Optimal Stenting Strategy For True Bifurcation Lesions

Study Overview
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Brief Summary
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It is unclear which stenting strategy will be optimal for true bifurcation coronary lesions.

Detailed Description
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The outcome of percutaneous coronary intervention of bifurcation lesions with bare-metal stents is hindered by increased rates of procedural complications and long-term major adverse cardiac events compared with non-bifurcated lesions.1 Randomized studies have demonstrated that drug-eluting stents reduce restenosis when used in relatively simple lesions; and recent data have demonstrated efficacy of the sirolimus-eluting stent for bifurcation lesions compared with historical data of BMS. In one study of bifurcation lesions, the overall restenosis rate was 23%, with the majority of side branch restenoses occurring at the ostium after use of a T-stenting technique. Indeed, side branch restenosis occurred in 16.7% after T-stenting, compared with 7.1% after other stenting techniques. The crush technique of bifurcation stenting with DESs was introduced by Colombo et al. in 2003 as a relatively simple technique that ensures complete coverage of the side branch ostium, thereby facilitating drug delivery at this site. Initial data of 20 patients treated with this technique with SES suggest that it is a safe method, with an acceptable rate of procedural complications and no further adverse events up to 30 days follow-up. Recently, angiographic data have shown the importance of simultaneous kissing balloon post-dilation in reducing restenosis and need for target lesion revascularization. They also reported that compared to T-stenting, crushing with final kissing balloon dilatation was associated with lower rate of restenosis and target lesion revascularization. Consequently, the crushing is currently most promising technique in treating bifurcation lesions using two stents. However, despite the advance of bifurcation stenting technique, the superiority of bifurcation stenting with crushing technique over simple stenting in bifurcation lesion has not been demonstrated. Therefore, we conducted the prospective randomized study comparing crushing technique with final kissing balloon dilatation and a simple technique (main vessel stenting and provisional T-stenting) for treatment of true bifurcation lesions.

Official Title
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Phase IV Study of Optimal Stenting Strategy For True Bifurcation Lesions

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Procedure: Crush technique
* Procedure: provisional T stenting


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical Patients with angina and documented ischemia or patients with documented silent ischemia Patients who are eligible for intracoronary stenting Age >18 years, <75 ages Angiographic De novo lesion located in a major bifurcation point with the MEDINA classification type 1.1.0, 1.0.0, or 0.1.0 Main vessel : >= 2.5 mm in vessel size, >= 50% in diameter stenosis and =< 50 mm in lesion length by visual estimation, in which the lesion seems to be covered with =< 2 stents Side branch : >= 2.0 mm in vessel size, >= 50% in diameter stenosis, and < 20 mm in lesion length by visual estimation, in which the lesion seems to be covered with single stent Exclusion Criteria: History of bleeding diathesis or coagulopathy Pregnant Known hypersensitivity or contra-indication to contrast agent, heparin, sirolimus and paclitaxel Limited life-expectancy (less than 1 year) due to combined serious disease ST-elevation acute myocardial infarction < 2 weeks Characteristics of lesion: Left main disease In-stent restenosis Graft vessels Chronic total occlusion TIMI flow =< grade 2 in the side branch Renal dysfunction, creatinine >= 2.0mg/dL Contraindication to aspirin, clopidogrel or cilostazol LV ejection fraction =< 35%

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: bifurcation stent technique<br>crush technique | Procedure: Crush technique<br>* Crush technique<br>* Other names: Sirolimus, Paclitaxel, Zotarolimus and Everolimus stents;|
| Active Comparator: bifurcation stent techniqe<br>provisional T stenting | Procedure: provisional T stenting<br>* Provisional T stenting<br>* Other names: Sirolimus, Paclitaxel, Zotarolimus and Everolimus stents;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Angiographic binary restenosis rate (diameter stenosis >= 50%) at 8 months in either main or side branch |  | 8 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite of major cardiac adverse events (MACE) including death, MI, stent thrombosis and ischemia-driven target vessel revascularization |  | 2 years | 
| Reocclusion rate at the side branch at 8 month angiographic follow-up |  | 8 months | 
| Late loss at the main vessel and the side branch |  | 8 months | 
| Restenosis rate at the main vessel and/or side branch |  | 8 months | 
| Influence of bifurcation angle |  | 8 months | 
| Influence of new three segment bifurcation QCA software |  | 8 months | 
| Fluoroscopic time |  | baseline | 
| Procedure time |  | baseline | 
| Amount of contrast agent |  | baseline | 
| Number of used stents |  | baseline | 
| FFR assessment in the side branch |  | baseline and 8 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stent, bifurcation, coronary artery stenosis, balloon angioplasty