Registry Assessment of Peripheral Interventional Devices: RAPID Moving Into Full SPEED
Total Page：16
File Type：pdf, Size：1020Kb
Registry Assessment of Peripheral Interventional Devices: RAPID moving into full SPEED Jack Cronenwett, Pablo Morales, Robert Thatcher, Co-Chairs Mitchell Krucoff, Danica Marinac Dabic, Key Advisors Rebecca Wilgus, Project Manager, Duke Clinical Research Institute RAPID Partners • 3 Major U.S. Societies / Registries • American College of Cardiology (ACC) • National Cardiovascular Disease Registry (NCDR) • Society of Interventional Radiology (SIR) • National Interventional Radiology Quality Registry (NIRQR) • Society for Vascular Surgery (SVS) • Vascular Quality Initiative (VQI) • 7 U.S. Agencies • FDA (CDRH pre- and post-market, and CEDR) • Agency for Healthcare Research and Quality (AHRQ) • Centers for Medicare and Medicaid Services (CMS) • Department of Defense (DOD) Healthcare Resources • Office of the National Coordinator (ONC) • National Heart, Lung and Blood Institute (NHLBI) • National Library of Medicine (NLM) RAPID Partners • 12 Peripheral Vascular Device Manufacturers • Abbott • Intact Vascular • Aortic Medical Inc. • Medtronic • Bard Peripheral Vascular • Spectranetics Corp • Boston Scientific • Terumo • Cardiovascular Systems Inc. • Volcano Corp /Phillips • Cook Medical • WL Gore • 16 Related Companies / Organizations • Boston Biomedical Assoc. • Healthjump Inc. • Cerner • M2S • Cognitive Medical Systems • MedStreaming • Deloite Healthcare • NEST • Device Events • Novella Clinical, Quintiles • Epic • PCPI • First Database, Inc. • Pharm3r • Global Healthcare Exchange • UltaMed Corp. INC Research RAPID Methods Public-Private Partnership Volunteer Work • Weekly conference calls of leadership (Tue, 7:30 am ET) • 6 Face-to-face workshops • June 5 and November 6, 2015 • April 13 and September 14, 2016 • May 25 and October 4, 2017 • Multiple specialized workgroup calls • Phase 1: Clinical, Informatics, GUDID • Phase 2/3: Informatics, GUDID, Protocol, Governance, Marketing • Funding: • $10,000 contributions by multiple manufacturers • MDEpiNet funding for DCRI coordinating center Why RAPID? Heterogeneity of Peripheral Artery Treatment • Variable Patient Conditions • Age, gender, diabetes influence outcomes • Variable Disease Severity • Claudication (life style) vs. Critical Ischemia (limb threat) • Differing lesion length, occlusion vs. narrowing, calcification • Variable Disease Location • Large (iliac), Medium (SFA, popliteal), Small (tibial) Arteries • Variable Physician Specialty, Training, Experience • Cardiologists, radiologists, surgeons • Variable Treatment Options • Numerous device types, on- and off-label use in practice RAPID Goals/Progress • Phase I: Identify minimal set of core data elements for registry assessment of lower extremity arterial devices, including methods to identify specific devices being used – Completed! Endovascular Today August, 2016 mdepinet.org/rapid Registry Assessment of Peripheral Interventional Devices Core Data Elements, Jones et al, J Vasc Surg, In Press RAPID Phase I: Delivered • Core Data Elements • Main elements, FDA device problem codes, medications, devices • Use Cases for Core Data Elements • Pre- and post-market and randomized clinical trial • Workflow Diagrams • Point of care, total product lifecycle and registry-based clinical trial • GUDID Project Summary • Key learnings about use of GUDID data useful to other projects • Download data elements: www.mdepinet.org/rapid • Scheduled publication J Vasc Surg, December, 2017 RAPID Goals • Phase I: Identify minimal set of core data elements for registry assessment of lower extremity arterial devices, including methods to identify specific devices being used • Phase II: Demonstrate the feasibility of data extraction interoperability across registries and hospital EHRs that provide patient-level data for core data elements. • Phase III: Use a coordinated registries network (CRN) for studies supporting a regulatory decision. RAPID Goals: May 17, 2017 Decisions • Phase I: Identify minimal set of core data elements for registry assessment of lower extremity arterial devices, including methods to identify specific devices being used • Phase II: Demonstrate the feasibility of data extraction interoperabilityCombine across Phaseregistries II and and III, hospitalby launching EHRs a that provide patientdevice-level evaluation data for coreproject data NOW, elements. that can be incrementally joined by registries and EMR systems as they are able to