Coronary Microcirculatory and Bioresorbable Vascular Scaffolds (EMPIRE-BVS)

Evaluation of Microcirculatory Protection In Percutaneous REvascularisation With Bioresorbable Vascular Scaffolds Versus Metallic Drug-eluting Stents: a Device- and Implant Technique-based Comparison

Angina and heart attacks are caused by narrowings in the coronary arteries (blood vessels) supplying the heart. These narrowings can be opened using a balloon and stent (angioplasty). Traditionally, stents are constructed from metal and are permanent. However, newer stents are being constructed from carbohydrate polymers (scaffolds), which allow them to reabsorb over time leaving no permanent implant. New data has suggested that these scaffolds appear to reduce recurrent angina and may alter the blood flow down the artery. However, it is not known whether this is due to the scaffolds themselves or the way the scaffolds are inserted. In this study we hope to measure the blood flow to the heart and assess changes in that flow during stent and scaffold insertion. It is also important to know whether these effects are durable and thus, a cohort of patients will return at 3-months to be restudied. These data are important to help us understand why blood flow is affected by stent/scaffold selection or device implantation technique and whether this results in better long-term outcomes.

Study Overview

• Status: Completed
• Conditions: Myocardial Ischemia; Angina, Stable; CHD - Coronary Heart Disease
• Intervention / Treatment: Device: Drug-Eluting Stent (DES) - standard(std); Device: Drug-Eluting Stent (DES) - slow; Device: Bioresorbable Vascular Scaffolds (BVS)

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Cambridgeshire
    • Cambridge, Cambridgeshire, United Kingdom, CB23 3RE
      • Papworth Hospital NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patient age >18 years, <75 years.
2. Lesion suitability for BVS deployment: target vessel calibre >2.3mm and <3.8mm reference diameter, without significant tortuosity or calcification.
3. Listed for single-vessel PCI procedure.
4. Lesion length≤28mm (to accommodate single BVS/DES)
5. Preserved left ventricular ejection fraction (EF≥50%).

Exclusion Criteria:

1. Patients with confirmed myocardial infarction within the preceding 2 months.
2. Allergy or intolerance to aspirin, clopidogrel, prasugrel or ticagrelor or contraindication to 12 months' dual antiplatelet therapy.
3. Contraindication to use of adenosine (asthma/chronic lung disease with documented bronchoreactivity).
4. Significant known comorbidity or terminal condition with life expectancy <6 months.
5. Pregnancy.
6. Coagulopathy or warfarin treatment.
7. Significant renal impairment (baseline creatinine>130 mmol/l).
8. Other comorbid condition that may affect microcirculatory function or troponin release (eg. Seropositive inflammatory conditions).
9. Inability to comply with follow-up requirements.
10. Target lesion in left mainstem, saphenous vein or arterial grafts.
11. Chronic total occlusion.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: DES-std group; (DES: drug-eluting stent). Metallic DES implanted in standard fashion. To be compared with the DES-slow group at interim analysis at the end of phase 1 stage.	Device: Drug-Eluting Stent (DES) - standard(std); Metallic DES implanted in standard fashion. To be compared with the DES-slow group at interim analysis at the end of phase 1 stage.; Other Names: Xience
Experimental: DES-slow group; (DES: drug-eluting stent). Slow device inflation (mandated in the BVS IFU). To be compared with the DES-std group at interim analysis at the end of phase 1 stage. After the interim analysis DES-slow to be compared with BVS.	Device: Drug-Eluting Stent (DES) - slow; Slow device inflation (mandated in the BVS IFU). To be compared with the DES-std group at interim analysis at the end of phase 1 stage. After the interim analysis DES-slow to be compared with BVS.; Other Names: Xience
Experimental: BVS group; (Bioresorbable Vascular Scaffold) Introduced after the interim analysis (phase 2) for comparison with DES-slow.	Device: Bioresorbable Vascular Scaffolds (BVS); Bioresorbable Vascular Scaffold. Introduced after the interim analysis (phase 2) for comparison with DES-slow.; Other Names: ABSORB

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in IMR between baseline and post-stent/scaffold implantation.	IMR: index of microvascular resistance	During procedure
Change in CFR between baseline and post-stent/scaffold implantation.	CFR: coronary flow reserve	During procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of troponin elevation post-PCI (MI4a).	Measuring serum troponin I levels by blood test	Measured 6 hours after stent insertion
Changes in IMR between baseline, post-implant and subsequent timepoints in subrandomized group.	IMR: index of microvascular resistance	3 months follow up
Incidence of post-PCI angina and quality of life by standardized Seattle angina questionnaire at telephone follow-up.	Description: The Seattle Angina Questionnaire is a points based question and answer system where a overall score can be assessed and compared	Up to 12 months
Incidence of stent & scaffold expansion & malapposition adjudged by strut-level OCT analysis.	OCT analysis of stent struts done quantitatively	During index procedure and at 3 month follow up
Incidence of stent/scaffold strut coverage/endothelialisation adjudged by strut-level OCT analysis.	OCT analysis of stent struts done quantitatively	During index procedure and at 3 month follow up
Nature/phenotype of underlying target lesion plaque by OCT analysis.	OCT analysis of lesion characteristics done quantitatively	During index procedure and at 3 month follow up
Adverse events	Adverse event assessed by clinical history and medical notes	At time points 1, 3, 6 & 12 months post-PCI
Serious adverse events	Serious adverse event assessed by clinical history and medical notes	At time points 1, 3, 6 & 12 months post-PCI

Collaborators and Investigators

• Sponsor: Papworth Hospital NHS Foundation Trust
• Investigators: Study Director: Melissa Duckworth, Papworth NHS Foundation Trust

Publications and helpful links

General Publications

• Aetesam-Ur-Rahman M, Zhao TX, Paques K, Oliveira J, Khialani B, Kyranis S, Braganza DM, Clarke SC, Bennett MR, West NEJ, Hoole SP. Coronary Flow Variations Following Percutaneous Coronary Intervention Affect Diastolic Nonhyperemic Pressure Ratios More Than the Whole Cycle Ratios. J Am Heart Assoc. 2022 May 3;11(9):e023554. doi: 10.1161/JAHA.121.023554. Epub 2022 Apr 26.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2017
• Primary Completion (Actual): March 10, 2021
• Study Completion (Actual): March 10, 2021

Study Registration Dates

• First Submitted: January 26, 2017
• First Submitted That Met QC Criteria: March 6, 2017
• First Posted (Actual): March 10, 2017

Study Record Updates

• Last Update Posted (Actual): April 22, 2022
• Last Update Submitted That Met QC Criteria: April 21, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: PCI; BVS; Coronary Stent; Index of microcirculatory resistance
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Pain; Neurologic Manifestations; Chest Pain; Angina Pectoris; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Ischemia; Angina, Stable
• Other Study ID Numbers: P02135

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