Evidence map›Paper›PMID 26886419›Full record

Trial reportThe New England journal of medicine2016

Randomized Trial of Stent versus Surgery for Asymptomatic Carotid Stenosis.

Kenneth Rosenfield, Jon S Matsumura, Seemant Chaturvedi, Tom Riles, Gary M Ansel, D Chris Metzger, Lawrence Wechsler, Michael R Jaff, William Gray, ACT I Investigators

2 registry-linked trialsOpen access · bronzeAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in The New England journal of medicine, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 205 papers, 11 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
205citing papers in PubMed, 11 pooled it
65.3field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00106938 naterminatednot on this map

Carotid Angioplasty and Stenting Versus Endarterectomy in Asymptomatic Subjects Who Are at Standard Risk for Carotid Endarterectomy With Significant Extracranial Carotid Stenotic Disease (ACT I)

TypeinterventionalSponsorAbbott Medical DevicesRan2005 to 2013Enrolled1,663ConditionsCarotid Artery Disease, Carotid Stenosis, Stroke, AtherosclerosisArmsCarotid artery stenting with filter (interventional), Carotid artery endarterectomy (surgical)
NCT04271033 naunknown statusnot on this map

Long-term Outcomes of MicroNet-covered Stent Routine Use for Stroke Prevention in Symptomatic and Increased-risk Asymptomatic Carotid Stenosis Patients Requiring Revascularization by Neurovascular Team Decision: PARADIGM-EXTEND

TypeinterventionalSponsorJohn Paul II Hospital, KrakowRan2015 to 2026Enrolled550ConditionsCarotid Artery DiseasesArmsCarotid Artery Stenting
3 · Its place in the literature

Who cites it

205 citing papers in PubMed, 11 syntheses or guidelines pooled it, 611 citations in OpenAlex.

  1. Pooled it
  2. Carotid Artery Stenting With Double-Layer Stent: A Systematic Review and Meta-Analysis.Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists · 2024
    Pooled it
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  10. Arquivos brasileiros de cardiologia · 2017
    Guideline
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  12. Trial
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  18. Long-Term Results of Stenting versus Endarterectomy for Carotid-Artery Stenosis.The New England journal of medicine · 2016 · on this map
    Trial
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145 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

10 authors at 7 institutions in 1 country.

