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| ID | Type | Description | Link |
|---|---|---|---|
| OUH | Other Identifier | Odense University Hospital |
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The aim of the Danish Organization for Randomized Trials with Clinical Outcome (SORT OUT) is to compare the safety and efficacy of the sirolimus eluting ORSIRO stent and the biolimus-eluting NOBORI stent in a population-based setting, using registry detection of clinically driven events
SORT OUT VII is a randomized, multicenter, all-comer, two-arm, non-inferiority trial comparing the sirolimus eluting ORSIRO stent to the biolimus-eluting NOBORI stent in treating atherosclerotic coronary artery lesions.
Primary Endpoint:
Target lesion failure within 12 months of stent implantation (combination of cardiac death, myocardial infarction (not index procedure related) not related to other than index lesion or target lesion revascularization).
Secondary Endpoints:
Individual components of the primary end point comprised the secondary end points and stent thrombosis rate according to the Academic Research Consortium definition (see protocol for further specification of secondary endpoints).
Clinically driven event detection will be used to avoid study-induced reinterventions. Data on mortality, hospital admission, coronary angiography, repeat percutaneous coronary intervention, and coronary bypass surgery will be obtained for all randomly allocated patients from the following national Danish administrative and healthcare registries: the Civil Registration System; the Western Denmark Heart Registry; the Danish National Registry of Patients, which maintains records on all hospitalizations in Denmark; and the Danish Registry of Causes of Death
Inclusion criteria:
at least 18 years old chronic stable coronary artery disease or acute coronary syndromes at least one coronary artery lesion with more than 50% diameter stenosis requiring treatment with a drug-eluting stent
Exclusion criteria:
life expectancy of less than one year allergy to aspirin, clopidogrel, sirolimus, or biolimus participation in another randomized trial nability to provide written informed consent
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ORSIRO stent | Active Comparator | ORSIRO stent group |
|
| NOBORI stent | Active Comparator | NOBORI stent group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Drug-eluting stent | Device |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Cardiac death, myocardial infarction or target lesion revascularization | Target lesion failure within 12 months of stent implantation (combination of cardiac death, myocardial infarction (not index procedure related) not related to other than index lesion or target lesion revascularization) | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiac death, myocardial infarction, target lesion revascularization, target vessel revascularization, all cause mortality, stent thrombosis | Cardiac mortality Myocardial infarction Target lesion revascularization Target vessel revascularization All cause mortality Stent thrombosis rate according to the Academic Research Consortium definition Secondary endpoints will be assessed after 1 year, 2 years, 3 years, 4 years and 5 years. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jens F Lassen, MD DMSci | Aarhus University Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Odense University Hospital | Odense | 5000 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22308301 | Background | Jensen LO, Thayssen P, Hansen HS, Christiansen EH, Tilsted HH, Krusell LR, Villadsen AB, Junker A, Hansen KN, Kaltoft A, Maeng M, Pedersen KE, Kristensen SD, Botker HE, Ravkilde J, Sanchez R, Aaroe J, Madsen M, Sorensen HT, Thuesen L, Lassen JF; Scandinavian Organization for Randomized Trials With Clinical Outcome IV (SORT OUT IV) Investigators. Randomized comparison of everolimus-eluting and sirolimus-eluting stents in patients treated with percutaneous coronary intervention: the Scandinavian Organization for Randomized Trials with Clinical Outcome IV (SORT OUT IV). Circulation. 2012 Mar 13;125(10):1246-55. doi: 10.1161/CIRCULATIONAHA.111.063644. Epub 2012 Feb 3. | |
| 39311502 |
| Label | URL |
|---|---|
| SORT OUT IV with same clinically event driven methodology | View source |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D017202 | Myocardial Ischemia |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
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| ID | Term |
|---|---|
| D054855 | Drug-Eluting Stents |
| ID | Term |
|---|---|
| D015607 | Stents |
| D019736 | Prostheses and Implants |
| D004864 | Equipment and Supplies |
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| 12 months |
| Derived |
| Troan J, Christiansen EH, Hansen KN, Eftekhari A, Jakobsen L, Maeng M, Freeman P, Jensen RV, Christensen MK, Noori M, Ellert-Gregersen J, Stottrup NB, Kahlert J, Veien KT, Jensen LO. Five-year outcomes of patients with diabetes mellitus treated with a sirolimus-eluting or a biolimus-eluting stents with biodegradable polymer. From the SORT OUT VII trial. Diab Vasc Dis Res. 2024 Sep-Oct;21(5):14791641241283939. doi: 10.1177/14791641241283939. |
| 36649389 | Derived | Hansen KN, Jensen LO, Maeng M, Christensen MK, Noori M, Kahlert J, Jakobsen L, Junker A, Freeman P, Ellert-Gregersen J, Raungaard B, Terkelsen CJ, Veien KT, Christiansen EH. Five-Year Clinical Outcome of the Biodegradable Polymer Ultrathin Strut Sirolimus-Eluting Stent Compared to the Biodegradable Polymer Biolimus-Eluting Stent in Patients Treated With Percutaneous Coronary Intervention: From the SORT OUT VII Trial. Circ Cardiovasc Interv. 2023 Jan;16(1):e012332. doi: 10.1161/CIRCINTERVENTIONS.122.012332. Epub 2023 Jan 17. |
| 27412869 | Derived | Jensen LO, Thayssen P, Maeng M, Ravkilde J, Krusell LR, Raungaard B, Junker A, Terkelsen CJ, Veien KT, Villadsen AB, Kaltoft A, Tilsted HH, Hansen KN, Aaroe J, Kristensen SD, Hansen HS, Jensen SE, Madsen M, Botker HE, Berencsi K, Lassen JF, Christiansen EH. Randomized Comparison of a Biodegradable Polymer Ultrathin Strut Sirolimus-Eluting Stent With a Biodegradable Polymer Biolimus-Eluting Stent in Patients Treated With Percutaneous Coronary Intervention: The SORT OUT VII Trial. Circ Cardiovasc Interv. 2016 Jul;9(7):e003610. doi: 10.1161/CIRCINTERVENTIONS.115.003610. |
| 26299216 | Derived | Jensen LO, Thayssen P, Maeng M, Ravkilde J, Hansen HS, Jensen SE, Botker HE, Berencsi K, Lassen JF, Christiansen EH. Randomized comparison of a sirolimus-eluting Orsiro stent with a biolimus-eluting Nobori stent in patients treated with percutaneous coronary intervention: Rationale and study design of the Scandinavian Organization for Randomized Trials with Clinical Outcome VII trial. Am Heart J. 2015 Aug;170(2):210-5. doi: 10.1016/j.ahj.2015.05.009. Epub 2015 May 22. |
| D001157 |
| Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |