Comparison of Intracoronary Endothelial Dysfunction in Patients With Coronary Artery Disease Treated With Drug Coated Balloon Angioplasty and Drug Eluting Stents

The primary objective is to establish the differences in vasomotor response of a DCB and DES treated artery by measurement of the percentage change in coronary surface area pre and post acetylcholine administration. This will be measured with incremental doses of acetylcholine at levels both proximally and distally to the site of treatment Also is to see how far endothelial dysfunction may propagate from an interventional site by measuring drug induced dilatation/constriction as in response to acetylcholine administration. This vasomotor response will be measured in the target vessel at extended distances from the treated segment.

To achieve a meaningful comparison, 34 patients will be recruited of which 17 patients would form either arm of the study having had either a DCB or DES.

The study will be performed at the Norfolk and Norwich University Hospital and patients will be enrolled prior to a second procedure. This may occur immediately after their stent or drug coated balloon treatment or if they re-attend hospital in the following recruitment period and this may include patients for a variety of different indications.

Patients who have a scheduled, clinically indicated procedure will be eligible to be recruited as participants. They must also fulfil the inclusion criteria and not be affected by any of the exclusion criteria.

A member of the research team will provide the Patient Information Sheet to potential participants and confirm that they would be happy to be contacted subsequently to discuss the proposed research. The subsequent contact will be undertaken by a clinical research fellow, who is both a member of the Norfolk and Norwich University Hospital NHS clinical team as well as the research team, prior to their subsequent visit to discuss the study, answer any questions and confirm if they fulfil the inclusion criteria. In view of Covid-19, to reduce in hospital exposure, we might instead opt to send the patient information to the eligible patients by post, and follow with a telephone call to confirm receipt.