Publications by authors named "Robert W Yeh"

374 Publications

Limited duration of antiarrhythmic drug use for newly diagnosed atrial fibrillation in a nationwide population under age 65.

J Cardiovasc Electrophysiol 2021 Mar 24. Epub 2021 Mar 24.

Richard A. and Susan F. Smith Center for Outcomes Research, Division of Cardiology, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, Massachusetts, USA.

Introduction: Antiarrhythmic drugs (AADs) are commonly used for the treatment of newly diagnosed symptomatic atrial fibrillation (AF), however initial AAD choice, duration of therapy, rates of discontinuation, and factors associated with a durable response to therapy are poorly understood. This study assesses the initial choice and duration of antiarrhythmic drug therapy in the first 2 years after diagnosis of AF in a younger, commercially insured population.

Methods: A large nationally representative sample of patients age 20-64 was studied using the IBM MarketScan Database. Patients who started an AAD within 90 days of AF diagnosis with continuous enrollment for 1-year pre-index diagnosis and 2 years post-index were included. A Cox proportional hazards model was used to determine factors associated with AAD discontinuation.

Results: Flecainide was used most frequently (26.8%), followed by amiodarone (22.5%), dronedarone (18.3%), sotalol (15.8%), and propafenone (14.0%), with other AADs used less frequently. Twenty-two percent of patients who started on an AAD underwent ablation within 2 years, with 79% discontinuing the AAD after ablation. Ablation was the strongest predictor of AAD discontinuation (hazard ratio [HR], 1.70; 95% confidence interval [CI]: 1.61-1.80), followed by the male gender (HR, 1.10; CI: 1.02-1.19). Older patients (HR, 0.76; CI: 0.72-0.80; reference age 18-49) and those with comorbidities, including cardiomyopathy (HR, 075; CI: 0.61-0.91), diabetes (HR, 0.83; CI: 0.75-0.91), and hypertension (HR, 0.87; CI: 0.81-0.94) were less likely to discontinue AADs.

Conclusion: Only 31% of patients remained on the initial AAD at 2 years, with a mean duration of initial therapy 7.6 months before discontinuation.
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http://dx.doi.org/10.1111/jce.15012DOI Listing
March 2021

Association Between the Proportion of Black Patients Cared for at Hospitals and Financial Penalties Under Value-Based Payment Programs.

JAMA 2021 03;325(12):1219-1221

Richard A. and Susan F. Smith Center for Outcomes Research, Beth Israel Deaconess Medical Center, Boston, Massachusetts.

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http://dx.doi.org/10.1001/jama.2021.0026DOI Listing
March 2021

Trends in Coded Indications for Percutaneous Coronary Interventions in Medicare and the Veterans Affairs After Implementation of Hospital-Level Reporting of Appropriate Use Criteria.

Circ Cardiovasc Qual Outcomes 2021 Mar 15:CIRCOUTCOMES120006887. Epub 2021 Mar 15.

Michael J. Crescenz Veterans Affairs Medical Center, Philadelphia, PA (E.J.D., J.G., P.W.G.).

Background: In 2009, the American College of Cardiology and American Heart Association published Appropriate Use Criteria for Coronary Revascularization (AUC) to aid patient selection for percutaneous coronary intervention (PCI). The subsequent decline in inappropriate PCIs was interpreted as a success of AUC. However, there are concerns clinicians reclassify nonacute PCIs to acute indications to fulfill AUC.

Methods: A longitudinal, observational difference-in-differences analysis was performed using administrative claims from US Department of Veterans Affairs (VA) beneficiaries coenrolled in Medicare and from a national random sample of Medicare beneficiaries, undergoing PCI from September 30, 2009, to December 31, 2013. Non-VA hospitals participating in the American College of Cardiology CathPCI registry began receiving AUC reports in 2011, while VA hospitals did not receive reports, serving as quasiexperimental and control cohorts, respectively. We measured the proportion of PCIs coded for acute myocardial infarction, unstable angina, and nonacute coronary syndrome indications by quarter.

Results: There were 87 464 and 30 251 PCIs performed in the Medicare and VA cohorts, respectively. In Medicare, proportion of PCIs coded for acute myocardial infarction and unstable angina changed from 31.9% and 12.6% in quarter 4 2009 to 41.0% and 10.5% in quarter 4 2013, an associated 2.00% (95% CI, 1.56%-2.44%; <0.001) increase per year in PCIs coded for acute coronary syndrome indications. In the VA, proportion of PCIs coded for acute myocardial infarction and unstable angina changed from 26.5% and 15.7% in quarter 4 2009 to 34.3% and 12.3% in quarter 4 2013, an associated 1.20% (95% CI, 0.56%-1.88%; =0.001) increase per year in PCIs coded for acute coronary syndrome indications. Difference-in-differences modeling found no statistically significant change in PCI coded for acute indications between Medicare and VA, pre- and post-AUC reporting.

Conclusions: After introduction of AUC assessments and reporting, we observed comparable increases in coding for acute myocardial infarction and corresponding decreases in coding for unstable angina and nonacute coronary syndrome indications among national cohorts of Medicare and VA enrollees. The provision of appropriate use reporting did not appear to have a substantial impact on the proportion of PCIs coded for acute indications during this study period.
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http://dx.doi.org/10.1161/CIRCOUTCOMES.120.006887DOI Listing
March 2021

Prognosis of Claims- Versus Trial-Based Ischemic and Bleeding Events Beyond 1 Year After Coronary Stenting.

J Am Heart Assoc 2021 Mar 6;10(6):e018744. Epub 2021 Mar 6.

Richard A. and Susan F. Smith Center for Outcomes Research in Cardiology Division of Cardiovascular Medicine Beth Israel Deaconess Medical Center Boston MA.

