1. RIVAL and the EVIDENCE BASE Howard A. Cohen, MD, FACC, FSCAI Professor of Medicine Director Temple Interventional Heart & Vascular Institute Director Cardiac Cardiac Intervention and Catheterization Laboratories Temple University Health System Howard A. Cohen, MD, FACC, FSCAI Professor of Medicine Director Temple Interventional Heart & Vascular Institute Director Cardiac Cardiac Intervention and Catheterization Laboratories Temple University Health System SCAI FALL FELLOWS COURSE LAS VEGAS, NEVADA DECEMBER 5-8,2012

2. DISCLOSURE Vascular Solutions – Grant support Abbott Vascular – Grant Support Medtronic – Honoraria, Grant Support Vascular Solutions – Grant support Abbott Vascular – Grant Support Medtronic – Honoraria, Grant Support

3. ARE YOU ON THIS TRAIN? TRANSFEMORAL EXPRESS

4. Transradial Access – Improving Outcomes, Patient Satisfaction and Decreasing Costs Background Trials of TRA vs TFA Meta-analyses of RCT’s and Registry Data Bleeding and Transfusion in PCI Current status of Transradial Access RIVAL Trial Background Trials of TRA vs TFA Meta-analyses of RCT’s and Registry Data Bleeding and Transfusion in PCI Current status of Transradial Access RIVAL Trial

5. Why Do Transradial Access? Background  Transradial access originally initiated because of bleeding associated with PCI/Stenting  Radial artery is superficial  Radial artery is easily compressible  No critical structures in proximity  Most patients have dual arterial supply to hand Background  Transradial access originally initiated because of bleeding associated with PCI/Stenting  Radial artery is superficial  Radial artery is easily compressible  No critical structures in proximity  Most patients have dual arterial supply to hand

6. Why Do Transradial Access? Improve outcomes  Decrease complications? Bleeding Transfusion requirements  Improve procedural success? Short-term Long-term  Decrease costs? Improve patient satisfaction? Improve outcomes  Decrease complications? Bleeding Transfusion requirements  Improve procedural success? Short-term Long-term  Decrease costs? Improve patient satisfaction?

7. Why Do Transradial Access? Patients to Consider Any patient with normal Allen test Patients in particular to consider PVD Acute MI (particularly post lytic RX) Patients who require anticoagulation, GP IIbIIIa Abnormal BMI (high or low) Elderly Female Chronic renal insufficiency Patients who cannot lie flat (CHF,COPD, back problems) Patients to Consider Any patient with normal Allen test Patients in particular to consider PVD Acute MI (particularly post lytic RX) Patients who require anticoagulation, GP IIbIIIa Abnormal BMI (high or low) Elderly Female Chronic renal insufficiency Patients who cannot lie flat (CHF,COPD, back problems)

8. TRANSRADIAL ACCESS LOW ADOPTION RATE Technically more difficult  Radial Artery Access  Central Aorta Access  Coronary engagement  Different than Transfemoral Access Few fellowship teaching programs Steep Learning Curve  Low volume operators  High volume operators  Commitment to technique Technically more difficult  Radial Artery Access  Central Aorta Access  Coronary engagement  Different than Transfemoral Access Few fellowship teaching programs Steep Learning Curve  Low volume operators  High volume operators  Commitment to technique

9. TRANSRADIAL CATHETERIZATION Learning Curve Spaulding et al. Cathet Cardiovasc Diagn 39:365-70, 1996 Learning Curve Spaulding et al. Cathet Cardiovasc Diagn 39:365-70, 1996 <80 PATIENTS>80 PATEINTS Access Failure14%2% Access Time10.2±12.9 m±2.8±2.5 Procedure Time25.7±12.9 m17.4±4,7

10. TRANSRADIAL PTCA The Access Trial 900 patients randomized to radial, brachial or femoral access 1993-1995 6 F guiding catheters Heparin 5000u Stents 5.5% (Palmaz-Schatz) Primary EP’s access and PTCA related Secondary EP’s QCA, procedural and fluoro times, equipment consumption and LOS Kiemeneij et al. J Am Coll Cardiol 1997:1269-75 The Access Trial 900 patients randomized to radial, brachial or femoral access 1993-1995 6 F guiding catheters Heparin 5000u Stents 5.5% (Palmaz-Schatz) Primary EP’s access and PTCA related Secondary EP’s QCA, procedural and fluoro times, equipment consumption and LOS Kiemeneij et al. J Am Coll Cardiol 1997:1269-75

11. TRANSRADIAL PTCA The Access Trial Kiemeneij et al. J Am Coll Cardiol 1997; 29:1269-75 The Access Trial Kiemeneij et al. J Am Coll Cardiol 1997; 29:1269-75 Radial N=300 Brachial N=300 Femoral N=300 p value Successful access 93.0%95.7%99.7%0.001 PTCA Success 91.7%90.7% ns Access Compl 0%2.3%2.0%0.035 Time40±2439±2538±24ns

12. TRANSRADIAL CATHETERIZTION Stenting in ACS: A Comparison of Radial vs Femoral Access Sites Mann et al. J Am Coll Cardiol 1998; 32:572-76 Stenting in ACS: A Comparison of Radial vs Femoral Access Sites Mann et al. J Am Coll Cardiol 1998; 32:572-76 RADIAL n=68 FEMORAL n=77 p value 1° Success65 (96%)74 (96%)ns D/MI/CABG00ns Access site Comp03 (4%)p<0.01

13. TRANSRADIAL CATHETERIZTION Stenting in ACS: A Comparison of Radial vs Femoral Access Sites Mann et al. J Am Coll Cardiol 1998;323:572-76 Stenting in ACS: A Comparison of Radial vs Femoral Access Sites Mann et al. J Am Coll Cardiol 1998;323:572-76 RADIALFEMORALp Value Post op LOS1.42.3p<0.01 Hospital LOS3.04.5p<0.01 Total Charges20,47623,389p<0.01

14. STEMI (n=29)NSTEMI (n=12) Admit to Access T (min)15.6NA Access to FBI T (min)25.3NA Success %100 IRA% LAD240 CFX2442 RCA5258 GP IIbIIIa (%)8675 DAP RX (%)100 MLOS (days)3.92.8 Cathet and Cardiovasc Interv 57:167-71,2002

15. TRANSRADIAL APPROACH in AMI Prospective Consecutive PTCA in Two Centers Study Center A Study Center B RA (n=180)FA-P (n=889) RA(n=87)FA-M(n=58) AGE 60  14 63±1659±1460±12 Male80%76%91%84% Primary75.6%85.8%79.3%75.9% Rescue24.4%14.2%20.7%24.1% Anterior43.9%47.6%70.1%60.3% Louvard et al: Cath and CV Interventions 55:206-211, 2002

16. TRANSRADIAL APPROACH in AMI Prospective Consecutive PTCA in Two Centers Study Center A Study Center B RA (180)FA-P (889)RA (87)FA-M (58) RA to FA 2% 4% Success 98% 96% 98% Stent 89% (91%) 83% 81% Time (min) 45±42 43±32 67±25 68±221 Access NA 25±9 23±9 FBI NA 50±14 50±18 Louvard et al: Cath and CV Interventions 55:206-211, 2002

17. TRANSRADIAL APPROACH in AMI Prospective Consecutive PTCA in Two Centers Study Center A Study Center B RA (180)FA-P (889) pRA (87)FA-M (58) p V compl 0 2 NS 0 10 <0.01 V repair 0 0 NS 0 3 M bleed 0 2 NS 0 7 <0.05 Louvard et al: Cath and CV Interventions 55:206-211, 2002

18. RANDOMIZED COMPARISON OF TRANSRADIAL AND TRANFEMORAL APPROACHES IN OCTOGENARIANS RADIAL P VALUE FEMORAL Crossover11.7NS9.5 Angio Duration(min) 18.1  10.8 NS 16.4  10.8 Xray Duration(min) 6.1  4.8 0.001 4.4  3.4 PCI Success (%)96.8NS94.7 PCI Duration(min) 27.6  18.2 NS 33.3  23.2 Xray Duration(min) 9.9  8.3 NS 10.7  10.2 Primary EP (%)1.40.085.9(58.5% FCD) Hematoma >3cm(%)2.20.00411.4 Louvard et al Am J Cardiol 92:17L, 2003

19. Meta-Analysis of transfemoral vs transradial access for coronary procedures Twelve randomized trials 3224 patients Failure, access complication, MACE Meta-Analysis of transfemoral vs transradial access for coronary procedures Twelve randomized trials 3224 patients Failure, access complication, MACE Agostononi et al. J Am Coll Cardiol 2004;44:349-56

20. TRANRADIAL VS TRANSFEMORAL ACCESS Agostononi et al. J Am Coll Cardiol 2004;44:349-56

21. TRANRADIAL VS TRANSFEMORAL ACCESS Agostononi et al. J Am Coll Cardiol 2004;44:349-56 MACE

22. TRANRADIAL VS TRANSFEMORAL ACCESS Agostononi et al. J Am Coll Cardiol 2004;44:349-56 ENTRY SITE COMPLICATIONS

23. TRANRADIAL VS TRANSFEMORAL ACCESS Agostononi et al. J Am Coll Cardiol 2004;44:349-56 RISK OF PROCEDURAL FAILURE

24. TRANRADIAL VS TRANSFEMORAL ACCESS Conclusions  TRA is as safe as TFA  TRA eliminates access site complications  Lower overall procedure success rate Conclusions  TRA is as safe as TFA  TRA eliminates access site complications  Lower overall procedure success rate Agostononi et al. J Am Coll Cardiol 2004;44:349-56

