Skip to main content

Table 3 Adjudication committee prespecified definitions of events

From: Retrospective analysis of arterial occlusive events in the PACE trial by an independent adjudication committee

Events Definitions
Cardiovascular (CV) death The cause of death will be determined by the principal condition that caused the death, not the immediate mode of death. Members of the adjudication committee will review all available information and use their clinical expertise to adjudicate the cause of death
CV death includes death resulting from an acute myocardial infarction (MI), sudden cardiac death, death due to heart failure (HF), death due to stroke, death due to CV procedures, death due to CV hemorrhage, death due to pulmonary embolism, and death due to other CV causes
 Death associated with acute myocardial infarction Refers to a death by any CV mechanism (e.g., arrhythmia, sudden death, heart failure, stroke, pulmonary embolus, peripheral arterial disease) ≤ 30 days after a MI related to the immediate consequences of the MI, such as progressive heart failure or recalcitrant arrhythmia. Acute MI should be verified to the extent possible by the diagnostic criteria outlined for acute MI (see below) or by autopsy findings showing recent MI or recent coronary thrombosis
Death resulting from a procedure to treat a MI (percutaneous coronary intervention (PCI), coronary artery bypass graft surgery (CABG), or to treat a complication resulting from MI, should also be considered death due to acute MI
Death resulting from an elective coronary procedure to treat myocardial ischemia (i.e., chronic stable angina) or death due to a MI that occurs as a direct consequence of a CV investigation/procedure/operation should be considered as a death due to a CV procedure
 Sudden cardiac death Sudden cardiac death refers to death that occurs unexpectedly, not following an acute MI (as defined above) and includes the following deaths:
 Witnessed and occurring without new or worsening symptoms
 Witnessed within 60 min of the onset of new or worsening cardiac symptoms, unless the symptoms suggest acute MI
 Witnessed and attributed to an identified arrhythmia (e.g., captured on an electrocardiographic (ECG) recording or witnessed on a monitor, or unwitnessed but found on implantable cardioverter-defibrillator review)
 After unsuccessful resuscitation from cardiac arrest (e.g., implantable cardioverter-defibrillator [ICD] unresponsive sudden cardiac death, pulseless electrical activity arrest)
 After successful resuscitation from cardiac arrest and without identification of a specific cardiac or non-cardiac etiology
 Unwitnessed death in a subject seen alive and clinically stable ≤ 24 h prior to being found dead without any evidence supporting a specific non-CV cause of death (information regarding the patient’s clinical status preceding death should be provided, if available)
Note: Unless additional information suggests an alternate specific cause of death (e.g., Death due to other CV causes), if a patient is seen alive ≤ 24 h of being found dead, sudden cardiac death should be recorded. For patients who were not observed alive within 24 h of death, undetermined cause of death should be recorded (e.g., a subject found dead in bed, but who had not been seen by family for several days)
Note: Successful resuscitation without death should be captured as a resuscitated sudden cardiac death in the non-fatal voting flow
 Death due to HF Refers to death associated with clinically worsening symptoms and/or signs of HF regardless of etiology. Deaths due to HF can have various etiologies, including single or recurrent MIs, ischemic or non-ischemic cardiomyopathy, hypertension, or valvular disease
Note: Due to the pro-thrombotic nature of the subject population, a thrombo-embolic option is included during voting. See rules in the non-fatal heart failure definition
 Death due to stroke Refers to death within 30 days that is either a direct consequence of the stroke or a complication of the stroke. Acute stroke should be verified to the extent possible by the diagnostic criteria outlined for stroke
 Death due to CV procedures Refers to death caused by the immediate complications of a cardiac procedure not in the context of treatment for acute MI
 Death due to CV hemorrhage Refers to death related to hemorrhage such as a non-stroke intracranial hemorrhage, non-procedural or non-traumatic vascular rupture (e.g., aortic aneurysm), or hemorrhage causing cardiac tamponade
 Death due to other CV causes Refers to a CV death not included in the above categories but with a specific, known cause (e.g., pulmonary embolism or peripheral vascular disease (venous or arterial disease)
