Conservative Versus Aggressive Revascularization in Patients With Intermediate Lesions Undergoing Percutaneous Coronary Intervention With Angiography Guidance Alone

Study Overview
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Brief Summary
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The aim of this study was to compare conservative versus aggressive strategy in patients with intermediate lesions with angiography guidance alone.

Detailed Description
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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.

Official Title
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Conservative Versus Aggressive Revascularization in Patients With Intermediate Lesions Undergoing Percutaneous Coronary Intervention With Angiography Guidance Alone (SMART-CASE)

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Procedure: The aggressive group
* Procedure: The conservative group


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>The aggressive group | Procedure: The aggressive group<br>* 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.<br>|
| Experimental: 2<br>The conservative group | Procedure: The conservative group<br>* Stenting was performed only in lesions with diameter stenosis >70% and reference diameter (RD) ≥2.25 mm<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A composite of all cause death, MI, or any revascularization |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All cause Death |  | 1 years | 
| Cardiac death |  | 1 years | 
| Myocardial infarction (Q-wave and non-Q wave) |  | 1 years | 
| Any revascularization |  | 1 years | 
| Stent thrombosis |  | 1 years | 
| Revascularization of target intermediate lesion |  | 1 years | 
| Target vessel failure |  | 1 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Angioplasty, Transluminal, Percutaneous Coronary, Everolimus-eluting stent