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Advances in trans-radial interventions Sotirios Patsilinakos Cardiology Department Konstantopoulio, Athens, Greece

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Page 1: Advances in trans-radial interventionsstatic.livemedia.gr/hcs2/documents/us89_20131216095050_patsilinakos.pdfof Radial vs. Femoral (N=7030) Radial better 1.0 Femoral better PCI Procedure

Advances in trans-radial

interventions

Sotirios Patsilinakos

Cardiology Department

Konstantopoulio, Athens, Greece

Page 2: Advances in trans-radial interventionsstatic.livemedia.gr/hcs2/documents/us89_20131216095050_patsilinakos.pdfof Radial vs. Femoral (N=7030) Radial better 1.0 Femoral better PCI Procedure
Page 3: Advances in trans-radial interventionsstatic.livemedia.gr/hcs2/documents/us89_20131216095050_patsilinakos.pdfof Radial vs. Femoral (N=7030) Radial better 1.0 Femoral better PCI Procedure

Impact of Major Bleed and MI after Elective and Urgent PCI

Stone GW. J Inv Cardiol 2004;16(suppl G):12–17.

Time from Randomization in Days

Cu

mu

lative

% M

ort

alit

y

With MI 5.7%

Without major bleed 2.0%

Without MI 1.9%

With major bleed 8.8%

1-Year Mortality (N=6,012)

Page 4: Advances in trans-radial interventionsstatic.livemedia.gr/hcs2/documents/us89_20131216095050_patsilinakos.pdfof Radial vs. Femoral (N=7030) Radial better 1.0 Femoral better PCI Procedure

R I V A L 30-Day Death According to Bleeding

OASIS Registry, OASIS-2, CURE

J Eikelboom et al Circulation 2006

02

46

81

01

21

4

0 5 10 15 20 25 30

Bleeding

No Bleeding

No. at Risk

No Bleeding

Bleeding

33676 33419 33157 32990 32879 32769 32710

470 (1.4%)

459 440 430 420 410 408

Cum

ula

tive E

vents

, %

Days

Page 5: Advances in trans-radial interventionsstatic.livemedia.gr/hcs2/documents/us89_20131216095050_patsilinakos.pdfof Radial vs. Femoral (N=7030) Radial better 1.0 Femoral better PCI Procedure

R I V A L Bleeding is Associated with an Increased

30-Day Mortality in NSTEMI Patients

Rao et al. Am J Cardiol 2005;96:1200-1206

N=26,452 ACS patients from

GUSTO IIb, PURSUIT and PARAGON A & B

Log-rank p values are 0.0001 for all 4 categories, 0.20 for no bleeding vs. mild bleeding, 0.0001 for

mild vs. moderate bleeding, and 0.001 for moderate vs. severe bleeding.

Adjusted HR

(95% CI)

% Death

2.9% 1.0

3.5% 1.6 (1.3-1.9)

5.9% 2.7 (2.3-3.4)

25.7% 10.6 (8.3-13.6)

GUSTO bleeding None Mild Moderate Severe

0 5 10 15 20 25 30

0.70

0.75

0.80

0.85

0.90

0.95

1.00

Days to Death

Cu

mu

lative

su

rviv

al

Page 6: Advances in trans-radial interventionsstatic.livemedia.gr/hcs2/documents/us89_20131216095050_patsilinakos.pdfof Radial vs. Femoral (N=7030) Radial better 1.0 Femoral better PCI Procedure

R I V A L

Bleeding is associated with

Death and Ischemic Events

Eikelboom JW et al. Circulation 2006;114(8):774-82.

HR 5.37 (3.97-7.26)

HR 4.44 (3.16-6.24)

HR 6.46 (3.54-11.79)

N=34,146

OASIS Registry,

OASIS 2, CURE trials

Page 7: Advances in trans-radial interventionsstatic.livemedia.gr/hcs2/documents/us89_20131216095050_patsilinakos.pdfof Radial vs. Femoral (N=7030) Radial better 1.0 Femoral better PCI Procedure

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

Page 8: Advances in trans-radial interventionsstatic.livemedia.gr/hcs2/documents/us89_20131216095050_patsilinakos.pdfof Radial vs. Femoral (N=7030) Radial better 1.0 Femoral better PCI Procedure

Bleeding Within 30 Days is a Powerful and Independent Predictor of 1-year Death After PCI

Ndrepepa G. JACC 2008;51:690-7 * Calculated for a 10-year increase in age.

5,384 patients from 4 RCT on the value of abciximab after pretreatment with

600 mg of clopidogrel: ISAR-REACT, SWEET, SMART-2 and REACT-2

“Our study demonstrates a strong relationship between the 30-day frequency of bleeding

and 1-year mortality after PCI and supports the inclusion of periprocedural bleeding in a

30-day quadruple endpoint for the assessment of outcome after PCI.”

