VISION and VQI Paclitaxel Safety Analysis

• Conditions: PAD
• Interventions: Device: pactlitaxel PAD device

• Registration Number: NCT04204564
• Lead Sponsor: University of Vermont Medical Center

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.

Study Timeline

• Study Start: 2012-10-01
• Primary Completion: 2016-12-31
• Status Verified: 2019-12
• Study First Submitted: 2019-12-12
• Study First Submitted QC: 2019-12-16
• Last Update Submitted: 2019-12-16
• Study First Posted: 2019-12-19
• Last Update Posted: 2019-12-19
• Study Completion: 2020-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
paclitaxel eluting stent	pactlitaxel PAD device	Procedures with paclitaxel eluting stenting of the superficial femoral-popliteal artery
paclitaxel coated balloon angioplasty	pactlitaxel PAD device	Procedures with paclitaxel coated balloon angioplasty of the superficial femoral-popliteal artery

Primary Outcome Measures

Name	Time	Method
overall mortality	5 years	death from any cause

Secondary Outcome Measures

Name	Time	Method
target vessel revascularization (TVR)	1-3-5 years	repeat intervention on the SFA-popliteal artery including open or endovascular revascularization
Major amputation	1-3-5 years	Major amputation for patients with chronic limb-threatening ischemia