Comparison of Success Rate Between Distal Radial Approach and Radial Approach in STEMI

Wonju Severance Christian Hospital

Status: Completed

Conditions: ST Elevation Myocardial Infarction; Distal Radial Artery Approach

Treatments: Procedure: Distal radial artery; Procedure: Radial artery

Study type: Interventional

Funder types: Other

Identifiers

NCT03611725

DRAMI

Details and patient eligibility

About

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.

Enrollment: 352 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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352 participants in 2 patient groups, including a placebo group

Distal radial artery

Active Comparator group

Description:

After subcutaneous injection of lidocaine, the distal radial artery around the bony surface area is punctured with a 20-gauge venipuncture catheter needle or steel needle according to the operator's discretion. After successful puncture, flexible, straight plastic 0.025" mini-guidewire is inserted through the hole of the puncture needle. Then, Radifocus® introducer sheath (Terumo, Tokyo, Japan) is inserted into the distal radial artery.

Treatment:

Procedure: Distal radial artery

Radial artery

Placebo Comparator group

Description:

After subcutaneous injection of lidocaine, the radial artery is punctured with a 20-gauge venipuncture catheter needle or steel needle according to the operator's discretion. After successful puncture, flexible, straight plastic 0.025" mini-guidewire is inserted through the hole of the puncture needle. Then, Radifocus® introducer sheath (Terumo, Tokyo, Japan) is inserted into the radial artery.

Treatment:

Procedure: Radial artery