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Original Contribution |

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

Steven P. Marso, MD; Amit P. Amin, MD; John A. House, MS; Kevin F. Kennedy, MS; John A. Spertus, MD, MPH; Sunil V. Rao, MD; David J. Cohen, MD, MSc; John C. Messenger, MD; John S. Rumsfeld, MD, PhD; for the National Cardiovascular Data Registry
[+] Author Affiliations

Author Affiliations: Saint Luke's Mid America Heart Institute, Kansas City, Missouri (Drs Marso, Amin, Spertus, and Cohen and Mssrs House and Kennedy); Duke Clinical Research Institute, Durham, North Carolina (Dr Rao); University of Colorado and Denver VA Medical Center, Denver, Colorado (Drs Messenger and Rumsfeld).


JAMA. 2010;303(21):2156-2164. doi:10.1001/jama.2010.708.
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Published online

Context 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.

Objective 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.

Design, Setting, and Patients 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.

Main Outcome Measure Periprocedural bleeding.

Results 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).

Conclusions 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.

Figures in this Article

Improving hospital safety is a recognized health care priority in the United States.1 There is an important opportunity to improve the safety of percutaneous coronary intervention (PCI), a treatment performed approximately 1 million times a year in the United States alone.2 Periprocedural bleeding is the most common noncardiac complication of PCI and is associated with risk of early mortality3,4 as well as higher costs of care.5 Moreover, the rate of periprocedural bleeding varies substantially across institutions and is modifiable through the use of bleeding avoidance strategies such as vascular closure devices, bivalirudin, and radial access. Underscoring the importance of bleeding complications and the opportunity for improvement, the Centers for Medicare & Medicaid Services has identified bleeding and hematoma after cardiovascular procedures to be quality indicators among centers participating in its Acute Care Episode demonstration.6

To assist clinicians in identifying patients' risks for periprocedural bleeding, a risk model was previously developed and validated using the National Cardiovascular Data Registry (NCDR) CathPCI Registry.7 This model uses preprocedural variables to predict risk of bleeding events after PCI. To date, however, whether this model is useful in identifying patients with greater potential to benefit from bleeding avoidance strategies is unknown. It is also unknown whether clinicians treat the highest-risk patients preferentially. Failure to treat the highest-risk patients with bleeding avoidance strategies would demonstrate the potential for risk-stratifying patients at the time of PCI to direct therapy.

To address these gaps in knowledge, we described peri-PCI bleeding rates associated with the use of manual compression, vascular closure devices, bivalirudin, or both strategies (vascular closure devices plus bivalirudin) in patients across a spectrum of preprocedural bleeding risk; we also examined current patterns of the use of these strategies as a function of bleeding risk.

Data Source and Definitions

The NCDR CathPCI Registry is a voluntary nationwide reporting system for diagnostic cardiac catheterization and PCI procedures jointly sponsored by the American College of Cardiology (ACC) and the Society for Cardiovascular Angiography and Interventions. Descriptions of the NCDR have been published.8,9 Demographic, clinical, procedural, and institutional data elements from diagnostic catheterization and PCI procedures are collected at more than 1100 participating centers. Data are entered via either a secure Web-based platform or software provided by ACC-certified vendors into a secure, centralized database (CathPCI version 3.04) stored at the ACC Heart House in Washington, DC. Data quality assurance includes automatic system validation and reporting of data completeness, random on-site auditing of participating centers, and education and training for site data managers.10 A comprehensive description of NCDR data elements and definitions is available at http://www.ncdr.com/WebNCDR/ELEMENTS.ASPX.

All data elements and definitions were prospectively defined by a committee of the ACC. Race/ethnicity data were reported by patients or family and recorded in the medical record. Trained chart abstractors recorded race/ethnicity on the standard NCDR CathPCI case report form. The options were white, black, Hispanic, Asian, Native American, and other. Glomerular filtration rate was calculated using admission serum creatinine values and the abbreviated Modification of Diet in Renal Disease formula.11

This study was approved by the Saint Luke's Health System institutional review board and was determined to meet the definition of research not requiring informed consent.

Study Patients and Exclusions

Only patients who underwent PCI via the femoral artery approach were included in this analysis. Exclusion criteria consisted of patients with more than 1 PCI procedure during a hospitalization (since bleeding events could not reliably be attributed to a specific procedure), incomplete data for calculation of expected bleeding rates, PCI through access of a nonfemoral artery (ie, radial, brachial), cardiogenic shock, missing device data, death in the catheterization laboratory, or unknown data on bleeding events.

Bleeding Avoidance Strategies and Risk Stratification

Candidate bleeding avoidance strategies consisted of vascular closure devices (Angio-Seal [St Jude Medical, St Paul, Minnesota], Perclose A-T [Abbott Vascular, Abbott Park, Illinois], or other) without bivalirudin; bivalirudin (Angiomax [The Medicines Company, Parsippany, New Jersey]) without vascular closure devices; or both strategies (vascular closure devices plus bivalirudin). Patients receiving manual compression did not receive vascular closure devices or bivalirudin and thus served as the reference group.

Bleeding rates were determined for all patients and within 3 clinically important subgroups, based on patients' pre-PCI bleeding risk scores derived using the NCDR CathPCI bleeding risk model.7 Risk scores were generated for each patient in this study based on the inverse logarithmic sum of the β coefficients for each of the following pre-PCI variables: ST-segment elevation myocardial infarction (MI), non–ST-segment elevation MI, female sex, previous congestive heart failure, no previous PCI, New York Heart Association/Canadian Cardiovascular Society Class IV heart failure, peripheral vascular disease, age, and estimated glomerular filtration rate.

Study Outcomes

In-hospital bleeding complications following PCI were ascertained and voluntarily reported by centers. The primary outcome for this study was periprocedural bleeding, which, as defined by the NCDR CathPCI data definition, required a blood transfusion or a prolonged hospital stay for management or was associated with a decrease (>3 g/dL) in hemoglobin level.

Statistical Analysis

Demographic data were described across treatment groups as mean (SD) for continuous variables and number (%) for categorical variables. Patients with attempted use of vascular closure devices were included with the vascular closure devices group. Based on individual risk scores calculated using the NCDR CathPCI bleeding risk model,7 patients were categorized into 3 groups of risk for post-PCI bleeding events occurring during hospitalization: low (<1%), intermediate (1%-3%), and high (>3%).

To minimize confounding, a propensity score match analysis was implemented. Scores for each bleeding avoidance strategy (manual compression, vascular closure devices, bivalirudin, or vascular closure devices plus bivalirudin) were derived using a multinomial regression model.1216 Variables used to derive these propensity scores were demographics (age, sex, race/ethnicity); clinical characteristics (body mass index, New York Heart Association heart failure classification); coronary artery disease risk factors (diabetes, hypertension, dyslipidemia, smoking, family history of coronary artery disease); coronary artery disease history (PCI, coronary artery bypass graft surgery, MI); other cardiovascular disease history (congestive heart failure, cerebrovascular disease, peripheral vascular disease, valve surgery, cardiac transplantation); other disease history (chronic obstructive pulmonary disease, renal failure); and presenting syndrome (no symptoms, atypical chest pain, stable angina, unstable angina, ST-segment elevation MI, and non–ST-segment elevation MI).

Matching was performed simultaneously on all strategy propensity scores within the bleeding risk groups using nearest-neighbor matching without replacement, with a caliper width of 0.5%.12 Absolute standardized differences were computed to evaluate matching effectiveness and displayed graphically1719; values less than 10% and closer to zero demonstrate a more balanced cohort.17 Hierarchical modeling was then performed on the matched cohort to account for hospital characteristics. From this model, odds ratios were obtained to estimate the number of patients needed to treat to prevent 1 bleeding event for each strategy compared with manual compression.2022

Statistical significance was defined as P < .05. All statistical analyses were performed by the Saint Luke's Mid America Heart Institute Department of Biostatistics using SAS version 9.2 (SAS Institute, Cary, North Carolina).

Population Characteristics

From January 1, 2004, to September 30, 2008, 1 759 408 patients underwent PCI. After exclusions (Figure), there were 1 522 935 eligible patients at 955 centers. Patient demographics, clinical characteristics, risk factors, disease history, admission presentation, and selected hospital characteristics for the entire population and for subgroups according to bleeding avoidance strategy are shown in Table 1 and Table 2.

Place holder to copy figure label and caption
Figure. Selection of Study Population by Bleeding Avoidance Strategies
Graphic Jump Location

Records retrieved from National Cardiovascular Data Registry CathPCI version 3.04. PCI indicates percutaneous coronary intervention.

Table Graphic Jump LocationTable 1. Patient and Clinical Characteristics by Treatment Typea
Table Graphic Jump LocationTable 2. Admission Presentation and Hospital Characteristics by Treatment Typea

Overall, bleeding occurred in 30 429 patients (2%). Bleeding rates by candidate strategy for the overall study population are shown in Table 3 and eFigure 1). Manual compression was used in 35% of patients, vascular closure devices in 24%, bivalirudin in 23%, and vascular closure devices plus bivalirudin in 18%. Bleeding events were reported in 2.8% of patients who received manual compression, compared with 2.1% receiving vascular closure devices, 1.6% receiving bivalirudin, and 0.9% receiving both strategies (P < .001) (Table 3 and eFigure 1).

Table Graphic Jump LocationTable 3. Bleeding Rates by Pre–Percutaneous Coronary Intervention Risk of Bleeding and Use of Bleeding Avoidance Strategiesa

According to the NCDR CathPCI bleeding risk model, bleeding risk was classified as low (<1%) in 475 152 patients (31%), intermediate (1%-3%) in 746 727 (49%), and high (>3%) in 301 056 (20%). Observed rates of bleeding in these categories were 0.72%, 1.73%, and 4.69%, respectively. Bleeding rates associated with candidate strategies stratified by preprocedural risk category are shown in Table 3 and eFigure 1. In the low-risk group, manual compression was associated with a bleeding rate of 0.9%, vascular closure devices with a rate of 0.9%, bivalirudin with a rate of 0.6%, and vascular closure devices plus bivalirudin with a rate of 0.4% (P < .001). As preprocedural risk of bleeding increased, differences in actual bleeding rates between strategies became more pronounced. In the intermediate-risk group, manual compression was associated with a bleeding rate of 2.3%, vascular closure devices with a rate of 1.9%, bivalirudin with a rate of 1.4%, and vascular closure devices plus bivalirudin with a rate of 0.8% (P < .001); in the high-risk group, the corresponding rates were 6.1%, 4.6%, 3.8%, and 2.3%, respectively (P < .001).

Propensity-Matched and Site-Adjusted Analysis

In the overall group, 508 455 of 529 247 eligible patients receiving manual compression (96%) were propensity matched using multinomial regression modeling to patients who received bleeding avoidance strategies. Corresponding values were 144 594 of 146 557 (99%) in the low-risk group, 252 898 of 261 363 (97%) in the intermediate-risk group, and 110 963 of 121 327 (91%) in the high-risk group. The effectiveness of propensity matching in the total cohort is demonstrated in eFigure 2, which is a standardized difference plot for variables used in the propensity model. After matching, the absolute standardized difference between patients who received bleeding avoidance strategies and controls for each covariable was 0% to 1%.

Table 4 shows in-hospital bleeding events, odds ratios, the estimated number needed to treat to prevent 1 bleeding event, and the estimated reduction in bleeding events per 1000 patients treated with each strategy relative to manual compression in the matched, site-adjusted cohort. Data are displayed for the overall population and by preprocedural bleeding risk group. Independent of preprocedural risk, the use of vascular closure devices, bivalirudin, and vascular closure devices plus bivalirudin were associated with fewer bleeding events per 1000 patients treated (6.7 [95% confidence interval {CI}, 5.7-7.7], 8.5 [95% CI, 7.6-9.3], and 14.2 [95% CI, 13.5-14.8] events, respectively). In patients receiving both strategies, the high-risk group had fewer bleeding events per 1000 patients treated compared with the intermediate- and low-risk groups (30.5 [95% CI, 27.9-32.8] vs 12.5 [95% CI, 11.6-13.3] and 5.3 [95% CI, 4.5-6.0] events, respectively).

Table Graphic Jump LocationTable 4. Estimated Reductions in Bleeding Events Relative to Manual Compression Following Site-Adjusted Propensity Matching
Use of Strategies by Strata of Bleeding Risk

The frequency of use of bleeding avoidance strategies according to estimated pre-PCI risk of bleeding is shown in Table 5. Manual compression was used most often in the highest-risk patients and least often in the intermediate- and lowest-risk cohorts (40.3% vs 35.0% and 30.8%, respectively; P < .001), while the use of vascular closure devices plus bivalirudin was highest in low-risk patients (21.0%) and lower in intermediate-risk (17.8%) and high-risk (14.4%) patients (P < .001).

Table Graphic Jump LocationTable 5. Use of Bleeding Avoidance Strategies by Estimated Pre–Percutaneous Coronary Intervention Risk of Bleedinga

Using data from more than 1.5 million patients in the NCDR CathPCI Registry, we compared bleeding rates among patients undergoing PCI and receiving strategies to mitigate bleeding across a spectrum of preprocedural risk for bleeding. Among high-risk patients, the use of vascular closure devices plus bivalirudin was associated with an absolute 3.8% lower bleeding rate, which translates into an estimated number needed to treat of 33 to prevent 1 bleeding event as compared with manual compression. Lower rates of bleeding associated with this treatment strategy were proportionately less in intermediate- and low-risk patients. Despite the association between the use of vascular closure devices plus bivalirudin and lower bleeding rates among the highest-risk patients, these patients were the least likely to receive both strategies and most likely to receive manual compression. This apparent risk-treatment paradox highlights an opportunity for routine preprocedural risk stratification as a means to identify patients ideally suited for individualized bleeding avoidance strategies with the goal of increasing the safety of PCI.

Targeting bleeding complications as a quality-improvement goal holds great potential for improving the safety and cost-effectiveness of PCI. Among the more than 1 million PCIs performed annually in US hospitals, bleeding is a morbid and costly complication, occurring in 2% to 6% of patients,2327 with wide variability across institutions. Major bleeding events result in an average 4- to 6-day increase in length of stay28,29 and, on average, increase hospital costs by $6000 to $8000.5 In addition to its association with nonfatal MI28,30 and stroke,30 periprocedural bleeding is also strongly associated with early3,4 and late3 mortality. Bleeding also exposes many patients to the added risk of blood transfusions.23 According the Healthcare Cost and Utilization Project, 50% of patients experiencing bleeding following PCI receive a blood transfusion, which is associated with greater median length of stay (2 vs 6 days) and greater mean hospital charges ($48 000 vs $85 000).31

The current study found that higher-risk patients—those with the greatest potential to benefit from bleeding avoidance strategies—were the least likely to be treated with such strategies in contemporary clinical practice. Conversely, the lowest-risk patients were the most likely to receive bleeding avoidance strategies, supporting the presence of a risk-treatment paradox.3235 This phenomenon has been demonstrated in a variety of medical treatment scenarios, including lower rates of angiotensin-converting enzyme inhibitor or β-blocker use in patients with severe heart failure,32 lower use of angiography after acute MI,3638 and lower use of statins in higher-risk patients with angiographically confirmed coronary disease.39

Several factors may contribute to the higher use of bleeding avoidance strategies in lower-risk patients found in this study. First, assessing the risk for bleeding in clinical practice is neither inherently intuitive nor commonly used. Second, physicians have more experience using bivalirudin in lower-risk patients, since it was first studied in patients undergoing elective PCI and only recently in higher-risk patients (ie, those with ST-segment elevation MI).40 Lastly, the prior published data for bleeding mitigation with vascular closure devices has been limited.4143