Non-CV death Non-CV death is defined as any death with a specific cause that is not thought to be of CV nature. Adjudication committee members will be asked to indicate the most likely cause of non-cardiovascular death on their voting form
  Examples of non-CV death are: pulmonary causes, renal causes, gastrointestinal causes, hepatobiliary causes, pancreatic causes, infection (including sepsis), inflammatory (e.g., systemic inflammatory response syndrome (SIRS))/immune (including autoimmune)(may include anaphylaxis from environmental (e.g., food allergies), hemorrhage that is neither cardiovascular bleeding or stroke, non-CV procedure or surgery, trauma, suicide, non-prescription drug reaction or overdose, prescription drug reaction or overdose (many include anaphylaxis), neurological (non-cardiovascular), malignancy (i.e., new malignancy, worsening of prior malignancy) or other (should be specified)
Undetermined cause of death Undetermined cause of death refers to a death not attributable to one of the above categories. Inability to classify the cause of death may be due to lack of information (e.g., the only available information is “patient died”) or when there is insufficient supporting information or detail to assign the cause of death. In general, most deaths should be classifiable as CV or non-CV, and the use of this category of death, therefore, should be discouraged and should apply to few patients in well-run clinical trials
Non-fatal event definitions
Myocardial infarction (non-fatal) Criteria for acute MI: The term MI should be used when there is evidence of myocardial necrosis in a clinical setting consistent with acute myocardial ischemia. In general MI is defined as a combination of evidence of myocardial necrosis (changes in cardiac biomarkers) and supporting information (derived from the clinical presentation, electrocardiographic changes or the results of a myocardial or coronary artery imaging). Under these conditions, any one of the following criteria A to G meets the diagnosis for MI
   Spontaneous MI (type 1): To identify a type 1 MI, patients should demonstrate spontaneous symptoms of myocardial ischemia unprovoked by supply/demand inequity, together with at least one of the following criteria:
    Cardiac biomarker elevation: Troponin is the preferred marker for use to adjudicate the presence of acute MI. At least one value should show a rise and/or fall above the lowest cut-point providing 10% imprecision (typically the upper reference limit for the troponin run per standard of clinical care). Creatine kinase-MB is a secondary choice to troponin; a rise of CK-MB above the local upper reference limit would be consistent with myocardial injury. Total CK may be used in the absence of CK-MB and troponin
    Imaging evidence of new non-viable myocardium or new wall motion abnormality
    ECG changes consistent with new ischemic changes
     ECG changes indicative of new ischemia [new ST-T changes or new left bundle branch block (LBBB)]*
     Development of pathological Q-waves in the ECG**
    *ECG manifestations of acute myocardial ischemia (in absence of left ventricular hypertrophy (LVH) and left bundle branch block (LBBB)):
     ST elevation: New ST elevation at the J-point in two contiguous leads with the cut-off points: ≥ 0.2 mV in men or ≥ 0.15 mV in women in leads V2–V3 and/or ≥ 0.1 mV in other leads
     ST depression and T-wave changes: New horizontal or down- sloping ST depression ≥ 0.05 mV in two contiguous leads; and/or T inversion ≥ 0.1 mV in two contiguous leads with prominent R-wave or R/S ratio > 1
    **Pathological Q-waves:
     Any Q-wave in leads V2–V3 ≥ 0.02 s or QS complex in leads V2 and V3
     Q-wave ≥ 0.03 s and ≥ 0.1 mV deep or QS complex in leads I, II, aVL, aVF, or V4-V6 in any two leads of a contiguous lead grouping (I, aVL, V6; V4–V6; II, III, and aVF)
   “Demand” related MI (type 2): Patients with type 2 MI should be considered with similar diagnostic criteria as a type 1 MI, however type 2 MI should be considered present when myocardial ischemia and infarction are consequent to supply/demand inequity, rather than a spontaneous plaque rupture and coronary thrombosis
   Percutaneous coronary intervention-related MI (type 4a): For percutaneous coronary interventions (PCI) in patients with normal baseline troponin values, elevations of cardiac biomarkers above the 99th percentile URL, within 24 h of the procedure, are indicative of peri-procedural myocardial necrosis. By convention, increases of biomarkers greater than 5 × 99th percentile URL (Troponin or CK-MB > 5 × 99th percentile URL) are consistent with PCI-related MI. If the cardiac biomarker is elevated prior to PCI, a ≥ 20% increase of the value in the second cardiac biomarker sample within 24 h of the PCI and documentation that cardiac biomarker values were decreasing (2 samples at least 6 h apart) prior to the suspected recurrent MI is also consistent with PCI-related MI. In addition to biomarker elevation one of the following must exist:
    Symptoms suggestive of myocardial ischemia
    New ischemic ECG changes or new LBBB
    Angiographic findings consistent with procedural complication (e.g., Loss of patency, persistent slow/non-flow or embolization)
    Imaging demonstration of new loss of viable myocardium or new regional wall motion abnormality
   MI associated with stent thrombosis or stent restenosis as documented by angiography or at autopsy will also be captured as subtypes 4b and 4c
   Stent thrombosis related MI (type 4b): MI associated with stent thrombosis as detected by coronary angiography or at autopsy, where symptoms suggestive of myocardial ischemia are present, and with a rise and/or fall of cardiac biomarker values with at least 1 value > 99th percentile of the URL. If found with autopsy, it will be captured under cardiac death
    Definite stent thrombosis is considered to have occurred by either angiographic or pathological confirmation:
     Angiographic confirmation of stent thrombosis (Incidental angiographic documentation of stent occlusion in the absence of clinical signs or symptoms is not considered a confirmed stent thrombosis [silent occlusion]). The presence of a thrombus (intracoronary) that originates in the stent or in the segment 5 mm proximal or distal to the stent and presence of at least 1 of the following criteria within a 48-h time window:
      Acute onset of ischemic symptoms at rest
      New ischemic ECG changes that suggest acute ischemia
      Typical rise and fall in cardiac biomarkers (refer to definition of spontaneous MI)
      Non-occlusive thrombus
      Intracoronary thrombus is defined as a (spheric, ovoid, or irregular) non-calcified filling defect or lucency surrounded by contrast material (on 3 sides or within a coronary stenosis) seen in multiple projections, or persistence of contrast material within the lumen, or a visible embolization of intraluminal material downstream
      Occlusive thrombus TIMI 0 or TIMI 1 intrastent or proximal to a stent up to the most adjacent proximal side branch or main branch (if originates from the side branch)
     Pathological confirmation of stent thrombosis: Evidence of recent thrombus within the stent determined at autopsy or via examination of tissue retrieved following thrombectomy
    Probable stent thrombosis: Clinical definition of probable stent thrombosis is considered to have occurred after intracoronary stenting in the following cases:
     Any unexplained death within the 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 and in the absence of any other obvious cause
   Stent restenosis-related MI (type 4c): MI associated with stent restenosis as detected by coronary angiography or at autopsy, occurring > 48 h after index PCI without evidence of stent thrombosis but with symptoms suggestive of myocardial ischemia, and with elevation of cardiac biomarker values to > 99th percentile of the URL. This classification also requires the following:
    Does not meet criteria for any other classification of MI
    Presence of a ≥ 50% stenosis at the site of previous successful stent PCI or a complex lesion and no other significant obstructive CAD of greater severity following:
     Initially successful stent deployment
     Dilatation of a coronary artery stenosis with balloon angioplasty to < 50% stenosis
    If found with autopsy, it will be captured under cardiac death
   Coronary artery bypass grafting-related MI (type 5): MI associated with CABG is arbitrarily defined by elevation of cardiac biomarker values > 10 × 99th percentile URL in patients with normal baseline cardiac biomarker values (≤ 99th percentile URL). In addition to any one of the following:
    New pathological Q-waves or new LBBB
    Angiographic documented new graft or new native coronary artery occlusion
    Imaging evidence of new loss of viable myocardium or new regional wall motion abnormality
Heart failure event A heart failure event includes hospitalization for heart failure and may include any urgent outpatient visits for heart failure. The date of this event will be the day of hospitalization of the patient (including any overnight stay at the emergency room or chest pain unit) or the day of visit to the urgent outpatient center. Due to the pro-thrombotic nature of the subject population, a thrombo-embolic option is included during voting
  The following rules may be applied to indicate if heart failure is attributed to an AOE/VTE:
   Heart failure may be attributed to an AOE/VTE if related to coronary artery disease, hypertension, cardiomyopathy or myocardial infarction
   The relationship of heart failure to an AOE/VTE may be excluded if the underlying cause of heart failure is heart valve disorders, congenital heart disorders or arrhythmias
