VISION and VQI Paclitaxel Safety Analysis

PAD Clinical Trial

— VISION-VQI  

Official title:

Vascular Implant Surveillance and Interventional Outcomes Network and the Vascular Quality Initiative Paclitaxel Safety Analysis

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04204564
• Other study ID #: 1
• Status: Active, not recruiting
• Start date: October 1, 2012
• Est. completion date: June 1, 2020

Study information

• Verified date: December 2019
• Source: University of Vermont Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Objectives

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.

Description:

The proposed safety analyses will evaluate two types of paclitaxel-coated interventional devices used to treat PAD and compare patient outcomes with propensity score-matched patients of similar risk who receive non-paclitaxel devices.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20000
• Est. completion date: June 1, 2020
• Est. primary completion date: December 31, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 100 Years

Eligibility

Inclusion Criteria:

• Age = 65 years old

• 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:

• Aneurysmal disease of the superficial femoral or popliteal artery

• 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

Related Conditions & MeSH terms

• PAD

Intervention

Device:
• pactlitaxel PAD device
Peripheral vascular intervention on femoral-popliteal occlusive disease with paclitaxel and non-paclitaxel devices.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
University of Vermont Medical Center	Society for Vascular Surgery Patient Safety Organization, The Medical Device Epidemiology Network (MDEpiNet)

References & Publications (15)

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. — View Citation

Chowdhury MM, McLain AD, Twine CP. Angioplasty versus bare metal stenting for superficial femoral artery lesions. Cochrane Database Syst Rev. 2014 Jun 24;(6):CD006767. doi: 10.1002/14651858.CD006767.pub3. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. Erratum in: J Am Coll Cardiol. 2017 Mar 21;69(11):1520. — View Citation

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. Review. — View Citation

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. Erratum in: Circulation. 2015 Nov 10;132(19):e234. — View Citation

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. — View Citation

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

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. — View Citation

Parzen M, Lipsitz SR. A global goodness-of-fit statistic for Cox regression models. Biometrics. 1999 Jun;55(2):580-4. — View Citation

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. — View Citation

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. Review. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall mortality	death from any cause	1 year
Primary	overall mortality	death from any cause	3 years
Primary	overall mortality	death from any cause	5 years
Secondary	target vessel revascularization (TVR)	repeat intervention on the SFA-popliteal artery including open or endovascular revascularization	1-3-5 years
Secondary	Major amputation	Major amputation for patients with chronic limb-threatening ischemia	1-3-5 years