Randomised Comparison of T-stenting Versus Culotte Technique for the Treatment of de Novo Coronary Bifurcation Lesion With Drug-eluting Stents.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Maximal percent diameter stenosis at the bifurcation (QCA)
研究概览
简要总结
BBK- 2 - study:
STUDY-SUMMARY
Background:
The need for stenting of the main and side branch (double stenting) in the treatment of coronary bifurcation lesion primarily depends on the complexity of the bifurcation lesion. If the bifurcation lesion is very complex (Medina classification 111, severe stenosis of both branches, severe calcified lesion, long lesions etc.) double stenting may be the treatment of choice. When double stenting is required, the most frequently used stenting techniques are T-stenting and Culotte-stenting. It is still unclear, however, which double stent technique yields the best long-term outcome.
Aim:
This randomized study will compare the long-term safety and efficacy of T-stenting versus Culotte-stenting in the treatment of de-novo coronary bifurcation lesions with drug-eluting stents.
Methods:
Three-hundred patients in whom a double-stenting technique is intended for the treatment of a de-novo coronary bifurcation lesion will be randomly assigned to T-stenting or Culotte-stenting with an approved drug-eluting stent. Patients will undergo 9-month angiographic follow-up with quantitative coronary angiography. Clinical follow-up is planed at 30 days, 6 months, 1 year, 2 years, 3 years and 5 years. The primary study endpoint is the maximal percent diameter stenosis in the bifurcation lesion at 9 months. Secondary endpoints include binary restenosis (estimated by Quantitative Coronary Angiography (QCA) analysis), Target Lesion Revascularisation (TLR), Freedom from Major Adverse Cardiac Events (MACE) and the rate of stent thrombosis according to the definition of the Academic Research Consortium (ARC definition). The study will have 90% power to detect a 25% reduction in the primary endpoint at p < 0.05.
详细描述
1. STUDY BACKGROUND:
Currently, a simple stepwise provisional T-stenting approach is most frequently used type of treatment in coronary bifurcation lesions. When stenting of both the side branch and the main branch (double stenting) is needed because of dissection, TIMI flow < 2, high residual stenosis > 75% there is a variety of techniques, which have been proposed. The most common techniques are T-stenting and Culotte-stenting.
Adriaenssens et al (1) have analysed the data of 132 patients treated with Culotte-stenting including Quantitative Coronary Angiography (QCA) analysis and clinical follow-up 1 year post Percutaneous Coronary Intervention (PCI). The authors demonstrated an incidence of binary angiographic restenosis of 22% for the whole bifurcation lesion. Procedural angiographic success was achieved in all lesions (final kissing balloon dilatation was performed in 62 % of patients). At 12 months, 28 of 132 (21%) patients had undergone target lesion revascularization. The incidence of stent thrombosis (at 1 year) was low (1.5%).
Ferenc et al. (2) compared systematic T-stenting with the provisional T-stenting in 202 patients of the BBK 1 study. There was no significant difference between the 2 strategies. Overall, maximum percent diameter stenosis in the bifurcation was 31 % at 9 months, corresponding to a binary restenosis rate of 11 %. Within 1-year follow-up, this prompted target lesion reintervention in 9,9 % of the patients. The risk of late stent thrombosis was low (2 %) at 2-year follow-up.
The randomised multicenter Nordic 2 study addressed the question whether Crush-stenting or Culotte-stenting achieves better angiographic and clinical outcome after PCI in bifurcation lesions (Erglis et al). The results demonstrated the superiority of Culotte-stenting as compared to the Crush-stenting. Major adverse cardiac events (MACE) as primary study endpoint occurred in 3.7 % in the Culotte study arm as compared to 4.3 in the Crush study arm (p =0.87). Likewise, in the double stent study arm of the BBC One study the Crush-stenting was used successfully (Hildick-Smith, TCT Late Breaking Trials 2008).
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
- •Clinical indication for interventional treatment of the bifurcation lesion.
- •There is indication to perform the double stenting as judged by the operator.
- •Bifurcation lesions according to the Medina classification of a native coronary artery with a reference vessel diameter: main branch >2,5 mm; side branch >2,25 mm (the difference between vessel diameter of the main and side branch should be ≤1 mm)
- •The target lesion (main branch and / or side branch) must be at least 50% diameter stenosis.
- •The target lesion has not been previously treated with any interventional procedure.
- •The target vessel (main branch and side branch) must be feasible for stent implantation (successful passage with the guide wire; successful predilataion with an appropriately sized balloon; no heavy calcification; no diffuse distal disease that might impede run off).
- •Patient has no other treatment planned within 30 days of the procedure.
- •Patient has been informed of the nature of the study and agrees to its provisions and has written informed consent as approved by the Ethics Committee.
- •Patient is willing to comply all required post-procedure follow-up.
排除标准
- •Patient had an acute myocardial infarction (> 3x normal CK ) within 72 hours preceding the index procedure and CK has not returned to normal limits at the time of the procedure.
- •Patient will have a known hypersensitivity or contraindication to aspirin, heparin, clopidogrel, prasugrel, stainless steel, sirolimus, everolimus, zotarolimus, biolimus or contrast sensitivity that cannot be adequately pre- medicated.
- •Non successful treatment of other lesion during the same procedure
- •Patient has a platelet count of <100,000 cells/mm³ or >700,000 cells/mm³, a White Blood Cells of <3,000 cells/mm³, or documented or liver disease.
- •Patient has a history of bleeding diathesis or coagulopathy.
- •Patient has suffered a stroke within the past six months.
- •Active peptic ulcer or upper gastrointestinal bleeding within the prior 6 months.
- •Patient has a co-morbidity (i.e. cancer or congestive heart failure) that may cause the patient to be non-compliant with the protocol, or is associated with limited life- expectancy (less than 2 years).
- •Indication for oral anticoagulation
- •Patient must be excluded from the study if any of these angiographic criteria are met:
- •The target vessel contains intraluminal thrombus.
- •The target lesion or vessel shows angiographic evidence of severe calcification.
- •The patient has undergone previous PCI to the target vessel within 6 months.
- •Pre treatment of the lesion is done with a technique other than balloon angioplasty.
结局指标
主要结局
Maximal percent diameter stenosis at the bifurcation (QCA)
时间窗: 9 months post index PCI
Maximal percent diameter stenosis at the bifurcation (QCA)
次要结局
- TLR of the main and side branch(12 months post index PCI)
研究者
Dr. Miroslaw FERENC
MD
University Heart Center Freiburg - Bad Krozingen