25. BLEEDING AND PCI OUTCOMES Access site hematoma requiring blood transfusion predicts mortality in patients undergoing PCI: Data from the NHLBI Dynamic Registry 6652 Patients between 1997 and 2002 In hospital mortality among patients with HRT was 9 times higher than patients without HRT and by one year patients with HRT were 4.5 times more likely to die Access site hematoma requiring blood transfusion predicts mortality in patients undergoing PCI: Data from the NHLBI Dynamic Registry 6652 Patients between 1997 and 2002 In hospital mortality among patients with HRT was 9 times higher than patients without HRT and by one year patients with HRT were 4.5 times more likely to die Yatskaar L et al. Catheter Cardiovasc Interv 2007;69:961-6

26. FACTORNO (n=6536)YES (n=120)P value AGE63.170.7<0.001 WOMEN35.4%62.5%<0.001 BMI28.828.00.007 PRIOR MI33.4%41.9%0.05 CHF10.5%18.4%0.006 HTN65.0%78.3%0.003 CRI4.9%13.3%<0.001 PVD7.6%15.8%<0.001 CGS1.7%8.3%<0.001 LYTIC RX6.1%11.7%0.01 Catheter Cardiovasc Interv 2007;69:961-6

27. RISK FACTORSODDS RATIO95% CIP value AGE > 653.112.00-4.84<0.001 FEMALE2.711.84-3.98<0.001 IIb/IIIa1.531.05-2.22 0.027 PRIOR MI1.481.01-2.18 0.044 3 VD1.511.03-2.23 0.037 CGS2.501.13-5.51 0.023 LYTICS1.891.02-3.52 0.043 EMERGENCY2.221.36-3.64 0.002 CRI2.121.20-3.76 0.01 PVD1.661.15-6.12 0.05 Catheter Cardiovasc Interv 2007;69:961-6

28. OutcomeNo HRT HRTPt est95% CIP valuePt est95% CIP value Death IH1.29.909.324.93-17.63<0.0013.591.66-7.770.001 Death 1y4.718.84.462.83-7.02<0.0011.651.01-2.700.048 Incidence %Unadjusted AnalysisAdjusted Analysis _________________________________

29. Radial Artery Access Improving Outcomes and Decreasing Costs “…hospital savings were due primarily to a reduction in major bleeding.”

30. BLEEDING AND OUTCOMES WITH PCI IN ACS J Am Coll Cardiol 2007;49:1362-8

31. BLEEDING AND OUTCOMES WITH PCI IN ACS Manoukian, S. V. et al. J Am Coll Cardiol 2007;49:1362-1368 INDEPENDENT PREDICTORS OF MAJOR BLEEDING

32. BLEEDING AND OUTCOMES WITH PCI IN ACS Manoukian, S. V. et al. J Am Coll Cardiol 2007;49:1362-1368 INDEPENDENT PREDICTORS OF MORTALITY

33. BLEEDING AND OUTCOMES WITH PCI IN ACS Manoukian, S. V. et al. J Am Coll Cardiol 2007;49:1362-1368 MORTALITY AND MAJOR BLEEDING

34. BLEEDING AND OUTCOMES WITH PCI IN ACS Types of Major Bleeding by Treatment Group Manoukian, S. V. et al. J Am Coll Cardiol 2007;49:1362-1368

35. TRANSFUSION AND OUTCOMES WITH PCI IN ACS Nikolsky, E. et al. J Am Coll Cardiol Intv 2009;2:624-632

36. Kaplan-Meier Estimates of Adverse Events at 1 Year TRANSFUSION AND OUTCOMES WITH PCI IN ACS Death Reinfarction Stroke TVR MACE

37. Purported disadvantage with limitation in guide catheter size in TRA Complex PCI with rotational atherectomy, bifurcation stenting, LMCA stenting can all be accomplished with 6F guiding catheters New 5F long “guiding sheath” with virtual 7F lumen is now available But – is bigger better? Purported disadvantage with limitation in guide catheter size in TRA Complex PCI with rotational atherectomy, bifurcation stenting, LMCA stenting can all be accomplished with 6F guiding catheters New 5F long “guiding sheath” with virtual 7F lumen is now available But – is bigger better? TRANSRADIAL ACCESS AND GUIDING CATHETER SIZE

38. PCI COMPLICATIONS AND GUIDE CATHETER SIZE BIGGER IS NOT BETTER Evaluation association between guide catheter size and complications of PCI 103,070 consecutive patients 6F (n=64,335), 7F(n=32,676), 8F(n=6,059) Univariate and multivariate logistic regression modeling to calculate unadjusted and adjusted odds for complications Evaluation association between guide catheter size and complications of PCI 103,070 consecutive patients 6F (n=64,335), 7F(n=32,676), 8F(n=6,059) Univariate and multivariate logistic regression modeling to calculate unadjusted and adjusted odds for complications Grossman, P. M. et al. J Am Coll Cardiol Intv 2009;2:636-644

