Background Coronary stent thrombosis (ST) remains the ‘Achilles Heel’ of percutaneous coronary intervention (PCI). Although relatively rare, it is associated with a high rate of acute myocardial infarction and death.A specific point of concern is the ongoing risk of very late ST, occurring more than one year after stent implantation, and the fact that this seems to occur steadily at an annual rate of 0.5% with a high risk of recurrence. The exact mechanisms are multi-factorial and poorly understood and previous studies have been hampered by small sample sizes, incomplete patient characterisation, and a lack of intracoronary imaging and platelet function data.
Methods The PRESTIGE study (PREvention of Stent Thrombosis by an Interdisciplinary Global European effort) is a European Union FP7-funded multi-centre European study that commenced in December 2010. Along with a number of preclinical work packages involving a large multidisciplinary consortium, the clinical arm is an observational study aiming to collect multi-source data from at least 500 ST patients recruited at multiple sites across Europe along with appropriately matched controls. Enrolment of ST cases is expected to be complete by April 2014.
We have so far recruited just over 450 ST cases in Europe, with a large contribution (96 ST cases and 120 controls) from the 12 UK centres. Data collection involves a full clinical history, including details of antithrombotic therapy, a careful assessment of the original PCI procedure, intracoronary thrombus histopathology, a DNA bank and platelet function testing, using both the VerifyNow and Multiplate systems, carried out acutely, at 24 h and 30 days post event. In addition, we are performing optical coherence tomography (OCT) in ST cases pre and post intervention. To date 130 OCT pullbacks have been received from participating centres in Europe and these are being analysed at a core lab in Munich, Germany.
Results The first 80 OCT pullbacks have been assessed systematically using both qualitative and quantitative criteria. Each frame is divided into 4 quadrants and analysed at 1mm intervals. A summary of the predominant underlying factors, along with an example frame of each, is shown below.
Conclusions Stent thrombosis continues to be a serious complication of PCI. The PRESTIGE study aims to identify and validate more selective strategies that reduce the risk of ST whilst minimising bleeding complications associated with current antithrombotic regimes. From the initial OCT studies analysed in the PRESTIGE study, the underlying mechanisms for early ST (within 30 days) have mostly been mechanical issues, predominantly uncovered struts and for late and very late ST (after 1 year), neoatherosclerosis appears to play a significant role.
Full details and findings of the PRESTIGE study, including results from the thrombus histopathology and platelet function sub-studies will be presented later next year.
- PRESTIGE study
- stent thrombosis
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