Clinical outcomes following protected carotid artery stenting in symptomatic and asymptomatic patients.
OBJECTIVE
To evaluate clinical outcomes in patients undergoing carotid artery stenting (CAS) with routine use of a cerebral embolic protection device (EPD).


METHODS
A retrospective cohort analysis was conducted of 490 consecutive patients (365 men; mean age 70.7+/-8.5 years) who underwent CAS with EPD between January 1999 and December 2007 at 2 institutions with large referral practices. There were 163 symptomatic patients with stenosis >or=50% and 327 asymptomatic patients with >or=80% diameter stenosis treated in 536 CAS procedures. Nearly a quarter (116, 23.7%) of the cohort had diabetes. High-risk surgical features were present in 141 (28.8%): 73 (14.9%) aged >or=80 years, 25 (5.1%) with significant heart disease, 23 (4.6%) with postsurgical restenosis, and 16 (3.2%) with contralateral carotid occlusion. An EPD was successfully placed in 512 (95.5%) patients.


RESULTS
The incidence of any stroke within 30 days was 3.3% (16/490), of which the majority (13, 2.6%) were ipsilateral [5 (1.0%) major and 8 (1.6%) minor]. The incidence of major adverse events (MAE), i.e., any stroke, death or myocardial infarction, within 30 days was 3.7% (18/490); the incidence of 30-day any stroke/death was 3.7% (18/490), while the cumulative incidence of any stroke/death at 1 year was 6.1% (30/490). In symptomatic patients, the 30-day MAE rate was 6.7% (11/163) versus 2.1% (7/237) in the asymptomatic group (p = 0.02). A subgroup analysis based on surgical risk showed that the 30-day MAE rate was similar between high-risk and non-high-risk patients [4.9% (7/144) versus 3.2% (11/346); p = 0.5].


CONCLUSIONS
In this large real-world cohort, CAS with routine use of EPDs was technically feasible, clinically safe, and associated with a low rate of periprocedural and 1-year events; results were similar irrespective of surgical risk.
Ielasi
Alfonso
A
Interventional Cardiology Unit, San Raffaele Scientific Institute, Milan, Italy.
Latib
Azeem
A
Godino
Cosmo
C
Sharp
Andrew S P
AS
Al Lamee
Rasha
R
Montorfano
Matteo
M
Airoldi
Flavio
F
Carlino
Mauro
M
Chieffo
Alaide
A
Sangiorgi
Giuseppe Massimo
GM
Colombo
Antonio
A
D000368:Aged; D000369:Aged, 80 and over; D017130:Angioplasty / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D016893:Carotid Stenosis / Q000150:complications / Q000000981:diagnostic imaging / Q000401:mortality / Q000628:therapy*; D016009:Chi-Square Distribution; D004739:England; D005240:Feasibility Studies; D005260:Female; D005374:Filtration / Q000295:instrumentation; D006801:Humans; D020766:Intracranial Embolism / Q000209:etiology / Q000517:prevention & control*; D007558:Italy; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000209:etiology / Q000517:prevention & control; D011859:Radiography; D012189:Retrospective Studies; D018570:Risk Assessment; D012307:Risk Factors; D012720:Severity of Illness Index; D015607:Stents; D020521:Stroke / Q000209:etiology / Q000517:prevention & control; D013997:Time Factors; D016896:Treatment Outcome