This prospective, multicenter, non-randomized, single arm, objective performance goal (OPG) study is designed to evaluate clinical outcomes after complete revascularization by PCI and imaging guidance (OCT) in patients with multivessel coronary artery disease including left anterior descending (LAD) presenting with stable angina, or documented silent ischemia, or non-ST segment elevation acute coronary syndrome (NSTE-ACS).
The PRESENT is an investigator-initiated, prospective, multicenter, non-randomized, single arm, OPG study. The objective performance goal is based on past results of CABG namely a rate of 7% MACCE at 1-year follow-up. All patients with multivessel disease without chronic total occlusion (CTO) and accepted for PCI are eligible for inclusion Primary endpoint The primary clinical endpoint of this study is a composite of death from any cause, stroke, myocardial infarction, or unplanned ischemia driven repeat revascularization at 1-year post index procedure. Secondary endpoint * Composite of death from any cause, stroke, myocardial infarction, or repeat revascularization at 30 days, 2, and 5 years post intervention. * All-cause mortality at 30 days, 1, 2, and 5 years * Myocardial Infarction at 30 days, 1, 2, and 5 years * Any revascularization at 30 days, 1, 2, and 5 years * Stroke at 30 days, 1, 2, and 5 years * Major bleeding at 30 days and 12 months * Need for renal replacement therapy at 30 days
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
609
Procedure will be optimize using pre-and post-stent OCT imaging, to improve the accuracy of stent placement and reduce geographic miss, but also to prevent malapposition of the stent and to discover dissections.
Erasmus Medical Center
Rotterdam, South Holland, Netherlands
RECRUITINGMACCE- 1 year
The primary clinical endpoint of this study is a composite of death from any cause, stroke, myocardial infarction, or unplanned ischemia driven repeat revascularization at 1-year post index procedure.
Time frame: 1 year
MACCE
Composite of death from any cause, stroke, myocardial infarction, or repeat revascularization
Time frame: 30 days, 2, and 5 years post intervention
All-cause mortality
All-cause mortality
Time frame: 30 days, 1, 2, and 5 years
Myocardial Infarction
Myocardial Infarction
Time frame: 30 days, 1, 2, and 5 years
Any revascularization
Any revascularization
Time frame: 30 days, 1, 2, and 5 years
Stroke
Stroke
Time frame: 30 days, 1, 2, and 5 years
Major bleeding
Major bleeding according to the ARC criteria
Time frame: 30 days and 12 months
Renal replacement therapy
Need for renal replacement therapy
Time frame: 30 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.