Randomized comparison of low (2500 IU) versus standard (5000 IU) heparin dose for prevention of forearm artery occlusion after coronary angiography

1. AIM-RADIAL 2013 Thursday, September 26, 2013
Hemostasis, Radial Artery Injury and Occlusion
Randomized comparison of low (2500 IU) versus
standard (5000 IU) heparin dose for prevention of
forearm artery occlusion after coronary
angiography
“SPIRIT OF ARTEMIS” (Studying the PrIoRITy OF Anticoagulation to PRevent
ArTErial Occlusion After ForearM AngIographIeS) Study.
George Hahalis, Gregory Tsigkas, Ioanna Xanthopoulou, Ioanna Koniari,
Nikos Grapsas, George Almpanis, John Christodoulou, Dimitrios Alexopoulos
University Hospital
Patras Medical School,
Rio, Patras, Greece

2. Disclosure: George Hahalis, M.D.
Dr. Hahalis has no relevant financial
interests to disclose

3. Background
 Radial artery occlusion (RAO) remains the “Achilles
heel” of transradial coronary procedures.
 Higher over lower levels of systemic anticoagulation
are believed to reduce RAO rates but this is illsupported by scientific evidence
 In the only to-date existing randomized trial, Bernat I et
al showed a non-significant reduction of RAOs with
5000 IU over 2000 IU unfractionated heparin from
5.9% to 2.9% (p=0.17) and recanalization of 3-4 hour
RAOs with one-hour ipsilateral ulnar artery occlusion
Bernat I, Bertrand O, ….Costerousse O. Am J Cardiol 2011:107:1698

4. Methods I
 Prospective, randomized, single-center, superiority study
of parallel design
 Comparison of standard (5000) with low dose (2500)
units of unfractionated heparin (UFH) as anticoagulation
strategy to prevent arterial occlusions in patients
subjected to transradial or transulnar diagnostic coronary
angiography.
 The primary end-point was arterial occlusion as
determined ultrasonographically within 60 days after
coronary angiography

5. Methods II-Inclusion criteria
 We first included patients within an investigator-initiated
randomized substudy of the Transulnar Compared With
Transradial Artery Approach as a Default Strategy for
Coronary Procedures: A Randomized Trial
(The AURA of ARTEMIS trial)
 Patients were enrolled if :
 they were scheduled for diagnostic coronary angiography
 the interventional cardiologist was willing to proceed with
either radial or ulnar access
 After that study had been completed, additional patients were
enrolled in the present trial

6. Methods II- Exclusion criteria
 Patients were excluded before randomization according to the
following exclusion criteria:
 chronic hemodialysis,
 oral anticoagulation
hemodynamic instability,
 severe dermo-myoskeletal forearm deformities,
 history of CABG and bilateral use of either the internal mammary or
radial artery, history of CABG and ipsilateral use of both the internal
mammary and radial artery

 Patients were excluded after randomization
 when crossover to another arterial access site had been required
 a different than 5F sheath size had been inserted

ad hoc PCI had been performed.

7. Methods II- Exclusion criteria
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8. Study flow chart

9. Table 1. Demographic and procedural characteristics of randomized patients
Heparin 2500 IU
Heparin 5000 IU
p
Age (years)
Male gender
BMI(kg/m2)
Heparin(IU)/Weight (Kg)
History
-Diabetes mellitus
-Smoking
-Hypertension
-Hypercholesterolemia
-Prior CAD
-Prior CABG
Diagnosis at admission
-STEMI*
-NSTE-ACS*
- Heart valve
disease/stable or
suspected CAD
N=302
65.8±10.6
226(74.8)
28.3±4.5
31.9±5.8
N=301
64.9±10.8
223(74.1)
28.8±4.2
62.4±11.8
value
0.3
0.9
0.2
<0.001
93(30.8)
119(39.4)
190(62.9)
182(60.3)
74(24.5)
13(4.3)
96(31.9)
121(40.2)
198(65.8)
186(61.8)
62(20.6)
10(3.3)
0.8
0.9
0.5
0.7
0.3
0.7
0.6
9(3.0)
111(36.8)
182(60.3)
11(3.7)
100(33.2)
190(63.1)

10. Table 1.Demographic and procedural characteristics of randomized patients
Heparin 2500 IU Heparin 5000 IU
p
N=302
N=301
Antithrombotic medication pre- or peri-procedural
-Aspirin
201(66.6)
179(59.5)
-P2Y12 platelet
164(54.3)
174(57.8)
receptor
antagonists
Other medication
-Statin
211(69.9)
207(68.8)
-β blocker
181(59.9)
161(53.5)
-ACE -I/ATII rec bl
154(51.0)
171(56.8)
-Ca2+ CB
43(14.2)
54(17.9)
-Insulin
15(5.0)
16(5.3)
N=256
N=254
Ht (%)
40.9±4.4
41.1±4.6
PLTs
233.0±76.4
227.0±58.8
CrCl (ml/min)
85.6±34.6
87.4±33.1
value
0.08
0.4
0.8
0.1
0.2
0.2
0.9
0.8
0.3
0.5

11. Table 1. Demographic and procedural characteristics of randomized patients
Heparin 2500 IU Heparin 5000 IU
pN=302
18(6.0)
4(1.3)
N=301
26(8.6)
2(0.7)
value
0.2
0.7
0.3
Allen’s test ischemic
Reversed Allen’s test ischemic
Arterial access
-Radial
-Ulnar
Attempts until successful
arterial access
Procedural time (min)
Contrast medium (ml)
203(67.2)
99(32.8)
2(1-3)
216(71.8)
85(28.2)
2(1-2)
0.9
10(6.2-14.1)
75.4
10(7.0-15.0)
79.0
0.6
0.4
Fluoroscopy time (min)
(51.9-104.3)
2.9(1.6-4.8)
(54.4-103.1)
2.7(1.7-4.3)
0.8

12. OR (95% CI’s): 1.45 (0.86-2.50)
P=0.2
 Median follow-up of 8(1-60) days
 60 arterial occlusions (10.2%) among the 589 analyzed patients
 No significant interaction was detected between the arterial
access site (i.e., radial and ulnar) and the effect of
anticoagulation dosage on occlusion rate (interaction p=0.2)

13. Conclusions (1)
 Despite using only 5F catheters for a short-
lasting procedure, the arterial occlusion rate
was relatively high in our patients
 Systemic anticoagulation with higher as
compared with lower heparin dose was not
superior in reducing the frequency of forearm
artery occlusions after coronary angiography
 Certain study limitations should be
acknowledged
(sheaths, hemostatic devices and nonuniform hemostatic approach)

14. Conclusions (2)
 In our experience, arterial occlusion remains the
silent protagonist in the complication spectrum
after forearm coronary procedures
 A multifaceted strategy, possibly including
higher anticoagulation dosage as well as more
research are needed to minimize incident
occlusions