AIM-RADIAL 2013 Thursday, September 26, 2013
Hemostasis, Radial Artery Injury and Occlusion

Randomized comparison of low ...
Disclosure: George Hahalis, M.D.
Dr. Hahalis has no relevant financial
interests to disclose
Background
 Radial artery occlusion (RAO) remains the “Achilles

heel” of transradial coronary procedures.
 Higher over ...
Methods I
 Prospective, randomized, single-center, superiority study

of parallel design
 Comparison of standard (5000) ...
Methods II-Inclusion criteria
 We first included patients within an investigator-initiated

randomized substudy of the Tr...
Methods II- Exclusion criteria
 Patients were excluded before randomization according to the

following exclusion criteri...
Methods II- Exclusion criteria
ters
nostic cathe
iag
nventional d
•Co
illic)
on-hydroph
(n
ostly Cordis
sm
ucer sheath
•In...
Study flow chart
Table 1. Demographic and procedural characteristics of randomized patients
Heparin 2500 IU
Heparin 5000 IU
p
Age (years)
M...
Table 1.Demographic and procedural characteristics of randomized patients
Heparin 2500 IU Heparin 5000 IU
p
N=302
N=301
An...
Table 1. Demographic and procedural characteristics of randomized patients
Heparin 2500 IU Heparin 5000 IU
pN=302
18(6.0)
...
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 ...
Conclusions (1)
 Despite using only 5F catheters for a short-

lasting procedure, the arterial occlusion rate
was relativ...
Conclusions (2)
 In our experience, arterial occlusion remains the

silent protagonist in the complication spectrum
after...
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Hahalis G - AIMRADIAL 2013 - Heparin and occlusion rate

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

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Hahalis G - AIMRADIAL 2013 - Heparin and occlusion rate

  1. 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. 2. Disclosure: George Hahalis, M.D. Dr. Hahalis has no relevant financial interests to disclose
  3. 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. 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. 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. 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. 7. Methods II- Exclusion criteria ters nostic cathe iag nventional d •Co illic) on-hydroph (n ostly Cordis sm ucer sheath •Introd s static device o •Diverse hem ly; stasis initial mo dy ressure” he alf of the stu inimal p •“M dh in the secon sis nt” hemosta “pate t; assessmen ler hy r flow Dopp •Colo rasonograp ult sion repeat cclu in case of o
  8. 8. Study flow chart
  9. 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. 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. 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. 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. 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. 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

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