Comparison of the Vasomotor Function and Myocardial Flow in Patients Treated With Bioresorbable and Metallic Stents at 1 Year (BVS-Flow)

Comparison of the Vasomotor Function and Myocardial Flow in Patients Treated

Background: A total of 25-50% of patients with stable coronary atherosclerosis treated with metallic stent implantation remain with effort angina despite optimal medical treatment and absence of stent restenosis at 1 year. The most plausible cause of persistent effort angina after stent implantation is microcirculatory dysfunction. Coronary circulation matches the myocardial blood supply and oxygen consumption. Metallic stent implantation has been related with endothelial dysfunction and impaired coronary blood flow reserve (relation between coronary blood flow at rest and maximal hyperemia) of the treated vessel at 1 year.

Bioresorbable Vascular Scaffold (BVS) has been shown to improve the endothelial function and to improve the angina symptoms at 1 year. However, the coronary blood flow of BVS has never been tested.

Main objective: To determine differences in the blood average peak velocity at maximal hyperemia with adenosine infusion between patients treated with bioresorbable and metallic coronary stents at 1 year after stent implantation.

Methodology: A total of 70 patients are 1:1 randomized to everolimus-eluting metallic stent (EES) versus everolimus-eluting BVS implantation in patients with stable coronary disease. At 1 year, patients undergo to invasive coronary angiography prior cessation of vasomotor drugs. A pressure/Doppler wire is advanced distally to the "treated segment" and the endothelial (acetylcholine) and non-endothelial (adenosine and nitroglycerine) vasomotor function is assessed with quantitative coronary angiography and pressure and Doppler measurements. Angina test questionnaires are obtained at different time-points of the study.

Expected results: A difference between patients treated with BVS and EES of 12.0 cm/sc in the maximal average peak velocity (APV) under maximal hyperemia (with adenosine administration) is expected, as assessed by Doppler measurements, at 1 year after stent implantation. The study is powered to assess superiority in terms of maximal APV favoring patients treated with BVS.

Study Overview

• Status: Completed
• Conditions: Stable Angina
• Intervention / Treatment: Device: Bioresorbable vascular scaffold; Device: Everolimus-eluting stent

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Phase 4

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08003
    • Hospital del Mar
  • Barcelona, Spain, 08036
    • Hospital Clinic
  • Barcelona
    • L´Hospitalet de Llobregat, Barcelona, Spain, 08173
      • Hospital Universitari de Bellvitge

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Patients with stable angina or silent angina with myocardial ischemia detected by non-invasive tests or patients with acute coronary syndromes with no increase of > 5 times the upper value of normality of cardiac biomarkers (troponin).
• Patients with coronary artery disease with angiographic stenosis >

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bioresorbable vascular scaffold (BVS); Patients with stable coronary angina with coronary artery disease suitable to be treated with a bioresorbable vascular scaffold.	Device: Bioresorbable vascular scaffold; Other Names: Bioresorbable stents
Active Comparator: Everolimus-eluting stent (EES); Patients with stable coronary angina with coronary artery disease suitable to be treated with a Everolimus-eluting stent .	Device: Everolimus-eluting stent

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Difference in the average peak velocity at maximal hyperemia between bioresorbable vascular scaffolds and everolimus-eluting stents as assessed by doppler wire measurement.	1-year after stent implantation

Secondary Outcome Measures

Outcome Measure	Time Frame
Difference in endothelial dysfunction with acetyl-choline infusion between bioresorbable vascular scaffolds and everolimus-eluting stents as assessed by quantitative coronary angiography (4% of lumen reduction)	1-year after stent implantation

Other Outcome Measures

Outcome Measure	Time Frame
Difference in fractional flow reserve at maximal hyperemia between the two treatment groups as assessed by pressure-wire measurement	1-year after stent implantation

Collaborators and Investigators

• Sponsor: Institut d'Investigació Biomèdica de Bellvitge
• Collaborators: Fundació La Marató de TV3

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2015
• Primary Completion (Actual): July 2, 2018
• Study Completion (Actual): July 2, 2018

Study Registration Dates

• First Submitted: April 11, 2016
• First Submitted That Met QC Criteria: April 13, 2016
• First Posted (Estimate): April 14, 2016

Study Record Updates

• Last Update Posted (Actual): July 3, 2018
• Last Update Submitted That Met QC Criteria: July 2, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: Coronary microcirculatory dysfunction; Coronary endothelium dysfunction
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Pain; Neurologic Manifestations; Chest Pain; Angina Pectoris; Angina, Stable; Physiological Effects of Drugs; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Everolimus
• Other Study ID Numbers: 20151810