Angina, Stable, CHD - Coronary Heart Disease, Myocardial Ischemia
Conditions
Keywords
Coronary Stent, PCI, BVS, Index of microcirculatory resistance
Brief summary
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.
Interventions
DEVICEBioresorbable Vascular Scaffolds (BVS)
Bioresorbable Vascular Scaffold. Introduced after the interim analysis (phase 2) for comparison with DES-slow.
DEVICEDrug-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.
DEVICEDrug-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.
Sponsors
Papworth Hospital NHS Foundation Trust
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in IMR between baseline and post-stent/scaffold implantation. | During procedure | IMR: index of microvascular resistance |
| Change in CFR between baseline and post-stent/scaffold implantation. | During procedure | CFR: coronary flow reserve |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | At time points 1, 3, 6 & 12 months post-PCI | Adverse event assessed by clinical history and medical notes |
| Incidence of troponin elevation post-PCI (MI4a). | Measured 6 hours after stent insertion | Measuring serum troponin I levels by blood test |
| Changes in IMR between baseline, post-implant and subsequent timepoints in subrandomized group. | 3 months follow up | IMR: index of microvascular resistance |
| Serious adverse events | At time points 1, 3, 6 & 12 months post-PCI | Serious adverse event assessed by clinical history and medical notes |
| Incidence of stent & scaffold expansion & malapposition adjudged by strut-level OCT analysis. | During index procedure and at 3 month follow up | OCT analysis of stent struts done quantitatively |
| Incidence of stent/scaffold strut coverage/endothelialisation adjudged by strut-level OCT analysis. | During index procedure and at 3 month follow up | OCT analysis of stent struts done quantitatively |
| Incidence of post-PCI angina and quality of life by standardized Seattle angina questionnaire at telephone follow-up. | Up to 12 months | Description: The Seattle Angina Questionnaire is a points based question and answer system where a overall score can be assessed and compared |
| Nature/phenotype of underlying target lesion plaque by OCT analysis. | During index procedure and at 3 month follow up | OCT analysis of lesion characteristics done quantitatively |
Countries
United Kingdom
Outcome results
None listed