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13 results on '"Stegher, S."'

1. Preliminary Results of Aorfix™ Stent Graft to Treat Infrarenal Abdominal Aortic Aneurysms with Severe Proximal Aortic Neck Angulation.

Author

Volpe P, Massara M, Alberti A, Marino S, Volpe A, Mazzaccaro D, Stegher S, and Nano G

Subjects
Aged, Alloys, Aortic Aneurysm, Abdominal diagnostic imaging, Aortography methods, Blood Vessel Prosthesis Implantation adverse effects, Computed Tomography Angiography, Endoleak etiology, Endovascular Procedures adverse effects, Female, Foreign-Body Migration etiology, Humans, Italy, Male, Preliminary Data, Prosthesis Design, Retrospective Studies, Time Factors, Treatment Outcome, Aortic Aneurysm, Abdominal surgery, Blood Vessel Prosthesis, Blood Vessel Prosthesis Implantation instrumentation, Endovascular Procedures instrumentation, Stents
Abstract

Background: We report a preliminary experience about endovascular aortic repair (EVAR) of infrarenal abdominal aortic aneurysm (iAAA) with severe proximal aortic neck angulation (NA) using the Aorfix™ stent graft., Methods: Data of consecutive patients with iAAA with severe proximal NA submitted to endovascular repair between September 2012 and December 2014 in 2 Italian centers of Vascular and Endovascular Surgery were retrospectively reviewed, and outcomes were analyzed using the software JMP 5.1.2., Results: A total of 26 patients were treated. Median proximal NA was 87.5° (range 68-108°), and 3 patients were treated outside the instruction for use of Aorfix because of a proximal NA > 90°. Eleven patients (42.3%) had severe iliac tortuosity. The primary success rate was 92.3%, as 2 patients required intraoperative correction of a type Ia endoleak. Within 30 days, a right limb occlusion was successfully resolved with endovascular recanalization. The median follow-up period was 14 months (range 1-48 months): 1 patient died for neoplasm and 1 patient presented a type II endoleak from lumbar arteries at 3 months, which is still under surveillance. No other complications were reported during the follow-up period., Conclusions: Preliminary results with the Aorfix stent graft seemed to be promising in the aim of reducing endoleak and migration rates in presence of iAAA with severe proximal aortic NA., (Copyright © 2017 Elsevier Inc. All rights reserved.)

Published
2017
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2. Tips About the Cordis INCRAFT Endograft.

Author

Mazzaccaro D, Occhiuto MT, Stegher S, Righini P, Malacrida G, and Nano G

Subjects
Aged, Aged, 80 and over, Aortic Aneurysm, Abdominal diagnosis, Aortic Aneurysm, Abdominal mortality, Female, Humans, Male, Prosthesis Design, Retrospective Studies, Treatment Outcome, Aortic Aneurysm, Abdominal surgery, Blood Vessel Prosthesis, Blood Vessel Prosthesis Implantation, Endovascular Procedures, Stents
Abstract

Background: Recently, the new Cordis INCRAFT abdominal aortic aneurysm (AAA) Stent-Graft System ultra low-profile device has been introduced in the clinical practice of endovascular aortic repair (EVAR) for the treatment of infrarenal AAAs (iAAAs). In our operative unit, it has been used since November 2014. We report our initial experience with the use of this novel device. We further discuss some technical aspects about the use of the endograft., Methods: Data of all patients undergoing elective EVAR in our Division of Vascular Surgery using the Cordis INCRAFT AAA Stent-Graft System from November 2014 till now were retrospectively collected in a database and outcomes reviewed. Follow-up data were analyzed to evaluate primary success, survival, complications, and device-related events. Statistical analysis was performed using JMP(®) 5.1.2 (SAS Institute Inc., Cary, NC). Continuous variables are reported as mean ± standard deviation, and categorical variables are presented as n (%)., Results: From November 2014 till now in our institution, a total of 10 patients (7 male; mean age, 76.3 years old; range, 65-87 years) underwent elective exclusion of an iAAA with a challenge iliac anatomy (minimum access vessel, 6.7 mm) using Cordis INCRAFT endoprosthesis. There were 9 AAA and a left common iliac artery aneurysm 50 mm in diameter, involving the internal iliac artery. Primary success was achieved in 90% as 1 patient presented an immediate type Ia endoleak which was resolved by the placement of a proximal aortic cuff. There was 1 intraoperative acute leg ischemia requiring a left popliteal Fogarty thrombectomy. Three patients (30%) presented a postimplantation syndrome. No other complications occurred neither during in-hospital stay (mean, 3.4 days; range, 2-4 days) nor during follow-up., Conclusions: In our experience, the Cordis INCRAFT AAA System was a safe and effective device. Our reflections about technical aspects of the use of this device will probably find their answer when further studies will report shared experiences and results about using this type of endograft., (Copyright © 2016 Elsevier Inc. All rights reserved.)

Published
2016
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3. A 16-year experience of carotid artery stenting for carotid artery stenosis.

Author

Nano G, Stegher S, Occhiuto MT, Muzzarelli L, Malacrida G, and Mazzaccaro DP

Subjects
Aged, Female, Humans, Male, Retrospective Studies, Time Factors, Carotid Stenosis surgery, Endovascular Procedures, Stents
Abstract

Aim: We report our experience of carotid artery stenting (CAS) for the endovascular treatment of significant carotid stenosis over 16 years., Materials and Methods: Data of all consecutive patients who came for a significant carotid artery stenosis from January 1st 1999 to August 31st 2015 were retrospectively collected and analyzed. Primary outcomes were the occurrence of death and major cerebrovascular events (MCE) both at 30-day and at long-term., Results: In our experience CAS was a safe and effective technique, with acceptable mortality and neurological complication rates, both at 30 days and in the long term., Key Words: Carotid stenting, Carotid stenosis, Long-term follow-up.

Published
2016

4. Immediate and Late Open Conversion after Ovation Endograft.

Author

Mazzaccaro D, Stegher S, Occhiuto MT, Malacrida G, and Nano G

Subjects
Aged, Aortic Aneurysm, Abdominal diagnosis, Aortography methods, Humans, Male, Polyethylene Terephthalates, Prosthesis Design, Time Factors, Tomography, X-Ray Computed, Treatment Outcome, Aortic Aneurysm, Abdominal surgery, Blood Vessel Prosthesis, Blood Vessel Prosthesis Implantation instrumentation, Conversion to Open Surgery, Endovascular Procedures instrumentation, Stents
Abstract

The risk of intraoperative open conversion during endovascular aortic repair (EVAR) still remains a main issue, albeit in a small percentage of cases. Open conversion can be extremely demanding and risky in relation to the type of the stent graft implanted and can be somehow challenging even for the most experienced vascular surgeons. We discuss a case of immediate conversion and 1 case of late conversion in patients previously treated with EVAR using the Ovation stent graft. The design of the endograft and its proximal sealing allowed the partial preservation of the graft and its use for proximal and distal anastomosis with a Dacron graft in both presented cases., (Copyright © 2015 Elsevier Inc. All rights reserved.)