Variable Hazard Ratio (95% CI) P Value

Bleeding within 30 days 2.96(1.96-4.48) <0.001

Myocardial infarction within 30 days 2.29(1.52-3.46) <0.001

Urgent revascularization within 30 days 2.49(1.16-5.35) 0.019

Age (years)* 2.27(1.78-2.89) <0.001

Diabetes 1.47(1.11-1.96) 0.008

Multivessel coronary disease 2.72(1.56-4.67) <0.001

Elevated troponin 1.77(1.27-2.47) <0.001

Left ventricular ejection fraction 0.71(0.60-0.85) <0.001

Creatinine level 1.10(1.06-1.14) <0.001

Page 9: Advances in trans-radial interventionsstatic.livemedia.gr/hcs2/documents/us89_20131216095050_patsilinakos.pdfof Radial vs. Femoral (N=7030) Radial better 1.0 Femoral better PCI Procedure

Bleeding Within 30 Days is a Powerful and Independent Predictor of 1-year Death After PCI

Ndrepepa G. JACC 2008;51:690-7 * Calculated for a 10-year increase in age.

5,384 patients from 4 RCT on the value of abciximab after pretreatment with

600 mg of clopidogrel: ISAR-REACT, SWEET, SMART-2 and REACT-2

“Our study demonstrates a strong relationship between the 30-day frequency of bleeding

and 1-year mortality after PCI and supports the inclusion of periprocedural bleeding in a

30-day quadruple endpoint for the assessment of outcome after PCI.”

Variable Hazard Ratio (95% CI) P Value

Bleeding within 30 days 2.96(1.96-4.48) <0.001

Myocardial infarction within 30 days 2.29(1.52-3.46) <0.001

Urgent revascularization within 30 days 2.49(1.16-5.35) 0.019

Age (years)* 2.27(1.78-2.89) <0.001

Diabetes 1.47(1.11-1.96) 0.008

Multivessel coronary disease 2.72(1.56-4.67) <0.001

Elevated troponin 1.77(1.27-2.47) <0.001

Left ventricular ejection fraction 0.71(0.60-0.85) <0.001

Creatinine level 1.10(1.06-1.14) <0.001

Page 10: Advances in trans-radial interventionsstatic.livemedia.gr/hcs2/documents/us89_20131216095050_patsilinakos.pdfof Radial vs. Femoral (N=7030) Radial better 1.0 Femoral better PCI Procedure

R I V A LBlood Transfusion is Associated with

an Increased 30-Day Mortality in NSTEMI

Rao et al. JAMA 2004;292:1555-62

N=24,112 ACS patients from GUSTO IIb, PURSUIT and PARAGON

*Adjusted for baseline characteristics, bleeding and transfusion propensity and nadir hematocrit

HR=3.94*;

95%CI: 3.26 to 4.75

30-day

death rate

Transfusion

No Transfusion

Cum

ula

tive m

ort

alit

y

Log-rank p<0.001

0

0.02

0.04

0.06

0.08

0.10

5 10 15 20 25 30

Day

8.00%

3.08%

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The landmark message from these and other

studies, which was incorporated into the 2007

NSTEACS Guidelines, is that prevention of

bleeding MUST be regarded at least as important

as the prevention of major ischemic events, such as

myocardial infarction.

Major bleeding (with or without blood product transfusions) has emerged as a powerful independent predictor of early and late mortality in pts with NSTEMI, STEMI and is at

least as important as MI and myocardial

reinfarction

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ACCESS Study

Radial Brachial Femoral p

Approach failure (%) 7 4.3 0.3 <0.001

Procedural success (%) 91.7 90.7 90.7 NS

Equipment:

Guiding cath. (n) 1.3 1.3 1.3 NS

Balloons (n) 1.3 1.3 1.3 NS

Stenting (%) 4.7 7 4.7 NS

Procedural time (Min) 40+24 39+25 38+24 NS

Fluoro. Time (Min 13+11 12+10 11+10 0.06

Hospital stay (days) 1.5+2.5 1.8+3.8 1.8+4.2 NS

Kiemeneij JACC 1997;29:1269-75

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R I V A L

Prior Meta-analysis of 23 RCTs

of Radial vs. Femoral (N=7030)

Radial better Femoral better1.0

PCI Procedure Failure

Death

Death, MI or stroke

Major bleeding

1.31 (0.87-1.96)

0.74 (0.42-1.30)

0.71 (0.49-1.01)

0.27 (0.16-0.45)

Jolly SS, et al. Am Heart J 2009;157:132-40.

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Bleeding is an independent predictor of outcome

Reducing bleeding improves outcome

The Therapeutic Hypothesis in the Radial World

Page 15: Advances in trans-radial interventionsstatic.livemedia.gr/hcs2/documents/us89_20131216095050_patsilinakos.pdfof Radial vs. Femoral (N=7030) Radial better 1.0 Femoral better PCI Procedure

R I V A LOCTOPLUS: Primary endpoint, Intention to treat analysis

Femoral Radial p value

n= 185 192

Vasc. Surgery (%) 0 0.5 ns

Transfusion (%) 1.6 1.0 ns

Hb drop > 3g/DL (%) 3.8 0.5 0.063

False aneurysm compression (%) 1.1 0.5 ns

Arm or leg ischemia (%) 0 0 ns

Forearm compartment syndrom (%) 0 0 ns

Large hematoma* (%) 6.5 1.6 0.031

COMPOSITE END-POINT $ (%) 6.5 1.6 0.029

Hematoma (%) 11.4 3.5 0.003

CVA (%) 0.6 0 Ns

$ surgery, transfusion, Hb loss>3g/100ml-Ht loss>10%, ischemia, FA, vasc.

Complic. leading to discharge delay *Large hematoma: discharge delay

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Page 19: Advances in trans-radial interventionsstatic.livemedia.gr/hcs2/documents/us89_20131216095050_patsilinakos.pdfof Radial vs. Femoral (N=7030) Radial better 1.0 Femoral better PCI Procedure

R I V A L

NSTE-ACS and STEMI(n=7021)

Radial Access(n=3507)

Femoral Access(n=3514)

Primary Outcome: Death, MI, stroke or non-CABG-related Major Bleeding at 30 days

Randomization

RIVAL Study Design

Key Inclusion:

• Intact dual circulation of hand required

• Interventionalist experienced with both (minimum 50 radial

procedures in last year)

Jolly SS et al. Am Heart J. 2011;161:254-60.

Blinded Adjudication of Outcomes

Page 20: Advances in trans-radial interventionsstatic.livemedia.gr/hcs2/documents/us89_20131216095050_patsilinakos.pdfof Radial vs. Femoral (N=7030) Radial better 1.0 Femoral better PCI Procedure

R I V A L

Operator Volume

Procedure Characteristics

Radial (n=3507)

Femoral (n=3514)

HR (95% CI)P

value

Operator Annual Volume

PCI/year (median, IQR)

300 (190, 400)

300 (190,400)

Percent Radial PCI(median, IQR)

40 (25,70)

40(25, 70)

PCI Success 95.4 95.2 1.01 (0.95-1.07) 0.83

• Vascular closure devices used in 26% of Femoral group

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R I V A L

Other Outcomes

Radial(n=3507)

%

Femoral(n=3514)

%HR 95% CI P

Major Vascular Access Site Complications

1.4 3.7 0.37 0.27-0.52 <0.0001

Other Definitions of Major Bleeding

TIMI Non-CABG Major Bleeding

0.5 0.5 1.00 0.53-1.89 1.00

ACUITY Non-CABG Major Bleeding*

1.9 4.5 0.43 0.32-0.57 <0.0001

* Post Hoc analysis

Page 22: Advances in trans-radial interventionsstatic.livemedia.gr/hcs2/documents/us89_20131216095050_patsilinakos.pdfof Radial vs. Femoral (N=7030) Radial better 1.0 Femoral better PCI Procedure

R I V A L

Other Outcomes

Radial(n=3507)

%

Femoral (n=3514)

%HR 95% CI P

Death 1.3 1.5 0.86 0.58-1.29 0.47

MI 1.7 1.9 0.92 0.65-1.31 0.65

Stroke 0.6 0.4 1.43 0.72-2.83 0.30

Stent Thrombosis 0.7 1.2 0.63 0.34-1.17 0.14

Page 23: Advances in trans-radial interventionsstatic.livemedia.gr/hcs2/documents/us89_20131216095050_patsilinakos.pdfof Radial vs. Femoral (N=7030) Radial better 1.0 Femoral better PCI Procedure

R I V A L

Other Outcomes

Radial(n=3507)

Femoral (n=3514)

P

Access site Cross-over (%) 7.6 2.0 <0.0001

PCI Procedure duration (min) 35 34 0.62

Fluoroscopy time (min) 9.3 8.0 <0.0001

Persistent pain at access site >2 weeks (%)

2.6 3.1 0.22

Patient prefers assigned access site for next procedure (%)

90 49 <0.0001

• Symptomatic radial occlusion requiring medical attention 0.2% in radial group

Page 24: Advances in trans-radial interventionsstatic.livemedia.gr/hcs2/documents/us89_20131216095050_patsilinakos.pdfof Radial vs. Femoral (N=7030) Radial better 1.0 Femoral better PCI Procedure

Death, MI, Stroke or non-CABG major Bleed

Subgroups: Primary OutcomeR I V A L

0.251.00 4.00

Radial better Femoral better

Hazard Ratio (95% CI)

<75≥75

FemaleMale

<2525-35>35

≤70

70-142.5>142.5

Lowest TertileMiddle TertileHighest Tertile

NSTE-ACSSTEMI

Age

Gender

BMI

Radial PCI Volume by Operator

Radial PCI Volume by Centre

Diagnosis at presentation

Overall

0.786

0.356

0.637

0.536

0.021

0.025

Interactionp-value

Page 25: Advances in trans-radial interventionsstatic.livemedia.gr/hcs2/documents/us89_20131216095050_patsilinakos.pdfof Radial vs. Femoral (N=7030) Radial better 1.0 Femoral better PCI Procedure

R I V A L

Conclusion

No significant difference between radial and

femoral access in primary outcome of death, MI,

stroke or non-CABG major bleeding

Rates of primary outcome appeared to be lower

with radial compared to femoral access in high

volume radial centres and STEMI

Radial had fewer major vascular complications with

similar PCI success

Page 26: Advances in trans-radial interventionsstatic.livemedia.gr/hcs2/documents/us89_20131216095050_patsilinakos.pdfof Radial vs. Femoral (N=7030) Radial better 1.0 Femoral better PCI Procedure

