Table 2. Randomised clinical trials comparing carotid endarterectomy to carotid stenting in patients with carotid artery stenosis.
| Trial | Recruitment | n | Follow-up | Procedural Hazards |
Long-Term Stroke Rate |
||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Definition | CEA | CAS | p-value | Definition | CEA | CAS | p-value | ||||
| Symptomatic | |||||||||||
| CAVATAS | 1992–1997 | 504 | Median 5 years | 30d disabling stroke & death | 5.9% | 6.4% | N.S. | Any stroke & periprocedural death | 23.5% | 29.7% | n.s. |
| SAPPHIRE (subgroup) | 2000–2002 | 96 | 78% at 3 years* | 30d MI, stroke, death | 9.3% | 2.1% | 0.18 | Periprocedural MI, stroke, death & post-procedural ipsilateral stroke & death | 21.7% | 32.0% | N.R. |
| EVA-3S | 2000–2005 | 527 | Median 3.5 years | 30d stroke & death | 3.9% | 9.6% | 0.01 | Periprocedural stroke, death, & post-procedural ipsilateral stroke | 6.2% | 11.1% | 0.03 |
| SPACE-1 | 2001–2006 | 1214 | 2 years | 30d ipsilateral stroke & death | 6.5% | 6.9% | 0.09† | Periprocedural stroke, death, & post-procedural ipsilateral stroke | 8.8% | 9.5% | 0.62 |
| ICSS | 2001–2008 | 1713 | Median 4.2 years | 30d procedural MI, stroke, death | 4.0% | 7.4% | 0.003 | Fatal or disabling stroke | 6.5% | 6.4% | 0.77 |
| CREST-1 (subgroup) | 2000–2008 | 1321 | Median 7.4 years* | 30d MI, stroke, death | 5.4% | 6.7% | n.s. | Periprocedural MI, stroke, death & postprocedural ipsilateral stroke | 5y: 8.7% 10y: 9.8% |
5y: 9.0% 10y: 13.4% |
0.40 |
| Asymptomatic | |||||||||||
| SAPPHIRE (subgroup) | 2000–2002 | 237 | 78% at 3 years* | 30d MI, stroke, death | 10.2% | 5.4% | 0.20 | Periprocedural MI, stroke, death & post-procedural ipsilateral stroke, death | 29.2% | 21.4% | N.R. |
| CREST-1 (subgroup) | 2000–2008 | 1181 | Median 7.4 years* | 30d MI, stroke, death | 3.6% | 3.5% | n.s. | Periprocedural MI, stroke, death & postprocedural ipsilateral stroke | 5y: 5.4% 10y: 10.1% |
5y: 6.1% 10y: 9.6% |
0.95 |
| ACT I | 2005–2013 | 1453 | Up to 5 years | 30d MI, stroke, death | 2.6% | 3.3% | 0.60† | Post-procedural ipsilateral stroke | 2.7% | 2.2% | 0.51† |
| SPACE-2 | 2009–2014 | 513 | Ongoing | 30d stoke, death | 1.97% | 2.54% | N.R. | Periprocedural stroke, death & post-procedural ipsilateral stroke | Pending | ||
CEA, carotid endarterectomy; CAS, carotid artery stenting; MI, myocardial infarction; N.R., not reported; n.s., not significant; CAVATAS, Carotid And Vertebral Artery Transluminal Angioplasty Study; SAPPHIRE, Stenting and Angioplasty with Protection in Patients at High Risk for Endarterectomy; EVA-3S, Endarterectomy versus Angioplasty in Patients with Symptomatic Severe Carotid Stenosis; SPACE, Stent-supported Percutaneous Angioplasty of the Carotid artery versus Endarterectomy; ICSS, International Carotid Stenting Study; CREST, Carotid Revascularization Endarterectomy vs Stenting Trial; ACT, Asymptomatic Carotid Trial.
*
For combined sample of trial participants (symptomatic and asymptomatic)
†
p-value for non-inferiority