Procedure-related complications and early neurological adverse events of unprotected and protected carotid stenting: temporal trends in a consecutive patient series.

Purpose: To report procedure-related complications and neurological adverse events of unprotected over-the-wire (OTW) and protected rapid exchange (RX) carotid artery stenting (CAS) in a single-center patient series during an 8-year period.

Methods: Between 1997 and 2004, 651 consecutive patients (445 men; median age 72 years, interquartile range 64-77) were enrolled in a registry database of carotid stent procedures; from 1997 to 2002, 471 patients underwent unprotected CAS using an OTW technique, while the other 180 patients were treated with protected CAS using RX monorail systems from 2003 to 2004. Technical success and complications (neurological, hemodynamic instability, and access site) up to 30 days post intervention were analyzed.

Results: Technical success improved from 95% with unprotected OTW CAS to 99% with protected RX CAS (p=0.025). Procedure-related complications occurred in 86 (18.3%) of 471 unprotected OTW CAS versus 18 (10.0%) of 180 protected RX CAS procedures (p=0.010). Transient ischemic attacks (3.2% versus 2.8%), minor stroke (1.7% versus 0.6%), and major stroke (2.1% versus 0.6%) showed a trend toward a difference between unprotected OTW and protected RX CAS (p=0.076); combined 30-day stroke/death rates were 3.8% for OTW versus 1.2% for RX CAS (p=0.073). During the 8-year period from 1997 to 2004, the annual rates of procedure-related complications (p=0.002), neurological events (p=0.040), and stroke and death (p=0.14) markedly decreased.

Conclusions: Carotid stenting became substantially safer in the era of protected RX technology. In addition to a reduction in neurological complications, which may be due to cerebral protection devices, the improved technical success and reduced non-neurological procedure-related complications are likely due to recent technical advances unrelated to cerebral protection.