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An overview of optimal endovascular strategy in treating the femoropopliteal artery: mechanical, biological, and procedural factors.

ABSTRACT: Treatment of the femoropopliteal (FP) artery remains a challenge to the endovascular specialist. Long-term patency is low with a high rate of target lesion revascularization. The true patency rate varies considerably between studies partly because there is a lack of uniform performance criteria and reporting standards in peripheral arterial interventions. Literature review supports three principles that emerge as important components of an optimal strategy in treating the FP artery: (1) improving vessel compliance and subsequently less dissections and bailout stenting, (2) reducing smooth muscle cell proliferation, and (3) protecting outflow vessels from distal embolization. In this overview, we examine current data that support the validity of this strategy.

SUBMITTER: Shammas NW

PROVIDER: S-EPMC3699227 | biostudies-literature | 2013 Mar

REPOSITORIES: biostudies-literature

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An overview of optimal endovascular strategy in treating the femoropopliteal artery: mechanical, biological, and procedural factors.

Shammas Nicolas W NW

The International journal of angiology : official publication of the International College of Angiology, Inc 20130301 1

Treatment of the femoropopliteal (FP) artery remains a challenge to the endovascular specialist. Long-term patency is low with a high rate of target lesion revascularization. The true patency rate varies considerably between studies partly because there is a lack of uniform performance criteria and reporting standards in peripheral arterial interventions. Literature review supports three principles that emerge as important components of an optimal strategy in treating the FP artery: (1) improvin ...[more]

PMID: 24436577

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Project description:AimsOptimal endovascular management of intermittent claudication (IC) remains disputed. This systematic review and meta-analysis compares efficacy and safety outcomes for balloon angioplasty (BA), bare-metal stents (BMS), drug-coated balloons (DCB), drug-eluting stents (DES), covered stents, and atherectomy.Methods and resultsElectronic databases were searched for randomized, controlled trials (RCT) from inception through November 2021. Efficacy outcomes were primary patency, target-lesion revascularization (TLR), and quality-of-life (QoL). Safety endpoints were all-cause mortality and major amputation. Outcomes were evaluated at short-term (<1 year), mid-term (1-2 years), and long-term (≥2 years) follow-up. The study was registered on PROSPERO (CRD42021292639). Fifty-one RCTs enrolling 8430 patients/lesions were included. In femoropopliteal disease of low-to-intermediate complexity, DCBs were associated with higher likelihood of primary patency [short-term: odds ratio (OR) 3.21, 95% confidence interval (CI) 2.44-4.24; long-term: OR 2.47, 95% CI 1.93-3.16], lower TLR (short-term: OR 0.33, 95% CI 0.22-0.49; long-term: OR 0.42, 95% CI 0.29-0.60) and similar all-cause mortality risk, compared with BA. Primary stenting using BMS was associated with improved short-to-mid-term patency and TLR, but similar long-term efficacy compared with provisional stenting. Mid-term patency (OR 1.64, 95% CI 0.89-3.03) and TLR (OR 0.50, 95% CI 0.22-1.11) estimates were comparable for DES vs. BMS. Atherectomy, used independently or adjunctively, was not associated with efficacy benefits compared with drug-coated and uncoated angioplasty, or stenting approaches. Paucity and heterogeneity of data precluded pooled analysis for aortoiliac disease and QoL endpoints.ConclusionCertain devices may provide benefits in femoropopliteal disease, but comparative data in aortoiliac arteries is lacking. Gaps in evidence quantity and quality impede identification of the optimal endovascular approach to IC.