Published
2015
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5. BRAVISSIMO: 12-month results from a large scale prospective trial.

Author

Bosiers M, Deloose K, Callaert J, Maene L, Beelen R, Keirse K, Verbist J, Peeters P, Schroë H, Lauwers G, Lansink W, Vanslembroeck K, D'archambeau O, Hendriks J, Lauwers P, Vermassen F, Randon C, Van Herzeele I, De Ryck F, De Letter J, Lanckneus M, Van Betsbrugge M, Thomas B, Deleersnijder R, Vandekerkhof J, Baeyens I, Berghmans T, Buttiens J, Van Den Brande P, Debing E, Rabbia C, Ruffino A, Tealdi D, Nano G, Stegher S, Gasparini D, Piccoli G, Coppi G, Silingardi R, Cataldi V, Paroni G, Palazzo V, Stella A, Gargiulo M, Muccini N, Nessi F, Ferrero E, Pratesi C, Fargion A, Chiesa R, Marone E, Bertoglio L, Cremonesi A, Dozza L, Galzerano G, De Donato G, and Setacci C

Subjects
Adult, Aged, Aged, 80 and over, Alloys, Female, Humans, Male, Middle Aged, Peripheral Arterial Disease pathology, Recurrence, Iliac Artery, Peripheral Arterial Disease therapy, Stents
Abstract

The BRAVISSIMO study is a prospective, non-randomized, multi-center, multi-national, monitored trial, conducted at 12 hospitals in Belgium and 11 hospitals in Italy. This manuscript reports the findings up to the 12-month follow-up time point for both the TASC A&B cohort and the TASC C&D cohort. The primary endpoint of the study is primary patency at 12 months, defined as a target lesion without a hemodynamically significant stenosis on Duplex ultrasound (>50%, systolic velocity ratio no greater than 2.0) and without target lesion revascularization (TLR) within 12 months. Between July 2009 and September 2010, 190 patients with TASC A or TASC B aortoiliac lesions and 135 patients with TASC C or TASC D aortoiliac lesions were included. The demographic data were comparable for the TASC A/B cohort and the TASC C/D cohort. The number of claudicants was significantly higher in the TASC A/B cohort, The TASC C/D cohort contains more CLI patients. The primary patency rate for the total patient population was 93.1%. The primary patency rates at 12 months for the TASC A, B, C and D lesions were 94.0%, 96.5%, 91.3% and 90.2% respectively. No statistical significant difference was shown when comparing these groups. Our findings confirm that endovascular therapy, and more specifically primary stenting, is the preferred treatment for patients with TASC A, B, C and D aortoiliac lesions. We notice similar endovascular results compared to surgery, however without the invasive character of surgery.

Published
2013

6. Long-term results of carotid artery stenting in patients 80 years and older.

Author

Mazzaccaro D, Occhiuto MT, Stegher S, Malacrida G, Caldana M, Tealdi DG, and Nano G

Subjects
Age Factors, Aged, Aged, 80 and over, Angioplasty, Balloon adverse effects, Angioplasty, Balloon mortality, Carotid Stenosis diagnosis, Carotid Stenosis mortality, Chi-Square Distribution, Embolic Protection Devices, Female, Humans, Kaplan-Meier Estimate, Male, Middle Aged, Patient Selection, Retrospective Studies, Risk Factors, Severity of Illness Index, Time Factors, Treatment Outcome, Angioplasty, Balloon instrumentation, Carotid Stenosis therapy, Stents
Abstract

Introduction: We report our experience about carotid artery stenting (CAS) in patients 80 years and older., Materials and Methods: Out of 582 patients who underwent CAS at our institution from January 1999 to June 2010, 102 patients (group A) were 80 years or older. The clinical data of these patients were retrospectively reviewed, outcomes analyzed, and compared with those of younger patients who underwent CAS during the same period (group B)., Results: Outcomes of group B were similar to those of group A, both at 30 days and at long term. Male gender, symptoms, and not using an embolic protection device were related to long-term complications in both groups. Occurrence of bradycardia/asystole during CAS was a risk factor for long-term myocardial infarction for group A only., Conclusions: CAS can be safely performed in patients 80 years or older, with results that compare favorably to those of younger patients.

Published
2012
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7. Endovascular treatment of iatrogenic axillary artery pseudoaneurysm under echographic control: a case report.

Author

Mazzaccaro D, Malacrida G, Occhiuto MT, Stegher S, Tealdi DG, and Nano G

Subjects
Aged, Aneurysm, False diagnosis, Aneurysm, False etiology, Fluoroscopy, Follow-Up Studies, Humans, Iatrogenic Disease, Male, Prosthesis Design, Aneurysm, False surgery, Angioscopy methods, Axillary Artery, Blood Vessel Prosthesis Implantation methods, Pacemaker, Artificial adverse effects, Stents
Abstract

Aim: Brief case report of the treatment of a large axillary artery pseudoaneurysm after a pacemaker using a left brachial cutdown and a retrograde delivery of a covered stent using ultrasound and fluoroscopic guidance. The patient's renal function precluded the use of contrast materials., Case Report: A 77 years old man presenting with acute renal failure and haemoglobin decrease arrived with an expanding pseudoaneurysm of the left axillary artery from a pacemaker placement. Considering the site of the lesion and patient's comorbidities, under echographic control, a Hemobahn® stent-graft was placed; fluoroscopy assisted manipulation of guidewires and sheaths into the aortic arch. The procedure was successfully ended without any complications. At 8 months the stent graft was still patent., Conclusion: Ultrasound guidance may represent an alternative for pseudo-aneurysm exclusion without any use of contrast medium, especially in those patient where lesions are easily detectable using ultrasonography and when comorbidities contraindicate aggressive surgical or angiographic approach.

Published
2011
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8. Retrograde aorto-mesenteric by-pass grafting as treatment option of recurrent chronic mesenteric ischemia after thrombosed superior mesenteric artery stenting. Report of a case.

Author

Nano G, Dalainas I, Bianchi P, Stegher S, Casana R, Malacrida G, and Tealdi DG

Subjects
Aged, Angiography, Female, Follow-Up Studies, Humans, Laparotomy, Mesenteric Artery, Superior diagnostic imaging, Mesenteric Vascular Occlusion diagnostic imaging, Mesenteric Vascular Occlusion surgery, Recurrence, Thrombosis diagnostic imaging, Thrombosis etiology, Thrombosis surgery, Time Factors, Treatment Outcome, Ultrasonography, Doppler, Color, Angioplasty, Balloon, Aorta, Abdominal surgery, Blood Vessel Prosthesis Implantation, Mesenteric Artery, Superior surgery, Mesenteric Vascular Occlusion therapy, Stents adverse effects, Thrombosis therapy
Abstract

We report a case of early stent failure in a patient with chronic mesenteric ischemia and its treatment with a retrograde aorto-mesenteric by-pass. The patient was initially treated with angioplasty and stenting. Seven months after the procedure complete thrombosis of the stent was achieved. A retrograde aorto-mesenteric by-pass was performed. After two years the patient remains asymptomatic and color Duplex scan confirm the patency of the graft.

