1. Transradial Approach [LEft vs right] aNd procedural Times during percutaneous coronary procedures: TALENT study ALESSANDRO SCIAHBASI, MD UO Cardiologia, Policlinico Casilino – ASL RM B, Rome, Italy

2. Background Coronary transradial procedures may be performed through right or left radial artery approach (RRA and LRA respectively) Most of studies assessing feasibility of the transradial approach have been performed through RRA, but the LRA may have some important anatomical advantages. Aim of this study was to evaluate safety and efficacy of RRA versus LRA approach in coronary diagnostic and interventional procedures. Policlinico CASILINO

3. Methods From January 2009 to December 2009 all patients who underwent percutaneous coronary procedures (diagnostic or PCI) Exclusion criteria: previous CABG, acute STEMI, haemodynamic instability, ischemic Allen test. Right Radial Approach Left Radial Approach Policlinico Casilino Policlinico Gemelli Policlinico CASILINO

4. Primary end point: fluoroscopy time and the Dose Area Product (DAP) adsorbed by the patients. Secondary end-points: contrast amount, cannulation time, access shift rate, number of catheters employed, major complications. A sub-analysis regarding patient’s age and operator’s skillness (senior compared to fellow) was also pre-specified Methods Policlinico CASILINO

5. 1540 consecutive patients were randomized to LRA (770) or RRA (770) 1467 patients 735 LRA732 RRA Diagnostic Group (coronary angiography) 688 patients 344 LRA 344 RRA PCI Group (PCI post angiography or stand alone) Methods Policlinico CASILINO

6. Results Right Radial (n=770) Left Radial (n=770) P Age (years)65.7 ± 11.266.4 ± 10.90.27 Sex (Male)526 (68%)527 (68%)0.95 Height (cm)168 ± 8168 ± 90.94 Weight (Kg) 77 ± 14 0.95 BMI 27 ± 428 ± 40.82 Diabetes (%)208 (27%)238 (31%)0.09 Hypertension (%)539 (70%)520 (68%)0.30 Creatinine (mg/dl)1.05 ± 0.61.04 ± 0.50.80 GFR (ml/min) 90 ± 36 89 ± 350.58 Hemoglobin (g/dl)13.5 ± 1.713.4 ± 1.70.88 Mean ± standard deviation; BMI: body mass index, GFR: glomerular filtration rate Policlinico CASILINO

7. Results RRA (n= 732) LRA (n= 735) 168 149 seconds Fluoroscopy time 0 150 170 (32-1238) (31-1290) P= 0.0025 12.1 10.7 0 11 13 Dose Area Product (Fluoroscopy) Gy/cm 2 (0.9-229) (0.8-378) P= 0.004 23.3 23.5 Dose Area Product (Fluorography) 0 20 25 Gy/cm 2 (6.4-172) (1.9-328) P= 0.40 Results are expressed as median with range in brackets Diagnostic Group (n= 1467) Policlinico CASILINO

8. 695 614 Fluoroscopy time 0 600 700 seconds (54-5087) (62-5653) P= 0.087 63.1 53.7 Dose Area Product (Fluoroscopy) 0 55 65 Gy/cm 2 (2.4-1058) (4.1-784) P= 0.17 Results are expressed as median with range in brackets PCI Group (n= 688) RRA (n= 344) LRA (n= 344) 37.8 41.5 Dose Area Product (Fluorography) 0 30 50 Gy/cm 2 (1.8-285) (5.7-307) P= 0.60 Results Policlinico CASILINO

9. Right Radial (n=770) Left Radial (n=770) P Cannulation Time (min)†5 (2-85)5 (2-60)0.27 Cross over to femoral6 (0.8%)9 (1.2%)0.43 Stroke/TIA1 (0.1%)0 (0%)0.31 Subclavian Tortuosity125 (16%)65 (8%)<0.001 Coronay angiography Contrast medium (ml)*68 ± 3565 ± 320.098 >2 Catheters84 (11%) 0.98 Coronary intervention Contrast medium (ml)*165 ± 91160 ± 920.44 >1 Catheter43 (13%)42 (12%)0.91 * Mean ± standard deviation; † Median with ranges Results Policlinico CASILINO

10. Cross-over to femoral: Incidence and classification RRA (n= 770) LRA (n= 770) Overall 14 puncture and radial failure vs 1 epi-aortic failure, p= 0.0008 Puncture Failure Lack of radial canalization 0 1 2 3 4 5 Cases P= 0.41 Radial Failure Radial tortuosity/anomalies Severe spasm P= 0.70 P= 0.31 Epi-Aortic Failure Subclavian-aortic tortuosity P= 0.31 Results Policlinico CASILINO

11. 0.01 0.1 1 5 10 50 Radial tortuosity OR=18.5; 95%CI, 6.4-54, p< 0.001 Multivariate analysis Predictors of cross over to femoral OR=2.6; 95%CI, 1.8-3.7, p< 0.001 Age >70 years 0.1 0.5 1 2 5 10 Predictors of subclavian tortuosity OR=2.7; 95%CI, 1.9- 4, p< 0.001 Right radial approach Results Policlinico CASILINO

12. Results are expressed as median with range in brackets Diagnostic Group (n= 1467) 9.3 9 Dose Area Product (Fluoroscopy) 0 5 10 Gy/cm 2 (0.9-201) (0.8-197) P= 0.26 140 132 seconds Fluoroscopy time 0 130 150 (32-1238) (31-1282) P= 0.11 SENIOR RRA (n= 487) LRA (n= 478) FELLOW 256 208 0 200 260 seconds (58-1170) (35-1290) P= 0.001 Fluoroscopy time RRA (n= 245) LRA (n= 257) 22.4 17.3 0 15 30 Gy/cm 2 (2.2-229) (1.3-378) P= 0.002 Dose Area Product (Fluoroscopy) Results Policlinico CASILINO

13. Results are expressed as median with range in brackets Diagnostic Group (n= 1467) 11.1 10.2 Gy/cm 2 0 10 12 (0.9-193) (0.8-305) P= 0.11 158 138 Fluoroscopy time 0 130 160 seconds (32-990) (32-1282) P= 0.048 Age <70 years RRA (n= 430) LRA (n= 425) Dose Area Product (Fluoroscopy) 199 171 Fluoroscopy time 0 170 200 seconds (56-1238) (31-1290) P= 0.01 14.2 11.2 0 10 15 (1.7-229) (0.9-378) P= 0.001 Age ≥70 years RRA (n= 302) LRA (n= 310) Dose Area Product (Fluoroscopy) Gy/cm 2 Results Policlinico CASILINO

14. Conclusions LRA for coronary angiography and interventions is associated with slight but significant lower fluoroscopy time and radiation dose compared to RRA The LRA advantage seems to be confined to operators at the beginning of learning curve (fellows) and to be more pronounced in older patients Policlinico CASILINO