Comparison of Vascular Access in STEMI

Comparison of Distal Radial, Proximal Radial and Femoral Access in ST-Segment Elevation Myocardial Infarction

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.

Study Overview

• Status: Completed
• Conditions: ST Elevation Myocardial Infarction
• Intervention / Treatment: Procedure: Distal radial access

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 Type: Observational
• Enrollment (Actual): 109

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyeonggi-do
    • Yongin, Gyeonggi-do, Korea, Republic of, 16995
      • Yongin Severance Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients who underwent primary PCI for STEMI without ECMO

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
access-site complication	puncture site related complication	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The success rate of the puncture	The success rate (%) of vascular puncture	Through procedure
The success rate of the primary PCI	Success rate (%) = Successful primary PCI / All PCI procedures	Through procedure
The percentage of puncture time in Door-to-wiring time (%)	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.	Through procedure

Collaborators and Investigators

• Sponsor: Yonsei University
• Investigators: Principal Investigator: Yongcheol Kim, Yongin Severance Hopistal

Study record dates

Study Major Dates

• Study Start (Actual): June 17, 2021
• Primary Completion (Actual): June 22, 2021
• Study Completion (Actual): June 29, 2021

Study Registration Dates

• First Submitted: June 18, 2021
• First Submitted That Met QC Criteria: June 25, 2021
• First Posted (Actual): June 28, 2021

Study Record Updates

• Last Update Posted (Actual): April 22, 2022
• Last Update Submitted That Met QC Criteria: April 20, 2022
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: Distal radial access; ST Elevation Myocardial Infarction; Snuffbox approach
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction; ST Elevation Myocardial Infarction
• Other Study ID Numbers: DRA-STEMI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No