Use Of Bleeding Avoidance Strategies Research Articles

Access-Site vs Non-Access-Site Major Bleeding and In-Hospital Outcomes Among STEMI Patients Receiving Primary PCI

BackgroundMajor bleeding (MB) is an independent predictor of mortality among ST-elevation myocardial infarction (STEMI) patients undergoing primary percutaneous coronary intervention (pPCI). Prevention of access-site MB has received significant attention. However, limited data have been obtained on the influence of access-site MB vs non-access-site MB and association with subsequent adverse in-hospital outcomes in the STEMI population undergoing pPCI. MethodsWe identified 1494 STEMI patients who underwent pPCI between 2012 and 2018. Unadjusted and adjusted differences among patients with no MB, access-site MB, non-access-site MB, and in-hospital clinical outcomes were assessed. The use of bleeding-avoidance strategies and their effects on MB were also evaluated. ResultsMB occurred in 121 (8.1%) patients. Access-site MB occurred in 34 (2.3%) patients, and non-access-site MB occurred in 87 (5.8%). The median reduction in hemoglobin was 31 g/L (interquartile range: 19-43) with access-site MB, and 44 g/L (interquartile range: 29-62) with non-access-site MB. After multivariable adjustment, non-access-site MB was independently associated with in-hospital death (adjusted odds ratio [aOR] 4.21; 95% confidence interval [CI] 2.04-8.68), cardiogenic shock (aOR 10.91; 95% CI 5.67-20.98), and cardiac arrest (aOR 5.63; 95% CI 2.88-11.01). Conversely, access-site MB was not associated with adverse in-hospital outcomes. Bleeding-avoidance strategies were used frequently; however, after multivariable adjustment, no single bleeding-avoidance strategy was significantly associated with reduced MB. ConclusionsIn STEMI patients undergoing pPCI, non-access-site MB was independently associated with adverse in-hospital outcomes, whereas access-site MB was not. Additional study of strategies to reduce the incidence and impact of non-access-site MB appears to be warranted.

Development and Evaluation of Novel Electronic Medical Record Tools For Avoiding Bleeding After Percutaneous Coronary Intervention.

BackgroundBleeding remains the most common complication of percutaneous coronary intervention. Guidelines recommend assessing bleeding risk before percutaneous coronary intervention to target use of bleeding avoidance strategies and mitigate bleeding events. Cedars‐Sinai Medical Center undertook an initiative to integrate these recommendations into the electronic medical record.Methods and ResultsThe intervention included a voluntary clinical decision alert to assess bleeding risk before percutaneous coronary intervention, a bleeding risk calculator tool based on the NCDR (National Cardiovascular Data Registry) risk prediction model and, when indicated, a second alert to consider 4 bleeding avoidance strategies. We tested for changes in the use of bleeding avoidance strategies and bleeding event rates by comparing procedures performed before versus after implementation of the electronic medical record–based intervention and with versus without use of the bleeding risk calculator tool. Use of radial access increased (47.6% versus 64.8%; P<0.001) and glycoprotein IIb/IIIa inhibitors decreased (12.8% versus 3.17%; P<0.001) from before to after implementation, though risk‐adjusted bleeding event rates were stable (odds ratio, 0.82; P=0.164), even for high‐risk procedures. Use versus nonuse of the bleeding risk calculator tool was associated with increased radial access and reductions in glycoprotein IIb/IIIa inhibitors, but no change in bleeding events.ConclusionsIntegrating guideline recommendations into the electronic medical record to promote assessments of bleeding risk and use of bleeding avoidance strategies was feasible and associated with changes in clinical practice. Future work is needed to ensure that bleeding avoidance strategies are not overused among lower‐risk patients, and that, for high‐risk patients, the potential benefits of elective percutaneous coronary intervention are carefully weighed against the risk of bleeding.

