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Dr Alex Chase

Bleeding Matters and How to Avoid It the radial approach. Dr Alex Chase. R ad I al V s. femor AL access for coronary intervention in patients with acute coronary syndromes study. 2006-2010. anecdotes. Fact 1. Bleeding is Bad. Fact 2 Radial reduces bleeding and transfusion.

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Dr Alex Chase

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  1. Bleeding Matters and How to Avoid It the radial approach Dr Alex Chase

  2. RadIal Vs. femorAL access for coronary intervention in patients with acute coronary syndromes study 2006-2010

  3. anecdotes

  4. Fact 1 Bleeding is Bad

  5. Fact 2Radial reduces bleeding and transfusion The evidence is conclusive 50-70% 6mm 2mm • PRCTrials:SYNERGY 9,404 ptsCantor et al CCI 2007;69:73 • Meta-analyses:1,371 pts Agostoni et al. JACC 2004;44 349 • Jolly et al Canadian CC 2008 • real life registries: 593,094 pts Rao et al JACCintv 2008 1 • 32,822 pts Chase et al Heart 2008

  6. So…..If bleeding is bad& 50-70% access site related… and radial access reducesbleeding........ Does radial access reduce 30 & 1 year mortality?

  7. M.O.R.T.A.L STUDY(Mortality benefit Of Reduced Transfusion after PCI via the Arm or Leg) Chase et al Heart 2008

  8. MORTAL: log regression (n=39,386) • age, sex, BMI, stroke, stable angina, emergency PCI, prior MI, PCI & CABG, diabetes, co-morbidities & creatinine • reduction in transfusion radial v femoral OR 0.56 95% CI 0.45-0.69, p<0.0001 • increase in 1 year mortality if transfused OR 3.74 95% CI 3.12-4.47, p<0.0001 OR 0.83 95% CI 0.71-0.98, p<0.001 • reduction in 1 year mortality radial v femoral Chase A, Hilton JD et al, Heart 2008

  9. Oasis 5 MACE&BLEEDING

  10. 21 study meta-analysis, >5600 pts radial vs femoral 70%   trend Jolly S. Canadian Cardiovascular Congress. October 25-29, 2008; Toronto, ON.

  11. RIVIERA Study Registry on IntraVenous anticoagulation In the Elective and primary Real world of Angioplasty • 7962 patients, 144 hospitals, 23 countries, 1 year • prospective study consecutive patients • 92% elective, 8% primary PCI (not NSTEMI) • 10.6% via radial, 3.4% any bleeding Montalescot et al 2007

  12. RIVIERA Studyindependent predictors of bleeding  bleeding: female, graft PCI, IIbIIIa, UFH & LMWH onlyradial access reduced bleeding (OR 0.52 CI 0.31-0.89) Montalescot et al 2007

  13. RIVIERA Studyindependent predictors of death & MI • radial, clopidogrel pre-Rx & LMWH reduction in • death or MI Montalescot et al 2007

  14. PREVAILProspective REgistry of Vascular Access in Interventions in Lazio region • 9 hospitals, 30 days, 1,052 consecutive vascular procedures (40% PCI) • 509 radial vs 543 femoral. After Adjustment: primary: In-hospital major & minor bleeds stroke entry complications secondary: In-hospital death/MI Heart 2008

  15. positives exclusion criteria • bleeding diathesis • recent bleed • anaemia • co-morbidity<1 year survival • arterial disease precluding vascular access • specifically designed to prospectively assess impact access site • multi- centre • 1,170 consecutive patients after ExCr/FU • end points: death,MI & bleeding in-hospital & 1 year • 2003 to 2006 Am J Cardiol 2009;103:796–800

  16. PRESTO-ACS Vascular Substudy In Hospital Outcomes radial femoral p bleeding 0.7% 2.4% 0.05 death&MI 2.6% 2.9% 0.79 Net Outcome 3.3% 4.6% 0.30 1 Year Outcomes radial femoral p bleeding 0.7% 2.7% 0.03 death&MI 4.9% 8.3% 0.05 Net Outcome 5.5% 9.9% 0.02 GpIIbIIIa Use 52% 34% 0.0001 Am J Cardiol 2009;103:796–800

  17. Observational Retrospective Statistics/voodoo anecdotes

  18. UnknownsWhat are possible explanations? No causality Bleeding is a marker of high risk and poor outcome Outcome is NOT because of the bleed Poor ‘pedigree’ or protoplasm Radial vs femoral result from chance, confounding (poor risk adjustment) Femoral bleeds kill patients Bleed to death Bleeding causes ischaemic events Our management of bleeding causes ischaemic events Antiplatelet cessation Transfusion with old blood Yes bleeding can cause death/ischaemic events but it’s GI or intracranial, not access bleeds –these are just a nuisance Our management of ischaemia differs because of bleeding risk More adjunct IIbIIIa in radials

  19. What Is The Evidence Linking Access Bleeds to Adverse Cardiac Events? Observational Retrospective Statistics/voodoo anecdotes

  20. Access site haematoma requiring transfusion predicts mortality Data from the National Heart, Lung, and Blood Institute Dynamic Registry N=6,656 Overall 120 (1.8%) patients had access site haematoma requiring transfusion Over 50% of the PCIs were elective Yatskar et al. CCI 2007;69: 961

  21. Retrospective Analysis Of the Bivalirudin Trials: Type Of Bleeding • TIMI major/minor 30-day bleeding dataset from the REPLACE-2, ACUITY and HORIZONS-AMI trials in 17,393 femoral PCI patients. • TIMI major/minor bleeding 5.3% (1.6%/3.7%) • 38.2% of which were only-access site bleeds. • After multivariable adjustment, TIMI bleeding increased risk of 1-year mortality (HR 3.17 (95%CI 2.51–4.00), p<0.0001). • mortality risk non-access site TIMI bleed HR 3.94 (95%CI 3.07–5.15), p<0.0001 • adjusted mortality risk access site-only TIMI bleed HR 1.82 (95%CI 1.17–2.83), p=0.008 • adjusted mortality risk non-access site bleed was 2 fold that of an access site bleed HR 2.27 (95%CI 1.42-3.64), p=0.0007 Verheugt, Steg et al Personal communication

  22. Bival Trials Mehran et al ESC 2009 17,002 pts ACUITY HORIZONS TIMI major Non TIMI REPLACE2 TIMI minor

  23. M.O.R.T.A.L STUDY Chart Review(Mortality benefit Of Reduced Transfusion after PCI via the Arm or Leg) • 38,952 patients 952 transfusions (2.5%) • Impact of source of bleeding alive dead 831 121 % % †: p<0.05 SD Robinson 2010 CCS

  24. M.O.R.T.A.L Study Chart Review • •higher transfusion volumes predicted increased risk of death (OR 1.25 [1.16-1.34], p=0.008) • patients dying within 30 days more often received blood stored for at least 28 days • (65.3 vs 52.9%, p=0.02) • • After adjustment for baseline risk, RBC storage • age >28 days (odds ratio 2.46 [95% CI 1.44 – • 4.21], p=0.001) • Transfusion of other blood products than RBCs After adjustment for baseline risk, transfusion of platelets (OR 2.27 [95% C.I. 1.17-4.44]) and plasma/cryoprecipitate (OR 4.95 [2.67-9.19]) predicted an increased risk of death at 30 days Undoes your anticoag SD Robinson 2010 CCS

  25. M.O.R.T.A.L Study Chart Review transfused alive transfused dead 30 days non transfused dead 30 days Robinson 2010 CCS

  26. PREVAIL- Internet Only AppendicesProspective REgistry of Vascular Access in Interventions in Lazio region • 9 hospitals, 30 days, 1,052 consecutive pts • 509 radial vs 543 femoral. After Adjustment: primary: In-hospital major & minor bleeds stroke entry complications secondary: In-hospital death/MI Heart 2008

  27. PREVAILBreakdown - Complex Composite End Point Per Treatment 9 hospitals, 30 days, 1,052 consecutive pts 509 radial vs 543 femoral bleeds- femoral access site • 1 death directly from femoral access bleed • 2 other major bleeds requiring transfusion • 4 pseudoaneurysms, 2 x AV fistula • 1 x stroke • 15 minor bleeds 1-10cm haematoma without transfusion bleeds radial access • 1 spontaneous RP haematoma (prosthetic valve) – death • no major access bleeds • zero transfusions • 6 minor bleeds 0-5cm haematoma without transfusion Massive haematoma NSTEMI death Heart 2008

  28. PREVAILIschemic Endpoint- Adjunct Therapy Hypothesis stable ACS ischemic endpoint (death & MI) IIbIIIa use radial 15% vs femoral 8%, p=0.002 Heart 2008

  29. Vascular Closure Devices Birmingham 2004-20051214 PCI (1077 fem:137 radial) 15 vascular complications 1.2% transfusion 0.64% femoral PCI n=7, 1077 Routledge, Ludman et al

  30. ? impactspeculative calculation • difference transfusion rate 2.8 -1.4%=1.4% • if save 3 patients transfusions / 200 PCI • need to prevent 7.4 transfusions to save 1 life @ 1 year • ? 1’avoided death’ / 500 cases • ? diagnostic angiograms 1.5 x106 74,000 Chase et al Heart 2008

  31. Bleeding Matters and How to Avoid It the radial approach • Increased patient comfort • Early ambulation • Reduced hospital stay • Reduced vascular complications • Reduced Nursing requirements • Reduced cost

  32. Questions

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