1 / 21

Marso et al. JAMA 2010;303:2156-2164

Association Between Use of Bleeding Avoidance Strategies and Risk of Periprocedural Bleeding Among Patients Undergoing Percutaneous Coronary Intervention. Marso et al. JAMA 2010;303:2156-2164. Background.

niesha
Download Presentation

Marso et al. JAMA 2010;303:2156-2164

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. Association Between Use of Bleeding Avoidance Strategies and Risk of Periprocedural Bleeding Among Patients Undergoing Percutaneous Coronary Intervention Marso et al. JAMA 2010;303:2156-2164

  2. Background • Percutaneous coronary intervention (PCI) is performed approximately 1 million times annually in the United States. • The safety of PCI continues to be excellent with very low rates of death, myocardial infarction (MI), and need for urgent revascularization. • PCI-related bleeding occurs in approximately 2-6% of patients in national PCI databases; marked institutional variability in rates exists. • Bleeding complications are associated with increased length of stay, hospital costs, and important clinical complications such as death and MI.

  3. Objective • To describe the use of 2 bleeding avoidance strategies—1) vascular closure devices and 2) bivalirudin—and associated post-PCl bleeding rates in a nationally representative PCI population. • Examine clinical usage patterns of these strategies as a function of bleeding risk. Marso et al. JAMA 2010;303:2156-2164

  4. Study Patients & Exclusions • NCDR® CathPCI Registry ® • Patients undergoing PCI via the femoral artery • Exclusion criteria: • >1 PCI procedure during same stay • Incomplete data on bleeding • PCI via radial, brachial artery • Cardiogenic shock • Missing device data • Death in cath lab • Unknown bleeding event data Marso et al. JAMA 2010;303:2156-2164

  5. Candidate Bleeding Avoidance Strategies • Bivalirudin • Vascular closure devices • Both therapies (bivalirudin + vascular closure) Marso et al. JAMA 2010;303:2156-2164

  6. Bleeding Risk Strata • Bleeding risk score calculated for each patient using NCDR bleeding risk model1 • Clinical elements used to calculate bleeding risk score: • STEMI/non-STEMI • Female sex • Previous CHF • No previous PCI • NYHA/CCS Class IV CHF • PVD • Age • Estimated glomerular filtration rate 1 Mehta et al. Circ Cardiovasc Intervent 2009;2:222-229 Marso et al. JAMA 2010;303:2156-2164

  7. Study Outcomes • In-hospital bleeding according to NCDR data definition: • Requiring transfusion and/or • Prolonged hospital stay and/or • Decrease in hemoglobin >3 g/dL Marso et al. JAMA 2010;303:2156-2164

  8. Statistical Analysis • Patients categorized into 3 groups of bleeding risk based on NCDR bleeding risk score: • Low (<1%) • Intermediate (1-3%) • High (>3%) • Propensity score matching with site adjustment using 26 clinical variables for each bleeding avoidance strategy performed to minimize confounding • Population was well matched (standard difference plot on next slide) Marso et al. JAMA 2010;303:2156-2164

  9. Standardized Difference Before and After Propensity Matching Marso et al. JAMA 2010;303:2156-2164

  10. Study Population Marso et al. JAMA 2010;303:2156-2164

  11. Patient Characteristics All P<0.001 Marso et al. JAMA 2010;303:2156-2164

  12. Patient Characteristics All P<0.001 Marso et al. JAMA 2010;303:2156-2164

  13. Patient Characteristics All data are N (%) All P<0.001 Marso et al. JAMA 2010;303:2156-2164

  14. Admission Characteristics All data are N (%) All P<0.001 Marso et al. JAMA 2010;303:2156-2164

  15. Hospital Characteristics All P<0.001 Marso et al. JAMA 2010;303:2156-2164

  16. High‡N=301,056 Low*N=475,152 Bleeding Rates* *Overall bleeding = 30,429 (2%) Intermediate†N=746,727 *NCDR bleeding risk <1%†NCDR bleeding risk 1-3%‡NCDR bleeding risk >3% M = Manual comp. C = Closure only B = Bival only BC = Bival+closure M C B BC M C B BC M C B BC M C B BC P<0.001 allintra-risk groupcomparisons Low(<1%) Intermediate(1-3%) High(>3%) Overall

  17. Estimated Bleeding Reductions—All Patients (Propensity Adjusted) Marso et al. JAMA 2010;303:2156-2164

  18. Estimated Bleeding Reductions (Propensity Adjusted) Marso et al. JAMA 2010;303:2156-2164

  19. High‡N=301,056 Low*N=475,152 Bleeding Avoidance Strategy Use by Pre-PCI Bleeding Risk Risk-Treatment Paradox Intermediate†N=746,727 *NCDR bleeding risk <1%†NCDR bleeding risk 1-3%‡NCDR bleeding risk >3% M = Manual comp. C = Closure only B = Bival only BC = Bival+closure M C B BC M C B BC M C B BC P<0.001 for allintra-risk groupcomparisons Low(<1%) Intermediate(1-3%) High(>3%)

  20. Limitations • Observational, non-randomized study • Potential unmeasured confounding • No data on activated clotting time • Contraindications to use of bleeding avoidance therapies: • Bivalirudin: in the setting of other anticoagulants, PCI of chronic total occlusion • Vascular closure devices: high risk anatomy • Data insufficient to warrant abandoning use of manual compression in favor of vascular closure devices: • Adequately powered randomized trial assessing bleeding endpoints is needed

  21. Conclusions • In 1.5 million PCI patients in the NCDR: • Post-PCI bleeding occurred in 2% • Use of bivalirudin plus vascular closure devices was associated with an absolute 3.8% lower rate in PCI related bleeding in high risk patients • To prevent 1 bleeding event in high risk patients would require treating 33 patients with both therapies • High risk patients were least likely to receive both strategies (risk-treatment paradox) Marso et al. JAMA 2010;303:2156-2164

More Related