Published
2006

9. Ballooning-induced bradycardia during carotid stenting in primary stenosis and restenosis.

Author

Nano G, Dalainas I, Bianchi P, Stegher S, Bet L, Malacrida G, and Tealdi DG

Subjects
Aged, Aged, 80 and over, Anti-Arrhythmia Agents therapeutic use, Atropine therapeutic use, Bradycardia drug therapy, Bradycardia epidemiology, Carotid Stenosis surgery, Female, Humans, Hypotension epidemiology, Incidence, Male, Recurrence, Retrospective Studies, Bradycardia etiology, Carotid Stenosis therapy, Catheterization adverse effects, Endarterectomy, Carotid, Hypotension etiology, Stents
Abstract

Introduction: We compared the incidence of intraprocedural bradycardia and hypotension during carotid artery stenting in patients with primary carotid artery stenosis and those with prior ipsilateral carotid endarterectomy., Methods: A total of 213 carotid stenting procedures were performed in our institution in a 4-year period. The mean degree of stenosis was 78% (range 60-99%). Of these 213 procedures, 43 were performed for carotid restenosis, 9 after stenting and 34 after endarterectomy, and 170 for primary stenosis. Atropine was selectively administrated if patients suffered bradycardia (a decrease in heart rate to <50% or an absolute heart rate of <40 bpm) or hypotension (systolic blood pressure <90 mmHg). We compared the group of patients with primary stenosis (n=170) and the group of patients with restenosis after carotid endarterectomy (n=34) in relation to intraprocedural hypotension or bradycardia/need for atropine administration., Results: Hypotension occurred in 49 patients with primary stenosis and 2 patients with restenosis. The difference was statistically significant. Atropine was administered for bradycardia to 58 patients with primary stenosis and 3 patients with restenosis. The difference was statistically significant., Conclusion: Intraprocedural bradycardia and hypotension occur more frequently in patients with primary carotid artery stenosis.

Published
2006
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10. Dual antiplatelet regime versus acetyl-acetic acid for carotid artery stenting.

Author

Dalainas I, Nano G, Bianchi P, Stegher S, Malacrida G, and Tealdi DG

Subjects
Aged, Aged, 80 and over, Carotid Stenosis diagnostic imaging, Female, Humans, Ischemic Attack, Transient epidemiology, Male, Middle Aged, Platelet Aggregation, Preoperative Care, Single-Blind Method, Stroke epidemiology, Tomography, X-Ray Computed, Treatment Outcome, Aspirin therapeutic use, Carotid Stenosis surgery, Platelet Aggregation Inhibitors therapeutic use, Stents adverse effects
Abstract

Carotid artery stenting has been proposed as an option treatment of carotid artery stenosis. The aim of this single-institution study is to compare the dual-antiplatelet treatment and heparin combined with acetyl-acetic acid, in patients who underwent carotid artery stenting. We compared 2 groups of 50 patents each who underwent carotid artery stenting for primary atherosclerotic disease. Group A received heparin for 24 h combined with 325 mg acetyl-acetic acid and group B received 250 mg ticlopidine twice a day combined with 325 mg acetyl-acetic acid. Outcome measurements included 30-day bleeding and neurological complications and 30-day thrombosis/occlusion rates. The neurological complications were 16% in group A and 2% in group B (p < 0.05). Bleeding complications occurred in 4% in group A and 2% in group B (p > 0.05). The 30-day thrombosis/occlusion rate was 2% in group A and 0% in group B (p > 0.05). Dual antiplatelet treatment is recommended in all patients undergoing carotid artery stenting.

Published
2006
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11. Midterm experience with the endovascular treatment of isolated iliac aneurysms.

Author

Casana R, Nano G, Dalainas I, Stegher S, Bianchi P, and Tealdi DG

Subjects
Angiography, Female, Follow-Up Studies, Humans, Iliac Aneurysm diagnostic imaging, Iliac Aneurysm surgery, Male, Middle Aged, Retrospective Studies, Time Factors, Tomography, X-Ray Computed, Blood Vessel Prosthesis Implantation, Iliac Aneurysm therapy, Stents
Abstract

Aim: The aim of this retrospective, single institution study was to describe our 4-year experience with the endovascular repair of isolated iliac artery aneurysms., Methods: Between May 1997 and June 2001, 16 patients (15 males; mean age 64+/-9 years), were treated with covered stent grafts. Twelve of the endovascular procedures were performed under epidural and 4 under local anaesthesia. The percutaneous approach was employed in 13 cases and the femoral artery had to be exposed in 3 cases that demanded simultaneous revascularization of the peripheral circulation (n=2) or required a 16 F sheath to employ a Baxter Lifepath stent graft (n=1). The mean size of the iliac aneurysms was 4.5 cm (range 3.5 to 5.2 cm). Four aneurysms involved the hypogastric ostium in absence of any distal neck., Results: All the patients underwent initially successful endovascular treatment of isolated iliac aneurysms and were followed from 3 to 52 months (mean 18 months). No procedural deaths and no acute or late graft thrombosis occurred. The perioperative complications included 1 dissection of the external iliac artery that required a further endovacular procedure and 1 case of endovascular leak fed to the hypogastric artery. A CT scan 4 months later showed spontaneous thrombosis of aneurysm and no further leakage. Two patients had undergone combinated femoro-popliteal arterial bypass., Conclusion: In our early clinical experience the use of self-expandable covered stent graft successful treated isolated iliac artery aneurysms. Endovascular repair is a safe and effective technique with good midterm results in patients at standard and high risk.