39. . 8F GUIDE USE

40. Grossman, P. M. et al. J Am Coll Cardiol Intv 2009;2:636-644 IN HOSPITAL OUTCOMES 8F VS 6F GUIDES

41. Grossman, P. M. et al. J Am Coll Cardiol Intv 2009;2:636-644 S STANDARDIZED MORTALITY RATE BASED ON GUIDE SIZE

42. Grossman, P. M. et al. J Am Coll Cardiol Intv 2009;2:636-644 TEMPORAL USE OF 6,7 AND 8F GUIDES

43. Association of the Arterial Access Site at Angioplasty with Transfusion and Mortality: the MORTAL Study (Mortality Benefit of Reduced Transfusion After Percutaneous Coronary Intervention via the Arm or Leg) Objective – To determine the association of arterial access site (radial or femoral) with transfusion and mortality in unselected patients Study Design: Retrospective, non-randomized analysis of three prospectively collated registries of 32,822 patients in British Columbia The association between access site, transfusion and outcomes assessed by logistic regression, propensity score matching and probit regression Objective – To determine the association of arterial access site (radial or femoral) with transfusion and mortality in unselected patients Study Design: Retrospective, non-randomized analysis of three prospectively collated registries of 32,822 patients in British Columbia The association between access site, transfusion and outcomes assessed by logistic regression, propensity score matching and probit regression Chase A J et al.Heart 2008;95:1019-1025

44. MORTAL STUDY Chase et al. Heart;94:1019-1025,2008

45. MORTAL STUDY Chase et al. Heart;94:1019-1025,2008 Predictors of 1-Year Mortality in the Mortal Study

46. MORTAL STUDY Chase et al. Heart;94:1019-1025,2008

47. MORTAL STUDY TransNo TransARRNNTRR95% CI 30 Day Mortality 7.7%2%5.7183.91.89-8.0 1 Year Mortality 19.3%5.7%12.57.43.382.22-5.14 914 Matched Patients p=0.96 Chase et al. Heart;94:1019-1025,2008

48. EFFECT of TRANSRADIAL ACCESS on QUALITY OF LIFE AND COST A RANDOMIZED COMPARISON Femoral (99)Radial (101)p Value Procedure Outcome Success % 98 99 NS Crossover % 1 2 NS Sheath insertion(m) 5.1±0.6 8.0±0.8 <0.01 Cath time (m) 16.4±1 18.6±0.9 NS Hemostasis time (m) 26.5÷2.3 4.7±0.6 <0.001 Total Proc time (m) 47.6±2,7 31.4±1.7 <0.001 Hospital stay (hrs) 10.4 (8.3,22.7) 3.6(3.0,4.6) <0.001 Complications% 0 0 NS Cooper et al. Am Heart J 138:430-436,1999

49. EFFECT of TRANSRADIAL ACCESS on QUALITY OF LIFE AND COST A RANDOMIZED COMPARISON Femoral (99)Radial (101)p Value Other Outcomes Costs (%) 2229 2010 <0.001 Patients Preference ++++ <0.001 Cooper et al. Am Heart J 138:430-436,1999

50. TRANSRADIAL CATHETERIZTION Stenting in ACS: A Comparison of Radial vs Femoral Access Sites Mann et al. J Am Coll Cardiol 1998;323:572-76 Stenting in ACS: A Comparison of Radial vs Femoral Access Sites Mann et al. J Am Coll Cardiol 1998;323:572-76 RADIALFEMORALp Value Post op LOS1.42.3p<0.01 Hospital LOS3.04.5p<0.01 Total Charges20,47623,389p<0.01

51. Radial Artery Access Improving Outcomes and Decreasing Costs “…hospital savings were due primarily to a reduction in major bleeding.”

52. Vascular Access Site Complication and Costs Caputo. J of Invasive Cardiol 21 Suppl;21:18-20

53. Conclusion: …same-day discharge after uncomplicated transradial coronary stenting and bolus only of abciximab is not clinically inferior, in a wide spectrum of patients, to the standard overnight hospitalization and a bolus followed by a 12-hour infusion. This novel approach offers a safe strategy for same-day discharge after uncomplicated coronary intervention. Conclusion: …same-day discharge after uncomplicated transradial coronary stenting and bolus only of abciximab is not clinically inferior, in a wide spectrum of patients, to the standard overnight hospitalization and a bolus followed by a 12-hour infusion. This novel approach offers a safe strategy for same-day discharge after uncomplicated coronary intervention. Bertrand et al. Circulation. 2006;114:2436-2643

55. Rao, S. V. et al. J Am Coll Cardiol Intv 2008;1:379-386 Proportion of PCI Cases Performed Via TRA

56. TRENDS IN TRANSRADIAL PCI Rao et al. J. Am. Coll. Cardiol. Intv:2008; 1:379-383

57. UNADJUSTED OUTCOMES Rao et al. J. Am. Coll. Cardiol. Intv:2008; 1:379-383

58. UNADJUSTED RATES OF BLEEDING & VASCULAR COMPLICATIONS IN KEY SUB-GROUPS Rao et al. J. Am. Coll. Cardiol. Intv:2008; 1:379-383 AGE Gender ACS and STEMI

