Evaluation of Neointimal Coverage After Guiding De-escalation of Antiplatelet Treatment in Patients with ST-elevation Myocardial Infarction Undergoing Percutaneous Coronary Intervention by Optical Coherence Tomography or Angiography: Rationale and De
Yang Li, Chaoqun Ma, Kai Xu, Miaohan Qiu, Bin Wang, Yi Li, Yaling HanBackground:
Dual antiplatelet therapy (DAPT) de-escalation strategies including early switching from a potent P2Y 12 inhibitor to clopidogrel become attractive for patients with ST-elevation Myocardial Infarction (STEMI). It is unclear whether DAPT de-escalation after optical coherence tomography (OCT)- or angiography-guided percutaneous coronary intervention (PCI) improves neointimal coverage in STEMI patients who have completed 1-month DAPT with aspirin plus ticagrelor.
Methods:
This report describes the design of a randomized study evaluating the neointimal coverage in STEMI patients after guiding de-escalation of DAPT from aspirin plus ticagrelor to aspirin plus clopidogrel at 1 month after PCI with drug eluting stent implantation by OCT or angiography and 1-month DAPT with aspirin plus ticagrelor. Eighty patients who meet the inclusion criteria and none of the exclusion criteria will be randomly assigned in a 1:1 fashion to the OCT- or angiography-guided group (first randomization). All patients will receive open label ticagrelor plus aspirin for 1 month after the index PCI. At 30 ± 7 days after the index PCI, patients with no major adverse cardiovascular and cerebrovascular events (MACCE) or major bleeding (⩾Bleeding Academic Research Consortium [BARC] 3a) will be randomized in a 1:1 fashion to either the ticagrelor plus aspirin group or clopidogrel plus aspirin group for an additional 11 months (second randomization). The primary endpoint is the stent-strut neointimal thickness by OCT assessment at 12-month follow up.
Discussion:
The data obtained from DAPT-OCT study will explore the neointimal coverage after guiding de-escalation of antiplatelet treatment in STEMI patients undergoing PCI by OCT.
Trial registration: