Patient Preference for Radial Versus Femoral Vascular Access (PREVAS)

Patient Preferences for Radial Versus Femoral Vascular Access Options by Coronary Angiography and Intervention

The purpose of this study is to determine the preference of patients regarding the vascular access site in future coronary procedures. We hypothesize that patients prefer the lesser invasive procedure via radial access.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Other: Questionnaire

Detailed Description

Rationale: To explore patient preference for vascular access site in percutaneous coronary procedures, by assessing the perceived importance of benefits and risks of both transradial access and transfemoral access. In addition, direct preference for vascular access and preference for shared decision-making were evaluated.

Objective: To investigate the patient preference of vascular access -transradial versus transfemoral- in future percutaneous coronary procedures, by use of the Best-Worst Scaling.

Study design: Single-center, prospective, observational registry

Study population: A consecutive series of patients, who between June and August 2014, underwent elective coronary procedures at Thoraxcentrum Twente in Enschede.

Intervention: All subjects will receive a questionnaire containing basic baseline questions and a best-worst scaling scenario in which they were asked to indicate the most and least desirable characteristics of the vascular access approach.

Furthermore, their direct preference was asked and to which extent they preferred to participate in the decision-making process regarding the choice for vascular access route in future percutaneous coronary procedures.

Main study endpoints:

• The primary endpoint is the patient preference on specific treatment characteristics with regard to vascular access in coronary procedures.

• Secondary endpoints include

  1. direct patient preference for transradial access or transfemoral access
  2. the valuation of participation in decision-making on the choice of vascular access together with the interventional cardiologist.

• Study Type: Observational
• Enrollment (Actual): 198

Contacts and Locations

Study Locations

• Netherlands
  • Enschede, Netherlands
    • Medisch Spectrum Twente

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

A consecutive series of patients, who between June and August 2014, underwent elective coronary procedures at Thoraxcentrum Twente in Enschede.

Description

Inclusion Criteria:

• All patients who undergoing an elective coronary procedure at Thoraxcenteum Twente in the period of June 2014 until August 2014

Exclusion Criteria:

• Language barrier

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
study population; All patients who underwent elective coronary procedures belonged to the one group, they received standard care without any additional interventions, but were asked to fill in a questionnaire.	Other: Questionnaire; Questionnaire containing a Best-worst Scaling scenario

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The best and worst treatment characteristics of transradial and transfemoral access, by using a software-generated Best-Worst Scaling Questionnaire - case 2	Best-Worst Scaling Questionnaire will be used to assess which treatment characteristics patients find most and least desirable in percutaneous coronary procedures performed via transradial and transfemoral access.	30 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of times that patients prefer transradial in future percutaneous coronary procedure, when given a discrete choice via a questionnaire.	When given the discrete choice, which access site patients would prefer in future percutaneous coronary procedures.	30 days
Percentage of patients that wants to be directly involved in the decision-making process when making the choice for access site in future coronary procedures, by use of a questionnaire.	The valuation of participation in decision-making on the choice of vascular access together with the interventional cardiologist	30 days

Collaborators and Investigators

• Sponsor: Thorax Centrum Twente
• Collaborators: Foundation of Cardiovascular Research and Education Enschede
• Investigators: Study Director: Harald Verheij, Research Manager

Publications and helpful links

General Publications

• Kok MM, Weernink MGM, von Birgelen C, Fens A, van der Heijden LC, van Til JA. Patient preference for radial versus femoral vascular access for elective coronary procedures: The PREVAS study. Catheter Cardiovasc Interv. 2018 Jan 1;91(1):17-24. doi: 10.1002/ccd.27039. Epub 2017 May 4.

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Actual): August 1, 2014
• Study Completion (Actual): October 1, 2015

Study Registration Dates

• First Submitted: November 30, 2015
• First Submitted That Met QC Criteria: December 4, 2015
• First Posted (Estimate): December 9, 2015

Study Record Updates

• Last Update Posted (Estimate): February 3, 2017
• Last Update Submitted That Met QC Criteria: February 2, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: Coronary angiography; Percutaneous coronary intervention; Patient Preference; Shared decision making; Radial access; Femoral access
• 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: Prevas-v2