Korean Prospective Registry for Evaluating the Safety and Efficacy of Distal Radial Approach (KODRA)

The left distal radial approach (DRA) has been introduced as a feasible and safe alternative route of the radial artery. However, there is still lack of evidence for DRA regarding the feasibility, safety, effective time for hemostasis and hemostasis method. This prospective multicenter registry aimed to investigate the safety and efficacy of DRA for CAG and PCI.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease; Radial Artery; Puncture
• Intervention / Treatment: Procedure: Distal radial approach

Detailed Description

Based on the results that radial approach (RA) reduced mortality and bleeding complications compared with femoral approach (FA), RA has become the standard of care for coronary angiography (CAG) and percutaneous coronary intervention (PCI). RA provides better comfortability for the patients and immediate mobilization after CAG or PCI. Therefore, 2018 ESC/EACTS guidelines recommend RA as the standard approach, unless there are overriding procedural considerations.

Operators usually prefer right RA because most of the operators are right-handed and right hand of the patient is closer to the operator. In contrast, longer distance to the left radial artery cause neck or back sprain of the operators, especially when the height of the operator is short, or the patient is obese. Nevertheless, left RA might be easier to manipulate catheter because of less tortuosity compared to the right RA and similar approach curvature with FA. Left RA also gives a chance to the right-handed patients to use their right hand freely.

Recently, the left distal radial approach (DRA) has been introduced as a feasible and safe alternative route of the radial artery. The left hand in the prone position is placed either on the left groin or beside the left hip according to operator preference. The operator punctures the distal radial artery around the anatomical snuffbox. After the first report for the feasibility and safety of left DRA in 70 patients, Lee et al. demonstrated that the success rates of arterial puncture, CAG and PCI were 95.5% (191/200), 100% (187/187), and 98.9% (86/87), respectively. The complication rates were only 7.9% including 14 (7.4%) minor hematomas and one (0.5%) arterial dissection. No serious complications were occurred such as distal radial artery occlusion, perforation, pseudoaneurysm, or arteriovenous fistula. Several studies for DRA also showed similar favorable results regarding procedural success and bleeding complications.

Radial arterial occlusion after RA remains an unsolved problem. According to the Leipzig prospective vascular ultrasound registry, the occlusion rate of radial artery was 14.4% in case of 5Fr sheath and 33.1% in 6Fr sheath, respectively. In this point of view, DRA could be a promising solution to lower the incidence rate of arterial occlusion. Moreover, DRA can have a potential benefit in patients requiring arteriovenous fistula and in patients who need the radial artery as a conduit for coronary artery bypass graft because of the absence of radial injury.

There is still lack of evidence for DRA regarding the feasibility, safety, effective time for hemostasis and hemostasis method. Unknown complications related to DRA also should be addressed. Therefore, this prospective multicenter registry aimed to investigate the safety and efficacy of DRA for CAG and PCI.

• Study Type: Observational
• Enrollment (Actual): 5000

Contacts and Locations

Study Locations

• Korea, Republic of
  • Busan, Korea, Republic of
    • Inje University Busan Paik Hospital
  • Busan, Korea, Republic of
    • Inje University Haeundae Paik Hospital
  • Busan, Korea, Republic of
    • Pusan National University Hospital
  • Busan, Korea, Republic of
    • Kosin Univeristy Gospel Hospital
  • Cheongju, Korea, Republic of
    • Chungbuk National University Hospital
  • Chuncheon, Korea, Republic of
    • Kangwon National University Hospital
  • Daegu, Korea, Republic of
    • Daegu Catholic University Medical Center
  • Gangneung, Korea, Republic of
    • GangNeung Asan Hospital
  • Goyang, Korea, Republic of
    • Inje University Ilsan Paik Hospital
  • Gyeongju, Korea, Republic of
    • Dongguk University Gyeongju Hospital
  • Incheon, Korea, Republic of
    • Uvis Hospital
  • Uijeongbu, Korea, Republic of
    • The Catholic University of Korea Uijeongbu St. Mary's Hospital
  • Wonju, Korea, Republic of
    • Wonju Severance Christian Hospital
  • Kyeonggi-do
    • Yongin-si, Kyeonggi-do, Korea, Republic of, 17046
      • Yongin Severance Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients who need coronary angiography will be enrolled.

Description

Inclusion Criteria:

• Patients aged ≥ 20 years who planned coronary angiography
• Patients with palpable distal radial artery
• Patients who give informed consent

Exclusion Criteria:

• Patients with small or non-palpable distal radial artery
• Positive result in modified Allen test (suspicious of single blood supply)
• Pregnant women, possible candidate for pregnancy, or breastfeeding women
• Patients who are deemed unsuitable by the investigator

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Success rate of coronary angiography	Success rate of coronary angiography (%)	Through procedure completion, up to 6 hours
Success rate of percutaneous coronary intervention	Success rate of percutaneous coronary intervention (%)	Through procedure completion, up to 6 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Success rate of distal radial artery puncture	Success rate of distal radial artery puncture (%)	Through procedure completion, up to 6 hours
Puncture time	Puncture time (minute)	Through procedure completion, up to 6 hours
Hemostasis time	Hemostasis time (minute)	Through procedure completion, up to 24 hours
Puncture-related complications	Puncture-related complications (%)	Up to 1 month
Total procedure time	Total procedure time (minutes)	Through procedure completion, up to 6 hours
Total fluoroscopic time	Total fluoroscopic time (minute)	Through procedure completion, up to 6 hours
Total fluoroscopic dose	Total fluoroscopic dose (Gray/cm2)	Through procedure completion, up to 6 hours

Collaborators and Investigators

• Sponsor: Wonju Severance Christian Hospital
• Investigators: Principal Investigator: Seung-Hwan Lee, MD, PhD, Yonsei University Wonju College of Medicine, Wonju Severance Christian Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 9, 2019
• Primary Completion (ACTUAL): October 30, 2021
• Study Completion (ACTUAL): January 23, 2022

Study Registration Dates

• First Submitted: August 31, 2019
• First Submitted That Met QC Criteria: September 5, 2019
• First Posted (ACTUAL): September 6, 2019

Study Record Updates

• Last Update Posted (ACTUAL): May 11, 2022
• Last Update Submitted That Met QC Criteria: May 10, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: KODRA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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