Heart failure requiring hospitalization Heart failure hospitalization is defined as an event that meets all the following criteria:
   Patient is admitted to the hospital with a primary diagnosis of HF
   Patient’s length of stay in hospital extends for at least 24 h (or a change in calendar date if the hospital admission and discharge times are unavailable)
   Patient exhibits documented new or worsening symptoms due to HF on presentation, including at least ONE of the following:
    Dyspnea with exertion
    Paroxysmal nocturnal dyspnea
    Decrease exercise tolerance
    Other symptoms of worsened end-organ perfusion or volume overload
   Patient has objective evidence of new/worsening HF, consisting of at least TWO physical examination findings OR one physical examination finding and at least one laboratory criterion, including:
    Physical examination findings considered to be due to heart failure
     Peripheral edema
     Increasing abdominal distention or ascites (in the absence of primary hepatic disease)
     Pulmonary rales/crackles/crepitations
     Increased jugular venous pressure and/or hepatojugular reflux
     S3 gallop
     Clinically significant or rapid weight gain thought to be related to fluid retention
    Laboratory evidence of new or worsening HF, if obtained within 24 h of presentation, including:
     Increased b-type natriuretic peptide (BNP)/N-terminal proBNP (NT-proBNP) concentrations consistent with decompensation of heart failure (such as BNP > 500 pg/mL or NT-proBNP > 1800 pg/mL). In patients with chronically elevated natriuretic peptides, a significant increase should be noted above baseline
     Radiological evidence of pulmonary congestion
     New or worsened bilateral pleural effusions
     Noninvasive diagnostic evidence of clinically significant elevated left or right-sided ventricular filling pressure or low cardiac input
     Invasive diagnostic evidence with right heart catheterization showing a pulmonary capillary wedge pressure (pulmonary artery occlusion pressure) ≥ 18 mmHg, central venous pressure ≥ 12 mmHg, or a cardiac index < 2.2 L/min/m2
   Patient receives initiation or intensification of treatment specifically for HF (at least one of the following):
    Augmentation in oral diuretic therapy or ACE inhibitor
    Intravenous diuretic or vasoactive agent (e.g., inotrope, vasopressor, or vasodilator)
    Mechanical or surgical intervention:
     Mechanical circulatory support (e.g., intra-aortic balloon pump, ventricular assist device, extracorporeal membrane oxygenation, total artificial heart)
     Mechanical fluid removal (e.g., dialysis, ultrafiltration, hemofiltration)
Urgent heart failure visit An urgent heart failure visit is defined as an event that meets all the following criteria:
   The patient has an urgent, unscheduled office/practice or emergency department visit for a primary diagnosis of heart failure, but not meeting the criteria for a heart failure hospitalization
   All signs/symptoms for heart failure hospitalization (i.e., symptoms, physical examination findings/lab evidence of new or worsening HF as indicated under definition for Heart Failure Hospitalization) must be met
   The patient receives initiation or intensification of treatment specifically for heart failure, as detailed in the heart failure hospitalization section with the exception of oral diuretic therapy (which will not be sufficient)
Hospitalization for unstable angina The date of this event will be the day of hospitalization of the patient including any overnight stay at an emergency room or chest pain unit
  Hospitalization for unstable angina is defined as an event that meets all the following criteria:
   Negative cardiac biomarkers and no evidence of acute MI
   Ischemic discomfort (angina or other symptoms thought to be equivalent) ≥ 10 min in duration occurring at rest or in an accelerating pattern with frequent episodes associated with progressively decreased exercise capacity
   Unscheduled hospitalization within 24 h of the most recent symptoms. Hospitalization is defined as an admission to an inpatient unit or a visit to an emergency department that results in at least a 24 h stay (or a change in calendar date if the hospital admission or discharge times are not available)
   At least one of the following:
    New or worsening ST or T-wave changes on resting ECG (in absence of confounders such as LBBB or LVH)
    ST Elevation: New transient (duration < 20 min) at the J point in two contiguous leads with the cut-points: ≥ 0.1 mV in all leads other than leads V2-V3 where the following cut-points apply: ≥ 0.2 mV in men ≥ 40 years (≥ 0.25 mV in men < 40 years) or ≥ 0.15 mV in women
