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Rao SV 201111


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Study of Access Site for Enhancement of PCI for Women (SAFE-PCI for Women)

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Rao SV 201111

  1. 1. Study of Access site ForEnhancement of PCI forWomen (SAFE-PCI forWomen)Sunil V. Rao MDDuke Clinical Research Institute
  2. 2. Disclosures  Consultant/Honoraria  Zoll, The Medicines Company, Terumo Medical, Daiichi Sankyo Lilly, Astra Zeneca  Research funding  Ikaria, Cordis  Off-label uses of drugs or devices will not be discussed in this presentation
  3. 3. TREATT I ThinkTank  The rate of radial approach is lower in the US compared with other countries  Lack of education and perhaps lack of large US- based randomized data may be responsible  Large appetite for a randomized trial looking at clinical outcomes  Less enthusiasm for labeling changes  Challenge is randomization  Femoralists unable to randomize to radial  Radialists unwilling to randomize to femoral
  4. 4. Female gender and access site complications Ahmed B, et. al. Circulation 2009
  5. 5. Predictors of Major Femoral BleedingN=17,901 pts from Mayo Clinic 1994-2005Major femoral bleeding defined as hematoma > 4 cm, external bleeding requiring surgeryor blood transfusion, or retroperitoneal hematoma Doyle BJ, et. al. JACC:Interventions 2008
  6. 6. PCI-related outcomes in womenN=22,725 PCI pts in the BMC2 RegistryRisk of PCI outcomes Women vs. Men Duvernoy CS, et. al. AHJ 2010
  7. 7. CATH-PCI Registry: Trend in the Use of radial PCI OverTime in Key Subgroups n=593,094 Radial access: 1.32% Rao, S. V. et al. J Am Coll Cardiol Intv 2008;1:379-386
  8. 8. Transradial PCI in women  Smaller diameter arteries  May not accommodate 6F systems readily  May be associated with greater degree of spasm  Female sex independently associated with forearm hematomas in the EASY trial Saito S, et. al. CCI 1999 Bertrand OF, et. al. AHJ 2009
  9. 9. SAFE-PCI Equipoise  Females at higher risk for vascular and bleeding complications  It may be more difficult to complete transradial procedures in women  Women may be at higher risk for bleeding after transradial PCI
  10. 10. SAFE-PCI for Women Trial Structure  Clinical and Data Coordinating Center - DCRI  Study chair - Mitch W. Krucoff MD,  Principal Investigator - Sunil V. Rao MD  DCRI Project lead – Britt Barham  Sponsors  Terumo Medical, Abbott Vascular, The Medicines Company, Eli Lilly others pending approval of applications  Partners  NCRI (David Kong, Eric Peterson, Bob Harrington), ACC, FDA Office of Women’s Health, CSRC  DSMB  Spencer King (chair), Olivier Bertrand, Alexandra Lansky, Statistician TBD
  11. 11. Objectives  To determine the efficacy and feasibilty of the transradial approach to PCI in women  Secondary:  To determine the association between transradial PCI and procedure time, radiation dose, and contrast volume  To determine the association between transradial PCI and resource use, patient preferences, and quality of life*  To determine the association between transradial PCI and 30-day death, vascular complications and repeat revascularization *If funding can be obtained
  12. 12. Inclusion/exclusion criteria Inclusion Exclusion  Age > 18 years  Non-palpable radial or femoral pulses  Female patient undergoing  Bilateral IMA grafts elective or urgent PCI or  Bilateral abnormal Barbeau tests  Undergoing diagnostic  Hemodialysis AV fistula or graft angiography to evaluate in arm to be used for PCI ischemic symptoms with the  INR ≥ 1.5 possibility of PCI  Planned staged PCI within 30d of index PCI  Have capacity to sign informed consent  Valvular heart disease requiring surgery  Planned RHC  Primary PCI for STEMI
  13. 13. Primary efficacy and feasibility endpoints  Efficacy – BARC Types 2, 3, and 5 bleeding or major vascular complications occurring within 72 hrs of PCI or hospital discharge, whichever comes first  Vascular complications defined as:  AV fistula  Arterial pseudoaneurysm Requiring surgical intervention  Arterial occlusion  Primary feasibility endpoint  Procedural failure – inability to complete the procedure from the assigned access site.  CEC adjudication of Bleeding and vascular complication endpoints
  14. 14. Study of Access site For Enhancing PCI forWomen (SAFE-PCI for Women)* Female patient undergoing urgent or elective PCI Best background medical therapy Bivalirudin, Clopidogrel, Prasugrel 2b3a at investigator’s discretion N=1800 pts, 30 sites Sites from NCRI Radial Femoral Patent hemostasis required Vascular closure devices allowed Primary Efficacy Endpoint: BARC Types 2, 3, or 5 bleeding or Vascular Complications requiring surgical intervention Primary Feasibility Endpoint: Procedural failure Secondary endpoints: Procedure duration, total radiation dose, total contrast volume *Planned in collaboration with ACC, CSRC, FDA Office of Women ’s Health
  15. 15. Sample size assumptions and calculations  Assumptions:  Rate of primary composite endpoint in femoral arm – 8.0%  Assume 50% reduction with radial approach  Sample size:  1800 patients provides >90% power at 2-sided alpha=0.05
  16. 16. NCRI  Case report form built on the CathPCI registry form  60% of the crf completed  Adding randomization to data acquisition harnesses the NCDR backbone to create an efficient platform for large simple randomized clinical trials.  Site identification (> 1000 sites represented in the registry)  How many radials are being at each site?  How many PCIs in women are being done at each sites?  How many radial PCIs are being done in women at each site?  21 CFR 11 compliant
  17. 17. Funding Support  American Recovery & Reinvestment Act of 2009 (ARRA)  NIH Research and Research Infrastructure “Grand Opportunities” (GO) initiative  “Substantially accelerate comparative effectiveness research, advance methods development and priority setting, and forge robust infrastructure to support the conduct of comparative effectiveness research.”  NHLBI Award 1RC2HL101512-01  $2.6M over 2 years
  18. 18. SAFE-PCI for Women  The first large multicenter collaborative trial comparing radial and femoral approaches in the modern (post-RIVAL) era  One of the few interventional randomized trials in women  Opportunities and challenges to answering important questions related to access site approaches and bleeding risks  Develop a template for future interventional trials