Drug-Coated Balloon Versus Drug-Eluting Stent for Treatment of De-Novo Coronary Lesions in Patients With High Bleeding Risk (DCB-HBR Trial)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,359
- 试验地点
- 34
- 主要终点
- Target vessel failure (TVF)
研究概览
简要总结
DCB-HBR trial is prospective, multi-center, open-label, randomized controlled, noninferiority trial.
The aim of the study is to compare clinical outcomes of drug-coated balloon (DCB) with drug-eluting stent (DES) for treatment of de-novo coronary lesion in patients with high bleeding risk (HBR).
详细描述
Second-generation DES is the standard of care for patients with coronary artery disease who are deemed eligible for percutaneous coronary intervention (PCI). Despite many advantages, DES inevitably accompany disadvantages such as the occurrence of late stent thrombosis and the need for maintaining dual antiplatelet (DAPT) for certain period due to permanent vascular implant, which lead to both increased ischemic and bleeding events.
As an alternative to DES, drug-coated balloon (DCB), a novel treatment strategy, which has benefit of having shorter DAPT maintenance duration due to the absence of metallic scaffolds and polymers, has been introduced. Based on meta-analysis based on many randomized clinical trials (RCT), its use has been established in in-stent restenosis of bare-metal stents (BMS) and DES. Furthermore, recently published RCT demonstrated efficacy and safety of DCB in de-novo coronary lesions in small vessels with reference vessel size<3.0mm. However, studies exploring the feasibility of DCB in de-novo coronary artery stenosis beyond small vessels are limited. Furthermore, there is scarce data comparing DCB with DES in patients with de-novo coronary artery stenosis and high bleeding risk (HBR), a situation in which long-term maintenance of DAPT is a clinical dilemma. In previous BASKET-SMALL 2 trial, DCB showed noninferiority to DES in patients with de-novo coronary artery stenosis and small vessel disease. However, this trial was conducted in non-HBR patients, and the number of participated patients was insufficient. In another RCT, DEBUT trial exclusively enrolled patients with HBR and de-novo coronary artery stenosis. Although the DEBUT trial showed superiority of DCB angioplasty over implantation of BMS to treat de-novo coronary artery stenosis in patients with HBR, the results could not be applicable in contemporary practice because BMS has been no longer in clinical use. Recently, multiple RCTs have proved short-term DAPT (1-3 months) has comparable efficacy to longer term DAPT in HBR patients using latest second-generation DES.
On this background, the current trial aims to compare clinical outcomes between DCB and DES to treat de-novo coronary artery stenosis in patients with HBR receiving guideline-directed short-term DAPT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Clinical outcome assessment will be performed under blinded assessment about the allocated treatment group.
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject must be at least 19 years of age
- •Subject who is able to understand risks, benefits and treatment alternatives and sign informed consent voluntarily.
- •Patients with at least one lesion with greater than 50% diameter stenosis or fractional flow reserve ≤0.80 requiring revascularization in de-novo coronary artery of reference vessel size ≥2.25 mm
- •Patients with high bleeding risk: one or more of the criteria listed (1) Adjunctive oral anticoagulation treatment planned to continue after PCI (2) Age ≥ 75 years old (3) Baseline Hemoglobin <11 g/dl (or anemia requiring transfusion during the 4 weeks prior to randomization) (4) Any prior intra-cerebral bleeding (5) Stroke at any time or transient ischemic attack in the previous 6 months. (6) Hospital admission for bleeding during the prior 12 months (7) Non skin cancer diagnosed or treated < 3 years (8) Planned daily NSAID (other than aspirin) or steroids for >30 days after PCI (9) Planned surgery that would require interruption of DAPT (within next 12 months) (10) Renal failure defined as calculated creatinine clearance <40 ml/min or on dialysis (11) Hematological disorders (platelet count <100,000/mm3 or any coagulation disorder) (12) Severe chronic liver disease defined as patients who have developed any of the following: variceal hemorrhage, ascites, hepatic encephalopathy or jaundice (13) Expected non-compliance to prolonged DAPT for other medical reasons
排除标准
- •Patients unable to provide consent
- •Patients with known intolerance to aspirin, P2Y12 inhibitors, or components of drug-eluting stents
- •Patients with angiographic findings of (1) Left main coronary artery disease (2) In-stent restenosis is the cause of target lesion (3) Target lesion in bypass graft (4) True bifurcation lesion that requires upfront 2-stenting
- •Patients who have non-cardiac co-morbid conditions with life expectancy <2 year
- •Patients who may result in protocol non-compliance (site investigator's medical judgment)
- •Patients with cardiogenic shock or cardiac arrest
- •Patients with severe left ventricular systolic dysfunction (ejection fraction <30%)
- •Patients with severe valvular heart disease requiring open heart surgery
- •Pregnant or lactating women
研究组 & 干预措施
DES group
Patients will be randomized to either the DCB group or the DES group with 1:1 ratio during the index procedure after diagnostic angiography.
