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Patterns of use and comparative effectiveness of bleeding avoidance strategies in men and women following percutaneous coronary interventions: an observational study from the National Cardiovascular Data Registry.

ABSTRACT: This study sought to compared the use and effectiveness of bleeding avoidance strategies (BAS) by sex.Women have higher rates of bleeding following percutaneous coronary intervention (PCI).Among 570,777 men (67.5%) and women (32.5%) who underwent PCI in the National Cardiovascular Data Registry's CathPCI Registry between July 1, 2009 and March 31, 2011, in-hospital bleeding rates and the use of BAS (vascular closure devices, bivalirudin, radial approach, and their combinations) were assessed. The relative risk of bleeding for each BAS compared with no BAS was determined in women and men using multivariable logistic regressions adjusted for clinical characteristics and the propensity for receiving BAS. Finally, the absolute risk differences in bleeding associated with BAS were compared.Overall, the use of any BAS differed slightly between women and men (75.4% vs. 75.7%, p = 0.01). When BAS was not used, women had significantly higher rates of bleeding than men (12.5% vs. 6.2%, p < 0.01). Both sexes had similar adjusted risk reductions of bleeding when any BAS was used (women, odds ratio: 0.60, 95% confidence interval [CI]: 0.57 to 0.63; men, odds ratio: 0.62, 95% CI: 0.59 to 0.65). Women and men had lower absolute bleeding risks with BAS; however, these absolute risk differences were greater in women (6.3% vs. 3.2%, p < 0.01).Women continue to have almost twice the rate of bleeding following PCI. The use of any BAS was associated with a similarly lower risk of bleeding for men and women; however, the absolute risk differences were substantially higher in women. These data underscore the importance of applying effective strategies to limit post-PCI bleeding, especially in women.

SUBMITTER: Daugherty SL

PROVIDER: S-EPMC3667414 | biostudies-literature | 2013 May

REPOSITORIES: biostudies-literature

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Patterns of use and comparative effectiveness of bleeding avoidance strategies in men and women following percutaneous coronary interventions: an observational study from the National Cardiovascular Data Registry.

Daugherty Stacie L SL Thompson Lauren E LE Kim Sunghee S Rao Sunil V SV Subherwal Sumeet S Tsai Thomas T TT Messenger John C JC Masoudi Frederick A FA

Journal of the American College of Cardiology 20130321 20

<h4>Objectives</h4>This study sought to compared the use and effectiveness of bleeding avoidance strategies (BAS) by sex.<h4>Background</h4>Women have higher rates of bleeding following percutaneous coronary intervention (PCI).<h4>Methods</h4>Among 570,777 men (67.5%) and women (32.5%) who underwent PCI in the National Cardiovascular Data Registry's CathPCI Registry between July 1, 2009 and March 31, 2011, in-hospital bleeding rates and the use of BAS (vascular closure devices, bivalirudin, radi ...[more]

PMID: 23524046

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Project description:ObjectiveTo examine whether prospective bleeding risk estimates for patients undergoing percutaneous coronary intervention could improve the use of bleeding avoidance strategies and reduce bleeding.DesignProspective cohort study comparing the use of bleeding avoidance strategies and bleeding rates before and after implementation of prospective risk stratification for peri-procedural bleeding.SettingNine hospitals in the United States.ParticipantsAll patients undergoing percutaneous coronary intervention for indications other than primary reperfusion for ST elevation myocardial infarction.Main outcome measuresUse of bleeding avoidance strategies, including bivalirudin, radial approach, and vascular closure devices, and peri-procedural bleeding rates, stratified by bleeding risk. Observed changes were adjusted for changes observed in a pool of 1135 hospitals without access to pre-procedural risk stratification. Hospital level and physician level variability in use of bleeding avoidance strategies was examined.ResultsIn a comparison of 7408 pre-intervention procedures with 3529 post-intervention procedures, use of bleeding avoidance strategies within intervention sites increased with pre-procedural risk stratification (odds ratio 1.81, 95% confidence interval 1.44 to 2.27), particularly among higher risk patients (2.03, 1.58 to 2.61; 1.41, 1.09 to 1.83 in low risk patients, after adjustment for control sites; P for interaction = 0.05). Bleeding rates within intervention sites were significantly lower after implementation of risk stratification (1.0% v 1.7%; odds ratio 0.56, 0.40 to 0.78; 0.62, 0.44 to 0.87, after adjustment); the reduction in bleeding was greatest in high risk patients. Marked variability in use of bleeding avoidance strategies was observed across sites and physicians, both before and after implementation.ConclusionsProspective provision of individualized bleeding risk estimates was associated with increased use of bleeding avoidance strategies and lower bleeding rates. Marked variability between providers highlights an important opportunity to improve the consistency, safety, and quality of care. Study registration Clinicaltrials.gov NCT01383382.

