Anticoagulation Alone vs Anticoagulation Plus Aspirin or DAPT Following Left Atrial Appendage Occlusion.

BACKGROUND: The prevalence of and outcomes associated with different antithrombotic strategies after left atrial appendage occlusion (LAAO) are not well described. OBJECTIVES: This study sought to evaluate patterns of antithrombotic medication strategies at discharge following LAAO with the Watchman FLX device in real-world practice and to compare the risk of adverse events among the different antithrombotic regimens. METHODS: The authors evaluated patients in the NCDR (National Cardiovascular Data Registry) LAAO Registry who underwent LAAO with the second-generation LAA closure device between 2020 and 2022. They grouped patients by mutually exclusive discharge antithrombotic strategies and compared the rates of adverse events at 45 days and 6 months using multivariable Cox proportional hazards regression. RESULTS: Among 53,878 patients undergoing successful LAAO with the second-generation LAA closure device, the most common antithrombotic discharge regimens were direct oral anticoagulant (DOAC) plus aspirin (48.3%), DOAC alone (22.6%), dual antiplatelet therapy (8.1%), warfarin plus aspirin (7.7%), and DOAC plus P2Y12 inhibitor (4.9%). In multivariate analysis, DOAC alone had a lower rate of major adverse events and major bleeding at 45 days of follow-up compared with DOAC plus aspirin (major adverse events: HR: 0.78; 95% CI: 0.68-0.91; major bleeding: HR: 0.69; 95% CI: 0.60-0.80). These differences persisted at 6 months. Warfarin without aspirin also showed lower rates of major bleeding at both time points. No differences were seen in stroke/transient ischemic attack or device-related thrombus. CONCLUSIONS: In real-world U.S. practice, discharge on DOAC alone or warfarin alone was associated with a lower rate of adverse events compared with DOAC plus aspirin.

Trends and Disparities in Ambulatory Follow-Up After Cardiovascular Hospitalizations : A Retrospective Cohort Study.

BACKGROUND: Timely follow-up after cardiovascular hospitalization is recommended to monitor recovery, titrate medications, and coordinate care. OBJECTIVE: To describe trends and disparities in follow-up after acute myocardial infarction (AMI) and heart failure (HF) hospitalizations. DESIGN: Retrospective cohort study. SETTING: Medicare. PARTICIPANTS: Medicare fee-for-service beneficiaries hospitalized between 2010 and 2019. MEASUREMENTS: Receipt of a cardiology visit within 30 days of discharge. Multivariable logistic regression models were used to estimate changes over time overall and across 5 sociodemographic characteristics on the basis of known disparities in cardiovascular outcomes. RESULTS: The cohort included 1 678 088 AMI and 4 245 665 HF hospitalizations. Between 2010 and 2019, the rate of cardiology follow-up increased from 48.3% to 61.4% for AMI hospitalizations and from 35.2% to 48.3% for HF hospitalizations. For both conditions, follow-up rates increased for all subgroups, yet disparities worsened for Hispanic patients with AMI and patients with HF who were Asian, Black, Hispanic, Medicaid dual eligible, and residents of counties with higher levels of social deprivation. By 2019, the largest disparities were between Black and White patients (AMI, 51.9% vs. 59.8%, difference, 7.9 percentage points [pp] [95% CI, 6.8 to 9.0 pp]; HF, 39.8% vs. 48.7%, difference, 8.9 pp [CI, 8.2 to 9.7 pp]) and Medicaid dual-eligible and non-dual-eligible patients (AMI, 52.8% vs. 60.4%, difference, 7.6 pp [CI, 6.9 to 8.4 pp]; HF, 39.7% vs. 49.4%, difference, 9.6 pp [CI, 9.2 to 10.1 pp]). Differences between hospitals explained 7.3 pp [CI, 6.7 to 7.9 pp] of the variation in follow-up for AMI and 7.7 pp [CI, 7.2 to 8.1 pp]) for HF. LIMITATION: Generalizability to other payers. CONCLUSION: Equity-informed policy and health system strategies are needed to further reduce gaps in follow-up care for patients with AMI and patients with HF. PRIMARY FUNDING SOURCE: National Institute on Aging.

