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Coronary Progenitor Cells and Soluble Biomarkers in Cardiovascular Prognosis after Coronary Angioplasty
Published on: January 28, 2020
Design and rationale of the EVOCATION trial: A prospective, randomized, exploratory study comparing the effect of
Masanori Asakura1, Kiyoshi Hibi2, Wataru Shimizu3
1Department of Cardiovascular and Renal Medicine, Hyogo College of Medicine, Hyogo, Japan.
Insights
Evolocumab may reduce microvascular damage during periprocedural myocardial infarction (PMI) in patients undergoing percutaneous coronary intervention (PCI). The EVOCATION trial investigated evolocumab
Area of Science:
- Cardiology
- Interventional Cardiology
- Pharmacology
Background:
- Periprocedural myocardial infarction (PMI) is a frequent complication of percutaneous coronary intervention (PCI) in stable coronary artery disease (CAD).
- Statin therapy can mitigate PMI by preventing coronary microvascular dysfunction, but its efficacy is limited in some patients.
- The potential of potent lipid-lowering agents like evolocumab to reduce microvascular damage post-PCI remains unexplored.
Purpose of the Study:
- To evaluate the efficacy of evolocumab pretreatment in reducing microvascular damage after PCI.
- To assess the impact of evolocumab on the index of microvascular resistance (IMR) in patients with stable CAD undergoing PCI.
- The EVOCATION trial aims to determine if evolocumab can diminish periprocedural microvascular dysfunction.
Main Methods:
- A multicenter, randomized, open-label, active-controlled, exploratory clinical study (EVOCATION trial).
- 100 patients with stable CAD and high LDL-C despite maximal statin therapy were enrolled.
- Patients received either standard care plus evolocumab or standard care alone for 2-6 weeks prior to PCI.
Main Results:
- The primary endpoint was the index of microvascular resistance (IMR) measured after PCI.
- The study assessed the reduction in microvascular damage as indicated by IMR.
- Results will elucidate the effect of evolocumab on periprocedural microvascular function.
Conclusions:
- The EVOCATION trial will provide crucial insights into the role of evolocumab in managing PMI.
- Findings may support the use of evolocumab as an adjunct therapy to reduce cardiovascular events in PCI patients.
- This study could establish a new therapeutic strategy for preventing microvascular complications during PCI.
Abstract:
Percutaneous coronary intervention (PCI) is a standard treatment in patients with stable coronary artery disease (CAD); however, periprocedural myocardial infarction (PMI) remains a common complication of PCI. Aggressive lipid-lowering therapy with statin has shown to reduce the incidence of PMI by preventing coronary microvascular dysfunction. It is unclear whether evolocumab, a potent lipid-lowering agent, could diminish microvascular damage after PCI. The EVOCATION trial (jRCTs051180022) is a multicenter, randomized, open-label, active-controlled, parallel-group, exploratory, investigator-initiated clinical study to evaluate whether pretreatment with evolocumab could decrease the index of microvascular resistance (IMR) after PCI in patients with stable CAD. This study population consists of 100 patients with stable CAD who will undergo PCI and have high low-density lipoprotein cholesterol levels despite administration of maximum tolerated dose of statins for at least 2 weeks. Eligible patients are randomized in a 1:1 ratio to receive either evolocumab 140 mg every 2 weeks in addition to standard of care treatment or standard of care treatment only for 2-6 weeks before PCI. The primary endpoint is IMR after PCI. The EVOCATION trial will evaluate whether pretreatment with evolocumab reduces periprocedural microvascular damage in patients with stable CAD undergoing PCI.
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