A randomized study on eversion versus standard carotid endarterectomy: Study design and preliminary results: The EVEREST Trial

P. Cao, G. Giordano, P. De Rango, S. Zannetti, R. Chiesa, G. Coppi, D. Palombo, C. Spartera, V. Stancanelli, E. Vecchiati, S. Caporali, M. Lenti, M. Maghini, L. Nardeli, B. Parente, G. Parlani, F. Verzini, M. G. Celani, A. Nora, G. MalferrariF. Peinetti, B. I. Cifiello, M. Udini, G. D'Allesandro, M. Di Giovanni, R. Castellano, G. Melisanno, G. Magnani, G. Truci, E. Piccinini, R. Santioni, G. G. Rebucci, G. Bafile, E. Gizzi, M. Ventura, A. Varroni, P. Aloisi, N. Tusini, D. Guidetti, L. Moggi, B. Sensi, G. Nenci, T. Cantisani, A. Del Favero, S. Ricci, E. Righetti, C. Setacci

Research output: Contribution to journalArticle

Abstract

Purpose: The EVEREST Trial was designed to determine whether the surgical technique influences the durability and complications of carotid endarterectomy (CEA). The current report focuses on the study design and preliminary results. Methods: EVEREST is a randomized multicenter trial. A total of 1353 patients with carotid stenosis requiring surgical treatment were randomly assigned to received standard (n = 675) or eversion (n = 678) CEA. Primary end points included carotid occlusion, major stroke, death, and restenosis rate. Results: The rate of perioperative major stroke and death (1.3 for each study group) and the incidence of early carotid occlusion (0.6% for eversion vs 0.4% for standard) were similar. No significant differences were found between eversion and standard CEA with respect to incidence of perioperative transient ischemic accident, minor stroke, cranial nerve injuries, neck hematoma, myocardial infarction, or surgical defects as detected with intraoperative quality controls. Clamping time was significantly shorter for eversion CEA compared with patch standard procedures (31.7 ± 15.9 vs 34.5 ± 14.4 minutes, p = 0.02). A shunt was inserted in 11% of patients undergoing eversion CEAs and in 16% of patients undergoing standard procedures. Overall 30-day events occurred in 13.3% of the eversion group and in 11.4% of the standard group (p = 0.3). At a mean follow-up of 14.9 months (range, 1 to 38 months), 16 (2.4%) restenoses occurred in the eversion group and 28 (4.1%) occurred in the standard group (odds ratio, 0.56; 95% confidence interval, 0.3 to 1.1; p = 0.08). Conclusion: The preliminary results of the EVEREST Trial suggest that eversion CEA is a safe and rapid procedure with low major complication rates. No significant differences in restenosis rates were observed between eversion and standard CEA at the available follow-up. Longer-term results are necessary to assess whether the eversion technique influences the durability of CEA.

Original languageEnglish
Pages (from-to)595-605
Number of pages11
JournalJournal of Vascular Surgery
Volume27
Issue number4
DOIs
Publication statusPublished - 1998

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Carotid Endarterectomy
Stroke
Cranial Nerve Injuries
Carotid Stenosis
Constriction
Quality Control
Hematoma
Multicenter Studies
Accidents
Cohort Studies
Neck
Odds Ratio
Myocardial Infarction
Confidence Intervals
Mortality
Incidence

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Surgery

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A randomized study on eversion versus standard carotid endarterectomy : Study design and preliminary results: The EVEREST Trial. / Cao, P.; Giordano, G.; De Rango, P.; Zannetti, S.; Chiesa, R.; Coppi, G.; Palombo, D.; Spartera, C.; Stancanelli, V.; Vecchiati, E.; Caporali, S.; Lenti, M.; Maghini, M.; Nardeli, L.; Parente, B.; Parlani, G.; Verzini, F.; Celani, M. G.; Nora, A.; Malferrari, G.; Peinetti, F.; Cifiello, B. I.; Udini, M.; D'Allesandro, G.; Di Giovanni, M.; Castellano, R.; Melisanno, G.; Magnani, G.; Truci, G.; Piccinini, E.; Santioni, R.; Rebucci, G. G.; Bafile, G.; Gizzi, E.; Ventura, M.; Varroni, A.; Aloisi, P.; Tusini, N.; Guidetti, D.; Moggi, L.; Sensi, B.; Nenci, G.; Cantisani, T.; Del Favero, A.; Ricci, S.; Righetti, E.; Setacci, C.

In: Journal of Vascular Surgery, Vol. 27, No. 4, 1998, p. 595-605.