59. Effect of Age, Gender,and Indication on Association of r-PCI Success and Bleeding Complications Rao et al. J. Am. Coll. Cardiol. Intv:2008; 1:379-383

60. Unadjusted and Adjusted Association Between PCI and Primary Outcomes (f PCI as Reference) Rao et al. J. Am. Coll. Cardiol. Intv:2008; 1:379-383 OutcomeUnadjusted Odds Ratio (95% CI) Adjusted Odds Ratio (95% CI) Procedural Success1.09 (0.97-1.23)0.92 (1.02-1.12) Any Bleeding Comp0.38 (0.26-.0.54)0.42 (0.31-0.56)

61. CONCLUSIONS Radial PCI….is infrequently used…but is associated with a rate of procedural success similar to the femoral approach with lower rates of bleeding and vascular complications These findings were present even among patients at high risk for PCI-related complications such as elderly patients, women and patients with ACS. These data, in the context of prior clinical trials, suggest that wider adoption of radial PCI in clinical practice may improve the safety of PCI Radial PCI….is infrequently used…but is associated with a rate of procedural success similar to the femoral approach with lower rates of bleeding and vascular complications These findings were present even among patients at high risk for PCI-related complications such as elderly patients, women and patients with ACS. These data, in the context of prior clinical trials, suggest that wider adoption of radial PCI in clinical practice may improve the safety of PCI Rao et al. J. Am. Coll. Cardiol. Intv:2008; 1:379-383

62. RIVAL Trial Radial vs Femoral Access for Coronary Angiography and Intervention in Patients with ACS: A Randomized, Parallel Group Multicenter Trial Jolly et al,The Lancet;377;1409-20,2011 7000 Pts 3500 Pts

63. RIVAL TRIAL Jolly et al,The Lancet;377;1409-20,2011

64. RIVAL TRIAL Jolly et al,The Lancet;377;1409-20,2011

65. RIVAL TRIAL Jolly et al,The Lancet;377;1409-20,2011 Prespecificed Sub-Group Analysis Radial PCI volume/center STEMI

66. RIVAL TRIAL Jolly et al,The Lancet;377;1409-20,2011 Outcomes by Center’s Radial PCI Volume Primary Outcome MVC Access Crossover

67. RIVAL TRIAL Jolly et al,The Lancet;377;1409-20,2011 Outcomes by STEMI vs NSTE-ACS DEATH PRIMARY OUTCOME – CLINICAL DX DEATH, MI OR CVA CLINICAL DX MVC ACCESS SITE CROSSOVER

68. RIVAL TRIAL CONCLUSIONS In pts with ACS undergoing coronary angiography, RA access did not reduce the primary outcome (D,MI,CVA or non-CABG related major bleeding) compared to FA TRA significantly reduced vascular access complications compared to TFA with similar success rates and was more commonly preferred by pts for subsequent procedures TRA was beneficial compared to TFA at high volume TRA centers. TFA was not superior to TRA at high volume TFA centers Among pts with STEMI, TRA particularly by experienced operators, reduced the primary outcome as well as the individual components of the primary outcome The effectiveness of TRA appears to be related to expertise and volume In pts with ACS undergoing coronary angiography, RA access did not reduce the primary outcome (D,MI,CVA or non-CABG related major bleeding) compared to FA TRA significantly reduced vascular access complications compared to TFA with similar success rates and was more commonly preferred by pts for subsequent procedures TRA was beneficial compared to TFA at high volume TRA centers. TFA was not superior to TRA at high volume TFA centers Among pts with STEMI, TRA particularly by experienced operators, reduced the primary outcome as well as the individual components of the primary outcome The effectiveness of TRA appears to be related to expertise and volume

69. BLEEDING/TRANSFUSION AND ADVERSE OUTCOMES IN PCI Potential Mechanisms  Hemodynamic compromise  Induction of hyperadrenergic state  Induction of inflammatory state  Cessation of anti-thrombotic/anti-platelet agents  Altered characteristics of older banked blood such as reduced O2 delivery, NO depletion, or stimulation of vasoconstriction  Is it bleeding per se, transfusion per se (or Tx only a confounder), or the combination that results in increased mortality? Potential Mechanisms  Hemodynamic compromise  Induction of hyperadrenergic state  Induction of inflammatory state  Cessation of anti-thrombotic/anti-platelet agents  Altered characteristics of older banked blood such as reduced O2 delivery, NO depletion, or stimulation of vasoconstriction  Is it bleeding per se, transfusion per se (or Tx only a confounder), or the combination that results in increased mortality?

