, while a minority (35%) expressed similar trust in the analytic methods in a public reporting system that operates outside Veterans Affairs (P<0.001). Similarly, a minority of respondents (44%) felt that in-hospital and 30-day mortality accurately reflected interventional quality in a nonpublic quality improvement system, though a smaller proportion of survey participants (15%) felt that the same outcome reflected procedural quality in public reporting systems (P<0.001). Despite these sentiments, the majority of operators did not feel pressured to avoid (82% and 75%; P=0.383) or perform (72% and 63%; P=0.096) high-risk procedures within or outside Veterans Affairs. Conclusions Interventional cardiologists express greater trust in analytic methods and clinical outcomes reported in a nonpublic quality improvement program than external public reporting environments. The majority of physicians did not feel pressured to avoid or perform high-risk procedures, which may improve access to interventional care among high-risk patients.

Same-day discharge among patients undergoing elective PCI: Insights from the VA CART Program.

BACKGROUND: Available data suggest that same-day discharge (SDD) after elective percutaneous coronary intervention (PCI) is safe in select patients. Yet, little is known about contemporary adoption rates, safety, and costs in a universal health care system like the Veterans Affairs Health System. METHODS: Using data from the Veterans Affairs Clinical Assessment Reporting and Tracking Program linked with Health Economics Resource Center data, patients undergoing elective PCI for stable angina between October 1, 2007 and Sepetember 30, 2016, were stratified by SDD versus overnight stay. We examined trends of SDD, and using 2:1 propensity matching, we assessed 30-day rates of readmission, mortality, and total costs at 30 days. RESULTS: Of 21,261 PCIs from 67 sites, 728 were SDDs (3.9% of overall cohort). The rate of SDD increased from 1.6% in 2008 to 9.7% in 2016 (P < .001). SDD patients had lower rates of atrial fibrillation, peripheral arterial disease, and prior coronary artery bypass grafting and were treated at higher-volume centers. Thirty-day readmission and mortality did not differ significantly between the groups (readmission: 6.7% SDD vs 5.6% for overnight stay, P = .24; mortality: 0% vs. 0.07%, P = .99). The mean (SD) 30-day cost accrued by patients undergoing SDD was $23,656 ($15,480) versus $25,878 ($17,480) for an overnight stay. The accumulated median cost savings for SDD was $1503 (95% CI $738-$2,250). CONCLUSIONS: Veterans Affairs Health System has increasingly adopted SDD for elective PCI procedures, and this is associated with cost savings without an increase in readmission or mortality. Greater adoption has the potential to reduce costs without increasing adverse outcomes.

Outcomes of Veterans Undergoing TAVR Within Veterans Affairs Medical Centers: Insights From the Veterans Affairs Clinical Assessment, Reporting, and Tracking Program.

OBJECTIVES: This study sought to describe clinical and procedural characteristics of veterans undergoing transcatheter aortic valve replacement (TAVR) within U.S. Department of Veterans Affairs (VA) centers and to examine their association with short- and long-term mortality, length of stay (LOS), and rehospitalization within 30 days. BACKGROUND: Veterans with severe aortic stenosis frequently undergo TAVR at VA medical centers. METHODS: Consecutive veterans undergoing TAVR between 2012 and 2017 were included. Patient and procedural characteristics were obtained from the VA Clinical Assessment, Reporting, and Tracking system. The primary outcomes were 30-day and 1-year survival, LOS >6 days, and rehospitalization within 30 days. Logistic regression and Cox proportional hazards analyses were performed to evaluate the associations between pre-procedural characteristics and LOS and rehospitalization. RESULTS: Nine hundred fifty-nine veterans underwent TAVR at 8 VA centers during the study period, 860 (90%) by transfemoral access, 50 (5%) transapical, 36 (3.8%) transaxillary, and 3 (0.3%) transaortic. Men predominated (939 of 959 [98%]), with an average age of 78.1 years. There were 28 deaths within 30 days (2.9%) and 134 at 1 year (14.0%). Median LOS was 5 days, and 141 veterans were rehospitalized within 30 days (14.7%). Nonfemoral access (odds ratio: 1.74; 95% confidence interval [CI]: 1.10 to 2.74), heart failure (odds ratio: 2.51; 95% CI: 1.83 to 3.44), and atrial fibrillation (odds ratio: 1.40; 95% CI: 1.01 to 1.95) were associated with increased LOS. Atrial fibrillation was associated with 30-day rehospitalization (hazard ratio: 1.79; 95% CI: 1.22 to 2.63). CONCLUSIONS: Veterans undergoing TAVR at VA centers are predominantly elderly men with significant comorbidities. Clinical outcomes of mortality and rehospitalization at 30 days and 1-year mortality compare favorably with benchmark outcome data outside the VA.