The results of this study suggest the need for additional research to better understand why higher-risk patients are least likely to receive bleeding avoidance strategies but also suggest the need to test interventions to overcome the risk-treatment paradox, such as enabling physicians to purposefully direct bleeding avoidance strategies to patients by providing preprocedural estimates of post-PCI bleeding. Translation of the findings in this study into clinical practice to optimally guide the use of such strategies will be challenging. Incorporating risk models into everyday care, which requires capturing risk factors, estimating individual risk, and presenting information in a clear and understandable manner at the point of care for physicians, is currently not feasible for many clinical environments. However, with the current national investment in health information technology, increasing literature on clinical decision support, increasing focus by regulatory and other agencies on the documentation of patient risk to guide care, and the development of quality-of-care tools by entities such as the ACC and the Society for Cardiovascular Angiography and Interventions, the health care environment is increasingly capable of supporting the implementation of point-of-care interventions to help guide effective and safe care.

It should be noted that there are more supporting data on the efficacy of bivalirudin than on that of vascular closure devices with regard to bleeding avoidance. In randomized trials including patients with broad indications for PCI (elective or acute coronary syndromes), bivalirudin has been demonstrated to reduce major bleeding following PCI to an extent comparable with the findings in this observational study.24,4446 Randomized controlled trials demonstrating reductions in bleeding associated with the use of vascular closure devices were designed to assess ambulation time rather than bleeding. A meta-analysis of 30 clinical studies, including 4000 patients, showed a trend for reduced vascular complications associated with the Angio-Seal device (odds ratio, 0.46; 95% CI, 0.20-1.04; P = .06).42 A recent analysis from the Acute Catheterization and Urgent Intervention Triage Strategy (ACUITY) trial also suggests that a significant reduction in major bleeding is associated not only with the use of bivalirudin but also with vascular closure devices in patients undergoing PCI in the setting of unstable angina or non–ST-segment elevation MI.43 Similar to our study, the greatest reduction in bleeding was seen in patients receiving both a vascular closure device and bivalirudin.

Given the findings of our observational study and that previous data linking vascular closure devices to bleeding are both limited and from nonrandomized studies, an adequately powered randomized trial of vascular closure devices evaluating post-PCI bleeding end points is needed. It is also important to note that data on vascular closure devices and bivalirudin were published during a period overlapping with data collection in the present study, and bivalirudin was not included in PCI guidelines47 until 2006. Thus, there may be important temporal trends for rates of strategies not investigated in this study.

Several aspects of this work should be considered when interpreting our results and in translating these findings to clinical practice. First, this was not a randomized trial; thus, a causal relationship between bleeding avoidance and evaluated strategies cannot be concluded. Second, potential unmeasured confounding is a limitation of all observational studies. We sought to minimize confounding through the use of a center-adjusted, multinomial propensity-matched analysis, which successfully balanced the observable patient and treatment characteristics; nevertheless, some unmeasured confounding may have been present. The NCDR CathPCI Registry also does not currently collect data on complications related to vascular closure devices. However, the reported frequency of such complications is low.48

Third, activated clotting time is not available in the NCDR CathPCI Registry, which limited our ability to assess the relationship between heparin dosing, level of anticoagulation, and bleeding, which could have further informed the observed variability in bleeding among the cohort receiving manual compression.

Fourth, some patients are not suited to receive bleeding avoidance strategies. For example, bivalirudin is not recommended in the setting of therapeutic anticoagulation with prior agents, including unfractionated or low-molecular-weight heparin with or without a glycoprotein IIb/IIIa agent. Bivalirudin is also not currently recommended in patients undergoing PCI for a chronic total occlusion.49 Furthermore, mitigation of bleeding risk may be neutralized with the concomitant use of glycoprotein IIb/IIIa inhibitors and in the setting of renal failure. Vascular closure devices are also not recommended for use given several anatomical limitations, such as puncture at the site of an anatomical arterial bifurcation, presence of severe calcification, or presence of severe obstructive peripheral artery disease; the reasons for not using a vascular closure device for a given patient are not collected in the CathPCI Registry. To the extent that some of these examples cluster more frequently in patients at intermediate or high risk for bleeding, there will be a reduction in potential to offset the apparent risk-treatment paradox observed in this study.

In a large, national PCI registry, the use of vascular closure devices and bivalirudin was associated with significantly lower rates of periprocedural bleeding. However, there was an apparent risk-treatment paradox, whereby patients at greatest risk of bleeding were least likely to receive a bleeding avoidance strategy. These findings emphasize the opportunity to improve the safety of PCI and to further explore cost efficacy by directing such strategies to those patients most likely to benefit from them.

Corresponding Author: Steven P. Marso, MD, Saint Luke's Mid America Heart Institute, University of Missouri Kansas City, 4401 Wornall Rd, Kansas City, MO 64111 (smarso@saint-lukes.org).

Author Contributions: Drs Marso and Rumsfeld had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.

Study concept and design: Marso, House, Kennedy, Spertus, Rumsfeld.

Acquisition of data: House.

Analysis and interpretation of data: Marso, Amin, House, Kennedy, Spertus, Rao, Cohen, Messenger, Rumsfeld.

