Registry Assessment of Peripheral Interventional Devices (RAPID): Registry assessment of peripheral interventional devices core data elements

Jones, W. Schuyler; Krucoff, Mitchell W.; Morales, Pablo; Wilgus, Rebecca W.; Heath, Anne H.; Williams, Mary Frances; Tcheng, James E.; Marinac-Dabic, J. Danica; Malone, Misti; Reed, Terrie L.; Fukaya, Rie; Lookstein, R.; Handa, Nobuhiro; Aronow, Herbert D.; Bertges, Daniel J.; Jaff, Michael R.; Tsai, Thomas T.; Smale, Joshua A.; Zaugg, Margo J.; Thatcher, Robert J.; Cronenwett, Jack L.

doi:10.1016/j.jvs.2017.07.141

Cited by 17 publications

(15 citation statements)

References 9 publications

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“…The current state of evaluating endovascular devices to treat patients with PAD is costly and difficult due to the heterogeneity of the disease and the multiple specialties that perform endovascular therapy on these patients. 33 This has spurred initiatives by the FDA to support peripheral endovascular therapy registry efforts and potential use of real-world evidence in FDA regulatory submissions and postmarket surveilance. 33,34 The LIBERTY registry provides a framework and an example for these initiatives going forward.…”

Section: Discussionmentioning

confidence: 99%

One-Year Results of the LIBERTY 360 Study: Evaluation of Acute and Midterm Clinical Outcomes of Peripheral Endovascular Device Interventions

et al. 2019

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Purpose: To report the 1-year results of a multicenter study of peripheral artery disease (PAD) treatment with a variety of endovascular treatment strategies employed in routine practice. Materials and Methods: The LIBERTY trial ( ClinicalTrials.gov identifier NCT01855412) is a prospective, observational, core laboratory–assessed, multicenter study of endovascular device intervention in 1204 subjects (mean age 69.8±10.7 years; 770 men) stratified by Rutherford category (RC): claudicants (RC2,3; n=501) and critical limb ischemia (CLI) with no/minimal tissue loss (RC4,5; n=603) or significant tissue loss (RC6; n=100). Key outcomes included quality of life (QoL) measures (VascuQol and EuroQol) and freedom from major adverse events (MAE), defined as death (within 30 days), major amputation, and target vessel revascularization based on Kaplan-Meier analysis. Results: Successful revascularization was beneficial, with RC improvement noted across all groups. Thirty-day freedom from MAE estimates were high across all groups: 99.2% in RC2,3, 96.1% in RC4,5, and 90.8% in RC6. At 12 months, the freedom from MAE was 82.6% in RC2,3, 73.2% in RC4,5, and 59.3% in RC6 patients. Estimates for freedom from major amputation at 12 months were 99.3%, 96.0%, and 81.7%, respectively. QoL scores improved significantly across all domains in all groups with 12-month VascuQol total scores of 5.3, 5.0, and 4.8 for RC2,3, RC4,5, and RC6, respectively. Conclusion: The results indicate that peripheral endovascular intervention is a viable treatment option for RC2,3, RC4,5, and RC6 patients as evidenced by the high freedom from major amputation, as well as the improvement in QoL and the RC at 12 months. Furthermore, primary unplanned amputation is often not necessary in RC6.

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Section: Discussionmentioning

confidence: 99%

One-Year Results of the LIBERTY 360 Study: Evaluation of Acute and Midterm Clinical Outcomes of Peripheral Endovascular Device Interventions

et al. 2019

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“…Among patients with lifestyle-limiting claudication, revascularization (ie, surgical or endovascular) and exercise are superior to medical management alone in terms of quality of life. 21,22 Our study showed that patients with RC 2-3 symptoms undergoing endovascular therapy had a 98.5% 36-month freedom from major amputation and a VascuQoL total score of 5.3±1.4, suggesting that it would be reasonable to intervene early in claudicants, when they have failed medical and/or exercise therapy, in order to improve their quality of life.…”

Section: Discussionmentioning

confidence: 79%

“…Furthermore, large peripheral endovascular therapy registries should be created for more accurate post-market surveillance. 22 Propensity score outcome data from retrospective comparisons showed that atherectomy was statistically superior to balloon angioplasty, stenting, and bypass surgery in a cohort of 36,000 patients with CLTI over the course of 4 years. 53 As we continue to evaluate different treatment modalities in prospective and retrospective analyses, the outcomes are pointing toward a favorable long-term benefit when CLTI patients are treated early rather than late, especially when the treatment includes atherectomy.…”