Improving anti-platelet therapy adherence in the Veterans Health Administration: A randomized multi-site hybrid effectiveness-implementation study protocol.

BACKGROUND: P2Y12 inhibitors are critical following percutaneous coronary intervention (PCI) with stent placement; they reduce the risk of stent thrombosis and myocardial infarction. Despite the importance of the therapy, non-adherence is common among Veterans. METHODS AND RESULTS: Our main objective is to conduct a multi-site randomized stepped wedge trial to test the effectiveness of a multi-faceted intervention to improve adherence to P2Y12 inhibitors and PCI outcomes as well as formatively evaluate and refine the intervention implementation process. The primary outcomes of the study are the proportion of patients whose P2Y12 inhibitor prescription was filled at the time of hospital discharge following PCI with stent placement as well as the proportion of patients who were adherent based on the pharmacy refill data in the year after PCI hospital discharge. We will also assess the secondary outcomes such as bleeding, myocardial infarction, stroke, and mortality among these patients, and the cost-effectiveness of the intervention. The study was conducted at Veterans Health Administration (VA) PCI sites. At each site, we enrolled patients over a 6-month period and followed them for 12 months after PCI. Additionally, we collected qualitative data to identify contextual factors and to assess barriers and facilitators to the implementation and maintenance of the intervention. CONCLUSIONS: The study will add to the current state of knowledge on improving medication adherence in patients receiving PCI with stent implantation. Moreover, the study includes an extensive examination of the implementation process and will contribute to the field of implementation science. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01609842 https://clinicaltrials.gov/ct2/show/NCT01609842?term=clopidogrel+adherence&cntry1=NA%3AUS&rank=1.

Temporal Trends in Coronary Angiography and Percutaneous Coronary Intervention: Insights From the VA Clinical Assessment, Reporting, and Tracking Program.

OBJECTIVES: The aim of this study was to evaluate temporal trends in characteristics and outcomes among patients referred for invasive coronary procedures within a national health care system for veterans. BACKGROUND: Coronary angiography and percutaneous coronary intervention remain instrumental diagnostic and therapeutic interventions for coronary artery disease. METHODS: All coronary angiographic studies and interventions performed in U.S. Department of Veterans Affairs cardiac catheterization laboratories for fiscal years 2009 through 2015 were identified. The demographic characteristics and management of these patients were stratified by time. Clinical outcomes including readmission (30-day) and mortality were assessed across years. RESULTS: From 2009 to 2015, 194,476 coronary angiographic examinations and 85,024 interventions were performed at Veterans Affairs facilities. The median numbers of angiographic studies (p = 0.81) and interventions (p = 0.22) remained constant over time. Patients undergoing these procedures were progressively older, with more comorbidities, as the proportion classified as having high Framingham risk significantly increased among those undergoing angiography (from 20% to 25%; p < 0.001) and intervention (from 24% to 32%; p < 0.001). Similarly, the median National Cardiovascular Data Registry CathPCI risk score increased for diagnostic (from 14 to 15; p = 0.005) and interventional (from 14 to 18; p = 0.002) procedures. Post-procedural medical management was unchanged over time, although there was increasing adoption of transradial access for diagnostic (from 6% to 36%; p < 0.001) and interventional (from 5% to 32%; p < 0.001) procedures. Complications and clinical outcomes also remained constant, with a trend toward a reduction in the adjusted hazard ratio for percutaneous coronary intervention mortality (hazard ratio: 0.983; 95% confidence interval: 0.967 to 1.000). CONCLUSIONS: Veterans undergoing invasive coronary procedures have had increasing medical complexity over time, without attendant increases in mortality among those receiving interventions. As the Department of Veterans Affairs moves toward a mix of integrated and community-based care, it will be important to account for these demographic shifts so that quality can be maintained.