integrate RAPID • Phase III: Usecore a coordinateddata elements. registries network (CRN) for studies supporting a regulatory decision. Selected superficial femoral and popliteal artery evidence development as first RAPID Phase 2/3 project. RAPID Phase II/III Combination Project SFA-Popliteal EvidencE Development (SPEED) • Why SPEED? • Mature space, but new drug-coated and other technologies in pipeline • Many devices are being used off-label, for patients and disease severity not tested in trials • Difficult for patients/physicians to chose wisely • Current objective performance goals for SFA- POP devices are out of date • Do not reflect contemporary practice SFA-Popliteal Objective Performance Goals Current Status • VIVA Physicians 2007: • 3 PMA trials: control subjects treated with plain balloon angioplasty • 116 pts with Rutherford class 2-4 disease and 4-15 cm lesions • Safety: 30 day freedom death, amp, TVR = 94 + 6% (OPG=88%) • Efficacy: Patency (no stenosis > 50%) at 1 year = 28% • Also evaluated 5 RCT (n=203 pts) patency at 1 year = 37% • Averaged 1 year patency = 33%, set OPG at 2x, OPG = 66% • Proposed as basis for single arm comparison of nitinol stents using this POBA control (superiority study) - Rocha-Singh et al, Cath Card Int 2007 SFA-Popliteal Objective Performance Goals Current Status • Society for Vascular Surgery 2009: • Based on 3 RCT of saphenous vein bypass for critical limb ischemia (Rutherford 4-6), n=838 • Safety: 30 day • MACE = 6.2% (OPG = 8%) • MALE = 6.1% (OPG = 8%) • Amputation = 1.9% (OPG = 3%) • Efficacy: 1 year • Death, MALE = 77% (OPG = 71%) • Limb salvage = 89% (OPG = 84%) • Re-intervention or stenosis = 47%% (OPG = 39%) • Proposed as non-inferiority comparison for new endovascular devices - Conte et al, J Vasc Surg 2009 SFA-Popliteal Objective Performance Goals Current Status • VIVA plus SVS • Based on < 1200 patients • Different endpoints (66% vs 39% one year stenosis, TVR) • Different disease severity (Rutherford 2-4 vs 4-6) • One based on superiority compared with plain balloon angioplasty • One based on non-inferiority compared with vein bypass surgery • Based on data >10 years old • Opportunity for SPEED • “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: J Vasc Surg 2009 Current Data Available for SPEED from VQI Registry • 2010 until Sept, 2016 (general device categories available): • 70,000 SFA-POP procedures, 70% one-year follow-up • POBA, stent, stent graft, atherectomy (laser, orbital, excisional) • Sept, 2016 – present (with device mfg, type, dia, length): • 20,000 SFA-POP procedures, with one-year follow-up accruing • Special balloons (31 unique devices, 13 companies, including DCBs) • Stents (UDI: 85 unique devices, 16 companies, 3,489 combinations of length and diameter) • Atherectomy devices (12 unique devices, 66 variations, 6 companies) • Plus CTO, embolic protection and thrombectomy devices • Plain balloon types not captured • Expect other registries and EMR systems to join future projects VQI Real World Current Treatment of SFA-POP (45,000 recent procedures) • Usually treated in combination with other arteries • Isolated SFA = 51% vs multiple arteries treated = 49% • Isolated Popliteal = 23% vs multiple arteries treated = 77% • Usually treated with more than one modality (eg, PTA + stent) • SFA: 33% One treatment type; 67% two treatment types • POP: 47% One treatment type; 53% two treatment types • Only mild disease treated with plain balloon only (11-13% overall) • TASC A-B: 75% vs. TASC C-D: 25 % • Occlusion < 5 cm: 70% vs occlusion > 5 cm: 25% • Patient characteristics (eg, age, cardiac disease, diabetes, smoking, tissue loss, urgency, ambulation status) and lesion severity (eg, length, occlusion) influence outcome and need to be considered in objective performance goals RAPID Phase II/III Combination Project SFA-Popliteal EvidencE Development (SPEED) • Goals: 1. Contemporary objective performance goals for endovascular PVI treatment • Dynamic OPGs depending on patient, lesion and treatment type characteristics 2. Device-specific data for companies that wish to expand indications for use of current devices • Line-by-line data to allow propensity matching to establish non-inferiority of new device compared with contemporary treatment of similar patients and lesions Today’s Agenda: Roll up our sleeves and work! • Working Groups: Objectives, break-outs, report back • Informatics • GUDID • Governance • Protocol • Marketing • Learning from Others: NEST and non-PAD Projects • Planning the details of next steps.