Use of Calcium Modification During Percutaneous Coronary Intervention After Introduction of Coronary Intravascular Lithotripsy.

Background: Calcified coronary lesions are a challenge for percutaneous coronary interventions (PCIs). Coronary intravascular lithotripsy (IVL) is a novel calcium modification technology approved for commercial use in February 2021, but little is known about its uptake in US clinical practice. Methods: We described trends in use of calcium modification strategies, variation in use across hospitals, and predictors of calcium modification and IVL use in PCI. We included National Cardiovascular Data Registry CathPCI Registry patients who underwent PCI between April 1, 2018, and December 31, 2022. We examined trends and hospital variation in calcium modification and IVL use. We used multivariate hierarchical logistic regression to identify predictors of calcium modification and IVL use at hospitals in 2022. Results: Of 2,733,494 PCIs across 1676 hospitals over 4.75 years, 11.4% were performed with calcium modification. Coronary IVL use increased rapidly from 0% of PCIs in Q4 2020 to 7.8% of PCIs in Q4 2022, which was accompanied by an overall increase in use of all calcium modification strategies (11.1%-16.0%) during this period with a slight corresponding decrease in coronary atherectomy use (5.4%-4.4%). In 2022, there was wide variation in IVL use across hospitals (median, 3.86%; IQR, 0%-8.19%), with IVL being the most common calcium modification strategy in 48% of hospitals. The treating hospital was the strongest predictor of calcium modification (median odds ratio [OR], 2.49; 95% CI, 2.40-2.57) and IVL use (median OR, 2.89; 95% CI, 2.74-3.04). Conclusions: IVL has rapidly changed the landscape of calcium modification use for PCI, although there remains wide variation across hospitals.

Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry.

BACKGROUND: PINNACLE FLX (Protection Against Embolism for Nonvalvular AF Patients: Investigational Device Evaluation of the WATCHMAN FLX LAA Closure Technology) demonstrated improved outcomes and low incidence of adverse events with the WATCHMAN FLX device in a controlled setting. The National Cardiovascular Disease Registry's Left Atrial Appendage Occlusion Registry was utilized to assess the safety and effectiveness of WATCHMAN FLX in contemporary clinical practice in the United States. METHODS: The WATCHMAN FLX Device Surveillance Post Approval Analysis Plan used data from the Left Atrial Appendage Occlusion registry to identify patients undergoing WATCHMAN FLX implantation between August 2020 and September 2022. The key safety end point was defined as all-cause death, ischemic stroke, systemic embolism, or device or procedure-related events requiring open cardiac surgery or major endovascular intervention between device implantation and hospital discharge. Major adverse events were reported at hospital discharge, 45 days, and 1 year. RESULTS: Among 97 185 patients in the Left Atrial Appendage Occlusion registry undergoing WATCHMAN FLX, successful implantation occurred in 97.5% (n=94 784) of patients. The key safety end point occurred in 0.45% of patients. At 45 days post-procedure, all-cause death occurred in 0.81% patients, ischemic stroke in 0.23%, major bleeding in 3.1%, pericardial effusion requiring intervention in 0.50%, device-related thrombus in 0.44%, and device embolism in 0.04% patients. No peri-device leak was observed in 83.1% of patients at 45 days. At 1 year, the rate of all-cause death was 8.2%, the rate of any stroke was 1.5% (ischemic stroke, 1.2%), and major bleeding occurred in 6.4% of patients. CONCLUSIONS: In a large contemporary cohort of patients with the WATCHMAN FLX device, the rates of implant success and clinical outcomes through 1 year were comparable with the PINNACLE FLX study, demonstrating that favorable outcomes achieved in the pivotal approval study can be replicated in routine clinical practice.

Factors Underlying Reduced Hospitalizations for Myocardial Infarction During the COVID-19 Pandemic.

