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Radial Approach: Clinical Trials and
Α-Δ. ΜΑΥΡΟΓΙΑΝΝΗΚΑΡΔΙΟΛΟΓΟΣ
AIMOΔΥΝΑΜΙΚΟ ΕΡΓΑΣΤΗΡΙΟΓ.Ν.Θ. «Γ.ΠΑΠΑΝΙΚΟΛΑΟΥ»
ΘΕΣΣΑΛΟΝΙΚΗTuesday, March 10, 15
Disclosure Statement of Financial Interest
None whatsoever…
Tuesday, March 10, 15
Why are we talking about access?
Michelangelo di Lodovico Buonarroti Simoni (1475 – 1564): The Creation of Adam, Sistine Chapel ceiling circa 1511–1512
Tuesday, March 10, 15
Why are we talking about access?
Michelangelo di Lodovico Buonarroti Simoni (1475 – 1564): The Creation of Adam, Sistine Chapel ceiling circa 1511–1512
Tuesday, March 10, 15
Why are we talking about access?
Michelangelo di Lodovico Buonarroti Simoni (1475 – 1564): The Creation of Adam, Sistine Chapel ceiling circa 1511–1512
…same painter, same painting, different perspective…
Tuesday, March 10, 15
Bleeding…
Tuesday, March 10, 15
Day 0 – 2 after MI 12.6 (7.8-20.4)12.6 (7.8-20.4) 29 (37.6) <0.0001<0.0001Day 3 – 7 after MI 5.3 (2.7-10.4)5.3 (2.7-10.4) 11 (14.3) <0.0001<0.0001
Day 8 – 35 after MI 1.6 (0.8-3.1)1.6 (0.8-3.1) 12 (15.6) 0.180.18Day > 35 after MI 1.2 (0.8-1.9)1.2 (0.8-1.9) 25 (32.5) 0.340.34
Day 0 – 2 after Major Bleed 3.0 (1.6-5.6)3.0 (1.6-5.6) 12 (12.9) 0.00090.0009Day 3 – 7 after Major Bleed 4.0 (2.1-7.5)4.0 (2.1-7.5) 15 (16.1) <0.0001<0.0001
Day 8 – 35 after Major Bleed 4.5 (2.8-7.4)4.5 (2.8-7.4) 25 (26.9) <0.0001<0.0001Day > 35 after Major Bleed 2.2 (1.5-3.2)2.2 (1.5-3.2) 41 (44.1) <0.0001<0.0001
P-value
Lessons Learnt from Acuity:Non CABG Major Bleeding and MI in the First 30 Days on the Risk of Death Over 1 Year
Deaths (n/%)HR ± 95% CI
0.5 1 2 4 8 16
HR (CI)
Mehran R. et al.Associations of major bleeding and myocardial infarction with the incidence and timing of mortality in patients presenting with non-ST-elevation acute
coronary syndromes: a risk model from the ACUITY trial. Eur Heart J.2009 Jun;30(12):1457-66
Tuesday, March 10, 15
Day 0 – 2 after MI 12.6 (7.8-20.4)12.6 (7.8-20.4) 29 (37.6) <0.0001<0.0001Day 3 – 7 after MI 5.3 (2.7-10.4)5.3 (2.7-10.4) 11 (14.3) <0.0001<0.0001
Day 8 – 35 after MI 1.6 (0.8-3.1)1.6 (0.8-3.1) 12 (15.6) 0.180.18Day > 35 after MI 1.2 (0.8-1.9)1.2 (0.8-1.9) 25 (32.5) 0.340.34
Day 0 – 2 after Major Bleed 3.0 (1.6-5.6)3.0 (1.6-5.6) 12 (12.9) 0.00090.0009Day 3 – 7 after Major Bleed 4.0 (2.1-7.5)4.0 (2.1-7.5) 15 (16.1) <0.0001<0.0001
Day 8 – 35 after Major Bleed 4.5 (2.8-7.4)4.5 (2.8-7.4) 25 (26.9) <0.0001<0.0001Day > 35 after Major Bleed 2.2 (1.5-3.2)2.2 (1.5-3.2) 41 (44.1) <0.0001<0.0001
P-value
Lessons Learnt from Acuity:Non CABG Major Bleeding and MI in the First 30 Days on the Risk of Death Over 1 Year
Deaths (n/%)HR ± 95% CI
0.5 1 2 4 8 16
HR (CI)
Mehran R. et al.Associations of major bleeding and myocardial infarction with the incidence and timing of mortality in patients presenting with non-ST-elevation acute
coronary syndromes: a risk model from the ACUITY trial. Eur Heart J.2009 Jun;30(12):1457-66
Tuesday, March 10, 15
Risk for 1 year mortality N=17393 pts from REPLACE-2, ACUITY, HORIZONS AMI
Verheugt FW. et al.Incidence, prognostic impact, and influence of antithrombotic therapy on access and nonaccess site bleeding inpercutaneous coronary intervention.
JACC Cardiovasc Interv. 2011 Feb;4(2):191-7Tuesday, March 10, 15
Doyle BJ. et al.Major femoral bleeding complications after percutaneous coronary intervention: incidence, predictors, and impact on long-term survival among 17,901
patients treated at the Mayo Clinic from 1994 to 2005. JACC Cardiovasc Interv. 2008 Apr;1(2):202-9
Tuesday, March 10, 15
Bleeding: NCDR CathPCI Rates
70%
30%
acces sitenon access site
70%
30%
non access siteaccess site
55%
45%
non access site access site
Stable Angina NSTEMI STEMI Overall Rate 2.1% Overall Rate 4.8% Overall Rate 12.7%
Rao SV. et al.The transradial approach to percutaneous coronary intervention: historical perspective, current concepts, and future directions.
J Am Coll Cardiol.2010 May 18;55(20):2187-95Tuesday, March 10, 15
RADIAL VERSUS FEMORAL RANDOMIZED INVESTIGATION
IN ST ELEVATION ACUTE CORONARY SYNDROME
Principal investigators:Enrico Romagnoli, MD PhDGiuseppe Biondi-Zoccai, MD
Giuseppe Sangiorgi, MD
F R
Tuesday, March 10, 15
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
Tuesday, March 10, 15
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
Femoral arm (N=501) Radial arm(N=500)
Tuesday, March 10, 15
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
Femoral arm (N=501) Radial arm(N=500)
Femoral arm (N=534) Radial arm(N=467)
Tuesday, March 10, 15
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
Femoral arm (N=501) Radial arm(N=500)
Femoral arm (N=534) Radial arm(N=467)
4.7% 1.4%
Tuesday, March 10, 15
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
4.7% 1.4%
Tuesday, March 10, 15
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%
Romagnoli E. et al.Radial versus femoral randomized investigation in ST-segment elevation acute coronary syndrome: the RIFLE-STEACS (Radial Versus Femoral
Randomized Investigation in ST-Elevation Acute Coronary Syndrome) study. J Am Coll Cardiol.2012 Dec 18;60(24):2481-9
Tuesday, March 10, 15
Cardiac death Myocardial InfarctionTarget Lesion RevascularizationCerebrovascular 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%
Romagnoli E. et al.Radial versus femoral randomized investigation in ST-segment elevation acute coronary syndrome: the RIFLE-STEACS (Radial Versus Femoral
Randomized Investigation in ST-Elevation Acute Coronary Syndrome) study. J Am Coll Cardiol.2012 Dec 18;60(24):2481-9
Tuesday, March 10, 15
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%
p = 0.002
Romagnoli E. et al.Radial versus femoral randomized investigation in ST-segment elevation acute coronary syndrome: the RIFLE-STEACS (Radial Versus Femoral
Randomized Investigation in ST-Elevation Acute Coronary Syndrome) study. J Am Coll Cardiol.2012 Dec 18;60(24):2481-9
Tuesday, March 10, 15
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
Romagnoli E. et al.Radial versus femoral randomized investigation in ST-segment elevation acute coronary syndrome: the RIFLE-STEACS (Radial Versus Femoral
Randomized Investigation in ST-Elevation Acute Coronary Syndrome) study. J Am Coll Cardiol.2012 Dec 18;60(24):2481-9
Tuesday, March 10, 15
A RANDOMIZED COMPARISON OF RADIAL VS. FEMORAL ACCESS FOR CORONARY INTERVENTION IN ACS
SS Jolly, S Yusuf, J Cairns, K Niemela, D Xavier, P Widimsky, A Budaj, M Niemela, V Valentin, BS Lewis,
A Avezum, PG Steg, SV Rao, P Gao, R Afzal, CD Joyner, S Chrolavicius, SR Mehta on behalf of the
RIVAL investigators
Jolly SS. et al.Design and rationale of the radial versus femoral access for coronary intervention (RIVAL) trial: a randomized comparison of radial versus femoral access
for coronary angiography or intervention in patients with acute coronary syndromes. Am Heart J. 2011 Feb;161(2):254-260
Tuesday, March 10, 15
NSTE-ACS and STEMI(n=7021)
RIVAL Study Design
Key Inclusion: • Intact dual circulation of hand required• Interventionalist experienced with both (minimum 50 radial
procedures in last year)
Tuesday, March 10, 15
NSTE-ACS and STEMI(n=7021)
Radial Access(n=3507)
Femoral Access(n=3514)
Randomization
RIVAL Study Design
Key Inclusion: • Intact dual circulation of hand required• Interventionalist experienced with both (minimum 50 radial
procedures in last year)
Tuesday, March 10, 15
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)
Blinded Adjudication of Outcomes
Tuesday, March 10, 15
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)
Blinded Adjudication of Outcomes
Diagnosis at presentationDiagnosis at presentationDiagnosis at presentation UA (%) 44.3 45.7
NSTEMI (%) 28.5 25.8
STEMI (%) 27.2 28.5
Tuesday, March 10, 15
RIVAL:Primary and Secondary Outcomes
Radial(n=3507)
%
Femoral (n=3514)
%HR 95% CI P
Primary OutcomePrimary OutcomePrimary OutcomePrimary OutcomePrimary OutcomePrimary OutcomeDeath, MI, Stroke, Non-CABG Major Bleed
3.7 4.0 0.92 0.72-1.17 0.50
Secondary OutcomesSecondary OutcomesSecondary OutcomesSecondary OutcomesSecondary OutcomesSecondary OutcomesDeath, MI, Stroke 3.2 3.2 0.98 0.77-1.28 0.90Non-CABG Major Bleeding 0.7 0.9 0.73 0.43-1.23 0.23
Jolly SS. et al.Radial versus femoral access for coronary angiography and intervention in patients with acute coronary syndromes (RIVAL): a randomised, parallel group,
multicentre trial. Lancet.2011 Apr 23;377(9775):1409-20
Tuesday, March 10, 15
RIVAL: 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 BleedingOther Definitions of Major BleedingOther Definitions of Major BleedingOther Definitions of Major BleedingOther Definitions of Major BleedingOther Definitions of Major BleedingTIMI 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
Jolly SS. et al.Radial versus femoral access for coronary angiography and intervention in patients with acute coronary syndromes (RIVAL): a randomised, parallel group,
multicentre trial. Lancet.2011 Apr 23;377(9775):1409-20
Tuesday, March 10, 15
NSTE/ACSSTEMI
NSTE/ACSSTEMI
NSTE/ACSSTEMI
NSTE/ACSSTEMI
NSTE/ACSSTEMI
50631958
50631958
50631958
50631958
50631958
3.55.2
2.74.6
0.83.2
1.00.9
3.83.5
3.83.1
3.42.7
1.21.3
0.60.8
1.41.3
0.25 1.00 4.00Radial better Femoral better
Hazard Ratio(95% CI)
0.025
0.011
0.001
0.56
0.89
Interactionp-value
2N Radial Femoral% %
Primary Outcome
Death, MI or stroke
Death
Non CABG Major Bleed
