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Bivalirudin or heparin and provisional IIb/IIIa inhibitors in primary angioplasty performed through transradial approach

Bivalirudin or heparin and provisional IIb/IIIa inhibitors in primary angioplasty performed through transradial approach

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  • Most of bleedings were located at genito-urinary or gastrointestinal tract (8 cases, 73%) but there were also two cases of femoral access site bleedings in patients with intra-aortic balloon pump and 1 case of intracranial bleeding
  • it is a retrospective study of prospectively collected data rather than a randomized clinical trial. Consequently we cannot exclude a selection bias for the therapy employed. Another limitation is due to the inclusion of only transradial access patients: in this way many patients with cardiogenic shock or highly unstable were probably excluded because performed through transfemoral access. Finally another limitation is the long time frame (5 years) of recruitment with differences in term of stents employed or antiplatelet therapy over time.
  • it is a retrospective study of prospectively collected data rather than a randomized clinical trial. Consequently we cannot exclude a selection bias for the therapy employed. Another limitation is due to the inclusion of only transradial access patients: in this way many patients with cardiogenic shock or highly unstable were probably excluded because performed through transfemoral access. Finally another limitation is the long time frame (5 years) of recruitment with differences in term of stents employed or antiplatelet therapy over time.

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  • 1. Bivalirudin or heparin and provisional IIb/IIIa inhibitors in primary angioplasty performed through transradial approach Alessandro Sciahbasi, Stefano Rigattieri, Bernardo Cortese, Flavia Belloni, Carmelo Russo, Pedro Silva, Alessandro Ferrarironi, Maurizio Tespili, Chiara Angeletti, Roberto Ricci, Francesco Bondanini, Paolo Loschiavo NEW YORK 27/09/2013
  • 2. Disclosures Lectures fee for Bayer HealthCare.
  • 3. Background Anticoagulant with antiplatelet proprieties
  • 4. Background Major bleedings (%) Indication obtained from the Horizon trial Heparin + GPIIb/IIIa inhibitors (n= 1802) Bivalirudin (n= 1800) 8.4% 5.0% HR [95%CI] = 0.59 [0.45, 0.76] P<0.0001 Days Few patients with transradial approach
  • 5. Background MacHalany et al. Am J Cardiol 2012; 110; 1742-1748 Hamon et al. Eurointervention 2009; 5: 115-120
  • 6. Background Baklanov et al. Circ Cardiovasc Interv 2013; 6: 347-353
  • 7. AIM OF THE STUDY Aim of our study was to compare the clinical effect of bivalirudin therapy and heparin in patients with acute STEMI who underwent primary PCI through transradial approach.
  • 8. Methods From January 2008 to June 2013 all patients who undewent primary PCI through transradial approach for acute STEMI at three Italian hospitals were retrospectively recruited No Exclusion criteria Bivalirudin Therapy Unfractionated Heparin Therapy
  • 9. End-point Two primary end-points were defined: an haemorragic end point defined as the rate of major bleeding and an ischemic end-point defined as the rate of major adverse cardiac events (MACE). Secondary end-points were minor bleeding, reinfarction, target vessel failure, stent thrombosis and a net clinical outcome end-point defined as the combination of the primary haemorragic and ischemic end-point.