Background It is unknown whether clinical events identified with administrative claims have similar prognosis compared with trial-adjudicated events in cardiovascular clinical trials. We compared the prognostic significance of claims-based end points in context of trial-adjudicated end points in the DAPT (Dual Antiplatelet Therapy) study. Methods and Results We matched 1336 patients aged ≥65 years who received percutaneous coronary intervention in the DAPT study with the CathPCI registry linked to Medicare claims. We compared death at 21 months post-randomization using Cox proportional hazards models among patients with ischemic events (myocardial infarction or stroke) and bleeding events identified by: (1) both trial adjudication and claims; (2) trial adjudication only; and (3) claims only. A total of 47 patients (3.5%) had ischemic events identified by both trial adjudication and claims, 24 (1.8%) in trial adjudication only, 15 (1.1%) in claims only, and 1250 (93.6%) had no ischemic events, with annualized unadjusted mortality rates of 12.8, 5.5, 14.9, and 1.26 per 100 person-years, respectively. A total of 44 patients (3.3%) had bleeding events identified with both trial adjudication and claims, 13 (1.0%) in trial adjudication only, 65 (4.9%) in claims only, and 1214 (90.9%) had no bleeding events, with annualized unadjusted mortality rates of 11.0, 16.8, 10.7, and 0.95 per 100 person-years, respectively. Among patients with no trial-adjudicated events, patients with events in claims only had a high subsequent adjusted mortality risk (hazard ratio (HR) ischemic events: 31.5; 95% CI, 8.9‒111.9; HR bleeding events 23.9; 95% CI, 10.7‒53.2). Conclusions In addition to trial-adjudicated events, claims identified additional clinically meaningful ischemic and bleeding events that were prognostically significant for death.
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http://dx.doi.org/10.1161/JAHA.120.018744DOI Listing
March 2021

Association of symptom status, myocardial viability, and clinical/anatomic risk on long-term outcomes after chronic total occlusion percutaneous coronary intervention.

Catheter Cardiovasc Interv 2021 Mar 2. Epub 2021 Mar 2.

National Clinical Research Center for Cardiovascular Diseases, Beijing, China.

Objectives: This study aimed to examine the association of less-certain indication of chronic total occlusion percutaneous coronary intervention (CTO-PCI) with subsequent clinical outcomes.

Background: The impact of patient symptoms, myocardial viability, and clinical and anatomic risk on long-term outcomes is underdetermined.

Methods: Consecutive patients undergoing CTO-PCI at a large-volume single center between 2010 and 2013 were included. Central adjudication was used to assess the appropriateness of three prespecified indications. The primary outcome was the 5-year composite endpoint of death or myocardial infarction (MI).

Results: Of 2,659 patients with 2,735 CTO lesions, the 348 (13.1%) asymptomatic patients, 164 (6.2%) patients without viable myocardium in the CTO territory, and 306 (11.5%) patients in whom the Synergy between PCI with Taxus and Cardiac Surgery Score II favored coronary artery bypass grafting (CABG) had higher 5-year death or MI compared with the rest patients in each category (12.0% vs. 8.6%, p = .04; 16.3% vs. 8.5%, p < .0001; 12.2% vs. 8.6%, p = .03), respectively. Multivariable regression analysis demonstrated that without symptom (hazard ratio: 1.51; 95% confidence interval: 1.06-2.15; p = .02), non-viable myocardium in CTO territory (hazard ratio: 1.77; 95% confidence interval: 1.16-2.72; p = .009), and deemed more favorable for CABG (hazard ratio:1.54; 95% confidence interval: 1.04-2.28; p = .03), but not the technical success (hazard ratio:0.85; 95% confidence interval: 0.62-1.18; p = .34), were independent predictors for the primary endpoint.

Conclusions: In this large cohort of CTO-PCI, those who were asymptomatic, non-viable myocardium in the CTO territory, or deemed more favorable for CABG were associated with higher risk of long-term mortality or MI.
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http://dx.doi.org/10.1002/ccd.29577DOI Listing
March 2021

Cerebral Embolic Protection and Outcomes of Transcatheter Aortic Valve Replacement: Results from the TVT Registry.

Circulation 2021 Feb 23. Epub 2021 Feb 23.

Cardiovascular Research Foundation, New York, NY; St. Francis Hospital, Roslyn, NY.

Stroke remains a devastating complication of transcatheter aortic valve replacement (TAVR), which has persisted despite refinements in technique and increased operator experience. While cerebral embolic protection devices (EPDs) have been developed to mitigate this risk, data regarding their impact on stroke and other outcomes after TAVR are limited. We performed an observational study using data from the STS/ACC-TVT Registry. Patients were included if they underwent elective or urgent transfemoral TAVR between January 2018 and December 2019. The primary outcome was in-hospital stroke. To adjust for confounding, the association between EPD use and clinical outcomes was evaluated using instrumental variable (IV) analysis, a technique designed to support causal inference from observational data, with site-level preference for EPD use within the same quarter of the procedure as the instrument. We also performed a propensity score-based secondary analysis using overlap weights. Our analytic sample included 123,186 patients from 599 sites. The use of EPD during TAVR increased over time, reaching 28% of sites and 13% of TAVR procedures by December 2019. There was wide variation in EPD use across hospitals, with 8% of sites performing >50% of TAVR procedures with an EPD and 72% performing zero procedures with an EPD in the last quarter of 2019. In our primary analysis using the IV model, there was no association between EPD use and in-hospital stroke (adjusted relative risk (0.90 [95% CI: 0.68, 1.13], absolute risk difference -0.15% [95% CI: -0.49, 0.20]). However, in our secondary analysis using the propensity score-based model, EPD use was associated with 18% lower odds of in-hospital stroke (adjusted OR 0.82 [95% CI 0.69, 0.97], absolute risk difference -0.28% [95% CI: -0.52, -0.03]). Results were generally consistent across the secondary endpoints as well as subgroup analyses. In this nationally-representative observational study, we did not find an association between EPD use for TAVR and in-hospital stroke in our primary IV analysis, and found only a modestly lower risk of in-hospital stroke in our secondary propensity-weighted analysis. These findings provide a strong basis for large-scale RCTs to test whether EPDs provide meaningful clinical benefit for patients undergoing TAVR.
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http://dx.doi.org/10.1161/CIRCULATIONAHA.120.052874DOI Listing
February 2021

Association of Acute Procedural Results With Long-Term Outcomes After CTO PCI.

JACC Cardiovasc Interv 2021 Feb 25;14(3):278-288. Epub 2020 Nov 25.

Catheterization Laboratories, Fu Wai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China; National Clinical Research Center for Cardiovascular Diseases, Beijing, China. Electronic address:

Objectives: The aim of this study was to determine the association of procedural outcomes with long-term mortality and myocardial infarction (MI) after chronic total occlusion (CTO) percutaneous coronary intervention (PCI).

Background: The association between acute procedural results and subsequent outcomes has received limited study.

Methods: Between January 2010 and December 2013, a total of 2,659 CTO PCI patients were consecutively enrolled. Procedural results were categorized into 3 groups: 1) optimal recanalization, with reperfusion of the occluded vessel and side branches (if any) with TIMI (Thrombolysis In Myocardial Infarction) flow grade 3; 2) suboptimal recanalization, meeting any of the following criteria: persistence of significant side branch occlusion, final TIMI flow grade 1 or 2, or residual percentage diameter stenosis >30%; and 3) procedural failure (i.e., failure to cross a lesion with a balloon angioplasty catheter). The primary outcome was the 5-year composite endpoint of cardiac death and MI.

