This is a multicenter, open-label, randomized controlled study meant to compare the safety and efficacy of scheduled drug-coated balloon (DCB) and conventional drug-eluting stent (DES) strategy in the treatment of de novo lesions of large coronary vessel with diameter larger than 2.75 mm. The trial was designed to provide high-quality evidence for expanding the clinical indications of DCB, and to explore a better way for coronary intervention based on DCB.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
2,700
* Patients treated with DCB will receive dual antiplatelet therapy (DAPT, aspirin plus P2Y12 inhibitor) for 1-3 months, followed by long-term single antiplatelet therapy (SAPT, aspirin or P2Y12 inhibitor). * Patients with bailout stenting will generally receive DAPT for 6 months unless deemed as with high ischemic and/or bleeding risks (see "special consideration" in Drug-eluting stent Arm), and then followed by long-term SAPT.
* Patients treated with DES will generally receive DAPT for 6 months unless deemed as with high ischemic and/or bleeding risks (see "special consideration" below), and then followed by long-term SAPT. * Special consideration: 1. Patients will take additional assessment (both DAPT score and PRECISE-DAPT score) to determine their personalized duration of DAPT. 2. The duration of DAPT is extended to 12 months for patients diagnosed as acute coronary syndrome within 12 months. 3. If anticoagulation is indicated, patient will receive a short-term triple antithrombotic therapy (generally 1 to 4 weeks), followed by a variable length of dual antithrombotic therapy (oral anticoagulation (OAC) plus a single antiplatelet agent, preferably clopidogrel) and subsequent long-term OAC mono-therapy. The duration of dual antithrombotic therapy is determined by bleeding risks (HAS-BLED score) according to current guidelines.
Fuwai Hospital, National Center for Cardiovascular Diseases,Chinese Academy of Medical Sciences
Beijing, China
Incidence of a composite of cardiac death, target-vessel myocardial infarction and clinically indicated target lesion revascularization
Incidence of a composite of cardiac death, target-vessel myocardial infarction and clinically indicated target lesion revascularization
Time frame: 12 months
Incidence of a composite of peri-procedural complications including cardiac death, perioperative myocardial infarction, acute thrombosis at target vessel and acute occlusion at target vessel
Incidence of a composite of peri-procedural complications including cardiac death, perioperative myocardial infarction, acute thrombosis at target vessel and acute occlusion at target vessel
Time frame: 48 hours
Incidence of cardiac death
Incidence of cardiac death
Time frame: 1, 12, 24, 36, and 60 months
Incidence of target-vessel myocardial infarction
Incidence of target-vessel myocardial infarction
Time frame: 1, 12, 24, 36, and 60 months
Incidence of clinically indicated target lesion revascularization
Incidence of clinically indicated target lesion revascularization
Time frame: 1, 12, 24, 36, and 60 months
Incidence of a composite of all-cause mortality, nonfatal myocardial infarction, nonfatal stroke, and re-hospitalization
Incidence of a composite of all-cause mortality, nonfatal myocardial infarction, nonfatal stroke, and re-hospitalization
Time frame: 1, 12, 24, 36, and 60 months
Incidence of BARC (Bleeding Academic Research Consortium [BARC] definition, type 2 to 5)
Incidence of BARC (Bleeding Academic Research Consortium \[BARC\] definition, type 2 to 5)
Time frame: 1, 12, 24, 36, and 60 months
Incidence of net clinical benefit (a composite of cardiac death, target-vessel myocardial infarction, clinically indicated target vessel revascularization and major bleeding)
Incidence of net clinical benefit (a composite of cardiac death, target-vessel myocardial infarction, clinically indicated target vessel revascularization and major bleeding (Bleeding type 3 or 5 according to the Bleeding ARC))
Time frame: 1,12, 24, 36, and 60 months
Score of Seattle Angina Questionnaire (SAQ)
SAQ, a 19-item questionnaire that quantifies physical limitations due to angina, any recent change in the severity of angina, the frequency of angina, satisfaction with treatment, and quality of life. SAQ scores range from 0 to 100 and higher scores indicate better health status.
Time frame: 1, 12, 24, 36, and 60 months
Score of EuroQol Five Dimensions-5L (EQ-5D-5L)
The EQ-5D-5L questionnaires assesses health in five dimensions (Mobility, Human Autonomy, Current Activities, Pain / Discomfort, Anxiety / Depression), each of which has 5 levels of response (no problems, slight problems, moderate problems, severe problems, extreme problems/unable to). Health state index scores generally range from less than 0 to 1, with higher scores indicating higher health utility. The second part of the questionnaire consists of a visual analogue scale on which the patient rates his/her perceived health from 0 to 100.
Time frame: 1, 12, 24, 36, and 60 months
Quality-adjusted life-years (QALYs)
Quality-adjusted life-years (QALYs)
Time frame: 1, 12, 24, 36, and 60 months
Total costs
Total costs including the expenditure of hospitalization, physicians, examination, nursing care and medication
Time frame: 12, 24, 36, and 60 months
Incremental cost-effectiveness ratios (ICER)
The ICER of scheduled DCB compared with conventional DES is defined as the ratio between incremental costs associated with scheduled DCB and the variation in effectiveness. Costs will be measured in Chinese yuan (RMB). Effectiveness will be considered both in terms of life years gained, measured in years, and in terms of quality of life gained, measured in QALY. In the first case, ICER will be measured as RMB/years; in the second, it will be measured as RMB/QALY.
Time frame: 12, 24, 36, and 60 months
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