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Comparison of bivalirudin and radial access across a spectrum of preprocedural risk of bleeding in percutaneous coronary intervention: analysis from the national cardiovascular data registry.

ABSTRACT: Bleeding is a common, noncardiac, preventable complication of percutaneous coronary intervention. We compared the relative safety of radial access and bivalirudin in percutaneous coronary intervention.From CathPCI Registry, we determined the association between the site of arterial access, bivalirudin, and periprocedural bleeding rates in 501?017 patients. Radial access patients receiving heparin (radial group) were compared with those receiving bivalirudin (radial combination group). Femoral access patients who had bivalirudin and a vascular closure device served as a reference group (femoral group). An inverse probability weighting analysis incorporating propensity scores was used to compare groups. The overall rate of bleeding was 2.59%. It was 2.71% in the femoral group, 2.5% in the radial group, and 1.82% in the radial combination groups (P<0.001). When compared with femoral group, the adjusted odds ratio for bleeding was significantly lower for patients with radial combination group (odds ratio, 0.79; 95% confidence interval, 0.72-0.86), but not for radial group (odds ratio, 0.96; 95% confidence interval, 0.88-1.05), unless patients treated with IIb/IIIa were excluded (radial group-IIb/IIIa odds ratio, 0.84; 95% confidence interval, 0.75-0.94).The number needed to treat to prevent 1 bleeding event with radial combination group was 138, whereas the number needed to treat to prevent 1 bleeding event in high-bleeding risk patients was 68.In this observational analysis, the combination of bivalirudin and radial access was associated with reduced bleeding event rate. This benefit was present across the entire spectrum of preprocedural risk of bleeding, with or without exposure to IIb/IIIa inhibitors. These data support an adequately powered randomized trial comparing bleeding avoidance strategies.

SUBMITTER: Baklanov DV

PROVIDER: S-EPMC3936790 | biostudies-literature | 2013 Aug

REPOSITORIES: biostudies-literature

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Comparison of bivalirudin and radial access across a spectrum of preprocedural risk of bleeding in percutaneous coronary intervention: analysis from the national cardiovascular data registry.

Baklanov Dmitri V DV Kim Sunghee S Marso Steven P SP Subherwal Sumeet S Rao Sunil V SV

Circulation. Cardiovascular interventions 20130806 4

<h4>Background</h4>Bleeding is a common, noncardiac, preventable complication of percutaneous coronary intervention. We compared the relative safety of radial access and bivalirudin in percutaneous coronary intervention.<h4>Methods and results</h4>From CathPCI Registry, we determined the association between the site of arterial access, bivalirudin, and periprocedural bleeding rates in 501 017 patients. Radial access patients receiving heparin (radial group) were compared with those receiving biv ...[more]

PMID: 23922144

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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.

Dataset Information

Comparison of bivalirudin and radial access across a spectrum of preprocedural risk of bleeding in percutaneous coronary intervention: analysis from the national cardiovascular data registry.

Publications

Comparison of bivalirudin and radial access across a spectrum of preprocedural risk of bleeding in percutaneous coronary intervention: analysis from the national cardiovascular data registry.

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