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Temporal trends in and factors associated with bleeding complications among patients undergoing percutaneous coronary intervention: a report from the National Cardiovascular Data CathPCI Registry.

ABSTRACT: The purpose of this study was to examine temporal trends in post-percutaneous coronary intervention (PCI) bleeding among patients with elective PCI, unstable angina (UA)/non-ST-segment elevation myocardial infarction (NSTEMI), and ST-segment elevation myocardial infarction (STEMI).The impact of bleeding avoidance strategies on post-PCI bleeding rates over time is unknown.Using the CathPCI Registry, we examined temporal trends in post-PCI bleeding from 2005 to 2009 among patients with elective PCI (n = 599,524), UA/NSTEMI (n = 836,103), and STEMI (n = 267,632). We quantified the linear time trend in bleeding using 3 sequential logistic regression models: 1) clinical factors; 2) clinical + vascular access strategies (femoral vs. radial, use of closure devices); and 3) clinical, vascular strategies + antithrombotic treatments (anticoagulant ± glycoprotein IIb/IIIa inhibitor [GPI]). Changes in the odds ratio for time trend in bleeding were compared using bootstrapping and converted to risk ratio.An approximate 20% reduction in post-PCI bleeding was seen (elective PCI: 1.4% to 1.1%; UA/NSTEMI: 2.3% to 1.8; STEMI: 4.9% to 4.5%). Radial approach remained low (<3%), and closure device use increased marginally from 44% to 49%. Bivalirudin use increased (17% to 30%), whereas any heparin + GPI decreased (41% to 28%). There was a significant 6% to 8% per year reduction in annual bleeding risk in UA/NSTEMI and elective PCI, but not in STEMI. Antithrombotic strategies were associated with roughly half of the reduction in annual bleeding risk: change in risk ratio from 7.5% to 4% for elective PCI, and 5.7% to 2.8% for UA/NSTEMI (both p <0.001).The nearly 20% reduction in post-PCI bleeding over time was largely due to temporal changes in antithrombotic strategies. Further reductions in bleeding complications may be possible as bleeding avoidance strategies evolve, especially in STEMI.

SUBMITTER: Subherwal S

PROVIDER: S-EPMC3908898 | biostudies-literature | 2012 May

REPOSITORIES: biostudies-literature

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Temporal trends in and factors associated with bleeding complications among patients undergoing percutaneous coronary intervention: a report from the National Cardiovascular Data CathPCI Registry.

Subherwal Sumeet S Peterson Eric D ED Dai David D Thomas Laine L Messenger John C JC Xian Ying Y Brindis Ralph G RG Feldman Dmitriy N DN Senter Shaun S Klein Lloyd W LW Marso Steven P SP Roe Matthew T MT Rao Sunil V SV

Journal of the American College of Cardiology 20120501 21

<h4>Objectives</h4>The purpose of this study was to examine temporal trends in post-percutaneous coronary intervention (PCI) bleeding among patients with elective PCI, unstable angina (UA)/non-ST-segment elevation myocardial infarction (NSTEMI), and ST-segment elevation myocardial infarction (STEMI).<h4>Background</h4>The impact of bleeding avoidance strategies on post-PCI bleeding rates over time is unknown.<h4>Methods</h4>Using the CathPCI Registry, we examined temporal trends in post-PCI blee ...[more]

PMID: 22595404

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Project description:ImportanceBetter prediction of major bleeding after percutaneous coronary intervention (PCI) may improve clinical decisions aimed to reduce bleeding risk. Machine learning techniques, bolstered by better selection of variables, hold promise for enhancing prediction.ObjectiveTo determine whether machine learning techniques better predict post-PCI major bleeding compared with the existing National Cardiovascular Data Registry (NCDR) models.Design, setting, and participantsThis comparative effectiveness study used the NCDR CathPCI Registry data version 4.4 (July 1, 2009, to April 1, 2015), machine learning techniques were used (logistic regression with lasso regularization and gradient descent boosting [XGBoost, version 0.71.2]), and output was then compared with the existing simplified risk score and full NCDR models. The existing models were recreated, and then performance was evaluated through additional techniques and variables in a 5-fold cross-validation in analysis conducted from October 1, 2015, to October 27, 2017. The setting was retrospective modeling of a nationwide clinical registry of PCI. Participants were all patients undergoing PCI. Percutaneous coronary intervention procedures were excluded if they were not the index PCI of admission, if the hospital site had missing outcomes measures, or if the patient underwent subsequent coronary artery bypass grafting.ExposuresClinical variables available at admission and diagnostic coronary angiography data were used to determine the severity and complexity of presentation.Main outcomes and measuresThe main outcome was in-hospital major bleeding within 72 hours after PCI. Results were evaluated by comparing C statistics, calibration, and decision threshold-based metrics, including the F score (harmonic mean of positive predictive value and sensitivity) and the false discovery rate.ResultsThe post-PCI major bleeding rate among 3 316 465 procedures (patients' median age, 65 years; interquartile range, 56-73 years; 68.1% male) was 4.5%. The existing full model achieved a mean C statistic of 0.78 (95% CI, 0.78-0.78). The use of XGBoost and full range of selected variables achieved a C statistic of 0.82 (95% CI, 0.82-0.82), with an F score of 0.31 (95% CI, 0.30-0.31). XGBoost correctly identified an additional 3.7% of cases identified as high risk who experienced a bleeding event and an overall improvement of 1.0% of cases identified as low risk who did not experience a bleeding event. The data-driven decision threshold helped improve the false discovery rate of the existing techniques. The existing simplified risk score model improved the false discovery rate from more than 90% to 78.7%. Modifying the model and the data decision threshold improved this rate from 78.7% to 73.4%.Conclusions and relevanceMachine learning techniques improved the prediction of major bleeding after PCI. These techniques may help to better identify patients who would benefit most from strategies to reduce bleeding risk.