Drafting of the manuscript: Marso, House, Spertus, Rumsfeld.

Critical revision of the manuscript for important intellectual content: Marso, Amin, House, Kennedy, Spertus, Rao, Cohen, Messenger, Rumsfeld.

Statistical analysis: Marso, Amin, House, Kennedy, Rao.

Administrative, technical, or material support: Marso, House, Spertus, Messenger, Rumsfeld.

Study supervision: Marso, Rumsfeld.

Financial Disclosures: Dr Marso reported receiving research support from the American Diabetes Association, Amylin Pharmaceuticals, Boston Scientific, The Medicines Company, Volcano Corporation, and Terumo Corporation and serving as a consultant for Abbott Vascular, NovoNordisk, Volcano Corporation, and The Medicines Company. Mr House reported receiving consulting fees from Volcano Corporation. Dr Spertus reported receiving research funding from the National Institutes of Health, American College of Cardiology Foundation, American Heart Association, Amgen, Lilly, Bristol-Myers Squibb/Sanofi-Aventis, EvaHeart, and Cordis Corporation; receiving in-kind research support from Atherotech and Roche Diagnostics; serving as a consultant for United Healthcare, St Jude Medical, and Amgen; serving as a copyright holder of the Seattle Angina Questionnaire, the Kansas City Cardiomyopathy Questionnaire, and the Peripheral Artery Questionnaire; having equity ownership in Health Outcomes Sciences; and holding a patent on the PRISM technology, which executes multivariable models at the point of clinical care. Dr Rao reported receiving research support from Momenta Pharmaceuticals, Portola Pharmaceuticals, and Cordis Corporation and serving as a consultant for Bristol-Myers Squibb, Sanofi-Aventis, The Medicines Company, AstraZeneca, and Terumo Corporation. Dr Cohen reported receiving research support from The Medicines Company, Schering-Plough, Eli Lilly, and Daichi Sankyo; serving as a consultant for Schering-Plough and Eli Lilly; and receiving speaking honoraria from The Medicines Company, Eli Lilly, and St Jude Medical. Dr Messenger reported receiving research support from Pfizer, Medtronic, and Sanofi-Aventis. Dr Rumsfeld reported receiving salary support for the position of chief science officer for the NCDR. No other authors reported financial disclosures.

Funding/Support: This was an investigator-initiated study. The analytical work was performed at the Saint Luke's Mid America Heart Institute, an NCDR analytical center. There was no other additional financial or material support.

Disclaimer: The views expressed in this article represent those of the authors and do not necessarily represent the American College of Cardiology Foundation or the Society for Cardiac Angiography and Interventions, which cosponsor the National Cardiovascular Data Registry.

Additional Contributions: We thank Jose Aceituno, MS, for preparation of graphics and Joseph Murphy, MBA, for editorial assistance and publication coordination. Both are employees of Saint Luke's Hospital, Kansas City, Missouri. Neither received additional compensation for their contributions.