  • 10. Results A total of 1009 patients was enrolled Bivalirudin (n= 154) Heparin (n= 855) P Age (years) 65 ± 14 63 ± 12 0.08 Male, n (%) 121 (79) 702 (82) 0.35 Height (cm) 168 ± 9 169 ± 8 0.14 Weight (kg) 79 ± 16 79 ± 14 0.65 BMI 28 ± 5 28 ± 4 0.71 Previous myocardial infarction 21 (14) 93 (11) 0.39 Previous PCI 17 (11) 74 (9) 0.42 Previous CABG 3 (2) 16 (2) 0.80 Previous stroke 8 (5) 20 (2) 0.09 Diabetes 32 (21) 184 (21) 0.92 Hypertension 99 (64) 460 (54) 0.02 Current smokers 72 (47) 418 (49) 0.69 Peripheral vascular disease 4 (3) 6 (4) 0.51 Dyslipidemia 43 (28) 321 (38) 0.03 Family History of ischemic heart disease 20 (13) 162 (19) 0.08 Peripheral vascular disease 8 (5) 84 (10) 0.09 Characteristic
  • 11. Results Bivalirudin (n= 154) Heparin (n= 855) P Number of stent/patient 1.3 ± 0.6 1.3 ± 0.7 0.34 Stent length (mm) 21 ± 6 21 ± 6 0.30 Stent diameter (mm) 3.1 ± 0.5 3.1 ± 0.5 0.28 Number of vessels diseased 1.8 ± 0.8 1.7 ± 0.8 0.13 Left main stem 1 (1) 22 (3) 0.24 Left anterior descending 78 (51) 407 (47) 0.54 Circumflex artery 22 (14) 129 (15) 0.89 Right coronary artery 53 (34) 293 (34) 0.96 Venous graft 0 (0) 4 (1) 0.88 Glycoprotein IIb/IIIa inhibitors N (%) 6 (4) 472 (55) <0.001 Intraortic balloon pump N (%) 4 (3) 30 (3) 0.74 Thrombus aspiration device N (%) 71 (46) 345 (40) 0.21 Symptoms to balloon time 198 (130-350) 215 (135-420) 0.49 Procedural data Infarct related artery N (%)
  • 12. Primary End-point % 15 P= 0.27 Bivalirudin 10.4 10 Heparin 7.1 5 P= 0.88 0.7 1.1 0 MACE Major Bleeding
  • 13. All End-points End-point N (%) Bivalirudin (n= 154) Heparin (n= 855) P MACE 11 (7.1) 89 (10.4) 0.27 Death 6 (3.9) 46 (5.4) 0.56 Re-infarction 3 (2) 30 (3.5) 0.45 Target vessel failure 2 (1.3) 13 (1.5) 0.83 Stent thrombosis 2 (1.3) 12 (1.4) 0.92 Stroke 0 (0) 1 (0.1) 1.00 TIMI Major 1 (0.7) 10 (1.1) 0.88 TIMI Minor 2 (1.3) 13 (1.5) 0.83 TIMI Major + Minor 3 (2) 23 (3) 0.80 12 (7.8) 99 (11.6) 0.21 Bleedings Net clinical end-point¶
  • 14. Results Parameter Bivalirudin Heparin P Haemoglobin – baseline (g/dL) 14.3 ± 1.6 14.4 ± 1.8 0.55 Haemoglobin – nadir (g/dL) 13.3 ± 1.6 13.3 ± 1.7 0.99 Haematocrit – baseline (%) 43 ± 5 42 ± 4 0.15 Haematocrit – nadir (%) 40 ± 5 40 ± 5 0.57 Platelet count – baseline (x103/μL) 244 ± 75 248 ± 75 0.59 Platelet count – nadir (x103/μL) 218 ± 79 224 ± 67 0.33 Creatinine – baseline (mg/dl) 0.97 ± 0.3 0.96 ± 0.2 0.81 Creatinine – nadir (mg/dl) 0.99 ± 0.5 0.99 ± 0.3 0.85
  • 15. Sites of major bleeding Gastrointestinal 5 cases 73% Genito-urinary 3 cases Femoral access site 2 cases Intracranial 1 case
  • 16. Multivariate analysis OR 95% CI P Age (1 year increase) 1.04 1.01-1.07 0.003 Ejection fraction (1 % increase) 0.94 0.91-0.97 <0.001 Left main PCI 5.32 1.69-16.73 0.004 Heparin alone 1.89 1.00-3.54 0.049 Intraortic balloon pump 7.16 2.91-17.62 <0.001 Diabetes 2.86 1.52-5.39 0.001 Glycoprotein IIb/IIIa inhibitors 2.67 1.1-6.46 0.029 Intraortic balloon pump 8.23 2.55-26.61 <0.001 MACE Bleedings (TIMI Major + Minor)
  • 17. Limitations No randomized study Small number of bivalirudin patients enrolled Long time frame of recruitment
  • 18. Conclusions In this large multicenter registry of patients with acute ST elevation myocardial infarction who underwent primary PCI through transradial approach we did not observe significant differences in terms of major bleeding or MACE comparing bivalirudin therapy with heparin. However the use of GP IIb/IIIa inhibitors was an independent risk factor for bleeding and heparin therapy alone an independent risk factor for MACE.
  • 19. In the Future… Is TRI superior to TFI ? Should Bivalirudin be prolonged Is Bivalirudin superior to UFH ? after PCI ?