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

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

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Transcript

  • 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. I, Enrico Romagnoli DO NOT have any real or apparent conflict of interest in the context of the subject of this presentation.
  • 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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