70. TRANSRADIAL CATHETERIZATION Complications  Radial artery occlusion 1-9% (heparin dose and pulse oximetry monitoring) of no consequence  Severe hematoma - very rare  Compartment syndrome - very rare – unsuspected guidewire perforation  Hand ischemia (should not occur with normal Allen Test) Complications  Radial artery occlusion 1-9% (heparin dose and pulse oximetry monitoring) of no consequence  Severe hematoma - very rare  Compartment syndrome - very rare – unsuspected guidewire perforation  Hand ischemia (should not occur with normal Allen Test)

71. TRANSRADIAL CATHETERIZATION Patients to Avoid Raynaud’s disease Buerger’s disease Patients who will need dialysis and AV fistula Small patient with small artery despite normal Allen test Patients to Avoid Raynaud’s disease Buerger’s disease Patients who will need dialysis and AV fistula Small patient with small artery despite normal Allen test

72. TRANSRADIAL ACCESS TR Access Advantage Decreased Complications Decreased Transfusion Decreased Mortality DecreasedCosts OP PCI Patient satisfaction TR Access Advantage Decreased Complications Decreased Transfusion Decreased Mortality DecreasedCosts OP PCI Patient satisfaction TR Access Disadvantage Steep learning curve Technically more difficult Increased radiation Decreased success

73. Improve outcomes – Yes  Decrease complications – Yes Decrease access site bleeding Decrease transfusion requirement  ImproveProcedural Success – Yes Short-term Long-term Decrease costs - Yes Improve patient satisfaction - Yes Improve outcomes – Yes  Decrease complications – Yes Decrease access site bleeding Decrease transfusion requirement  ImproveProcedural Success – Yes Short-term Long-term Decrease costs - Yes Improve patient satisfaction - Yes Why Do Transradial Access

74. DO YOU AND YOUR PATIENT PREFER THIS TRAIN GET ON THE TRANSRADIAL EXPRESS

75. THANK YOU

76. TRANSRADIAL ACCESS Dr. L. Yogi Berra “Just remember, it’s not over ‘til it’s over” The PCI is not over with the successful delivery of the stent The successful PCI is over when the patient leaves the hospital with a good angiographic result and no early or late complication Dr. L. Yogi Berra “Just remember, it’s not over ‘til it’s over” The PCI is not over with the successful delivery of the stent The successful PCI is over when the patient leaves the hospital with a good angiographic result and no early or late complication

78. TRANSRADIAL VS SMD POST PTCA Systematic Use of Transradial Approach or Suture of the Femoral Artery After Angioplasty: Attempt at Achieving Zero Access Site Complications 956 patients (60.7% SMC and 39.3% Transradial) Transradial – 0% complications 580 pts SMC group – 96.9% had SMC, immediately effective in 508 (90.4%) with only 3 pts requiring prolonged compression Significant hematoma (0.2%) requiring Tx in SMC group Infection at puncture site in 2 pts (0.3%) rx’ed with AB’s “After the completion of the learning curve, the two techniques (radial and SMC) permit the almost total elimination of access site complications” Morice et al. Cathet. And Cardiovasc. Intervent.2000;51417-421 Systematic Use of Transradial Approach or Suture of the Femoral Artery After Angioplasty: Attempt at Achieving Zero Access Site Complications 956 patients (60.7% SMC and 39.3% Transradial) Transradial – 0% complications 580 pts SMC group – 96.9% had SMC, immediately effective in 508 (90.4%) with only 3 pts requiring prolonged compression Significant hematoma (0.2%) requiring Tx in SMC group Infection at puncture site in 2 pts (0.3%) rx’ed with AB’s “After the completion of the learning curve, the two techniques (radial and SMC) permit the almost total elimination of access site complications” Morice et al. Cathet. And Cardiovasc. Intervent.2000;51417-421

79. TRANSRADIAL APPROACH in AMI Feasibility of Transradial Access for Coronary Intervention in Patients with Acute MI 31 Consecutive patients (20 ST , 11 non ST  ) Age 39-80 years old, 68% male Mean time from admission to lab to access 12.6 min Mean time from access to FBI 25.3 min Successful procedure - 100% Major or minor complication 2° access site - 0% Discharge within 3 days -87%, longer LOS not related to catheterization procedure Mulukutla SR, Cohen HA. Cath and CV Interv 2002; 57:167-171 Feasibility of Transradial Access for Coronary Intervention in Patients with Acute MI 31 Consecutive patients (20 ST , 11 non ST  ) Age 39-80 years old, 68% male Mean time from admission to lab to access 12.6 min Mean time from access to FBI 25.3 min Successful procedure - 100% Major or minor complication 2° access site - 0% Discharge within 3 days -87%, longer LOS not related to catheterization procedure Mulukutla SR, Cohen HA. Cath and CV Interv 2002; 57:167-171

