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.

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

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

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

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

log rank p-value for all four categories <0.0001log-rank p-value for no bleeding vs. mild bleeding = 0.02log-rank p-value for mild vs. moderate bleeding <0.0001log-rank p-value for moderate vs. severe <0.001

Bleeding & OutcomesBleeding & OutcomesN=26,452 pts from PURSUIT, GUSTO IIb, PARAGON A & BN=26,452 pts from PURSUIT, GUSTO IIb, PARAGON A & B

Rao SV, et al. Rao SV, et al. Am J CardiolAm J Cardiol. 2005. 2005Rao SV, et al. Rao SV, et al. Am J CardiolAm J Cardiol. 2005. 2005

Kaplan Meier Curves for 30-Day Death, Stratified by Bleed SeverityKaplan Meier Curves for 30-Day Death, Stratified by Bleed Severity

Bleeding rates reduced with Bivalirudin, but are still 5% in STEMI

Stone G, et al, NEJM 2008;358 : 2218 - 30

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)

Prevalence of radial approach in the US

0

10

20

30

40

50

60

70

80

90

100

0-9.9 10-19.9 20-29.9 30-39.9 > 40%

% r-PCI

% H

os

pit

als

N = 593,094 PCI procedures 2004-2007N = 593,094 PCI procedures 2004-2007 606 sites606 sites1.3% of all PCI procedures1.3% of all PCI procedures

Rao SV, et. al. SV, et. al. JACC: CI 2008JACC: CI 2008

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

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.

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

Similar Procedure Times. Higher Access Failures With TRA

Hetherington et al. Heart Online, July 2009

• Contrast and Radiation dose less in the radial group

• Length of stay less in the radial group

Hetherington et al. Heart Online, July 2009

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)

Lahey TRA times similar to Tran-femoral approach for STEMI

Radial failureRate: 3%

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

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 ?

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

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.