Prospective Outcome Analysis of the Safety and Efficacy of Partial and Complete Cryoablation in Organ-confined Prostate Cancer.

OBJECTIVE: To determine the rate of complications and change in International Prostate Symptom Score and Sexual Health Inventory for Men scores following cryotherapy treatment of low- and intermediate-risk prostate cancer. The secondary end points were the change in prostate-specific antigen post cryotherapy and biopsy-proven recurrence. MATERIALS AND METHODS: Enrollment occurred from 2007 to 2015 to assess long-term complications of cryotherapy. A prostate biopsy was performed at 1 year or in the event of biochemical failure. Subjects were staged and graded by standard 12- to 14-core transrectal ultrasound (TRUS) biopsy. A subset of subjects underwent additional 3-dimensional mapping biopsy if the cancer was suspected to be downgraded. Analyses of functional outcomes were stratified into focal and nonfocal treatments. RESULTS: The study consisted of 393 men with low- and intermediate-risk prostate cancer, aged 44-89 years. Patient IPSS scores improved significantly in the nonfocal treatment strata at all time points and after 1 year in the focal strata with a median drop at 1 year of 4 points (P <.001). No significant difference was detected for a change in preprocedural SHIM score in either treatment strata after 2 years (P >.7). Eighty-two patients (20.9%) had a rise in prostate-specific antigen resulting in biochemical failure. Seventy patients had detected recurrence for an overall recurrence rate of 20.4% in 343 patients. A total of 109 patients (27.7%) reported urinary retention and urgency post cryotherapy, with 15.3% requiring catheterization for up to 3 weeks. Thirty-seven patients (9.4%) experienced urethral meatal stricture, and 36 patients (9.2%) reported unresolved new-onset erectile dysfunction. CONCLUSION: Complication rates, most significantly erectile dysfunction, are decreased in this study compared with those previously reported in the literature for cryotherapy for prostate cancer.

Incidence, procedural management, and clinical outcomes of coronary in-stent restenosis: Insights from the National VA CART Program.

BACKROUND: In-stent restenosis (ISR) remains a common clinical problem associated with significant morbidity. We sought to evaluate the temporal trends in incidence and procedural management of coronary restenosis as well as evaluate the association between different treatment modalities and clinical outcomes. METHODS: We identified all patients treated for coronary ISR within the Veterans Affairs Healthcare System from October 1, 2006 to September 30, 2014. The temporal trends in incidence as well as intraprocedural management were assessed. Among patients treated for single vessel restenosis, a propensity matched cohort was created for those treated with drug-eluting stents (DES) or other treatment modalities. Target vessel revascularization (TVR) and mortality were compared between the two subpopulations. RESULTS: From 2006 to 2014, 65,443 patients underwent percutaneous coronary intervention and 6,872 patients (10.5%) with 8,921 lesions were treated for ISR. The proportion of patients undergoing revascularization for restenosis increased 0.28% per year (P = 0.055). Among a propensity-matched cohort of 6,231, the rates of TVR (subdistribution HR: 0.623, 95% CI: 0.511-0.760) and mortality (HR: 0.730, 95% CI: 0.641-0.830) were significantly lower among patients treated with a DES compared with other treatments. After adjustment for known risk factors, treatment with DES continued to be associated with a reduction in mortality rate (Adjusted HR: 0.802, 95% CI: 0.704-0.913). CONCLUSIONS: There is a trend toward an increasing proportion of coronary interventions for ISR in a national cohort of Veterans and treatment with a DES is associated with the lowest rate of TVR and overall mortality.

Primary non-transecting bulbar urethroplasty long-term success rates are similar to transecting urethroplasty.

