Coronary Artery Disease
Conditions
Keywords
Angioplasty, Transluminal, Percutaneous Coronary, Everolimus-eluting stent
Brief summary
The aim of this study was to compare conservative versus aggressive strategy in patients with intermediate lesions with angiography guidance alone.
Detailed description
To investigate whether conservative revascularization using criteria of 70% diameter stenosis would be non-inferior to aggressive revascularization using criteria of 50% diameter stenosis in coronary intermediate lesions, we conducted the Conservative Revascularization versus Aggressive Revascularization for Coronary Stenting with Everolimus-Eluting Stents (SMART-CASE) trial.
Interventions
PROCEDUREThe aggressive group
Stents were implanted in lesions with diameter stenosis \>50% and RD ≥2.25 mm and balloon angioplasty was performed in lesions with diameter stenosis \>50% and RD ≥2.0 mm and \<2.25 mm.
PROCEDUREThe conservative group
Stenting was performed only in lesions with diameter stenosis \>70% and reference diameter (RD) ≥2.25 mm
Sponsors
Samsung Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Intermediate coronary lesion(s) (diameter stenosis between 50% and 70% by quantitative coronary analysis) * Target lesion(s) must be located in a native coronary artery with diameter of ≥2.25 mm and ≤4.25 mm
Exclusion criteria
* cardiogenic shock * myocardial infarction (MI) within 48 hours * left main lesion * drug-eluting stent implantation in the target vessel prior to enrollment * ≥2 chronic total occlusions in major coronary territories * history of bleeding diathesis or known coagulopathy * gastrointestinal or genitourinary bleeding within 3 months or major surgery within 2 months * platelet count \<100,000 cells/mm3 * planned elective surgical procedure that would necessitate interruption of thienopyridine during the first 6 months after enrollment * non-cardiac co-morbid conditions with life expectancy \<1 year or that may result in protocol non-compliance (per site investigator's medical judgment).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A composite of all cause death, MI, or any revascularization | 1 year |
Secondary
| Measure | Time frame |
|---|---|
| Cardiac death | 1 years |
| Myocardial infarction (Q-wave and non-Q wave) | 1 years |
| Any revascularization | 1 years |
| All cause Death | 1 years |
| Revascularization of target intermediate lesion | 1 years |
| Target vessel failure | 1 years |
| Stent thrombosis | 1 years |
Countries
South Korea
Outcome results
None listed