Update From the Longitudinal Assessment of Safety of Femoropopliteal Endovascular Treatment With Paclitaxel-Coated Devices Among Medicare Beneficiaries: The SAFE-PAD Study.
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SUBMITTER: Secemsky EA
PROVIDER: S-EPMC9473309 | biostudies-literature | 2022 Jun
REPOSITORIES: biostudies-literature
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Update From the Longitudinal Assessment of Safety of Femoropopliteal Endovascular Treatment With Paclitaxel-Coated Devices Among Medicare Beneficiaries: The SAFE-PAD Study.
Secemsky Eric A EA Song Yang Y Schermerhorn Marc M Yeh Robert W RW
Circulation. Cardiovascular interventions 20220520 6
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Project description:ImportancePaclitaxel-coated peripheral devices have been associated with increased mortality, yet this harm signal has not been replicated outside of meta-analyses of small trials.ObjectiveTo provide a longitudinal assessment of the safety of femoropopliteal endovascular treatment with peripheral drug-coated devices (DCDs) among Medicare beneficiaries.Design, setting, and participantsSAFE-PAD (Safety Assessment of Femoropopliteal Endovascular Treatment With Paclitaxel-Coated Devices) was a retrospective cohort study designed with the US Food and Drug Administration to evaluate the noninferiority of mortality between DCDs and non-drug-coated devices (NDCDs) for femoropopliteal revascularization performed in 2978 inpatient and outpatient facilities in the US from April 1, 2015, through December 31, 2018. Evaluation of the primary outcome was assessed through May 31, 2020. Participants were Medicare fee-for-service beneficiaries 66 years and older with 1 or more years of enrollment prior to femoropopliteal revascularization. Prespecified subgroups included low-risk cohorts, procedure location, disease severity, and device type. Inverse probability weighting was used to account for imbalances of observed characteristics. Sensitivity analyses were used to evaluate the potential influence of unmeasured confounding.ExposuresTreatment with DCDs vs NDCDs as determined by claims codes during the index procedure.Main outcomes and measuresThe primary outcome was all-cause mortality. Secondary outcomes included repeated hospitalization, repeated lower extremity revascularization, and lower extremity amputation. Falsification end points were acute myocardial infarction, congestive heart failure, and pneumonia.ResultsOf 168 553 patients, 70 584 (41.9%) were treated with a DCD. The mean (SD) age was 77.0 (7.6) years, 75 744 (44.9%) were female, 136 916 of 167 197 (81.9%) were White individuals, 85 880 of 168 553 (51.0%) had diabetes, 82 554 of 168 553 (49.0%) used tobacco, 78 665 of 168 553 (45.7%) had critical limb ischemia (CLI), and 13 296 of 168 553 (7.9%) had a prior amputation. Median follow-up was 2.72 years (interquartile range, 0.87-3.77; longest, 5.16 years). After weighting, the cumulative incidence of all-cause mortality was 53.8% with DCDs and 55.1% with NDCDs (hazard ratio [HR], 0.95; 95% CI, 0.94-0.97; noninferiority P < .001). Cox regression and instrumental variable analyses were consistent with the primary findings. No harm associated with DCDs was observed among subgroups, including those treated with stents (HR, 0.97; 95% CI, 0.95-1.00) or balloons (HR, 0.94; 95% CI, 0.92-0.96), with or without CLI (CLI: HR, 0.95; 95% CI, 0.93-0.97; non-CLI: HR, 0.97; 95% CI, 0.95-0.99), and those within the lowest quartile of total comorbidities (HR, 0.95; 95% CI, 0.92-0.99).Conclusions and relevanceIn this initial report from the SAFE-PAD cohort study, DCDs were found to be noninferior to NCDCs in respect to mortality through a median follow-up of 2.72 years. This finding remained robust in sensitivity analyses and was consistent across prespecified subgroups.
| S-EPMC8126993 | biostudies-literature
Project description:BackgroundClinical benefit of paclitaxel-coated devices for patients with peripheral arterial disease has been confirmed in randomized controlled trials (RCTs). A meta-analysis published in 2018 identified late mortality risk over a long follow-up period due to use of paclitaxel-coated devices in the femoropopliteal arteries, which caused enormous controversy and debates globally. This study aims to further evaluate the safety of paclitaxel-coated devices by incorporating the most recently published data.MethodsWe searched for candidate studies in PubMed (MEDLINE), Scopus, EMBASE (Ovid) online databases, government web archives and international cardiovascular conferences. Safety endpoints of interest included all-cause mortality rates at one, two and five years and the risk ratio (RR) was used as the summary measure. The primary analysis was performed using random-effects models to account for potential clinical heterogeneity.FindingsThirty-nine RCTs including 9164 patients were identified. At one year, the random-effects model yielded a pooled RR of 1.06 (95% CI [0.87, 1.29]) indicating no difference in short-term all-cause deaths between the paclitaxel and control groups (crude mortality, 4.3%, 214/5025 versus 4.5%, 177/3965). Two-year mortality was reported in 26 RCTs with 382 deaths out of 3788 patients (10.1%) in the paclitaxel arm and 299 out of 2955 patients (10.1%) in the control arm and no association was found between increased risk of death and usage of paclitaxel-coated devices (RR 1.08, 95% CI [0.93, 1.25]). Eight RCTs recorded all-cause deaths up to five years and a pooled RR of 1.18 (95% CI [0.92, 1.51]) demonstrated no late mortality risk due to use of paclitaxel-coated devices (crude mortality, paclitaxel 18.2%, 247/1360 versus control 15.2%, 122/805).ConclusionsWe found no significant difference in either short- or long-term all-cause mortalities between patients receiving paclitaxel-coated and uncoated devices. Further research on the longer-term safety of paclitaxel usage (e.g., 8- or 10-year) is warranted.RegistrationPROSPERO, CRD42021246291.
| S-EPMC9560511 | biostudies-literature
Project description:BackgroundThe connection between paclitaxel-coated devices (PCD) use during peripheral vascular interventions (PVI) and mortality is debated. We aimed to analyze patterns of PCD use and the safety and effectiveness of PCD use in the superficial femoral and/or popliteal arteries.MethodsPatients undergoing PVI of femoropopliteal lesions with and without PCD between January 1, 2015 and June 30, 2017 were compared using the American College of Cardiology's National Cardiovascular Data Registry PVI Registry. Outcomes were derived from Centers for Medicare & Medicaid claims data. The primary outcome was all-cause mortality at 6-, 12-, and 24-months following PVI. Inverse probability weighting and frailty models were used to assess the differences between groups. The analysis was IRB-approved.ResultsIn the overall cohort consisting of 6,302 femoropopliteal PVIs, PCD-PVI patients were more likely to be treated for claudication (63.5% vs 51.3%, P< .001), less likely to have a chronic total occlusion (24.6% vs 34.7%, P < .001), and more likely to be treated in certain geographic and practice settings. In the analytic cohort consisting of 1,666 femoropopliteal PVIs with linked claims outcomes (888 PCD-PVI, 53.3%), unadjusted rates of all outcomes were lower in PCD-PVI patients. After adjustment, there were no significant differences in mortality following PCD-PVI versus non-PCD PVI at 1 year (adjusted RR 0.78, 95% CI 0.60-1.01, P= .055) or 2 years (aRR 0.98, 95% CI 0.77-1.24, P= .844).ConclusionThere were significant differences between the patients in whom and settings in which PCD-PVI was versus was not used. PCD-PVI was not associated with an increased risk of 2-year mortality in real-world use.
| S-EPMC8078180 | biostudies-literature
Project description:ImportanceIn a recent meta-analysis of randomized clinical trials, femoropopliteal artery revascularization with paclitaxel drug-coated devices was associated with increased long-term all-cause mortality compared with non-drug-coated devices. However, to our knowledge, these findings have not been replicated in other data sources and may be subject to confounding from missing data associated with patient withdrawal and loss to follow-up.ObjectiveTo evaluate differences in all-cause mortality between patients who were treated with drug-coated devices vs non-drug-coated devices for femoropopliteal artery revascularization.Design, setting, and participantsThis nationwide, multicenter retrospective cohort study included 16 560 Centers for Medicare and Medicaid Services beneficiaries who were admitted for femoropopliteal artery revascularization from January 1, 2016, to December 31, 2016. All-cause mortality was analyzed through September 30, 2017.ExposuresDrug-coated devices (drug-eluting stent [DES] or drug-coated balloon [DCB]) compared with non-drug-coated devices (bare metal stent or uncoated percutaneous transluminal angioplasty balloon).Main outcomes and measuresThe primary outcome was all-cause mortality analyzed through the end of follow-up.ResultsAmong 16 560 patients treated at 1883 hospitals, the mean (SD) age was 72.9 (11) years, 7734 (46.7%) were men, 12 232 (73.9%) were white, 8222 (49.7%) currently or had previously used tobacco, 9817 (59.3%) had diabetes, and 8450 (51.0%) had critical limb ischemia (CLI). Drug-coated devices were used in 5989 participants (36.2%). The median follow-up was 389 days (interquartile range, 277-508 days). Among all patients, treatment with drug-coated devices was associated with a lower cumulative incidence of all-cause mortality compared with treatment with non-drug-coated devices through 600 days postprocedure (32.5% vs 34.3%, respectively; log-rank P = .007). Similar survival trends were observed when treatment was stratified by using a DCB alone or DES with or without DCB. After multivariable adjustment, drug-coated devices were not associated with a difference in all-cause mortality compared with non-drug-coated devices (hazard ratio [HR], 0.97; 95% CI, 0.91-1.04; P = .43). These findings were consistent among those with CLI (HR, 0.93; 95% CI, 0.85-1.01; P = .09) or without CLI (HR, 0.94; 95% CI, 0.85-1.03; P = .20), and for those treated with DCB alone (HR, 0.94; 95% CI, 0.86-1.03; P = .17) or DES with or without DCB (HR, 0.97; 95% CI, 0.89-1.06; P = .48).Conclusions and relevanceIn this large nationwide analysis of Centers for Medicare and Medicaid Services beneficiaries, there was no evidence of increased all-cause mortality following femoropopliteal artery revascularization with drug-coated devices compared with non-drug-coated devices.
| S-EPMC6484791 | biostudies-literature
Project description:BackgroundIntravascular ultrasound (IVUS) may be a useful adjunct to lower extremity peripheral vascular interventions (PVI) in certain clinical scenarios. We aimed to identify patient- and physician-level characteristics associated with the use of IVUS during first-time femoropopliteal PVI.MethodsWe included all Medicare beneficiaries undergoing elective femoropopliteal PVI for claudication or chronic limb-threatening ischemia between 01/01/2019 and 12/31/2019. We excluded patients with prior open or endovascular femoropopliteal intervention and all physicians performing ≤10 PVI during the study period. We calculated the proportion of patients who had IVUS performed as part of their index PVI for each physician. Hierarchical logistic regression was used to evaluate patient- and physician-level factors associated with use of IVUS.ResultsWe identified 58,552 patients who underwent index femoropopliteal PVI, of whom 11,394 (19%) received IVUS. A total of 1,628 physicians performed >10 procedures during the study period, with IVUS utilization ranging from 0-100%. After hierarchical regression, claudication (versus chronic limb-threatening ischemia: OR 1.23, 95% CI 1.11-1.36), stenting (versus angioplasty alone: OR 1.57, 1.33-1.86) and atherectomy (versus angioplasty alone: OR 2.09, 1.83-2.39) were associated with higher odds of IVUS utilization. Higher-volume providers (tertile 3 vs. tertile 1: OR 3.78, 2.43-5.90) and those with high rates of service provided in an office-based laboratory (tertile 3 vs. tertile 1: OR 10.72, 6.78-19.93) were more likely to utilize IVUS. Radiologists (OR 11.23, 5.96-21.17) and cardiologists (OR 1.97, 1.32-2.93) used IVUS more frequently than vascular surgeons.ConclusionsWide variability exists in the use of IVUS for first-time femoropopliteal PVI. The association of IVUS with claudication, atherectomy, and office-based laboratories raises concern about its potential overuse by some physicians.
| S-EPMC8897245 | biostudies-literature
Project description:ObjectiveLifelong imaging follow-up is essential to the safe and appropriate management of patients who undergo endovascular abdominal aortic aneurysm repair (EVAR). We sought to evaluate the rate of compliance with imaging follow-up after EVAR and to identify factors associated with being lost to imaging follow-up.MethodsWe identified a 20% sample of continuously enrolled Medicare beneficiaries who underwent EVAR between 2001 and 2008. Using data through 2010 from Medicare Inpatient, Outpatient, and Carrier files, we identified all abdominal imaging studies that may have been performed for EVAR follow-up. Patients were considered lost to annual imaging follow-up if they did not undergo any abdominal imaging study within their last 2 years of follow-up. Multivariable models were constructed to identify independent factors associated with being lost to annual imaging follow-up.ResultsAmong 19,962 patients who underwent EVAR, the incidence of loss to annual imaging follow-up at 5 years after EVAR was 50%. Primary factors associated with being lost to annual imaging follow-up were advanced age (age 65-69 years, reference; age 75-79 years: hazard ratio [HR], 1.23; 95% confidence interval [CI], 1.15-1.32; age 80-85 years: HR, 1.45; 95% CI, 1.35-1.55; age >85 years: HR, 2.03; 95% CI, 1.88-2.20) and presentation with an urgent/emergent intact aneurysm (HR, 1.27; 95% CI, 1.20-1.35) or ruptured aneurysm (HR, 1.84; 95% CI, 1.63-2.08). Additional independent factors included several previously diagnosed chronic diseases and South and West regions of the United States.ConclusionsAnnual imaging follow-up compliance after EVAR in the United States is significantly below recommended levels. Quality improvement efforts to encourage improved compliance with imaging follow-up, especially in older patients with multiple comorbidities and in those who underwent EVAR urgently or for rupture, are necessary.
