Association of Clinical Setting With Sociodemographics and Outcomes Following Endovascular Femoropopliteal Artery Revascularization in the United States.

BACKGROUND: After the Centers for Medicare and Medicaid Services modified reimbursement rates for outpatient peripheral vascular intervention in 2008 with the intent of improving access to care, providers began to increasingly perform peripheral vascular interventions in privately owned office-based clinics. Little is known about the characteristics of patients treated in this setting and their long-term outcomes as compared with those treated in hospital-based centers. METHODS: In this retrospective cohort study, Medicare beneficiaries ≥66 years undergoing outpatient femoropopliteal peripheral vascular interventions in office-based clinics and hospital-based centers from 2015 to 2017 were identified. Sociodemographics, comorbidities, and institutional characteristics were compared across sites. Multivariable Cox proportional hazards models were used to estimate the adjusted associations between practice site location and outcomes. The primary outcome was the composite of major amputation or death analyzed through the end of follow-up. RESULTS: Among 134 869 patients, 29.9% were treated in office-based clinics and 70.1% in hospital-based centers. Patients treated in office-based clinics were more often Black (16.9% versus 11.9%), dually enrolled in Medicaid (26.3% versus 19.6%), and residents of lower-resourced regions (32.6% versus 25.6%). Over a median follow-up time of 800 days (interquartile range, 531-1119 days), patients treated in office-based clinics had reduced risks of major amputation or death compared with outpatients treated in hospital-based centers (hazard ratio, 0.92 [95% CI, 0.89-0.95]). They also had lower adjusted all-cause mortality (hazard ratio, 0.93 [95% CI, 0.90-0.96]), major lower extremity amputation (hazard ratio, 0.84 [95% CI, 0.79-0.89]), and all-cause hospitalization (hazard ratio, 0.86 [95% CI, 0.84-0.88]). These findings persisted after stratification by critical limb ischemia, race, dual enrollment, and regional socioeconomic status, as well as among operators treating patients in both clinical settings. CONCLUSIONS: In this large nationwide analysis of Medicare beneficiaries, office-based clinics treated a more socioeconomically disadvantaged population compared with hospital-based centers. Long-term outcomes were comparable between locations. As such, these clinics appear to be selecting lower-risk patients for outpatient peripheral vascular interventions, although there remains the possibility of unmeasured confounding.

Long-term outcomes of peripheral atherectomy for femoropopliteal endovascular interventions.

BACKGROUND: The use of atherectomy during peripheral endovascular interventions (PVI) has increased dramatically, but data regarding its safety and effectiveness are lacking.  Aims: This study sought to determine the long-term safety of atherectomy in contemporary practice.  Methods: Medicare fee-for-service beneficiaries who underwent femoropopliteal artery PVI from 2015-2018 were identified in a 100% sample of inpatient, outpatient, and carrier file data using procedural claims codes. The primary exposure was the use of atherectomy. Inverse probability of treatment weighting was used to adjust for measured differences in patient populations. Kaplan-Meier methods and multivariable Cox proportional hazards regression were used to compare outcomes.  Results: Among 168,553 patients who underwent PVI, 59,142 (35.1%) underwent atherectomy. The mean patient age was 77.0±7.6 years, 44.9% were female, 81.9% were white, and 46.7% had chronic limb-threatening ischaemia. Over a median follow-up time of 993 days (interquartile range 319-1,377 days), atherectomy use was associated with no difference in the risk of either the composite endpoint of death and amputation (adjusted hazard ratio [aHR] 0.99, 95% confidence interval [CI]: 0.97-1.01; p=0.19) or of major adverse limb events (aHR 1.02, 95% CI: 0.99-1.05; p=0.26). Patients who underwent atherectomy had a modest reduction in the risk of subsequently undergoing amputation or surgical revascularisation (aHR 0.92, 95% CI: 0.90-0.94; p<0.01) but an increase in the risk of undergoing a subsequent PVI (aHR 1.19, 95% CI: 1.16-1.21; p<0.01). CONCLUSIONS: The use of atherectomy during femoropopliteal artery PVI was not associated with an increase in the risk of long-term adverse safety outcomes among patients with peripheral artery disease.

Association of Frailty With Treatment Selection and Long-Term Outcomes Among Patients With Chronic Limb-Threatening Ischemia.

Background The optimal treatment strategy for patients with chronic limb-threatening ischemia (CLTI) is often unclear. Frailty has emerged as an important factor that can identify patients at greater risk of poor outcomes and guide treatment selection, but few studies have explored its utility among the CLTI population. We examine the association of a health record-based frailty measure with treatment choice and long-term outcomes among patients hospitalized with CLTI. Methods and Results We included patients aged >65 years hospitalized with CLTI in the Medicare Provider Analysis and Review data set between October 1, 2009 and September 30, 2015. The primary exposure was frailty, defined by the Claims-based Frailty Indicator. Baseline frailty status and revascularization choice were examined using logistic regression. Cox proportional hazards regression was used to determine the association between frailty and death or amputation, stratifying by treatment strategy. Of 85 060 patients, 35 484 (42%) were classified as frail. Frail patients had lower likelihood of revascularization (adjusted odds ratio [OR], 0.78; 95% CI, 0.75‒0.82). Among those revascularized, frailty was associated with lower likelihood of surgical versus endovascular treatment (adjusted OR, 0.76; CI, 0.72‒0.81). Frail patients experienced increased risk of amputation or death, regardless of revascularization status (revascularized: adjusted hazard ratio [HR], 1.34; CI, 1.30‒1.38; non-revascularized: adjusted HR, 1.22; CI, 1.17‒1.27). Among those revascularized, frailty was independently associated with amputation or death irrespective of revascularization strategy (surgical: adjusted HR, 1.36; CI, 1.31‒1.42; endovascular: aHR, 1.29; CI, 1.243‒1.35). Conclusions Among patients hospitalized with CLTI, frailty is an important independent predictor of revascularization strategy and longitudinal adverse outcomes.

Comparative Outcomes of Percutaneous Coronary Intervention for ST-Segment-Elevation Myocardial Infarction Among Medicare Beneficiaries With Multivessel Coronary Artery Disease: An National Cardiovascular Data Registry Research to Practice Project.

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Rationale and Design of the SAFE-PAD Study.

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 International Classification of Diseases, Tenth Revision 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.