Comparison of 1-month Versus 12-month Dual Antiplatelet Therapy After Implantation of Drug-Eluting Stents Guided by Either Intravascular Ultrasound or Angiography in Patients With Acute Coronary Syndrome: The Prospective, Multicenter, Randomized, Placebo-controlled IVUS-ACS and ULTIMATE-DAPT Trials
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 3,710
- Locations
- 1
- Primary Endpoint
- Target vessel failure (TVF)
Study Overview
Brief Summary
Prospective, multicenter, randomized, double-blind, placebo-controlled trials.
Detailed Description
A total of 3486 subjects with ACS who met inclusion criteria and do not have any exclusion criterion will be randomized to IVUS- or Angiography-guidance group (first randomization). In the IVUS-guidance group, IVUS will be used to evaluate the lesion's specificity and to measure lesion length, landing zone, and reference vessel diameter prior-to stenting; and to assess stent expansion, extension, apposition, and possible complications after stent implantation. The IVUS- defined criteria for the optimal stent deployment included: 1) the minimal stent area (MSA) in the stented segment is >5.0 mm^2, or 90% of the MLA at the distal reference segments; 2) plaque burden 5-mm proximal or distal to the stent edge is <55%; and 3) absence of >Type B edge dissection. Further treatment will be required if stenting procedure is defined as suboptimal according to IVUS definition. IVUS will be not allowed to be used in the Angiography-guidance group.
Those patients who have had no death, STEMI, stroke, ST, TVR or major bleeding (BARC 3 or 5) within 30 days and have continued on aspirin and ticagrelor for 30 days without interruption for >48 hours will be randomized 1:1 to:
- Ticagrelor plus+ matching placebo for an additional 11 months (SAPT group)
- Ticagrelor plus aspirin (study drug) for an additional 11 months (DAPT group) Follow-up of all subjects will continue for 1 year with an option for additional follow-up to 3 years.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Enrollment into the study will require meeting at least one of these clinical syndromes within 1 month.
- •Unstable angina, defined as rest pain for 5-30 minutes or deteriorative exertional angina with either a) transient ST segment depression or elevation, or b) angiography showing a visually estimated diameter stenosis ≥90% or a ruptured plaque or thrombotic lesion
- •Non-ST elevation myocardial infarction (NSTEMI), defined as positive troponin consistent with clinical syndrome.
- •ST elevation MI (STEMI)
Exclusion Criteria
- •Unable or unwilling to provide informed consent
- •Stroke within 3 months or any permanent neurologic deficit, and prior intracranial bleed, or any intracranial disease such as aneurysm or fistula
- •Previous coronary artery bypass graft (CABG)
- •Any planned surgery within 90 days
- •Any reason why any antiplatelet therapy might need to be discontinued within 12 months
- •Severe chronic kidney disease defined as an estimated glomerular filtration rate (eGFR) < 20 ml/min/1.73m^2
- •Need for chronic oral anticoagulation (warfarin/coumadin or direct oral anticoagulants)
- •Platelet count < 100,000 mm^3
- •Contraindication to aspirin
- •Contraindication to ticagrelor
- •Liver cirrhosis
- •Women of child-bearing potential
- •Life expectancy < 1 year
- •Any condition likely to interfere with study processes including medication compliance or follow-up visits (e.g. dementia, alcohol abuse, severe frailty, long distance to travel for follow-up visits, etc.)
Arms & Interventions
IVUS-guidance
In the IVUS-guided DES implantation group, optimal stent deployment criteria included: 1) the MLA in the stented segment is >5.0 mm^2, or 90% of the MLA at the distal reference segments; 2) plaque burden 5-mm proximal or distal to the stent edge is <55%; and 3) absence of >=Type B edge dissection. Further treatment will be required if any of those 3 criteria was not met.
Intervention: AntiPlatelet therapy (Drug)
IVUS-guidance
In the IVUS-guided DES implantation group, optimal stent deployment criteria included: 1) the MLA in the stented segment is >5.0 mm^2, or 90% of the MLA at the distal reference segments; 2) plaque burden 5-mm proximal or distal to the stent edge is <55%; and 3) absence of >=Type B edge dissection. Further treatment will be required if any of those 3 criteria was not met.
Intervention: Percutaneous coronary intervention (Procedure)
Angiography-guidance
In the Angiography-guided DES implantation group, stent diameter and length will be selected by visual estimation with a stent/artery ratio of 1.1:1.0. Post-dilation with a noncompliant balloon (balloon/stent diameter=1.0:1.0) inflated at >18 atm will be performed for all lesions. Angiographic success is defined as Thrombolysis In Myocardial Infarction (TIMI) grade 3, residual stenosis <20%, and the absence of >Type B dissection.
Intervention: AntiPlatelet therapy (Drug)
Angiography-guidance
In the Angiography-guided DES implantation group, stent diameter and length will be selected by visual estimation with a stent/artery ratio of 1.1:1.0. Post-dilation with a noncompliant balloon (balloon/stent diameter=1.0:1.0) inflated at >18 atm will be performed for all lesions. Angiographic success is defined as Thrombolysis In Myocardial Infarction (TIMI) grade 3, residual stenosis <20%, and the absence of >Type B dissection.
Intervention: Percutaneous coronary intervention (Procedure)
SAPT group
Ticagrelor + aspirin for 1 month followed by ticagrelor plus matching placebo for an additional 11 months.
Intervention: AntiPlatelet therapy (Drug)
SAPT group
Ticagrelor + aspirin for 1 month followed by ticagrelor plus matching placebo for an additional 11 months.
Intervention: Percutaneous coronary intervention (Procedure)
DAPT group
Ticagrelor + aspirin for 12 month.
Intervention: AntiPlatelet therapy (Drug)
DAPT group
Ticagrelor + aspirin for 12 month.
Intervention: Percutaneous coronary intervention (Procedure)
Outcomes
Primary Outcomes
Target vessel failure (TVF)
Time Frame: 12 months
The difference in TVF will be calculated from 0 month to 12 months between IVUS- and Angiography guidance groups.
Clinically-relevant bleeding
Time Frame: 11 months
The difference in clinically-relevant bleeding (BARC ≥2) will be calculated from 1 month to 12 months between SAPT and DAPT groups.
Major adverse cardiovascular and cerebrovascular events (MACCE)
Time Frame: 11 months
The difference in MACCE will be calculated from 1 month to 12 months between SAPT and DAPT groups.
Secondary Outcomes
- Net adverse clinical events (NACE)(12 months)
Investigators
Shaoliang Chen, MD
Vice President
Nanjing First Hospital, Nanjing Medical University