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

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 ?