Project description:To estimate the clinical and economic impact of drug-eluting endovascular treatment strategies for femoropopliteal artery disease compared with current standard of care.Systematic literature search to pool target lesion revascularisations (TLR). Model-based per-patient cost impact and quasi-cost-effectiveness projection over 24 months based on pooled TLRs and current reimbursement.The UK's National Health Service (NHS).Patients presenting with symptomatic femoropopliteal disease eligible for endovascular treatment.Current National Institute for Health and Care Excellence (NICE) guideline-recommended treatment with percutaneous transluminal balloon angioplasty (PTA) and bailout bare metal stenting (BMS) versus primary BMS placement, or drug-coated balloon (DCB), or drug-eluting stent (DES) treatment.24-month per-patient cost impact to NHS (primary outcome).pooled 24-month TLR rates; numbers needed to treat (NNTs); cost per TLR avoided and estimated incremental cost-effectiveness ratio (ICER) in £ per quality-adjusted life year (QALY).N=28 studies were identified, reporting on 5167 femoropopliteal lesions. Over 24 months, DCB, DES and BMS reduced TLRs of de novo lesions from 36.2% to 17.6%, 19.4% and 26.9%, respectively, at an increased cost of £43, £44 and £112. NNTs to avoid 1 TLR in 24 months were 5.4, 6.0 and 10.8, resulting in cost per TLR avoided of £231, £264 and £1204. DCB was estimated to add 0.011 QALYs, DES 0.010 QALYs and BMS 0.005 QALYs, resulting in estimated ICERs of £3983, £4534 and £20 719 per QALY gained. A subset analysis revealed more favourable clinical and economic outcomes for a 3.5 µg/mm(2) DCB with urea excipient, compared with the rest of DCBs. A modest reduction of 10% in DCB and DES prices made drug-eluting treatments dominant.Widespread adoption of drug-eluting endovascular therapies for femoropopliteal disease would add meaningful clinical benefit at reasonable additional costs to the NHS. Based on currently available data, DCBs offer the highest clinical and economic value.

Project description:BackgroundAfter 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.MethodsIn 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.ResultsAmong 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.ConclusionsIn 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.

Project description:BackgroundBlack adults have a higher incidence of peripheral artery disease and limb amputations than White adults in the United States. Given that peripheral endovascular intervention (PVI) is now the primary revascularization strategy for peripheral artery disease, it is important to understand whether racial differences exist in PVI incidence and outcomes.MethodsData from fee-for-service Medicare beneficiaries ≥66 years of age from 2016 to 2018 were evaluated to determine age- and sex-standardized population-level incidences of femoropopliteal PVI among Black and White adults over the 3-year study period. Patients' first inpatient or outpatient PVIs were identified through claims codes. Age- and sex-standardized risks of the composite outcome of death and major amputation within 1 year of PVI were examined by race.ResultsBlack adults underwent 928 PVIs per 100 000 Black beneficiaries compared with 530 PVIs per 100 000 White beneficiaries (risk ratio, 1.75 [95% CI, 1.73-1.77]; P<0.01). Black adults who underwent PVI were younger (mean age, 74.5 years versus 76.4 years; P<0.01), were more likely to be female (52.8% versus 42.7%; P<0.01), and had a higher burden of diabetes (70.6% versus 56.0%; P<0.01), chronic kidney disease (67.5% versus 56.6%; P<0.01), and heart failure (47.4% versus 41.7%; P<0.01) than White adults. When analyzed by indication for revascularization, Black adults were more likely to undergo PVI for chronic limb-threatening ischemia than White adults (13 023 per 21 352 [61.0%] versus 59 956 per 120 049 [49.9%]; P<0.01). There was a strong association between Black race and the composite outcome at 1 year (odds ratio, 1.21 [95% CI, 1.16-1.25]). This association persisted after adjustment for socioeconomic status (odds ratio, 1.08 [95% CI, 1.03-1.13]) but was eliminated after adjustment for comorbidities (odds ratio, 0.96 [95% CI, 0.92-1.01]).ConclusionsAmong fee-for-service Medicare beneficiaries, Black adults had substantially higher population-level PVI incidence and were significantly more likely to experience adverse events after PVI than White adults. The association between Black race and adverse outcomes appears to be driven by a higher burden of comorbidities. This analysis emphasizes the critical need for early identification and aggressive management of peripheral artery disease risk factors and comorbidities to reduce Black-White disparities in the development and progression of peripheral artery disease and the risk of adverse events after PVI.

Dataset Information

An overview of optimal endovascular strategy in treating the femoropopliteal artery: mechanical, biological, and procedural factors.

Publications

An overview of optimal endovascular strategy in treating the femoropopliteal artery: mechanical, biological, and procedural factors.

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