R I V A L

Conclusion

No significant difference between radial and

femoral access in primary outcome of death, MI,

stroke or non-CABG major bleeding

Rates of primary outcome appeared to be lower

with radial compared to femoral access in high

volume radial centres and STEMI

Radial had fewer major vascular complications with

similar PCI success

Page 27: Advances in trans-radial interventionsstatic.livemedia.gr/hcs2/documents/us89_20131216095050_patsilinakos.pdfof Radial vs. Femoral (N=7030) Radial better 1.0 Femoral better PCI Procedure

Radial versus Femoral

Randomized Investigation

in ST Elevation Acute

Coronary Syndrome

the RIFLE STEACS study

Principal investigators:Enrico Romagnoli, MD PhDGiuseppe Biondi-Zoccai, MD

Giuseppe Sangiorgi, MD

F R

Page 28: Advances in trans-radial interventionsstatic.livemedia.gr/hcs2/documents/us89_20131216095050_patsilinakos.pdfof Radial vs. Femoral (N=7030) Radial better 1.0 Femoral better PCI Procedure

R I V A L

RIFLE STEACS - flow chartDesign

• DESIGN:

Prospective, randomized (1:1),

parallel group, multi-center trial.

• INCLUSION CRITERIA:

all ST Elevation Myocardial

infarction (STEMI) eligible for

primary percutaneous coronary

intervention.

• ESCLUSION CRITERIA:

contraindication to any of both

percutaneous arterial access.

international normalized ratio (INR)

> 2.0.

1001 patients enrolled between January 2009

and July 2011 in 4 clinical sites in Italy

Clinical follow-up at 1

month in 100%

Femoral arm

(N=501)

Radial arm

(N=500)

Femoral arm

(N=534)

Radial arm

(N=467)

Clinical follow-up at 1

month in 100%

Intention-to-treat analysis

Page 29: Advances in trans-radial interventionsstatic.livemedia.gr/hcs2/documents/us89_20131216095050_patsilinakos.pdfof Radial vs. Femoral (N=7030) Radial better 1.0 Femoral better PCI Procedure

NACE MACCE Bleedings

femoral arm radial armp = 0.003

• Net Adverse Clinical Event (NACE) = MACCE + bleeding

30-day NACE rate

RIFLE STEACS – results

p = 0.029 p = 0.026

21.0%

11.4%

7.2%

12.2%

7.8%

13.6%

Page 30: Advances in trans-radial interventionsstatic.livemedia.gr/hcs2/documents/us89_20131216095050_patsilinakos.pdfof Radial vs. Femoral (N=7030) Radial better 1.0 Femoral better PCI Procedure

NACE MACCE Bleedings

femoral arm radial armp = 0.003

• Net Adverse Clinical Event (NACE) = MACCE + bleeding

• Major Adverse Cardiac and Cerebrovascular event (MACCE) = composite of cardiac

death, myocardial infarction, target lesion revascularization, stroke

30-day NACE rate

RIFLE STEACS – results

p = 0.029 p = 0.026

21.0%

11.4%

7.2%

12.2%

7.8%

13.6%

Page 31: Advances in trans-radial interventionsstatic.livemedia.gr/hcs2/documents/us89_20131216095050_patsilinakos.pdfof Radial vs. Femoral (N=7030) Radial better 1.0 Femoral better PCI Procedure

30-day bleeding rate

RIFLE STEACS – results

p = 1.000

12.2%

6.8%

2.6%

5.4% 5.2%

p = 0.026

Bleedings Access site related Non access site related

femoral arm radial arm

7.8%

47%

p = 0.002

Page 32: Advances in trans-radial interventionsstatic.livemedia.gr/hcs2/documents/us89_20131216095050_patsilinakos.pdfof Radial vs. Femoral (N=7030) Radial better 1.0 Femoral better PCI Procedure

Cardiac death Myocardial

Infarction

Target Lesion

Revascularization

Cerebrovascular

Accident

femoral arm radial armp = 0.020

30-day MACCE rate

RIFLE STEACS – results

p = 1.000 p = 0.604 p = 0.725

9.2%

5.2%

1.4% 1.2% 1.8%1.2% 0.6% 0.8%

Page 33: Advances in trans-radial interventionsstatic.livemedia.gr/hcs2/documents/us89_20131216095050_patsilinakos.pdfof Radial vs. Femoral (N=7030) Radial better 1.0 Femoral better PCI Procedure

p = 0.7

30-day MACE

STEMI RADIAL - results

p = 0.64

p = 0.72

p = 1.0

4.2%

3.5%3.1%

2.3%

0.8%1.2%

0.3% 0.3%

MACE = composite of death, myocardial infarction and stroke

Page 34: Advances in trans-radial interventionsstatic.livemedia.gr/hcs2/documents/us89_20131216095050_patsilinakos.pdfof Radial vs. Femoral (N=7030) Radial better 1.0 Femoral better PCI Procedure

p = 0.0028

30-day NACE

STEMI RADIAL - results

p = 0.7

p = 0.0001

11.0%

7.2%

1.4%

4.2%3.5%

4.6%

Net Adverse Clinical Event (NACE) = MACE + major bleeding

MACE = composite of death, myocardial infarction and stroke

80%

58%

Page 35: Advances in trans-radial interventionsstatic.livemedia.gr/hcs2/documents/us89_20131216095050_patsilinakos.pdfof Radial vs. Femoral (N=7030) Radial better 1.0 Femoral better PCI Procedure

Transradial approach: the best

way to reduce the vascular

complication rate and the cost,

and to improve patient comfort

Institut Cardiovasculaire Paris Sud

Transradial approach: the best way to reduce the vascular complication rate and the cost, and to improve

patient comfort

Page 36: Advances in trans-radial interventionsstatic.livemedia.gr/hcs2/documents/us89_20131216095050_patsilinakos.pdfof Radial vs. Femoral (N=7030) Radial better 1.0 Femoral better PCI Procedure

R I V A L

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Myths of TRANSRADIAL APPROACH

1. Delay in accessing the radial artery

2. Spasms and other anatomical problems

3. Poor guiding catheter support

4. Difficulty in CTO lesions

5. Difficulty in complex lesions

6. Difficulty in using aspiration systems

7. Difficulty in using rotablator and other devices

8. Difficulty in CABG patients

Page 38: Advances in trans-radial interventionsstatic.livemedia.gr/hcs2/documents/us89_20131216095050_patsilinakos.pdfof Radial vs. Femoral (N=7030) Radial better 1.0 Femoral better PCI Procedure

Myths of TRANSRADIAL APPROACH

1. Delay in accessing the radial artery

2. Spasms and other anatomical problems

3. Poor guiding catheter support

4. Difficulty in CTO lesions

5. Difficulty in complex lesions

6. Difficulty in using aspiration systems

7. Difficulty in using rotablator and other devices

8. Difficulty in CABG patients

Page 39: Advances in trans-radial interventionsstatic.livemedia.gr/hcs2/documents/us89_20131216095050_patsilinakos.pdfof Radial vs. Femoral (N=7030) Radial better 1.0 Femoral better PCI Procedure

•High volume center: >146 radial PCI/year/ median operator at centre

•Medium volume center: 61-146 radial PCI/year/ median operator at centre

•Low volume center: ≤60 radial PCI/year/ median operator at centre

RADIAL EXPERIENCE

Page 40: Advances in trans-radial interventionsstatic.livemedia.gr/hcs2/documents/us89_20131216095050_patsilinakos.pdfof Radial vs. Femoral (N=7030) Radial better 1.0 Femoral better PCI Procedure

Transradial Approach Failure in Relation to Volume

y = -1,2931Ln(x) + 11,464

0

1

2

3

4

5

6

7

8

0 400 800 1200 1600 2000 2400 2800

p= 0.002

%

*Failure to enter ascending aortaY. Louvard, unpublished

Page 41: Advances in trans-radial interventionsstatic.livemedia.gr/hcs2/documents/us89_20131216095050_patsilinakos.pdfof Radial vs. Femoral (N=7030) Radial better 1.0 Femoral better PCI Procedure

Myths of TRANSRADIAL APPROACH

1. Delay in accessing the radial artery

2. Spasms and other anatomical problems

3. Poor guiding catheter support

4. Difficulty in CTO lesions

5. Difficulty in complex lesions

6. Difficulty in using aspiration systems

7. Difficulty in using rotablator and other devices

8. Difficulty in CABG patients

Page 42: Advances in trans-radial interventionsstatic.livemedia.gr/hcs2/documents/us89_20131216095050_patsilinakos.pdfof Radial vs. Femoral (N=7030) Radial better 1.0 Femoral better PCI Procedure
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Predictive Factors of Radial Approach

FailureSuccess Failure* p

n= 2347 53

Age (years) 61.6+11.3 65+11.2 0.03

Male (%) 84 73.7 0.068

Hypertension (%) 42.2 43.4 ns

Dyslipidemia (%) 72.9 69.8 ns

Diabetes (%) 8.4 13.2 ns

Smoking (%) 26.9 22.6 ns

Left radial (%) 3.2 18.9 0.000

Re-radial (%) 21.9 17 ns

N° of Same Radial (n) 1.3+0.7 1.3+0.6 ns

N° Dis. Coro. Vessels (n) 1.8+0.8 1.7+0.7 ns

Weight (kg) 76.9+13.5 72.8+13.8 0.029

Height (cm) 169.3+8.3 166.4+10.3 0.03

*Failure to enter ascending aorta

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0

1

2

3

4

5

6

<40 y

n=64

40-49 y

n=298

50-59 y

n=606

60-69 y

n=779

70-79 y

n=552

> 80 y

n=110

Radial approach failure rate%

Radial Approach Failure Rate

in Relation to Age

Y. Louvard, unpublished

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Radial Approach Failure Rate in Relation to Weight

0

1

2

3

4

5

6

7

8

9

10

<50 kg 50-59 kg 60-69 kg 70-79 kg 80-89 kg 90-99 kg 100-09 kg >110 kg

Total Male Female

Y. Louvard, unpublished

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R I V A L

Tortuous Right Subclavian Artery:

Prevalence and Predictive Factors

2,341 consecutive right radial approaches

Prevalence (%) 10.8

Cross-over to Left Radial or Femoral (%) 4

Complications (%) 0

Independent predictive factors:

OR 95% CI p

Hypertension 1.6 1.3-2.1 <0.0003

Age 1.4 1.2-1.7 0.0001

BMI 1.2 1.0-1.4 0.015

Cha CCVI 2002; 56: abst 69

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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

PoliclinicoCASILINO

TALENT study (left vs right radial)

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PCI Group

11.8

11.1

Gy/c

m2

0

10

12P= 0.23

153

132

Fluoroscopy time

0

130

160

se

co

nd

s

P= 0.034

Height <160 cm

(n=236)

RRA (n= 132)

LRA (n= 104)

Dose Area Product (Fluoroscopy)

183

167

Fluoroscopy time

0

170

200

se

co

nd

s

P= 0.001

14.7

11.5

0

10

15

P= 0.001

Age ≥75 years

(n=343)

RRA (n= 168)

LRA (n= 175)

Dose Area Product (Fluoroscopy)

Gy/c

m2

Results

Konstantopoulio/KAT hemodynamic dpts

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80-year old man from the STEMI-RADIAL trial :

Radial PCI one week after randomization to femoral primary PCI

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Myths of TRANSRADIAL APPROACH

1. Delay in accessing the radial artery

2. Spasms and other anatomical problems

3. Poor guiding catheter support

4. Difficulty in CTO lesions

5. Difficulty in complex lesions

6. Difficulty in using aspiration systems

7. Difficulty in using rotablator and other devices

8. Difficulty in CABG patients

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“Mother and child” technique - quideliner

Konstantopoulio hemodynamic dpt

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“Mother and child” technique - quideliner

Konstantopoulio hemodynamic dpt

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Myths of TRANSRADIAL APPROACH

1. Delay in accessing the radial artery

2. Spasms and other anatomical problems

3. Poor guiding catheter support

4. Difficulty in CTO lesions

5. Difficulty in complex lesions

6. Difficulty in using aspiration systems

7. Difficulty in using rotablator and other devices

8. Difficulty in CABG patients

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Radial Artery Diameter (Ultrasound)n=120

0

10

20

30

40

50

<2,1mm 2,1-2,4mm 2,5-2,7mm 2,8-3,1mm >3,1mm

2,9+0,6 mm

5f 6f 7f 8f

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Myths of TRANSRADIAL APPROACH

1. Delay in accessing the radial artery

2. Spasms and other anatomical problems

3. Poor guiding catheter support

4. Difficulty in CTO lesions

5. Difficulty in complex lesions

6. Difficulty in using aspiration systems

7. Difficulty in using rotablator and other devices

8. Difficulty in CABG patients

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bifurcation: RRA – XB 3,5 6F

Konstantopoulio hemodynamic dpt

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Konstantopoulio hemodynamic dpt

bifurcation: RRA – XB 3,5 7F

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bifurcation: RRA – XB 3,5 7F

Konstantopoulio hemodynamic dpt

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LM-distal trifurcation: RRA – XB 3,5 7F

technique - quideliner

Konstantopoulio hemodynamic dpt

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Radial Artery Diameter (Ultrasound)n=120

0

10

20

30

40

50

<2,1mm 2,1-2,4mm 2,5-2,7mm 2,8-3,1mm >3,1mm

2,9+0,6 mm

5f 6f 7f 8f

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R I V A L

Catheters / Devices/ Technique Compatibility

Catheter Size Devices Techniques Radial Compatibility

5f Balloons < 5 mm

Stents < 4.5 mm

Ivus

Rota 1.25 mm

No Kissing Balloon

100%

6f All Coronary balloons

All Coronary stents

Cutting Balloon

Rota < 1.75 mm

Protection device(EPI…)

Kissing Balloon

86.9%

7f Angioguard

Rota 2 mm

Kissing Stent76.9%

8f Percusurge

Simpson

Rota >2 mm

64.7%

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Myths of TRANSRADIAL APPROACH

1. Delay in accessing the radial artery

2. Spasms and other anatomical problems

3. Poor guiding catheter support

4. Difficulty in CTO lesions

5. Difficulty in complex lesions

6. Difficulty in using aspiration systems

7. Difficulty in using rotablator and other devices

8. Difficulty in CABG patients

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RCA: Aspiration device – anjiojet, XBRCA 6F

Konstantopoulio hemodynamic dpt

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Myths of TRANSRADIAL APPROACH

1. Delay in accessing the radial artery

2. Spasms and other anatomical problems

3. Poor guiding catheter support

4. Difficulty in CTO lesions

5. Difficulty in complex lesions

6. Difficulty in using aspiration systems

7. Difficulty in using rotablator and other devices

8. Difficulty in CABG patients

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R I V A L

Catheters / Devices/ Technique Compatibility

Catheter Size Devices Techniques Radial Compatibility

5f Balloons < 5 mm

Stents < 4.5 mm

Ivus

Rota 1.25 mm

No Kissing Balloon

100%

6f All Coronary balloons

All Coronary stents

Cutting Balloon

Rota < 1.75 mm

Protection device(EPI…)

Kissing Balloon

86.9%

7f Angioguard

Rota 2 mm

Kissing Stent76.9%

8f Percusurge

Simpson

Rota >2 mm

64.7%

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Myths of TRANSRADIAL APPROACH

1. Delay in accessing the radial artery

2. Spasms and other anatomical problems

3. Poor guiding catheter support

4. Difficulty in CTO lesions

5. Difficulty in complex lesions

6. Difficulty in using aspiration systems

7. Difficulty in using rotablator and other devices

8. Difficulty in CABG patients

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LIMA via RRA

Konstantopoulio hemodynamic dpt

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Konstantopoulio hemodynamic dpt