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PubMed   |  Link to Article
Wiviott SD, Braunwald E, McCabe CH,  et al;  TRITON-TIMI 38 Investigators.  Prasugrel versus clopidogrel in patients with acute coronary syndromes.  N Engl J Med. 2007;357(20):2001-2015
PubMed   |  Link to Article
Kirtane AJ, Piazza G, Murphy SA,  et al; TIMI Study Group.  Correlates of bleeding events among moderate- to high-risk patients undergoing percutaneous coronary intervention and treated with eptifibatide: observations from the PROTECT-TIMI-30 trial.  J Am Coll Cardiol. 2006;47(12):2374-2379
PubMed   |  Link to Article
Kinnaird TD, Stabile E, Mintz GS,  et al.  Incidence, predictors, and prognostic implications of bleeding and blood transfusion following percutaneous coronary interventions.  Am J Cardiol. 2003;92(8):930-935
PubMed   |  Link to Article
Aronow HD, Peyser PA, Eagle KA,  et al.  Predictors of length of stay after coronary stenting.  Am Heart J. 2001;142(5):799-805
PubMed   |  Link to Article
Segev A, Strauss BH, Tan M, Constance C, Langer A, Goodman SG.Canadian Acute Coronary Syndromes Registries Investigators.  Predictors and 1-year outcome of major bleeding in patients with non-ST-elevation acute coronary syndromes: insights from the Canadian Acute Coronary Syndrome Registries.  Am Heart J. 2005;150(4):690-694
PubMed   |  Link to Article
 Databases and Related Tools from the Healthcare Cost and Utilization Project (HCUP). Agency for Healthcare Research and Quality Web site. http://www.ahrq.gov/data/hcup/datahcup.htm. Accessed December 15, 2009
Lee DS, Tu JV, Juurlink DN,  et al.  Risk-treatment mismatch in the pharmacotherapy of heart failure.  JAMA. 2005;294(10):1240-1247
PubMed   |  Link to Article
Alter DA, Manuel DG, Gunraj N, Anderson G, Naylor CD, Laupacis A. Age, risk-benefit trade-offs, and the projected effects of evidence-based therapies.  Am J Med. 2004;116(8):540-545
PubMed   |  Link to Article
Bhatt DL, Roe MT, Peterson ED,  et al; CRUSADE Investigators.  Utilization of early invasive management strategies for high-risk patients with non-ST-segment elevation acute coronary syndromes: results from the CRUSADE Quality Improvement Initiative.  JAMA. 2004;292(17):2096-2104
PubMed   |  Link to Article
Halon DA, Adawi S, Dobrecky-Mery I, Lewis BS. Importance of increasing age on the presentation and outcome of acute coronary syndromes in elderly patients.  J Am Coll Cardiol. 2004;43(3):346-352
PubMed   |  Link to Article
Spertus JA, Weiss NS, Every NR, Weaver WD.Myocardial Infarction Triage and Intervention Project Investigators.  The influence of clinical risk factors on the use of angiography and revascularization after acute myocardial infarction.  Arch Intern Med. 1995;155(21):2309-2316
PubMed   |  Link to Article
Yan AT, Yan RT, Huynh T,  et al; Canadian Acute Coronary Syndrome Registry 2 Investigators.  Understanding physicians' risk stratification of acute coronary syndromes: insights from the Canadian ACS 2 Registry.  Arch Intern Med. 2009;169(4):372-378
PubMed   |  Link to Article
Pilote L, Miller DP, Califf RM, Rao JS, Weaver WD, Topol EJ. Determinants of the use of coronary angiography and revascularization after thrombolysis for acute myocardial infarction.  N Engl J Med. 1996;335(16):1198-1205
PubMed   |  Link to Article
McAlister FA, Oreopoulos A, Norris CM,  et al; Alberta Provincial Project for Outcome Assessment in Coronary Heart Disease (APPROACH) Investigators.  Exploring the treatment-risk paradox in coronary disease.  Arch Intern Med. 2007;167(10):1019-1025
PubMed   |  Link to Article
Mehran R, Lansky AJ, Witzenbichler B,  et al;  HORIZONS-AMI Trial Investigators.  Bivalirudin in patients undergoing primary angioplasty for acute myocardial infarction (HORIZONS-AMI): 1-year results of a randomised controlled trial.  Lancet. 2009;374(9696):1149-1159
PubMed   |  Link to Article
Arora N, Matheny ME, Sepke C, Resnic FS. A propensity analysis of the risk of vascular complications after cardiac catheterization procedures with the use of vascular closure devices.  Am Heart J. 2007;153(4):606-611
PubMed   |  Link to Article
Koreny M, Riedmuller E, Nikfardjam M, Siostrzonek P, Mullner M. Arterial puncture closing devices compared with standard manual compression after cardiac catheterization: systematic review and meta-analysis.  JAMA. 2004;291(3):350-357
PubMed   |  Link to Article
Sanborn TA, Ebrahimi R, Manoukian SV,  et al.  Impact of femoral vascular closure devices and antithrombotic therapy on access site bleeding in acute coronary syndromes: the Acute Catheterization and Urgent Intervention Triage Strategy (ACUITY) trial.  Circ Cardiovasc Interv. 2010;3(1):57-62
PubMed   |  Link to Article
Cohen DJ, Lincoff AM, Lavelle TA,  et al.  Economic evaluation of bivalirudin with provisional glycoprotein IIB/IIIA inhibition versus heparin with routine glycoprotein IIB/IIIA inhibition for percutaneous coronary intervention: results from the REPLACE-2 trial.  J Am Coll Cardiol. 2004;44(9):1792-1800
PubMed
Lincoff AM, Bittl JA, Kleiman NS,  et al;  REPLACE-1 Investigators.  Comparison of bivalirudin versus heparin during percutaneous coronary intervention (the Randomized Evaluation of PCI Linking Angiomax to Reduced Clinical Events [REPLACE]-1 trial).  Am J Cardiol. 2004;93(9):1092-1096
PubMed   |  Link to Article
Stone GW, McLaurin BT, Cox DA,  et al; ACUITY Investigators.  Bivalirudin for patients with acute coronary syndromes.  N Engl J Med. 2006;355(21):2203-2216
PubMed   |  Link to Article
Smith SC Jr, Feldman TE, Hirshfeld JW Jr,  et al; American College of Cardiology/American Heart Association Task Force on Practice Guidelines; American College of Cardiology/American Heart Association/Society for Cardiovascular Angiography and Interventions Writing Committee to Update the 2001 Guidelines for Percutaneous Coronary Intervention.  ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention—summary article: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (ACC/AHA/SCAI Writing Committee to Update the 2001 Guidelines for Percutaneous Coronary Intervention).  Circulation. 2006;113(1):156-175
PubMed   |  Link to Article
Tavris DR, Dey S, Albrecht-Gallauresi B,  et al.  Risk of local adverse events following cardiac catheterization by hemostasis device use—phase II.  J Invasive Cardiol. 2005;17(12):644-650
PubMed
Grantham JA, Marso SP, Spertus J, House J, Holmes DR Jr, Rutherford BD. Chronic total occlusion angioplasty in the United States.  JACC Cardiovasc Interv. 2009;2(6):479-486
PubMed   |  Link to Article

Figures

Place holder to copy figure label and caption
Figure. Selection of Study Population by Bleeding Avoidance Strategies
Graphic Jump Location

Records retrieved from National Cardiovascular Data Registry CathPCI version 3.04. PCI indicates percutaneous coronary intervention.

