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

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.

SUBMITTER: Dhruva SS

PROVIDER: S-EPMC7070203 | biostudies-literature | 2020 Feb

REPOSITORIES: biostudies-literature

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

Dhruva Sanket S SS Parzynski Craig S CS Gamble Ginger M GM Curtis Jeptha P JP Desai Nihar R NR Yeh Robert W RW Masoudi Frederick A FA Kuntz Richard R Shaw Richard E RE Marinac-Dabic Danica D Sedrakyan Art A Normand Sharon-Lise T ST Krumholz Harlan M HM Ross Joseph S JS

Journal of the American Heart Association 20200216 4

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 Dat ...[more]

PMID: 32063087

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Project description:BACKGROUND:The correct perioperative management of antiplatelet therapy (APT) in patients undergoing non-cardiac surgery (NCS) is often debated by clinicians. American College of Cardiology (ACC) and American Heart Association (AHA) guidelines recommend postponing elective NCS at least 3 months after stent implantation. Regardless of the timing of surgery, ACC/AHA guidelines recommend continuing at least ASA throughout the perioperative period and ideally continuing dual APT (DAPT) therapy "unless surgery demands discontinuation." The objective of this review was to ascertain the risks and benefits of APT in the perioperative period, to assess how these risks and benefits vary by APT management, and the significance of length of time since stent implantation before operative intervention. METHODS:PubMed, Web of Science, and Scopus were searched from inception through October 2017. Articles were included if patients were post PCI with stent placement (bare metal [BMS] or drug eluting [DES]), underwent elective NCS, and had rates of major adverse cardiac events (MACE) or bleeding events associated with pre and perioperative APT therapy. RESULTS:Of 4882 screened articles, we included 16 studies in the review (1 randomized controlled trial and 15 observational studies). Studies were small (< 50: n = 5, 51-150: n = 5, >150: n = 6). All studies included DES with 7 of 16 also including BMS. Average time from stent to NCS was variable (< 6 months: n = 3, 6-12 months: n = 1, > 12 months: n = 6). At least six different APT strategies were described. Six studies further utilized bridging protocols using three different pharmacologic agents. Studies typically included multiple surgical fields with varying degrees of invasiveness. Across all APT strategies, rates of MACE/bleeding ranged from 0 to 21% and 0 to 22%. There was no visible trend in MACE/bleeding rates within a given APT strategy. Stratifying the articles by type of surgery, timing of discontinuation of APT therapy, bridging vs. no bridging, and time since stent placement did not help explain the heterogeneity. CONCLUSIONS:Evidence regarding perioperative APT management in patients with cardiac stents undergoing NCS is insufficient to guide practice. Other clinical factors may have a greater impact than perioperative APT management on MACE and bleeding events. SYSTEMATIC REVIEW REGISTRATION:PROSPERO CRD42016036607.

Project description:BackgroundAnaphylaxis events are increasing worldwide, based on studies of single administrative datasets including hospital admissions, emergency room presentations, and prescription and medical claims data. Linking multiple administrative datasets may provide better epidemiological estimates, by capturing a greater number of anaphylaxis events occurring at the individual level. In this linked data study in Western Australia, we combined 4 population-based datasets to identify anaphylaxis events, factors influencing occurrence, and change in event rates from 2002 to 2013.MethodsFour linked administrative datasets from the Western Australian Data Linkage System were used, representing ambulance attendances, emergency department presentations, hospital inpatient admissions and death registrations. An anaphylaxis cohort was identified using ICD-9-CM, ICD-10-AM and additional anaphylaxis diagnosis codes, with event rates calculated. We explored the impact of age, gender, cause, Indigenous status and socioeconomic index on event rates. Standard Poisson regression models were used to examine the significance of the change in anaphylaxis event rates over time.ResultsA total 12,637 individuals (mean age 31.8 years, 49.6% female) experienced 15,462 anaphylaxis events between 2002 and 2013 (97.5% in non-Indigenous patients and 59.5% residing in the area of greatest socioeconomic advantage). Anaphylaxis event rates increased from 15.4 to 82.5/105 population between 2002 and 2013. The greatest increase in anaphylaxis events was seen in those coded as unspecified anaphylaxis (all ages, males and females combined, p < 0.001), with the highest rates of unspecified anaphylaxis in males 0-4 years (171.9/105 population in 2013), and females 15-19 years (104.0/105 in 2013). The average annual percent increase (95% CI) for food-related anaphylaxis was 9.2% (6.6-12.0); for medication-related anaphylaxis was 5.8% (4.5-7.1); and for unspecified anaphylaxis was 10.4% (9.8-11.0); all p < 0.001. There was a significant increase in ambulance attendance, emergency presentations and inpatient admissions for anaphylaxis between 2002 and 2013, with emergency presentations (56.0/105 population), inpatient admissions (43.2/105), and ambulance attendance (21.6/105) highest in 2013. Only 25 anaphylaxis-related deaths were recorded in the mortality register with no significant change in rates over time.ConclusionUsing multiple linked administrative datasets, we identified significantly higher rates of total anaphylaxis than previously reported, with more than 5-fold increases in anaphylaxis events between 2002 and 2013. While the combination of 4 population-level datasets provides a more comprehensive capture of cases, even at the individual dataset level, admission rates for anaphylaxis in Western Australia are substantially higher than those previously reported for similar time periods, both in Australia and worldwide.

Dataset Information

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

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

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