RADIAL VERSUS FEMORAL
APPROACH COMPARISON IN
PERCUTANEOUS CORONARY
INTERVENTION WITH INTRA-AORTIC
BALLOON PUMP SUPPORT
	
 ...
I, Enrico Romagnoli DO NOT have any real
or apparent conflict of interest in the
context of the subject of this presentati...
Radial Pump up – rationale

§  The

role of intra-aortic balloon pump (IABP)
during percutaneous coronary intervention (P...
Radial Pump up – objectives
To evaluate if the selection of transradial approach still
represents an advantage in terms of...
Radial Pump up – methods
§  Multicenter investigator-initiated registry
§ We retrospectively analysed 321 consecutive pa...
Radial Pump up – population
Demographic characteristics
Double Femoral
(n=209)

Radial + femoral
(n=112)

p value

70 (61-...
Radial Pump up – population
Clinical characteristics
Double Femoral
(n=209)

Radial + femoral
(n=112)

p value

STEMI

79....
Radial Pump up – population
Clinical characteristics
Double Femoral
(n=209)

Radial + femoral
(n=112)

Severity of CAD

p ...
Radial Pump up – population
Procedural characteristics
Double Femoral
(n=209)

Radial + femoral
(n=112)

p value

≤ 6 Fren...
Radial Pump up – results
30-day NACE
Double +femoral arm
p = 0.001
p = 0.001

p = 0.027

57.4%

36.6%

33.5%

Radial + fem...
Radial Pump up – results
30-day NACE
Double +femoral arm
p = 0.001
p = 0.001

p = 0.027

57.4%

36.6%

33.5%

Radial + fem...
Radial Pump up – results
30-day bleedings* (BARC)
Double +femoral arm
Radial + femoral arm

p = 0.001

p = 0.002

p = 0.20...
Radial Pump up – results
BARC definitions*

321 consecutive patients requiring
peri-procedural IABP support

•  TYPE 1: bl...
Radial Pump up – results
30-day NACE
Double +femoral arm
p = 0.001
p = 0.001

p = 0.027

57.4%

36.6%

33.5%

Radial + fem...
Radial Pump up – results
30-day NACE
Double +femoral arm
p = 0.001
p = 0.001

p = 0.027

57.4%

36.6%

33.5%

Radial + fem...
Radial Pump up – results
30-day MACCE
Double +femoral arm
Radial + femoral arm

p = 0.004
34.9%

19.6%

p = 0.523

6.7% 7....
Radial Pump up – results
30-day outcome and hospital stay*
Double +femoral arm

OR	
  0.57	
  
(CI	
  95%	
  0.4-­‐0.9)	
 ...
Radial Pump up – conclusions

§  Transradial approach use for PCI requiring IABP
support positively impacts peri-procedur...
Radial Pump up – NACE & access site
12	
  (10.7%)	
  RF	
  group	
  
Pa4ent	
  with	
  only	
  
bleeding	
  52	
  (16.2%)	...
Radial Pump up – participating Centres
Ospedale	
  Morgagni	
  
Pierantoni,	
  Forlì	
  	
  
(Fabio	
  Taran4ni)	
  

Poli...
RADIAL VERSUS FEMORAL
APPROACH COMPARISON IN
PERCUTANEOUS CORONARY
INTERVENTION WITH INTRA-AORTIC
BALLOON PUMP SUPPORT
	
 ...
Radial Pump up – IABP & radial trend
88	
  
72	
  
78%	
  

52	
  

64%	
  

80%	
  

58	
  
51	
  
62%	
  

22%	
  

36%	...
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Romagnoli E - AIMRADIAL 2013 - Radial and IABP

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Radial versus femoral approach comparison in percutaneous coronary intervention with intra-aortic balloon pump support

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  • Transcript of "Romagnoli E - AIMRADIAL 2013 - Radial and IABP"

