1. Trans-Radial Approach for STEMI Evolution of TRA in single center Rationale behind increased TRA use Progression to use in STEMI Data analysis of STEMI DTB times Rationale for a Randomized Trial

2. Brief History of TRA @ Lahey 95 – 03: Must only 2004: Single operator “ramp – up” 2005 – 07: Mostly single operator 2008 - : Broad operator application with routine STEMI use

3. Factors behind TRA “Boom” Patient preference for a more comfortable procedure Literature supporting less bleeding and possibly improved outcomes Improved technical proficiency allowing application of procedure to a wide subset of patients with high success rates

4. Rationale for TRA for ACS and MI ACS and STEMI patients are frequently aggressively anti- coagulated with high rates of access site bleeding Access site bleeding is an independent predictor of mortality in ACS TRA lowers access site bleeding rates

5. log rank p-value for all four categories <0.0001 log-rank p-value for no bleeding vs. mild bleeding = 0.02 log-rank p-value for mild vs. moderate bleeding <0.0001 log-rank p-value for moderate vs. severe <0.001 Bleeding & Outcomes N=26,452 pts from PURSUIT, GUSTO IIb, PARAGON A & B Rao SV, et al. Am J Cardiol. 2005 Kaplan Meier Curves for 30-Day Death, Stratified by Bleed Severity

6. Bleeding rates reduced with Bivalirudin, but are still 5% in STEMI Stone G, et al, NEJM 2008;358 : 2218 - 30

7. TRI reduces access site complications and bleeding results Cantor WJ, et al, CCI 69:73-83 (2007) Procedural factors affecting major bleeding in the Synergy trial (UFH vs. Enoxaparin in ACS – non STEMI)

8. Prevalence of radial approach in the US N = 593,094 PCI procedures 2004-2007 606 sites 606 sites 1.3% of all PCI procedures SV, et. al. JACC: CI 2008 Rao SV, et. al. JACC: CI 2008

9. Limitations to TRA in STEMI Most centers have no formal TRA program Operators fear technical failure Operators assume even successful TRA will be slower than the trans- femoral approach for STEMI

10. Data on TRI for STEMI Most Data is Single Center Registry No Multi – Center randomized trials exist comparing the management of STEMI with Trans – Radial vs. Trans – Femoral approach.

11. Hetherington et al. reviewed 4 years of STEMI at a lab of both high volume radial and femoral approach operators. Approach determined by physician preference Initially most radial cases done by single physician More physicians adopted the radial approach with time Hetherington et al. Heart Online, July 2009

12. Similar Procedure Times. Higher Access Failures With TRA Hetherington et al. Heart Online, July 2009

13. Contrast and Radiation dose less in the radial group Length of stay less in the radial group Hetherington et al. Heart Online, July 2009

14. Lahey Clinic Experience with Radial Access for STEMI Reviewed 103 consecutive STEMI cases managed with radial access Divided Radial cases into early experience (n=32) and late experience (n=71). Compared early and late radial experience Compared late experience to 2008 femoral “controls” (n=166)

15. Lahey TRA times similar to Tran- femoral approach for STEMI Radial failure Rate: 3%

16. Future Directions in TRI Research Rao et al. Initiating Multi – Center Registry to examine the effect of TRI on bleeding in wide spectrum of patients and anti-coagulation regiments Pyne, Jeon et al. Initiating a multi-center randomized clinical trial comparing TRI vs. femoral approach for the management of STEMI

17. Randomized TRA vs. TFA is needed Can TRA be done for STEMI with a high success rate with good PCI results ? Can TRA be done quickly enough to compare to TFA for D2B ? Does TRA decrease bleeding in STEMI ? Are MACE rates improved using the radial approach ?

18. Multi – Center RTC comparing TRI to Femoral for the management of STEMI 8 – 10 centers enrolling 600 STEMI patients randomized to TRI vs. Femoral with standardized anti-coagulation protocols. Primary endpoints: Procedural time and Bleeding rates Secondary endpoint: MACE

19. Conclusions Bleeding confers a significant morbidity in ACS and is reduced with TRI. Single center experiences demonstrate good procedural success with favorable room times. RCT trial is necessary to truly evaluate TRI in STEMI.