OBJECTIVES: To review the long-term outcomes of transecting versus non-transecting urethroplasty to repair bulbar urethral strictures. METHODS: A retrospective review was conducted of 342 patients who underwent anterior urethroplasty performed by a single surgeon from 2003 to 2014. Patients were excluded from further analysis if there had been prior urethroplasty, stricture location outside the bulbous urethra, or age <18 years. In the transecting group, surgical techniques used included excision and primary anastomosis and augmented anastomotic urethroplasty. In the non-transecting group, surgical techniques used included non-transecting anastomotic urethroplasty and dorsal and/or ventral buccal grafting. The primary endpoint was stricture resolution in transecting vs. non-transecting bulbar urethroplasty. Success was defined as freedom from secondary procedures including dilation, urethrotomy, or repeat urethroplasty. RESULTS: One hundred and fifty-two patients met inclusion criteria. At a mean follow-up of 65 months (range: 10-138 months), stricture-free recurrence in the transecting and non-transecting groups was similar, 83% (n = 85/102) and 82% (n = 41/50), respectively (p = 0.84). Surgical technique (p = 0.91), stricture length (p = 0.8), and etiology (p = 0.6) did not affect stricture recurrence rate on multivariate analysis. There was no difference detected in time to stricture recurrence (p = 0.21). CONCLUSIONS: In this retrospective series, transecting and non-transecting primary bulbar urethroplasty resulted in similar long-term stricture resolution rate. Prospective studies are needed to determine what differences may present in outcomes related to sexual function and long-term success.

Guideline Recommended Medical Therapy for Cardiovascular Diseases in the Obese: Insights From the Veterans Affairs Clinical Assessment, Reporting, and Tracking (CART) Program.

BACKGROUND: Stigma against the obese is well described in health care and may contribute to disparities in medical decision-making. It is unknown whether similar disparity exists for obese patients in cardiovascular care. We evaluated the association between body mass index (BMI) and prescription of guideline-recommended medications in patients undergoing elective percutaneous coronary intervention. METHODS AND RESULTS: Using data from the Veterans Affairs Clinical Assessment, Reporting, and Tracking System Program, we identified patients undergoing elective percutaneous coronary intervention from 2007 to 2012, stratifying them by category of BMI. We described rates of prescription for class I guideline recommended medications for each BMI category (normal, overweight, and obese). Multivariable logistic regression assessed the association between BMI category and medication prescription. Seventeen thousand thirty-seven patients were identified, with 35.3% having overweight BMI, and 50.8% obese BMI. Obese patients were more likely than normal BMI patients to be prescribed ß-blockers (OR 1.34), statins (OR 1.39), or ACE/ARB (odds ratio [OR] 1.52; all significant) when indicated. Overweight patients were more likely than normal BMI patients to be prescribed statins (OR 1.29) and angiotensin-converting enzymes/angiotensin II receptor blockers (OR 1.41) when indicated. There was no association between BMI category and prescription of anticoagulants. CONCLUSIONS: Over 85% of patients undergoing elective percutaneous coronary intervention in the Veterans Affairs are overweight or obese. Rates of guideline-indicated medication prescription were <70% among all patients, and across BMI categories, with an association between increased BMI and greater use of guideline-recommended medications. Our findings offer a possible contribution to the obesity paradox seen in many cardiovascular conditions.

Hospital Variation in Premature Clopidogrel Discontinuation After Drug-Eluting Stent Placement in the Veterans Affairs (VA) Healthcare System.

BACKGROUND: Premature clopidogrel discontinuation after drug-eluting stent placement is associated with adverse outcomes. Little is known about patient and hospital factors associated with premature discontinuation or whether less variation in premature discontinuation exists in integrated health care systems such as the Veterans Affairs (VA). METHODS AND RESULTS: We evaluated the frequency of premature clopidogrel discontinuation, defined as a gap between clopidogrel refills of ≥90 days during the first 6 months of treatment, among 12 707 patients who received drug-eluting stents in VA hospitals between 2008 and 2010. We evaluated the association between premature discontinuation and all-cause mortality and/or acute myocardial infarction, variation in the proportion of premature discontinuation among hospitals, the patient and hospital characteristics associated with premature discontinuation, and the extent to which unexplained hospital characteristics contribute to premature discontinuation. Of the patients, 963 (7.6%) discontinued clopidogrel prematurely. Premature discontinuation was associated with acute myocardial infarction and all-cause mortality (hazard ratio 1.65, 95% CI 1.37-1.99, P<0.001). The proportion of patients with premature discontinuation varied across hospitals from 0% to 16.5% (P<0.001). We found a median of 24% greater odds of patients with identical covariates with premature discontinuation at one randomly selected hospital compared with another (median odds ratio 1.24, 95% CI 1.17-1.44). Patient factors associated with premature discontinuation included lack of cardiology follow-up within 30 days of discharge and smaller initial clopidogrel fill. CONCLUSION: One in 13 patients prematurely discontinued clopidogrel, and variation in discontinuation across hospitals was observed. Patient factors were associated with premature discontinuation that may represent targets for quality improvement.