Published
2003

12. Status update and interim results from the asymptomatic carotid surgery trial-2 (ACST-2)

Author

Bulbulia, R, Gray, W, Naughten, A, den Hartog, A, Delmestri, A, Wallis, C, le Conte, S, Macdonald, S, Radak, D, Nessi, F, Torsello, G, Hendriks, J, Bjorses, K, Davidovic, L, Tusini, N, Gillgren, P, Casana, R, Tolva, V, Bausback, Y, Mehrzad, A, Gottsäter, A, Esisi, B, Cras, P, Hendriks, Jm, Lauwers, P, Hertoghs, M, Van Schil, P, De Jaegher, L, Peeters, P, Verbist, J, Dendooven, D, De Letter, J, Vanhooren, G, Astarci, P, Capron, I, Choghari, C, Hammer, F, Lacroix, V, Peeters, A, Verhelst, R, Bosiers, M, De Meester, K, Deloose, K, Van Buggenhout, E, Vinck, E, Geenens, M, Hemelsoet, D, Van Herzeele, I, Vermassen, F, De Koster, G, Desiron, Q, Maertens de Noordhout, A, Malmendier, D, Massoz, M, Saad, G, Cirelli, S, Dormal, P, Lerut, P, Thues, E, Coutts, S, Demchuk, A, Hill, M, Hudon, M, Klein, G, Mcclelland, M, Morrish, W, Samis, G, Sutherland, G, Watson, T, Wong, J, Liu, B, Liu, Cw, Barankova, L, Chlouba, V, Fiedler, J, Priban, V, Sterba, L, Kalabova, L, Kriz, Z, Krupa, P, Privara, M, Reif, M, Souckova, L, Staffa, R, Vlachovsky, R, Vojtisek, B, Hrbac, T, Kuliha, M, Prochazka, V, Roubec, M, Skoloudik, D, Abd Allah, F, Eldessoki, Mh, Kassem, Hh, Gharieb, Hs, Cardon, Jm, Le Gallou Wittenberg, A, Allaire, E, Becquemin, Jp, Cochennec, F, Desgranges, P, Hosseini, H, Kobeiter, H, Marzelle, J, Bergeron, P, Padovani, R, Trastour, Jc, Biermaier, B, Gissler, Hm, Klotzsch, C, Pfeiffer, T, Schneider, R, Soehl, L, Wennrih, M, Botsios, S, Branzan, D, Braunlich, S, Holzer, H, Lenzer, J, Reichenbecher, C, Piorkowski, C, Schuster, J, Scheinert, D, Schmidt, A, Ulrich, M, Werner, M, Coster, A, Engelhardt, A, Ratusinski, Cm, Berekoven, B, Frerker, K, Gordon, V, Bellenis, I, Polydorou, A, Polydorou, V, Tavernarakis, A, Ioannou, N, Terzoudi, M, Chatzinikou, E, Giannoukas, A, Hadjigeorgiou, G, Koutsias, S, Ralli, S, Rousas, N, Nemes, B, Jàrànyi, Z, Szabo, A, Varga, D, Barzo, P, Bodosi, M, Fako, E, Fulop, B, Kuncz, A, Nagy, E, Nemeth, T, Pazdernyik, S, Skoba, K, Voros, E, Haider, Sn, Harbison, J, Madhavan, P, Moore, D, Beyar, R, Hoffman, A, Karram, T, Kerner, A, Nikolsky, E, Nitecki, S, Amatucci, G, Vittorio, P, Frederico, Marinazzo, D, Regina, G, Giaquinta, A, Patti, F, Veroux, M, Veroux, P, Adobbati, L, Bertoni, G, Bianchi, P, Cireni, L, Martello, L, Arcuri, L, Casoni, F, Coppi, G, Moratto, R, Veronesi, J, Bajardi, G, Savettieri, G, Corbetta, R, Odero, A, Quaretti, P, Thyrion, Z, Cao, P, Caso, V, Derango, P, Farchioni, L, Parlani, G, Malferrari, G, Strozzi, F, Vecchiati, E, Biello, Antonella, Capoccia, Laura, Menna, Danilo, Rizzo, ANNA RITA, Sbarigia, Enrico, Speziale, Francesco, Toni, D, Giovanni, M, Meola, G, Nano, G, Occiuto, Mt, Stegher, S, Tealdi, D, Accrocca, F, Ambrogi, C, Barbazza, R, Marcucci, G, Cappelli, A, de Donato, G, Palasciano, G, Pieragalli, D, Setacci, C, Settaci, F, Labate, C, Ferrero, E, Ferri, M, Viazzo, A, Castelli, P, Delodovici, Ml, Ferrario, M, Piffaretti, G, Tomei, G, Furui, E, Inoue, T, Kondo, R, Matsumoto, Y, Shimizu, H, Aidashova, B, Kospanov, N, Lyssenko, R, Mussagaliev, D, De Borst GJ, Den Hartog AG, Lo, R, Moll, F, Toorop, R, Van Der Worp HB, Vonken, Ej, Bakke, S, Krohg Sorensen, K, Skjelland, M, Andziak, P, Drelichowski, S, Dratwicki, M, Gil, R, Iwanowski, W, Koncewicz, K, Nowicki, M, Pniewski, J, Rzezak, J, Seweryniak, P, Bialek, P, Biejat, Z, Czepel, W, Czlonkowska, A, Dowzenko, A, Jedzrejewska, J, Kobayashi, A, Leszezyuski, J, Malek, A, Polanski, J, Proczka, R, Skorski, M, Szostek, M, Aleksic, N, Babic, S, Kolar, J, Sagic, D, Tanaskovic, S, Colic, M, Jovanovic, D, Koncar, I, Bartko, D, Beno, P, Rusnak, F, Zelenak, K, Gasparini, M, Grad, A, Kompara, I, Milosevic, Z, Flis, V, Matela, J, Miksic, K, Milotic, F, Mrdja, B, Stirn, B, Tetickovic, E, Chamorro, A, Obach, V, Riambau, V, Roman, S, Blanco, E, Izquierdo, Ay, Guerra, M, Campbell, E, Lindgren, H, Nyberg, J, Plate, G, Parsson, H, Qvarfordt, P, Acosta, S, Brandt, K, Dias, N, Gottsater, A, Holst, J, Kristmundsson, T, Kuhme, T, Kolbel, T, Lindblad, B, Lindh, M, Malina, M, Ohrlander, T, Resch, T, Rönnle, V, Sonesson, B, Warvsten, M, Zdanowski, Z, Bengt, B, Delle, M, Formgren, J, Jarl, L, Kall, Tb, Konrad, P, Nyman, N, Skioldebrand, C, Steuer, J, Takolander, R, Ahlhelm, Fj, Bonati, L, Engelter, Ss, Eugster, T, Gensicke, H, Lyrer, P, Mariani, L, Stierli, P, Stippich, C, Wolff, T, Brown, E, Butler, N, Day, Dj, Hayes, P, Higgins, N, Jumilla, E, Martin, P, Mitchell, J, Varty, K, Birt, A, Davies, P, George, J, Graham, A, Jonker, L, Joseph, T, Kelsall, N, Potts, C, Wilson, T, Davey, P, Hayman, R, Tervitt, G, Abdul Hamiq, A, Bryce, J, Chetter, I, Ettles, D, Lakshminarayan, R, Mitchelsonm, K, Rhymes, C, Robinson, G, Scott, P, Vickers, A, Baht, H, Balogun, I, Burger, I, Cowie, L, Gunathilagan, G, Hargroves, D, Insall, R, Jones, S, Rudenko, H, Senaratne, J, Thomas, G, Thomson, A, Enevoldson, P, Nahser, H, O'Brian, I, Torella, F, Watling, D, White, R, Clifton, A, Eley, C, Khanom, N, O'Reilly, J, Pereira, A, Bicknell, C, Cheshire, N, Gibbs, R, Hamady, M, James, A, Jenkins, M, Lacey, A, Mireskandari, M, Sachs, T, Wolfe, J, Hardy, D, Justin, F, Phiri, L, Sekaran, L, Sethuraman, S, Tate, L, Akyea Mensah, J, Chrisopoulou, A, Smyth, Jv, Nichol, I, Parry, A, Young, G, Clarke, M, Davis, M, Dixit, A, Dyker, A, Ford, G, Jackson, R, Kappadath, S, Lambert, D, Lees, T, Louw, S, Parr, N, Stansby, G, Wales, L, Wealleans, V, Wilson, L, Wyatt, M, Dorman, P, Hughes, A, Jones, D, Mendelow, Ad, Rodgers, H, Macsweeney, S, Mcconachie, N, Southam, A, Sunman, W, Briley, D, Darby, C, Handa, A, Hands, L, Kuker, W, Michael, K, Perkins, J, Schulz, U, Smith, D, Teal, R, Donnelly, M, D'Souza, S, Asehosem Egun, A, Gregory, B, Kelly, C, Punekar, S, Raj, S, Seriki, D, Thomson, G, Beard, J, Cleveland, T, Humphreys, J, Jenkins, A, King, C, Lonsdale, R, Nair, R, Nawaz, S, Okhuoya, F, Turner, D, Venables, G, Brown, J, Durairajan, R, Guyler, P, Harman, P, Jakeways, M, Khuoge, C, Kundu, A, Loganathan, T, Sinha, D, Thompson, V, Tysoe, S, Barer, Brown, A, Crawford, S, Dunlop, P, Majmudar, Mitchell, D, O'Brien, O'Connell, Scott, Vetrivel, S, Ashleigh, R, Butterfield, S, Gamble, G, Ghosh, J, Mccollum, C, Welch, M, Welsh, S, Kazan, V, Nazzal, M, Ramsey Williams, V, Halliday, A, Davies, C, Peto, R, Gray, A, Mihaylova, B, Potter, J, Flather, M, Mansfield, A, Farrell, B, Rahimi, K, Simpson, D, Thomas, D, Gough, M, Rothwell, P, Giles, M, Leopold, P, Belli, A, Sandercock, P, Gray, R, Shearman, C, Molyneux, A, Hayter, E, Lay, M, Munday, A, Young, A, Delmestri, A., Halliday, A, Bulbulia, R, Gray, W, Naughten, A, den Hartog, A, Delmestri, A, Wallis, C, le Conte, S, Macdonald, S, Tolva, V, Cras, Patrick, Hendriks, Jeroen, Lauwers, Patrick, van Schil, Paul, ACST-2 Collaborative Group, UCL - SSS/IONS/NEUR - Clinical Neuroscience, UCL - SSS/IREC/CARD - Pôle de recherche cardiovasculaire, UCL - SSS/IREC/IMAG - Pôle d'imagerie médicale, UCL - (SLuc) Service de chirurgie cardiovasculaire et thoracique, UCL - (SLuc) Service de radiologie, and UCL - (SLuc) Service de neurologie