Abstract 16927: Validation of CathPCI Bleeding Model in Transradial vs. Transfemoral PCI Patients

Background: Estimation of bleeding risk in patients undergoing PCI informs the use of bleeding avoidance strategies, allows for personalized consent, and supports quality improvement efforts. The CathPCI Bleeding Model (CPBM) was developed in patients undergoing PCI between 2008 and 2011, when PCI was performed predominantly via transfemoral (TF) access. Whether this model functions equally well in transradial (TR) PCI is unclear. Objectives: This study sought to determine if the CPBM behaves differently for PCI performed via TF vs TR access. Methods: Patients who underwent PCI between Q4 2010 and Q4 2016 were identified from an institutional CathPCI Registry. The primary outcome was post-PCI bleeding within 72 hours or before hospital discharge. A logistic regression model was created predicting CPBM on the 10-variable reduced model. Interactions between each variable and access site were tested. Using the CPBM integer scoring system, the interaction between low, moderate, and high risk groups with the access site was tested. Results: TR access increased from 14% in 2010 to 60% in 2016. Major bleeding was lower for TR than TF PCI (2.5% vs 7.3%, p &lt; 0.001). Prior PCI was protective of bleeding in the TF, but predictive of bleeding in the TR group. There was no significant interaction between access site and all remaining variables (Fig. 1). There was no difference in the discriminative capacity of the CPBM between TR and TF access (Fig. 1). The CPBM integer score behaved similarly between groups, without significant interaction, p = 0.53 (Fig. 2). Conclusions: The CPBM may be used to estimate patients’ bleeding risk regardless of PCI access site.

Reversing the "Risk-Treatment Paradox" of Bleeding in Patients Undergoing Percutaneous Coronary Intervention: Risk-Concordant Use of Bleeding Avoidance Strategies Is Associated With Reduced Bleeding and Lower Costs.

BackgroundBleeding is a common, morbid, and costly complication of percutaneous coronary intervention. While bleeding avoidance strategies (BAS) are effective, they are used paradoxically less in patients at high risk of bleeding. Whether a patient‐centered approach to specifically increase the risk‐concordant use of BAS and, thus, reverse the risk‐treatment paradox is associated with reduced bleeding and costs is unknown.Methods and ResultsWe implemented an intervention to reverse the bleeding risk‐treatment paradox at Barnes‐Jewish Hospital, St. Louis, MO, and examined: (1) the temporal trends in BAS use and (2) the association of risk‐concordant BAS use with bleeding and hospital costs of percutaneous coronary intervention. Among 3519 percutaneous coronary interventions, there was a significantly increasing trend (P=0.002) in risk‐concordant use of BAS. The bleeding incidence was 2% in the risk‐concordant group versus 9% in the risk‐discordant group (absolute risk difference, 7%; number needed to treat, 14). Risk‐concordant BAS use was associated with a 67% (95% confidence interval, 52–78%; P<0.001) reduction in the risk of bleeding and a $4738 (95% confidence interval, 3353–6122; P<0.001) reduction in per‐patient percutaneous coronary intervention hospitalization costs (21.6% cost‐savings).ConclusionsIn this study, patient‐centered care directly aimed to make treatment‐related decisions based on predicted risk of bleeding, led to more risk‐concordant use of BAS and reversal of the risk‐treatment paradox. This, in turn, was associated with a reduction in bleeding and hospitalization costs. Larger multicentered studies are needed to corroborate these results. As clinical medicine moves toward personalization, both patients and hospitals can benefit from a simple practice change that encourages objectivity and mitigates variability in care.

THE IMPACT OF BLEEDING AVOIDANCE STRATEGIES ON HOSPITAL-LEVEL VARIATION IN BLEEDING RATES FOLLOWING PERCUTANEOUS CORONARY INTERVENTION: INSIGHTS FROM THE NCDR CATHPCI REGISTRY

Prior studies have reported that bleeding rates following percutaneous coronary intervention (PCI) vary markedly among hospitals, but the extent to which use of bleeding avoidance strategies (BAS) explains this variation is unknown. Using the American College of Cardiology National Cardiovascular

A Personalized Bleeding-Avoidance Strategy Can Reduce PCI Bleeding Rates

To encourage the use of bleeding-avoidance strategies (BAS) based on individual risk in patients undergoing percutaneous coronary interventions,

Access and non-access site bleeding after percutaneous coronary intervention and risk of subsequent mortality and major adverse cardiovascular events: systematic review and meta-analysis.

The prognostic impact of site-specific major bleeding complications after percutaneous coronary intervention (PCI) has yielded conflicting data. The aim of this study is to provide an overview of site-specific major bleeding events in contemporary PCI and study their impact on mortality and major adverse cardiovascular event outcomes. We conducted a meta-analysis of PCI studies that evaluated site-specific periprocedural bleeding complications and their impact on major adverse cardiovascular events and mortality outcomes. A systematic search of MEDLINE and Embase was conducted to identify relevant studies and random effects meta-analysis was used to estimate the risk of adverse outcomes with site-specific bleeding complications. Twenty-five relevant studies including 2,400,645 patients that underwent PCI were identified. Both non-access site (risk ratio [RR], 4.06; 95% confidence interval [CI], 3.21-5.14) and access site (RR, 1.71; 95% CI, 1.37-2.13) related bleeding complications were independently associated with an increased risk of periprocedural mortality. The prognostic impact of non-access site-related bleeding events on mortality related to the source of anatomic bleeding, for example, gastrointestinal RR, 2.78; 95% CI, 1.25 to 6.18; retroperitoneal RR, 5.87; 95% CI, 1.63 to 21.12; and intracranial RR, 22.71; 95% CI, 12.53 to 41.15. The prognostic impact of bleeding complications after PCI varies according to anatomic source and severity. Non-access site-related bleeding complications have a similar prevalence to those from the access site but are associated with a significantly worse prognosis partly related to the severity of the bleed. Clinicians should minimize the risk of major bleeding complications during PCI through judicious use of bleeding avoidance strategies irrespective of the access site used.

Precision medicine to improve use of bleeding avoidance strategies and reduce bleeding in patients undergoing percutaneous coronary intervention: prospective cohort study before and after implementation of personalized bleeding risks

Objective To examine whether prospective bleeding risk estimates for patients undergoing percutaneous coronary intervention could improve the use of bleeding avoidance strategies and reduce bleeding.Design Prospective cohort study comparing the...

Abstract 12274: A Regional Pharmacoinvasive PCI Strategy Incorporating Bleeding Avoidance Strategies

Background: Pharmacoinvasive Therapy (PIT) is a potential treatment for STEMI patients who are not able to achieve primary PCI within guideline recommended time limits. The risk of bleeding complications with PIT has not been studied in the setting of routine use of bleeding avoidance strategies (BAS). Methods: We analyzed a contemporary multicenter registry (2009-2013) of consecutive patients undergoing PCI as part of a 10 hospital regional algorithm involving 1 PCI center and 9 transfer centers: PIT for hospitals &gt; 60 minutes (N=140) and Primary PCI if &lt; 60 minutes travel time to PCI center (N=346). We compared the risk of HORIZONS Major Bleeding for patients undergoing PIT vs Primary PCI in the setting of routine use of BAS and determined the independent predictors of major bleeding in the entire cohort. Results: The PIT patients had a median travel time of 103±49 minutes and were more frequently female, had a higher incidence of renal failure and less cardiogenic shock than the primary PCI group. BAS was routine and similar in both groups (Table). Rates of death, stroke, ischemic and major bleeding outcomes were similar among the two groups, and length of stay was shorter in the PIT group. Multivariate logistic models indicated that two independent predictors of major bleeding were cardiac arrest (OR=3.89, 95% CI: 1.2-12.1, p=0.02) and bailout GPI utilization (OR=3.23, 95% CI 1.2-9.9, p =0.03). The PIT strategy in conjunction with BAS did not predict major bleeding (OR=2.1, 95% CI: 0.85-5.44, p=0.11). Conclusions: We report the largest study of BAS in conjunction with a regional STEMI strategy of PIT: PIT is associated with low rates of bleeding and thrombotic complications. Bleeding and ischemic rates were similar to the primary PCI strategy. PIT in conjunction with BAS is not an independent predictor of bleeding risk in a regional STEMI population.

Identification of hospital outliers in bleeding complications after percutaneous coronary intervention.

