Registry Assessment of Peripheral Interventional Devices (RAPID)
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1 Registry Assessment of Peripheral Interventional Devices (RAPID) Adding Data Sources May 2, 2018 W. Schuyler Jones, MD Duke Clinical Research Institute Duke Heart Center
2 Disclosures Research Grants: Agency for Healthcare Research and Quality American Heart Association AstraZeneca Bristol Myers Squibb Doris Duke Charitable Foundation Patient-Centered Outcomes Research Institute Honararia/Other: Bayer Bristol-Myers Squibb Daiichi Sankyo Janssen
3 Objectives Background Data options Why a single data source is insufficient Potential solutions
4 Treatment Framework for PAD Less severe More severe PAD Asymptomatic Atypical Leg Pain Intermittent Claudication Critical Limb Ischemia Ischemic Rest Pain Tissue Ulceration Gangrene DECISION REGARDING REVASCULARIZATION Medical Therapy & Exercise Training ** MEDICATIONS Effect of antiplatelet and statin medication use ANATOMY Surgery Endovascular Revascularization Outcomes Pre Post 90% stenosis Stent Factors associated with use DEVICES 1. Mortality 2. MI/stroke 3. Amputation 4. Repeat revascularization 5. Repeat hospitalization 6. Costs
5 So What Is the Problem? Few ongoing clinical trials Current data sources are inadequate Heterogeneity complicates our understanding of PAD treatment Anatomy and disease severity varies Multiple specialties with different training, experience, bias Multiple devices available for treating similar lesions: Lack of clinical outcomes in electronic health records CMS data has limited insight into anatomic severity, symptom status, laterality, patients < 65 years old Many single-center studies, very few large heterogeneous datasets Need data about real-world treatment from multiple sources 5
6
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8 As of March 2018: >30,000 LE PVI procedures >230 hospitals 45% claudication, 40% CLI >80% procedures performed in cath labs Lower Extremity PVI, CAS, CEA Procedures in the Registry over Time Q22014Q32014Q42015Q12015Q22015Q32015Q42016Q12016Q22016Q32016Q42017Q12017Q22017Q CAS CEA LE PVI
9 ACC PVI Data Domains Patient characteristics Symptom burden Anatomic characteristics Medical history Provider and facility characteristics Procedural characteristics (including device) Adverse events Clinical outcomes
10
11 Modules Current Carotid Artery Stenting Carotid Endarterectomy Lower Extremity Arterial Catheter Based Interventions Future Open and Endovascular Abdominal Aortic Aneurysm Repair Infra-Inguinal Repair Supra-Inguinal Repair Renal Intervention Venous Intervention Inferior Vena Cava Filter Intervention
12 Duke University Hospitals Computable Phenotype History of PAD History of Endovascular Revascularization History of Surgical Revascularization ** via clinical information or administrative claims data Data Extraction using Retrieve Form for Data Capture (RFD) Source Document Review and Data Abstraction by Clinical Experts Duke Lifepoint Hospitals REDCAP Database ICD-10 Diagnosis Codes for PAD: I70.2x Atherosclerosis of native arteries I70.3x - I70.7x Atherosclerosis of bypass graft(s) I73.9 PVD, unspecified ICD-9 Diagnosis Codes for PAD: 440.2x 444.8x 440.3x 445.0x 440.9x x ICD-9 Procedure Codes: Angioplasty: , Atherectomy: Stenting: , CPT Codes: Angioplasty: 35450, 35470, 35473, Atherectomy: 35492, 35493, Stenting: Medicare Outcomes Dataset All Patients with ICD-9 and/or ICD-10 codes for PAD in North Carolina Outcomes of interest include: Death, Myocardial Infarction, Stroke, Lower Extremity Amputation *** linkage of REDCAP and Medicare datasets Outcomes for PAD care Combined Analytic File
13 National Evidence Generation Infrastructure Medical Product Safety Surveillance FDA Sentinel Coordinating Center Coordinating Center(s) Sentinel PCORnet Payers Public Private Common Data Model Data Standards Quality of Care Health Plans, others Coordinating Center(s) FDA, Industry Medical Product Safety Providers Hospitals Physicians Integrated Systems Registries Disease-specific Product-specific Coordinating Center(s) Sponsor(s) Public Health Surveillance Coordinating Center(s) Results CDC NIH, Industry Clinical Research Coordinating Center(s) PCORI, NIH, Industry Comparative Effectiveness Research 13
14 Future Possibilities J Am Coll Cardiol 2018 Page 14
15 Conclusions ACC PVI is expanding and contributes a different perspective (cardiology) than current dataset Clinical outcomes are limited EHR offers ability to supplement registries, but linkage to claims data and ultimately patientreported outcomes will be paramount
16 Schuyler Jones, MD Office Cell
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