Major Vascular Complications
Outcomes stratified by STEMI vs. NSTEACS
Tuesday, March 10, 15
0.25 1.00 4.00 16.00Radial better Femoral better
High MediumLow
High MediumLow
High MediumLow
HighMediumLow
HighMediumLow
0.021
0.013
0.538
0.019
0.003
Interactionp-valueHR (95% CI)
Primary Outcome
Death, MI or stroke
Non CABG Major Bleed
Major Vascular Complications
Access site Cross-over
Results stratified by High*, Medium* and Low* Volume Radial Centres
No significant interaction by Femoral PCI center volume
Tertiles of Radial PCI Centre Volume/yr
*High (>146 radial PCI/year/ median operator at centre), Medium (61-146), Low (≤60)
Tuesday, March 10, 15
MACE Death MI Stroke
femoral arm radial arm
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%
Bernat I. et al.ST-segment elevation myocardial infarction treated by radial or femoral approach in a multicenter randomizedclinical trial: the STEMI-RADIAL trial.
J Am Coll Cardiol. 2014 Mar 18;63(10):964-72
Tuesday, March 10, 15
NACE Bleeding MACE
femoral radialp = 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% 80%
58%
Bernat I. et al.ST-segment elevation myocardial infarction treated by radial or femoral approach in a multicenter randomizedclinical trial: the STEMI-RADIAL trial.
J Am Coll Cardiol. 2014 Mar 18;63(10):964-72
Tuesday, March 10, 15
NACE Bleeding MACE
femoral radialp = 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% 80%
58%
Bernat I. et al.ST-segment elevation myocardial infarction treated by radial or femoral approach in a multicenter randomizedclinical trial: the STEMI-RADIAL trial.
J Am Coll Cardiol. 2014 Mar 18;63(10):964-72
Tuesday, March 10, 15
Gastro- intestinalHb drop ≥4g/dL w/o overtHb drop ≥3g/dL with overtHematoma ≥15cm Transfusion Vascular complication
0.3%0%0.6%0.9%
0.3%0.3% 0.8%0.8%
5.3%
2.8%
0.3%1.1%
femoral radial
STEMI RADIAL - results30-day bleeding and access site compl.
Bernat I. et al.ST-segment elevation myocardial infarction treated by radial or femoral approach in a multicenter randomizedclinical trial: the STEMI-RADIAL trial.
J Am Coll Cardiol. 2014 Mar 18;63(10):964-72Tuesday, March 10, 15
Gastro- intestinalHb drop ≥4g/dL w/o overtHb drop ≥3g/dL with overtHematoma ≥15cm Transfusion Vascular complication
0.3%0%0.6%0.9%
0.3%0.3% 0.8%0.8%
5.3%
2.8%
0.3%1.1%
femoral radial
STEMI RADIAL - results30-day bleeding and access site compl.
Primary EP
1.4%
7.2% p=0.0001
Bernat I. et al.ST-segment elevation myocardial infarction treated by radial or femoral approach in a multicenter randomizedclinical trial: the STEMI-RADIAL trial.
J Am Coll Cardiol. 2014 Mar 18;63(10):964-72Tuesday, March 10, 15
Gastro- intestinalHb drop ≥4g/dL w/o overtHb drop ≥3g/dL with overtHematoma ≥15cm Transfusion Vascular complication
0.3%0%0.6%0.9%
0.3%0.3% 0.8%0.8%
5.3%
2.8%
0.3%1.1%
femoral radial
STEMI RADIAL - results30-day bleeding and access site compl.
Primary EP
1.4%
7.2% p=0.0001
80%
Bernat I. et al.ST-segment elevation myocardial infarction treated by radial or femoral approach in a multicenter randomizedclinical trial: the STEMI-RADIAL trial.