    ST depression and T-wave changes: New horizontal or down-sloping ST depression ≥ 0.05 mV in two contiguous leads and/or a new T inversion ≥ 0.3 mV in two contiguous leads with prominent R -wave or R/S ratio > 1
    Definite evidence of inducible myocardial ischemia as demonstrated by one of the following and believed to be responsible for symptoms:
     Early positive stress test (defined as ST elevation or ≥ 2 mm ST depression prior to 5 mets)
     Stress echocardiography (reversible wall motion abnormality)
     Myocardial scintigraphy (reversible perfusion defect)
     MRI (myocardial perfusion deficit under pharmacologic stress)
     Angiographic evidence of new or worse ≥ 70% lesion (≥ 50% for left main lesion) and/or thrombus in an epicardial coronary artery that is believed to be responsible for the myocardial ischemic symptoms/signs
     Need for coronary revascularization procedure (PCI or CABG) for the presumed culprit lesion(s). This criterion would be fulfilled if revascularization was undertaken during the unscheduled hospitalization, or subsequent to transfer to another institution without interceding home discharge
Stroke Stroke is defined as an acute episode of focal or global neurological dysfunction caused by brain, spinal cord, or retinal vascular injury as a result of hemorrhage or infarction. Strokes will be classified as ischemic, hemorrhagic, retinal artery occlusion or thrombosis or undetermined
  Stroke is defined as an acute episode of focal or global neurological dysfunction caused by brain, spinal cord, or retinal vascular injury as a result of hemorrhage or infarction, with symptom duration of 24 h or more. Episodes lasting less than 24 h can be considered a stroke if there is an intervention to abort the stroke (e.g., thrombolytic therapy), diagnostic confirmation of the stroke, or patient death prior to reaching the 24 h duration
  Subdural and epidural hematomas are intracranial hemorrhagic events and are not strokes
  Diagnosis of stroke
  For the diagnosis of stroke, the following 4 criteria should be fulfilled:
   Acute onset* of a focal/global neurological deficit with at least one of the following:
    Change in level of consciousness
    Numbness or sensory loss affecting one side of the body
    Hemianopia (loss of half of the field of vision of one or both eyes)
    Other new neurological sign(s)/symptom(s) consistent with stroke
   *If the mode of onset is uncertain, a diagnosis of stroke may be made provided that there is no plausible non-stroke cause for the clinical presentation
   Duration of a focal/global neurological deficit ≥ 24 h
   < 24 h if
     This is because of at least one of the following therapeutic interventions:
      Pharmacologic (i.e., thrombolytic drug administration)
      Non-pharmacologic (i.e., neurointerventional procedure (e.g., intracranial angioplasty))
     available brain imaging clearly documents a new hemorrhage or infarct
     the neurological deficit results in death
   No other readily identifiable non-stroke cause for the clinical presentation (e.g., brain tumor, trauma, infection, hypoglycemia, peripheral lesion)
   Confirmation of the diagnosis by at least one of the following:**
    Neurology or neurosurgical specialist
    Brain imaging procedure (at least one of the following):
     CT scan
     MRI scan
     Cerebral vessel angiography
    Lumbar puncture (i.e., spinal fluid analysis diagnostic of subarachnoid hemorrhage)
  **If a stroke is reported but evidence of confirmation of the diagnosis by the methods outlined above is absent, the event will be discussed at a full EAC meeting. In such cases, the event may be adjudicated as a stroke on the basis of the clinical presentation alone, but full EAC consensus will be mandatory
  Classification of stroke
  Strokes are sub-classified as follows:
   Ischemic (non-hemorrhagic)
   Ischemic stroke is defined as an acute episode of focal cerebral, spinal or retinal dysfunction caused by infarction of central nervous system tissue. Hemorrhage may be a consequence of ischemic stroke. In this situation, the stroke is an ischemic stroke with hemorrhagic transformation and not a hemorrhagic stroke
   Hemorrhagic stroke is defined as an acute episode of focal or global cerebral or spinal dysfunction caused by intraparenchymal, intraventricular, or subarachnoid hemorrhage
   Retinal artery occlusion or thrombosis
   Retinal artery occlusion or thrombosis is defined as a blockage in one of the retinal arteries
   Occlusions may be caused by a thromboembolism or other risk factors such as atherosclerosis and arrhythmias
   Note: Amaurosis fugax is not considered part of this endpoint
   Undetermined stroke
   Undetermined stroke is defined as an acute episode of focal or global neurological dysfunction caused by presumed brain, spinal cord, as a result of hemorrhage or infarction but with insufficient information to allow categorization as #1 and #2 above