Kenneth RosenfieldFrom Massachusetts General Hospital, Boston (K.R., M.R.J.); the University of Wisconsin, Madison (J.S.M.); the University of Miami, Miami (S.C.); NYU Langone School of Medicine, New York (T.R.); Ohio Health System, Columbus (G.M.A.); Wellmont Cardiovascular Associates Heart Institute, Kingsport, TN (D.C.M.); the University of Pittsburgh Medical Center, Pittsburgh (L.W.); and the Main Line Health System, Philadelphia (W.G.).
Jon S MatsumuraFrom Massachusetts General Hospital, Boston (K.R., M.R.J.); the University of Wisconsin, Madison (J.S.M.); the University of Miami, Miami (S.C.); NYU Langone School of Medicine, New York (T.R.); Ohio Health System, Columbus (G.M.A.); Wellmont Cardiovascular Associates Heart Institute, Kingsport, TN (D.C.M.); the University of Pittsburgh Medical Center, Pittsburgh (L.W.); and the Main Line Health System, Philadelphia (W.G.).
Seemant ChaturvediFrom Massachusetts General Hospital, Boston (K.R., M.R.J.); the University of Wisconsin, Madison (J.S.M.); the University of Miami, Miami (S.C.); NYU Langone School of Medicine, New York (T.R.); Ohio Health System, Columbus (G.M.A.); Wellmont Cardiovascular Associates Heart Institute, Kingsport, TN (D.C.M.); the University of Pittsburgh Medical Center, Pittsburgh (L.W.); and the Main Line Health System, Philadelphia (W.G.).
Tom RilesFrom Massachusetts General Hospital, Boston (K.R., M.R.J.); the University of Wisconsin, Madison (J.S.M.); the University of Miami, Miami (S.C.); NYU Langone School of Medicine, New York (T.R.); Ohio Health System, Columbus (G.M.A.); Wellmont Cardiovascular Associates Heart Institute, Kingsport, TN (D.C.M.); the University of Pittsburgh Medical Center, Pittsburgh (L.W.); and the Main Line Health System, Philadelphia (W.G.).
Gary M AnselFrom Massachusetts General Hospital, Boston (K.R., M.R.J.); the University of Wisconsin, Madison (J.S.M.); the University of Miami, Miami (S.C.); NYU Langone School of Medicine, New York (T.R.); Ohio Health System, Columbus (G.M.A.); Wellmont Cardiovascular Associates Heart Institute, Kingsport, TN (D.C.M.); the University of Pittsburgh Medical Center, Pittsburgh (L.W.); and the Main Line Health System, Philadelphia (W.G.).
D Chris MetzgerFrom Massachusetts General Hospital, Boston (K.R., M.R.J.); the University of Wisconsin, Madison (J.S.M.); the University of Miami, Miami (S.C.); NYU Langone School of Medicine, New York (T.R.); Ohio Health System, Columbus (G.M.A.); Wellmont Cardiovascular Associates Heart Institute, Kingsport, TN (D.C.M.); the University of Pittsburgh Medical Center, Pittsburgh (L.W.); and the Main Line Health System, Philadelphia (W.G.).
Lawrence WechslerFrom Massachusetts General Hospital, Boston (K.R., M.R.J.); the University of Wisconsin, Madison (J.S.M.); the University of Miami, Miami (S.C.); NYU Langone School of Medicine, New York (T.R.); Ohio Health System, Columbus (G.M.A.); Wellmont Cardiovascular Associates Heart Institute, Kingsport, TN (D.C.M.); the University of Pittsburgh Medical Center, Pittsburgh (L.W.); and the Main Line Health System, Philadelphia (W.G.).
Michael R JaffFrom Massachusetts General Hospital, Boston (K.R., M.R.J.); the University of Wisconsin, Madison (J.S.M.); the University of Miami, Miami (S.C.); NYU Langone School of Medicine, New York (T.R.); Ohio Health System, Columbus (G.M.A.); Wellmont Cardiovascular Associates Heart Institute, Kingsport, TN (D.C.M.); the University of Pittsburgh Medical Center, Pittsburgh (L.W.); and the Main Line Health System, Philadelphia (W.G.).
William GrayFrom Massachusetts General Hospital, Boston (K.R., M.R.J.); the University of Wisconsin, Madison (J.S.M.); the University of Miami, Miami (S.C.); NYU Langone School of Medicine, New York (T.R.); Ohio Health System, Columbus (G.M.A.); Wellmont Cardiovascular Associates Heart Institute, Kingsport, TN (D.C.M.); the University of Pittsburgh Medical Center, Pittsburgh (L.W.); and the Main Line Health System, Philadelphia (W.G.).
ACT I Investigators
Massachusetts General Hospital · USMain Line Health · USOhioHealth · USUniversity of Miami · USUniversity of Pittsburgh Medical Center · USUniversity of Wisconsin–Madison · USWellmont Health Systems · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPrevious clinical trials have suggested that carotid-artery stenting with a device to capture and remove emboli ("embolic protection") is an effective alternative to carotid endarterectomy in patients at average or high risk for surgical complications.

methodsIn this trial, we compared carotid-artery stenting with embolic protection and carotid endarterectomy in patients 79 years of age or younger who had severe carotid stenosis and were asymptomatic (i.e., had not had a stroke, transient ischemic attack, or amaurosis fugax in the 180 days before enrollment) and were not considered to be at high risk for surgical complications. The trial was designed to enroll 1658 patients but was halted early, after 1453 patients underwent randomization, because of slow enrollment. Patients were followed for up to 5 years. The primary composite end point of death, stroke, or myocardial infarction within 30 days after the procedure or ipsilateral stroke within 1 year was tested at a noninferiority margin of 3 percentage points.

resultsStenting was noninferior to endarterectomy with regard to the primary composite end point (event rate, 3.8% and 3.4%, respectively; P=0.01 for noninferiority). The rate of stroke or death within 30 days was 2.9% in the stenting group and 1.7% in the endarterectomy group (P=0.33). From 30 days to 5 years after the procedure, the rate of freedom from ipsilateral stroke was 97.8% in the stenting group and 97.3% in the endarterectomy group (P=0.51), and the overall survival rates were 87.1% and 89.4%, respectively (P=0.21). The cumulative 5-year rate of stroke-free survival was 93.1% in the stenting group and 94.7% in the endarterectomy group (P=0.44).

conclusionsIn this trial involving asymptomatic patients with severe carotid stenosis who were not at high risk for surgical complications, stenting was noninferior to endarterectomy with regard to the rate of the primary composite end point at 1 year. In analyses that included up to 5 years of follow-up, there were no significant differences between the study groups in the rates of non-procedure-related stroke, all stroke, and survival. (Funded by Abbott Vascular; ACT I ClinicalTrials.gov number, NCT00106938.).

Indexed as

Endarterectomy, CarotidStentsAdultAgedAngioplastyAnticoagulantsCarotid StenosisDisease-Free SurvivalFemaleHumansIncidenceKaplan-Meier EstimateMaleMiddle AgedProspective StudiesStrokeAnticoagulants

Identifiers

PMID26886419
OpenAlexW2329275711

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.