J Am Coll Cardiol. 2014 Mar 18;63(10):964-72Tuesday, March 10, 15
Femoral vs Radial:Rates of Bleeding and Vascular Complications in Key Subgroups
Rao SV. et al.Trends in the prevalence and outcomes of radial and femoral approaches to percutaneous coronary intervention: a report from the National
Cardiovascular Data Registry. JACC Cardiovasc Interv. 2008 Aug;1(4):379-86
Tuesday, March 10, 15
Femoral vs Radial:Rates of Bleeding and Vascular Complications in Key Subgroups
Rao SV. et al.Trends in the prevalence and outcomes of radial and femoral approaches to percutaneous coronary intervention: a report from the National
Cardiovascular Data Registry. JACC Cardiovasc Interv. 2008 Aug;1(4):379-86
Tuesday, March 10, 15
Femoral vs Radial:Rates of Bleeding and Vascular Complications in Key Subgroups
Rao SV. et al.Trends in the prevalence and outcomes of radial and femoral approaches to percutaneous coronary intervention: a report from the National
Cardiovascular Data Registry. JACC Cardiovasc Interv. 2008 Aug;1(4):379-86
Tuesday, March 10, 15
Femoral vs Radial: Outcomes “(cont.)”
Feldman DN. et al.Adoption of radial access and comparison of outcomes to femoral access in percutaneous coronary intervention: an updated report from the national
cardiovascular data registry (2007-2012). Circulation. 2013 Jun 11;127(23):2295-306
Tuesday, March 10, 15
Femoral vs Radial: Outcomes “(cont.)”
Feldman DN. et al.Adoption of radial access and comparison of outcomes to femoral access in percutaneous coronary intervention: an updated report from the national
cardiovascular data registry (2007-2012). Circulation. 2013 Jun 11;127(23):2295-306
Tuesday, March 10, 15
Vascular Complications Associated with FA and RARetrospective review of 5,234 cath and PCIVascular complications by BMI: lower rate of vascular complications using TR vs. TF approach for obese and non obese patients
Cox N. et al.Comparison of the risk of vascular complications associated with femoral and radial access coronary catheterization procedures in obese versus
nonobese patients. Am J Cardiol. 2004 Nov 1;94(9):1174-7
Tuesday, March 10, 15
Access Site Practice and Procedural Outcomes in Relation toClinical Presentation in Patients Undergoing PCI
Multivariate Analysis:Multivariate Analysis:Multivariate Analysis:Radial vs Femoral PCI OR 95% CIRadial vs Femoral PCI OR 95% CIRadial vs Femoral PCI OR 95% CI
30-Day MortalityStable 0.77 0.61-0.97NSTE-ACS 0.76 0.67-0.85STEMI 0.72 0.65-0.79
BleedingStable 0.24 0.16-0.36NSTE-ACS 0.35 0.27-0.44STEMI 0.47 0.39-0.58
Ratib K et al.Access site practice and procedural outcomes in relation to clinical presentation in 439,947 patients undergoing percutaneous coronary intervention in the
United kingdom. JACC Cardiovasc Interv. 2015 Jan;8(1 Pt A):20-9
Tuesday, March 10, 15
Arterial Access Site Selection on Outcomes in PPCIAre the Results of Randomized Trials Achievable in Clinical
Mamas MA. et al.Baseline bleeding risk and arterial access site practice in relation to procedural outcomes after percutaneous coronary intervention.
J Am Coll Cardiol. 2014 Oct 14;64(15):1554-64
Tuesday, March 10, 15
Arterial Access Site Selection on Outcomes in PPCIAre the Results of Randomized Trials Achievable in Clinical
Mamas MA. et al.Baseline bleeding risk and arterial access site practice in relation to procedural outcomes after percutaneous coronary intervention.
