For octogenarian patients with NSTEMI (non-ST segment elevation myocardial infarction) an invasive-guided strategy will prove superior to a conservative strategy with respect to a combined endpoint of all cause mortality and non-fatal myocardial infarction.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
250
crossover to angiogram only if predefined criteria met
angiogram with PCI or CABG revascularisation if appropriate
Royal Sussex County Hospital
Brighton, United Kingdom
Death
The cause of death will be adjudicated as being due to cardiovascular causes, non cardiovascular causes, or undetermined causes. * Cardiovascular Death includes sudden cardiac death, death due to acute myocardial infarction, death due to heart failure or cardiogenic shock, death due to stroke or death due to other cardiovascular causes * Non-Cardiovascular Death is defined as any death not covered by cardiac death or vascular death. * Undetermined cause of death refers to a death not attributable to one of the above categories of cardiovascular death or to a non-cardiovascular cause. N.B For this trial all deaths with undetermined causes will be included in the cardiovascular category.
Time frame: 1 year
non-fatal myocardial infarction
The ESC/ACC (European Society of Cardiology and the American College of Cardiology) definition of myocardial infarction will be applied, including the special circumstances of same admission myocardial re-infarction, or myocardial infarction peri-PCI.
Time frame: 1 year
Unplanned revascularisation
Shall be deemed to have occurred at follow-up if any coronary vessel requires or undergoes attempted repeat revascularisation with either balloon angioplasty, stenting, or coronary artery bypass grafting.
Time frame: 1 years
Permanent Stroke
A stroke is a loss of neurological function caused by an ischemic or hemorrhagic event with residual symptoms at least 24 hours after onset or leading to death
Time frame: 1 year
Major bleeding
BARC (Bleeding Academic Research Consortium) definition
Time frame: 1 year
Deterioration of renal function during hospital admission
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Worsening renal function is an absolute increase in serum creatinine of ≥ 0.3mg/dl (26.5 umol/l) at any time during hospitalization compared to the valve obtained at admission
Time frame: During index admission
Angina symptoms (3 months; 1yr)
CCS (Canadian Cardiovascular Society Classification of angina) grading of angina
Time frame: 3 months and 1 year
Stent thrombosis
ARC definition of stent Thrombosis
Time frame: 1 year
All cause mortality
Cardiac and non cardiac mortality
Time frame: 2,3 and 4 year
Hospital readmission for ACS/STEMI
ESC/ACC definition ACS/STEMI (Acute coronary syndrome/ST-segment elevation myocardial infarction)
Time frame: At 3, 6 and 12 months and at 2,3 and 4 years
In-hospital major complications
In hospital major complications defined as death, myocardial infarction, stent thrombosis, target restenosis, repeat target- and non-target vessel-related percutaneous coronary intervention, target lesion revascularization, coronary artery bypass surgery and stroke.
Time frame: At 3, 6 and 12 months and at 2,3 and 4