Table 1

Landmark randomized controlled trials for carotid endarterectomy, carotid artery stenosis, transcarotid artery revascularization, and their outcomes

Carotid endarterectomyNumber needed to treat*
Recruitment periodNo of patientsPopulationPerioperative risk of any stroke and deathRisk of any stroke (including perioperative) and death
ACAS8 1987–19931662Asymptomatic (never symptomatic)2.3%5 year: 5.1% (CEA) vs 11.0% (BMT)17
ACST-19 1993–20033120Asymptomatic (6 months or longer)3.1%5 year: 6.4% (CEA) vs 11.8% (BMT)19
Carotid artery stenting Relative risk
SAPPHIRE13 2000–2002334Symptomatic (97)/asymptomatic (237)5.5% (CAS) vs 8.4% (CEA), p=0.36‡3 year: 21.4% (CAS) vs 29.2% (CEA)†0.74 (95% CI 0.47 to 1.14)
CREST-114 2005–20082502Symptomatic (1321)/asymptomatic (1181)2.5% (CAS) vs 1.4% (CEA), p=0.1510 year: 11.8% (CAS) vs 9.9% (CEA)†1.10 (95% CI 0.83 to 1.44)
ACT-I15 2005–20131453Asymptomatic2.9% (CAS) vs 1.7% (CEA), p=0.335 year: 3.8% (CAS) vs 3.3% (CEA)†1.14 (95% CI 0.61 to 2.15)
ACST-216 2008–20203625Asymptomatic3.7% (CAS) vs 2.7% (CEA), p=0.125 year: 5.3% (CAS) vs 4.5% (CEA)1.11 (95% CI 0.91 to 1.32)
Transcarotid artery revascularization
ROADSTER-119 2012–2014141Symptomatic (36)/asymptomatic (105)2.8%‡No follow-up data
ROADSTER-220§2015–2019692Symptomatic (180)/asymptomatic (512)1.4%No follow-up data
  • All reported risks specifically pertain to asymptomatic patients except for the SAPPHIRE and ROADSTER-1 trials that report combined risk of asymptomatic and symptomatic populations.

  • *Number needed to treat to prevent one stroke.

  • †These trials include the incidence of myocardial infarction in addition to risk of any stroke and death.

  • ‡The value represents numerical risk combined for both asymptomatic and symptomatic populations.

  • §Interim result of ongoing trial.

  • BMT, best medical therapy; CAS, carotid artery stenosis; CEA, carotid endarterectomy.