Outcome of Coronary High Angulated Bifurcation Lesions Treated With Kissing Ballooning or Sequential Ballooning Techniques (MV:main branch)

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.

Study Overview

• Status: Completed
• Conditions: Stable Angina

• Study Type: Observational
• Enrollment (Actual): 214

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 52005
    • Taipei City Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 95 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

patients revceived coronary intervention between 2009-2014/3.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
sequential ballooning; include BMS or DES
final kissing ballooning; include BMS or DES

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Taipei City Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2015
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): November 1, 2017

Study Registration Dates

• First Submitted: April 19, 2014
• First Submitted That Met QC Criteria: May 10, 2014
• First Posted (Estimate): May 13, 2014

Study Record Updates

• Last Update Posted (Actual): October 4, 2019
• Last Update Submitted That Met QC Criteria: September 13, 2019
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: stable angina; BMS; DES; SYNTAX; high angulated bifurcation
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Pain; Neurologic Manifestations; Chest Pain; Angina Pectoris; Angina, Stable
• Other Study ID Numbers: TCHIRB-1030209-E