Kim Eagle , MD , and the editors of ACC . org , present relevant articles taken from various journals .
CLINICAL
NEWS
JOURNAL WRAP
Kim Eagle , MD , and the editors of ACC . org , present relevant articles taken from various journals .
Do Arterial Closure Devices in PCI Lower Major Bleeding Risk ?
Arterial closure devices ( ACDs ) are associated with a reduction in major bleeding after percutaneous coronary intervention ( PCI ), according to new research published in Circulation : Cardiovascular Interventions .
Neil J . Wimmer , MD , MSc , and colleagues used data from the ACC ’ s CathPCI Registry™ . In this analysis data from 1,121,714 patients with PCI performed at 1,375 centers were assessed . The study included 2,296 high- and 2,035 low-ACD use operators . Among those treated by low-ACD use operators , 94.1 % of patients received no ACD , 3.9 % received a sealant device , 0.9 % received a suture device , and 0.6 % received a patch-based device . Among those patients treated by the high-ACD use operators , 9.6 % of patients received no ACD , 60.5 % of patients received a sealant device , 17.7 % of patients received a suture-based device , and 5.8 % of patients received a patch-based device .
Vascular access complications were observed in 1.5 % of patients overall and major bleeding occurred in 4.6 % of patients . Nonaccess site bleeding occurred in 0.4 % of patients . In those treated by high-ACD use operators , vascular access site complications occurred in 1.6 %, major bleeding occurred in 3.6 %, and nonaccess site bleeding occurred in 0.4 %. In low-ACD use operators , vascular access site complications occurred in 1.3 %, major bleeding occurred in 5.7 %, and nonaccess site bleeding occurred in 0.3 %.
Patient and procedural characteristics were similar with high- versus low- ACD operators . High-ACD use operators used ACDs in 90.3 % of PCIs , whereas low-ACD use operators used ACDs in 5.9 % of PCIs . The use of ACDs was associated with a 0.36 % absolute risk reduction in vascular access site complications . The use of ACDs was associated with a 0.73 % absolute risk reduction in major bleeding , as well as with a 0.12 day reduction in length of stay post-PCI . However , it was not associated with a reduction in in-hospital mortality .
The researchers determined that 250 patients need to be treated with ACDs to prevent one vascular access site complication .
Given their “ relatively modest cost in the scheme of an overall PCI ,” patient and physician convenience may be enough to justify ACD use ,” the study authors note . However , they also acknowledge “ that given the low rates of bleeding and vascular complications , even interventions that are highly efficacious would still have a relatively large cost per complication prevented .”
Wimmer , NJ , Secemsky , EA , Mauri , L , et al . Circulation : Cardiol Intv . 2016 ; 9 ( 4 ).
Lesion Characteristics and Risk of Stroke with Carotid Stents
Longer lesion length and sequential and remote lesions appear to be the reason for higher stroke and death risk for patients treated with carotid artery stenting ( CAS ) compared to those treated with carotid endarterectomy ( CAE ), according to a study published in the Journal of Vascular Surgery .
The CREST ( Carotid Revascularization Endarterectomy versus Stenting Trial ) investigators assessed the impact of patient and arterial characteristics on the relative risk of stroke in 2,502 patients treated in the CREST trials .
Risk of stroke was higher with CAS for those with longer lesion length ( ≥ 12.85 mm ) ( odds ratio [ OR ], 3.42 ; 95 % confidence interval [ CI ], 1.19 – 9.78 ). Among patients with sequential or remote lesions extending beyond the bulb , the risk for stroke or death was also higher for CAS relative to
CEA ( OR , 9.01 ; 95 % CI , 1.20 – 67.8 ). In contrast , for the 37 % of patients with lesions that were both short and contiguous , the outcome was favorable in those treated with CAS ( OR for stroke or death , 0.72 ; 95 % CI , 0.21 – 2.46 ).
The higher risk of stroke observed with CAS ( compared to CEA ) appears to be limited to those with long or sequential stenosis .
“ This relative outcome of CEA and CAS continues to be debated , although more recent data suggest that outcomes are broadly similar in asymptomatic patients with either approach ,” writes Hitinder S . Gurm , MBBS , in an ACC . org Journal Scan . “ This study suggests that the anatomical characteristics of the lesion could help select lower-risk patients for CAS . The role for carotid revascularization for stable patients ( in addition to contemporary medical therapy ) remains unclear , and the ongoing CREST-2 trial will help clarify the role for CEA and CAS in this population ( in addition to contemporary medical therapy ) remains unclear , and the ongoing CREST-2 trial will help clarify the role for carotid endarterectomy and carotid endarterectomy in this population .”
Moore WS , Popma JJ , Roubin GS , et al . J Vasc Surg . 2016 ; 63:851-8 .
Is Carotid Endarterectomy Superior to Carotid Stenting in Elderly Patients ?
Carotid endarterectomy ( CEA ) is superior to carotid stenting ( CAS ) in patients aged 70 years and older , according to a recent study in the Lancet . According to the findings , this difference is due to the increasing periprocedural stroke risk in patients treated with CAS .
This study is a meta-analysis of patients with symptomatic carotid disease who were enrolled in the EVA-
3S , SPACE , ICSS , and CREST trials that compared carotid endarterectomy with CAS . The primary outcome was any stroke or death in the periprocedural period ( randomization to 120 days after randomization ) and ipsilateral ischemic stroke in the post-procedural period ( after 120 days ). The authors focused on the effects of age , classified as < 60 , 60 – 64 , 65 – 69 , 70 – 74 , 75 – 79 , and > 80 years , on outcomes . The analyses included Kaplan-Meier methods as well as Cox proportional hazards techniques , which were used to estimate hazard ratios ( HRs ), after adjusting for trial .
There were 4,754 patients randomized to CEA or CAS across the four studies . There was a similar balance of vascular risk factors between the various age groups , with the exception of older patients being less likely to smoke . For patients randomized to CEA , there was no difference in the risk of periprocedural stroke or death across the age strata ( HRs , 0.81 – 1.29 ; p = 0.34 ). For patients randomized to CAS , the risk of periprocedural stroke or death increased with age : 2.1 % in the < 60 group compared with ~ 11 % for those ≥ 70 years ( p < 0.0001 ). While there was no difference between CEA and CAS in the event rate for patients < 69 years , patients ≥ 70 years who had CAS had a higher risk of stroke or death than those who had a CEA . There were 4,289 patients included in the post-procedure analyses and 90 ( 2.3 %) had an ipsilateral stroke . The risk of post-procedural ipsilateral stroke did not differ between the age strata in the CEA or CAS groups .
While there do not appear to be age differences in the risk of ipsilateral stroke after CEA or CAS , in older patients , the periprocedural risk of CAS is higher than CEA .
In an ACC . org Journal Scan , Eric Elsner Adelman , MD , suggests additional research to determine which factors predict stroke or death in older patients undergoing CAS . “ It is reasonable to favor CEA in patients ≥ 70 years with symptomatic carotid disease .” ■
Howard G , Roubin GS , Jansen O , et al . Lancet . 2016 ; 387:1305-11 .
18 CardioSource WorldNews : Interventions May / June 2016