Association between use of bleeding avoidance strategies and risk of periprocedural bleeding among patients undergoing percutaneous coronary intervention

JAMA

Volumn 303, Issue 21, 2010, Pages 2156-2164

  Marso, Steven P ^a   Amin, Amit P ^a   House, John A ^a   Kennedy, Kevin F ^a   Spertus, John A ^a   Rao, Sunil V ^b   Cohen, David J ^a   Messenger, John C ^c   Rumsfeld, John S ^c  

^a UNIVERSITY OF MISSOURI KANSAS CITY   (United States)

^b DUKE CLINICAL RESEARCH INSTITUTE   (United States)

^c UNIVERSITY OF COLORADO   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

HIRULOG; ANTICOAGULANT AGENT; HIRUDIN DERIVATIVE; PEPTIDE FRAGMENT; RECOMBINANT PROTEIN;

ADULT; AGED; ARTICLE; BLEEDING; COMPARATIVE STUDY; COMPRESSION THERAPY; DEVICE; FEMALE; HIGH RISK PATIENT; HUMAN; MAJOR CLINICAL STUDY; MALE; PERCUTANEOUS CORONARY INTERVENTION; PRIORITY JOURNAL; REGISTER; RISK ASSESSMENT; ARTIFICIAL EMBOLISM; MIDDLE AGED; PRESSURE; RETROSPECTIVE STUDY; RISK; TRANSLUMINAL CORONARY ANGIOPLASTY; UNITED STATES;

AGED; ANGIOPLASTY, TRANSLUMINAL, PERCUTANEOUS CORONARY; ANTICOAGULANTS; EMBOLIZATION, THERAPEUTIC; FEMALE; HEMORRHAGE; HIRUDINS; HUMANS; MALE; MIDDLE AGED; PEPTIDE FRAGMENTS; PRESSURE; RECOMBINANT PROTEINS; REGISTRIES; RETROSPECTIVE STUDIES; RISK; UNITED STATES;

EID: 77952995935     PISSN: 00987484     EISSN: 15383598     Source Type: Journal    
DOI: 10.1001/jama.2010.708     Document Type: Article

References (49)

1. National Priorities Partnership. National Priorities and Goals: Aligning Our Efforts to Transform America's Healthcare. Washington, DC: National Quality Forum; 2008.
2. 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.
3. 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. (Pubitemid 44268228)
4. Manoukian SV, Feit F, Mehran R, et al. Impact of major bleeding on 30-day mortality and clinical outcomes in patients with acute coronary syndromes: an analysis from the ACUITY Trial. J Am Coll Cardiol. 2007;49(12):1362-1368.
5. 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.
6. Details for Medicare Acute Care Episode (ACE) Demonstration. Centers for Medicare & Medicaid Services Web site. http://www.cms.gov. Accessed January 4, 2010.
7. Mehta SK, Frutkin AD, Lindsey JB, et al; National Cardiovascular Data Registry. Bleeding in patients undergoing percutaneous coronary intervention: the development of a clinical risk algorithm from the National Cardiovascular Data Registry. Circ Cardiovasc Interv. 2009;2(3):222-229.
8. 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.
9. Weintraub WS,McKay CR, Riner RN, et al; American College of Cardiology Database Committee. The American College of Cardiology National Database: progress and challenges. J Am Coll Cardiol. 1997; 29(2):459-465.
10. CathPCI Registry Companion Guide to YourNCDR Data Quality Report. Washington, DC: American College of Cardiology Foundation; 2008.
11. Levey AS, Bosch JP, Lewis JB, Greene T, Rogers N, Roth D; Modification of Diet in Renal Disease Study Group. A more accurate method to estimate glomerular filtration rate from serum creatinine: a new prediction equation. Ann Intern Med. 1999;130(6): 461-470.
12. Rosenbaum PR, Rubin DB. The central role of the propensity score in observational studies for causal effects. Biometrika. 1983;70:41-55 http://biomet.oxfordjournals.org/cgi/content/abstract/70/1/41. Accessed May 6, 2010.
13. Rosenbaum PR. Constructing a control group using multivariate matched sampling methods that incorporate the propensity score. Am Stat. 1985;39: 33-38 http://www.jstor.org/pss/2683903. Accessed May 6, 2010.
14. Armstrong BG, Sloan M. Ordinal regression models for epidemiologic data. Am J Epidemiol. 1989; 129(1):191-204.
15. Imbens GW. The role of the propensity score in estimating dose-response functions. Biometrika. 2000; 87:706-710 http://biomet.oxfordjournals.org/cgi/ content/abstract/87/3/706. Accessed May 6, 2010.
16. Joffe MM, Rosenbaum PR. Invited commentary: propensity scores. Am J Epidemiol. 1999;150(4): 327-333.
17. 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.
18. 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.
19. 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.
20. Bender R. Calculating confidence intervals for the number needed to treat. Control Clin Trials. 2001; 22(2):102-110. (Pubitemid 32289446)
21. Chatellier G, Zapletal E, Lemaitre D, Menard J, Degoulet P. The number needed to treat: a clinically useful nomogram in its proper context. BMJ. 1996; 312(7028):426-429. (Pubitemid 26055360)
22. McQuay HJ, Moore RA. Using numerical results from systematic reviews in clinical practice. Ann Intern Med. 1997;126(9):712-720. (Pubitemid 27184043)
23. 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. (Pubitemid 351221218)
24. 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.
25. 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. (Pubitemid 47576015)
26. 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.
27. 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.
28. 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.
29. Aronow HD, Peyser PA, Eagle KA, et al. Predictors of length of stay after coronary stenting. Am Heart J. 2001;142(5):799-805. (Pubitemid 33016196)
30. 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.
31. 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.
32. Lee DS, Tu JV, Juurlink DN, et al. Risk-treatment mismatch in the pharmacotherapy of heart failure. JAMA. 2005;294(10):1240-1247. (Pubitemid 41352112)
33. 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. (Pubitemid 38452646)
34. 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.
35. 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.
36. 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.
37. 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.
38. 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 JMed. 1996; 335(16):1198-1205.
39. 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.
40. 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.
41. 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.
42. KorenyM, 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. (Pubitemid 38101608)
43. 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.
44. 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.
45. 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.
46. 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.
47. 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.
48. 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.
49. 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.