Importance: The incidence of hospital encounters for acute myocardial infarction (AMI) decreased sharply early in the COVID-19 pandemic and has not returned to prepandemic levels. There has been an ongoing debate about what mechanism may underlie this decline, including patients avoiding the hospital for treatment, excess mortality from COVID-19 among patients who would otherwise have had an AMI, a reduction in the incidence or severity of AMIs due to pandemic-related changes in behavior, or a preexisting temporal trend of lower AMI incidence. Objective: To describe drivers of changing incidence in AMI hospital encounters during the COVID-19 pandemic. Design, Setting, and Participants: This cross-sectional study used traditional Medicare claims from all patients enrolled in traditional Medicare from January 2016 to June 2023 (total of 2.85 billion patient-months) to calculate the rate of AMI hospital encounters (emergency department visits, observation stays, or inpatient admissions) per capita at all short-term acute care and critical access hospitals in the United States overall and by patient characteristics. Observed rates were compared with expected rates that accounted for shifts in population characteristics and the prepandemic temporal trend (as estimated over 2016-2019). Data were analyzed in November 2023. Main Outcomes and Measures: Hospital encounters for AMI. Results: On average, the study sample included 31 623 928 patients each month from January 2016 through June 2023, for a total of 2 846 153 487 patient-months during the 90-month study period. In June 2023, there were 0.044 AMI hospital encounters per 100 patients, which was 20% lower than in June 2019 (0.055 encounters per 100 patients). Early in the pandemic, AMI rates moved inversely with COVID-19 death rates and tracked patterns seen for other painful acute conditions, such as nephrolithiasis, suggesting these changes were associated with care avoidance. Changes in patient characteristics driven by excess deaths during the pandemic explained little of the decline. Later in the pandemic, the decline may be explained by the long-standing downward trend in AMI incidence; by April 2022, the observed rate of encounters matched the expected rate that accounted for this trend. During the full pandemic period, from March 2020 to June 2023, there were an estimated 5% (95% prediction interval, 1%-9%) fewer AMI hospital encounters than expected. Conclusions and Relevance: The early reduction in AMI encounters was likely driven by care avoidance, while ongoing reductions through June 2023 likely reflect long-standing temporal trends. During the pandemic, there were 5% fewer AMI encounters than expected.

Failure to Rescue After Percutaneous Coronary Intervention: Insights From the National Cardiovascular Data Registry.

BACKGROUND: Failure to rescue (FTR) describes in-hospital mortality following a procedural complication and has been adopted as a quality metric in multiple specialties. However, FTR has not been studied for percutaneous coronary intervention (PCI) complications. METHODS: This is a retrospective study of patients undergoing PCI from the American College of Cardiology National Cardiovascular Data Registry's CathPCI Registry between April 1, 2018, and June 30, 2021. PCI complications evaluated were significant coronary dissection, coronary artery perforation, vascular complication, significant bleeding within 48 hours, new cardiogenic shock, and tamponade. Secular trends for FTR were evaluated with descriptive analysis, and hospital-level variation and clinical predictors were analyzed with logistic regression. RESULTS: Among 2 196 661 patients undergoing PCI at 1483 hospitals, 3.5% had at least 1 PCI complication. In-hospital mortality occurred more frequently following a complication compared with cases without a complication (19.7% versus 1.3%). FTR increased during the study period from 17.1% to 20.1% (P<0.001). The median odds ratio for FTR was 1.48 (95% CI, 1.44-1.53) indicating significant hospital-level variation. Spearman rank correlation demonstrated the modest correlation between FTR and in-hospital mortality, 0.525 (P<0.001). CONCLUSIONS: Major procedural complications during PCI are infrequent, but FTR occurs in roughly 1 in 5 patients following a PCI procedural complication with significant hospital-level variation. Improved understanding of practices associated with low FTR could meaningfully improve patient outcomes following a PCI complication.

Who Should Undergo Chronic Total Occlusions Percutaneous Coronary Intervention and When?: An Evidence-Based Approach to the Patient Referred for Percutaneous Coronary Intervention of Chronic Total Occlusion.