80. BLEEDING AND PCI OUTCOMES Relationship of Blood Transfusion and Clinical Outcomes in Patients with ACS  24,112 patients in 3 large international trials (Gusto IIb, PURSUIT, and Paragon B)  Patients grouped according to transfusion status during hospitalization  Blood transfusion in ACS is associated with higher mortality and this relationship persists after adjustment for other predictive factors and timing of events – independent of bleeding and hematocrit nadir Relationship of Blood Transfusion and Clinical Outcomes in Patients with ACS  24,112 patients in 3 large international trials (Gusto IIb, PURSUIT, and Paragon B)  Patients grouped according to transfusion status during hospitalization  Blood transfusion in ACS is associated with higher mortality and this relationship persists after adjustment for other predictive factors and timing of events – independent of bleeding and hematocrit nadir Rao et al. JAMA 2004;292:1555-62

82. . Cohen, D. J. et al. J Am Coll Cardiol 2004;44:1792-1800 Stratified analyses of aggregate 30-day costs by treatment group according to prespecified patient characteristics

83. TRENDS IN TRANSRADIAL PCI Rao et al. J. Am. Coll. Cardiol. Intv:2008; 1:379-383

84. UNADJUSTED OUTCOMES Rao et al. J. Am. Coll. Cardiol. Intv:2008; 1:379-383

85. TRANSRADIAL APPROACH in AMI Prospective Consecutive PTCA in Two Centers Study Center A Study Center B RA (n=180) FA-P (n=889) RA(n=87) FA-M(n=58) Age 60  1463  16 59  14 60  12 Male 80%76% 91% 84% Primary 75.6%85.8% 79.3% 75.9% Rescue 24.4%14.2% 20.7% 24.1% Anterior 43.9% 47.6% 70.1% 60.3% Louvard et al: Cath and CV Interventions 55:206-211, 2002 Study Center A Study Center B RA (n=180) FA-P (n=889) RA(n=87) FA-M(n=58) Age 60  1463  16 59  14 60  12 Male 80%76% 91% 84% Primary 75.6%85.8% 79.3% 75.9% Rescue 24.4%14.2% 20.7% 24.1% Anterior 43.9% 47.6% 70.1% 60.3% Louvard et al: Cath and CV Interventions 55:206-211, 2002

86. TRANSRADIAL APPROACH in AMI Prospective Consecutive PTCA in Two Centers Study Center A Study Center B RA (n=180) FA-P (n=889) RA(n=87) FA-M(n=58) RA to FA(%)2 4 Access(%)2 2 Spasm(%)0 2 Success (%) 98 97 96 98 Stent (%) 89 91 83 81 Time 45  42 43  32 67  25 68±21 Access NA NA 25  9 23  9 FBI NA NA 50  14 50  18 Louvard et al: Cath and CV Interventions 55:206-211, 2002 Study Center A Study Center B RA (n=180) FA-P (n=889) RA(n=87) FA-M(n=58) RA to FA(%)2 4 Access(%)2 2 Spasm(%)0 2 Success (%) 98 97 96 98 Stent (%) 89 91 83 81 Time 45  42 43  32 67  25 68±21 Access NA NA 25  9 23  9 FBI NA NA 50  14 50  18 Louvard et al: Cath and CV Interventions 55:206-211, 2002

87. TRANSRADIAL APPROACH in AMI Prospective Consecutive PTCA in Two Centers Study Center A Study Center B RA (n=180) FA-P (n-889) p RA(n=87) FA-M(n=58) p Local Comp 02 NS 0 10 <0.01 v repair 00 NS0 3 NS M bleed 02 NS0 7 <0.05 Louvard et al: Cath and CV Interventions 55:206-211, 2002 Study Center A Study Center B RA (n=180) FA-P (n-889) p RA(n=87) FA-M(n=58) p Local Comp 02 NS 0 10 <0.01 v repair 00 NS0 3 NS M bleed 02 NS0 7 <0.05 Louvard et al: Cath and CV Interventions 55:206-211, 2002

88. EFFECT of TRANSRADIAL ACCESS on QUALITY OF LIFE AND COST A RANDOMIZED COMPARISON FemoralRadialp Value (n=99)(n=101) Procedure Outcome Success9899 ns Crossover12 ns Sheath Insertion (min)5.1  0.68  0.8<0.01 Cath time(min)16.4  118.6  0.9 ns Hemostasis time(min)26.5  2.34.7  0.6<0.001 Total Procedure (min)47.6  2.731.4  1.7<0.001 Hospital stay (hours)10.4(8.3,22.7)3.6(3.0,4.6)<0.001 Complications ns Cooper et al. Am Heart J 138:430-436,1999 FemoralRadialp Value (n=99)(n=101) Procedure Outcome Success9899 ns Crossover12 ns Sheath Insertion (min)5.1  0.68  0.8<0.01 Cath time(min)16.4  118.6  0.9 ns Hemostasis time(min)26.5  2.34.7  0.6<0.001 Total Procedure (min)47.6  2.731.4  1.7<0.001 Hospital stay (hours)10.4(8.3,22.7)3.6(3.0,4.6)<0.001 Complications ns Cooper et al. Am Heart J 138:430-436,1999