Subjects
Male, Time Factors, Carotid artery stenosis, Carotid artery stenting, Carotid endarterectomy, Randomized controlled trial, Stroke, medicine.medical_treatment, Myocardial Infarction, Severity of Illness Index, law.invention, law, Risk Factors, MED/22 - CHIRURGIA VASCOLARE, Carotid Stenosis, Endarterectomy, Endarterectomy, Carotid, Middle Aged, Treatment Outcome, Female, Stents, medicine.symptom, Cardiology and Cardiovascular Medicine, medicine.medical_specialty, Aged, Angioplasty, Asymptomatic Diseases, Cardiovascular Agents, Humans, Patient Selection, Risk Assessment, Asymptomatic, medicine, Carotid, business.industry, Vascular surgery, medicine.disease, Surgery, Cardiovascular agent, Human medicine, business
Abstract

Objectives: ACST-2 is currently the largest trial ever conducted to compare carotid artery stenting (CAS) with carotid endarterectomy (CEA) in patients with severe asymptomatic carotid stenosis requiring revascularization. Methods: Patients are entered into ACST-2 when revascularization is felt to be clearly indicated, when CEA and CAS are both possible, but where there is substantial uncertainty as to which is most appropriate. Trial surgeons and interventionalists are expected to use their usual techniques and CE-approved devices. We report baseline characteristics and blinded combined interim results for 30-day mortality and major morbidity for 986 patients in the ongoing trial up to September 2012. Results: A total of 986 patients (687 men, 299 women), mean age 68.7 years (SD ± 8.1) were randomized equally to CEA or CAS. Most (96%) had ipsilateral stenosis of 70-99% (median 80%) with contralateral stenoses of 50-99% in 30% and contralateral occlusion in 8%. Patients were on appropriate medical treatment. For 691 patients undergoing intervention with at least 1-month follow-up and Rankin scoring at 6 months for any stroke, the overall serious cardiovascular event rate of periprocedural (within 30 days) disabling stroke, fatal myocardial infarction, and death at 30 days was 1.0%. Conclusions: Early ACST-2 results suggest contemporary carotid intervention for asymptomatic stenosis has a low risk of serious morbidity and mortality, on par with other recent trials. The trial continues to recruit, to monitor periprocedural events and all types of stroke, aiming to randomize up to 5,000 patients to determine any differential outcomes between interventions. Clinical trial: ISRCTN21144362. © 2013 European Society for Vascular Surgery. Published by Elsevier Ltd. All rights reserved.

Published
2016

13. Second asymptomatic carotid surgery trial (ACST-2): a randomised comparison of carotid artery stenting versus carotid endarterectomy

