A study led by Wrightington, Wigan and Leigh Teaching Hospitals NHS Foundation Trust (WWL) has recruited the first patient to a UK-wide study.
The LOVE DEB Registry, (“Large de-nOVo coronary artEry disease treated with sirolimus Drug Eluting Balloon”), is led by the Cardiology Team at WWL and will explore whether drug-coated balloons can be safely used in large coronary arteries instead of stents in patients undergoing an angioplasty procedure.
The Chief Investigator and WWL Cardiology Consultant, Dr Abhishek Kumar, recruited the first patient to the study at the Trust’s Royal Albert Edward Infirmary, Wigan, with plans to expand the research to a further nine NHS hospitals across the UK.
Dr Kumar commented: “With stents there is risk of narrowing of the blood vessels in short, medium and longer term, plus the patients are bound to take blood thinners without interruption for a period of six to 12 month which can increase risk of major bleeding and can also potentially delay any major or minor operations.
“It is a matter of great pride for the Trust to sponsor this national multi-centre study and while there are no personal benefits to taking part in this study for patients, in time we hope that the information we acquire will result in better treatments for future patients.”
Percutaneous Coronary Intervention (PCI), also commonly called as angioplasty, is a procedure done to help to widen a narrowed artery in the heart and help restore proper blood flow. This is done by inserting a catheter into a blood vessel and, when it reaches the narrowed artery, inflating a small balloon to expand it. Some of these balloons are known as Drug Eluting Balloons (DEBs). These balloons have a coating of a drug on them which sticks to the walls of the artery when inflated to help treat the narrowed artery.
The study will create a registry to monitor the outcomes of patients who have already undergone PCI with the balloon, for twelve months after use. In addition to the data collected about the procedure itself, patients on the study will be asked to complete a short questionnaire about their cardiac health.
Dr Kumar added: “Any patient scheduled for a PCI and fits the inclusion criteria for the study will be approached by the clinical team to take part for the next 12 months.”
WWL’s Medical Director, Prof. Sanjay Arya commented: “A big congratulations to everyone involved with the recruitment, a big well-done to Abhishek and the rest of the team.”