J Am Coll Cardiol. 2014 Oct 14;64(15):1554-64
Tuesday, March 10, 15
Baseline Bleeding Risk and Benefit of Transradial PCI: Making Lemonade out of Lemons
Mamas MA. et al.Baseline bleeding risk and arterial access site practice in relation to procedural outcomes after percutaneous coronary intervention.
J Am Coll Cardiol. 2014 Oct 14;64(15):1554-64
Tuesday, March 10, 15
Baseline Bleeding Risk and Benefit of Transradial PCI: Making Lemonade out of Lemons
Mamas MA. et al.Baseline bleeding risk and arterial access site practice in relation to procedural outcomes after percutaneous coronary intervention.
J Am Coll Cardiol. 2014 Oct 14;64(15):1554-64
Tuesday, March 10, 15
Baseline Bleeding Risk and Benefit of Transradial PCI: Making Lemonade out of Lemons
Mamas MA. et al.Baseline bleeding risk and arterial access site practice in relation to procedural outcomes after percutaneous coronary intervention.
J Am Coll Cardiol. 2014 Oct 14;64(15):1554-64
Tuesday, March 10, 15
Arterial Access Site Selection on Outcomes in PPCIAre the Results of Randomized Trials Achievable in Clinical Practice?
Mamas MA. et al.Baseline bleeding risk and arterial access site practice in relation to procedural outcomes after percutaneous coronary intervention.
J Am Coll Cardiol. 2014 Oct 14;64(15):1554-64
Tuesday, March 10, 15
Arterial Access Site Selection on Outcomes in PPCIAre the Results of Randomized Trials Achievable in Clinical Practice?
Mamas MA. et al.Baseline bleeding risk and arterial access site practice in relation to procedural outcomes after percutaneous coronary intervention.
J Am Coll Cardiol. 2014 Oct 14;64(15):1554-64
Tuesday, March 10, 15
Arterial Access Site Selection on Outcomes in PPCIAre the Results of Randomized Trials Achievable in Clinical Practice?
Mamas MA. et al.Baseline bleeding risk and arterial access site practice in relation to procedural outcomes after percutaneous coronary intervention.
J Am Coll Cardiol. 2014 Oct 14;64(15):1554-64
Tuesday, March 10, 15
TRI vs TFI: Death
Piccolo R. et al.Transradial versus transfemoral approach in patients undergoing percutaneous coronary intervention for acute coronary syndrome.
A meta-analysis and trial sequential analysis of randomized controlled trials. PLoS One. 2014 May 12;9(5):e96127
Tuesday, March 10, 15
TRI vs TFI: Death
Piccolo R. et al.Transradial versus transfemoral approach in patients undergoing percutaneous coronary intervention for acute coronary syndrome.
A meta-analysis and trial sequential analysis of randomized controlled trials. PLoS One. 2014 May 12;9(5):e96127
Tuesday, March 10, 15
TRI vs TFI: Major Bleeding
Piccolo R. et al.Transradial versus transfemoral approach in patients undergoing percutaneous coronary intervention for acute coronary syndrome.
A meta-analysis and trial sequential analysis of randomized controlled trials. PLoS One. 2014 May 12;9(5):e96127
Tuesday, March 10, 15
TRI vs TFI: Major Bleeding
Piccolo R. et al.Transradial versus transfemoral approach in patients undergoing percutaneous coronary intervention for acute coronary syndrome.
A meta-analysis and trial sequential analysis of randomized controlled trials. PLoS One. 2014 May 12;9(5):e96127
Tuesday, March 10, 15
TRI vs TFI: Vascular Complications
Piccolo R. et al.Transradial versus transfemoral approach in patients undergoing percutaneous coronary intervention for acute coronary syndrome.
A meta-analysis and trial sequential analysis of randomized controlled trials. PLoS One. 2014 May 12;9(5):e96127
Tuesday, March 10, 15
TRI vs TFI: Vascular Complications
Piccolo R. et al.Transradial versus transfemoral approach in patients undergoing percutaneous coronary intervention for acute coronary syndrome.