Author

Alison Halliday, Richard Bulbulia, Leo H Bonati, Johanna Chester, Andrea Cradduck-Bamford, Richard Peto, Hongchao Pan, John Potter, Hans Henning Eckstein, Barbara Farrell, Marcus Flather, Averil Mansfield, Boby Mihaylova, Kazim Rahimi, David Simpson, Dafydd Thomas, Peter Sandercock, Richard Gray, Andrew Molyneux, Cliff P Shearman, Peter Rothwell, Anna Belli, Will Herrington, Parminder Judge, Peter Leopold, Marion Mafham, Michael Gough, Piergiorgio Cao, Sumaira MacDonald, Vasha Bari, Clive Berry, S Bradshaw, Wojciech Brudlo, Alison Clarke, Robin Cox, Susan Fathers, Kamran Gaba, Mo Gray, Elizabeth Hayter, Constance Holliday, Rijo Kurien, Michael Lay, Steffi le Conte, Jessica McManus, Zahra Madgwick, Dylan Morris, Andrew Munday, Sandra Pickworth, Wiktor Ostasz, Michiel Poorthuis, Sue Richards, Louisa Teixeira, Sergey Tochlin, Lynda Tully, Carol Wallis, Monique Willet, Alan Young, Renato Casana, Chiara Malloggi, Andrea Odero Jr, Vincenzo Silani, Gianfranco Parati, Giuseppe Malchiodi, Giovanni Malferrari, Francesco Strozzi, Nicola Tusini, Enrico Vecchiati, Gioacchino Coppi, Antonio Lauricella, Roberto Moratto, Roberto Silingardi, Jessica Veronesi, Andrea Zini, Emanuele Ferrero, Michelangelo Ferri, Andrea Gaggiano, Carmelo Labate, Franco Nessi, Daniele Psacharopulo, Andrea Viazzo, Giovanni Malacrida, Daniela Mazzaccaro, Giovanni Meola, Alfredo Modafferi, Giovanni Nano, Maria Teresa Occhiuto, Paolo Righini, Silvia Stegher, Stefano Chiarandini, Filippo Griselli, Sandro Lepidi, Fabio Pozzi Mucelli, Marcello Naccarato, Mario D'Oria, Barbara Ziani, Andrea Stella, Mortalla Dieng, Gianluca Faggioli, Mauro Gargiulo, Sergio Palermo, Rodolfo Pini, Giovanni Maria Puddu, Andrea Vacirca, Domenico Angiletta, Claudio Desantis, Davide Marinazzo, Giovanni Mastrangelo, Guido Regina, Raffaele Pulli, Paolo Bianchi, Lea Cireni, Elisabetta Coppi, Rocco Pizzirusso, Filippo Scalise, Giovanni Sorropago, Valerio Tolva, Valeria Caso, Enrico Cieri, Paola DeRango, Luca Farchioni, Giacomo Isernia, Massimo Lenti, Gian Battista Parlani, Guglielmo Pupo, Grazia Pula, Gioele Simonte, Fabio Verzini, Federico Carimati, Maria Luisa Delodovici, Federico Fontana, Gabriele Piffaretti, Matteo Tozzi, Efrem Civilini, Giorgio Poletto, Bernhard Reimers, Barbara Praquin, Sonia Ronchey, Laura Capoccia, Wassim Mansour, Enrico Sbarigia, Francesco Speziale, Pasqualino Sirignano, Danilo Toni, Roberto Galeotti, Vincenzo Gasbarro, Francesco Mascoli, Tiberio Rocca, Elpiniki Tsolaki, Giulia Bernardini, Ester DeMarco, Alessia Giaquinta, Francesco Patti, Massimiliano Veroux, Pierfrancesco Veroux, Carla Virgilio, Nicola Mangialardi, Matteo Orrico, Vincenzo Di Lazzaro, Nunzio Montelione, Francesco Spinelli, Francesco Stilo, Carlo Cernetti, Sandro Irsara, Giuseppe Maccarrone, Diego Tonello, Adriana Visonà, Beniamino Zalunardo, Emiliano Chisci, Stefano Michelagnoli, Nicola Troisi, Maela Masato, Massimo Dei Negri, Andrea Pacchioni, Salvatore Saccà, Giovanni Amatucci, Alfredo Cannizzaro, Federico Accrocca, Cesare Ambrogi, Renzo Barbazza, Giustino Marcucci, Andrea Siani, Guido Bajardi, Giovanni Savettieri, Angelo Argentieri, Riccardo Corbetta, Attilio Odero, Pietro Quaretti, Federico Z Thyrion, Alessandro Cappelli, Domenico Benevento, Gianmarco De Donato, Maria Agnese Mele, Giancarlo Palasciano, Daniela Pieragalli, Alessandro Rossi, Carlo Setacci, Francesco Setacci, Domenico Palombo, Maria Cecilia Perfumo, Edoardo Martelli, Aldo Paolucci, Santi Trimarchi, Viviana Grassi, Luigi Grimaldi, Giuliana La Rosa, Domenico Mirabella, Matteo Scialabba, Leonildo Sichel, Costantino L D'Angelo, Gian Franco Fadda, Holta Kasemi, Mario Marino, Francesco Burzotta, Francesco Alberto Codispoti, Angela Ferrante, Giovanni Tinelli, Yamume Tshomba, Claudio Vincenzoni, Deborah Amis, Dawn Anderson, Martin Catterson, Mike Clarke, Michelle Davis, Anand Dixit, Alexander Dyker, Gary Ford, Ralph Jackson, Sreevalsan Kappadath, David Lambert, Tim Lees, Stephen Louw, James McCaslin, Noala Parr, Rebecca Robson, Gerard Stansby, Lucy Wales, Vera Wealleans, Lesley Wilson, Michael Wyatt, Hardeep Baht, Ibrahim Balogun, Ilse Burger, Tracy Cosier, Linda Cowie, Gunaratnam Gunathilagan, David Hargroves, Robert Insall, Sally Jones, Hannah Rudenko, Natasha Schumacher, Jawaharlal Senaratne, George Thomas, Audrey Thomson, Tom Webb, Ellen Brown, Bernard Esisi, Ali Mehrzad, Shane MacSweeney, Norman McConachie, Alison Southam, Wayne Sunman, Ahmed Abdul-Hamiq, Jenny Bryce, Ian Chetter, Duncan Ettles, Raghuram Lakshminarayan, Kim Mitchelson, Christopher Rhymes, Graham Robinson, Paul Scott, Alison Vickers, Ray Ashleigh, Stephen Butterfield, Ed Gamble, Jonathan Ghosh, Charles N McCollum, Mark Welch, Sarah Welsh, Leszek Wolowczyk, Mary Donnelly, Stephen D'Souza, Anselm A Egun, Bindu Gregary, Thomas Joseph, Christine Kelly, Shuja Punekar, M Asad Rahi, Sonia Raj, Dare Seriki, George Thomson, James Brown, Ragunath Durairajan, Iris Grunwald, Paul Guyler, Paula Harman, Matthew Jakeways, Christopher Khuoge, Ashish Kundu, Thayalini Loganathan, Nisha Menon, Raji O Prabakaran, Devesh Sinha, Vicky Thompson, Sharon Tysoe, Dennis Briley, Chris Darby, Linda Hands, Dominic Howard, Wilhelm Kuker, Ursula Schulz, Rachel Teal, David Barer, Andrew Brown, Susan Crawford, Paul Dunlop, Ramesh Krishnamurthy, Nikhil Majmudar, Duncan Mitchell, Min P Myint, Richard O'Brien, Janice O'Connell, Naweed Sattar, Shanmugam Vetrivel, Jonathan Beard, Trevor Cleveland, Peter Gaines, John Humphreys, Alison Jenkins, Craig King, Daniel Kusuma, Ralph Lindert, Robbie Lonsdale, Raj Nair, Shah Nawaz, Faith Okhuoya, Douglas Turner, Graham Venables, Paul Dorman, Andrea Hughes, Deborah Jones, David Mendelow, Helen Rodgers, Aidas Raudoniitis, Peter Enevoldson, Hans Nahser, Imelda O'Brien, Francesco Torella, Dave Watling, Richard White, Pauline Brown, Dipankar Dutta, Lorraine Emerson, Paula Hilltout, Sachin Kulkarni, Jackie Morrison, Keith Poskitt, Fiona Slim, Sarah Smith, Amanda Tyler, Joanne Waldron, Mark Whyman, Milda Bajoriene, Lucy Baker, Amanda Colston, Bekky Eliot-Jones, Gita Gramizadeh, Catherine Lewis-Clarke, Laura McCafferty, Deborah Oliver, Debbie Palmer, Abhijeet Patil, Suzannah Pegler, Gopi Ramadurai, Aisling Roberts, Tracey Sargent, Shivaprasad Siddegowda, Ravi Singh-Ranger, Akintunde Williams, Lucy Williams, Steve Windebank, Tadas Zuromskis, Lanka Alwis, Jane Angus, Asaipillai Asokanathan, Caroline Fornolles, Diana Hardy, Sophy Hunte, Frances Justin, Duke Phiri, Marie Mitabouana-Kibou, Lakshmanan Sekaran, Sakthivel Sethuraman, Margaret L Tate, Joyce Akyea-Mensah, Stephen Ball, Angela Chrisopoulou, Elizabeth Keene, Alison Phair, Steven Rogers, John V Smyth, Colin Bicknell, Jeremy Chataway, Nicholas Cheshire, Andrew Clifton, Caroline Eley, Richard Gibbs, Mohammad Hamady, Beth Hazel, Alex James, Michael Jenkins, Nyma Khanom, Austin Lacey, Maz Mireskandari, Joanna O'Reilly, Antony Pereira, Tina Sachs, John Wolfe, Philip Davey, Gill Rogers, Gemma Smith, Gareth Tervit, Ian Nichol, Andrew Parry, Gavin Young, Simon Ashley, James Barwell, Francis Dix, Azlisham M Nor, Chris Parry, Angela Birt, Paul Davies, Jim George, Anne Graham, Leon Jonker, Nicci Kelsall, Caroline Potts, Toni Wilson, Jamie Crinnion, Larissa Cuenoud, Nikola Aleksic, Srdan Babic, Nenad Ilijevski, Đorde Radak, Dragan Sagic, Slobodan Tanaskovic, Momcilo Colic, Vladimir Cvetic, Lazar Davidovic, Dejana R Jovanovic, Igor Koncar, Perica Mutavdžic, Miloš