SORT OUT X - Combo Stent Versus ORSIRO Stent

Study Overview
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Brief Summary
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The aim of the Danish Organisation for randomised trials with clinical outcome (SORT OUT) is to compare the safety and efficacy of the ComboTM stent and Orsiro™ stent in the treatment of unselected patients with ischemic heart disease, using registry detection of clinically driven events.

Detailed Description
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Randomized Clinical Comparison of a Combined Sirolimus Eluting and endothelial progenitor cell COMBO Stent with a Sirolimus-eluting OSIRO stent in Patients Treated with Percutaneous Coronary Intervention.

Official Title
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Randomized Clinical Comparison of a Combined Sirolimus Eluting and Endothelial Progenitor Cell COMBO Stent With a Sirolimus-eluting OSIRO Stent in Patients Treated With Percutaneous Coronary Intervention - The SORT-OUT X Study

Conditions
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Coronary Heart Disease, Angina Pectoris, Myocardial Infarction

Intervention / Treatment
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* Device: COMBO
* Device: ORSIRO


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients aged ≥18 years who are eligible for treatment with one or several drug-eluting coronary stents at Rigshospitalet or one of the three heart centers in Aarhus, Odense and Aalborg can be included in the study. The patients will be treated in accordance with the criteria applicable at the individual sites. The investigators plan to include 3,140 patients. Exclusion Criteria: Age < 18 years The patient does not wish to participate The patient is not able to consent to randomization (eg intubated patients) The patient do not speak Danish The patient is already included in this study The patient is already participating in other stent studies Life expectancy <1 year Allergic to aspirin, clopidogrel, prasugrel or ticagrelor Allergic to sirolimus

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: COMBO<br>PCI with COMBO stent | Device: COMBO<br>* PCI with COMBO stent<br>* Other names: Combined Sirolimus eluting and endothelial progenitor cell stent;|
| Active Comparator: ORSIRO<br>PCI with ORSIRO stent | Device: ORSIRO<br>* PCI with ORSIRO stent<br>* Other names: Sirolimus-eluting stent;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device-related Target Lesion Failure (TLF) The composite of cardiac death, target-vessel myocardial infarction (MI), or ischemia-driven target-lesion revascularization | Analysing the Kaplan-Meier method. Hazard ratios between groups will be calculated using a Cox proportional hazard model and the primary endpoint in the two per protocol treated groups will be compared with an upper one-sided 95% confidence interval. Patients treated with the OsiroTM stent will be used as the reference group | Within 12 months | 
| Target Lesion Revascularisation (TLR) | Repeat/new revascularization (PCI or CABG) within the stent or within a 5-mm border proximal or distal to the stent. (Angina, CCS > 1 related to the index lesion/vessel and diameter stenosis ≥ 50%. Diameter stenosis will be assessed by eyeballing, FFR <0.80, or iFR< 0.90). TLR will be clinically driven. | Within 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Individual components of the primary end point comprise the secondary end points | cardiac death; MI; clinically indicated TLR; all death (cardiac and noncardiac) and target vessel revascularisation (TVR); definite, probable, possible, and overall stent thrombosis according to the Academic Research Consortium definition (22); and a patient-related composite end point (all death, all MI (including procedure related MI), or any revascularization). For continuous variables, the difference between the treatment groups will be evaluated using Wilcoxon's rank-sum test. For discrete variables, the differences will be given as numbers and in percentages and will be analyzed using Fisher's exact test. Two-sided test will be used, and a pvalue of 0.05 considered significant. | Clinical follow-up will be continued through 5 years | 
| Cardiac death |  | Through 5 years | 
| MI | The acute MI diagnosis follows The Joint ESC/ACCF/AHA/WHF Task Force on Third Universal Definition of MI (23), which has been adapted by Academy Research Consortium (22). In cases of updates of the definition of MI, the latest definition will be used. | Through 5 years | 
| Clinically indicated TLR | Angina, CCS > 1 related to the index lesion/vessel and diameter stenosis ≥ 50%. Diameter stenosis will be assessed by eyeballing, FFR <0.80, or iFR< 0.90. | Through 5 years | 
| All death | Cardiac and noncardiac | Through 5 years | 
| TVR | Angina, CCS > 1 related to the index lesion/vessel and diameter stenosis ≥ 50%. Diameter stenosis will be assessed by eyeballing, FFR <0.80, or iFR< 0.90. | Through 5 years | 
| Stent thrombosis | Definite, probable, possible and overall according to the Academic Research Consortium definition (22) | Through 5 years | 
| Patient-related composite end point | All death, all MI (including procedure related MI) or any revascularisation | Through 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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DES, Angina pectoris, Stent