Results: Overall, optimal recanalization was achieved in 1,562 patients (58.7%), suboptimal recanalization was achieved in 399 patients (15.0%), and recanalization failed in 698 patients (26.3%). The 5-year incidence of the primary outcome was significantly higher in the suboptimal recanalization group compared with the optimal recanalization and the failure groups (10.1% vs. 6.5% vs. 6.3%; p = 0.046), which was driven mainly by higher risk for MI. In subgroup analysis, significant side branch occlusion was associated with numerically higher risk for 5-year MI (hazard ratio: 1.55; 95% confidence interval: 0.99 to 2.43; p = 0.054).

Conclusions: In this large cohort of CTO PCI patients, suboptimal recanalization was associated with significantly higher long-term incidence of cardiac death and MI compared with optimal recanalization or procedural failure.
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http://dx.doi.org/10.1016/j.jcin.2020.10.003DOI Listing
February 2021

Association Between County-Level Change in Economic Prosperity and Change in Cardiovascular Mortality Among Middle-aged US Adults.

JAMA 2021 02;325(5):445-453

Penn Cardiovascular Outcomes, Quality, & Evaluative Research Center, Perelman School of Medicine, University of Pennsylvania, Philadelphia.

Importance: After a decline in cardiovascular mortality for nonelderly US adults, recent stagnation has occurred alongside rising income inequality. Whether this is associated with underlying economic trends is unclear.

Objective: To assess the association between changes in economic prosperity and trends in cardiovascular mortality in middle-aged US adults.

Design, Setting, And Participants: Retrospective analysis of the association between change in 7 markers of economic prosperity in 3123 US counties and county-level cardiovascular mortality among 40- to 64-year-old adults (102 660 852 individuals in 2010).

Exposures: Mean rank for change in 7 markers of economic prosperity between 2 time periods (baseline: 2007-2011 and follow-up: 2012-2016). A higher mean rank indicates a greater relative increase or lower relative decrease in prosperity (range, 5 to 92; mean [SD], 50 [14]).

Main Outcomes And Measures: Mean annual percentage change (APC) in age-adjusted cardiovascular mortality rates. Generalized linear mixed-effects models were used to estimate the additional APC associated with a change in prosperity.

Results: Among 102 660 852 residents aged 40 to 64 years living in these counties in 2010 (51% women), 979 228 cardiovascular deaths occurred between 2010 and 2017. Age-adjusted cardiovascular mortality rates did not change significantly between 2010 and 2017 in counties in the lowest tertile for change in economic prosperity (mean [SD], 114.1 [47.9] to 116.1 [52.7] deaths per 100 000 individuals; APC, 0.2% [95% CI, -0.3% to 0.7%]). Mortality decreased significantly in the intermediate tertile (mean [SD], 104.7 [38.8] to 101.9 [41.5] deaths per 100 000 individuals; APC, -0.4% [95% CI, -0.8% to -0.1%]) and highest tertile for change in prosperity (100.0 [37.9] to 95.1 [39.1] deaths per 100 000 individuals; APC, -0.5% [95% CI, -0.9% to -0.1%]). After accounting for baseline prosperity and demographic and health care-related variables, a 10-point higher mean rank for change in economic prosperity was associated with 0.4% (95% CI, 0.2% to 0.6%) additional decrease in mortality per year.

Conclusions And Relevance: In this retrospective study of US county-level mortality data from 2010 to 2017, a relative increase in county-level economic prosperity was significantly associated with a small relative decrease in cardiovascular mortality among middle-aged adults. Individual-level inferences are limited by the ecological nature of the study.
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http://dx.doi.org/10.1001/jama.2020.26141DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7856543PMC
February 2021

Rural-Urban Disparities In All-Cause Mortality Among Low-Income Medicare Beneficiaries, 2004-17.

Health Aff (Millwood) 2021 Feb;40(2):289-296

Rishi K. Wadhera is an assistant professor of medicine at Harvard Medical School and an investigator at the Richard A. and Susan F. Smith Center for Outcomes Research, Beth Israel Deaconess Medical Center.

There is growing concern about the health of older US adults who live in rural areas, but little is known about how mortality has changed over time for low-income Medicare beneficiaries residing in rural areas compared with their urban counterparts. We evaluated whether all-cause mortality rates changed for rural and urban low-income Medicare beneficiaries dually enrolled in Medicaid, and we studied disparities between these groups. The study cohort included 11,737,006 unique dually enrolled Medicare beneficiaries. Between 2004 and 2017 all-cause mortality declined from 96.6 to 92.7 per 1,000 rural beneficiaries (relative percentage change: -4.0 percent). Among urban beneficiaries, declines in mortality were more pronounced (from 86.9 to 72.8 per 1,000 beneficiaries, a relative percentage change of -16.2 percent). The gap in mortality between rural and urban beneficiaries increased over time. Rural mortality rates were highest in East North Central states and increased modestly in West North Central states during the study period. Public health and policy efforts are urgently needed to improve the health of low-income older adults living in rural areas.
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http://dx.doi.org/10.1377/hlthaff.2020.00420DOI Listing
February 2021

Cardiovascular Deaths During the COVID-19 Pandemic in the United States.

J Am Coll Cardiol 2021 01;77(2):159-169

Richard and Susan Smith Center for Outcomes Research in Cardiology, Division of Cardiology, Beth Israel Deaconess Medical and Harvard Medical School, Boston, Massachusetts, USA.

Background: Although the direct toll of COVID-19 in the United States has been substantial, concerns have also arisen about the indirect effects of the pandemic. Hospitalizations for acute cardiovascular conditions have declined, raising concern that patients may be avoiding hospitals because of fear of contracting severe acute respiratory syndrome- coronavirus-2 (SARS-CoV-2). Other factors, including strain on health care systems, may also have had an indirect toll.

Objectives: This investigation aimed to evaluate whether population-level deaths due to cardiovascular causes increased during the COVID-19 pandemic.

Methods: The authors conducted an observational cohort study using data from the National Center for Health Statistics to evaluate the rate of deaths due to cardiovascular causes after the onset of the pandemic in the United States, from March 18, 2020, to June 2, 2020, relative to the period immediately preceding the pandemic (January 1, 2020 to March 17, 2020). Changes in deaths were compared with the same periods in the previous year.

