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Incidence, impact and preventative strategies for non-access site bleeding in the PCI patient

Incidence, impact and preventative strategies for non-access site bleeding in the PCI patient. Martial Hamon. MD. FESC University Hospital. Caen. France. P<0.001 For trend. 1994-95. 1996-99. 2000-05. Changing Incidence from the earliest (8.4%) to the contemporary time period (3.5%).

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Incidence, impact and preventative strategies for non-access site bleeding in the PCI patient

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  1. Incidence, impact and preventative strategies for non-access site bleedingin the PCI patient Martial Hamon. MD. FESC University Hospital. Caen. France

  2. P<0.001 For trend 1994-95 1996-99 2000-05 Changing Incidence from the earliest (8.4%) to the contemporary time period (3.5%) Vascular Complications (%) Doyle BJ et al. JACC Intervention 2008;1:202-209.

  3. Impact on Survival Major Femoral Bleeding Complications After PCI Doyle BJ et al. JACC Intervention 2008;1:202-209.

  4. Radial vs Femoral Access Impact on Major Bleeding RADIAL VS FEMORAL Favours RADIAL Favours FEMORAL Meta-analysis of 18 Randomized Trials (5 had no bleeding events) 4.458 patients Major Bleeding: 0.54% vs 2.32% Jolly S et al. Am Heart J 2009

  5. Radial vs Femoral Access Impact on Ischemic Outcomes RADIAL VS FEMORAL Favours RADIAL Favours FEMORAL Death,MI or Stroke Meta-analysis of Randomized Trials Trend for reduction in composite of death.MI. stroke (2.5% vs 3.8%. P = .06) Jolly S et al. Am Heart J 2009

  6. Endpoint OR (95% CI) adjusted Femoral (n=11.988) Risk ratio ±95% CI Radial (n=798) p-value Net clinical outcome 10.5% 11.1% 0.95 (0.77-1.17) 0.62 Ischemic composite 0.45 8.1% 7.4% 1.10 (0.86-1.40) Major bleeding 3.0% 4.8% 0.63 (0.42-0.95) 0.02 Radial better Femoral better Endpoint Measures at Day 30 ACUITY Radial vs. Femoral

  7. ACUITY: Femoral vs. Radial AccessMajor or Minor Organ Bleeding 10 Heparin+GPI 5 Bivalirudin 7.2% 4.9% 7.4% 4.1% 0 Femoral Radial Major or minor organ bleeding were reduced to a similar extent in patients treated with bivalirudin alone compared to heparin plus a GPI and were present with both femoral access (4.1% vs 7.4% respectively. p<0.0001) and radial access (4.9% vs 7.2% respectively. p=0.26). Hamon M. Rasmussen LH. Manoukian SV. et al. EuroIntervention 2009.

  8. Early Non-CABG Major Bleeding in ACS Trials in PCI-Treated Patients 7 88% Femoral Access 84% Radial Access 6 5 4 3 5 . 9 2 3 . 7 3 . 7 3 . 1 1 1 . 2 0 . 67 0 ACUITY TRITON EARLY ACS SYNERGY OASIS 5 ABOARD 30 Days 3 Days 120 hours 30 Days 9 days 30 Days Percent Protocol Major Bleed

  9. Variation in definitions Bleeding definitions TIMI Major Intracranial hemorrhage Bleeding with 5g/dL fall in hemoglobin Blood transfusion  3 units TIMI Minor Bleeding with 3g/dL fall in hemoglobin 4g/dL fall in hemoglobin without site Retroperitoneal hemorrhage Gross hematuria or hematemesis Lincoff et al. JAMA 2003

  10. Beyond Access Site Bleeding: Incidence, Sources, and Impact of Antithrombotic Therapy in the PCI Patient A Combined Analysis of 17,393 Patients REPLACE-2, ACUITY and HORIZONS-AMI Freek W.A. Verheugt, Steven R. Steinhubl, Martial Hamon, Harald Darius,Ph. Gabriel Steg, Marco Valgimigli, Steven P. Marso, Sunil V. Rao, Anthony H. Gershlick. Onze Lieve Vrouwe Gasthuis, Amsterdam

  11. Bleeding Definitions - 30-day Endpoint Protocol Major (different between REPLACE-2 and ACUITY, HORIZONS) TIMI Major TIMI Minor TIMI Major + Minor

  12. Purpose To identify the incidence and source of bleeding events unrelated to access site among over 17,300 patients undergoing a PCI for a wide variety of clinical diagnoses. Evaluate the impact of antithrombotic therapy (bivalirudin versus heparin + GPIIb/IIIa antagonist) on the occurrence of bleeding unrelated to the access site.

  13. Analysis Population: All PCI patients (ITT) from: REPLACE-2 N = 6,002 ACUITY N = 7,789 HORIZONS N = 3,602 Total N = 17,393* * For primary antithrombotic comparisons the GPIIb/IIIa antagonist + bivalirudin arm (n=2609) of ACUITY was excluded, leaving a total of 14,784 patients.

  14. Patient Demographics – N=17,393 Age (years) Age ≥ 75 years (%) Weight (kg) Female (%) Diabetes (%) Current Smoker (%) CrCl < 60 Baseline Diagnosis STEMI NSTEMI Unstable Angina Stable Angina Other 62.3 ± 11.4 16.0% 85.6 ± 17.8 25.7% 25.1% 32.3% 17.0% 20.7% 30.0% 29.5% 8.6% 11.2%

  15. Sources of Bleeding Access Site Only Both Access and Non-Access Non-Access Site Only No Identified Location • Intracranial • Intraocular • Gastrointestinal • Genitourinary • Pleural • Pulmonary • Head and Neck • Epistaxis • Hemoptysis • Hematemasis • Gingival • Other Location of bleeds were determined post hoc using investigator-identified location and without knowledge of randomized therapy.

  16. Sources and Incidence of TIMI Bleeding Among 17,393 PCI Patients 5.3% (n=925) of the study population experienced a TIMI (Major + Minor) bleeding event. Access-site only bleeds occurred in 357 (39.6%) of patients. Bleeding events not limited to the access site occurred in 568 (60.4%) of patients.

  17. Incidence and Location of Bleeding Events Excluding Access Site Figure 2

  18. Adjusted Relative Risk of 1-Year Mortality Based on TIMI Bleeding Source Compared to No Bleeding P<0.0001 for all bleeding versus none

  19. Impact of Randomized Antithrombotic Therapy: All Bleeding Sources RR=0.55 P<0.0001 RR=0.55 P<0.0001 RR=0.52 P<0.0001

  20. Impact of Randomized Antithrombotic Therapy on TIMI Major + Minor Bleeding by Source Bivalirudin better Hep + GPI better Figure 3

  21. Impact of Randomized Therapy on TIMI Bleeding by Location Exclusive of Access Site Bivalirudin better Hep + GPI better

  22. Conclusions Two-thirds of PCI patients with a TIMI bleed unrelated to the access site. Bleeding, irrespective of the source, significantly associated with increased mortality at 1 year. Non-access-related bleeding associated with double the risk of mortality compared to access bleeding. The use of bivalirudin during a PCI associated with ~40% reduction in non-access site bleeding compared with heparin + a GPIIb/IIIa antagonist.

  23. Identification of Risk Factors For Bleeding in ACS Patients and Preventive actions Identification Prevention Hamon M. et al. EuroIntervention 2007

  24. PCI in ACS: Choice of Access Site 1. Radial Access Feasible? Default radial operators YES NO 2. Consider Bleeding risk? HIGH LOW 3. Consider Ischemic Risk? HIGH LOW Radial Access Consider bleeding risk Femoral Access Adjunctive therapy needed? Bivalirudin or GPI Bivalirudin Am J Cardiol 2009 Hamon et al.

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