Clinical trial NCT04204564: VISION and VQI Paclitaxel Safety Analysis
Official title: Vascular Implant Surveillance and Interventional Outcomes Network and the Vascular Quality Initiative Paclitaxel Safety Analysis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: PAD
Keywords: paclitaxel
drug coated balloon
drug eluting stent
perihpheral vascular intervention
registry
Lead sponsor: University of Vermont Medical Center
Sponsor class: OTHER
Collaborators: name: The Medical Device Epidemiology Network (MDEpiNet)
name: Society for Vascular Surgery Patient Safety Organization
First posted: 2019-12-19
Enrollment: 20000
Sex: ALL
Minimum age (years): 65
Maximum age (years): 100
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: All patients, aged 65 or older, who underwent endovascular interventional treatment of the femoral or popliteal arteries for symptomatic PAD between 10/1/2012 and the latest available CMS dataset (12/31/2016) will be included.

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: overall mortality
timeFrame: 1 year
measure: overall mortality
timeFrame: 3 years
measure: overall mortality
timeFrame: 5 years
Secondary outcomes:
measure: target vessel revascularization (TVR)
timeFrame: 1-3-5 years
measure: Major amputation
timeFrame: 1-3-5 years
Other outcomes:
Locations:
Study officials:
affiliation: SVS VQI
name: Daniel Bertges, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: SVS VQI
name: Philip Goodney, MD
role: STUDY_DIRECTOR
affiliation: Weill Medical College of Cornell University
name: Art Sedrakyan, PhD
role: STUDY_DIRECTOR
affiliation: SVS PSO
name: Jens Jorgensen
role: STUDY_CHAIR
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