Results: There were 397,042 cardiovascular deaths from January 1, 2020, to June 2, 2020. Deaths caused by ischemic heart disease increased nationally after the onset of the pandemic in 2020, compared with changes over the same period in 2019 (ratio of the relative change in deaths per 100,000 in 2020 vs. 2019: 1.11, 95% confidence interval: 1.04 to 1.18). An increase was also observed for deaths caused by hypertensive disease (1.17, 95% confidence interval: 1.09 to 1.26), but not for heart failure, cerebrovascular disease, or other diseases of the circulatory system. New York City experienced a large relative increase in deaths caused by ischemic heart disease (2.39, 95% confidence interval: 1.39 to 4.09) and hypertensive diseases (2.64, 95% confidence interval: 1.52 to 4.56) during the pandemic. More modest increases in deaths caused by these conditions occurred in the remainder of New York State, New Jersey, Michigan, and Illinois but not in Massachusetts or Louisiana.

Conclusions: There was an increase in deaths caused by ischemic heart disease and hypertensive diseases in some regions of the United States during the initial phase of the COVID-19 pandemic. These findings suggest that the pandemic may have had an indirect toll on patients with cardiovascular disease.
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http://dx.doi.org/10.1016/j.jacc.2020.10.055DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7800141PMC
January 2021

Rationale and Design of the SAFE-PAD Study.

Circ Cardiovasc Qual Outcomes 2021 Jan 13;14(1):e007040. Epub 2021 Jan 13.

Richard A. and Susan F. Smith Center for Outcomes Research in Cardiology (E.A.S., A.R., C.S., L.R.V., R.W.Y.), Beth Israel Deaconess Medical Center, Boston, MA.

Background: Recent evidence from randomized controlled trials has raised concerns about the long-term safety of paclitaxel-coated peripheral devices used for femoropopliteal artery revascularization. In response to a call for more real-world data on the safety of these devices, the SAFE-PAD study (Safety Assessment of Femoropopliteal Endovascular treatment with Paclitaxel-coated Devices) was designed with input from the Food and Drug Administration to provide a long-term, comprehensive evaluation of the mortality risk associated with paclitaxel-coated devices among Medicare beneficiaries.

Methods And Results: SAFE-PAD is an observational cohort study of fee-for-service Medicare beneficiaries that underwent femoropopliteal artery revascularization with either a drug-coated device or nondrug-coated device from 2015 through 2018. All patients age 66 years or older who underwent revascularization will be identified using a combination of procedural codes, Current Procedural Terminology codes, and Healthcare Common Procedure Coding System C-codes. The safety end point of all-cause death will be updated semiannually and continued until the median duration of follow-up surpasses 5 years. Sub-group analyses will be conducted by device type, patient characteristics, and procedural setting. Registration: The SAFE-PAD study has been registered on URL: https://www.clinicaltrials.gov; Unique identifier: NCT04496544.

Conclusions: The SAFE-PAD study will evaluate the long-term safety of drug-coated devices compared with nondrug-coated devices for femoropopliteal artery revascularization among a broad, real-world population of patients with peripheral artery disease.
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http://dx.doi.org/10.1161/CIRCOUTCOMES.120.007040DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7886015PMC
January 2021

Comparability of Event Adjudication Versus Administrative Billing Claims for Outcome Ascertainment in the DAPT Study: Findings From the EXTEND-DAPT Study.

Circ Cardiovasc Qual Outcomes 2021 Jan 13;14(1):e006589. Epub 2021 Jan 13.

Richard A. and Susan F. Smith Center for Outcomes Research in Cardiology, Division of Cardiovascular Medicine, Beth Israel Deaconess Medical Center, Boston MA (K.F.F., H.T., C.S., E.A.S., J.B.S., R.W.Y.).

Background: Data from administrative claims may provide an efficient alternative for end point ascertainment in clinical trials. However, it is uncertain how well claims data compare to adjudication by a clinical events committee in trials of patients with cardiovascular disease.

Methods: We matched 1336 patients ≥65 years old who received percutaneous coronary intervention in the DAPT (Dual Antiplatelet Therapy) Study with the National Cardiovascular Data Registry CathPCI Registry linked to Medicare claims as part of the EXTEND (Extending Trial-Based Evaluations of Medical Therapies Using Novel Sources of Data) Study. Adjudicated trial end points were compared with Medicare claims data with codes from inpatient hospitalizations using time-to-event analyses, sensitivity, specificity, positive predictive value, negative predictive value, and kappa statistics.

Results: At 21-month follow-up, the cumulative incidence of major adverse cardiovascular and cerebrovascular events (combined mortality, myocardial infarction, and stroke) was similar between trial-adjudicated events and claims data (7.9% versus 7.2%, respectively; =0.50). Bleeding rates were lower using adjudicated events compared with claims (5.0% versus 8.6%, respectively; <0.001). The sensitivity and positive predictive value of comprehensive billing codes for identifying adjudicated events were 65.6% and 85.7% for myocardial infarction, 61.5% and 47.1% for stroke, and 76.8% and 39.3% for bleeding, respectively. Specificity and negative predictive value for all outcomes ranged from 93.7% to 99.5%. All 39 adjudicated deaths were identified using Medicare data. Kappa statistics assessing agreement between events for myocardial infarction, stroke, and bleeding were 0.73, 0.52, and 0.49, respectively.

Conclusions: Claims data had moderate agreement with adjudication for myocardial infarction and poor agreement but high specificity for bleeding and stroke in the DAPT Study. Deaths were identified equivalently. Using claims data in clinical trials could be an efficient way to assess mortality among Medicare patients and may help detect other outcomes, although additional monitoring is likely needed to ensure accurate assessment of events.
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http://dx.doi.org/10.1161/CIRCOUTCOMES.120.006589DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7855905PMC
January 2021

Long-Term Safety of Drug-Coated Devices for Peripheral Revascularisation.

EuroIntervention 2020 Dec 22. Epub 2020 Dec 22.

Smith Center for Outcomes Research in Cardiology, Beth Israel Deaconess Medical Center, Bolton, MA, USA.

Aims: Meta-analyses of randomised trials of paclitaxel-coated peripheral devices found an association with worse long-term survival. We assessed long-term mortality in patients treated with drug-coated devices insured by Medicare Advantage (MA), an alternative to traditional Medicare that represents >30% of the Medicare eligible population.

Methods And Results: Patients treated with or without drug-coated devices for femoropopliteal artery revascularisation from 4/2015-12/2017 were studied using Optum's De-identified Clinformatics® Datamart Database. Mortality was assessed through December 2019 using Kaplan Meier cumulative mortality curves and Cox-proportional hazard models. Inverse probability of treatment weighting was used to adjust for differences between groups. Of 16,796 patients revascularised, 4,427 (26.4%) were treated with drug-coated devices: 3,600 (81.3%) balloons and 827 (18.7%) stents. The median follow-up was 2.66 years (IQR 2.02-3.52). Treatment with drug-coated devices was associated with similar long-term mortality as nondrug-coated devices (adjusted HR 1.03; 95%CI=0.96-1.10; P=0.39). Results were comparable for patients treated with balloons alone (adjusted HR 1.00; 95%CI=0.92-1.08; P=0.96) or stents (adjusted HR 1.02; 95%CI=0.88-1.18; P=0.78). These findings did not differ based on treatment setting, disease severity, age, sex or comorbidity burden (interaction P>0.05 for all).

