VISION and VQI Paclitaxel Safety Analysis

Study Overview
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Brief Summary
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Objectives 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. 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. 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 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: 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. Paclitaxel delivering DES (Cook Zilver PTX) as compared with propensity-matched cases using bare-metal stents (BMS). 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.

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

Conditions
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PAD

Intervention / Treatment
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* Device: pactlitaxel PAD device


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| paclitaxel coated balloon angioplasty<br>Procedures with paclitaxel coated balloon angioplasty of the superficial femoral-popliteal artery | Device: pactlitaxel PAD device<br>* Peripheral vascular intervention on femoral-popliteal occlusive disease with paclitaxel and non-paclitaxel devices.<br>* Other names: Cook Zilver PTX stent;|
| plain balloon angioplasty<br>Procedures with plain balloon angioplasty of the superficial femoral-popliteal artery | |
| paclitaxel eluting stent<br>Procedures with paclitaxel eluting stenting of the superficial femoral-popliteal artery | Device: pactlitaxel PAD device<br>* Peripheral vascular intervention on femoral-popliteal occlusive disease with paclitaxel and non-paclitaxel devices.<br>* Other names: Cook Zilver PTX stent;|
| bare metal stenting<br>Procedures with bare metal self expanding stenting of the superficial femoral-popliteal artery | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall mortality | death from any cause | 1 year | 
| overall mortality | death from any cause | 3 years | 
| overall mortality | death from any cause | 5 years | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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paclitaxel, drug coated balloon, drug eluting stent, perihpheral vascular intervention, registry