LIMA via RRA

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LIMA via RRA

Konstantopoulio hemodynamic dpt

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Real problems of TRANSRADIAL APPROACH

1. Most centers have no formal TRA program

2. Operators fear technical failure and care for fluoroscopy time

3. Ruin of radial graft after transradial catheterization

4. Post-procedure occlussion of radial artery

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Real problems of TRANSRADIAL APPROACH

1. Most centers have no formal TRA program

2. Operators fear technical failure and care for fluoroscopy time

3. Ruin of radial graft after transradial catheterization

4. Post-procedure occlussion of radial artery

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R I V A L

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•High volume center: >146 radial PCI/year/ median operator at centre

•Medium volume center: 61-146 radial PCI/year/ median operator at centre

•Low volume center: ≤60 radial PCI/year/ median operator at centre

RADIAL EXPERIENCE

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Transradial Approach Failure in Relation to Volume

y = -1,2931Ln(x) + 11,464

0

1

2

3

4

5

6

7

8

0 400 800 1200 1600 2000 2400 2800

p= 0.002

%

*Failure to enter ascending aortaY. Louvard, unpublished

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R I V A L

Other Outcomes

Radial(n=3507)

Femoral (n=3514)

P

Access site Cross-over (%) 7.6 2.0 <0.0001

PCI Procedure duration (min) 35 34 0.62

Fluoroscopy time (min) 9.3 8.0 <0.0001

Persistent pain at access site >2 weeks (%)

2.6 3.1 0.22

Patient prefers assigned access site for next procedure (%)

90 49 <0.0001

• Symptomatic radial occlusion requiring medical attention 0.2% in radial group

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Real problems of TRANSRADIAL APPROACH

1. Most centers have no formal TRA program

2. Operators fear technical failure and care for fluoroscopy time

3. Ruin of radial graft after transradial catheterization

4. Post-procedure occlussion of radial artery

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R I V A L

Use of the radial artery graft after transradial

catheterization: is it suitable as a bypass conduit?

67 pts underwent isolated CABG using the radial artery (RA)

preop. transradial no transradial p value

catheterization catheterization

N= 22 45

Stenosis-free graft patency

Left mammary artery (%) 88 90 0.87

Radial artery (%) 77 98 0.017

Saphenous vein (%) 87 84 0.42

Intimal hyperplasia of RA (%) 68 39 0.046

Kamiya Ann Thorac Surg. 2003; 76(5): 1505-9

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R I V A L

Use of the radial artery graft after transradial

catheterization: is it suitable as a bypass conduit?

67 pts underwent isolated CABG using the radial artery (RA)

preop. transradial no transradial p value

catheterization catheterization

N= 22 45

Stenosis-free graft patency

Left mammary artery (%) 88 90 0.87

Radial artery (%) 77 98 0.017

Saphenous vein (%) 87 84 0.42

Intimal hyperplasia of RA (%) 68 39 0.046

Kamiya Ann Thorac Surg. 2003; 76(5): 1505-9

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R I V A L

IVUS after transradial approach

JACC 2003;41;1109-14

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Early ultrasonic results

Pre-procedure Post-procedure p

Diameter (mm) 3.64 ± 0.74 3.55 ± 0.77 ns

Upstream flow (cm/sec) 29.13 ± 9.51 30.8 ± 11.26 ns

Downstream flow(cm/sec) 28.73 ± 11.84 ns

Duration (mn) 2.92 ± 0.55 3.35 ± 0.83 ns

270 patients

4 radial occluded (1.3%) :

- 2 with a negative flow

- 2 without flow

J. Monsegu

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R I V A L Radial Artery/Sheath Diameter Ratio: A

Predictor of Severe Radial Artery Flow

Reduction

0

2

4

6

8

10

12

14

Radial Inner

Diameter / Sheath

>1

Radial Inner

Diameter / Sheath

<1

Severe Radial Flow Reduction

Saïto CCVI 46: 173-178, 1999

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Real problems of TRANSRADIAL APPROACH

1. Most centers have no formal TRA program

2. Operators fear technical failure and care for fluoroscopy time

3. Ruin of radial graft after transradial catheterization

4. Post-procedure occlussion of radial artery

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Thrombotic occlusion of the radial artery:

3-6% in trials with mandatory doppler (Mann 1996, BRAFE Stent 1997, ACCESS 1997)

0-9% loss of radial pulse in the others

Radial Artery Occlussion

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R I V A LReduction of RAO

Introducer vs radial artery size

Procedure manipulations

Post procedure artery compression

0

2

4

6

8

10

12

14

Radial Inner

Diameter / Sheath

>1

Radial Inner

Diameter / Sheath

<1

Severe Radial Flow Reduction

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Damn

Femoral!Hi hi hi,

mine was randomized

to radial

I guess,

It’s just not

my day

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R I V A L

Casual approach is dangerous…

Even for this job….

