J Korean Med Sci.  2013 Sep;28(9):1307-1315. 10.3346/jkms.2013.28.9.1307.

The Impact of Vascular Access for In-Hospital Major Bleeding in Patients with Acute Coronary Syndrome at Moderate- to Very High-Bleeding Risk

• Park KH
• Jeong MH
• Ahn Y
• Jung SS
• Kim MH
• Yang HM
• Yoon J
• Rha SW
• Park KS
• Han KR
• Cho BR
• Cha KS
• Kim BO
• Hyon MS
• Shin WY
• Choe H
• Bae JW
• Kim HY
• Trans-Radial Intervention Registry Investigators

• KMID: 1793045
• DOI: http://doi.org/10.3346/jkms.2013.28.9.1307

Abstract

The aim of our study was to determine the impact of vascular access on in-hospital major bleeding (IHMB) in acute coronary syndrome (ACS). We analyzed 995 patients with non-ST elevation myocardial infarction and unstable angina at the Can Rapid risk stratification of Unstable angina patients Suppress ADverse outcomes with Early implementation of the ACC/AHA guidelines (CRUSADE) moderate- to very high-bleeding risk scores in trans-radial intervention (TRI) retrospective registry from 16 centers in Korea. A total of 402 patients received TRI and 593 patients did trans-femoral intervention (TFI). The primary end-point was IHMB as defined in the CRUSADE. There were no significant differences in in-hospital and 1-yr mortality rates between two groups. However, TRI had lower incidences of IHMB and blood transfusion than TFI (6.0% vs 9.4%, P = 0.048; 4.5% vs 9.4%, P = 0.003). The patients suffered from IHMB had higher incidences of in-hospital and 1-yr mortality than those free from IHMB (3.1% vs 15.0%, P < 0.001; 7.2% vs 30.0%, P < 0.001). TRI was an independent negative predictor of IHMB (odds ratio, 0.305; 95% confidence interval, 0.109-0.851; P = 0.003). In conclusions, IHMB is still significantly correlated with in-hospital and 1-yr mortality. Our study suggests that compared to TFI, TRI could reduce IHMB in patients with ACS at moderate- to very high-bleeding risk.

Keyword

Acute Coronary Syndrome; Radial Artery; Hemorrhage

MeSH Terms

Acute Coronary Syndrome/mortality/*pathology
Aged
Female
Femoral Artery
*Hemorrhage
Hospital Mortality
Humans
Kaplan-Meier Estimate
Male
Middle Aged
Odds Ratio
Percutaneous Coronary Intervention
Radial Artery
Retrospective Studies
Risk Factors
Stents
Treatment Outcome

Figure

• 

  Fig. 1 Flow chart of this study. TRI, trans-radial intervention; PCI, percutaneous coronary intervention; NSTE-ACS, non ST elevation acute coronary syndrome; UAP, unstable angina pectoris; CRUSADE, Can Rapid risk stratification of Unstable angina patients Suppress ADverse outcomes with Early implementation of the ACC/AHA guidelines; TFI, trans-femoral intervention.

• 

  Fig. 2 Incidences of in-hospital major bleeding according to the CRUSADE risk groups. MB, major bleeding.

• 

  Fig. 3 In-hospital and 1-yr clinical outcomes in patients with and without in-hospital major bleeding. TLR, target lesion revascularization; ST, stent thrombosis; CVA, cerebrovascular accident; MACCE, major adverse cerebro-cardiovascular events.

• 

  Fig. 4 Kaplan-Meier survival curves for 1-yr mortality according to occurrence of in-hospital major bleeding. IHMB, in-hospital major bleeding.

• 

  Fig. 5 Subgroup analyses for in-hospital major bleeding according to vascular access. OR, odds ratio; CI, confidence interval.

Reference

1. Ferguson JJ, Califf RM, Antman EM, Cohen M, Grines CL, Goodman S, Kereiakes DJ, Langer A, Mahaffey KW, Nessel CC, et al. Enoxaparin vs unfractionated heparin in high-risk patients with non-ST-segment elevation acute coronary syndromes managed with an intended early invasive strategy: primary results of the SYNERGY randomized trial. JAMA. 2004; 292:45–54.

2. Stone GW, McLaurin BT, Cox DA, Bertrand ME, Lincoff AM, Moses JW, White HD, Pocock SJ, Ware JH, Feit F, et al. Bivalirudin for patients with acute coronary syndromes. N Engl J Med. 2006; 355:2203–2216.

3. Singh M, Rihal CS, Gersh BJ, Lennon RJ, Prasad A, Sorajja P, Gullerud RE, Holmes DR Jr. Twenty-five-year trends in in-hospital and long-term outcome after percutaneous coronary intervention: a single-institution experience. Circulation. 2007; 115:2835–2841.

4. Hamm CW, Bassand JP, Agewall S, Bax J, Boersma E, Bueno H, Caso P, Dudek D, Gielen S, Huber K, et al. ESC Guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation: the Task Force for the management of acute coronary syndromes (ACS) in patients presenting without persistent ST-segment elevation of the European Society of Cardiology (ESC). Eur Heart J. 2011; 32:2999–3054.

5. Subherwal S, Bach RG, Chen AY, Gage BF, Rao SV, Newby LK, Wang TY, Gibler WB, Ohman EM, Roe MT, et al. Baseline risk of major bleeding in non-ST-segment-elevation myocardial infarction: the CRUSADE (Can Rapid risk stratification of Unstable angina patients Suppress ADverse outcomes with Early implementation of the ACC/AHA Guidelines) Bleeding Score. Circulation. 2009; 119:1873–1882.

6. Kim JS, Park SM, Kim BK, Ko YG, Choi D, Hong MK, Seong IW, Kim BO, Gwon HC, Hong BK, et al. Efficacy of clotinab in acute myocardial infarction trial-ST elevation myocardial infarction (ECLAT-STEMI). Circ J. 2012; 76:405–413.

7. Mehta SK, Frutkin AD, Lindsey JB, House JA, Spertus JA, Rao SV, Ou FS, Roe MT, Peterson ED, Marso SP. Bleeding in patients undergoing percutaneous coronary intervention: the development of a clinical risk algorithm from the National Cardiovascular Data Registry. Circ Cardiovasc Interv. 2009; 2:222–229.

8. Yusuf S, Mehta SR, Chrolavicius S, Afzal R, Pogue J, Granger CB, Budaj A, Peters RJ, Bassand JP, Wallentin L, et al. Comparison of fondaparinux and enoxaparin in acute coronary syndromes. N Engl J Med. 2006; 354:1464–1476.

9. Stone GW, White HD, Ohman EM, Bertrand ME, Lincoff AM, McLaurin BT, Cox DA, Pocock SJ, Ware JH, Feit F, et al. Bivalirudin in patients with acute coronary syndromes undergoing percutaneous coronary intervention: a subgroup analysis from the Acute Catheterization and Urgent Intervention Triage strategy (ACUITY) trial. Lancet. 2007; 369:907–919.

10. Stone GW, Witzenbichler B, Guagliumi G, Peruga JZ, Brodie BR, Dudek D, Kornowski R, Hartmann F, Gersh BJ, Pocock SJ, et al. Bivalirudin during primary PCI in acute myocardial infarction. N Engl J Med. 2008; 358:2218–2230.

11. Mehran R, Pocock SJ, Nikolsky E, Clayton T, Dangas GD, Kirtane AJ, Parise H, Fahy M, Manoukian SV, Feit F, et al. A risk score to predict bleeding in patients with acute coronary syndromes. J Am Coll Cardiol. 2010; 55:2556–2566.

12. 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; 114:774–782.

13. Rao SV, O'Grady K, Pieper KS, Granger CB, Newby LK, Van de Werf F, Mahaffey KW, Califf RM, Harrington RA. Impact of bleeding severity on clinical outcomes among patients with acute coronary syndromes. Am J Cardiol. 2005; 96:1200–1206.

14. Ndrepepa G, Berger PB, Mehilli J, Seyfarth M, Neumann FJ, Schömig A, Kastrati A. 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; 51:690–697.

15. Lopes RD, Subherwal S, Holmes DN, Thomas L, Wang TY, Rao SV, Magnus Ohman E, Roe MT, Peterson ED, Alexander KP. The association of in-hospital major bleeding with short-, intermediate-, and long-term mortality among older patients with non-ST-segment elevation myocardial infarction. Eur Heart J. 2012; 33:2044–2053.

16. Suh JW, Mehran R, Claessen BE, Xu K, Baber U, Dangas G, Parise H, Lansky AJ, Witzenbichler B, Grines CL, et al. Impact of in-hospital major bleeding on late clinical outcomes after primary percutaneous coronary intervention in acute myocardial infarction the HORIZONS-AMI (Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction) trial. J Am Coll Cardiol. 2011; 58:1750–1756.