Research output: Contribution to journalArticle

Cao, P, Giordano, G, De Rango, P, Zannetti, S, Chiesa, R, Coppi, G, Palombo, D, Spartera, C, Stancanelli, V, Vecchiati, E, Caporali, S, Lenti, M, Maghini, M, Nardeli, L, Parente, B, Parlani, G, Verzini, F, Celani, MG, Nora, A, Malferrari, G, Peinetti, F, Cifiello, BI, Udini, M, D'Allesandro, G, Di Giovanni, M, Castellano, R, Melisanno, G, Magnani, G, Truci, G, Piccinini, E, Santioni, R, Rebucci, GG, Bafile, G, Gizzi, E, Ventura, M, Varroni, A, Aloisi, P, Tusini, N, Guidetti, D, Moggi, L, Sensi, B, Nenci, G, Cantisani, T, Del Favero, A, Ricci, S, Righetti, E & Setacci, C 1998, 'A randomized study on eversion versus standard carotid endarterectomy: Study design and preliminary results: The EVEREST Trial', Journal of Vascular Surgery, vol. 27, no. 4, pp. 595-605. https://doi.org/10.1016/S0741-5214(98)70223-X
Cao, P. ; Giordano, G. ; De Rango, P. ; Zannetti, S. ; Chiesa, R. ; Coppi, G. ; Palombo, D. ; Spartera, C. ; Stancanelli, V. ; Vecchiati, E. ; Caporali, S. ; Lenti, M. ; Maghini, M. ; Nardeli, L. ; Parente, B. ; Parlani, G. ; Verzini, F. ; Celani, M. G. ; Nora, A. ; Malferrari, G. ; Peinetti, F. ; Cifiello, B. I. ; Udini, M. ; D'Allesandro, G. ; Di Giovanni, M. ; Castellano, R. ; Melisanno, G. ; Magnani, G. ; Truci, G. ; Piccinini, E. ; Santioni, R. ; Rebucci, G. G. ; Bafile, G. ; Gizzi, E. ; Ventura, M. ; Varroni, A. ; Aloisi, P. ; Tusini, N. ; Guidetti, D. ; Moggi, L. ; Sensi, B. ; Nenci, G. ; Cantisani, T. ; Del Favero, A. ; Ricci, S. ; Righetti, E. ; Setacci, C. / A randomized study on eversion versus standard carotid endarterectomy : Study design and preliminary results: The EVEREST Trial. In: Journal of Vascular Surgery. 1998 ; Vol. 27, No. 4. pp. 595-605.
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abstract = "Purpose: The EVEREST Trial was designed to determine whether the surgical technique influences the durability and complications of carotid endarterectomy (CEA). The current report focuses on the study design and preliminary results. Methods: EVEREST is a randomized multicenter trial. A total of 1353 patients with carotid stenosis requiring surgical treatment were randomly assigned to received standard (n = 675) or eversion (n = 678) CEA. Primary end points included carotid occlusion, major stroke, death, and restenosis rate. Results: The rate of perioperative major stroke and death (1.3 for each study group) and the incidence of early carotid occlusion (0.6{\%} for eversion vs 0.4{\%} for standard) were similar. No significant differences were found between eversion and standard CEA with respect to incidence of perioperative transient ischemic accident, minor stroke, cranial nerve injuries, neck hematoma, myocardial infarction, or surgical defects as detected with intraoperative quality controls. Clamping time was significantly shorter for eversion CEA compared with patch standard procedures (31.7 ± 15.9 vs 34.5 ± 14.4 minutes, p = 0.02). A shunt was inserted in 11{\%} of patients undergoing eversion CEAs and in 16{\%} of patients undergoing standard procedures. Overall 30-day events occurred in 13.3{\%} of the eversion group and in 11.4{\%} of the standard group (p = 0.3). At a mean follow-up of 14.9 months (range, 1 to 38 months), 16 (2.4{\%}) restenoses occurred in the eversion group and 28 (4.1{\%}) occurred in the standard group (odds ratio, 0.56; 95{\%} confidence interval, 0.3 to 1.1; p = 0.08). Conclusion: The preliminary results of the EVEREST Trial suggest that eversion CEA is a safe and rapid procedure with low major complication rates. No significant differences in restenosis rates were observed between eversion and standard CEA at the available follow-up. Longer-term results are necessary to assess whether the eversion technique influences the durability of CEA.",
author = "P. Cao and G. Giordano and {De Rango}, P. and S. Zannetti and R. Chiesa and G. Coppi and D. Palombo and C. Spartera and V. Stancanelli and E. Vecchiati and S. Caporali and M. Lenti and M. Maghini and L. Nardeli and B. Parente and G. Parlani and F. Verzini and Celani, {M. G.} and A. Nora and G. Malferrari and F. Peinetti and Cifiello, {B. I.} and M. Udini and G. D'Allesandro and {Di Giovanni}, M. and R. Castellano and G. Melisanno and G. Magnani and G. Truci and E. Piccinini and R. Santioni and Rebucci, {G. G.} and G. Bafile and E. Gizzi and M. Ventura and A. Varroni and P. Aloisi and N. Tusini and D. Guidetti and L. Moggi and B. Sensi and G. Nenci and T. Cantisani and {Del Favero}, A. and S. Ricci and E. Righetti and C. Setacci",
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TY - JOUR

T1 - A randomized study on eversion versus standard carotid endarterectomy

T2 - Study design and preliminary results: The EVEREST Trial

AU - Cao, P.