   Note: Given the scope of this study, stroke disability will not be measured. TIA definition was intentionally left out for this study; suspected TIA events will be identified for adjudication in order to rule out stroke
Venous thrombosis Superficial vein thrombosis
  Superficial vein thrombosis (SVT) refers to a blood clot in one of the superficial veins near the surface of the body. There is usually an inflammatory reaction around the vein and may present with as a painful induration with erythema. An SVT can lead to a serious complication such as a higher risk for pulmonary embolism
  Superficial vein thrombosis could be documented by one of the following:
   Clinical symptoms (such as warmth, edema, ‘cord-like’ palpable mass, erythema, pain)
   Duplex ultrasound
Deep vein thrombosis Deep vein thrombosis (DVT) refers to a blood clot in one of the deep veins (to include distal and proximal DVT). It may occur anywhere in the body but is most common in the extremities, a clot blocks blood circulation through these veins, which carry blood back to the heart. This commonly causes pain and swelling distal to the thrombus. Severe complications of DVT may occur when a clot embolizes to the lung
  Deep vein thrombosis could be documented by one of the following:
   Venous ultrasonography
   Compression ultrasonography (CUS)
   Impedance plethysmography (IPG)
   CT scan
   At autopsy
  Venous thrombosis (DVT and SVT) will be categorized for location by the EAC
  Members as follows:
   Lower limb
   Upper limb
   Retinal vein
   Abdominal viscera
   Other (e.g., more unusual sites of cerebral venous thrombosis)
Pulmonary embolism A pulmonary embolism (PE) is a blood clot in the arteries of the lung that typically arise from the veins. The embolus not only prevents the exchange of oxygen and carbon dioxide via the lungs, but it also decreases blood supply to the lung tissue itself, potentially causing infarction. The most common symptoms include pleuritic chest pain, dyspnea, and hemoptysis. A PE may lead to sudden death. Death due to PE refers to death that is either a direct consequence or complication of a PE. Fatal PE is captured in the fatal definition section as death due to other CV causes
  Pulmonary embolism should be documented by supporting evidence found within any one of the following:
   CT scan
   Pulmonary angiogram
   Ventilation/perfusion lung scan (VPLS)
   Inconclusive spiral CT, pulmonary angiography or lung scintigraphy with demonstration of DVT in the lower extremities by CUS or venography with clinical, lab and EKG findings consistent with PE
   At autopsy
Other AOE/VTE Peripheral vascular disease (PVD)
  Peripheral vascular disease refers to a blood circulation disorder outside of the heart and brain that causes the blood vessels to block, narrow or spasm. PVD can be either in veins or arteries. Physical symptoms may include weak pulses, wounds/ulcers that won’t heal, thin or pale skin
  PVD could be documented by one of the following:
   Doppler ultrasound
   Ankle-brachial index
   Magnetic resonance angiography
   Computerized tomography angiography
  Members will be asked to choose if this is a venous or arterial occlusive event
Revascularization procedures For fatal and non-fatal cardiovascular endpoint events, members must also indicate if the event is associated with a revascularization procedure (PCI, CABG or PVI)
  Percutaneous coronary intervention (PCI)
  Defined as the placement of an angioplasty guidewire, balloon, or other device (e.g., stent, atherectomy, brachytherapy or thrombectomy catheter) into a native coronary artery or CABG for the purpose of mechanical coronary revascularization. The assessment of coronary lesion severity by intravascular ultrasonography, coronary flow reserve, or fractional flow reserve is not considered a PCI procedure
  Coronary artery bypass graft (CABG)
  Defined as a procedure performed to bypass partially or completely occluded coronary arteries with veins and/or arteries harvested from elsewhere in the body, thereby improving the blood supply to the coronary circulation supplying the myocardium
  Peripheral vascular intervention (PVI)
  Peripheral vascular intervention is a catheter-based or open surgical procedure designed to improve arterial or venous blood flow or otherwise modify or revise vascular conduits. Procedures may include, but are not limited to percutaneous transluminal balloon angioplasty, stent placement, thrombectomy, embolectomy, atherectomy, dissection repair, aneurysm exclusion, treatment of dialysis conduits, placement of various devices, intravascular thrombolysis or other pharmacotherapies, and open surgical bypass or revision