17. Spencer FA, Moscucci M, Granger CB, Gore JM, Goldberg RJ, Steg PG, Goodman SG, Budaj A, FitzGerald G, Fox KA. Does comorbidity account for the excess mortality in patients with major bleeding in acute myocardial infarction? Circulation. 2007; 116:2793–2801.

18. Manoukian SV, Feit F, Mehran R, Voeltz MD, Ebrahimi R, Hamon M, Dangas GD, Lincoff AM, White HD, Moses JW, 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; 49:1362–1368.

19. Sabatine MS, Morrow DA, Giugliano RP, Burton PB, Murphy SA, McCabe CH, Gibson CM, Braunwald E. Association of hemoglobin levels with clinical outcomes in acute coronary syndromes. Circulation. 2005; 111:2042–2049.

20. Moscucci M, Fox KA, Cannon CP, Klein W, López-Sendón J, Montalescot G, White K, Goldberg RJ. Predictors of major bleeding in acute coronary syndromes: the Global Registry of Acute Coronary Events (GRACE). Eur Heart J. 2003; 24:1815–1823.

21. Yan AT, Yan RT, Huynh T, DeYoung P, Weeks A, Fitchett DH, Langer A, Goodman SG. INTERACT Investigators. Bleeding and outcome in acute coronary syndrome: insights from continuous electrocardiogram monitoring in the Integrilin and Enoxaparin Randomized Assessment of Acute Coronary Syndrome Treatment (INTERACT) trial. Am Heart J. 2008; 156:769–775.

22. Lincoff AM, Bittl JA, Harrington RA, Feit F, Kleiman NS, Jackman JD, Sarembock IJ, Cohen DJ, Spriggs D, Ebrahimi R, et al. Bivalirudin and provisional glycoprotein IIb/IIIa blockade compared with heparin and planned glycoprotein IIb/IIIa blockade during percutaneous coronary intervention: REPLACE-2 randomized trial. JAMA. 2003; 289:853–863.

23. Alexander KP, Chen AY, Roe MT, Newby LK, Gibson CM, Allen-LaPointe NM, Pollack C, Gibler WB, Ohman EM, Peterson ED. Excess dosing of antiplatelet and antithrombin agents in the treatment of non-ST-segment elevation acute coronary syndromes. JAMA. 2005; 294:3108–3116.

24. Pocock SJ, Mehran R, Clayton TC, Nikolsky E, Parise H, Fahy M, Lansky AJ, Bertrand ME, Lincoff AM, Moses JW, et al. Prognostic modeling of individual patient risk and mortality impact of ischemic and hemorrhagic complications: assessment from the Acute Catheterization and Urgent Intervention Triage Strategy trial. Circulation. 2010; 121:43–51.

25. Doyle BJ, Rihal CS, Gastineau DA, Holmes DR Jr. Bleeding, blood transfusion, and increased mortality after percutaneous coronary intervention: implications for contemporary practice. J Am Coll Cardiol. 2009; 53:2019–2027.

26. Rao SV, Eikelboom JA, Granger CB, Harrington RA, Califf RM, Bassand JP. Bleeding and blood transfusion issues in patients with non-ST-segment elevation acute coronary syndromes. Eur Heart J. 2007; 28:1193–1204.

27. Sciahbasi A, Pristipino C, Ambrosio G, Sperduti I, Scabbia EV, Greco C, Ricci R, Ferraiolo G, Di Clemente D, Giombolini C, et al. Arterial access-site-related outcomes of patients undergoing invasive coronary procedures for acute coronary syndromes (from the ComPaRison of Early Invasive and Conservative Treatment in Patients With Non-ST-ElevatiOn Acute Coronary Syndromes [PRESTO-ACS] Vascular Substudy). Am J Cardiol. 2009; 103:796–800.

28. Jolly SS, Amlani S, Hamon M, Yusuf S, Mehta SR. Radial versus femoral access for coronary angiography or intervention and the impact on major bleeding and ischemic events: a systematic review and meta-analysis of randomized trials. Am Heart J. 2009; 157:132–140.

29. Valgimigli M, Saia F, Guastaroba P, Menozzi A, Magnavacchi P, Santarelli A, Passerini F, Sangiorgio P, Manari A, Tarantino F, et al. Transradial versus transfemoral intervention for acute myocardial infarction: a propensity score-adjusted and -matched analysis from the REAL (REgistro regionale AngiopLastiche dell'Emilia-Romagna) multicenter registry. JACC Cardiovasc Interv. 2012; 5:23–35.