89. EFFECT of TRANSRADIAL ACCESS on QUALITY OF LIFE AND COST A RANDOMIZED COMPARISON FemoralRadialp Value (n=99)(n=101) Procedure Outcome Success9899 ns Crossover12 ns Sheath Insertion (min)5.1  0.68  0.8<0.01 Cath time(min)16.4  118.6  0.9 ns Hemostasis time(min)26.5  2.34.7  0.6<0.001 Total Procedure (min)47.6  2.731.4  1.7<0.001 Hospital stay (hours)10.4(8.3,22.7)3.6(3.0,4.6)<0.001 Complications ns Cooper et al. Am Heart J 138:430-436,1999 FemoralRadialp Value (n=99)(n=101) Procedure Outcome Success9899 ns Crossover12 ns Sheath Insertion (min)5.1  0.68  0.8<0.01 Cath time(min)16.4  118.6  0.9 ns Hemostasis time(min)26.5  2.34.7  0.6<0.001 Total Procedure (min)47.6  2.731.4  1.7<0.001 Hospital stay (hours)10.4(8.3,22.7)3.6(3.0,4.6)<0.001 Complications ns Cooper et al. Am Heart J 138:430-436,1999

90. EFFECT of TRANSRADIAL ACCESS on QUALITY OF LIFE AND COST A RANDOMIZED COMPARISON FemoralRadialp Value (n=99)(n=101) Other Outcomes Costs ($)22292010<0.001 Patient preference++++<0.001 Cooper et al. Am Heart J 138:430-436,1999 FemoralRadialp Value (n=99)(n=101) Other Outcomes Costs ($)22292010<0.001 Patient preference++++<0.001 Cooper et al. Am Heart J 138:430-436,1999

91. PREVAIL STUDY Prospective observational study involving nine centers and 1052 patients All consecutive patients who underwent an invasive procedure Arterial access site and technique employed was made by individual practitioner according to usual practice Multivariate analysis adjusted with propensity score Prospective observational study involving nine centers and 1052 patients All consecutive patients who underwent an invasive procedure Arterial access site and technique employed was made by individual practitioner according to usual practice Multivariate analysis adjusted with propensity score Pristipino et al. Heart:2009;95:476-82

92. PREVAIL STUDY Overall (1052)Femoral (543)Radial (509)P Value Male gender71%66%75%<0.002 Prior radial 9% 4%14%<0.0001 Prior PCI20%17%24%<0.01 Chronic SAP35%28%42%<0.0001 ACS31%35%28%<0.01 Sheath size F5.96.15.7<0.0001 Heparin IU495042705650<0.0001 GP II IIIa RA12% 8%15%<0.002 Pristipino et al. Heart:2009;95:476-82

93. Major Improvement of PCI Outcomes with Radial Artery Access from the Prevail Study Pristipino et al. Heart:2009;95:476-82

94. Major Improvement of PCI Outcomes with Radial Artery Access from the Prevail Study Pristipino et al. Heart:2009;95:476-82 Stable ACS

95. Major Improvement of PCI Outcomes with Radial Artery Access from the Prevail Study Pristipino et al. Heart:2009;95:476-82 Adjusted Multivariate Analysis

96. PREVAIL STUDY 86% Reduction in clinical and procedural adjusted risk of in-hospital death or infarction/reinfarction in patients undergoing PCI by the radial approach (based on intention- to-treat) Confirmed by multivariate analysis and propensity adjustment Highest baseline risk patients (ACS,STEMI) contributed mostly to the outcome benefit by the radial approach suggests that baseline bias is less relevant in this study 86% Reduction in clinical and procedural adjusted risk of in-hospital death or infarction/reinfarction in patients undergoing PCI by the radial approach (based on intention- to-treat) Confirmed by multivariate analysis and propensity adjustment Highest baseline risk patients (ACS,STEMI) contributed mostly to the outcome benefit by the radial approach suggests that baseline bias is less relevant in this study

97. TRANSRADIAL ACCESS Just remember, “it’s not over until the fat lady (your patient) sings” But is she singing your praises or the “blues” The “black and blues” Try radial access. Try it you’ll like it! Your patients will love it!!! Just remember, “it’s not over until the fat lady (your patient) sings” But is she singing your praises or the “blues” The “black and blues” Try radial access. Try it you’ll like it! Your patients will love it!!!

98. RANDOMIZED COMPARISON OF TRANSRADIAL AND TRANFEMORAL APPROACHES IN OCTAGENARIANS RADIALP VALUEFEMORAL Crossover11.7NS9.5 Angio Duration(min) 18.1  10.8 NS 16.4  10.8 Xray Duration(min) 6.1  4.8 0.001 4.4  3.4 PCI Success (%)96.8NS94.7 PCI Duration(min) 27.6  18.2 NS 33.3  23.2 Xray Duration(min) 9.9  8.3 NS 10.7  10.2 Primary EP (%)1.40.085.9(58.5% FCD) Hematoma >3cm(%)2.20.00411.4 Louvard et al Am J Cardiol 92:17L, 2003