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Is Bivalirudin and Femoral Access as Safe as Radial Access?

Is Bivalirudin and Femoral Access as Safe as Radial Access?. Philippe Genereux, MD, Columbia University Medical Center New York Presbyterian Hospital New York, NY ACC 2011, New Orleans . Disclosure. None. 1) Bleeding is frequent. Bivalirudin. Heparin.

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Is Bivalirudin and Femoral Access as Safe as Radial Access?

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  1. Is Bivalirudin and Femoral Access as Safe as Radial Access? Philippe Genereux, MD, Columbia University Medical Center New York Presbyterian Hospital New York, NY ACC 2011, New Orleans

  2. Disclosure None

  3. 1) Bleeding is frequent

  4. Bivalirudin Heparin Bivalirudin trials - Major Bleeding Bleeding is the most common non cardiac complication HORIZONS-AMI* (N=3602) ACUITY* (N=13,819) REPLACE-2* (N=6002) REPLACE-1† (N=1056) CACHET‡ (N=208) Bittl et al.‡ (N=4312) TIMI-8§ (N=133) • 30 days; †48 hours; ‡ 7 days; §14 days Antman et al AHJ 2002; Bittl et alAHJ 2001;Lincoff et al AJC 2004; Lincoff et al 2002; Stone et al NEJM 2006; Stone et al NEJM 2008

  5. Bleeding is frequent • Bleeding is bad

  6. ISAR Meta-Analysis*: Significant Association of Any TIMI Bleeding Event With 1-Year Mortality Meta-analysis of 5,384 patients undergoing PCI from 4 randomized trials to assess 1-year mortality Any bleeding (n=215) No bleeding (n=5,169) 14.1% Mortality (%) 3.3% *ISAR-REACT, ISAR-SWEET, ISAR-SMART-2, and ISAR-REACT-2. ISAR-REACT=Intracoronary Stenting and Antithrombotic Regimen: Rapid Early Action for Coronary Treatment; ISAR-SMART=Intracoronary Stenting or Angioplasty for Restenosis Reduction in Small Arteries-2; ISAR-SWEET=Intracoronary Stenting and Antithrombotic Regimen: Is Abciximab a Superior Way to Eliminate Elevated Thrombotic Risk in Diabetics Reproduced with permission from Ndrepepa G et al. J Am Coll Cardiol. 2008;51:690-697.

  7. Non-CABG Major Bleeding and Early MI Were Associated With Increased Rates of Mortality at 1 Year Multivariate analysis of 13,819 patients from ACUITY HR ± 95% CI P value HR (CI) 0.5 1 2 4 8 16

  8. Bleeding is frequent • Bleeding is bad • Not all bleeding is equal

  9. Incidence, Prognostic Impact, and Influence of Antithrombotic Therapy on Access and Nonaccess Site Bleeding in PCI 17,393 pts from REPLACE-2, ACUITY, and HORIZONS-AMI randomized to Bivalirudin or Heparin plus a GPI. Conclusion: The mortality risk of nonaccess site bleeding is almost twice that of access site bleeding. Bivalirudin reduces both risks by about 40% compared with heparin and a GPI. Verheugt FWA, et al. J Am CollCardiolIntv. 2011;4:191-197.

  10. Bleeding is frequent • Bleeding is bad • Not all bleeding is equal • Bleeding costs money

  11. Independent Predictors of Initial Hospital Costs (NSTEMI)ACUITY

  12. What can we do? • Radial? • Bivalirudin? • Closure devices? • Bleeding is frequent • Bleeding is bad • Not all bleeding is equal • Bleeding costs money

  13. Radial Access vs. Vascular Closure Devices in Bivalirudin Patients NSTEMI ACUITY-RADIAL Sandborn et al. STEMI HORIZON-RADIAL NCDR 2004-2008 What is the latest evidence?

  14. Study Design – ACUITY Trial Medical management UFH or Enoxaparin + GP IIb/IIIa PCI Bivalirudin + GP IIb/IIIa Angiography within 72h R* Bivalirudin Alone CABG Moderate-high risk unstable angina or NSTEMI undergoing an invasive strategy (N = 13,819) Moderate- high risk ACS Aspirin in all Clopidogrel dosing and timing per local practice

  15. ACUITY – Outcomes 30 days Radial (6.2%) vs. Femoral Endpoint OR (95% CI) adjusted Femoral (n=11,989) Risk ratio ±95% CI Radial (n=798) p-value Net clinical outcome 10.5% 11.2% 0.97 (0.76-1.23) 0.78 Ischemic composite 0.18 8.1% 7.5% 1.20 (0.92-1.58) Non CABG-Major bleeding 3.0% 4.8% 0.03 0.61 (0.40-0.94) Transfusion rates were lower in radial group Radial better Femoral better Hamon et al. Eurointervention 2009;5:115-120

  16. ACUITY: Any TIMI BleedingMultivariate Analysis Hamon et al. Eurointervention 2009;5:115-120

  17. Acuity trialRadial Bivalirudin vs. Femoral Bivalirudin p = ns % p = ns p = ns Hamon et al. Eurointervention 2009;5:115-120

  18. Access site bleeding by Antithrombin Group and VCD Use 1.1 1.1 R+B R+B Sanborn Circ Cardiovasc Interv 2010; 3: 57-62

  19. Harmonizing Outcomes with Revascularization and Stents in AMI 3602 pts with STEMI R 1:1 UFH + GP IIb/IIIa N=1802 Bivalirudin N=1800 214 Radial 5.9% Stent rand. eligible R 3:1 R 3:1 N=1479 N=1527 Stratified by 1st rand. TAXUS N=1111 EXPRESS N=368 TAXUS N=1146 EXPRESS N=381 Primary endpoint: NACE: Net Adverse Clinical Events and Major Bleeding (non CABG). NACE= Major Bleeding (non CABG) or Major adverse cardiovascular events (MACE, All-Cause death, Reinfarction, Ischemic TVR, Stroke)

  20. Radial Femoral Kaplan-Meier Curves of 1-Year Cumulative NACE 20 17.8% 15 NACE (%) 10 8.5% 5 HR: 0.45 [95% CI: 0.28, 0.74] p= <.001 0 0 1 2 3 4 5 6 7 8 9 10 11 12 Time in Months Number at risk Radial 200 186 185 182 Femoral 3134 2669 2587 2511 P. Genereux HORIZONS-RADIAL , ACC 2010

  21. Radial Femoral Kaplan-Meier Curves of 1-Year Cumulative Major Bleeding (non-CABG Related) 15 10 Major Bleed (%) 8.1% 5 3.5% HR: 0.42 [95% CI: 0.20, 0.89] p= 0.019 0 0 1 2 3 4 5 6 7 8 9 10 11 12 Time in Months Number at risk Radial 200 188 188 187 Femoral 3134 2785 2753 2716 P. Genereux HORIZONS-RADIAL , ACC 2010

  22. Multivariable Analysis 30 days and 1-year The following potential covariates were included in the model : age, sex, race, BMI, Killip class, baseline anemia (defined as baseline hematocrit below 39% for men and 36% for women), platelet counts, creatinine clearance <60ml/min, white blood cell count, left ventricular ejection fraction, hypertension, hyperlipidemia, smoking, diabetes, insulino-dependent diabetes, previous MI, previous CABG, previous CAD (coronary artery disease), angina, heart failure, peripheral vascular disease, clopidogrel loading dose, pre-randomization heparin, baseline and discharge aspirin, baseline and discharge thienopyridines, randomization to bivalirudin vs. UFH+GP, symptom to first balloon time, LAD disease and access site (Radial vs. Femoral).

  23. P. Genereux HORIZONS-RADIAL , ACC 2010

  24. Access and Closure device used in HORIZONS

  25. 30-day outcomes based on Access site and Closure device used in HORIZONS:Bivalirudin only

  26. Records from NCDR 2004-2008 Total population 1,522 935 Propensity matched and Stratify by bleeding risk Overall bleeding = 30,429 (2%) M = Manual comp. C = Closure only B = Bival only BC = Bival+closure P<0.001 allintra-risk groupcomparisons M C B BC M C B BC M C B BC M C B BC Low(<1%) Intermediate(1-3%) High(>3%) Overall Marso et al. JAMA 2010;303:2156-2164

  27. Records from NCDR 2004-2008 Bleeding Risk and Access/Pharmacotherapy strategy n=982,077 P<0.001

  28. Bleeding Risk and Access/Pharmacotherapy strategyn=982,077 MC = Manual compression BV = Bivalirudin R = Radial PCI BR = Bivalirudin + radial *P<0.001, 4-way comparison P=0.05 P=0.06 MC BV R BR MC BV R BR MC BV R BR MC BV R BR Overall* Low*(<1%) Intermediate*(1-3%) High*(>3%) Risk Category Marso et al. ACC/i2 Scientific Sessions 2010; abstract 2505-458

  29. What can we do? Radial? Bivalirudin? Closure device?

  30. Meta-Analysis 200430 Studies 37,066 patients • Limitations • Heterogeneity in Definition of bleeding • No Bivalirudin used • Old generation of closure devices (up to 20%faillure rate) • Lots of studies using 7-8Fr sheath… • Bias in selection of patients suitable for VCD Conclusion In the setting of Dx angiography, the risk of access-site-related complications was similar for VCD compared with mechanical compression. In the setting of PCI, the rate of complications appeared higher with VasoSeal. Favor VCD Favor Manual compression Nikolsky et al. J Am Coll Cardiol 2004;44:1200 –9

  31. Key points While both are associated with a bad prognosis, non-access site bleeding is associated with a worse outcome than access site bleeding Bivalirudin is associated with the lowest rate of bleeding Radial has been shown to be superior to femoral access according to bleeding outcomes in many studies but has never been compared head to head with closure devices in the bivalirudin era

  32. Key points 5) Current Data comparing radial vs. femoral access with closure devices are retrospective/post-hoc analysis contaminated with selection bias 6) Randomized control trials are needed RIVAL trial

  33. My personal recommendations: Use Bivalirudin in ACS and high risk bleeding patients Radial access should be the default technique in all patients If you don’t know how to do radial and/or are not planning to learn it, at least use bivalirudin + vascular closure device in high risk patients…

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