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Attribution of Adverse Events Following Coronary Stent Placement Identified Using Administrative Claims Data
Sanket S Dhruva1,2,3, Craig S Parzynski3, Ginger M Gamble3
1University of California, San Francisco, School of Medicine and San Francisco Veterans Affairs Healthcare System San Francisco CA.
Insights
Linking Medicare claims to registry data for drug-eluting stents (DESs) shows only half of repeat procedures are linked to the original artery. This highlights the need for careful review of claims data to accurately assess DES safety.
Area of Science:
- Cardiology
- Health Informatics
- Medical Device Surveillance
Background:
- Over 600,000 coronary stents are implanted annually in the U.S. during percutaneous coronary interventions (PCIs).
- Existing surveillance systems for long-term medical device safety are lacking, leading to reliance on claims data.
- The accuracy of attributing adverse events identified in claims data to specific medical devices like coronary stents is uncertain.
Purpose of the Study:
- To assess the reliability of using Medicare claims data to monitor the long-term safety of drug-eluting stents (DESs).
- To determine the extent to which adverse events identified in claims data can be accurately attributed to the index DES implantation site.
Main Methods:
- Linked the National Cardiovascular Data Registry (NCDR) CathPCI Registry with Medicare fee-for-service claims for patients (≥65 years) receiving DESs.
- Identified repeat PCIs within one year of index PCI in claims data as potential safety events.
- Linked repeat PCIs back to the registry to ascertain target vessel revascularization and attribute events to the index DES.
Main Results:
- Of 415,306 DES implantations, 33,174 repeat PCIs were found in claims data within one year.
- Over 86% of repeat PCIs were linkable to the registry; 51.1% were target vessel revascularizations.
- Only 50.4% of target vessel revascularizations involved a previously placed DES (in-stent restenosis or stent thrombosis).
- 27.5% of acute myocardial infarction claims and 1.1% of death claims were attributed to the target vessel.
Conclusions:
- While claims data can be linked to registry data for DES surveillance, only about half of repeat PCIs are attributable to the index coronary artery.
- Attribution of adverse events like acute myocardial infarction or death to the index DES is even less frequent.
- Claims data alone requires thorough validation with registry data for accurate assessment of coronary stent safety and to identify meaningful safety signals.
Abstract:
Background More than 600 000 coronary stents are implanted during percutaneous coronary interventions (PCIs) 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) CathPCI 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 PCIs within 1 year of the index procedure in Medicare claims as potential safety events. We linked these subsequent PCIs back to the NCDR CathPCI 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 PCIs were identified in Medicare claims within 1 year. Of these, 28 632 (86.3%) could be linked back to the NCDR CathPCI Registry; 16 942 (51.1% of repeat PCIs) 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 PCIs 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.
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