Project description:ObjectivesThe purpose of this study was to evaluate ischemic and bleeding outcomes of unselected cancer patients undergoing percutaneous coronary intervention (PCI).BackgroundThe number of cancer patients undergoing PCI is increasing despite concerns regarding ischemic and bleeding risks.MethodsBetween 2009 and 2017, consecutive patients undergoing PCI were prospectively included in the Bern PCI Registry. Cancer-specific data including type, date of initial diagnosis, and health status at index PCI were collected. We performed propensity score matching to adjust for baseline differences between patients with and without cancer. The primary ischemic endpoint was the device-oriented composite endpoint (cardiac death, target vessel myocardial infarction, target lesion revascularization) at 1 year, and the primary bleeding endpoint was Bleeding Academic Research Consortium (BARC) 2 to 5 at 1 year.ResultsAmong 13,647 patients, 1,368 (10.0%) had an established diagnosis of cancer. The 3 leading cancer types were prostate (n = 294), gastrointestinal tract (n = 188), and hematopoietic (n = 177). At index PCI, 179 (13.1%) patients were receiving active cancer treatment. In matched analysis, there was no significant difference in device-oriented composite endpoint (11.5% vs. 10.2%; p = 0.251), whereas cardiac death and BARC 2 to 5 bleeding occurred more frequently among patients with cancer compared with those without cancer (6.8% vs. 4.5%; p = 0.010 and 8.0% vs. 6.0%; p = 0.026, respectively). Cancer diagnosis within 1 year before PCI emerged as an independent predictor for cardiac death and BARC 2 to 5 bleeding at 1 year.ConclusionsCancer patients carry an increased risk of cardiac mortality that was not associated with stent-related ischemic events among patients undergoing PCI in routine clinical practice. Higher risk of bleeding in cancer patients undergoing PCI deserves particular attention. (CARDIOBASE Bern PCI Registry; NCT02241291).

Project description:Diagnostic coronary angiography in asymptomatic patients may lead to inappropriate percutaneous coronary intervention (PCI) due to a diagnostic-therapeutic cascade. Understanding the association between patient selection for coronary angiography and PCI appropriateness may inform strategies to minimize inappropriate procedures.To determine if hospitals that frequently perform coronary angiography in asymptomatic patients, a clinical scenario in which the benefit of angiography is less clear, are more likely to perform inappropriate PCI.Multicenter observational study of 544 hospitals participating in the CathPCI Registry between July 1, 2009, and September 30, 2013.Hospital proportion of asymptomatic patients at diagnostic coronary angiography and hospital rate of inappropriate PCI as defined by 2012 appropriate use criteria for coronary revascularization.Of 1?225?562 patients who underwent elective coronary angiography, 308?083 (25.1%) were asymptomatic. The hospital proportion of angiography among asymptomatic patients ranged from 1.0% to 73.6% (median, 24.7%; interquartile range, 15.9%-35.9%). By hospital quartile of asymptomatic patients at angiography, hospitals with higher rates of asymptomatic patients at angiography had higher median rates of inappropriate PCI (14.8% vs 20.2% vs 24.0 vs 29.4% from lowest to highest quartile, P?<?.001 for trend). This outcome was attributable to more frequent use of inappropriate PCI in asymptomatic patients at hospitals with higher rates of angiography in asymptomatic patients (5.4% vs 9.9% vs 14.7% vs 21.6% from lowest to highest quartile, P?<?.001 for trend). Hospitals with higher rates of asymptomatic patients at angiography also had lower rates of appropriate PCI (38.7% vs 33.0% vs 32.3% vs 32.9% from lowest to highest quartile, P?<?.001 for trend).In a national sample of hospitals, performance of coronary angiography in asymptomatic patients was associated with higher rates of inappropriate PCI and lower rates of appropriate PCI. Improving preprocedural risk stratification and thresholds for coronary angiography may be one strategy to improve the appropriateness of PCI.

Project description:ImportanceRecent data support percutaneous revascularization as an alternative to coronary artery bypass grafting in unprotected left main (ULM) coronary lesions. However, the relevance of these trials to current practice is unclear, as patterns and outcomes of ULM percutaneous coronary intervention (PCI) in contemporary US clinical practice are not well studied.ObjectiveTo define the current practice of ULM PCI and its outcomes and compare these with findings reported in clinical trials.Design, setting, and participantsThis cross-sectional multicenter analysis included data collected from 1662 institutions participating in the National Cardiovascular Data Registry (NCDR) CathPCI Registry between April 2009 and July 2016. Data were collected from 33 128 patients undergoing ULM PCI and 3 309 034 patients undergoing all other PCI. Data were analyzed from June 2017 to May 2018.Main outcomes and measuresPatient and procedural characteristics and their temporal trends were compared between ULM PCI and all other PCI. In-hospital major adverse clinical events (ie, death, myocardial infarction, stroke, and emergent coronary artery bypass grafting) were compared using hierarchical logistic regression. Characteristics and outcomes were also compared against clinical trial cohorts.ResultsOf the 3 342 162 included patients, 2 223 570 (66.5%) were male, and the mean (SD) age was 64.2 (12.1) years. Unprotected left main PCI represented 1.0% (33 128 of 3 342 162) of all procedures, modestly increasing from 0.7% to 1.3% over time. The mean (SD) annualized ULM PCI volume was 0.5 (1.5) procedures for operators and 3.2 (6.1) procedures for facilities, with only 1808 of 10 971 operators (16.5%) and 892 of 1662 facilities (53.7%) performing an average of 1 or more ULM PCI annually. After adjustment, major adverse clinical events occurred more frequently with ULM PCI compared with all other PCI (odds ratio, 1.46; 95% CI, 1.39-1.53). Compared with clinical trial populations, patients in the CathPCI Registry were older with more comorbid conditions, and adverse events were more frequent.Conclusions and relevanceUse of ULM PCI has increased over time, but overall use remains low. These findings suggest that ULM PCI occurs infrequently in the United States and in an older and more comorbid population than that seen in clinical trials.

Project description:Large-scale registries have demonstrated that in-hospital mortality after percutaneous coronary intervention (PCI) varies widely across institutions. However, whether this variation is related to major procedural complications (e.g., bleeding) is unclear. In this study, institutional variation in in-hospital mortality and its association with PCI-related bleeding complications were investigated. We analyzed 388,866 procedures at 718 hospitals performed from 2017 to 2018, using data from a nationwide PCI registry in Japan. Hospitals were stratified into quintiles according to risk-adjusted in-hospital mortality (very low, low, medium, high, and very high). Incidence of bleeding complications, defined as procedure-related bleeding events that required a blood transfusion, and in-hospital mortality in patients who developed bleeding complications were calculated for each quintile. Overall, 4,048 (1.04%) in-hospital deaths and 1,535 (0.39%) bleeding complications occurred. Among patients with bleeding complications, 270 (17.6%) died during hospitalization. In-hospital mortality ranged from 0.22% to 2.46% in very low to very high mortality hospitals. The rate of bleeding complications varied modestly from 0.27% to 0.57% (odds ratio, 1.95; 95% confidence interval, 1.58-2.39). However, mortality after bleeding complications markedly increased by quintile and was 6-fold higher in very high mortality hospitals than very low mortality hospitals (29.0% vs. 4.8%; odds ratio, 12.2; 95% confidence interval, 6.90-21.7). In conclusion, institutional variation in in-hospital mortality after PCI was associated with procedure-related bleeding complications, and this variation was largely driven by differences in mortality after bleeding complications rather than difference in their incidence. These findings underscore the importance of efforts toward reducing not only bleeding complications but also, even more importantly, subsequent mortality once they have occurred.

Dataset Information

Temporal trends in and factors associated with bleeding complications among patients undergoing percutaneous coronary intervention: a report from the National Cardiovascular Data CathPCI Registry.

Publications

Temporal trends in and factors associated with bleeding complications among patients undergoing percutaneous coronary intervention: a report from the National Cardiovascular Data CathPCI Registry.

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