AU - Giordano, G.

AU - De Rango, P.

AU - Zannetti, S.

AU - Chiesa, R.

AU - Coppi, G.

AU - Palombo, D.

AU - Spartera, C.

AU - Stancanelli, V.

AU - Vecchiati, E.

AU - Caporali, S.

AU - Lenti, M.

AU - Maghini, M.

AU - Nardeli, L.

AU - Parente, B.

AU - Parlani, G.

AU - Verzini, F.

AU - Celani, M. G.

AU - Nora, A.

AU - Malferrari, G.

AU - Peinetti, F.

AU - Cifiello, B. I.

AU - Udini, M.

AU - D'Allesandro, G.

AU - Di Giovanni, M.

AU - Castellano, R.

AU - Melisanno, G.

AU - Magnani, G.

AU - Truci, G.

AU - Piccinini, E.

AU - Santioni, R.

AU - Rebucci, G. G.

AU - Bafile, G.

AU - Gizzi, E.

AU - Ventura, M.

AU - Varroni, A.

AU - Aloisi, P.

AU - Tusini, N.

AU - Guidetti, D.

AU - Moggi, L.

AU - Sensi, B.

AU - Nenci, G.

AU - Cantisani, T.

AU - Del Favero, A.

AU - Ricci, S.

AU - Righetti, E.

AU - Setacci, C.

PY - 1998

Y1 - 1998

N2 - Purpose: The EVEREST Trial was designed to determine whether the surgical technique influences the durability and complications of carotid endarterectomy (CEA). The current report focuses on the study design and preliminary results. Methods: EVEREST is a randomized multicenter trial. A total of 1353 patients with carotid stenosis requiring surgical treatment were randomly assigned to received standard (n = 675) or eversion (n = 678) CEA. Primary end points included carotid occlusion, major stroke, death, and restenosis rate. Results: The rate of perioperative major stroke and death (1.3 for each study group) and the incidence of early carotid occlusion (0.6% for eversion vs 0.4% for standard) were similar. No significant differences were found between eversion and standard CEA with respect to incidence of perioperative transient ischemic accident, minor stroke, cranial nerve injuries, neck hematoma, myocardial infarction, or surgical defects as detected with intraoperative quality controls. Clamping time was significantly shorter for eversion CEA compared with patch standard procedures (31.7 ± 15.9 vs 34.5 ± 14.4 minutes, p = 0.02). A shunt was inserted in 11% of patients undergoing eversion CEAs and in 16% of patients undergoing standard procedures. Overall 30-day events occurred in 13.3% of the eversion group and in 11.4% of the standard group (p = 0.3). At a mean follow-up of 14.9 months (range, 1 to 38 months), 16 (2.4%) restenoses occurred in the eversion group and 28 (4.1%) occurred in the standard group (odds ratio, 0.56; 95% confidence interval, 0.3 to 1.1; p = 0.08). Conclusion: The preliminary results of the EVEREST Trial suggest that eversion CEA is a safe and rapid procedure with low major complication rates. No significant differences in restenosis rates were observed between eversion and standard CEA at the available follow-up. Longer-term results are necessary to assess whether the eversion technique influences the durability of CEA.

AB - Purpose: The EVEREST Trial was designed to determine whether the surgical technique influences the durability and complications of carotid endarterectomy (CEA). The current report focuses on the study design and preliminary results. Methods: EVEREST is a randomized multicenter trial. A total of 1353 patients with carotid stenosis requiring surgical treatment were randomly assigned to received standard (n = 675) or eversion (n = 678) CEA. Primary end points included carotid occlusion, major stroke, death, and restenosis rate. Results: The rate of perioperative major stroke and death (1.3 for each study group) and the incidence of early carotid occlusion (0.6% for eversion vs 0.4% for standard) were similar. No significant differences were found between eversion and standard CEA with respect to incidence of perioperative transient ischemic accident, minor stroke, cranial nerve injuries, neck hematoma, myocardial infarction, or surgical defects as detected with intraoperative quality controls. Clamping time was significantly shorter for eversion CEA compared with patch standard procedures (31.7 ± 15.9 vs 34.5 ± 14.4 minutes, p = 0.02). A shunt was inserted in 11% of patients undergoing eversion CEAs and in 16% of patients undergoing standard procedures. Overall 30-day events occurred in 13.3% of the eversion group and in 11.4% of the standard group (p = 0.3). At a mean follow-up of 14.9 months (range, 1 to 38 months), 16 (2.4%) restenoses occurred in the eversion group and 28 (4.1%) occurred in the standard group (odds ratio, 0.56; 95% confidence interval, 0.3 to 1.1; p = 0.08). Conclusion: The preliminary results of the EVEREST Trial suggest that eversion CEA is a safe and rapid procedure with low major complication rates. No significant differences in restenosis rates were observed between eversion and standard CEA at the available follow-up. Longer-term results are necessary to assess whether the eversion technique influences the durability of CEA.

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