Clinical event adjudication: Stent thrombosis

Editors-in-Chief: C. Michael Gibson, M.S., M.D. [1]

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

Stent thrombosis

Stent Thrombosis: Timing

Stent thrombosis should be reported as a cumulative value over time and at the various individual time points as specified below. Time 0 is defined as the time point after the guiding catheter has been removed and the subject has left the cardiac catheterization laboratory.

Timing

• Acute stent thrombosis¹: 0-24 hours post stent implantation
• Subacute stent thrombosis¹: > 24 hours – 30 days post stent implantation
• Late stent thrombosis²: > 30 days – 1 year post stent implantation
• Very late stent thrombosis²: > 1 year post stent implantation

¹Acute or subacute can also be replaced by the term early stent thrombosis. Early stent thrombosis (0-30 days) will be used herein.
²Includes “primary” as well as “secondary” late stent thrombosis; “secondary” late stent thrombosis is a stent thrombosis after a target lesion revascularization.

Stent Thrombosis: Categories

We propose three categories of evidence to define stent thrombosis, as follows:

1. Definite Stent Thrombosis

Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation:

a. Angiographic confirmation of stent thrombosis^a

• Thrombolysis in Myocardial Infarction (TIMI) flow is:
  • TIMI flow grade 0 with occlusion originating in the stent or in the segment 5 mm proximal or distal to the stent region in the presence of a thrombus^b,c OR
  • TIMI flow grade 1, 2, or 3 originating in the stent or in the segment 5 mm proximal or distal to the stent region in the presence of a thrombus^b,c

AND at least one of the following criteria has been fulfilled within a 48 our time window:

• New acute onset of ischemic symptoms at rest (typical chest pain with duration > 20 minutes)
• New ischemic ECG changes suggestive of acute ischemia
• Typical rise and fall in cardiac biomarkers (See definition of non-procedural-related MI (i.e. spontaneous MI) in Chapter 4.

^a The incidental angiographic documentation of stent occlusion in the absence of clinical signs or symptoms is not considered a confirmed stent thrombosis (silent occlusion).
^b Non-occlusive thrombus: Intracoronary thrombus is defined as a (spheric, ovoid, or irregular) non-calcified filling defect or lucency surrounded by contrast material (on three 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
^c Occlusive thrombus: TIMI 0 or TIMI 1 flow intra-stent or proximal to a stent up to the most adjacent proximal side branch or main branch (if originating from the side branch)

b. Pathologic Confirmation of Stent Thrombosis

Evidence of recent thrombus within the stent determined at autopsy or via examination of tissue retrieved following thrombectomy.

2. Definite Stent Thrombosis

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
  

§ In patients undergoing PCI for STEMI, one may consider excluding unexplained death within 30 days of the procedure as evidence of probable stent thrombosis.

3. Possible Stent Thrombosis

Possible stent thrombosis is considered to have occurred with any unexplained death from 30 days following intracoronary stenting until end of trial follow-up.

References

1. ACC/AHA 2007 Guidelines for the Management of Patients with Unstable Angina/Non ST-Elevation Myocardial Infarction: Executive Summary: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the 2002 Guidelines for the Management of Patients With Unstable Angina/Non ST-Elevation Myocardial Infarction): Developed in Collaboration with the American College of Emergency Physicians, the Society for Cardiovascular Angiography and Interventions, and the Society of Thoracic Surgeons: Endorsed by the American Association of Cardiovascular and Pulmonary Rehabilitation and the Society for Academic Emergency Medicine, Circulation, 2007, 116:803-877.
   
2. Campeau L, Grading of angina pectoris (letter), Circulation, 1976, 54:522-23.
   
3. Cutlip DE, S Windecker, R Mehran, A Boam, DJ Cohen, G-A van Es, PG Steg, M-A Morel, L Mauri, P Vranckx, E McFadden, A Lansky, M Hamon, MW Krucoff, PW Serruys and on behalf of the Academic Research Consortium, Clinical End Points in Coronary Stent Trials: A Case for Standardized Definitions, Circulation, 2007, 115:2344-2351.
   
4. Easton JD, Saver JL, Albers GW, Alberts MJ, Chaturvedi S, Feldmann E, Hatsukami TS, Higashida RT, Johnston SC, Kidwell CS, Lutsep HL, Miller E, Sacco RL; Definition and Evaluation of Transient Ischemic Attack, A Scientific Statement for Healthcare Professionals from the American Heart Association; American Stroke Association Stroke Council; Council on Cardiovascular Surgery and Anesthesia; Council on Cardiovascular Radiology and Intervention; Council on Cardiovascular Nursing; and the Interdisciplinary Council on Peripheral Vascular Disease, Stroke, 2009 Jun; 40(6):2276-93. Epub 2009 May 7. Review.
   
5. Thygesen, Kristian, Alpert JS, White HD on behalf of the Joint ESC/ACCF/AHA/WHF Task Force for the Redefinition of Myocardial Infarction. Universal Definition of Myocardial Infarction, Circulation, 2007, 116:1-20.