Chronic total occlusions (CTO) of the coronary arteries are common among patients presenting to the cardiac catheterization laboratory, and data suggests a worse overall prognosis in patients with CTOs. Percutaneous coronary intervention (PCI) of CTOs has been shown to improve anginal symptoms in observational studies and in a limited number of randomized trials. However, CTO PCI has not been shown to lead to a reduction in other important end points such as myocardial infarction or death. Furthermore, despite recent advances in the field, CTO PCI still carries higher risks and a lower likelihood of success compared with non-CTO PCI. Thus, determining which patients may be appropriate for CTO PCI is challenging and must involve a comprehensive risk-benefit analysis and discussion with the patient. Therefore, we review the currently available data regarding CTO PCI, including the clinical outcomes, the role of preprocedural ischemia testing, and various procedural success and risk stratification scores. Finally, we present our approach to the patient referred for CTO PCI.

Projected Changes in Statin and Antihypertensive Therapy Eligibility With the AHA PREVENT Cardiovascular Risk Equations.

Importance: Since 2013, the American College of Cardiology (ACC) and American Heart Association (AHA) have recommended the pooled cohort equations (PCEs) for estimating the 10-year risk of atherosclerotic cardiovascular disease (ASCVD). An AHA scientific advisory group recently developed the Predicting Risk of cardiovascular disease EVENTs (PREVENT) equations, which incorporated kidney measures, removed race as an input, and improved calibration in contemporary populations. PREVENT is known to produce ASCVD risk predictions that are lower than those produced by the PCEs, but the potential clinical implications have not been quantified. Objective: To estimate the number of US adults who would experience changes in risk categorization, treatment eligibility, or clinical outcomes when applying PREVENT equations to existing ACC and AHA guidelines. Design, Setting, and Participants: Nationally representative cross-sectional sample of 7765 US adults aged 30 to 79 years who participated in the National Health and Nutrition Examination Surveys of 2011 to March 2020, which had response rates ranging from 47% to 70%. Main Outcomes and Measures: Differences in predicted 10-year ASCVD risk, ACC and AHA risk categorization, eligibility for statin or antihypertensive therapy, and projected occurrences of myocardial infarction or stroke. Results: In a nationally representative sample of 7765 US adults aged 30 to 79 years (median age, 53 years; 51.3% women), it was estimated that using PREVENT equations would reclassify approximately half of US adults to lower ACC and AHA risk categories (53.0% [95% CI, 51.2%-54.8%]) and very few US adults to higher risk categories (0.41% [95% CI, 0.25%-0.62%]). The number of US adults receiving or recommended for preventive treatment would decrease by an estimated 14.3 million (95% CI, 12.6 million-15.9 million) for statin therapy and 2.62 million (95% CI, 2.02 million-3.21 million) for antihypertensive therapy. The study estimated that, over 10 years, these decreases in treatment eligibility could result in 107 000 additional occurrences of myocardial infarction or stroke. Eligibility changes would affect twice as many men as women and a greater proportion of Black adults than White adults. Conclusion and Relevance: By assigning lower ASCVD risk predictions, application of the PREVENT equations to existing treatment thresholds could reduce eligibility for statin and antihypertensive therapy among 15.8 million US adults.

Impact of Cerebral Embolic Protection Devices on Disabling Stroke After TAVR: Updated Results From the STS/ACC TVT Registry.

