A Randomized Multicentre Trial to Evaluate the Utilization of Revascularization or Optimal Medical Therapy for the Treatment of Chronic Total Coronary Occlusions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 450
- 试验地点
- 38
- 主要终点
- Quality of Life Seattle Angina Questionnaire (SAQ)
研究概览
简要总结
CTOs are common among patients with angina, and are detected in around 20% of patients undergoing coronary angiography. Treatment of CTO has been found to constitute only 7% of PCI practice on average. One of the reasons for the under-presentation of CTOs in PCI target lesions is the lack of evidence-based medical data on treatment indications, and the continued low level of accepted evidence for the treatment of CTOs by PCI in PCI guidelines.
Patients with a CTO represent patients with stable coronary artery disease. The COURAGE trial comparing PCI with optimal medical therapy in stable coronary disease did not show a difference in mortality or myocardial infarction between the two treatment options. However, CTOs were not included in the COURAGE trial. But that trial did confirm the superiority of PCI over OMT in controlling symptoms of angina, with a high cross-over rate to PCI. Whether PCI for CTO is superior to OMT in reducing MACE in those patients with a large ischaemic burden has never been tested in a randomized controlled trial.
While there is compelling evidence from registry studies of a clinical and prognostic benefit following successful PCI of CTO compared with PCI failure, there has been no randomized controlled trial of contemporary PCI using drug-eluting stents versus optimal medical therapy. The COURAGE trial nuclear sub-study confirms both that prognosis is closely related to the extent of residual ischaemia and that PCI is more effective in reducing residual ischaemia than optimal medical therapy alone. This confirms earlier retrospective data suggesting that the benefit of PCI is greatest in patients with moderate (10-20%) or severe (>20%) ischaemia.
Study hypothesis: PCI with Biolimus eluting stent implantation plus OMT will be superior to OMT alone in improving health status at 12-month follow-up, and will be noninferior with respect to the composite of all cause death/ non fatal MI at 36-month follow up, in patients with a CTO in an epicardial coronary artery >2.5 mm diameter and chronic stable angina with evidence of ischemia and viability in the territory subtended by the CTO
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
- None
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
- •≥ 18 years of age with written informed consent
- •CTO in native coronary artery
- •a) Stable angina, or b) myocardial ischaemia in a territory supplied by CTO, and c) viability in akinetic myocardium (<50% transmural late enhancement on MRI or normal resting perfusion scan)
- •CTO located in segments 1-3 (RCA), 6-7 (LAD), 11-12 (LCx)
- •target artery ≥2.5mm
排除标准
- •AMI or NSTE-ACS within 1 month
- •Significant untreated coronary stenosis in a territory other than CTO
- •Patients with MVD and significant non-CTO stenoses where it is deemed unsafe to treat the non-CTO lesion first (e.g. Significant proximal LAD lesion with chronically occluded RCA)
- •Patient unsuitable for 12 month dual anti-platelet therapy
- •Any exclusion criteria for PCI or DES
- •Pregnant or nursing patients and those who plan pregnancy in the period up to 1 year following index procedure
研究组 & 干预措施
Biolimus-eluting stent implantation
PCI of CTO using a Biomatrix drug-eluting stent system + optimal medical therapy.
干预措施: Biolimus-eluting stent implantation (Device)
Medical therapy
Optimal medical therapy. Subsequent PCI only if symptoms of angina persist despite optimal medical therapy. At least 2 anti-anginal agents or the maximum tolerated anti-anginal therapy should be used before crossover. Medical therapy should include adequate ventricular rate-limiting medication (i.e. Beta-blocker or rate-limiting calcium antagonist) where appropriate.
结局指标
主要结局
Quality of Life Seattle Angina Questionnaire (SAQ)
时间窗: Baseline and 12 months
Seattle Angina Questionnaire and EQ-5D for health outcomes measurement
Major cardiovascular events
时间窗: 36 months
Cumulative composite endpoint of cardiovascular death, non-fatal MI at 3 years
次要结局
- Protocol adherence(36 months)
- Safety and efficacy endpoints(12 and 36 months)
- Procedural complications(baseline upto 36 months)
- Per protocol analysis(36 months)