    1. 1. RADIAL VERSUS FEMORAL APPROACH COMPARISON IN PERCUTANEOUS CORONARY INTERVENTION WITH INTRA-AORTIC BALLOON PUMP SUPPORT   Enrico Romagnoli, MD, PhD Policlinico Casilino, Rome Italy 2nd Advanced International Masterclass AIM-RADIAL 2013
    2. 2. I, Enrico Romagnoli DO NOT have any real or apparent conflict of interest in the context of the subject of this presentation.
    3. 3. Radial Pump up – rationale §  The role of intra-aortic balloon pump (IABP) during percutaneous coronary intervention (PCI) in high-risk acute patients remains debated ( device-related complications?, complex patient management?) §  Transradial approach seems to improve outcome by means of an evident peri-procedural bleeding prevention, especially in the context of acute coronary syndromes… but is it always true?
    4. 4. Radial Pump up – objectives To evaluate if the selection of transradial approach still represents an advantage in terms of bleeding reduction and clinical outcome also in patients needing intraaortic balloon pump (IABP) support: §  Primary end-point 30-day procedural success (NACE)* §  Secondary end-points access-related bleeding rate hospital stay length *NACE = composite of post-procedural bleeding, cardiac death, myocardial infarction, target lesion revascularization and stroke)
    5. 5. Radial Pump up – methods §  Multicenter investigator-initiated registry § We retrospectively analysed 321 consecutive patients receiving IABP support during PCI in four independent high-volume centres. §  Patients were further divided in two groups: §  209 patients receiving double femoral (FF) access; §  112 patients receiving both radial and femoral (RF) approaches.
    6. 6. Radial Pump up – population Demographic characteristics Double Femoral (n=209) Radial + femoral (n=112) p value 70 (61-80) 69 (57-77) 0.104 Female gender (%) 29.2 23.2 0.251 Body mass index 26 (24-29) 26 (24-28) 0.257 CKD (GRF <60 ml/min/1.732) (%) 49.3 42.9 0.250 Peripheral arterial disease (%) 31.1 31.3 0.978 Diabetes (%) 28.2 31.3 0.571 30 (25-40) 30 (25-42) 0.587 Prior MI (%) 21.5 24.1 0.598 Prior stroke (%) 6.7 3.6 0.246 Prior revascularization (%) 24.4 26.8 0.639 Age (years) LVEF (%)
    7. 7. Radial Pump up – population Clinical characteristics Double Femoral (n=209) Radial + femoral (n=112) p value STEMI 79.0% 70.5% 0.101 NSTEMI 12.9% 17.9% 0.233 Unstable angina 1.4% 4.5% 0.115 Stable angina 3.8% 7.1% 0.193 Acute heart failure 2.9% 0.0% 0.095 Diagnosis (%) Killip class (%) 0.210 I 6.7% 3.6% 0.246 II 11.0% 17.0% 0.131 III 10.5% 16.1% 0.152 IV 71.8% 63.4% 0.122
    8. 8. Radial Pump up – population Clinical characteristics Double Femoral (n=209) Radial + femoral (n=112) Severity of CAD p value 0.517 Not significant (%) 3.3% 0.0% 0.101 Single vessel disease (%) 22.0% 25.9% 0.433 Double vessel disease (%) 32.1% 26.8% 0.327 Triple vessel disease (%) 42.6% 47.3% 0.415 88 (70-95) 90 (80-100) 0.006 Inotropic support (%) 67.9 58.0 0.077 Mechanical ventilation (%) 36.8 26.8 0.068 EuroSCORE additive 11 (9-14) 11 (8-13) 0.132 EuroSCORE logistic 27 (12-48) 24 (12-41) 0.190 SAP at admission (mmHg)
    9. 9. Radial Pump up – population Procedural characteristics Double Femoral (n=209) Radial + femoral (n=112) p value ≤ 6 French 76.1% 98.2% <0.001 ≥ 7 French 23.9% 1.8% <0.001 (Failed) thrombolysis 1.9% 4.5% 0.187 Heparin dose (U/Kg) 83 (68-100) 88 (70-100) 0.420 GP IIb/IIIa inhibitors 48.3% 39.3% 0.121 Thrombectomy device use 34.9% 44.6% 0.089 Bail-out IABP 27.8% 31.3% 0.368 Angiographic failure 17.2% 13.4% 0.372 Arterial sheath size (TIMI flow <3 and/or residual stenosis ≥30%)
    10. 10. Radial Pump up – results 30-day NACE Double +femoral arm p = 0.001 p = 0.001 p = 0.027 57.4% 36.6% 33.5% Radial + femoral arm 38.3% 25.9% 16.1% Bleedings NACE MACCE •  Bleeding = type 2, type 3 nd type 5 from BARC classification •  Major Adverse Cardiac and Cerebrovascular event (MACCE) = composite of cardiac death, myocardial infarction, target vessel revascularization, stroke •  Net Adverse Clinical Event (NACE) = MACCE + bleeding
    11. 11. Radial Pump up – results 30-day NACE Double +femoral arm p = 0.001 p = 0.001 p = 0.027 57.4% 36.6% 33.5% Radial + femoral arm 38.3% 25.9% 16.1% Bleedings NACE MACCE •  Bleeding = type 2, type 3 nd type 5 from BARC classification •  Major Adverse Cardiac and Cerebrovascular event (MACCE) = composite of cardiac death, myocardial infarction, target vessel revascularization, stroke •  Net Adverse Clinical Event (NACE) = MACCE + bleeding
