Clinical event adjudication: Interventional cardiology

For the list of clinical event adjudication definitions, click here Editors-in-Chief: C. Michael Gibson, M.S., M.D. [mailto:mgibson@perfuse.org]

=Interventional cardiology= This chapter presents interventional cardiology definitions used in the Clinical Event Committee adjudication processes. These definitions are current as of 3/26/10.

1. Coronary Revascularization Procedure
A coronary revascularization procedure is a catheter-based or open surgical procedure designed to improve myocardial blood flow. Catheter-based tools (e.g., balloon catheters, cutting balloons, atherectomy devices, lasers, bare metal stents, and drug-eluting stents) improve myocardial blood flow by increasing the luminal area at a site of an obstructive coronary lesion. Aortocoronary bypass grafts (arterial, venous, or synthetic) improve myocardial blood flow by providing a conduit for blood flow distal to an obstructive coronary lesion. Insertion of a guidewire through a coronary guide catheter into a coronary vessel or aortocoronary bypass graft for the purpose of percutaneous coronary intervention (PCI) is considered intention for PCI. However, in the assessment of the severity of intermediate lesions with the use of intravascular ultrasound, Doppler flow velocity, or fractional flow reserve, insertion of a guidewire will NOT be considered PCI.

2. Procedural Success
Achievement of <30 % residual diameter stenosis of the target lesion assessed by visual inspection or quantitative coronary angiography (QCA) and no in-hospital major adverse cardiac events (MACE, a composite of death, MI, or repeat coronary revascularization of the target lesion). Ideally, the assessment of the residual stenosis at the end of the procedure should be performed by an angiographic core laboratory.

3. Elective and Non-elective Procedures
Elective: An elective procedure is one performed on a patient with stable cardiac function in the days or weeks prior to the procedure. Elective cases are usually scheduled at least 1 day prior to the procedure. Non-elective: A non-elective procedure is one performed on a patient who has been stabilized following initial treatment of acute coronary ischemia, and there is clinical consensus that the procedure should occur within the next 24 hours. OR A procedure that is performed without delay on a patient with evidence of ongoing refractory ischemia with or without hemodynamic instability.

4. Target Lesion
A target lesion is any lesion treated or attempted to be treated during the trial procedure with the study device. The target lesion is the treated segment starting 5 mm proximal and ending 5 mm distal to the study device (stent, in most cases).

5. Target Vessel
A target vessel is any native coronary vessel (e.g., left main coronary artery (LMCA), left anterior descending coronary artery (LAD), left circumflex coronary artery (LCX), or right coronary artery (RCA)) or aortocoronary bypass graft to the LAD, LCX, or RCA containing the target lesion. The target vessel includes the target lesion as well as segments of the vessel that are upstream and downstream to the target lesion, including side branches (native vessel).

6. Non-target Lesion
A non-target lesion is one for which revascularization is not attempted or one in which revascularization is performed using a non-study device.

7. Non-target Vessel
A non-target vessel is one for which revascularization is not attempted or one in which revascularization is performed using a non-study device.

8. Target Vessel, Non-Target Lesion
Any lesion or revascularization of a lesion in the target vessel other than the target lesion.

9. Target Lesion Revascularization (TLR)
Target lesion revascularization is any repeat percutaneous intervention of the target lesion (including 5 mm proximal and distal to the target lesion) or surgical bypass of the target vessel performed for restenosis or other complication involving the target lesion. In the assessment of TLR, angiograms should be assessed by an angiographic core laboratory (if designated) and made available to the Clinical Events Committee (CEC) for review.

10. Target Vessel Revascularization (TVR)
Target vessel revascularization is any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. In the assessment of TVR, angiograms should be assessed by an angiographic core laboratory (if designated) and made available to the CEC for review.

11. Clinically-Driven Target Lesion Revascularization
Revascularization is clinically-driven if the subject has a target lesion diameter stenosis ≥ 50% by QCA and clinical or functional ischemia which cannot be explained by another native coronary or bypass graft lesion. Clinical or functional ischemia includes any of the following:
 * a. A history of angina pectoris, presumably related to the target vessel
 * b. Objective signs of ischemia at rest (ECG changes) or during exercise test (or equivalent), presumably related to the target vessel
 * c. Abnormal results of any invasive functional diagnostic test (e.g., Doppler flow velocity reserve or fractional flow reserve (FFR))
 * d. A diameter stenosis ≥70% by QCA even in the absence of the above signs or symptoms.  Comment : In the absence of QCA data or if a <50% stenosis is present, TLR may be considered clinically-driven by the CEC if severe ischemic signs and symptoms attributed to the target lesion are present.