The purpose of this study is to explore the role of lipoprotein(a) and apolipoprotein(a) phenotype in fatal and non-fatal cardiovascular disease (CVD) events risk in coronary disease patients divided on the basis of management strategy - medical, endovascular or open cardiac surgery.
Between January 1993 and September 2006, we enrolled 1400 consecutive patients from the Atherosclerosis Department with known Lp(a) levels and coronary heart disease (CHD) verified by angiography. In accordance with clinical condition and angiography data were assigned them into three parallel treatment arms and followed up to 15 years. This study was conducted according to the principles of the Declaration of Helsinki and the Institutional Ethics Committee.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,400
elective percutaneous coronary balloon angioplasty and/or stenting
elective surgical myocardial revascularisation
non-fatal myocardial infarction and cardiovascular death
we took a composite primary outcome measure because anticipated a low number of hard-end-points in each treatment arm
Time frame: up to 15 years
non-fatal myocardial infarction and cardiovascular death and myocardial revascularisation and hospitalization for recurrent or unstable angina
we chose a composite secondary outcome mesure as a standard for such type studies and to obtain a statistical difference between the groups
Time frame: up to 15 years
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