Distal Radial Artery Approach, ST Elevation Myocardial Infarction
Conditions
Keywords
Distal radial approach, ST Elevation Myocardial Infarction
Brief summary
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.
Interventions
PROCEDUREDistal radial artery
The distal radial artery will be punctured with a puncture needle. Then, coronary angiography and percutaneous coronary intervention will be performed.
PROCEDURERadial artery
The radial artery will be punctured with a puncture needle. Then, coronary angiography and percutaneous coronary intervention will be performed.
Sponsors
Hanmi Pharmaceutical co., ltd.
Wonju Severance Christian Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Patients will be randomized either distal radial approach or radial approach.
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 20 years * ST-segment elevation myocardial infarction * Palpable unilateral distal radial and radial artery
Exclusion criteria
* Cardiogenic shock * Thrombolysis before primary percutaneous coronary intervention * Inability to obtain written informed consent * Patient with ipsilateral arteriovenous fistula * Participation in another ongoing clinical trial * Pregnancy * Expected lifespan \<12 months \* Eligible operator criteria * Qualified operator who had experienced ≥ 100 cases of distal radial artery puncture
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Puncture success rate (%) | Through procedure completion, up to 6 hours | The success rate (%) of arterial puncture will be compared between distal radial artery approach and radial artery approach group. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Puncture time (minute) | Through procedure completion, up to 6 hours | Scale range: 0 - 60 minutes Shorter time is considered better result. An averaged time value will be compared and reported between two groups. |
| Success rate of coronary angiography (%) | Through procedure completion, up to 6 hours | The success rate (%) of coronary angiography will be compared between distal radial artery approach and radial artery approach group. |
| Success rate of percutaneous coronary intervention (%) | Through procedure completion, up to 6 hours | The success rate (%) of percutaneous coronary intervention will be compared between distal radial artery approach and radial artery approach group. |
| Procedure success rate (%) | Through procedure completion, up to 6 hours | The success rate (%) of final procedure will be compared between distal radial artery approach and radial artery approach group. |
| MACE (%) | 1 month | Incidence rate (%) of composite endpoints defined as all-cause death, any myocardial infarction, and any revascularization |
| Total procedure time (minutes) | Through procedure completion, up to 6 hours | Scale range: 0 - 360 minutes Shorter time is associated with better outcome. An averaged time value will be compared and reported between two groups. |
| Total fluoroscopic time (minute) | Through procedure completion, up to 6 hours | Scale range: 0 - 360 minutes Shorter time is associated with better outcome. An averaged time value will be compared and reported between two groups. |
| Total fluoroscopic dose (Gray/cm2) | Through procedure completion, up to 6 hours | Scale range: 0 - 500 Gray/cm2 Lesser fluoroscopic dose is better. An averaged value will be compared and reported between two groups. |
| Bleeding complication rate (%) | During hospitalization, up to 1 month | The bleeding complication rate (%) will be compared between distal radial artery approach and radial artery approach group. |
Countries
South Korea
Outcome results
None listed