Tables

Table Graphic Jump LocationTable 1. Patient and Clinical Characteristics by Treatment Typea
Table Graphic Jump LocationTable 2. Admission Presentation and Hospital Characteristics by Treatment Typea
Table Graphic Jump LocationTable 3. Bleeding Rates by Pre–Percutaneous Coronary Intervention Risk of Bleeding and Use of Bleeding Avoidance Strategiesa
Table Graphic Jump LocationTable 4. Estimated Reductions in Bleeding Events Relative to Manual Compression Following Site-Adjusted Propensity Matching
Table Graphic Jump LocationTable 5. Use of Bleeding Avoidance Strategies by Estimated Pre–Percutaneous Coronary Intervention Risk of Bleedinga

References

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Lloyd-Jones D, Adams R, Carnethon M,  et al; American Heart Association Statistics Committee and Stroke Statistics Subcommittee.  Heart disease and stroke statistics—2009 update: a report from the American Heart Association Statistics Committee and Stroke Statistics Subcommittee.  Circulation. 2009;119(3):480-486
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Eikelboom JW, Mehta SR, Anand SS, Xie C, Fox KA, Yusuf S. Adverse impact of bleeding on prognosis in patients with acute coronary syndromes.  Circulation. 2006;114(8):774-782
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Pinto DS, Stone GW, Shi C,  et al; ACUITY (Acute Catheterization and Urgent Intervention Triage Strategy) Investigators.  Economic evaluation of bivalirudin with or without glycoprotein IIb/IIIa inhibition versus heparin with routine glycoprotein IIb/IIIa inhibition for early invasive management of acute coronary syndromes.  J Am Coll Cardiol. 2008;52(22):1758-1768
PubMed   |  Link to Article
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Brindis RG, Fitzgerald S, Anderson HV, Shaw RE, Weintraub WS, Williams JF. The American College of Cardiology-National Cardiovascular Data Registry (ACC-NCDR): building a national clinical data repository.  J Am Coll Cardiol. 2001;37(8):2240-2245
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Austin PC. Balance diagnostics for comparing the distribution of baseline covariates between treatment groups in propensity-score matched samples.  Stat Med. 2009;28(25):3083-3107
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Austin PC. Goodness-of-fit diagnostics for the propensity score model when estimating treatment effects using covariate adjustment with the propensity score.  Pharmacoepidemiol Drug Saf. 2008;17(12):1202-1217
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Austin PC. The relative ability of different propensity score methods to balance measured covariates between treated and untreated subjects in observational studies.  Med Decis Making. 2009;29(6):661-677
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Bender R. Calculating confidence intervals for the number needed to treat.  Control Clin Trials. 2001;22(2):102-110
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Ndrepepa G, Berger PB, Mehilli J,  et al.  Periprocedural bleeding and 1-year outcome after percutaneous coronary interventions: appropriateness of including bleeding as a component of a quadruple end point.  J Am Coll Cardiol. 2008;51(7):690-697
PubMed   |  Link to Article
Stone GW, Witzenbichler B, Guagliumi G,  et al; HORIZONS-AMI Trial Investigators.  Bivalirudin during primary PCI in acute myocardial infarction.  N Engl J Med. 2008;358(21):2218-2230
PubMed   |  Link to Article
Feit F, Voeltz MD, Attubato MJ,  et al.  Predictors and impact of major hemorrhage on mortality following percutaneous coronary intervention from the REPLACE-2 Trial.  Am J Cardiol. 2007;100(9):1364-1369
PubMed   |  Link to Article
Wiviott SD, Braunwald E, McCabe CH,  et al;  TRITON-TIMI 38 Investigators.  Prasugrel versus clopidogrel in patients with acute coronary syndromes.  N Engl J Med. 2007;357(20):2001-2015
PubMed   |  Link to Article
Kirtane AJ, Piazza G, Murphy SA,  et al; TIMI Study Group.  Correlates of bleeding events among moderate- to high-risk patients undergoing percutaneous coronary intervention and treated with eptifibatide: observations from the PROTECT-TIMI-30 trial.  J Am Coll Cardiol. 2006;47(12):2374-2379
PubMed   |  Link to Article
Kinnaird TD, Stabile E, Mintz GS,  et al.  Incidence, predictors, and prognostic implications of bleeding and blood transfusion following percutaneous coronary interventions.  Am J Cardiol. 2003;92(8):930-935
PubMed   |  Link to Article
Aronow HD, Peyser PA, Eagle KA,  et al.  Predictors of length of stay after coronary stenting.  Am Heart J. 2001;142(5):799-805
PubMed   |  Link to Article
Segev A, Strauss BH, Tan M, Constance C, Langer A, Goodman SG.Canadian Acute Coronary Syndromes Registries Investigators.  Predictors and 1-year outcome of major bleeding in patients with non-ST-elevation acute coronary syndromes: insights from the Canadian Acute Coronary Syndrome Registries.  Am Heart J. 2005;150(4):690-694
PubMed   |  Link to Article
 Databases and Related Tools from the Healthcare Cost and Utilization Project (HCUP). Agency for Healthcare Research and Quality Web site. http://www.ahrq.gov/data/hcup/datahcup.htm. Accessed December 15, 2009
