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Ankaferd Blood Stopper as a New Strategy to Avoid Early
Complication After Transradial Procedures:
A Randomized Clinical Trial
Sevket Gorgulu, MD, Acibadem University
Professor of Cardiology
Istanbul/Turkey 1
I have no conflict of interest
3
Courtesy Prof.Samir Pancholy
4
5
Courtesy Prof.Samir Pancholy
6
Courtesy Prof.Samir Pancholy
7
Courtesy Prof.Samir Pancholy
8
9
Randomized(n=567)
Lost to
follow- up
10
Group1:Ankaferd Blood Stopper(ABS)
Final dressing
Ulnar artery
Radial artery
Group 2: Folded Sterile
Gauze (FSG)
11
12
Baseline Characteristics
(n=482)
ABS
(n=160)
FGAUZE
(n=161)
TR BAND
(n=161)
P value
P<0.05
Age (year) 62,53 61,90 61,47 NS
Female (%) 30 34 36 NS
Smoke(n=) 41 42 47 NS
Diabetes(n=) 62 56 61 NS
Hypertension(n=) 100 100 104 NS
Previous MI(n=) 11 4 12 NS
BMI (kg/m2) 28,79 29,29 29,16 NS
PVD(n=) 16 7 12 NS
Previous CABG(n=) 18 15 21 NS
Dyslipidemia(n=) 37 23 35 NS
Chronic p2y12 inhibitor therapy 2 4 3 NS
Chronic aspirin therapy(n=) 73 84 90 NS
Chronic clopidogrel therapy 33 31 34 NS
Warfarin (n=) 5 6 6 NS
New Oral Anticoagulants(n=) 5 1 2 NS
Height(cm) 167 168 168 NS13
Clinical and Procedural
Characteristics (n=482)
ABS
(n=160)
FGAUZE
(n=161)
TR BAND
(n=161)
P value
P<0.05
Asymptomatic 53 59 47 NS
Stable Angina Pectoris 85 85 92 NS
Acute Coronary Syndrome 17 15 17 NS
Peripheral Procedure 5 2 7 NS
Previous radial puncture 35 25 31 NS
Tirofiban usage 7 5 6 NS
Right radial aproach 134 144 138 NS
Radial anomaly on angiography 22 11 20 NS
Radial artery diameter (mm) 2,10 2,16 217 NS
Procedural time (minute) 15,6 16,2 14,4 NS
Volume of Contrast(ml) 94.2 95.1 90,1 NS
Loading dose of clopidogrel 40 52 43 NS
Unsuccessful patent hemostasis 2 1 0 NS
Total nursing time after procedure
(minute)
2,43 2,78 2,57 NS
Pain after 24 hours 1,83 2 1,15 0,001
Need for manuel compression 16 41 32 0,004
14
Outcome Measures (n=482) ABS
(n=160)
FGAUZE
(n=161)
TR BAND
(n=161)
P value
P<0.05
RAO at the end of hemostasis 0 1 1 NS
RAO 24 hours follow-up 0 1 1 NS
RAO 30-Day follow-up 0 0 0 NS
Hematoma 5 6 1 NS
Active bleeding after device
removal
16 42 33 0,001
Univariate analysis for bleeding
P value P<0.05
Kreatinin NS
Diabetes NS
Previous radial puncture NS
Chronic clopidogrel therapy NS
Loading dose of clopidogrel NS
Chronic aspirin therapy NS
Procedural time NS
Radial artery diameter 0,036
Heparin dose 0,016
15
% RAO
16
17
Conclusion
• RAO with ABS (immediate,24 hr,30-day)
0%
• Re-bleeding with ABS 10%
• Hypotesis generating:
18
Compression time duration Re-bleeding
19

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04 Gorgulu aimradial20170922 Hemostatic agents

  • 1. Ankaferd Blood Stopper as a New Strategy to Avoid Early Complication After Transradial Procedures: A Randomized Clinical Trial Sevket Gorgulu, MD, Acibadem University Professor of Cardiology Istanbul/Turkey 1
  • 2. I have no conflict of interest
  • 3. 3
  • 5. 5
  • 9. 9
  • 11. Group1:Ankaferd Blood Stopper(ABS) Final dressing Ulnar artery Radial artery Group 2: Folded Sterile Gauze (FSG) 11
  • 12. 12
  • 13. Baseline Characteristics (n=482) ABS (n=160) FGAUZE (n=161) TR BAND (n=161) P value P<0.05 Age (year) 62,53 61,90 61,47 NS Female (%) 30 34 36 NS Smoke(n=) 41 42 47 NS Diabetes(n=) 62 56 61 NS Hypertension(n=) 100 100 104 NS Previous MI(n=) 11 4 12 NS BMI (kg/m2) 28,79 29,29 29,16 NS PVD(n=) 16 7 12 NS Previous CABG(n=) 18 15 21 NS Dyslipidemia(n=) 37 23 35 NS Chronic p2y12 inhibitor therapy 2 4 3 NS Chronic aspirin therapy(n=) 73 84 90 NS Chronic clopidogrel therapy 33 31 34 NS Warfarin (n=) 5 6 6 NS New Oral Anticoagulants(n=) 5 1 2 NS Height(cm) 167 168 168 NS13
  • 14. Clinical and Procedural Characteristics (n=482) ABS (n=160) FGAUZE (n=161) TR BAND (n=161) P value P<0.05 Asymptomatic 53 59 47 NS Stable Angina Pectoris 85 85 92 NS Acute Coronary Syndrome 17 15 17 NS Peripheral Procedure 5 2 7 NS Previous radial puncture 35 25 31 NS Tirofiban usage 7 5 6 NS Right radial aproach 134 144 138 NS Radial anomaly on angiography 22 11 20 NS Radial artery diameter (mm) 2,10 2,16 217 NS Procedural time (minute) 15,6 16,2 14,4 NS Volume of Contrast(ml) 94.2 95.1 90,1 NS Loading dose of clopidogrel 40 52 43 NS Unsuccessful patent hemostasis 2 1 0 NS Total nursing time after procedure (minute) 2,43 2,78 2,57 NS Pain after 24 hours 1,83 2 1,15 0,001 Need for manuel compression 16 41 32 0,004 14
  • 15. Outcome Measures (n=482) ABS (n=160) FGAUZE (n=161) TR BAND (n=161) P value P<0.05 RAO at the end of hemostasis 0 1 1 NS RAO 24 hours follow-up 0 1 1 NS RAO 30-Day follow-up 0 0 0 NS Hematoma 5 6 1 NS Active bleeding after device removal 16 42 33 0,001 Univariate analysis for bleeding P value P<0.05 Kreatinin NS Diabetes NS Previous radial puncture NS Chronic clopidogrel therapy NS Loading dose of clopidogrel NS Chronic aspirin therapy NS Procedural time NS Radial artery diameter 0,036 Heparin dose 0,016 15
  • 17. 17
  • 18. Conclusion • RAO with ABS (immediate,24 hr,30-day) 0% • Re-bleeding with ABS 10% • Hypotesis generating: 18 Compression time duration Re-bleeding
  • 19. 19

Editor's Notes

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