Drug eluting balloon angioplasty might be a better alternative than medical treatment or stenting in subjects with plaque erosion, which is the second most common cause of myocardial infarction.
The main objective of this pilot study is to gain clear insights on the effect of percutaneous coronary intervention (PCI) with size matched DCB (SeQuent) as compared to treatment with GP IIbIIIa inhibitor or heparin \& dual antiplatelet therapy in a predominantly Caucasian population at 2 days and at 1 year after the procedure.
Patients aged ≥18 years presenting with MI where the culprit de-novo (stent restenosis/thrombosis excluded) lesion has a Thrombolysis in Myocardial Infarction (TIMI) flow of ≥ I with signs of thrombus on angiographic (or CCTA followed by conventional coronary angiography) evaluation located in a native coronary artery (a by-pass graft vessel excluded) addressable by PCI;
Presence of thrombus
Absence of an overt ruptured plaque flap
Area of stenosis of ≥ 50%
Culprit lesion located or extending in the Left Main coronary artery;
Presence of large coronary aneurysms;
Large thrombus burden (extending for more than > 15 mm);
Patients with severe tortuous lesions (OCT judged not possible);
Parallel
PCI with size matched DCB
DeviceSubjects will be treated with PCI with size matched DCB (SeQuent)
GP IIbIIIa inhibitor or heparin & dual antiplatelet therapy
DrugGP IIbIIIa inhibitor or heparin \& dual antiplatelet therapy
Optical Coherence Tomography (OCT)-assessed Minimum Lumen Area (MLA) during the control procedure
Coronary Computed Tomography Angiography (CCTA) assessed MLA at 1-year
Target Lesion Failure (TLF) at 1-year
TLF is defined as Cardiac death, Target Vessel-MI (TV-MI), and Clinically-Driven Target Lesion Revascularization (CD-TLR)
TLF at 2-years
TLF is defined as Cardiac death, TV-MI, and CD-TLR
CCTA-assessed plaque burden at baseline
CCTA-assessed plaque burden post PCI
CCTA-assessed plaque burden at 1-year
CCTA-assessed lipid pool volume at baseline
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