Conclusions: In this large cohort, there was no evidence of increased long-term mortality following treatment with drug-coated devices.
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http://dx.doi.org/10.4244/EIJ-D-20-01018DOI Listing
December 2020

Assessing Health-Related Quality of Life among Patients with Peripheral Artery Disease: A Review of the Literature and Focus on Patient-Reported Outcome Measures.

Vasc Med 2020 Dec 9:1358863X20977016. Epub 2020 Dec 9.

Richard A and Susan F Smith Center for Outcomes Research in Cardiology, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, MA, USA.

Peripheral artery disease (PAD) is a progressive atherosclerotic disease associated with high rates of morbidity and mortality. Symptomatic PAD typically presents with claudication, and symptom severity strongly associates with reduced health-related quality of life (HRQoL). Existing treatment strategies for PAD are aimed at reducing symptom severity and improving functional outcomes. However, there is a need to incorporate patient-reported outcome measures (PROMs) into PAD treatment and research in order to provide more patient-centered care. This review will discuss the impact of PAD on HRQoL, existing PROMs available to assess PAD-related HRQoL, utilization of PROMs in research studies and registries, and challenges and solutions related to the integration of PROMs into research and clinical settings.
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http://dx.doi.org/10.1177/1358863X20977016DOI Listing
December 2020

Longitudinal Management and Outcomes of Acute Coronary Syndrome in Persons Living with HIV Infection.

Eur Heart J Qual Care Clin Outcomes 2020 Nov 23. Epub 2020 Nov 23.

Department of Medicine, University of California San Francisco.

Aims: Persons living with HIV (PLWH) have increased cardiovascular mortality, which may in part be due to differences in the management of acute coronary syndromes (ACS). The purpose of this study was to compare the in-hospital and post-discharge management and outcomes of ACS among persons with and without HIV.

Methods And Results: This was a retrospective cohort study using data from Symphony Health, a data warehouse. All patients admitted between 1/1/2014-12/31/2016 with ACS were identified by ICD billing codes. Multivariate logistic regression models were used to examine in-hospital, 30-day and 12-month event rates between groups. 1,125,126 individuals were included, 6,612 (0.59%) with HIV. PLWH were younger (57.4 ± 10.5 vs 67.4 ± 12.9 years, p<.0001) and had more medical comorbidities. ACS type did not differ significantly with HIV status. PLWH were less likely to undergo coronary angiography (35.2% vs 37.2%, adjusted OR 0.87, 95% CI 0.83-0.92, p <.0001), and those with both HIV and STEMI underwent fewer drug eluting stents (60.1% vs 68.5%, adjusted OR 0.81, 95% CI 0.68-0.96, p = 0.016). PLWH had higher adjusted rates of inpatient mortality (OR 1.29, 95% CI 1.15-1.44, p <.0001), 30-day readmission (OR 1.18, 95% CI 1.09-1.27, p <.0001) and 12-month mortality (OR 1.32, 95% CI 1.22-1.44, p <.0001). 12 months following discharge, PLWH filled cardiac medications at lower rates.

Conclusion: In a contemporary cohort of persons hospitalized for ACS, PLWH received less guideline-supported interventional and medical therapies and had worse clinical outcomes. Strategies to optimize care are warranted in this unique population.
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http://dx.doi.org/10.1093/ehjqcco/qcaa088DOI Listing
November 2020

Impact of adherence to the hybrid algorithm for initial crossing strategy selection in chronic total occlusion percutaneous coronary intervention.

Rev Esp Cardiol (Engl Ed) 2020 Nov 12. Epub 2020 Nov 12.

Coronary Artery Disease Science Center, Minneapolis Heart Institute, Minneapolis Heart Institute Foundation, Abbott Northwestern Hospital, Minneapolis, Minnesota, United States. Electronic address:

Introduction And Objectives: The hybrid algorithm was designed to assist with initial and subsequent crossing strategy selection in chronic total occlusion (CTO) percutaneous coronary interventions (PCIs). However, the success of the initially selected strategy has received limited study.

Methods: We examined the impact of adherence to the hybrid algorithm recommendation for initial CTO crossing technique selection in 4178 CTO PCIs from a large multicenter registry.

Results: The initial crossing strategy was concordant with the hybrid algorithm recommendation in 1833 interventions (44%). Patients in the concordant group had a similar age to those in the discordant group but a lower mean J-CTO score (2.0 ± 1.4 vs 2.8 ± 1.1; P < .01). The concordant group showed higher technical success with the first crossing strategy (68% vs 48%; P < .01) and higher overall technical success (88% vs 83%; P < .01) with no difference in the incidence of in-hospital major adverse events (1.8% vs 2.3%; P = .26). In multivariable analysis, after adjustment for age, prior myocardial infarction, prior PCI, prior coronary artery bypass grafting, J-CTO score, and scheduled CTO PCI, nonadherence to the hybrid algorithm was independently associated with lower technical success of the initial crossing strategy (odds ratio, 0.55; 95% confidence interval, 0.48-0.64; P < .01).

Conclusions: Adherence to the hybrid algorithm for initial crossing strategy selection is associated with higher CTO PCI success but similar in-hospital major adverse cardiac events.
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http://dx.doi.org/10.1016/j.rec.2020.09.009DOI Listing
November 2020

Temporal Changes and Institutional Variation in Use of Percutaneous Coronary Intervention for ST-Elevation Myocardial Infarction With Multivessel Coronary Artery Disease in the United States: An NCDR Research to Practice Project.

JAMA Cardiol 2020 Nov 4. Epub 2020 Nov 4.

Richard A. and Susan F. Smith Center for Outcomes Research in Cardiology, Department of Medicine, Beth Israel Deaconess Medical Center, Boston, Massachusetts.

Importance: After disparate results from observational and small randomized studies, the COMPLETE trial demonstrated superiority of multivessel (MV) percutaneous coronary intervention (PCI) over culprit-only PCI for ST-elevation myocardial infarction (STEMI).

Objective: To describe temporal trends and institutional variation of MV PCI use for STEMI in the United States to inform how new evidence may influence clinical practice.

Design, Setting, And Participants: This cohort study included STEMI admissions involving MV disease from 1598 institutions in the National Cardiovascular Data Registry CathPCI Registry from the third quarter of 2009 to the first quarter of 2018. An MV PCI was defined as a PCI to a nonculprit lesion within 45 days of the index procedure.

