Sunil V. Rao MD FACC, Fang-Shu Ou MS, Tracy Y. Wang MD, Richard E. Shaw PhD, Ralph Brindis MD, John S. Rumsfeld MD PhD,

1. The Radial Approach to Percutaneous Coronary Intervention Is Associated With a Lower Risk for Complications Regardless of Radial Procedure Volume: A Report From the American College of Cardiology- National Cardiovascular Data Registry Sunil V. Rao MD FACC, Fang-Shu Ou MS, Tracy Y. Wang MD, Richard E. Shaw PhD, Ralph Brindis MD, John S. Rumsfeld MD PhD, Eric D. Peterson MD MPH

2. Author Disclosure Information • Financial disclosure • None of the authors have financial disclosures related to this presentation • Unlabeled/unapproved uses disclosure • none

3. Advantages & Disadvantages of Radial Approach • Disadvantages • Potentially steep learning curve • Not all patients are candidates (abnormal Allen’s Test) • Can be technically difficult (spasm, tortuosity, recurrent loop) • Potentially lower procedural success (less guide support) • Advantages1,2,3 • Potentially lower risk for bleeding and vascular complications • Patient comfort • Shorter procedure time (one catheter used for both the Right and Left Coronary Arteries) 1Mann T, et al. J Am Coll Cardiol 1998;32:572– 6. 2Louvard Y, et al. Catheter Cardiovasc Interv 2001;52:181–7. 3Kiemeneij F, et al. J Am Coll Cardiol 1997;29:1269 –75.

4. Selected prior studies comparing femoral & radial approaches • Mann T, et. al. JACC 1998 • 142 ACS patients undergoing stenting randomized to radial vs. femoral approach • No difference in procedure success, but significantly lower access site complications (0% radial vs. 4% femoral, P<0.01) • Mann T, et. al. CCI 2000 • “Natural” randomization of 218 pts. to femoral with closure device vs. radial based on operator call schedule • No difference in procedure success but significantly lower access site complications, and higher rate of same-day ambulation with radial approach

5. Limitations of prior studies • Small sample sizes • Generally involved experienced operators • Relatively older data

6. Aims & Goals • To determine the variation in use of the radial approach to PCI in clinical practice • To compare the incidence of procedural complications between femoral and radial approaches to PCI in clinical practice • Bleeding and vascular outcomes • Procedural success

7. CathPCI data • > 2,000,000 Patient Admissions • > 800,000 PCI procedures • 150,000 records a quarter • CathPCI averages include institutions who pass inclusion threshold criteria • Average Pass Rate is 92%+

8. Methods • 305,425 PCI procedures in the CathPCI Registry (2004- 2006) analyzed to evaluate variation in use of radial approach to PCI (r-PCI) and outcomes across centers • Multivariable logistic regression with general estimating equation was used to evaluate the adjusted association between r-PCI use & procedural complications (procedural success, bleeding & vascular outcomes) • Definitions • Bleeding: Access site, Retroperitoneal, GI, GU, Other • Vascular: Access site occlusion, Peripheral embolization, Dissection, Pseudoaneurysm

9. Results • r-PCI accounted for 1.33% of the total procedures (N=4,074) with marked variation in use across centers • Patients who underwent r-PCI had higher BMI & more often had peripheral vascular disease • Compared with f-PCI, r-PCI had longer fluoroscopy time (13.20 vs. 11.50 minutes, p<0.0001) but did not involve more contrast use)

10. Results - r-PCI use across centers Rao SV, et al. J. Am. Coll. Cardiol. Intv. 2008;1;379-386

11. Results - Unadjusted Radial N=4074 Femoral N=301351 P<0.001 P<0.0001 P=0.69 Rao SV, et al. J. Am. Coll. Cardiol. Intv. 2008;1;379-386

12. Results - Complications by r-PCI volume Rao SV, et al. J. Am. Coll. Cardiol. Intv. 2008;1;379-386

13. Results - Multivariable modeling (femoral PCI as reference) Unadjusted Adjusted for patient differences Adjusted for patient & procedure differences Lower risk for any complication 1.0 Higher risk for any complication Adjusted for center clustering in each model Rao SV, et al. J. Am. Coll. Cardiol. Intv. 2008;1;379-386

14. Limitations • Observational non-randomized analysis • Reflects clinical practice • Unmeasured confounders may be present • The Results seen may be driven by high volume r-PCI operators at low r-PCI volume centers

15. Conclusions • r-PCI use is infrequent overall and varies across centers • r-PCI is independently associated with a lower risk for bleeding and vascular complications • Adjusted for patient & procedure differences • Adjusted for clustering within centers • There is no significant difference between the two approaches with respect to procedural success

16. Conclusions • Even at centers with relatively low use of r- PCI, complication rates are lower compared with the femoral approach • These contemporary data corroborate prior smaller studies and suggest that wider use of r-PCI can improve the safety of PCI