Cardiac surgery trials in cardiac surgery

1. IMPORTANT CTVS TRIALS OF
2020-2021
Dr Hitesh J/ Dr Amulya

3. EXCEL CLINICAL TRIAL
Evaluation of XIENCE stent Versus Coronary Artery Bypass Surgery for
Effectiveness of Left Main Revascularization.

5. AIM
• To establish the safety and efficacy of the commercially approved
XIENCE Family Stent System in subjects with unprotected left main
coronary artery disease by comparing to coronary artery bypass graft
surgery

30. • A non target vessel revascularization will be considered
ischemia-driven if any lesion the non target vessel has a
diameter stenosis ≥ 50% by QCA with any of the above
criteria for ischemia met.

33. RESULTS

85. • A target lesion (vessel) revascularization will be considered ischemia-
driven if the target lesion diameter stenosis is ≥ 50% by QCA
(analysis segment measurement, involving the lesion itself and 5 mm
of proximal and/or distal margin) and any of the following criteria for
ischemia are met:
• A positive functional study corresponding to the area served by the target
lesion;
• Ischemic ECG changes at rest in a distribution consistent with the target vessel;
• Typical ischemic symptoms referable to the target lesion;
• IVUS of the target lesion with a minimal lumen area (MLA) of ≤ 4 mm^2 for
non left main lesions or ≤ 6 mm^2 for left main lesions. If the lesions are de
novo (i.e. not restenotic), the
• plaque burden must also be ≥ 60%;
• FFR of the target lesion ≤ 0.80
• A non target vessel revascularization will be considered ischemia-
driven if any lesion the non target vessel has a diameter stenosis ≥
50% by QCA with any of the above criteria for ischemia met.

94. Percentage of Participants With Major
Adverse Events (MAE)
• Composite of death, myocardial infarction, stroke,
transfusion of ≥ 2 units of blood, major arrhythmia,
unplanned coronary revascularization for ischemia, any
unplanned surgery or radiologic procedure, renal failure,
sternal wound dehiscence, infection requiring antibiotics
for treatment, intubation for > 48 hours, or post-
pericardiotomy syndrome.

97. Number of Participants With Stent
Thrombosis (ARC Definition)
Definite/Probable
• Definite stent thrombosis occurred by either angiographic/pathologic confirmation of stent thrombosis.
• Angiographic confirmation:The presence of a thrombus that originates in the stent or in the segment 5 mm
proximal or distal to the stent&presence of at least 1 of the following criteria within a 48-hour time window:
• Acute onset of ischemic symptoms at rest
• New ischemic ECG changes
• Typical rise&fall in cardiac biomarkers
• Non-occlusive thrombus
• Occlusive thrombus.
• Pathological confirmation: Evidence of recent thrombus within the stent determined at autopsy or via
examination of tissue retrieved following thrombectomy.
• Probable stent thrombosis may occur after intracoronary stenting due to:
• Unexplained death within first 30 days
• Irrespective of the time after the index procedure,any MI that is related to documented acute ischemia in the
territory of the implanted stent without angiographic confirmation of stent thrombosis&in the absence of any
other obvious cause.

103. Number of Participants With Graft
Stenosis or Occlusion
•
Graft stenosis or occlusion is defined as Ischemic
symptoms in the presence of ≥50% diameter stenosis in a
coronary bypass graft.

120. CONCLUSION
• High probability that PCI was associated not only with statistical
inferiority but also with clinical inferiority to CABG for treatment of
patients with LMCAD.
• However, clinicians must also recognise the need for individual
personalization and consequently acknowledge that PCI may be an
appropriate choice for selected patients, such as those with a reduced
overall life expectancy of less than 2 to 3 years or those with very high
surgical risk profiles.