Comparison of Hybrid Versus Two-Stent Strategies in Patients With Unprotected True Left Main Coronary Artery Bifurcation Disease: A Streamlined, Multicentre, Investigator-Initiated, Randomized Superiority Trial (HYBRID MAIN)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 800
- 主要终点
- Target Lesion Failure (TLF)
研究概览
简要总结
The number of deaths from heart disease is rising globally, particularly in developing countries. This condition involves the narrowing of arteries that supply blood to the heart. The most critical narrowing occurs in the left main coronary artery (LMCA), which supplies blood to over two-thirds of the heart muscle. Treating this narrowing is essential to prevent heart attacks or death. The LMCA divides into two branches, known as a bifurcation, both of which require treatment if narrowed.
Currently, narrowing in both branches-the left anterior descending artery (LAD) and the left circumflex artery (LCx)-is treated with a two-stent strategy, where metallic stents are placed in each branch to keep the arteries open. However, this approach is prone to re-narrowing, particularly at the origin of the LCx. A new procedure, called the hybrid strategy, offers an alternative. It involves placing one stent in the LMCA and LAD while inflating a special balloon in the LCX. This balloon, known as a drug-coated balloon, releases a chemical that reduces narrowing over time without needing a stent. At present, there is uncertainty which strategy is better. This study will assess whether the hybrid strategy is more effective than the two-stent strategy in preventing death, heart attacks, and re-narrowing of the arteries.
Participants will have an equal chance of receiving either the two-stent or hybrid strategy and will only join the study if their doctor is unsure which method is best. To minimise the burden on participants, all study procedures and follow-ups will be integrated into standard routine care.
The results of this study have the potential to offer a new, safer treatment that could save the lives of millions of people with this condition.
详细描述
Percutaneous coronary intervention (PCI) of unprotected distal left main bifurcation (UTLMB) lesions remains technically demanding and is associated with higher risks than interventions in non-left main coronary lesions.
Several revascularisation strategies are in use:
- Provisional strategy - Implant a single drug-eluting stent (DES) from the left main coronary artery (LMCA) to the left anterior descending artery (LAD), leaving the left circumflex artery (LCx) unstented.
- Stepwise provisional strategy - Begin with the LMCA to LAD DES as in the provisional strategy, then implant a stent in the LCx only if required (e.g., for flow limitation or suboptimal angiographic result) using the operator's preferred method.
- Two-stent strategy - From the outset, plan to implant DES in both LAD and LCx using a recognised bifurcation technique.
- Hybrid strategy - Implant a DES from LMCA to LAD and treat the LCx with a drug-coated balloon (DCB) after adequate preparation and in the absence of a flow-limiting dissection.
While provisional approaches are less complex, they may be inadequate in true bifurcation lesions where both branches have significant disease.
Conversely, two-stent strategies offer full anatomical coverage but are technically challenging, associated with longer procedures, greater contrast use, higher radiation exposure, and potentially more periprocedural complications. Optimal outcomes heavily depend on the operator's skill, which contributes partly to the ongoing debate on this topic. Regardless of the operator's skill or chosen two-stent approach, the persistent risk of restenosis at the LCx ostium remains a significant vulnerability in the two-stent strategy.
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)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Floating eligibility criteria
- •De novo unprotected true left main bifurcation (UTLMB) (Medina 1,1,1; 1,0,1; and 0,1,1).
- •Optimal LCx lesion preparation (residual stenosis less than 30% with absence of flow-limiting dissection).
- •The operator feels it might be appropriate to place either a drug-eluting stent (DES) or drug-coated balloon (DCB) to the LCX
- •Clinically stable at the time of randomisation.
- •Able to complete 2-year follow-up.
- •Able to complete dual antiplatelet therapy (DAPT) as per guidelines.
- •Written informed consent (or verbal consent on-table with written consent as soon as possible thereafter).
排除标准
- •Protected left main (patent graft to LAD and LCX)
- •Need for anticoagulation
- •LCx reference vessel diameter less than 2.5 mm (< 2.5 mm)
- •Cardiogenic shock
- •Severe left ventricular (LV) dysfunction making either strategy unsafe
- •Contraindication to antiplatelet therapy or study devices
- •Life expectancy less than 2 years
- •Participation in another trial that may affect results
结局指标
主要结局
Target Lesion Failure (TLF)
时间窗: 2 years
Target lesion failure (TLF) at 2 years defined as a composite of: time to first event of cardiovascular death, time to first event of target vessel myocardial infarction (TVMI), time to first event of clinically driven target lesion revascularisation (CD-TLR).
次要结局
- Composite of cardiovascular death and TVMI(2 years)
- Safety endpoints(2 years)
- Individual components of primary endpoint(2 years)
研究者
Dharmaraj Karthikesan
Consultant Interventional Cardiologist
Hospital Sultanah Bahiyah