| S-EPMC4276501 | biostudies-literature
Project description:PurposeDrug-coated devices have been widely accepted as one of the most promising therapies for femoropopliteal artery revascularization. A recent meta-analysis showed increased mortality in patients treated with drug-coated devices. We sought to examine the association between mortality and drug-coated devices after the treatment of the femoropopliteal artery based on the Korea national administrative claims data.MethodsIn the National Health Insurance Service database from August 2015 to December 2017, we identified patients with femoropopliteal artery revascularization using percutaneous transluminal angioplasty (PTA), bare metal stents (BMS), drug-coated balloon (DCB), or drug-eluting stents (DES). Kaplan-Meier methods were used to estimate the survival among devices, and log-rank tests were used to evaluate differences between groups. Adjusted hazard ratios (aHRs) were computed using the inverse probability of treatment weightings (IPTW).ResultsThere were 1,724 patients (mean age, 70.9 ± period was 552 days (interquartile range, 404-688 days). There was a difference in IPTW-adjusted mortality risk among device types (26.3% in PTA, 22.1% in BMS, 17.7% in DCB, and 17.8% in DES; P = 0.004). IPTW-adjusted Cox nproportional hazard analysis showed that drug-coated devices were associated with decreased all-cause mortality risk (aHR, 0.70; 95% confidence interval, 0.58-0.86).ConclusionOur real-world analysis showed that there was no evidence of increased all-cause mortality after femoropopliteal artery revascularization with drug-coated devices compared with non-drug-coated devices.
| S-EPMC8255583 | biostudies-literature
Project description:ImportanceA growing proportion of the population is enrolling in Medicare Advantage (MA), which typically offers additional benefits compared with traditional Medicare (TM).ObjectiveTo determine whether frailty and frailty trajectories differ between MA enrollees and TM enrollees.Design, setting, and participantsThis retrospective cohort study used data from the National Health and Aging Trends Study (2015-2016). Analyses were conducted from August 2023 to March 2024. Participants were community-dwelling Medicare beneficiaries aged 65 years and older.ExposureEnrollment in MA vs TM.Main outcomes and measuresFrailty was calculated by a frailty index (FI) (range, 0-1, with higher values indicating greater frailty) and the Fried Frailty Phenotype (FFP) score (range, 0-5, with higher values indicating greater frailty). Physical performance, including Short Physical Performance Battery (SPPB) score (range, 0-12, with higher values indicating better performance), and gait speed (meters per second) were measured. The primary outcome was the difference in FI and FFP scores from the 2015 baseline assessment to the 2016 follow-up assessment. Secondary outcomes include the 1-year changes in SPPB and gait speed.ResultsThe final cohort consisted of 7063 participants (2775 [23.1%] aged >80 years; 4040 [54.7%] female), representing a sample of the 38.8 million beneficiaries. There were 2583 (35.0%) MA enrollees (13.6 million) and 4480 (65.0%) TM enrollees (25.2 million). At baseline, the FI score was similar between MA and TM enrollees (mean [SD], 0.22 [0.15] vs 0.21 [0.14]), although MA enrollees had worse phenotypic frailty (496 participants [15.2%] vs 811 participants [13.7%] considered frail by FFP score), SPPB scores (mean [SD], 6.91 [3.34] vs 7.21 [3.27]), and gait speed (0.79 [0.24] m/s vs 0.82 [0.23] m/s) than TM enrollees. One year later, there were no differences between MA and TM enrollees in the 1-year change in FI score (mean [SD], 0.016 [0.071] vs 0.014 [0.066]; adjusted mean difference, 0.001 [95% CI, -0.004 to 0.005]), FFP score (mean [SD], 0.017 [1.004] vs 0.007 [0.958]; adjusted mean difference, -0.009 [95% CI, -0.067 to 0.049]), SPPB score (mean [SD], -0.144 [2.064] vs -0.211 [1.968]; adjusted mean difference, 0.068 [95% CI, -0.076 to 0.212]), and gait speed (mean [SD], -0.0160 [0.148] m/s vs -0.007 [0.148] m/s; adjusted mean difference, -0.010 m/s [95% CI, -0.067 to 0.049 m/s]).Conclusions and relevanceIn this cohort study of Medicare beneficiaries from 2015, MA enrollees experienced similar declines in frailty over 1 year compared with TM enrollees. Future work should examine whether the specific types of services covered by health insurance can impact frailty and health trajectories for older adults.
| S-EPMC11365002 | biostudies-literature
Project description:ObjectivesTo provide updated information on the burdens of sepsis during acute inpatient admissions for Medicare beneficiaries.DesignAnalysis of paid Medicare claims via the Centers for Medicare and Medicaid Services DataLink Project.SettingAll U.S. acute-care hospitals, excluding federally operated hospitals (Veterans Administration and Defense Health Agency).PatientsAll Medicare beneficiaries, January 2012-February 2020, with an explicit sepsis diagnostic code assigned during an inpatient admission.InterventionsNone.Measurements and main resultsThe count of Medicare Part A/B (fee-for-service) plus Medicare Advantage inpatient sepsis admissions rose from 981,027 (CY2012) to 1,700,433 (CY 2019). The proportion of total admissions with sepsis in the Medicare Advantage population rose from 21.43% to 35.39%, reflecting the increasing beneficiary proportion enrolled in Medicare Advantage. In CY2019, 6-month mortality rates in Medicare fee-for-service beneficiaries for sepsis continued to decline, but remained high: 59.9% for septic shock, 35.5% for severe sepsis, 30.8% for sepsis attributed to a specific organism, and 26.5% for unspecified sepsis. Total fee-for-service-only inpatient hospital costs rose from $17.79B (CY2012) to $22.98B (CY2019). We estimated that the aggregate cost of sepsis hospital care for the entire U.S. population was at least $57.47B in 2019. Inclusion of 14 months' (January 2019-February 2020) newer data exposed new trends: the cost per patient, number of admissions, and fraction of patients with sepsis labeled as present on admission inflected around November 2015, coincident with the change to International Classification of Diseases, 10th Edition, and introduction of the Severe Sepsis and Septic Shock Management Bundle (SEP-1) metric.ConclusionsSepsis among Medicare beneficiaries precoronavirus disease 2019 imposed immense burdens upon patients, their families, and the taxpayers.
| S-EPMC8594514 | biostudies-literature
Project description:BackgroundNumerous randomised controlled trials (RCTs) have demonstrated the superiority of paclitaxel drug-coated balloons (DCBs) over non-coated angioplasty balloons for treatment of femoropopliteal peripheral arterial disease (PAD). There is a paucity of clinical evidence in more complex patients who are often excluded from RCTs and long-term data up to 5 years are very limited in PAD revascularisation studies.AimsThis is a report of the 5-year outcomes from the prospective, single-arm, international IN.PACT Global Study. The IN.PACT Admiral DCB was evaluated for femoropopliteal atherosclerotic disease treatment in a real-world patient population.MethodsIn total, 1,535 patients were enrolled at 64 international sites. The prespecified clinical cohort included 1,406 patients with claudication or rest pain. Patients were evaluated up to 5 years for the occurrence of adverse events and clinically driven target lesion revascularisations (CD-TLR).ResultsThe mean lesion length was 12.1±9.5 cm in 1,774 lesions, 18.0% had in-stent restenosis, 35.5% were total occlusions and 68.7% were calcified. Per independent clinical events committee adjudication, the Kaplan-Meier estimate of freedom from CD-TLR up to 5 years was 69.4%, and the restricted mean survival time to first CD-TLR was 1,470.1 days. Outcomes were similar for males and females; freedom from CD-TLR was 69.1% in females and 69.6% in males (p=0.602). The cumulative incidence of major adverse events for the clinical cohort was 45.9% and freedom from all-cause mortality with the vital status update was 78.9% up to 5 years.ConclusionsThe IN.PACT Admiral DCB demonstrated safe and durable outcomes in real-world participants with complex femoropopliteal disease.Clinicaltrialsgov: NCT01609296.
| S-EPMC9743239 | biostudies-literature