    12. 12. Radial Pump up – results 30-day bleedings* (BARC) Double +femoral arm Radial + femoral arm p = 0.001 p = 0.002 p = 0.204 33.5% 16.1% 18.7% 14.8% 6.3% Bleedings* Access site related 9.8% Non access site related •  including Type 2, Type 3 and Type 5 from BARC classification.
    13. 13. Radial Pump up – results BARC definitions* 321 consecutive patients requiring peri-procedural IABP support •  TYPE 1: bleeding not actionable and does not cause unscheduled studies, treatment or hospitalization •  TYPE 2: any overt, actionable sign Double Femoral arm (N=209) Radial + femoral arm (N=112) of hemorrhage that does not fit the criteria for type 3, 4, or 5 Bleeding •  TYPE 3: • overt bleeding plus Hb drop >3g/dL • any transfusion with overt bleeding • cardiac tamponade • bleeding requiring surgical intervention • bleeding requiring intravenous vasoactive agents 33.5% Bleeding 16.1% Type 0-1 66.5% Type 0-1 83.9% Type 2 7.7% Type 2 6.3% Type 3 24.4% Type 3 8.9% Type 4 0% Type 4 0% Type 5 1.4% Type 5 0.9% •  TYPE 4: CABG-related bleeding •  TYPE 5: fatal bleeding P = 0.001 *Mehran R. et al, Circulation 2011;123(23):2736-47
    14. 14. Radial Pump up – results 30-day NACE Double +femoral arm p = 0.001 p = 0.001 p = 0.027 57.4% 36.6% 33.5% Radial + femoral arm 38.3% 25.9% 16.1% Bleedings NACE MACCE •  Bleeding = type 2, type 3 nd type 5 from BARC classification •  Major Adverse Cardiac and Cerebrovascular event (MACCE) = composite of cardiac death, myocardial infarction, target vessel revascularization, stroke •  Net Adverse Clinical Event (NACE) = MACCE + bleeding
    15. 15. Radial Pump up – results 30-day NACE Double +femoral arm p = 0.001 p = 0.001 p = 0.027 57.4% 36.6% 33.5% Radial + femoral arm 38.3% 25.9% 16.1% Bleedings NACE MACCE •  Bleeding = type 2, type 3 nd type 5 from BARC classification •  Major Adverse Cardiac and Cerebrovascular event (MACCE) = composite of cardiac death, myocardial infarction, target vessel revascularization, stroke •  Net Adverse Clinical Event (NACE) = MACCE + bleeding
    16. 16. Radial Pump up – results 30-day MACCE Double +femoral arm Radial + femoral arm p = 0.004 34.9% 19.6% p = 0.523 6.7% 7.1% Cardiac death p = 0.881 3.8% 5.4% Myocardial Infarction Target Vessel Revascularization p = 0.364 1.9% 3.6% Cerebrovascular Accident
    17. 17. Radial Pump up – results 30-day outcome and hospital stay* Double +femoral arm OR  0.57   (CI  95%  0.4-­‐0.9)   p=  0.007†   Radial + femoral arm Double Femoral Radial + femoral (n=209) (n=112) 10 (7-18) 9 (7-14) 0.379 Intensive coronary care unit 6 (3-9) 4 (2-7) 0.078 Cardiology ward 4 (1-6) 4 (1-7) 0.975 Hospital stay † Propensity adjusted * Expressed as median and quartiles p value
    18. 18. Radial Pump up – conclusions §  Transradial approach use for PCI requiring IABP support positively impacts peri-procedural NACEs rate by means of a significant accesssite-related bleeding prevention. §  Further studies are warranted to assess whether the routine application of transradial approach might represent an opportunity to improve outcome in high-risk patients undergoing PCI.
    19. 19. Radial Pump up – NACE & access site 12  (10.7%)  RF  group   Pa4ent  with  only   bleeding  52  (16.2%)   p  =  0.073   40  (19.1%)  FF  group   23  (20.5%)  RF  group   Pa4ent  with  NACE   162  (50.2%)   Pa4ent  with  only   MACCE  73  (22.7%)   p  =  0.582   50  (23.9%)  FF  group   6  (5.4%)  RF  group   Pa4ent  with  MACCE   +  bleeding  36  (11.2%)   p  =  0.024   30  (14.3%)  FF  group  
    20. 20. Radial Pump up – participating Centres Ospedale  Morgagni   Pierantoni,  Forlì     (Fabio  Taran4ni)   Policlinico  Casilino     (Ernesto  Lioy)   Azienda  Ospedaliera   Fatebenefratelli   (Bernardo  Cortese)   Università  CaTolica   del  Sacro  Cuore     (Carlo  Trani)  
    21. 21. RADIAL VERSUS FEMORAL APPROACH COMPARISON IN PERCUTANEOUS CORONARY INTERVENTION WITH INTRA-AORTIC BALLOON PUMP SUPPORT   Enrico Romagnoli, MD, PhD Policlinico Casilino, Rome Italy 2nd Advanced International Masterclass AIM-RADIAL 2013
    22. 22. Radial Pump up – IABP & radial trend 88   72   78%   52   64%   80%   58   51   62%   22%   36%   2008 2009 20%   2007 total  IABP  use Double  Femoral 32%   38%   68%   2010 2011 Radial  +  Femoral

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