ST-segment elevation myocardial infarction (STEMI) is an emergent disease to treat as soon as possible. 2017 ESC guidelines for the management of STEMI recommend using radial approach (RA) rather than femoral approach (FA) to reduce mortality and bleeding complications if the operators are expert for RA. Recently, Ferdinand Kiemeneij reported that distal radial approach (DRA) could be a feasible and safe route for coronary angiography (CAG) and percutaneous coronary intervention (PCI) in 70 patients. The right-handed patient could feel more comfortable in left DRA than right RA. Left DRA also could provide a better comfortable position for the operator compared to left RA. Distal radial artery is located around the anatomical snuffbox, which doesn't contain nerve and vein beside artery. Therefore, the possibility of procedure-related complications such as nerve injury or arteriovenous fistula is very low. Also, the superficial location of DRA could make easier hemostasis. There were no vascular-related complications from the report of Kiemeneij. But, the rate of puncture failure was 11%, which was higher than RA-based study (5.34% in STEMI patients of RIVAL trial, 6% in RIFLESTEACS trial and 5.8% in MATRIX trial). Nevertheless, this study was a pilot study with a small number of patients. There is no clinical study to compare the feasibility and safety for CAG and PCI between DRA and RA in patients with STEMI. Therefore, this study aimed to evaluate whether DRA is feasible and safe compared to RA in STEMI setting.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
352
The distal radial artery will be punctured with a puncture needle. Then, coronary angiography and percutaneous coronary intervention will be performed.
The radial artery will be punctured with a puncture needle. Then, coronary angiography and percutaneous coronary intervention will be performed.
Kangwon National University College of Medicine
Chuncheon, Gangwon-do, South Korea
Wonju Severance Christian Hospital
Wŏnju, Gangwon-do, South Korea
The Catholic university of Korea Uijeongbu St. Mary's hospital
Uijeongbu-si, Gyeonggi-do, South Korea
Puncture success rate (%)
The success rate (%) of arterial puncture will be compared between distal radial artery approach and radial artery approach group.
Time frame: Through procedure completion, up to 6 hours
Success rate of coronary angiography (%)
The success rate (%) of coronary angiography will be compared between distal radial artery approach and radial artery approach group.
Time frame: Through procedure completion, up to 6 hours
Success rate of percutaneous coronary intervention (%)
The success rate (%) of percutaneous coronary intervention will be compared between distal radial artery approach and radial artery approach group.
Time frame: Through procedure completion, up to 6 hours
Procedure success rate (%)
The success rate (%) of final procedure will be compared between distal radial artery approach and radial artery approach group.
Time frame: Through procedure completion, up to 6 hours
Bleeding complication rate (%)
The bleeding complication rate (%) will be compared between distal radial artery approach and radial artery approach group.
Time frame: During hospitalization, up to 1 month
Total procedure time (minutes)
Scale range: 0 - 360 minutes Shorter time is associated with better outcome. An averaged time value will be compared and reported between two groups.
Time frame: Through procedure completion, up to 6 hours
Total fluoroscopic time (minute)
Scale range: 0 - 360 minutes Shorter time is associated with better outcome. An averaged time value will be compared and reported between two groups.
Time frame: Through procedure completion, up to 6 hours
Total fluoroscopic dose (Gray/cm2)
Scale range: 0 - 500 Gray/cm2 Lesser fluoroscopic dose is better. An averaged value will be compared and reported between two groups.
Time frame: Through procedure completion, up to 6 hours
MACE (%)
Incidence rate (%) of composite endpoints defined as all-cause death, any myocardial infarction, and any revascularization
Time frame: 1 month
Puncture time (minute)
Scale range: 0 - 60 minutes Shorter time is considered better result. An averaged time value will be compared and reported between two groups.
Time frame: Through procedure completion, up to 6 hours
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