In DES group, latest second-generation DES will be used (Ultimaster Tansei) during the index procedure
干预措施: Percutaneous coronary intervention (Procedure)
DCB group
Patients will be randomized to either the DCB group or the DES group with 1:1 ratio during the index procedure after diagnostic angiography.
In DCB group, Agent (Boston Scientific, USA), Prevail (Medtronic, USA), or SeQuent Please, SeQuent Please NEO (B-Braun, Germany) will be used during the index procedure.
干预措施: Percutaneous coronary intervention (Procedure)
结局指标
主要结局
Target vessel failure (TVF)
时间窗: 2 years from last patient enrollment
a composite of cardiovascular death, target-vessel myocardial infarction (MI), and clinically indicated target-vessel revascularization (TVR)
次要结局
- Vessel or stent thrombosis at Extended Follow-up(4 years from last patient enrollment)
- Cardiovascular death at Extended Follow-up(4 years from last patient enrollment)
- All-cause death at Extended Follow-up(4 years from last patient enrollment)
- Target-vessel MI at Extended Follow-up(4 years from last patient enrollment)
- Non-target vessel related MI at Extended Follow-up(4 years from last patient enrollment)
- Non-fatal MI at Extended Follow-up(4 years from last patient enrollment)
- Cardiovascular death(2 years from last patient enrollment)
- All-cause death(2 years from last patient enrollment)
- Target-vessel MI(2 years from last patient enrollment)
- Non-target vessel related MI(2 years from last patient enrollment)
- Non-fatal MI(2 years from last patient enrollment)
- Clinically indicated target-lesion revascularization (TLR)(2 years from last patient enrollment)
- Clinically indicated TVR(2 years from last patient enrollment)
- Non-target vessel revascularization(2 years from last patient enrollment)
- Any revascularization(2 years from last patient enrollment)
- Vessel or stent thrombosis(2 years from last patient enrollment)
- Cardiovascular death or target-vessel MI(2 years from last patient enrollment)
- Target vessel failure without procedure-related MI(2 years from last patient enrollment)
- Target lesion failure (TLF)(2 years from last patient enrollment)
- Cardiovascular death, target-vessel MI, or vessel or stent thrombosis(2 years from last patient enrollment)
- All-cause death, non-fatal MI, or any revascularization(2 years from last patient enrollment)
- BARC type 2, 3 or 5 bleeding (Major secondary endpoint)(2 years from last patient enrollment)
- Bleeding according to BARC definition(2 years from last patient enrollment)
- Bleeding according to TIMI definition(2 years from last patient enrollment)
- Cerebrovascular accident (CVA)(2 years from last patient enrollment)
- Target vessel failure (TVF) at Extended Follow-up(4 years from last patient enrollment)
- Clinically indicated target-lesion revascularization (TLR) at Extended Follow-up(4 years from last patient enrollment)
- Clinically indicated TVR at Extended Follow-up(4 years from last patient enrollment)
- Non-target vessel revascularization at Extended Follow-up(4 years from last patient enrollment)
- Any revascularization at Extended Follow-up(4 years from last patient enrollment)
- Target vessel failure without procedure-related MI at Extended Follow-up(4 years from last patient enrollment)
- Cardiovascular death or target-vessel MI at Extended Follow-up(4 years from last patient enrollment)
- Target lesion failure (TLF) at Extended Follow-up(4 years from last patient enrollment)
- Cardiovascular death, target-vessel MI, or vessel or stent thrombosis at Extended Follow-up(4 years from last patient enrollment)
- All-cause death, non-fatal MI, or any revascularization at Extended Follow-up(4 years from last patient enrollment)
- BARC type 2, 3 or 5 bleeding (Major secondary endpoint) at Extended Follow-up(4 years from last patient enrollment)
- Bleeding according to BARC definition at Extended Follow-up(4 years from last patient enrollment)
- Bleeding according to TIMI definition at Extended Follow-up(4 years from last patient enrollment)
- Cerebrovascular accident (CVA) at Extended Follow-up(4 years from last patient enrollment)
研究者
Joo Myung Lee
Professor
Samsung Medical Center