BACKGROUND: Cerebral embolic protection devices (EPDs) were developed to mitigate the risk of stroke during transcatheter aortic valve replacement (TAVR), but their benefit remains unproven. In the PROTECTED-TAVR trial (Stroke Protection With Sentinel During Transcatheter), EPD use did not reduce periprocedural stroke (primary study outcome) but led to a 62% reduction in the secondary end point of disabling stroke. Given these results, the impact of EPDs during TAVR remains unclear. METHODS: We used STS/ACC TVT registry data to examine the association between EPD use and a proxy for disabling stroke among transfemoral TAVR patients between January 2018 and June 2023. The primary outcome was in-hospital disabling stroke-defined as stroke associated with either in-hospital death or discharge to a nonhome location. We evaluated the association between EPD use and disabling stroke using instrumental variable analysis with a site-level preference for EPD use as the instrument-a quasi-experimental approach that can support causal inference. In addition, we performed a propensity score-based comparison using overlap weighting as a secondary analysis. RESULTS: The study population consisted of 414 649 patients of whom 53 389 (12.9%) received an EPD. The unadjusted rate of in-hospital disabling stroke was 0.7% among the EPD group and 0.9% in the no-EPD group. EPD use was associated with a reduction in disabling stroke in both instrumental variable analysis (relative risk, 0.87 [95% CI, 0.73-1.00]) and propensity-weighted analysis (odds ratio, 0.79 [95% CI, 0.70-0.90]) but was not associated with a reduction in nondisabling stroke. In subgroup analyses, the benefit of EPD was greater among those with versus without prior stroke (Pinteraction<0.05 for both instrumental variable and propensity-weighted analyses). CONCLUSIONS: In the largest study to date, among patients undergoing TAVR, EPD use was associated with a small, borderline significant reduction in stroke associated with death or discharge to a nonhome location (a proxy for disabling stroke) that is likely to be causal in nature. Taken together with previous mechanistic and clinical studies, these findings provide credible evidence that EPDs benefit patients undergoing TAVR.

Outcomes of Atrial Fibrillation Ablation Among Older Adults in the United States: A Nationwide Study.

BACKGROUND: Pulmonary vein isolation (PVI) is increasingly recommended as first-line therapy for atrial fibrillation. Recent data suggest growing PVI volumes but rising complication rates, although comprehensive real-world outcomes including both inpatient and outpatient encounters remain unclear. OBJECTIVES: The purpose of this study was to evaluate patient characteristics, population rates, and 30-day outcomes of PVI in a nationwide sample of U.S. adults aged >65 years. METHODS: First-time PVIs were identified among U.S. Medicare fee-for-service beneficiaries using Current Procedural Terminology procedural codes. Comorbidities were ascertained using International Classification of Diseases-10th Revision diagnosis codes associated with each procedural claim. Outcomes included periprocedural complications, all-cause hospitalizations, and mortality at 30 days. RESULTS: From January 2017 through December 2021, a total of 227,133 patients underwent PVI (mean age 72.5 years, 42% women, 92.7% White) with an increasing comorbidity burden over time. PVI volume increased from 83.8 (2017) to 111.6 per 100,000 patient-years (2021), which was driven by outpatient procedures (87.8% of all PVIs). Concurrently, there was a significant decrease in complication rates (3.9% in 2017 vs 3.1% in 2021; P < 0.001) and hospitalizations (8.8% vs 7.0%; P < 0.001), with no significant change in mortality (0.4%; P = 0.08). The most common periprocedural complications were bleeding (1.8%), pericardial effusion (1.4%), and vascular access damage (0.8%). CONCLUSIONS: The use of PVI has steadily increased among older patients in contemporary U.S. clinical practice; yet, cumulative complication and hospitalization rates at 30 days have decreased over time, with stably low rates of short-term mortality despite rising comorbidity burden among treated patients. These data may reassure patients and providers on the safety of PVI as an increasingly common first-line procedure for atrial fibrillation.

Drug-Coated Balloons in the Management of Coronary Artery Disease.

Drug-coated balloons (DCBs) are specialized coronary devices comprised of a semicompliant balloon catheter with an engineered coating that allows the delivery of antiproliferative agents locally to the vessel wall during percutaneous coronary intervention. Although DCBs were initially developed more than a decade ago, their potential in coronary interventions has recently sparked renewed interest, especially in the United States. Originally designed to overcome the limitations of conventional balloon angioplasty and stenting, they aim to match or even improve upon the outcomes of drug-eluting stents without leaving a permanent implant. Presently, in-stent restenosis is the condition with the most robust evidence supporting the use of DCBs. DCBs provide improved long-term vessel patency compared with conventional balloon angioplasty and may be comparable to drug-eluting stents without the need for an additional stent layer, supporting their use as a first-line therapy for in-stent restenosis. Beyond the treatment of in-stent restenosis, DCBs provide an additional tool for de novo lesions for a strategy that avoids a permanent metal scaffold, which may be especially useful for the management of technically challenging anatomies such as small vessels and bifurcations. DCBs might also be advantageous for patients with high bleeding risk due to the decreased necessity for extended antiplatelet therapy, and in patients with diabetes and patients with diffuse disease to minimize long-stented segments. Further studies are crucial to confirm these broader applications for DCBs and to further validate safety and efficacy.

Community Socioeconomic Status, Acute Cardiovascular Hospitalizations, and Mortality in Medicare, 2003 to 2019.

BACKGROUND: Socioeconomically disadvantaged communities in the United States disproportionately experience poor cardiovascular outcomes. Little is known about how hospitalizations and mortality for acute cardiovascular conditions have changed among Medicare beneficiaries in socioeconomically disadvantaged and nondisadvantaged communities over the past 2 decades. METHODS: Medicare files were linked with the Centers for Disease Control and Prevention's social vulnerability index to examine age-sex standardized hospitalizations for myocardial infarction, heart failure, ischemic stroke, and pulmonary embolism among Medicare fee-for-service beneficiaries ≥65 years of age residing in socioeconomically disadvantaged communities (highest social vulnerability index quintile nationally) and nondisadvantaged communities (all other quintiles) from 2003 to 2019, as well as risk-adjusted 30-day mortality among hospitalized beneficiaries. RESULTS: A total of 10 942 483 Medicare beneficiaries ≥65 years of age were hospitalized for myocardial infarction, heart failure, stroke, or pulmonary embolism (mean age, 79.2 [SD, 8.7] years; 53.9% female). Although age-sex standardized myocardial infarction hospitalizations declined in socioeconomically disadvantaged (990-650 per 100 000) and nondisadvantaged communities (950-570 per 100 000) from 2003 to 2019, the gap in hospitalizations between these groups significantly widened (adjusted odds ratio 2003, 1.03 [95% CI, 1.02-1.04]; adjusted odds ratio 2019, 1.14 [95% CI, 1.13-1.16]). There was a similar decline in hospitalizations for heart failure in socioeconomically disadvantaged (2063-1559 per 100 000) and nondisadvantaged communities (1767-1385 per 100 000), as well as for ischemic stroke, but the relative gap did not change for both conditions. In contrast, pulmonary embolism hospitalizations increased in both disadvantaged (146-184 per 100 000) and nondisadvantaged communities (153-184 per 100 000). By 2019, risk-adjusted 30-day mortality was similar between hospitalized beneficiaries from socioeconomically disadvantaged and nondisadvantaged communities for myocardial infarction, heart failure, and ischemic stroke but was higher for pulmonary embolism (odds ratio, 1.10 [95% CI, 1.01-1.20]). CONCLUSIONS: Over the past 2 decades, hospitalizations for most acute cardiovascular conditions decreased in both socioeconomically disadvantaged and nondisadvantaged communities, although significant disparities remain, while 30-day mortality is now similar across most conditions.

Medicare Transitional Care Management Program and Changes in Timely Postdischarge Follow-Up.

