Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
20000 participants
OBSERVATIONAL
2012-10-01
2020-06-01
Brief Summary
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1. The VQI-VISION Paclitaxel Device Safety Analysis seeks to assess the comparative safety of paclitaxel-coated balloons and stents in the treatment of PAD through analysis of the Vascular Quality Initiative (VQI) Peripheral Vascular Intervention (PVI) registry module with linkage to claims. By linking VQI patients to Medicare claims retrospectively from 2012 to 2016, we will be able to identify additional paclitaxel devices enabling longitudinal follow-up of mortality out to 5 years for paclitaxel-eluting stents and 3 years for paclitaxel-coated balloons.
2. To analyze factors associated with mortality, specifically comparing paclitaxel patients surviving vs. paclitaxel patients with mortality. The goal is to identify independent factors predictive of mortality in US pivotal trials and model registry data exposures with sufficient factors to track competing risk paradox and show emulation or not of mortality outcomes with both PTX and PTA exposures.
3. To confirm the effectiveness of paclitaxel devices by comparing reintervention for paclitaxel and non-paclitaxel devices. In-hospital mortality from open and percutaneous target vessel revascularization (TVR) will be reported to determine the impact of subsequent revascularizations on survival. Major amputation will be comparted for patients with chronic limb-threatening ischemia.
Detailed Description
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The primary outcome will be freedom from all-cause death using propensity-matched survival analysis.
Three principle analyses are planned:
1. Paclitaxel DCB (including the Bard Lutonix, Medtronic In.Pact Admiral, and Philips Spectranetics Stellarex DCB's) as compared with propensity-matched patients treated with plain balloons.
2. Paclitaxel delivering DES (Cook Zilver PTX) as compared with propensity-matched cases using bare-metal stents (BMS).
3. Patients treated with either Paclitaxel DCB or Paclitaxel DES compared with propensity-matched controls (with DCB patients matched to patients treated with plain balloons, and DES patients matched to patients treated with BMS).
Note that this analysis is planned at the device class level and is not intended to compare early or late mortality between specific devices or brands.
Conditions
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Keywords
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Study Design
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COHORT
OTHER
Study Groups
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paclitaxel coated balloon angioplasty
Procedures with paclitaxel coated balloon angioplasty of the superficial femoral-popliteal artery
pactlitaxel PAD device
Peripheral vascular intervention on femoral-popliteal occlusive disease with paclitaxel and non-paclitaxel devices.
plain balloon angioplasty
Procedures with plain balloon angioplasty of the superficial femoral-popliteal artery
No interventions assigned to this group
paclitaxel eluting stent
Procedures with paclitaxel eluting stenting of the superficial femoral-popliteal artery
pactlitaxel PAD device
Peripheral vascular intervention on femoral-popliteal occlusive disease with paclitaxel and non-paclitaxel devices.
bare metal stenting
Procedures with bare metal self expanding stenting of the superficial femoral-popliteal artery
No interventions assigned to this group
Interventions
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pactlitaxel PAD device
Peripheral vascular intervention on femoral-popliteal occlusive disease with paclitaxel and non-paclitaxel devices.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Date of index procedure is within 10/1/2012 to 12/31/2016
* Symptomatic disease ranging from intermittent claudication to chronic limb-threatening ischemia (including ischemic rest pain and/or tissue loss)
* Elective or urgent procedures
Exclusion Criteria
* Treatment for acute limb ischemia
* Treatment of common femoral artery or profunda femoral artery occlusive disease
* Emergency procedures
* PVI and concomitant femoral endarterectomy, suprainguinal or infrainguinal bypass
65 Years
100 Years
ALL
No
Sponsors
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The Medical Device Epidemiology Network (MDEpiNet)
UNKNOWN
Society for Vascular Surgery Patient Safety Organization
OTHER
University of Vermont Medical Center
OTHER
Responsible Party
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Daniel Bertges, MD
Associate Professor of Surgery and Medicine
Principal Investigators
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Daniel Bertges, MD
Role: PRINCIPAL_INVESTIGATOR
SVS VQI
Philip Goodney, MD
Role: STUDY_DIRECTOR
SVS VQI
Art Sedrakyan, PhD
Role: STUDY_DIRECTOR
Weill Medical College of Cornell University
Jens Jorgensen
Role: STUDY_CHAIR
SVS PSO
References
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Katsanos K, Spiliopoulos S, Kitrou P, Krokidis M, Karnabatidis D. Risk of Death Following Application of Paclitaxel-Coated Balloons and Stents in the Femoropopliteal Artery of the Leg: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. J Am Heart Assoc. 2018 Dec 18;7(24):e011245. doi: 10.1161/JAHA.118.011245.