A meta-analysis and trial sequential analysis of randomized controlled trials. PLoS One. 2014 May 12;9(5):e96127
Tuesday, March 10, 15
TRI Complication Decrease:One Size Fits All
Piccolo R. et al.Transradial versus transfemoral approach in patients undergoing percutaneous coronary intervention for acute coronary syndrome.
A meta-analysis and trial sequential analysis of randomized controlled trials. PLoS One. 2014 May 12;9(5):e96127
Tuesday, March 10, 15
“Paradox”: a Self-Contradictory and False Proposition
Maurits Cornelis Escher (1898 – 1972) : Impossible Realities/ Drawing Hands 1948, Relativity 1953
Tuesday, March 10, 15
The Radial Paradox: Underutilization in Key Subgroups
Rao SV. et al.Trends in the prevalence and outcomes of radial and femoral approaches to percutaneous coronary intervention: a report from the National
Cardiovascular Data Registry. JACC Cardiovasc Interv. 2008 Aug;1(4):379-86
Tuesday, March 10, 15
The Radial Paradox: Underutilization in Key Subgroups
Rao SV. et al.Trends in the prevalence and outcomes of radial and femoral approaches to percutaneous coronary intervention: a report from the National
Cardiovascular Data Registry. JACC Cardiovasc Interv. 2008 Aug;1(4):379-86
Tuesday, March 10, 15
Radial Access for All: Practice Makes Better
! Superficial position: easy to find! Improved techniques! Improved materials! Early days: access failure 7.3%! Nowadays: need for conversion < 1.5%! Mean difference in procedural time ~ 1.76´ ! Learning Curve
Spaulding C. et al.Left radial approach for coronary angiography: results of a prospective study.
Cathet Cardiovasc Diagn.1996 Dec;39(4):365-70
Tuesday, March 10, 15
How, Who, When: Guidelines and Recommendations
Authors/Task Force members2014 ESC/EACTS Guidelines on myocardial revascularization: The Task Force on Myocardial Revascularization of the European Society of Cardiology (ESC) and
the European Association for Cardio-Thoracic Surgery (EACTS)Developed with the special contribution of the European Association of Percutaneous Cardiovascular Interventions (EAPCI).
Eur Heart J. 2014 Oct 1;35(37):2541-619
Hamon M. et al.Consensus document on the radial approach in percutaneous cardiovascular interventions: position paper by the European Association of Percutaneous Cardiovascular
Interventions and Workin Groups on Acute Cardiac Care** and Thrombosis of the European Society of Cardiology. EuroIntervention. 2013 Mar;8(11):1242-51
Tuesday, March 10, 15
! Vascular access is the first procedural interaction you have with the patient! They remember the access, not the fact that you saved their life with PCI
! There is no one approach that suits all patients ! All interventional cardiologists should be proficient
Albrecht Dürer (1471 – 1528): Study of three hands circa 1490
Tuesday, March 10, 15
One has to know the Whole Picture…
Michelangelo di Lodovico Buonarroti Simoni (1475 – 1564): The Creation of Adam,Sistine Chapel ceiling circa 1511–1512
Tuesday, March 10, 15
TRI vs TFI: Reduced Complications and Mortality NSTEMI Patients
AdjustedAdjustedAdjustedAdjusted
Radial vs Femoral OR/HR 95%CI P Value
Total Bleeding 0.21 0.08-0.57 .002
1 Year Mortality 0.72 0.54-0.94 .017
Iqbal MB. et al.Radial versus femoral access is associated with reduced complications and mortality in patients with non-ST-segment-elevation myocardial infarction:
an observational cohort study of 10,095 patients. Circ Cardiovasc Interv.2014 Aug;7(4):456-64
10,095 consecutive NSTEMI patients who underwent radial (n = 2,275) or femoral (n = 7,820) PCI 8 centers in London, 2005 to 2011
Tuesday, March 10, 15
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