Jun-Won Lee, Sang Wook Park, Jung-Woo Son, Young Jin Youn, Min-Soo Ahn, Sung Gyun Ahn, Jang-Young Kim, Byung-Soo Yoo, Junghan Yoon, Seung-Hwan Lee
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1 The procedural success and complication rate of the left distal radial approach for coronary angiography and percutaneous coronary intervention. Prospective observational study (LeDRA) Jun-Won Lee, Sang Wook Park, Jung-Woo Son, Young Jin Youn, Min-Soo Ahn, Sung Gyun Ahn, Jang-Young Kim, Byung-Soo Yoo, Junghan Yoon, Seung-Hwan Lee Division of cardiology, Department of internal medicine, Yonsei University Wonju College of Medicine, Wonju, Korea
2 Disclosure Study funding: Samjin Pharmaceutical Co., Ltd, Korea
3 What is let distal radial approach?
4 Background and Purpose The radial artery has been established as a preferred route for coronary angiography (CAG) and percutaneous coronary intervention (PCI). Recently, a left distal radial artery has been proposed as an alternative to selected patients with high procedural success rate and low complication rate. Whether a distal radial approach can be a primary access site for CAG and PCI is inconclusive. Therefore, we aimed to evaluate the feasibility and safety of the use of left distal radial approach as a default route for CAG and PCI through the present all-comers registry.
5 Study flow diagram Enrollment: 11 Oct Jan 2018 (NCT ) Consecutive patients with palpable left distal radial artery punctured by 3 experienced radial operators (n=200) Puncture failure (n=9) Patients with successful puncture (n=191) Baseline ultrasonographic evaluation (n=151) Clinical follow-up at 1 month (n=171) Follow-up ultrasonographic evaluation (n=141) Follow-up loss (n=18) Cardiac death (n=2)
6 Study Endpoints Primary endpoint Success rate of coronary angiography (%) Success rate of PCI (%) Secondary endpoints Success rate of puncture of left distal radial artery (%) Complications at the puncture site (%) Puncture time (minute) Procedure time (minute) Fluoroscopic time (minute) Fluoroscopic dose (Gy/cm2) Contrast volume (ml) Hemostasis time (minute) Diameter of left distal radial artery by ultrasonography (mm) Questionaire (pain, satisfaction)
7 Baseline characteristics (n=200) Age, years 66.1±12.2 Male 132 (66) Height, cm 161.2±9.4 Weight, kg 65.0±12.9 BMI, kg/m2 24.9±3.5 BSA 1.7±0.2 Medical history Hypertension 121 (60.5) Diabetes mellitus 71 (35.5) Dyslipidemia 119 (59.5) Chronic kidney disease 15 (7.5) CKD stage by baseline Ccr 1 ( 90) 87 (43.5) 2 (60-89) 76 (38) 3 (30-59) 27 (13.5) 4 (15-29) 7 (3.5) 5 (<15 or dialysis) 3 (1.5) Ccr<60 37 (18.5) Dialysis 3 (1.5) PAOD 4 (2) COPD 9 (4.5) Old CVA 7 (3.5) Prev. MI 26 (13) CABG 1 (0.5) Current smoking 53 (26.5) Clinical Diagnosis Stable angina 38 (19) Unstable angina 74 (37) NSTEMI 45 (22.5) STEMI 17 (8.5) Others 26 (13) Data are expressed n(%) or mean±sd. BMI, body mass index; BSA, body surface area; PAOD, peripheral arterial occlusive disease; CVA, cerebrovascular accident; Ccr, creatinine clearance; CKD, chronic kidney disease.
8 Procedural characteristics (n=191) Patients with left distal radial puncture success Patients with LeDRA (n=191) CAG perform 187/191 (97.9) Disease extent Near normal or minimal 69 (36.1) 1-vessel disease 49 (25.7) 2-vessel disease 31 (16.2) 3-vessel disease 42 (22) Introducer sheath 4Fr 87 (45.5) 5Fr 41 (21.5) 6Fr 62 (32.5) 7Fr 1 (0.5) Diagnostic catheter 4Fr 120 (62.8) 5Fr 63 (33) 6Fr 7 (3.7) 7Fr 1 (0.5) Total used diagnostic catheter (53.4) 2 81 (42.4) 3 8 (4.2) Ergonovine provocation test 8 (4.2) FFR 4 (2.1) Patients performed PCI (n=87) PCI perform 87/191 (45.5) Ad hoc 78/87 (89.7) Staged 9/87 (10.3) Culprit lesion Left main 6 (6.9) Left anterior descending 47 (54) Left circumflex 6 (6.9) Right coronary artery 28 (32.2) Bifurcation 28 (32.2) In-stent restenosis 9 (10.3) CTO 8 (9.8) Guiding catheter 5Fr 5 (5.7) 6.5 Fr sheathless 19 (21.8) 6Fr 62 (71.3) 7Fr 1 (1.1) IVUS use 55 (63.2) Data are expressed as n(%). LeDRA, left distal radial approach; CAG, coronary angiography; FFR, fractional flow reserve; PCI, percutaneous coronary intervention; CTO, chronic total occlusion; IVUS, intravascular ultrasonography.
9 Study outcomes Primary endpoints CAG success 187/187 (100) PCI success 86/87 (98.9) Secondary endpoints Puncture success 191/200 (95.5) Crossover 9 (4.5) Left radial 7 (3.5) Right distal radial 2 (1) Procedural variables n=191 Mean±SD Median (IQR) Puncture time, min 3.0±2.8 2 (1,4) Procedure time, min 35.6± (6, 50) Fluoroscopic time, min 11.3± (2.3, 14.5) Fluoroscopic dose, Gy cm ± (34.1, 146.8) Contrast volume, ml 127.9± (70, 180) Hemostasis time, min 151.8± (120, 175) Data are expressed as n(%), mean±sd or median (IQR). CAG, coronary angiography; PCI, percutaneous coronary intervention; BARC, bleeding academic research consortium Access site complications 15/191 (7.9) BARC bleeding type 2,3,5 0 (0) Hematoma grade <2cm 10 (5.2) 2-5cm 1 (0.5) >5cm 3 (1.6) Distal radial artery occlusion 0 (0) Perforation 0 (0) Pseudoaneurysm 0 (0) Dissection 1 (0.5) AV fistula 0 (0) Clinical follow-up N=171 Lost follow-up 18 (10.5) Follow-up duration, mean±sd 24.4±11.6 median (IQR) 28 (16,32) Cardiac death 2 (1) Ultrasonographic follow-up N=141 Distal radial artery occlusion 0 (0) Neuropathy 2 (1.4) Questionaire N=182 Pain score (0-10) 2.6±2.4 Satisfaction score (0-10) 9.0±1.5
10 Diameter distribution by ultrasonography & Learning curve for puncture time Artery/Sheath ratio CAG>1 : 59.6% (90/151) PCI>1 : 46% (29/63) Diameter of left distal radial artery 5Fr 6Fr Puncture time by experience p < % 35.1% compatible by diameter N=49 N=47 N=49 N=46
11 Conclusion In this prospective observational registry, left distal radial approach demonstrated high success rate and low complication rate in an unselected cohort. Left distal radial approach can be a new viable route for CAG and PCI to experienced radial operators.
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