Columbo JA, Kang R, Hoel AW, Kang J, Leinweber KA, Tauber KS, Hila R, Ramkumar N, Sedrakyan A, Goodney PP. A comparison of reintervention rates after endovascular aneurysm repair between the Vascular Quality Initiative registry, Medicare claims, and chart review. J Vasc Surg. 2019 Jan;69(1):74-79.e6. doi: 10.1016/j.jvs.2018.03.423. Epub 2018 Jun 15.
Schillinger M, Minar E. Past, present and future of femoropopliteal stenting. J Endovasc Ther. 2009 Feb;16 Suppl 1:I147-52. doi: 10.1583/1545-1550-16.16.I-147.
Dick P, Wallner H, Sabeti S, Loewe C, Mlekusch W, Lammer J, Koppensteiner R, Minar E, Schillinger M. Balloon angioplasty versus stenting with nitinol stents in intermediate length superficial femoral artery lesions. Catheter Cardiovasc Interv. 2009 Dec 1;74(7):1090-5. doi: 10.1002/ccd.22128.
Chowdhury MM, McLain AD, Twine CP. Angioplasty versus bare metal stenting for superficial femoral artery lesions. Cochrane Database Syst Rev. 2014 Jun 24;2014(6):CD006767. doi: 10.1002/14651858.CD006767.pub3.
Eliason JL, Wainess RM, Proctor MC, Dimick JB, Cowan JA Jr, Upchurch GR Jr, Stanley JC, Henke PK. A national and single institutional experience in the contemporary treatment of acute lower extremity ischemia. Ann Surg. 2003 Sep;238(3):382-9; discussion 389-90. doi: 10.1097/01.sla.0000086663.49670.d1.
Earnshaw JJ, Whitman B, Foy C. National Audit of Thrombolysis for Acute Leg Ischemia (NATALI): clinical factors associated with early outcome. J Vasc Surg. 2004 May;39(5):1018-25. doi: 10.1016/j.jvs.2004.01.019.
Howard DP, Banerjee A, Fairhead JF, Hands L, Silver LE, Rothwell PM; Oxford Vascular Study. Population-Based Study of Incidence, Risk Factors, Outcome, and Prognosis of Ischemic Peripheral Arterial Events: Implications for Prevention. Circulation. 2015 Nov 10;132(19):1805-15. doi: 10.1161/CIRCULATIONAHA.115.016424. Epub 2015 Sep 8.
Baril DT, Ghosh K, Rosen AB. Trends in the incidence, treatment, and outcomes of acute lower extremity ischemia in the United States Medicare population. J Vasc Surg. 2014 Sep;60(3):669-77.e2. doi: 10.1016/j.jvs.2014.03.244. Epub 2014 Apr 24.
Gerhard-Herman MD, Gornik HL, Barrett C, Barshes NR, Corriere MA, Drachman DE, Fleisher LA, Fowkes FGR, Hamburg NM, Kinlay S, Lookstein R, Misra S, Mureebe L, Olin JW, Patel RAG, Regensteiner JG, Schanzer A, Shishehbor MH, Stewart KJ, Treat-Jacobson D, Walsh ME. 2016 AHA/ACC Guideline on the Management of Patients With Lower Extremity Peripheral Artery Disease: Executive Summary: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. J Am Coll Cardiol. 2017 Mar 21;69(11):1465-1508. doi: 10.1016/j.jacc.2016.11.008. Epub 2016 Nov 13. No abstract available.
Oakes D, Feng C. Combining stratified and unstratified log-rank tests in paired survival data. Stat Med. 2010 Jul 20;29(16):1735-45. doi: 10.1002/sim.3921.
M Grambsch and TM Therneau, Proportional Hazards Tests and Diagnostics Based on Weighted Residuals, Biometrika 1994, 81(3): 515-526, https://doi.org/10.1093/biomet/81.3.515
Royston P, Parmar MK. Restricted mean survival time: an alternative to the hazard ratio for the design and analysis of randomized trials with a time-to-event outcome. BMC Med Res Methodol. 2013 Dec 7;13:152. doi: 10.1186/1471-2288-13-152.
Parzen M, Lipsitz SR. A global goodness-of-fit statistic for Cox regression models. Biometrics. 1999 Jun;55(2):580-4. doi: 10.1111/j.0006-341x.1999.00580.x.
Heinze G, Wallisch C, Dunkler D. Variable selection - A review and recommendations for the practicing statistician. Biom J. 2018 May;60(3):431-449. doi: 10.1002/bimj.201700067. Epub 2018 Jan 2.
Provided Documents
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Document Type: Statistical Analysis Plan
Other Identifiers
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1
Identifier Type: -
Identifier Source: org_study_id