Stable Angina
Conditions
Keywords
stable angina, high angulated bifurcation, SYNTAX, DES, BMS
Brief summary
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.
Interventions
None listed
Sponsors
Taipei City Hospital
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 95 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Major Adverse Cardiac Events(MACE) | periprocedure up to 12 months | 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). |
| Percentage of Participants With Cardiovascular Mortality(%) | periprocedure up to 12 months | Percentage of Participants with cardiovascular mortality was defined as death related to cardiovascular causes within 2 years. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Angiographic Success(%) | periprocedure up to 12 months. | Percentage of Participants with angiographic success was defined as residual stenosis\<50% under fluoroscopy at the end of procedure. |
| Percentage of Participants With Target Vessel Revascularization Rate | periprocedure up to 12 months. | Percentage of Participants with target vessel revascularization rate, both arms |
| Fluoroscopy Time(Minutes) of Each Participants | periprocedure up to 12 months. | as medical chart record. |
| Procedure Time(Minutes) of Each Participants | periprocedure up to 12 months. | as medical chart record. |
Countries
Taiwan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Sequential Ballooning treated with drug eluting stent or bare metal stent. | 112 |
| Final Kissing Ballooning treated with drug eluting stent or bare metal stent. | 102 |
| Total | 214 |
Baseline characteristics
| Characteristic | Final Kissing Ballooning | Sequential Ballooning | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 24 Participants | 30 Participants | 54 Participants |
| Age, Categorical Between 18 and 65 years | 78 Participants | 82 Participants | 160 Participants |
| Age, Continuous | 67.67 years STANDARD_DEVIATION 11.49 | 68.69 years STANDARD_DEVIATION 11.43 | 67.98 years STANDARD_DEVIATION 11.54 |
| Region of Enrollment Taiwan | 102 participants | 112 participants | 214 participants |
| Sex: Female, Male Female | 21 Participants | 25 Participants | 46 Participants |
| Sex: Female, Male Male | 81 Participants | 87 Participants | 168 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 112 | 1 / 102 |
| other Total, other adverse events | 0 / 112 | 0 / 102 |
| serious Total, serious adverse events | 0 / 112 | 0 / 102 |
Outcome results
Primary
Percentage of Participants With Cardiovascular Mortality(%)
Percentage of Participants with cardiovascular mortality was defined as death related to cardiovascular causes within 2 years.
Time frame: periprocedure up to 12 months
Population: 100%x0/112; 100%x1/102
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Sequential Ballooning | Percentage of Participants With Cardiovascular Mortality(%) | 0 Participants |
| Final Kissing Ballooning | Percentage of Participants With Cardiovascular Mortality(%) | 1 Participants |
Primary
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).
Time frame: periprocedure up to 12 months
Population: 100%x2/112; 100%x7/102
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sequential Ballooning | Percentage of Participants With Major Adverse Cardiac Events(MACE) | 1.72 percentage of participants |
| Final Kissing Ballooning | Percentage of Participants With Major Adverse Cardiac Events(MACE) | 6.86 percentage of participants |
Secondary
Fluoroscopy Time(Minutes) of Each Participants
as medical chart record.
Time frame: periprocedure up to 12 months.
Population: fluoroscopy time(minutes) of each participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sequential Ballooning | Fluoroscopy Time(Minutes) of Each Participants | 24 minutes | Standard Deviation 6 |
| Final Kissing Ballooning | Fluoroscopy Time(Minutes) of Each Participants | 36 minutes | Standard Deviation 4 |
Secondary
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.
Time frame: periprocedure up to 12 months.
Population: lesions of participants; 100%x90/112; 100%x84/102.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Sequential Ballooning | Percentage of Participants With Angiographic Success(%) | 90 Participants |
| Final Kissing Ballooning | Percentage of Participants With Angiographic Success(%) | 84 Participants |
Secondary
Percentage of Participants With Target Vessel Revascularization Rate
Percentage of Participants with target vessel revascularization rate, both arms
Time frame: periprocedure up to 12 months.
Population: Percentage of Participants with target vessel revascularization rate, both arms
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Sequential Ballooning | Percentage of Participants With Target Vessel Revascularization Rate | 24 Participants |
| Final Kissing Ballooning | Percentage of Participants With Target Vessel Revascularization Rate | 19 Participants |
Secondary
Procedure Time(Minutes) of Each Participants
as medical chart record.
Time frame: periprocedure up to 12 months.
Population: procedure time(minutes) of each participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sequential Ballooning | Procedure Time(Minutes) of Each Participants | 84 minutes | Standard Deviation 8 |
| Final Kissing Ballooning | Procedure Time(Minutes) of Each Participants | 92 minutes | Standard Deviation 4 |