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:BackgroundCoronary artery diseases remain the leading cause of death in the world. The management of this condition has improved remarkably in the recent years owing to the development of new technical tools and multicentric registries.ObjectiveThe aim of this study is to investigate the in-hospital and 1-year clinical outcomes of patients treated with percutaneous coronary intervention (PCI) in Tunisia.MethodsWe will conduct a prospective multicentric observational study with patients older than 18 years who underwent PCI between January 31, 2020 and June 30, 2020. The primary end point is the occurrence of a major adverse cardiovascular event, defined as cardiovascular death, myocardial infarction, cerebrovascular accident, or target vessel revascularization with either repeat PCI or coronary artery bypass grafting (CABG). The secondary end points are procedural success rate, stent thrombosis, and the rate of redo PCI/CABG for in-stent restenosis.ResultsIn this study, the demographic profile and the general risk profile of Tunisian patients who underwent PCI and their end points will be analyzed. The complexity level of the procedures and the left main occlusion, bifurcation occlusion, and chronic total occlusion PCI will be analyzed, and immediate as well as long-term results will be determined. The National Tunisian Registry of PCI (NATURE-PCI) will be the first national multicentric registry of angioplasty in Africa. For this study, the institutional ethical committee approval was obtained (0223/2020). This trial consists of 97 cardiologists and 2498 patients who have undergone PCI with a 1-year follow-up period. Twenty-eight catheterization laboratories from both public (15 laboratories) and private (13 laboratories) sectors will enroll patients after receiving informed consent. Of the 2498 patients, 1897 (75.9%) are managed in the public sector and 601 (24.1%) are managed in the private sector. The COVID-19 pandemic started in Tunisia in March 2020; 719 patients (31.9%) were included before the COVID-19 pandemic and 1779 (60.1%) during the pandemic. The inclusion of patients has been finished, and we expect to publish the results by the end of 2022.ConclusionsThis study would add data and provide a valuable opportunity for real-world clinical epidemiology and practice in the field of interventional cardiology in Tunisia with insights into the uptake of PCI in this limited-income region.Trial registrationClinicaltrials.gov NCT04219761; https://clinicaltrials.gov/ct2/show/NCT04219761.International registered report identifier (irrid)RR1-10.2196/24595.

Project description:BackgroundPatients treated with percutaneous coronary intervention are often considered to be at a high bleeding risk (HBR). Drug-eluting stents have been shown to be superior to bare-metal stents in patients with HBR, even when patients were given abbreviated periods of dual antiplatelet therapy (DAPT). Short DAPT has not been evaluated with the EluNIR ridaforolimus-eluting stent. The aim of this study was to evaluate the safety and efficacy of a shortened period of DAPT following implantation of the ridaforolimus-eluting stent in patients with HBR.Methods and resultsThis was a prospective, multicenter, binational, single-arm, open-label trial. Patients were defined as HBR according to the LEADERS-FREE (Prospective Randomized Comparison of the BioFreedom Biolimus A9 Drug-Coated Stent versus the Gazelle Bare-Metal Stent in Patients at High Bleeding Risk) trial criteria. After percutaneous coronary intervention, DAPT was given for 1 month to patients presenting with stable angina. In patients presenting with an acute coronary syndrome, DAPT was given for 1 to 3 months, at the investigator's discretion. The primary end point was a composite of cardiac death, myocardial infarction, or stent thrombosis up to 1 year (Academic Research Consortium definite and probable). Three hundred fifteen patients undergoing percutaneous coronary intervention were enrolled, and 56.4% presented with acute coronary syndrome; 33.7% were receiving oral anticoagulation. At 1 year, the primary end point occurred in 15 patients (4.9%), meeting the prespecified performance goal of 14.1% (P<0.0001). Stent thrombosis (Academic Research Consortium definite and probable) occurred in 2 patients (0.6%). Bleeding Academic Research Consortium type 3 and 5 bleeding occurred in 6 patients (1.9%).ConclusionsWe observed favorable results in patients with HBR who underwent percutaneous coronary intervention with a ridaforolimus-eluting stent and received shortened DAPT, including a low rate of ischemic events and low rate of stent thrombosis.RegistrationURL: https://www.clinicaltrials.gov; Unique identifier: NCT03877848.

Dataset Information

Patterns of use and comparative effectiveness of bleeding avoidance strategies in men and women following percutaneous coronary interventions: an observational study from the National Cardiovascular Data Registry.

Publications

Patterns of use and comparative effectiveness of bleeding avoidance strategies in men and women following percutaneous coronary interventions: an observational study from the National Cardiovascular Data Registry.

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