Percutaneous Coronary Intervention in Native Coronary Arteries Versus Bypass Grafts in Patients With Prior Coronary Artery Bypass Graft Surgery: Insights From the Veterans Affairs Clinical Assessment, Reporting, and Tracking Program.

OBJECTIVES: The aim of this study was to examine the frequency, associations, and outcomes of native coronary artery versus bypass graft percutaneous coronary intervention (PCI) in patients with prior coronary artery bypass grafting (CABG) in the Veterans Affairs (VA) integrated health care system. BACKGROUND: Patients with prior CABG surgery often undergo PCI, but the association between PCI target vessel and short- and long-term outcomes has received limited study. METHODS: A national cohort of 11,118 veterans with prior CABG who underwent PCI between October 2005 and September 2013 at 67 VA hospitals was examined, and the outcomes of patients who underwent native coronary versus bypass graft PCI were compared. Logistic regression with generalized estimating equations was used to adjust for correlation between patients within hospitals. Cox regressions were modeled for each outcome to determine the variables with significant hazard ratios (HRs). RESULTS: During the study period, patients with prior CABG represented 18.5% of all patients undergoing PCI (11,118 of 60,171). The PCI target vessel was a native coronary artery in 73.4% and a bypass graft in 26.6%: 25.0% in a saphenous vein graft and 1.5% in an arterial graft. Compared with patients undergoing native coronary artery PCI, those undergoing bypass graft PCI had higher risk characteristics and more procedure-related complications. During a median follow-up period of 3.11 years, bypass graft PCI was associated with significantly higher mortality (adjusted HR: 1.30; 95% confidence interval: 1.18 to 1.42), myocardial infarction (adjusted HR: 1.61; 95% confidence interval: 1.43 to 1.82), and repeat revascularization (adjusted HR: 1.60; 95% confidence interval: 1.50 to 1.71). CONCLUSIONS: In a national cohort of veterans, almost three-quarters of PCIs performed in patients with prior CABG involved native coronary artery lesions. Compared with native coronary PCI, bypass graft PCI was significantly associated with higher incidence of short- and long-term major adverse events, including more than double the rate of in-hospital mortality.

Facility-Level Variation in Hospitalization, Mortality, and Costs in the 30 Days After Percutaneous Coronary Intervention: Insights on Short-Term Healthcare Value From the Veterans Affairs Clinical Assessment, Reporting, and Tracking System (VA CART) Program.

BACKGROUND: Policies to reduce unnecessary hospitalizations after percutaneous coronary intervention (PCI) are intended to improve healthcare value by reducing costs while maintaining patient outcomes. Whether facility-level hospitalization rates after PCI are associated with cost of care is unknown. METHODS AND RESULTS: We studied 32,080 patients who received PCI at any 1 of 62 Veterans Affairs hospitals from 2008 to 2011. We identified facility outliers for 30-day risk-standardized hospitalization, mortality, and cost. Compared with the risk-standardized average, 2 hospitals (3.2%) had a lower-than-expected hospitalization rate, and 2 hospitals (3.2%) had a higher-than-expected hospitalization rate. We observed no statistically significant variation in facility-level risk-standardized mortality. The facility-level unadjusted median per patient 30-day total cost was $23,820 (interquartile range, $19,604-$29,958). Compared with the risk-standardized average, 17 hospitals (27.4%) had lower-than-expected costs, and 14 hospitals (22.6%) had higher-than-expected costs. At the facility level, the index PCI accounted for 83.1% of the total cost (range, 60.3%-92.2%), whereas hospitalization after PCI accounted for only 5.8% (range, 2.0%-12.7%) of the 30-day total cost. Facilities with higher hospitalization rates were not more expensive (Spearman ρ=0.16; 95% confidence interval, -0.09 to 0.39; P=0.21). CONCLUSIONS: In this national study, hospitalizations in the 30 day after PCI accounted for only 5.8% of 30-day cost, and facility-level cost was not correlated with hospitalization rates. This challenges the focus on reducing hospitalizations after PCI as an effective means of improving healthcare value. Opportunities remain to improve PCI value by reducing the variation in total cost of PCI without compromising patient outcomes.