Attribution of Adverse Events Following Coronary Stent Placement Identified Using Administrative Claims Data

Autor: Harlan M. Krumholz, Nihar R. Desai, Richard Kuntz, Craig S. Parzynski, Richard E. Shaw, Danica Marinac-Dabic, Sanket S. Dhruva, Jeptha P. Curtis, Joseph S. Ross, Ginger M. Gamble, Robert W. Yeh, Frederick A. Masoudi, Art Sedrakyan, Sharon-Lise T. Normand
Rok vydání: 2020
Předmět:
Male
Time Factors
Percutaneous
Databases
Factual
medicine.medical_treatment
Myocardial Infarction
Psychological intervention
registry
030204 cardiovascular system & hematology
0302 clinical medicine
Risk Factors
drug‐eluting stent
Stent
Registries
030212 general & internal medicine
Original Research
Aged
80 and over
Quality and Outcomes
Drug-Eluting Stents
Health Services
real‐world data
3. Good health
Treatment Outcome
Drug-eluting stent
Retreatment
surveillance
Female
Cardiology and Cardiovascular Medicine
medicine.medical_specialty
Medicare
Risk Assessment
Coronary Restenosis
03 medical and health sciences
Percutaneous Coronary Intervention
Coronary stent
Product Surveillance
Postmarketing
medicine
Humans
Adverse effect
Aged
business.industry
Coronary Thrombosis
Revascularization
Percutaneous coronary intervention
United States
Administrative claims
Emergency medicine
business
Attribution
Administrative Claims
Healthcare
Health Services and Outcomes Research
Zdroj: Journal of the American Heart Association: Cardiovascular and Cerebrovascular Disease
ISSN: 2047-9980
DOI: 10.1161/jaha.119.013606
Popis: Background More than 600 000 coronary stents are implanted during percutaneous coronary interventions ( PCI s) annually in the United States. Because no real‐world surveillance system exists to monitor their long‐term safety, claims data are often used for this purpose. The extent to which adverse events identified with claims data can be reasonably attributed to a specific medical device is uncertain. Methods and Results We used deterministic matching to link the NCDR (National Cardiovascular Data Registry) Cath PCI Registry to Medicare fee‐for‐service claims for patients aged ≥65 years who underwent PCI with drug‐eluting stents ( DESs ) between July 1, 2009 and December 31, 2013. We identified subsequent PCI s within 1 year of the index procedure in Medicare claims as potential safety events. We linked these subsequent PCI s back to the NCDR Cath PCI Registry to ascertain how often the revascularization could be reasonably attributed to the same coronary artery as the index PCI (ie, target vessel revascularization). Of 415 306 DES placements in 368 194 patients, 33 174 repeat PCI s were identified in Medicare claims within 1 year. Of these, 28 632 (86.3%) could be linked back to the NCDR Cath PCI Registry; 16 942 (51.1% of repeat PCI s) were target vessel revascularizations. Of these, 8544 (50.4%) were within a previously placed DES : 7652 for in‐stent restenosis and 1341 for stent thrombosis. Of 16 176 patients with a claim for acute myocardial infarction in the follow‐up period, 4446 (27.5%) were attributed to the same coronary artery in which the DES was implanted during the index PCI (ie, target vessel myocardial infarction). Of 24 288 patients whose death was identified in claims data, 278 (1.1%) were attributed to the same coronary artery in which the DES was implanted during the index PCI . Conclusions Most repeat PCI s following DES stent implantation identified in longitudinal claims data could be linked to real‐world registry data, but only half could be reasonably attributed to the same coronary artery as the index procedure. Attribution among those with acute myocardial infarction or who died was even less frequent. Safety signals identified using claims data alone will require more in‐depth examination to accurately assess stent safety.
Databáze: OpenAIRE
Externí odkaz: