DEFER-STEMI
Research type
Research Study
Full title
A clinical trial of routine DEFERral of stenting vs. standard care with immediate stenting in higher risk STEMI patients undergoing emergency PCI (DEFER-STEMI).
IRAS ID
180438
Contact name
Colin Berry
Contact email
Sponsor organisation
Golden Jubilee Research Institute
Duration of Study in the UK
19 years, 11 months, 28 days
Research summary
'Heart attack' is a sudden life threatening condition with longer term risk of health problems, including heart failure. The initial emergency standard care treatment involves opening the blocked heart artery with a balloon followed by a stent (a thin metal tube), to keep the artery open in the longer term. However, around half of heart attack survivors will have persistent severe heart injury placing them at risk of future heart failure. In about 1 in 10 patients, placing the stent dislodges blood clot which passes into the smaller branches blocking off blood flow to the heart muscle. This problem is called ‘No-reflow’ and ‘microvascular obstruction’. We recently conducted a pilot study of brief deferral of stenting which involved separating the standard care procedure into two procedures (1) to open the blocked artery and then (2) after an average time-delay of 9 hours in the ward, returning for a 2nd procedure to place the stent. We found that heart muscle heart injury was reduced with the deferred stent approach compared to standard care with immediate stenting. We now wish to assess whether deferred stenting improves survival & reduces heart failure in the longer term. To answer this question, our trial would need to enrol 3600 heart attack patients in the UK&Ireland, half of whom would be randomly assigned to standard care with immediate stenting and the other half to deferred stenting. The project will involve hospitals in the NHS and in order to enhance the statistical power & global relevance of the results, we have invited hospitals in Australia, Brazil and France based on expressions of interest (we anticipate ~540 patients). The total sample size is 4140 and the project will last 5 years. The BHF have approved the outline & invited a full application. Lay and expert reviewers have been supportive.
REC name
West of Scotland REC 1
REC reference
15/WS/0117
Date of REC Opinion
8 Jun 2015
REC opinion
Favourable Opinion