Post-percutaneous coronary intervention (PCI) bleeding complications are an important quality metric. We sought to characterize site-level variation in post-PCI bleeding and explore the influence of patient and procedural factors on hospital bleeding performance. Hospital-level bleeding performance was compared pre- and postadjustment using the newly revised CathPCI Registry(®) bleeding risk model (c-index, 0.77) among 1292 National Cardiovascular Data Registry(®) hospitals performing >50 PCIs from 7/2009 to 9/2012 (n=1,984,998 procedures). Using random effects models, outlier sites were identified based on 95% confidence intervals around the hospital's random intercept. Bleeding 72 hours post-PCI was defined as: arterial access site, retroperitoneal, gastrointestinal, or genitourinary bleeding; intracranial hemorrhage; cardiac tamponade; nonbypass surgery-related blood transfusion with preprocedure hemoglobin ≥ 8 g/dL; or absolute decrease in hemoglobin value ≥ 3 g/dL with preprocedure hemoglobin ≤ 16 g/dL. Overall, the median unadjusted post-PCI bleeding rate was 5.2% and varied among hospitals from 2.6% to 10.4% (5th, 95th percentiles). Center-level bleeding variation persisted after case-mix adjustment (2.8%-9.5%; 5th, 95th percentiles). Although hospitals' observed and risk-adjusted bleeding ranks were correlated (Spearman ρ: 0.88), individual rankings shifted after risk-adjustment (median Δ rank order: ± 91.5; interquartile range: 37.0, 185.5). Outlier classification changed postadjustment for 29.3%, 16.1%, and 26.5% of low-, non-, and high-outlier sites, respectively. Hospital use of bleeding avoidance strategies (bivalirudin, radial access, or vascular closure device) was associated with risk-adjusted bleeding rates. Despite adjustment for patient case-mix, there is wide variation in rates of hospital PCI-related bleeding in the United States. Opportunities may exist for best performers to share practices with other sites.

TCT-273 Patient Characteristics that Deter use of a Bleeding Avoidance Strategy during PCI

Use of bleeding avoidance strategies (BAS) such as transradial access, bivalirudin, and femoral closure devices have been shown to lower bleeding events after PCI but used most often in those at lowest risk of bleeding. Patient characteristics that deter use of BAS in higher risk patients for

Bleeding-Avoidance Strategies and Outcomes in Patients ≥80 Years of Age With ST-Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention (from the NCDR CathPCI Registry)

The purpose of our study was to evaluate the use of bleeding-avoidance strategies (BAS) and risk-adjusted bleeding over time in patients ≥80 years of age undergoing primary percutaneous coronary intervention (PCI) for ST-segment elevation myocardial infarction. We analyzed data from the CathPCI Registry from July 1, 2006 through June 30, 2009. Patients were included if they were ≥80 years old, presented with ST-segment elevation myocardial infarction, and underwent primary PCI. We evaluated trends in use of BAS (direct thrombin inhibitors, vascular closure devices, and radial access) and risk-adjusted bleeding over time. Of 10,469 patients ≥80 years old undergoing primary PCI, 1,002, (9.6%) developed a bleeding complication. Use of direct thrombin inhibitors and vascular closure devices increased over time (12.8% to 24.9% and 29.2% to 32.7%, p <0.01 and <0.05 for trends, respectively). Radial access was extremely uncommon (<1%) and did not change over the course of the study. In multivariable analyses, use of BAS was associated with lower bleeding. However, over the course of the study period, overall risk-adjusted bleeding did not decrease significantly (9.9% to 9.4%, p = 0.14 for trend). In conclusion, patients ≥80 years old undergoing primary PCI are at high risk of bleeding, and despite significant increases in use of BAS, the overall rate of bleeding complications remains high.

