Coronary Artery Disease
Conditions
Brief summary
Objectives: To assess the safety of tailored antiplatelet therapy (short DAPT followed by P2Y12 inhibitor alone strategy) in patients who received optimized DES implantation guided by intravascular imaging (IVUS or OCT) Hypothesis: Tailored antiplatelet strategy (short DAPT followed by P2Y12 inhibitor alone) is superior to conventional antiplatelet strategy in terms of clinically relevant bleeding and noninferior for ischemic composite adverse events in patients who received intravascular imaging-guided optimized DES implantation. (Optimized stent evaluated by on-site IVUS/OCT could act as an essential criterion for decision making for tailored antithrombotic strategy)
Detailed description
Objective: To assess the safety of tailored antiplatelet strategy (short DAPT followed by P2Y12 inhibitor alone) in patients who received optimized DES implantation guided by intravascular imaging (IVUS or OCT) Design: Prospective, open label, multi-center, dual arm, randomized trial Number of Subjects 3,944 subjects (1972:1972) Study Population: Patients with coronary artery disease undergoing imaging-guided PCI Study Design: * Eligible subjects will be randomized 1:1 to a) conventional DAPT strategy or b) tailored anti-platelet strategy (short DAPT followed by P2Y12 inhibitor alone) after optimized DES implantation guided by intravascular imaging. * All subjects will be clinically followed at 1(or 3), 6, and 12, 18, 24, 36, 48, 50 months Co-primary Endpoints: 1. Ischemic composite of all-cause death, myocardial infarction, ischemia-driven target-vessel revascularization, and definite or probable stent thrombosis at 12 months post-PCI 2. Net adverse clinical events, defined as the ischemic composite plus clinically relevant bleeding at 12 months post-PCI 3. Clinically relevant bleeding, defined as Bleeding Academic Research Consortium type 2, 3, or 5 bleeding at 12 months post-PCI Statistics and Analysis: The study was designed to test the hypothesis that tailored antithrombotic strategy, as compared to the conventional DAPT, would be superior for clinically relevant bleeding, noninferior to the ischemic composite adverse events and NACE. The primary analysis would be evaluated by intention-to-treat analysis. With 3756 (each 1,878) patients, this study has \>80% power to detect noninferiority of tailored antiplatelet strategy for ischemic composite adverse event, \>85% power to detect noninferiority of tailored antiplatelet strategy for NACE, and \>85% power to detect superiority of the tailored antiplatelet arm on clinically relevant bleeding. To compensate for 5% attrition rate, 3,944 (each 1,972) patients will be randomized.
Interventions
DRUGaspirin
DAPT strategy
Sponsors
Asan Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
* Eligible subjects will be randomized 1:1 to a) conventional DAPT strategy or b) tailored anti-platelet strategy (short DAPT followed by P2Y12 inhibitor alone) after optimized DES implantation guided by intravascular imaging. * All subjects will be clinically followed at 1(or 3), 6, and 12, 18, 24, 36, 48, 50 months
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Men or women ≥19 years 2. Typical chest pain or objective evidence of myocardial ischemia suitable for PCI 3. Significant de novo coronary artery lesions suitable for DES implantation 4. Patients who underwent optimized stent implantation either by IVUS or OCT * Using IVUS * MSA \>5.5 mm2, or MSA \>90% of the MLA at the distal reference segment * Plaque burden \<50% with 5 mm of both stent edge * No edge dissection; thrombus or plaque protrusion occupying \< 10% of the stent area * Using OCT * MSA \>4.5 mm2, or MSA \>90% of the MLA at the distal reference segment * No significant malapposition * No significant edge dissection†; thrombus or plaque protrusion occupying \< 10% of the stent area (\*Significant malapposition is defined as strut separation ≥ 0.3 mm from the vessel wall extending over a length \> 3 mm. †Significant dissection is defined as a dissection penetrating the medial layer and extending over more than one quadrant.) 5. The patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site
Exclusion criteria
1. Angiographic
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite ischemic endpoint | 12 month | Ischemic composite adverse event of all-cause death, myocardial infarction (MI), ischemia-driven target vessel revascularization (TVR), definite/probable stent thrombosis (ST) |
| Net adverse clinical events (NACE) | 12 month | Net clinical outcome defined as a composite of all-cause death, myocardial infarction (MI), ischemia-driven target vessel revascularization (TVR), definite/probable stent thrombosis (ST), and clinically relevant bleeding \[BARC 2, 3, or 5\] |
| Clinically relevant bleeding | 12 month | Clinically relevant bleeding \[Bleeding Academic Research Consortium (BARC) 2, 3, or 5\] |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Individual components of the composite ischemic endpoint | 12 month | Individual components of the composite ischemic endpoints including 1) all-cause death; 2) myocardial infarction (MI); 3) ischemia-driven target-vessel revascularization (TVR); and 4) definite or probable stent thrombosis (ST) |
| Cardiovascular death | 12 month | Sudden cardiac death; death due to acute myocardial infarction (MI), heart failure, cardiogenic shock, stroke, other cardiovascular causes, or fatal bleeding |
| Stroke | 12 month | An acute focal neurologic deficit of presumed vascular origin lasting ≥ 24 h or resulting in death and classified as ischemic or hemorrhagic |
| Individual BARC bleeding categories | 12 month | Type 0 (No bleeding); Type 1 (Minor, Non-Actionable Bleeding); Type 2 (Actionable Bleeding); Type 3 (Major Bleeding); Type 4 (CABG-Related Bleeding); Type 5 (Fatal Bleeding) |
| Stent strut coverage in the OCT substudy | 1 or 3 month | % difference of strut coverage on FU OCT between optimal vs. suboptimal DES implantation group |
Countries
South Korea
Contacts
CONTACTJi Sue Hong, RN
CONTACTSeung-Whan Lee, MD
Outcome results
None listed