Lee DS, Tu JV, Juurlink DN,  et al.  Risk-treatment mismatch in the pharmacotherapy of heart failure.  JAMA. 2005;294(10):1240-1247
PubMed   |  Link to Article
Alter DA, Manuel DG, Gunraj N, Anderson G, Naylor CD, Laupacis A. Age, risk-benefit trade-offs, and the projected effects of evidence-based therapies.  Am J Med. 2004;116(8):540-545
PubMed   |  Link to Article
Bhatt DL, Roe MT, Peterson ED,  et al; CRUSADE Investigators.  Utilization of early invasive management strategies for high-risk patients with non-ST-segment elevation acute coronary syndromes: results from the CRUSADE Quality Improvement Initiative.  JAMA. 2004;292(17):2096-2104
PubMed   |  Link to Article
Halon DA, Adawi S, Dobrecky-Mery I, Lewis BS. Importance of increasing age on the presentation and outcome of acute coronary syndromes in elderly patients.  J Am Coll Cardiol. 2004;43(3):346-352
PubMed   |  Link to Article
Spertus JA, Weiss NS, Every NR, Weaver WD.Myocardial Infarction Triage and Intervention Project Investigators.  The influence of clinical risk factors on the use of angiography and revascularization after acute myocardial infarction.  Arch Intern Med. 1995;155(21):2309-2316
PubMed   |  Link to Article
Yan AT, Yan RT, Huynh T,  et al; Canadian Acute Coronary Syndrome Registry 2 Investigators.  Understanding physicians' risk stratification of acute coronary syndromes: insights from the Canadian ACS 2 Registry.  Arch Intern Med. 2009;169(4):372-378
PubMed   |  Link to Article
Pilote L, Miller DP, Califf RM, Rao JS, Weaver WD, Topol EJ. Determinants of the use of coronary angiography and revascularization after thrombolysis for acute myocardial infarction.  N Engl J Med. 1996;335(16):1198-1205
PubMed   |  Link to Article
McAlister FA, Oreopoulos A, Norris CM,  et al; Alberta Provincial Project for Outcome Assessment in Coronary Heart Disease (APPROACH) Investigators.  Exploring the treatment-risk paradox in coronary disease.  Arch Intern Med. 2007;167(10):1019-1025
PubMed   |  Link to Article
Mehran R, Lansky AJ, Witzenbichler B,  et al;  HORIZONS-AMI Trial Investigators.  Bivalirudin in patients undergoing primary angioplasty for acute myocardial infarction (HORIZONS-AMI): 1-year results of a randomised controlled trial.  Lancet. 2009;374(9696):1149-1159
PubMed   |  Link to Article
Arora N, Matheny ME, Sepke C, Resnic FS. A propensity analysis of the risk of vascular complications after cardiac catheterization procedures with the use of vascular closure devices.  Am Heart J. 2007;153(4):606-611
PubMed   |  Link to Article
Koreny M, Riedmuller E, Nikfardjam M, Siostrzonek P, Mullner M. Arterial puncture closing devices compared with standard manual compression after cardiac catheterization: systematic review and meta-analysis.  JAMA. 2004;291(3):350-357
PubMed   |  Link to Article
Sanborn TA, Ebrahimi R, Manoukian SV,  et al.  Impact of femoral vascular closure devices and antithrombotic therapy on access site bleeding in acute coronary syndromes: the Acute Catheterization and Urgent Intervention Triage Strategy (ACUITY) trial.  Circ Cardiovasc Interv. 2010;3(1):57-62
PubMed   |  Link to Article
Cohen DJ, Lincoff AM, Lavelle TA,  et al.  Economic evaluation of bivalirudin with provisional glycoprotein IIB/IIIA inhibition versus heparin with routine glycoprotein IIB/IIIA inhibition for percutaneous coronary intervention: results from the REPLACE-2 trial.  J Am Coll Cardiol. 2004;44(9):1792-1800
PubMed
Lincoff AM, Bittl JA, Kleiman NS,  et al;  REPLACE-1 Investigators.  Comparison of bivalirudin versus heparin during percutaneous coronary intervention (the Randomized Evaluation of PCI Linking Angiomax to Reduced Clinical Events [REPLACE]-1 trial).  Am J Cardiol. 2004;93(9):1092-1096
PubMed   |  Link to Article
Stone GW, McLaurin BT, Cox DA,  et al; ACUITY Investigators.  Bivalirudin for patients with acute coronary syndromes.  N Engl J Med. 2006;355(21):2203-2216
PubMed   |  Link to Article
Smith SC Jr, Feldman TE, Hirshfeld JW Jr,  et al; American College of Cardiology/American Heart Association Task Force on Practice Guidelines; American College of Cardiology/American Heart Association/Society for Cardiovascular Angiography and Interventions Writing Committee to Update the 2001 Guidelines for Percutaneous Coronary Intervention.  ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention—summary article: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (ACC/AHA/SCAI Writing Committee to Update the 2001 Guidelines for Percutaneous Coronary Intervention).  Circulation. 2006;113(1):156-175
PubMed   |  Link to Article
Tavris DR, Dey S, Albrecht-Gallauresi B,  et al.  Risk of local adverse events following cardiac catheterization by hemostasis device use—phase II.  J Invasive Cardiol. 2005;17(12):644-650
PubMed
Grantham JA, Marso SP, Spertus J, House J, Holmes DR Jr, Rutherford BD. Chronic total occlusion angioplasty in the United States.  JACC Cardiovasc Interv. 2009;2(6):479-486
PubMed   |  Link to Article
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