Sladojevic, Ivan Tomic, Eike S Debus, Ulrich Grzyska, Dagmar Otto, Götz Thomalla, Jessica Barlinn, Johannes Gerber, Kathrin Haase, Christian Hartmann, Stefan Ludwig, Volker Pütz, Christian Reeps, Christine Schmidt, Norbert Weiss, Sebastian Werth, Simon Winzer, Janine Gemper, Albrecht Günther, Bianka Heiling, Elisabeth Jochmann, Panagiota Karvouniari, Carsten Klingner, Thomas Mayer, Julia Schubert, Friederike Schulze-Hartung, Jürgen Zanow, Yvonne Bausback, Franka Borger, Spiridon Botsios, Daniela Branzan, Sven Bräunlich, Henryk Hölzer, Janin Lenzer, Christopher Piorkowski, Nadine Richter, Johannes Schuster, Dierk Scheinert, Andrej Schmidt, Holger Staab, Matthias Ulrich, Martin Werner, Hermann Berger, Gábor Biró, Hans-Henning Eckstein, Michael Kallmayer, Kornelia Kreiser, Alexander Zimmermann, Bärbel Berekoven, Klaus Frerker, Vera Gordon, Giovanni Torsello, Sebastian Arnold, Cora Dienel, Martin Storck, Bernhard Biermaier, Hans Martin Gissler, Christof Klötzsch, Tomas Pfeiffer, Ralph Schneider, Leander Söhl, Michael Wennrich, Angelika Alonso, Michael Keese, Christoph Groden, Andreas Cöster, Andreas Engelhardt, Christoph-Maria Ratusinski, Bengt Berg, Martin Delle, Johan Formgren, Peter Gillgren, Lotta Jarl, Torbjörn B Kall, Peter Konrad, Niklas Nyman, Claes Skiöldebrand, Johnny Steuer, Rabbe Takolander, Jonas Malmstedt, Stefan Acosta, Katarina Björses, Kerstin Brandt, Nuno Dias, Anders Gottsäter, Jan Holst, Thorarinn Kristmundsson, Tobias Kühme, Tilo Kölbel, Bengt Lindblad, Mats Lindh, Martin Malina, Tomas Ohrlander, Tim Resch, Viola Rönnle, Björn Sonesson, Margareta Warvsten, Zbigniew Zdanowski, Erik Campbell, Per Kjellin, Hans Lindgren, Johan Nyberg, Björn Petersen, Gunnar Plate, Håkan Pärsson, Peter Qvarfordt, Pavel Ignatenko, Andrey Karpenko, Vladimir Starodubtsev, Mikhail A Chernyavsky, Maria S Golovkova, Boris B Komakha, Nikolay N Zherdev, Andrey Belyasnik, Pavel Chechulov, Dmitry Kandyba, Igor Stepanishchev, Csaba Csobay-Novák, Edit Dósa, László Entz, Balázs Nemes, Zoltán Szeberin, Pál Barzó, Mihaly Bodosi, Eniko Fákó, Béla Fülöp, Tamás Németh, Szilárd Pazdernyik, Krisztina Skoba, Erika Vörös, Eleni Chatzinikou, Athanasios Giannoukas, Christos Karathanos, Stylianos Koutsias, Georgios Kouvelos, Miltiadis Matsagkas, Styliani Ralli, Christos Rountas, Nikolaos Rousas, Konstantinos Spanos, Elias Brountzos, John D Kakisis, Andreas Lazaris, Konstantinos G Moulakakis, Leonidas Stefanis, Georgios Tsivgoulis, Spyros Vasdekis, Constantine N Antonopoulos, Ion Bellenis, Dimitrios Maras, Antonios Polydorou, Victoria Polydorou, Antonios Tavernarakis, Nikolaos Ioannou, Maria Terzoudi, Miltos Lazarides, Michalis Mantatzis, Kostas Vadikolias, Lukasz Dzieciuchowicz, Marcin Gabriel, Zbigniew Krasinski, Grzegorz Oszkinis, Fryderyk Pukacki, Maciej Slowinski, Michal-Goran Stanišic, Ryszard Staniszewski, Jolanta Tomczak, Maciej Zielinski, Piotr Myrcha, Dorota Rózanski, Stanislaw Drelichowski, Wojciech Iwanowski, Katarzyna Koncewicz, Pawel Bialek, Zbigniew Biejat, Wojciech Czepel, Anna Czlonkowska, Anatol Dowzenko, Julia Jedrzejewska, Adam Kobayashi, Jerzy Leszczynski, Andrzej Malek, Jerzy Polanski, Robert Proczka, Maciej Skorski, Mieczyslaw Szostek, Piotr Andziak, Maciej Dratwicki, Robert Gil, Miroslaw Nowicki, Jaroslaw Pniewski, Jaroslaw Rzezak, Piotr Seweryniak, Pawel Dabek, Michal Juszynski, Grzegorz Madycki, Bartosz Pacewski, Witold Raciborski, Piotr Slowinski, Walerian Staszkiewicz, Martin Bombic, Vladimír Chlouba, Jirí Fiedler, Karel Hes, Petr Koštál, Jindrich Sova, Zdenek Kríž, Mojmír Prívara, Michal Reif, Robert Staffa, Robert Vlachovský, Bohuslav Vojtíšek, Tomáš Hrbác, Martin Kuliha, Václav Procházka, Martin Roubec, David Školoudík, David Netuka, Anna Šteklácová, Vladimír Beneš III, Pavel Buchvald, Ladislav Endrych, Miroslav Šercl, Walter Campos Jr, Ivan B Casella, Nelson de Luccia, André E V Estenssoro, Calógero Presti, Pedro Puech-Leão, Celso R B Neves, Erasmo S da Silva, Cid J Sitrângulo Jr, José A T Monteiro, Gisela Tinone, Marcelo Bellini Dalio, Edwaldo E Joviliano, Octávio M Pontes Neto, Mauricio Serra Ribeiro, Patrick Cras, Jeroen M H Hendriks, Mieke Hoppenbrouwers, Patrick Lauwers, Caroline Loos, Laetitia Yperzeele, Mia Geenens, Dimitri Hemelsoet, Isabelle van Herzeele, Frank Vermassen, Parla Astarci, Frank Hammer, Valérie Lacroix, André Peeters, Robert Verhelst, Silvana Cirelli, Pol Dormal, Annelies Grimonprez, Bart Lambrecht, Philipe Lerut, Eddy Thues, Guy De Koster, Quentin Desiron, Alain Maertens de Noordhout, Danielle Malmendier, Mireille Massoz, Georges Saad, Marc Bosiers, Joren Callaert, Koen Deloose, Estrella Blanco Cañibano, Beatriz García Fresnillo, Mercedes Guerra Requena, Pilar C Morata Barrado, Miguel Muela Méndez, Antonio Yusta Izquierdo, Fernando Aparici Robles, Paula Blanes Orti, Luis García Dominguez, Rafael Martínez López, Manuel Miralles Hernández, José I Tembl Ferrairo, Ángel Chamorro, Juan Macho, Víctor Obach, Vincent Riambau, Luis San Román, Frank J Ahlhelm, Kristine Blackham, Stefan Engelter, Thomas Eugster, Henrik Gensicke, Lorenz Gürke, Philippe Lyrer, Luigi Mariani, Marina Maurer, Edin Mujagic, Mandy Müller, Marios Psychogios, Peter Stierli, Christoph Stippich, Christopher Traenka, Thomas Wolff, Benjamin Wagner, Martina M Wiegert, Sandra Clarke, Michael Diepers, Ernst Gröchenig, Philipp Gruber, Andrej Isaak, Timo Kahles, Regula Marti, Krassen Nedeltchev, Luca Remonda, Nadir Tissira, Martina Valença Falcão, Gert J de Borst, Rob H Lo, Frans L Moll, Raechel Toorop, Bart H van der Worp, Evert J Vonken, Jaap L Kappelle, Ommid Jahrome, Floris 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Miksic, Franko Milotic, Božidar Mrdja, Barbara Stirn, Erih Tetickovic, Mladen Gasparini, Anton Grad, Ingrid Kompara, Zoren Miloševic, Veronika Palmiste, Toomas Toomsoo, Balzhan Aidashova, Nursultan Kospanov, Roman Lyssenko, Daulet Mussagaliev, Rafi Beyar, Aaron Hoffman, Tony Karram, Arthur Kerner, Eugenia Nikolsky, Samy Nitecki, Silva Andonova, Chavdar Bachvarov, Vesko Petrov, Ivan Cvjetko, Vinko Vidjak, Damir Halužan, Mladen Petrunic, Bao Liu, Chang-Wei Liu, Daniel Bartko, Peter Beno, František Rusnák, Kamil Zelenák, Masayuki Ezura, Takashi Inoue, Naoto Kimura, Ryushi Kondo, Yasushi Matsumoto, Hiroaki Shimizu, Hidenori Endo, Eisuke Furui, Søren Bakke, Kristen Krohg-Sørensen, Terje Nome, Mona Skjelland, Bjørn Tennøe, João Albuquerque e Castro, Gonçalo Alves, Frederico Bastos Gonçalves, José de Aragão Morais, Ana C Garcia, Hugo Valentim, Leonor Vasconcelos, Fernando Belcastro, Fernando Cura, Patricio Zaefferer, Foad Abd-Allah, Mohamed H Eldessoki, Hussein Heshmat Kassem, Haytham Soliman 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Subjects
Male, medicine.medical_specialty, Time Factors, Time Factor, medicine.medical_treatment, Carotid Stenosi, MEDLINE, Carotid endarterectomy, Rate ratio, Risk Assessment, Asymptomatic, law.invention, Randomized controlled trial, law, Risk Factors, carotid artery stenting (CAS), carotid endarterectomy (CEA), Stent, medicine, Humans, Carotid Stenosis, Stroke, Endarterectomy, Aged, Endarterectomy, Carotid, business.industry, carotid artery, Risk Factor, Articles, General Medicine, trial, medicine.disease, Settore MED/22 - CHIRURGIA VASCOLARE, Surgery, Stenosis, Treatment Outcome, Settore MED/11 - MALATTIE DELL'APPARATO CARDIOVASCOLARE, Female, Stents, Human medicine, medicine.symptom, business, Human
Abstract

