18 aimradial2016 thu A Ziakas MEMORY Study

18 aimradial2016 thu A Ziakas MEMORY Study

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  The MEMORY Study ManualvErsus Mechanical cOmpression of the Radial arterY after transradial coronary angiography A.Ziakas As.Professor Cardiology AHEPA University Hospital Aristotle University Thessaloniki -Greece
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  CONFLICT OF INTEREST •There is no conflict of interest present
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  BACKGROUND • There arecontroversial results regarding vascular complications of manual compression versus use of closure devices post trans-femoral catheterization. • More recent data show that closure devices are not inferior to manual compression (ISAR-CLOSURE, metanalysis). However, many “femoralists“ consider manual hemostasis superior regarding safety.
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  BACKGROUND • Mechanical compressionwith radial artery compression devices is almost always used post trans-radial angiography and PCI due to its convenience. • However some people use manual compression routinely, because it allows earlier hemostasis and so… earlier patient discharge, the cost is lower, and because of the “belief” that manual is superior in the leg, so… why not the same in the arm. • Manual compression of the radial artery is preferred in private hospitals in Greece for the same reasons. • There are no data comparing the 2 approaches in radial artery hemostasis.
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  Design of theStudy • Randomized –multicenter • Goal 600pts –here we report the results of the first 400pts • 5 cath labs across Greece  1st Department of Cardiology, Aristotle University of Thessaloniki  Department of Cardiology, Patras University Hospital (Dr Hahalis, Dr Tsigkas)  Department of Cardiology, Heraklion University Hospital (Dr Hamilos)  2nd department of Cardiology, Hellenic Red Cross Hospital, Athens (Dr Koutouzis)  Department of Cardiology, Veroia General Hospital (Dr Datsios) • Prospective cohort study aiming to compare mechanical vs manual compression of the radial artery post coronary angiography. • Inclusion criteria-methods: • Any patient > 25 y.o. undergoing transradial coronary angiography for any reason. • All patients underwent angiography with the use of 5F sheath and received 50 iu/kg UFH. • Patent hemostasis was pursued in all patients
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  Design of theStudy EXCLUSION CRITERIA Pre-Randomization • No written consent • Pathologic Barbeau test • Anticoagulant therapy • Cardiogenic shock • Renal Insufficiency on dialysis or eGFR < 30ml/min • Bleeding predisposition • Hepatic Insufficiency • PLT < 100.000 • Ad-hoc angioplasty • Sheath diameter > 5F Post-Randomization • Inability for radial artery tripplex 24h after coronary angiography • Consent withdrawal STUDY END-POINTS Primary Early (within) 24h radial artery occlusion (RAO) (Radial artery triplex 24h post angiography) Secondary Bleeding (BARC score) Hematomas (EASY classification) Hemostasis Duration
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  Hemostasis Protocol • MECHANICAL Immediatesheath removal after angiography • Attempt for patent hemostasis • hemostatic device with titratable pressure MANUAL • Immediate sheath removal after angiography • Pressure with three fingers over the puncture site and centrally • Attempt for patent hemostasis • Patency checked every 1-2 min • Compression for at least 10 mins and for as long needed to stop bleeding • When hemostasis achieved, wound covered with gauze and elastic bandage (patency rechecked after wound coverage) • Remove bandage after 1-2 h
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  Patients Characteristics (First400) Manual (N=195) Mechanical (N=205) P value DEMOGRAPHICS Male Sex 136 (69.7%) 145 (70.7%) 0.83 Age (y.o.) 63.5 ± 11 64 ± 11 0.66 Weight (kg) 82.6 ± 16 84.9 ± 16 0.16 BSA (kg/m2) 1.94 ± 0.2 1.97 ± 0.19 0.42 CAG INDICATION ACS 62 (31.7%) 51 (26.3%) 0.12 Stable CAD 67 (34.5%) 77 (37.4%) 0.50 Other 66 (33.8%) 77 (37.6%) 0.44 CO-MORBIDITIES Known CAD 39 (20%) 48 (23.4%) 0.41 Art. Hypertension 124 (63.6%) 119 (58%) 0.26 Diabetes Melitus 62 (31.8%) 60 (29.3%) 0.58 Dyslipidemia 94 (48.2%) 94 (45.9%) 0.64 Active Smoking 77 (39.5%) 67 (32.7%) 0.16 Familial History of Premature CAD 29 (14.9%) 24 (11.7%) 0.35 PROCEDURAL ASPECTS Right Radial Artery 191 (97.9%) 198 (96.6%) 0.40 Fluoroscopy Time (min) 3.37 ± 1.87 3.54 ± 2.66 0.26 UFH dose (iu) 4116 ± 828 4276 ± 809 0.057 Contrast Volume (ml) 71 ± 24 76 ± 27 0.059
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  Success of PatentHemostasis 88.7% Manual Patent Not Patent 82.9% Mechanical P=0.098
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  Early RAO 0 50 100 150 200 250 11,3% 6.3% P=0.08 Patent RAO 0 20 40 60 80 100 120 140 160 180 7.5%2.9% Patent RAO P=0.059 All patients Successful patent hemostasis subgroup
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  Hematomas* 0 50 100 150 200 250 Manual Mechanical 17.9% 21.4% P=0.38Normal Hematoma * All hematomas were insignificant (EASY class I-II), with the exception of 1 class III hematoma in the manual group.
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  Bleeding* 0 50 100 150 200 250 Manual Mechanical P=0.28 1% 2.4% Normal Bleeding *Allhemorrhages were minor (BARC 1-2)
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  Hemostasis Duration 13±10.6 min 108±58.7min 0 50 100 150 200 250 300 Manual Mechanical P<0.0001 In all 5 centers 1 or 2 the most doctors performed manual compression There was no relation between time of hemostasis and rao in the manual group We did not also notice any learning curve in radial artery patency in the manual group
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  0 1 2 3 4 5 6 7 8 9 10 1 2 3 manualcompression mechanical compression First 1/3pts second 1/3pts last 1/3 pts RAO Rao incidence during the study
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  CONCLUSIONS • There seemsto be a trend (although not statistically significant yet) towards more early RAOs in the manual compression group. • There is no difference in hematomas and bleeding complications between the two groups. • Hemostasis duration is significantly shorter in the manual group.
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  THESSALONIKI-GREECE