CAPTURE 2 risk-adjusted stroke outcome benchmarks for carotid artery stenting with distal embolic protection.
OBJECTIVE
Many medical procedures undergo rapid evolution and process of care improvements after introduction. National outcome standards are useful to help physicians, institutions, and other stakeholders evaluate the quality of their programs and take action when suboptimal outcomes are identified. The purpose of this analysis was to derive contemporary risk-adjusted stroke rates from a large, contemporary, independently assessed outcome database within 30 days after carotid artery stenting (CAS) in the United States.


METHODS
The second phase of carotid ACCULINK/ACCUNET post approval trial to uncover rare events (CAPTURE 2) is an ongoing prospective, multicenter, clinical trial conducted to assess CAS outcomes in the general practice setting after device approval for high surgical risk patients (symptomatic with >50% stenosis or asymptomatic with >80% stenosis). A neurologist examined the patients before the procedure, at 1 day and 30 days after CAS. The primary endpoint was a composite of death, any stroke, or myocardial infarction (MI) within the periprocedural period. Strokes and neurologic events suspected to be strokes were adjudicated by an independent clinical events adjudication committee. Logistic regression analysis including stepwise logistic and multivariable modeling was performed to determine clinical predictors of periprocedural stroke outcome and generate a parsimonious model that could be used for a clinical standard.


RESULTS
Five thousand two hundred ninety-seven consecutive patients (5297) had CAS performed by 459 physicians at 186 sites before the data cutoff of January 10, 2009. The 30-day rate of stroke was 2.7% (95% confidence interval [CI], 2.3-3.2). Multivariable predictors of periprocedural stroke included age, symptomatic status, and dwell time of embolic protection device. A parsimonious model P(i) = 1/(1+e (-(-3.83 + 0.51 x (symptomatic) + 0.31 x (age >or=80) + 0.62 x (age >or=80 x symptomatic))), including symptomatic and octogenarian status and the term of the interaction of the two, was established based on consideration of clinical predictors, clinical interaction, and practicability.


CONCLUSIONS
CAS outcomes in patients at high surgical risk have comparable periprocedural outcomes to published randomized trials of endarterectomy for patients at standard surgical risk. A model is presented for calculating a contemporary national standard for risk-adjusted stroke rates. Quality improvement measures could be based on relative performance to this benchmark and could improve overall outcomes for patients undergoing CAS.
Matsumura
Jon S
JS
Division of Vascular Surgery, University of Wisconsin School of Medicine and Public Health, Madison, Wisc 53792, USA. matsumura@surgery.wisc.edu
Gray
William
W
Chaturvedi
Seemant
S
Gao
Xingyu
X
Cheng
Jin
J
Verta
Patrick
P
D000367:Age Factors; D000368:Aged; D000369:Aged, 80 and over; D017130:Angioplasty / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D019985:Benchmarking; D016893:Carotid Stenosis / Q000401:mortality / Q000628:therapy*; D016009:Chi-Square Distribution; D015897:Comorbidity; D019992:Databases as Topic; D005260:Female; D005374:Filtration / Q000295:instrumentation*; D006801:Humans; D020766:Intracranial Embolism / Q000209:etiology / Q000401:mortality / Q000517:prevention & control*; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000209:etiology; D011446:Prospective Studies; D018570:Risk Assessment; D012307:Risk Factors; D012720:Severity of Illness Index; D015607:Stents; D020521:Stroke / Q000209:etiology / Q000401:mortality / Q000517:prevention & control*; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States