Abstract P24: Clinical Strategies and Bleeding Outcomes in Octogenarians Undergoing Primary PCI: Results from the NCDR®

Background: Patients ≥80 years of age with ST-elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI) are at increased risk for bleeding. Specific clinical strategies may reduce the bleeding risk associated with PCI. However, the use and outcomes associated with these strategies in patients ≥80 have not been described. Methods: We analyzed data from the CathPCI Registry® between July 1, 2005 and June 30, 2009. Patients were included if they were ≥80, presented with STEMI, and underwent primary PCI. We evaluated trends in bleeding avoidance strategies (direct thrombin inhibitors, closure devices, radial access) and risk-adjusted bleeding (drop in hemoglobin &gt;3 gm/dl, transfusion, or bleeding resulting in prolonged hospitalization) over time. Results: Among 10,469 patients age ≥80 undergoing primary PCI, 1002 (9.6%) experienced a bleeding complication. Only a minority of patients were treated with a direct thrombin inhibitor or vascular closure device, but the use of these strategies increased over time (p for trend &lt;0.001) (Figure). Radial access was extremely uncommon and did not change over the course of the study. Risk-adjusted in-hospital bleeding decreased from 9.96% to 9.39% (absolute difference 0.57%) during the study period (p = 0.002). Conclusions: Despite significant increases in the use of bleeding avoidance strategies, patients ≥80 undergoing primary PCI remain at high risk of bleeding. These findings suggest the need to increase adoption of existing bleeding avoidance strategies and develop novel approaches to reducing bleeding risk in this vulnerable population.

Bleeding avoidance strategies among patients undergoing percutaneous coronary intervention

Evaluation of: Marso SP, Amin AP, House JA et al.: Association between use of bleeding avoidance strategies and risk of periprocedural bleeding among patients undergoing percutaneous coronary intervention. JAMA 303(21), 2156–2164 (2010). Major bleeding during percutaneous coronary intervention (PCI) is associated with an adverse outcome. While a number of models exist to identify patients at risk of bleeding during PCI, it is not known whether targeted bleeding avoidance strategies lead to a reduction in major bleeding rates in these patient groups. This study aimed to address this knowledge gap and examined the use of two bleeding avoidance strategies: vascular closure devices and bivalirudin. Periprocedural major bleeding rates were obtained from a very large national registry of 1,522,935 patients undergoing procedures at 955 US centers. Bleeding occurred in 2% of patients. Use of one or more of these strategies resulted in reduced bleeding rates in both high- and low-risk cohorts. When both strategies...

Association Between Use of Bleeding Avoidance Strategies and Risk of Periprocedural Bleeding Among Patients Undergoing Percutaneous Coronary Intervention

Bleeding complications with percutaneous coronary intervention (PCI) are associated with adverse patient outcomes. The association between the use of bleeding avoidance strategies and post-PCI bleeding as a function of a patient's preprocedural risk of bleeding is unknown. To describe the use of 2 bleeding avoidance strategies, vascular closure devices and bivalirudin, and associated post-PCI bleeding rates in a nationally representative PCI population. Analysis of data from 1,522,935 patients undergoing PCI procedures performed at 955 US hospitals participating in the National Cardiovascular Data Registry (NCDR) CathPCI Registry from January 1, 2004, through September 30, 2008. Periprocedural bleeding. Bleeding occurred in 30,654 patients (2%). Manual compression, vascular closure devices, bivalirudin, or vascular closure devices plus bivalirudin were used in 35%, 24%, 23%, and 18% of patients, respectively. Bleeding events were reported in 2.8% of patients who received manual compression, compared with 2.1%, 1.6%, and 0.9% of patients receiving vascular closure devices, bivalirudin, and both strategies, respectively (P < .001). Bleeding rates differed by preprocedural risk assessed with the NCDR bleeding risk model (low risk, 0.72%; intermediate risk, 1.73%; high risk, 4.69%). In high-risk patients, use of both strategies was associated with lower bleeding rates (manual compression, 6.1%; vascular closure devices, 4.6%; bivalirudin, 3.8%; vascular closure devices plus bivalirudin, 2.3%; P < .001). This association persisted following adjustment using a propensity-matched and site-controlled model. Use of both strategies was used least often in high-risk patients (14.4% vs 21.0% in low-risk patients, P < .001). In a large national PCI registry, vascular closure devices and bivalirudin were associated with significantly lower bleeding rates, particularly among patients at greatest risk for bleeding. However, these strategies were less often used among higher-risk patients.