Exposures: Multivessel PCI, defined as placement of coronary stents in 2 or more major epicardial vessels or the staged placement of 1 or more coronary stents in a major epicardial vessel distinct from the index culprit vessel, within 45 days of the index PCI.

Main Outcomes And Measures: Outcomes included the proportional use of MV PCI among STEMI admissions with MV disease, and the timing of MV PCI (an index procedure, a staged procedure during index hospitalization, or a postdischarge procedure within 45 days).

Results: Among 359 879 admissions with STEMI and MV disease, MV PCI was performed in 38.5% (n = 138 380; mean [SD] age of patients, 62.3 [12.3] years; 102 266 men [73.9%]) within 45 days. Of those receiving MV PCIs, 30.8% (n = 42 629) had a procedure performed during the index procedure, 31.6% (n = 43 696) as a staged procedure during the index hospitalization, and 37.6% (n = 52 055) within 45 days of discharge. Complete revascularization of all diseased arteries was performed in 76.2% (n = 105 389). From the third quarter of 2009 to the second quarter of 2013, MV PCI use declined by 10%, from 42.7% (3230 of 7572 cases) to a nadir of 32.7% (3386 of 10 342 cases), followed by an increase to 44.0% (5062 of 11 497 cases) by the fourth quarter of 2017. During this time, there was a 13.6% decline in use of postdischarge staged MV PCI (from 23.4% of STEMI cases [1772 of 7572 cases] in the third quarter of 2009 to 9.9% [1094 of 11 171 cases] in the fourth quarter of 2014) and an 12.5% increase in MV PCI performed during the index admission (from 19.3% [1458 of 7572 cases] in the third quarter of 2009 to 31.8% [3557 of 11 171 cases] in the first quarter of 2018). Multivessel PCI use varied substantially across institutions, with a median use of 37.9% (interquartile range, 30.0%-46.5%).

Conclusions And Relevance: In this large, nationwide analysis, MV PCI use for patients with STEMI has been increasing through early 2018 but was used in the minority of patients and with wide variability across US institutions. The adoption of new trial results into guidelines and practice may further promote the growth of MV PCI.
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http://dx.doi.org/10.1001/jamacardio.2020.5354DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7643043PMC
November 2020

Utility of the dual antiplatelet therapy score to guide antiplatelet therapy: A systematic review and meta-analysis.

Catheter Cardiovasc Interv 2021 Mar 28;97(4):569-578. Epub 2020 Oct 28.

Richard A. and Susan F. Smith Center for Outcomes Research, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts, USA.

Background: The dual antiplatelet therapy (DAPT) score, one of the first prediction tools to attempt to uncouple bleeding and ischemic risk following percutaneous coronary intervention, can help guide antiplatelet duration after coronary intervention. Evaluating the generalizability of the score is important to understand its utility in clinical practice.

Methods: We conducted a systematic review and meta-analysis of studies that validated the DAPT score. A random effect meta-analysis was performed of ischemic and bleeding risk based on DAPT score. A secondary analysis assessed the risk of longer versus shorter P2Y inhibitor duration on ischemic and bleeding risk in randomized controlled trials of DAPT duration.

Results: We identified 10 patient cohorts involving 88,563 patients. Compared with a low DAPT score, a high DAPT score was associated with increased ischemic risk (RR: 1.62, 95% CI: 1.41-1.87) and reduced bleeding risk (RR: 0.80, 95% CI: 0.70-0.92). In three randomized trials of DAPT duration that contained information on the DAPT score, the relative risk of net adverse clinical events (combined ischemic and bleeding events) with longer duration of DAPT was 1.56 (95% CI: 0.77-3.19) for low DAPT score patients, and 0.86 (95% CI: 0.61-1.21) for high DAPT score patients (p = .14).

Conclusions: In this large meta-analysis, the DAPT score consistently stratified bleeding and ischemic risk in opposing directions across several different study populations. More evaluation is needed to understand if the effect of longer DAPT duration on NACE is modified by the DAPT score in current practice.
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http://dx.doi.org/10.1002/ccd.29352DOI Listing
March 2021

Intermediate procedural and health status outcomes and the clinical care pathways after chronic total occlusion angioplasty: A report from the OPEN-CTO (outcomes, patient health status, and efficiency in chronic total occlusion hybrid procedures) study.

Catheter Cardiovasc Interv 2020 Oct 27. Epub 2020 Oct 27.

Saint Luke's Mid America Heart Institute, Kansas City, Missouri, USA.

Background: No previous reports have described the comprehensive care pathways involved in chronic total occlusion percutaneous coronary intervention (CTO PCI).

Methods: In a study of 1,000 consecutive patients undergoing CTO PCI using hybrid approach, a systematic algorithm of selecting CTO PCI strategies, the procedural characteristics, complication rates, and patient reported health status outcomes through 12 months were assessed.

Results: Technical success of the index CTO PCI was 86%, with 89% of patients having at least one successful CTO PCI within 12 months. A total of 13.8% underwent CTO PCI of another vessel or reattempt of index CTO PCI within 1 year. At 1 year, the unadjusted major adverse cardiac and cerebral event (MACCE) rate was lower in patients with successful index CTO PCI compared to patients with unsuccessful index CTO PCI (9.4% vs. 14.6%, p = .04). The adjusted hazard ratios of myocardial infarction and death at 12 months were numerically lower in patients with successful index CTO PCI, compared to patients with unsuccessful index CTO PCI. Patients with successful index CTO PCI reported significantly greater improvement in health status throughout 12-months compared to patients with unsuccessful index CTO PCI.

Conclusion: CTO-PCI in the real-world often require treatment of second CTO, non-CTO PCI or repeat procedures to treat initially unsuccessful lesions. Successful CTO PCI is associated with numerically lower MACCE at 1 year and persistent symptomatic improvement compared to unsuccessful CTO PCI. Understanding the relationship between the care pathways following CTO PCI and health status benefit requires further study.
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http://dx.doi.org/10.1002/ccd.29343DOI Listing
October 2020

Misclassification of Hospital Performance Under the Hospital Readmissions Reduction Program: Implications for Value-Based Programs.

JAMA Cardiol 2021 Mar;6(3):332-335

Richard A. and Susan F. Smith Center for Outcomes Research in Cardiology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts.

Importance: The Centers for Medicare and Medicaid Services (CMS) use point estimates of 30-day risk-standardized readmission rates (RSRRs) to compare hospitals under the Hospital Readmissions Reduction Program (HRRP). An important characteristic of this measure is that it is a point estimate with a margin of error, which may affect the CMS's ability to accurately evaluate and distinguish hospital performance in the program.

