RAPID and VISION September 10, 2018 VISION Think Tank Meeting Daniel J. Bertges, MD University of Vermont Medical Center VQI PVI Registry Chair

Remember two things 1. Provide background and update on RAPID - Registry Assessment of Peripheral Intervention Devices and SFA-Popliteal EvidencE Development 2. RAPID partnership with VISION

RAPIDs Objective To develop a public-private partnership to advance the nations approach to the evaluation of medical devices used to treat and manage peripheral artery disease throughout the total product life cycle

RAPID Leadership Principal Investigators MDEpiNet Key Advisors Pablo Morales, MD, FDA Robert Thatcher, 4C Medical Technologies Jack Cronenwett, MD, Society for Vascular Surgery (SVS), Vascular Quality Initiative (VQI) MDEpiNet Key Advisors Mitchell Krucoff, MD, Duke Clinical Research Institute (DCRI) Danica Marinac-Dabic, MD, PhD, MMSc, FDA Project Management and Informatics Support DCRI (Mina Baqai, Katy Knowlin, Sarah Palmer, Rebecca Wilgus) Daniel Bertges, MD; Chair of VQI PVI registry 2014-present

RAPID- Registry Assessment of Peripheral Interventional Devices Members include: United States federal agencies (FDA, CMS, AHRQ, ONC, NHLBI, NLM) Professional societies and their registries (VQI, NCDR, SIR) Academia Medical device manufacturers International partners (ICVR) Health information technology vendors Clinical research organizations (DCRI, Weill Cornell Medical College) Reference: Morales JP, Cronenwett J and Thatcher R. Endovascular Today 2016;15:85-94; Jones WS et al. J Vasc Surg 2018;67:637-45

RAPID- Registry Assessment of Peripheral Interventional Devices Work Groups Clinical Protocol & Statistics Informatics GUDID = Global Unique Device Identification Database Governance Outreach/Visibility

RAPID Phase 1 Completed! August, 2016 Endovascular Today August, 2016 mdepinet.org/rapid

PAD specific core data elements Model for International Consortium of Vascular Registries

Use Cases

RAPID Progress Move beyond proof of concept Combined project phase II/III that will use RAPID core data elements to facilitate peripheral device evaluation while addressing regulatory needs SFA-Popliteal EvidencE Development

The Goal Of SPEED is to use the VQI PVI Database to develop contemporary, dynamic Objective Performance Goals (OPG) for Superficial Femoral & Popliteal Artery Endovascular Interventions 5/2/2018

Why SPEED? Actionable with available VQI data Off the shelf ready: VQI incorporated RAPID core elements as of 9/2016 Multiple potential end users for OPGs FDA, industry, physicians Build out the infrastructure for future coordinated registry based device trials

Why SPEED OPGs? Mature space but with new technologies (drug coated balloons and stents) Many devices used off-label for patients with disease severity not tested in clinical trials Difficult for physicians and impossible for patients to chose wisely Current Objective Performance Goals for SFA-pop devices are out dated and do not reflect the current practice of medicine

Previous OPGs Small population 1,200 patients combined Different endpoints (66% vs 39% 1-year restenosis, TVR) Different disease severity (Rutherford 2-4 vs 4-6) VIVA based on superiority vs PTA SVS based on non-inferiority vs leg bypass Data > 10 years old

“We hope that as the body of available clinical evidence becomes larger, the performance goals can be updated and further refined to reflect more robust data from endovascular approaches, from which performance goals can be generated for use in evaluating the next generation of devices.” - Kumar, Brooks, Cavanaugh,Zuckerman JVS 2009

Outcomes of Interest Mortality, any cause Major amputation: below or above knee amputation rate of index limb Amputation free survival (AFS):): composite of freedom from mortality and major amputation Target lesion revascularization (TLR): repeat intervention (open surgical or percutaneous) on the index artery(ies) Open surgery: any endarterectomy or infrainguinal bypass of target lesion previously treated with PVI Interventional: any angioplasty, atherectomy, stent or stent graft or thrombolysis performed on target lesion previously treated with PVI Target lesion occlusion: binary loss of patency or occluded at follow-up Target vessel revascularization: any reintervention within the target vessel Technical failure: inability to cross lesion (with wire or device) or occlusion, or superficial femoral-popliteal artery dissection or perforation requiring treatment, or distal embolization requiring treatment, or residual stenosis >=30%. Excludes access site complications. Excludes device malfunction that is not specifically captured in VQI

Sample OPG Tables

RAPID and VISION Challenges of complex analysis time and manpower costs are real Solve or at least minimize the follow-up problem at least for core limb based outcomes Fill blind spots in registries