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Clear Choice

TRANSRADIAL ROUTE IS THE CLEAR

OPTION FOR ALMOST ALL PATIENTS

Only after your “new

learning curve” is over

BUT:

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Radial access: just another

artery?ACCESS Study

Randomised comparison of different access sites

Experienced operators

No difference in procedural or fluoroscopy times

Radial Brachial Femoral

PCI’s (n) 300 300 300

Coronary cannulation 93% 95.7% 99.7%

Procedural success 91.7% 90.7% 90.7%

Length of stay (days) 1.5(2.5) 1.8(3.8) 1.8(4.2)

Major access site complications 0 2.3 2.0

JACC 1997; 29: 1269-75. Amsterdam, NL

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Radial access: just another

artery?Multiple procedures

812 patients

1438 procedures

6F – 45%

5F – 55%

Failed procedures

(%)

5th3rd2nd

30103.5Men

50207.9Women

CCVI 2001;54: 204-8. Fukuoka, Japan

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Radial access: just another

artery?Difficult radial anatomy – small vessels (1) Randomised trial of 5Fr vs 6Fr transradial

PCI in 171 patients with a +ve Allen test

5Fr 6Fr

Procedural success 95.4% 92.9%

Failed coronary cannulation 1.1% 4.8%

Minor haematoma 1.1% 4.8%

Radial occlusion 1.1% 5.9%

CCVI 2002; 57: 172-6. Greifswa, FRG

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Radial access: just another

artery?GP IIb/IIIa inhibitors

150 consecutive patients treated with GPIIb/IIIa inhibitors

Radial Femoral

PCI’s (n) 83 67

Event free @ 1/12 94% 94%

Length of stay (days) 5.0 4.9

Major access site bleeding

0 5 (7.4%)

Eur Heart J 2000; 21: 662-7. Toulouse, Fr.

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Radial Artery Diameter (Ultrasound)n=120

0

10

20

30

40

50

<2,1mm 2,1-2,4mm 2,5-2,7mm 2,8-3,1mm >3,1mm

2,9+0,6 mm

5f 6f 7f 8f

Y. Louvard unpublished

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Procedure- and Non-Procedure-Related Bleeds are Associated with an higher 30-Day Mortality in NSTEMI

Procedure-related

GUSTO bleeds

Non-procedure-related

GUSTO bleeds

Ris

k o

f death

(hazard

Ratio)

None

1.0

Mild

1.3

Severe

16.5

0

5

20

10

15

None

1.0

Mild

2.1

Moderate

2.5

Severe

10.9

Moderate

3.7

Rao et al. Am J Cardiol 2005;96:1200-1206

N=26,452 ACS patients from

GUSTO IIb, PURSUIT and PARAGON A & B

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R I V A L Major Bleeding is Associated with an Increased

Risk of Hospital Death in ACS Patients

Moscucci et al. Eur Heart J 2003;24:1815-23

GRACE Registry in 24,045 ACS patients

*After adjustment for comorbidities, clinical presentation and hospital therapies

**p<0.001 for differences in unadjusted death rates

OR (95% CI)

1.64 (1.18 to 2.28*)

0

Overall ACS UA NSTEMI STEMI

10

20

30

40

**

** **

**

5.1

18.6

3.0

16.1

5.3

15.3

7.0

22.8

Inhospital death

(%

)

In hospital major bleeding YesNo

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Variable Groups O.R. (95% CI) p-value

Creatinine clearance

<30 mL/min 7.21 (2.53–20.51)

<0.000130–60 mL/min 3.34 (1.92–5.78)

60–90 mL/min 1.57 (0.96–2.57)

CHF Yes 4.38 (2.83–6.78) <0.0001

Major Bleeding Yes 3.26 (1.78–5.96) 0.0001

MI @30day Yes 2.77 (1.62–4.75) 0.0002

Urg Revasc @30d Yes 2.77 (1.15–6.71) .024

Hx angina Yes 2.18 (1.25–3.81) 0.006

Prior MI Yes 1.81 (1.09–3.03) 0.023

Diabetes Yes 1.64 (1.10–2.44) 0.015

Predictors of 1-year Mortality

after Elective and Urgent PCI

Stone GW. J Inv Cardiol 2004;16(suppl G):12–17.

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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

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R I V A L

Definitions

Major Bleeding (CURRENT/OASIS 7)

• Fatal

• > 2 units of Blood transfusion

• Hypotension requiring inotropes

• Leading to hemoglobin drop of ≥ 5 g/dl

• Requiring surgical intervention

• ICH or Intraocular bleeding leading to significant vision loss

MajorVascular Access Site Complications

• Large hematoma

• Pseudoaneurysm requiring closure

• AV fistula

• Other vascular surgery related to the access site

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R I V A L

Site of Non-CABG Major Bleeds

(RIVAL definition)

*Sites of Non Access site Bleed: Gastrointestinal (most common site), ICH,

Pericardial Tamponade and Other

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R I V A L

Use of the radial artery graft after transradial

catheterization: is it suitable as a bypass

conduit?

67 pts underwent isolated CABG using the radial artery (RA)

preop. transradial no transradial p value

catheterization catheterization

N= 22 45

Stenosis-free graft patency

Left mammary artery (%) 88 90 = 0.87

Radial artery (%) 77 98 = 0.017

Saphenous vein (%) 87 84 = 0.42

Intimal hyperplasia of RA (%) 68 39 = 0.046

Kamiya Ann Thorac Surg. 2003; 76(5): 1505-9

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