Comparison of Vascular Access in STEMI

Completed

• Conditions: ST Elevation Myocardial Infarction

• Registration Number: NCT04941638
• Lead Sponsor: Yonsei University

Brief Summary

Distal radial access (DRA) has recently introduced and previous studies have demonstrated that it is feasible option, showing several advantages including less bleeding and access-site complications over proximal radial access (PRA). Previous study reported the feasibility of DRA as an alternative option for primary percutaneous coronary intervention (PCI) in STEMI patients without major complication. However, comparison study of each vascular access for primary PCI have not been conducted until now. Here, The investigators aim to compare the DRA, PRA and femoral access (FA), in terms of feasibility and safety, in patients with STEMI.

This is a retrospective study with patients who underwent primary PCI for STEMI between March 2020 to May 2021. The primary outcome of this study is the access-site complication including major bleeding requiring transfusion or surgery, hematoma and arterial occlusion.

Detailed Description

Recently, DRA has gained the interest of interventional cardiologists and previous studies have demonstrated several advantages including patient and operator comfort, shorter hemostasis duration, less bleeding, and access-site complications over PRA. More recently, randomized trial demonstrated that DRA prevents radial artery occlusion after the procedure compared with PRA. From this perspective, DRA could be considered an alternative access route for primary PCI in selected STEMI patients using potent P2Y12 inhibitors such as ticagrelor or prasugrel, or glycoprotein IIb/IIIa inhibitors.

Study Timeline

• Status Verified: 2021-06
• Study Start: 2021-06-17
• Study First Submitted: 2021-06-18
• Primary Completion: 2021-06-22
• Study First Submitted QC: 2021-06-25
• Study First Posted: 2021-06-28
• Study Completion: 2021-06-29
• Last Update Submitted: 2022-04-20
• Last Update Posted: 2022-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 109

Inclusion Criteria

• Between March 2020 to May 2021, patients who underwent primary PCI for STEMI at the Yongin Severance Hospital

Exclusion Criteria

• Refractory cardiogenic shock requiring extracorporeal membrane oxygenation (ECMO)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
access-site complication	1 month	puncture site related complication

Secondary Outcome Measures

Name	Time	Method
The success rate of the puncture	Through procedure	The success rate (%) of vascular puncture
The percentage of puncture time in Door-to-wiring time (%)	Through procedure	Puncture time = time interval from local anesthesia induction to successful sheath cannulation.; Door-to-wiring time = time elapsed from arrival of patient at the emergency department to guide wire passage through the lesion.
The success rate of the primary PCI	Through procedure	Success rate (%) = Successful primary PCI / All PCI procedures

Trial Locations

Locations (1)

Yongin Severance Hospital; 🇰🇷 Yongin, Gyeonggi-do, Korea, Republic of