Outcome of Coronary High Angulated Bifurcation Lesions Treated With Kissing Ballooning or Sequential Ballooning Techniques

Study Overview
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Brief Summary
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Coronary artery bifurcation lesions prone to occur with the worsening of atherosclerosis. Their structural properties make angioplasty technique to increase the difficulty of implementation, but also increased the risks of the in-stent thrombosis and restenosis. Standard treatment of coronary bifurcation lesions remains controversial manner, especially when the side branch (SB) was large combined with high angulated bifurcation lesions. Complex procedures and certain types of lesions are associated with poor prognosis. There is no standard treatment for such lesions even with the development of drug-eluting stents solve partial problems. The investigators reviewed patients who received coronary intervention between 2009-2012 years and met the inclusion criteria, and then analyzed the prognostic relevance of these cases the use of different treatment modalities. We introduced a retrospective analysis for high angulated bifurcation lesions treated with either DES or BMS. Primary endpoint: cardiovascular mortality, TLR, MACE. secondary endpoint: procedure time, fluoroscopy time, procedure success, angiographic success.

Official Title
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Outcome of Coronary High Angulated Bifurcation Lesions Treated With Kissing Ballooning or Sequential Ballooning Techniques

Conditions
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Stable Angina

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Angulated bifurcation:MV(main branch) and SB(side branch) angle>70 degree. MV diameter≥2.5mm and eligible for stenting. lesion stenotic severity>70% by QCA(Quantitative coronary analysis). 1 stent strategy. SYNTAX>22 Procedure success. de novo lesion Exclusion Criteria: Bifurcation lesions intervention without side br. ballooning after stents deployment or procedure incomplete. Left main coronary artery bifurcational lesions. Elective,provisional or bail-out stenting for side br.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 95 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| sequential ballooning<br>include BMS or DES | |
| final kissing ballooning<br>include BMS or DES | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Major Adverse Cardiac Events(MACE) | Percentage of Participants with major adverse cardiac events(MACE) was defined as rates of target lesion revascularization (TLR) and restenosis during first post-treatment year, and rates of acute, subacute, and late in-stent thrombosis, periprocedure MI(myocardial infarction). | periprocedure up to 12 months | 
| Percentage of Participants With Cardiovascular Mortality(%) | Percentage of Participants with cardiovascular mortality was defined as death related to cardiovascular causes within 2 years. | periprocedure up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Angiographic Success(%) | Percentage of Participants with angiographic success was defined as residual stenosis<50% under fluoroscopy at the end of procedure. | periprocedure up to 12 months. | 
| Percentage of Participants With Target Vessel Revascularization Rate | Percentage of Participants with target vessel revascularization rate, both arms | periprocedure up to 12 months. | 
| Fluoroscopy Time(Minutes) of Each Participants | as medical chart record. | periprocedure up to 12 months. | 
| Procedure Time(Minutes) of Each Participants | as medical chart record. | periprocedure up to 12 months. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stable angina, high angulated bifurcation, SYNTAX, DES, BMS