Clinical trial NCT01956448: SORT-OUT VI - Randomized Clinical Comparison of Biomatrix Flex® and Resolute Integrity®
Official title: Randomized Clinical Comparison of Biomatrix Flex® and Resolute Integrity® Coronary Stents in Non-selected Patients With Ischemic Heart Disease The SORT OUT VI Study*
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Angina Pectoris
Keywords: Percutaneous coronary intervention
DES
Angina pectoris
Stent
Lead sponsor: Aarhus University Hospital Skejby
Sponsor class: OTHER
Collaborators: name: Biosensors International
name: Medtronic Cardiovascular
First posted: 2013-10-08
Enrollment: 2800
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To perform a randomized comparison between the BioMatrix Flex™ and the Resolute Integrity® stents in the treatment of unselected patients with ischemic heart disease.

Detailed description: SORT OUT VI is a randomized, multicenter, all-comer, two-arm, non-inferiority trial comparing the Biolimus-eluting Biomatrix Flex and the Zotarolimus-eluting Medtronic Resolute Integrity in treatment of 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

Eligibility criteria: Inclusion Criteria:

* Patients aged 18 years or over with chronic stable coronary artery disease or acute coronary syndromes, and 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
* an allergy to aspirin, clopidogrel, ticagrelor, prasugrel, sirolimus, or biolimus
* participation in another randomized trial
* inability to provide written informed consent

Primary outcomes:
measure: Device-related combined endpoint
timeFrame: 1,2,3 and 5 years
Secondary outcomes:
measure: Device success rate
timeFrame: 12 months
measure: Procedure success rate
timeFrame: 12 months
measure: Procedure time
timeFrame: 12 months
measure: Fluoroscopy time
timeFrame: 12 months
measure: Amount of contrast
timeFrame: 12 months
measure: Combined endpoint of cardiac death, non-index procedure related acute myocardial infarction, not clearly related to another lesion than target lesion, target lesion revascularisation
timeFrame: 30 days
measure: Target lesion revascularisation
timeFrame: 1,2,3 and 5 years
measure: Death and myocardial infarction
timeFrame: 1 and 12 months
measure: Stent thrombosis
timeFrame: 1,2,3 and 5 years
measure: Device-related combined endpoint hierarchically cardiac death, non-index procedure related AMI, not clearly related to another lesion than target lesion
timeFrame: 2,3 and 5 years
measure: Patient-related combined endpoint hierarchically: all-cause death, non-index procedure related acute myocardial infarction, all new revascularizations
timeFrame: 1,2,3 and 5 years
measure: All-cause death
timeFrame: 10 years
Other outcomes:
Locations:
city: Skejby
country: Denmark
facility: Aarhus University Hospital
state: Aarhus N
city: Aalborg
country: Denmark
facility: Aalborg University Hospital
city: Odense
country: Denmark
facility: Odense University Hospital
Study officials:
affiliation: Aalborg University Hospital
name: Jan Ravkilde, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Raungaard B, Christiansen EH, Botker HE, Hansen HS, Ravkilde J, Thuesen L, Aaroe J, Villadsen AB, Terkelsen CJ, Krusell LR, Maeng M, Kristensen SD, Veien KT, Hansen KN, Junker A, Madsen M, Andersen SL, Jensen SE, Jensen LO; SORT OUT VI Investigators. Comparison of Durable-Polymer Zotarolimus-Eluting and Biodegradable-Polymer Biolimus-Eluting Coronary Stents in Patients With Coronary Artery Disease: 3-Year Clinical Outcomes in the Randomized SORT OUT VI Trial. JACC Cardiovasc Interv. 2017 Feb 13;10(3):255-264. doi: 10.1016/j.jcin.2016.11.007. Epub 2017 Jan 18.
citation: Raungaard B, Jensen LO, Tilsted HH, Christiansen EH, Maeng M, Terkelsen CJ, Krusell LR, Kaltoft A, Kristensen SD, Botker HE, Thuesen L, Aaroe J, Jensen SE, Villadsen AB, Thayssen P, Veien KT, Hansen KN, Junker A, Madsen M, Ravkilde J, Lassen JF; Scandinavian Organization for Randomized Trials with Clinical Outcome (SORT OUT). Zotarolimus-eluting durable-polymer-coated stent versus a biolimus-eluting biodegradable-polymer-coated stent in unselected patients undergoing percutaneous coronary intervention (SORT OUT VI): a randomised non-inferiority trial. Lancet. 2015 Apr 18;385(9977):1527-35. doi: 10.1016/S0140-6736(14)61794-3. Epub 2015 Jan 16.