Objective: To determine the number and percentage of hospitals with a penalty status misclassified under the HRRP.

Design, Setting, And Participants: This cross-sectional study used the bayesian deconvolution method to estimate the rate of penalty status misclassification for hospitals participating in the HRRP in fiscal year 2019, using data from the CMS Hospital Compare website that were collected between July 1, 2014, and June 30, 2017. Beneficiaries of Medicare fee-for-service coverage who were 65 years or older and hospitalized with acute myocardial infarction, heart failure, or pneumonia in hospitals with 25 or more discharges per condition were included in the data set. Data analysis occurred from November 2019 to July 2020.

Exposures: None.

Main Outcomes And Measures: The rate of penalty status misclassification for acute myocardial infarction, heart failure, or pneumonia under the HRRP.

Results: The study included 1633, 2626, and 2705 hospitals for acute myocardial infarction, heart failure, and pneumonia, respectively, that participated in the HRRP in fiscal year 2019. The percentages of hospitals that should have been penalized, but were not, were 20.9% (95% CI, 16.0%-25.8%) for acute myocardial infarction, 13.5% (95% CI, 9.8%-17.2%) for heart failure, and 13.2% (95% CI, 10.3%-16.1%) for pneumonia. In contrast, the percentages of hospitals that were incorrectly penalized by the HRRP were 10.1% (95% CI, 5.8%-14.4%) for acute myocardial infarction, 10.9% (95% CI, 7.2%-14.6%) for heart failure, and 12.3% (95% CI, 9.9%-14.6%) for pneumonia.

Conclusions And Relevance: The margin of error associated with the 30-day RSRRs resulted in the misclassification of condition-specific penalty status for up to 31% of hospitals. These findings suggest that the hospital-level 30-day RSRR measure may not reliably distinguish hospital performance in the HRRP. This has important implications for CMS value-based programs that use risk-standardized outcomes to evaluate and compare hospital performance.
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http://dx.doi.org/10.1001/jamacardio.2020.4746DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7557505PMC
March 2021

Evaluation of Hospital Performance Using the Excess Days in Acute Care Measure in the Hospital Readmissions Reduction Program.

Ann Intern Med 2021 01 13;174(1):86-92. Epub 2020 Oct 13.

Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, Massachusetts (R.K.W., B.E.L., C.S., R.W.Y.).

The Hospital Readmissions Reduction Program (HRRP) has penalized hospitals with higher 30-day readmission rates more than $3 billion to date. Clinicians and policy experts have raised concerns that the 30-day readmission measure used in this program provides an incomplete picture of performance because it does not capture all hospital encounters that may occur after discharge. In contrast, the excess days in acute care (EDAC) measure, which currently is not used in the HRRP, captures the full spectrum of hospital encounters (emergency department, observation stay, inpatient readmission) and their associated lengths of stay within 30 days of discharge. This study of 3173 hospitals that participated in the HRRP in fiscal year 2019 compared performance on the readmission and EDAC measures and evaluated whether using the EDAC measure would change hospitals' penalty status for 3 conditions targeted by the HRRP. Overall, only moderate agreement was found on hospital performance rankings by using the readmission and EDAC measures (weighted κ statistic: heart failure, 0.45 [95% CI, 0.42 to 0.47]; acute myocardial infarction [AMI], 0.37 [CI, 0.35 to 0.40]; and pneumonia, 0.50 [CI, 0.47 to 0.52]). Under the HRRP, the penalty status of 769 (27.0%) of 2845 hospitals for heart failure, 581 (28.3%) of 2055 for AMI, and 724 (24.9%) of 2911 for pneumonia would change if the EDAC measure were used instead of the readmission measure to evaluate performance. Fewer small and rural hospitals would receive penalties. The Centers for Medicare & Medicaid Services should consider using the EDAC measure, which provides a more comprehensive picture of postdischarge hospital use, rather than the 30-day readmission measure to evaluate health care system performance under federal quality, reporting, and value-based programs.
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http://dx.doi.org/10.7326/M20-3486DOI Listing
January 2021

Trends and Outcomes of Restenosis After Coronary Stent Implantation in the United States.

J Am Coll Cardiol 2020 09;76(13):1521-1531

AbioMed Inc., Danvers, Massachusetts.

Background: There is a paucity of data on the burden of in-stent restenosis (ISR) in the United States as well as on its presentation and appropriate treatment strategies.

Objectives: This study aims to provide an analysis of the temporal trends, clinical presentation, treatment strategies, and in-hospital outcomes of patients undergoing percutaneous coronary intervention (PCI) for ISR in the United States.

Methods: This study is a retrospective analysis of data collected in the Diagnostic Catheterization and Percutaneous Coronary Intervention (CathPCI) registry of the National Cardiovascular Data Registry (NCDR) between 2009 and 2017. Of the total patients undergoing PCI, we identified those undergoing PCI for ISR lesions. For comparison of in-hospital outcomes, propensity-score matching was employed.

Results: Among the 5,100,394 patients undergoing PCI, 10.6% of patients underwent PCI for ISR lesions. Patients with bare-metal stent ISR declined from 2.6% in 2009 Q3 to 0.9% in 2017 Q2 (p < 0.001), and drug-eluting stent ISR rose from 5.4% in 2009 Q3 to 6.3% in 2017 Q2 (p < 0.001). Patients with ISR PCI were less likely to present with non-ST-segment elevation myocardial infarction (MI) (18.7% vs. 22.5%; p < 0.001) or ST-segment elevation MI (8.5% vs. 15.7%; p < 0.001). In the propensity-matched population of patients, there were no significant differences between patients with ISR and non-ISR PCI for in-hospital complications and hospital length of stay.

Conclusions: ISR represents approximately 10% of all PCI and is treated most commonly with another stent. Approximately 25% of patients present with acute MI. In-hospital outcomes of patients with ISR PCI are comparable with those undergoing non-ISR PCI.
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http://dx.doi.org/10.1016/j.jacc.2020.08.002DOI Listing
September 2020

CMS Quality Measure Development-Reply.

JAMA 2020 09;324(12):1214-1215

Richard A. and Susan F. Smith Center for Outcomes Research in Cardiology, Beth Israel Deaconess Medical Center, Boston, Massachusetts.

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http://dx.doi.org/10.1001/jama.2020.12073DOI Listing
September 2020

Association Between 90-Minute Door-to-Balloon Time, Selective Exclusion of Myocardial Infarction Cases, and Access Site Choice: Insights From the Cardiac Care Outcomes Assessment Program (COAP) in Washington State.

Circ Cardiovasc Interv 2020 09 4;13(9):e009179. Epub 2020 Sep 4.

Cardiovascular Division, Hospital of the University of Pennsylvania, Philadelphia (A.S.N., S.A.M.K., H.C.H., J.G., A.C.F.).

Background: For patients presenting with ST-segment-elevation myocardial infarction, national quality initiatives monitor hospitals' proportion of cases with door-to-balloon (D2B) time under 90 minutes. Hospitals are allowed to exclude patients from reporting and may modify behavior to improve performance. We sought to identify whether there is a discontinuity in the number of cases included in the D2B time metric at 90 minutes and whether operators were increasingly likely to pursue femoral access in patients with less time to meet the 90-minute quality metric.

Methods: Adult patients with ST-segment-elevation myocardial infarction undergoing primary percutaneous coronary intervention from 2011 to 2018 were identified from the Cardiac Care Outcomes Assessment Program, a quality improvement registry in Washington state. We used the regression discontinuity framework to test for discontinuity at 90 minutes among the included cases. We defined a novel variable, remaining D2B as 90 minutes minus the time between hospital arrival and catheterization laboratory arrival. We estimated multivariable logistic regression models to assess the relationship between remaining D2B time and access site.

Results: A total of 19 348 patients underwent primary percutaneous coronary intervention and were included in the analysis. Overall, 7436 (38.4%) were excluded from the metric. There appeared to be a visual discontinuity in included cases around 90 minutes; however, local quadratic regression around the 90-minute cutoff did not reveal evidence of a significant discontinuity (=0.66). Multivariable analysis showed no significant relationship between remaining D2B time and the odds of undergoing femoral access (=0.73).

Conclusions: Among patients undergoing percutaneous coronary intervention for ST-segment-elevation myocardial infarction, we did not find evidence of a statistically significant discontinuity in the frequency of included cases around 90 minutes or an increased preference for femoral access correlated with decreasing time to meet the 90-minute D2B time quality metric. Together, these findings indicate no evidence of widespread inappropriate methods to improve performance on D2B time metrics.
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http://dx.doi.org/10.1161/CIRCINTERVENTIONS.120.009179DOI Listing
September 2020

Outcomes of retrograde chronic total occlusion percutaneous coronary intervention: A report from the OPEN-CTO registry.

Catheter Cardiovasc Interv 2020 Sep 2. Epub 2020 Sep 2.

Center for Interventional Vascular Therapy, Columbia University Irving Medical Center, New York, New York.

Objectives: We sought to assess in-hospital and long-term outcomes of retrograde compared with antegrade-only percutaneous coronary intervention for chronic total occlusion (CTO PCI).

Background: Procedural and clinical outcomes following retrograde compared with antegrade-only CTO PCI remain unknown.

Methods: Using the core-lab adjudicated OPEN-CTO registry, we compared the outcomes of retrograde to antegrade-only CTO PCI. Primary endpoints included were in-hospital major adverse cardiac and cerebrovascular events (MACCE) (all-cause death, stroke, myocardial infarction [MI], emergency cardiac surgery, or clinically significant perforation) and MACCE at 1-year (all-cause death, MI, stroke, target lesion revascularization, or target vessel reocclusion).

Results: Among 885 single CTO procedures from the OPEN-CTO registry, 454 were retrograde and 431 were antegrade-only. Lesion complexity was higher (J-CTO score: 2.7 vs. 1.9; p < .001) and technical success lower (82.4 vs. 94.2%; p < .001) in retrograde compared with antegrade-only procedures. All-cause death was higher in the retrograde group in-hospital (2 vs. 0%; p = .003), but not at 1-year (4.9 vs. 3.3%; p = .29). Compared with antegrade-only procedures, in-hospital MACCE rates (composite of all-cause death, stroke, MI, emergency cardiac surgery, and clinically significant perforation) were higher in the retrograde group (10.8 vs. 3.3%; p < .001) and at 1-year (19.5 vs. 13.9%; p = .03). In sensitivity analyses landmarked at discharge, there was no difference in MACCE rates at 1 year following retrograde versus antegrade-only CTO PCI. Improvements in Seattle Angina Questionnaire Quality of Life scores at 1-year were similar between the retrograde and antegrade-only groups (29.9 vs 30.4; p = .58).

Conclusions: In the OPEN-CTO registry, retrograde CTO procedures were associated with higher rates of in-hospital MACCE compared with antegrade-only; however, post-discharge outcomes, including quality of life improvements, were similar between technical modalities.
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http://dx.doi.org/10.1002/ccd.29230DOI Listing
September 2020

Long-Term Outcomes of In-Stent Restenosis Percutaneous Coronary Intervention among Medicare Beneficiaries.

EuroIntervention 2020 Sep 1. Epub 2020 Sep 1.

Richard A. and Susan F. Smith Center for Outcomes Research in Cardiology, Division of Cardiology, Beth Israel Deaconess Medical Center, Boston, MA, USA.

Aims: This study evaluated the long-term outcomes of patients undergoing percutaneous coronary intervention (PCI) for in-stent restenosis (ISR).

Methods And Results: National Cardiovascular Data Registry CathPCI records for individuals aged ≥65 years undergoing PCI from July 2009-December 2014 were linked to Medicare claims. Baseline characteristics and long-term rates of death, myocardial infarction (MI), repeat revascularization including target vessel revascularization (TVR), and major adverse cardiovascular and cerebrovascular events (MACCE) were compared between ISR PCI versus de novo lesion PCI. Of 653,304 individuals, 10.2% underwent ISR PCI and 89.8% underwent de novo lesion PCI. The median duration of follow-up was 825 days (quartile 1: 352 days - quartile 3: 1379 days). Frequency of MACCE (55.6% vs. 45.0%; P<0.001), all-cause mortality (27.8% vs. 25.5%; P<0.001), MI (19.0% vs. 12.3%; P<0.001), repeat revascularization (31.9% vs. 18.6%; P<0.001), TVR (22.4% vs. 8.0%; P<0.001), and stroke (8.8% vs. 8.3%; P=0.005) were higher after ISR PCI. After multivariable adjustment, ISR PCI remained associated with worse long-term outcomes (hazard ratio [HR] for MACCE 1.24 [95% CI: 1.22, 1.26], mortality 1.07 [95% CI: 1.05, 1.09], MI 1.44 [95% CI: 1.40, 1.48], repeat revascularization 1.55 [95% CI: 1.51, 1.59], and TVR 2.50 [95% CI: 2.42, 2.58]).

Conclusions: ISR PCI was common and associated with significantly higher risk of recurrent long-term major ischemic events compared to patients undergoing de novo lesion PCI. There remains a need for new strategies to minimize ISR.
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http://dx.doi.org/10.4244/EIJ-D-19-01031DOI Listing
September 2020