Importance: In 2013, Medicare implemented payments for transitional care management (TCM) services, which provide increased reimbursement to clinicians providing ambulatory care to patients after discharge from medical facilities to the community. Objective: To determine whether the introduction of TCM payments was associated with an increase in timely postdischarge follow-up. Design, Setting, and Participants: This cross-sectional interrupted time-series study assessed quarterly postdischarge visit rates before (2010-2012) and after (2013-2019) TCM implementation 100% sample of Medicare fee-for-service beneficiaries discharged to the community after a hospital or skilled nursing facility stay. Data analyses were performed February 1 to December 15, 2023. Exposure: Implementation of payments for TCM. Main Outcomes and Measures: Timely postdischarge primary care follow-up, defined as receipt of a primary care ambulatory visit within 14 days of discharge. Secondary outcomes included receipt of a TCM visit and specialty care follow-up. Results: The study sample comprised 79 125 965 eligible discharges. Of these, 55.4% were female; 1.5% were Asian, 12.1% Black, 5.6% Hispanic, and 79.0% were White individuals; and 79.6% were beneficiaries aged 65 years and older. Timely primary care follow-up increased from 31.5% in 2010 to 38.8% in 2019 (absolute increase 7.3%), whereas specialist follow-up increased from 27.6% to 30.8% (absolute increase 3.2%). By 2019, 11.3% of eligible patients received TCM services. Interrupted time-series analyses demonstrated an increased slope of timely primary care follow-up after the introduction of TCM services (pre-TCM slope, 0.12% per quarter vs post-TCM slope, 0.29% per quarter; difference, 0.13%; 95% CI, 0.02% to 0.22%). Receipt of timely follow-up increased for all demographic groups; however, Black, Hispanic, and Medicaid dual-eligible patients and patients residing in urban areas and counties with high-level social deprivation were less likely to receive follow-up during the study period. These disparities widened for Black patients (difference-in-differences in pre-TCM vs post-TCM slope, -0.14%; 95% CI, -0.25% to -0.2%) and patients who were Medicaid dual-eligible (difference-in-differences pre-TCM vs post-TCM slope, -0.21%; 95% CI, -0.35% to -0.07%). Conclusions: These findings indicate that Medicare's introduction of payments for TCM services was associated with a persistent increase in the rate of timely postdischarge primary care but did not narrow demographic or socioeconomic disparities. Most beneficiaries did not receive timely primary care follow-up.

Paclitaxel-Coated Balloon vs Uncoated Balloon for Coronary In-Stent Restenosis: The AGENT IDE Randomized Clinical Trial.

Importance: Drug-coated balloons offer a potentially beneficial treatment strategy for the management of coronary in-stent restenosis. However, none have been previously evaluated or approved for use in coronary circulation in the United States. Objective: To evaluate whether a paclitaxel-coated balloon is superior to an uncoated balloon in patients with in-stent restenosis undergoing percutaneous coronary intervention. Design, Setting, and Participants: AGENT IDE, a multicenter randomized clinical trial, enrolled 600 patients with in-stent restenosis (lesion length <26 mm and reference vessel diameter >2.0 mm to ≤4.0 mm) at 40 centers across the United States between May 2021 and August 2022. One-year clinical follow-up was completed on October 2, 2023. Interventions: Participants were randomized in a 2:1 allocation to undergo treatment with a paclitaxel-coated (n = 406) or an uncoated (n = 194) balloon. Main Outcomes and Measures: The primary end point of 1-year target lesion failure-defined as the composite of ischemia-driven target lesion revascularization, target vessel-related myocardial infarction, or cardiac death-was tested for superiority. Results: Among 600 randomized patients (mean age, 68 years; 157 females [26.2%]; 42 Black [7%], 35 Hispanic [6%] individuals), 574 (95.7%) completed 1-year follow-up. The primary end point at 1 year occurred in 17.9% in the paclitaxel-coated balloon group vs 28.6% in the uncoated balloon group, meeting the criteria for superiority (hazard ratio [HR], 0.59 [95% CI, 0.42-0.84]; 2-sided P = .003). Target lesion revascularization (13.0% vs 24.7%; HR, 0.50 [95% CI, 0.34-0.74]; P = .001) and target vessel-related myocardial infarction (5.8% vs 11.1%; HR, 0.51 [95% CI, 0.28-0.92]; P = .02) occurred less frequently among patients treated with paclitaxel-coated balloon. The rate of cardiac death was 2.9% vs 1.6% (HR, 1.75 [95% CI, 0.49-6.28]; P = .38) in the coated vs uncoated balloon groups, respectively. Conclusions and Relevance: Among patients undergoing coronary angioplasty for in-stent restenosis, a paclitaxel-coated balloon was superior to an uncoated balloon with respect to the composite end point of target lesion failure. Paclitaxel-coated balloons are an effective treatment option for patients with coronary in-stent restenosis. Trial Registration: ClinicalTrials.gov Identifier: NCT04647253.