Summary Background Among asymptomatic patients with severe carotid artery stenosis but no recent stroke or transient cerebral ischaemia, either carotid artery stenting (CAS) or carotid endarterectomy (CEA) can restore patency and reduce long-term stroke risks. However, from recent national registry data, each option causes about 1% procedural risk of disabling stroke or death. Comparison of their long-term protective effects requires large-scale randomised evidence. Methods ACST-2 is an international multicentre randomised trial of CAS versus CEA among asymptomatic patients with severe stenosis thought to require intervention, interpreted with all other relevant trials. Patients were eligible if they had severe unilateral or bilateral carotid artery stenosis and both doctor and patient agreed that a carotid procedure should be undertaken, but they were substantially uncertain which one to choose. Patients were randomly allocated to CAS or CEA and followed up at 1 month and then annually, for a mean 5 years. Procedural events were those within 30 days of the intervention. Intention-to-treat analyses are provided. Analyses including procedural hazards use tabular methods. Analyses and meta-analyses of non-procedural strokes use Kaplan-Meier and log-rank methods. The trial is registered with the ISRCTN registry, ISRCTN21144362. Findings Between Jan 15, 2008, and Dec 31, 2020, 3625 patients in 130 centres were randomly allocated, 1811 to CAS and 1814 to CEA, with good compliance, good medical therapy and a mean 5 years of follow-up. Overall, 1% had disabling stroke or death procedurally (15 allocated to CAS and 18 to CEA) and 2% had non-disabling procedural stroke (48 allocated to CAS and 29 to CEA). Kaplan-Meier estimates of 5-year non-procedural stroke were 2·5% in each group for fatal or disabling stroke, and 5·3% with CAS versus 4·5% with CEA for any stroke (rate ratio [RR] 1·16, 95% CI 0·86–1·57; p=0·33). Combining RRs for any non-procedural stroke in all CAS versus CEA trials, the RR was similar in symptomatic and asymptomatic patients (overall RR 1·11, 95% CI 0·91–1·32; p=0·21). Interpretation Serious complications are similarly uncommon after competent CAS and CEA, and the long-term effects of these two carotid artery procedures on fatal or disabling stroke are comparable. Funding UK Medical Research Council and Health Technology Assessment Programme.

Published
2021

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