Section: Discussionmentioning

confidence: 99%

Three-Year Outcomes From the LIBERTY 360 Study of Endovascular Interventions for Peripheral Artery Disease Stratified by Rutherford Category

Giannopoulos

Mustapha²,

Gray

et al. 2020

J Endovasc Ther

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Purpose: To report the 3-year results of the LIBERTY 360 study, which investigated outcomes of endovascular treatment of symptomatic peripheral artery disease (PAD). Materials and Methods: The LIBERTY trial ( ClinicalTrials.gov identifier NCT01855412) was a prospective, observational, core laboratory–assessed, multicenter study of endovascular interventions enrolling >1200 participants treated at 51 sites. Data from 1189 patients were stratified according to Rutherford category (RC) and analyzed [RC 2-3 (n=500), RC 4-5 (n=589), and RC 6 (n=100)]. The primary outcomes were major amputation of the target limb and all-cause death; secondary outcomes were target vessel revascularization (TVR) or target lesion revascularization (TLR); major adverse events (MAEs; death within 30 days, TVR or TLR, and major amputation); death or major amputation combined; and change in self-reported quality of life (QoL) measures (VascuQol-25). The Kaplan-Meier (KM) method was employed to estimate the outcomes; estimates are presented with the 95% confidence intervals (CI). Predictors of 3-year MAE, death, TVR, and major amputation were analyzed using Cox proportional hazard regression modeling. Results: The 36-month KM survival rates were 86.0% in RC 2-3, 79.8% in RC 4-5, and 62.0% in RC 6 groups. The KM estimates of freedom from major amputation at 36 months were 98.5% in RC 2-3, 94.0% in RC 4-5, and 79.9% in RC 6. The 36-month KM estimates for freedom from TVR/TLR were 71.1% in RC 2-3, 64.2% in RC 4-5 and 61.9% in RC 6 groups. Patients with claudication at baseline were at lower risk for MAEs compared with RC 4-5 and RC 6 patients during the 36-month follow-up. Vascular QoL improved from baseline and persisted up to 36 months in all patients. Conclusion: Endovascular therapy is a viable treatment option for patients with symptomatic PAD, with sustained improved quality of life in both claudicants and patients with chronic limb-threatening ischemia. These results provide important point estimates for midterm outcomes after modern endovascular interventions for PAD.

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“…Similar work has been reported by the Registry Assessment of Peripheral Arterial Devices (RAPID) group for multispecialty collaboration within USA. 17,18 The ICVR-recommended data set has many agreements with data elements and definitions in RAPID, which is focused on device evaluation for peripheral vascular intervention in USA. The current ICVR database recommendations extend those of RAPID to encompass both open and endovascular revascularisation and for international studies, while still allowing device evaluation.…”

Section: Discussionmentioning

confidence: 99%

International Consortium of Vascular Registries Consensus Recommendations for Peripheral Revascularisation Registry Data Collection

Behrendt

Bertges

Eldrup

et al. 2018

European Journal of Vascular and Endovascular Surgery

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A modified Delphi study allowed 25 international vascular registry experts to achieve a consensus recommendation for a minimum core data set and an optimum data set for peripheral arterial revascularisation registries. Continued global harmonisation of registry infrastructure and definition of items will overcome limitations related to single country investigations and enhance the development of real world evidence.

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Registry Assessment of Peripheral Interventional Devices (RAPID): Registry assessment of peripheral interventional devices core data elements

Abstract: Ultimately, we hope this work will facilitate and improve device evaluation and surveillance for patients, clinicians, health outcomes researchers, industry, policymakers, and regulators.

Cited by 17 publications

References 9 publications

One-Year Results of the LIBERTY 360 Study: Evaluation of Acute and Midterm Clinical Outcomes of Peripheral Endovascular Device Interventions

One-Year Results of the LIBERTY 360 Study: Evaluation of Acute and Midterm Clinical Outcomes of Peripheral Endovascular Device Interventions

Three-Year Outcomes From the LIBERTY 360 Study of Endovascular Interventions for Peripheral Artery Disease Stratified by Rutherford Category

International Consortium of Vascular Registries Consensus Recommendations for Peripheral Revascularisation Registry Data Collection

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