| Autor: |
Dhruva SS; University of California, San Francisco, School of Medicine and San Francisco Veterans Affairs Healthcare System San Francisco CA.; National Clinician Scholars Program Yale School of Medicine New Haven CT.; Center for Outcomes Research and Evaluation Yale-New Haven Hospital New Haven CT., Parzynski CS; Center for Outcomes Research and Evaluation Yale-New Haven Hospital New Haven CT., Gamble GM; Center for Outcomes Research and Evaluation Yale-New Haven Hospital New Haven CT., Curtis JP; Center for Outcomes Research and Evaluation Yale-New Haven Hospital New Haven CT.; Section of Cardiovascular Medicine Department of Medicine, and National Clinician Scholars Program Yale School of Medicine New Haven CT., Desai NR; Center for Outcomes Research and Evaluation Yale-New Haven Hospital New Haven CT.; Section of Cardiovascular Medicine Department of Medicine, and National Clinician Scholars Program Yale School of Medicine New Haven CT., Yeh RW; Richard A. and Susan F. Smith Center for Outcomes Research in Cardiology Boston MA.; Division of Cardiovascular Medicine Beth Israel Deaconess Medical Center Boston MA.; Harvard Medical School Boston MA.; Baim Institute for Clinical Research Boston MA., Masoudi FA; Division of Cardiology Department of Medicine University of Colorado Anschutz Medical Campus Aurora CO., Kuntz R; Medtronic, Inc. Minneapolis MN., Shaw RE; Department of Clinical Informatics California Pacific Medical Center San Francisco CA., Marinac-Dabic D; Office of Clinical Evidence and Analysis Center for Devices and Radiological Health U.S. Food and Drug Administration Silver Spring MD., Sedrakyan A; Department of Health Policy and Research Weill Cornell Medicine New York Presbyterian Hospital New York NY., Normand ST; Department of Health Care Policy Harvard Medical School Boston MA.; Department of Biostatistics Harvard T.H. Chan School of Public Health Harvard University Boston MA., Krumholz HM; National Clinician Scholars Program Yale School of Medicine New Haven CT.; Center for Outcomes Research and Evaluation Yale-New Haven Hospital New Haven CT.; Section of Cardiovascular Medicine Department of Medicine, and National Clinician Scholars Program Yale School of Medicine New Haven CT.; Department of Health Policy and Management Yale School of Public Health New Haven CT., Ross JS; National Clinician Scholars Program Yale School of Medicine New Haven CT.; Center for Outcomes Research and Evaluation Yale-New Haven Hospital New Haven CT.; Department of Health Policy and Management Yale School of Public Health New Haven CT.; Section of General Medicine Department of Medicine, and National Clinician Scholars Program Yale School of Medicine New Haven CT. |
| Abstrakt: |
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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