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 disclosureFinancial disclosure –None of the authors have financial disclosures related to this presentation Unlabeled/unapproved uses disclosureUnlabeled/unapproved uses disclosure –none

3. Advantages & Disadvantages of Radial Approach Advantages 1,2,3Advantages 1,2,3 –Potentially lower risk for bleeding and vascular complications –Patient comfort –Shorter procedure time (one catheter used for both the Right and Left Coronary Arteries) DisadvantagesDisadvantages –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) 1 Mann T, et al. J Am Coll Cardiol 1998;32:572– 6. 2 Louvard Y, et al. Catheter Cardiovasc Interv 2001;52:181–7. 3 Kiemeneij F, et al. J Am Coll Cardiol 1997;29:1269 –75.

4. Selected prior studies comparing femoral & radial approaches Mann T, et. al. JACC 1998Mann 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 2000Mann 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 sizesSmall sample sizes Generally involved experienced operatorsGenerally involved experienced operators Relatively older dataRelatively older data

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

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

8. Methods 305,425 PCI procedures in the CathPCI Registry (2004- 305,425 PCI procedures in the CathPCI Registry (2004- 2006) analyzed to evaluate variation in use of radial 2006) analyzed to evaluate variation in use of radial approach to PCI (r-PCI) and outcomes across centers approach to PCI (r-PCI) and outcomes across centers Multivariable logistic regression with general estimating Multivariable logistic regression with general estimating equation was used to evaluate the adjusted association equation was used to evaluate the adjusted association between r-PCI use & procedural complications between r-PCI use & procedural complications (procedural success, bleeding & vascular outcomes) (procedural success, bleeding & vascular outcomes) Definitions 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 r-PCI accounted for 1.33% of the total procedures (N=4,074) with marked variation in use across centers procedures (N=4,074) with marked variation in use across centers Patients who underwent r-PCI had higher Patients who underwent r-PCI had higher BMI & more often had peripheral vascular disease BMI & more often had peripheral vascular disease Compared with f-PCI, r-PCI had longer Compared with f-PCI, r-PCI had longer fluoroscopy time (13.20 vs. 11.50 minutes, fluoroscopy time (13.20 vs. 11.50 minutes, p<0.0001) but did not involve more contrast use) 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<0.001P<0.0001P=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) 1.0 Higher risk for any complicationLower risk for any complication Unadjusted Adjusted for patient differences Adjusted for patient & procedure differences 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 Observational non-randomized analysis –Reflects clinical practice Unmeasured confounders may be present Unmeasured confounders may be present The Results seen may be driven by high The Results seen may be driven by high volume r-PCI operators at low r-PCI volume r-PCI operators at low r-PCI volume centers volume centers

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

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