Prospective, Randomised Two Centre Trial of Endovascular Repair of Abdominal Aortic Aneurysm With or Without Sac Embolisation
The benefit of aneurysm sac coil embolisation (ASCE) during endovascular aortic repair (EVAR) of abdominal aortic aneurysm (AAA) remains unclear. This prospective randomised two centre study (SCOPE 1: Sac COil embolisation for Prevention of Endoleak) compared the outcomes of standard EVAR in patient...
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| Veröffentlicht in: | European journal of vascular and endovascular surgery 2021-02, Vol.61 (2), p.201-209 |
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| creator | Fabre, Dominique Mougin, Justine Mitilian, Delphine Cochennec, Frederic Garcia Alonso, Carlos Becquemin, Jean-Pierre Desgranges, Pascal Allaire, Eric Hamdi, Sarah Brenot, Philippe Bourkaib, Riyad Haulon, Stephan |
| description | The benefit of aneurysm sac coil embolisation (ASCE) during endovascular aortic repair (EVAR) of abdominal aortic aneurysm (AAA) remains unclear. This prospective randomised two centre study (SCOPE 1: Sac COil embolisation for Prevention of Endoleak) compared the outcomes of standard EVAR in patients with AAA at high risk of type II endoleak (EL with EVAR with ASCE during the period 2014–2019.
Patients at high risk of type II EL were randomised to standard EVAR (group A) or EVAR with coil ASCE (group B). The primary endpoint was the rate of all types of EL during follow up. Secondary endpoints included freedom from type II EL related re-interventions, and aneurysm sac diameter and volume variation at two year follow up. Adverse events included type II EL and re-interventions. CTA and Duplex ultrasound scans were scheduled at 30 days, six months, one year, and two years after surgery.
Ninety-four patients were enrolled, 47 in each group. There were no intra-operative complications. At M1, 16/47 early type II EL occurred (34%) in group A vs. 2/47 (4.3%) in group B (p |
| doi_str_mv | 10.1016/j.ejvs.2020.11.028 |
| format | Article |
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Patients at high risk of type II EL were randomised to standard EVAR (group A) or EVAR with coil ASCE (group B). The primary endpoint was the rate of all types of EL during follow up. Secondary endpoints included freedom from type II EL related re-interventions, and aneurysm sac diameter and volume variation at two year follow up. Adverse events included type II EL and re-interventions. CTA and Duplex ultrasound scans were scheduled at 30 days, six months, one year, and two years after surgery.
Ninety-four patients were enrolled, 47 in each group. There were no intra-operative complications. At M1, 16/47 early type II EL occurred (34%) in group A vs. 2/47 (4.3%) in group B (p < .001). At M6, 15/36 type II EL (41.7%) occurred in group A vs. 2/39 (4.26%) in group B (p < .001). At M12, 15/37 type II El (40.5%) occurred in group A vs. 5/35 (14.3%) in group B (p = .018). At 24 months, 8/32 type 2 El (25%) occurred in group A vs. 3/29 (6.5%) in group B (p = .19). Kaplan–Meier curves of survival free from EL and re-interventions were significantly in favour of group B (p < .001). Aneurysm sac volume decreased significantly in group B compared with group A at M6 (p = .081), at M12 (p = .004), and M24 (p = .001).
For selected patients at risk of EL, ASCE seems effective in preventing EL at one, six, and at 12 months. However, the difference was not statistically significant at 24 months. ASCE decreases the re-intervention rate two years after EVAR. A significantly faster aneurysm volume shrinkage was observed at one and two years following surgery. (SCOPE 1 trial: NCT01878240)</description><identifier>ISSN: 1078-5884</identifier><identifier>EISSN: 1532-2165</identifier><identifier>DOI: 10.1016/j.ejvs.2020.11.028</identifier><identifier>PMID: 33342658</identifier><language>eng</language><publisher>England: Elsevier B.V</publisher><subject>Adult ; Aged ; Aged, 80 and over ; Aneurysm ; Aortic Aneurysm, Abdominal - therapy ; Blood Vessel Prosthesis Implantation - methods ; Combined Modality Therapy ; Embolisation ; Embolization, Therapeutic - methods ; Endoleak ; Endovascular ; Endovascular Procedures - methods ; Female ; Follow-Up Studies ; Humans ; Kaplan-Meier Estimate ; Life Sciences ; Male ; Middle Aged ; Prevention ; Proportional Hazards Models ; Prospective Studies ; Reoperation - statistics & numerical data ; Treatment Outcome</subject><ispartof>European journal of vascular and endovascular surgery, 2021-02, Vol.61 (2), p.201-209</ispartof><rights>2020 European Society for Vascular Surgery</rights><rights>Copyright © 2020 European Society for Vascular Surgery. Published by Elsevier B.V. All rights reserved.</rights><rights>Attribution - NonCommercial</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c434t-761f3a1d7a402b565e969afb63db8ea8c694fa0586b892fc8817c902c22156093</citedby><cites>FETCH-LOGICAL-c434t-761f3a1d7a402b565e969afb63db8ea8c694fa0586b892fc8817c902c22156093</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://dx.doi.org/10.1016/j.ejvs.2020.11.028$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>230,314,780,784,885,3548,27923,27924,45994</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/33342658$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink><backlink>$$Uhttps://hal.science/hal-04534954$$DView record in HAL$$Hfree_for_read</backlink></links><search><creatorcontrib>Fabre, Dominique</creatorcontrib><creatorcontrib>Mougin, Justine</creatorcontrib><creatorcontrib>Mitilian, Delphine</creatorcontrib><creatorcontrib>Cochennec, Frederic</creatorcontrib><creatorcontrib>Garcia Alonso, Carlos</creatorcontrib><creatorcontrib>Becquemin, Jean-Pierre</creatorcontrib><creatorcontrib>Desgranges, Pascal</creatorcontrib><creatorcontrib>Allaire, Eric</creatorcontrib><creatorcontrib>Hamdi, Sarah</creatorcontrib><creatorcontrib>Brenot, Philippe</creatorcontrib><creatorcontrib>Bourkaib, Riyad</creatorcontrib><creatorcontrib>Haulon, Stephan</creatorcontrib><title>Prospective, Randomised Two Centre Trial of Endovascular Repair of Abdominal Aortic Aneurysm With or Without Sac Embolisation</title><title>European journal of vascular and endovascular surgery</title><addtitle>Eur J Vasc Endovasc Surg</addtitle><description>The benefit of aneurysm sac coil embolisation (ASCE) during endovascular aortic repair (EVAR) of abdominal aortic aneurysm (AAA) remains unclear. This prospective randomised two centre study (SCOPE 1: Sac COil embolisation for Prevention of Endoleak) compared the outcomes of standard EVAR in patients with AAA at high risk of type II endoleak (EL with EVAR with ASCE during the period 2014–2019.
Patients at high risk of type II EL were randomised to standard EVAR (group A) or EVAR with coil ASCE (group B). The primary endpoint was the rate of all types of EL during follow up. Secondary endpoints included freedom from type II EL related re-interventions, and aneurysm sac diameter and volume variation at two year follow up. Adverse events included type II EL and re-interventions. CTA and Duplex ultrasound scans were scheduled at 30 days, six months, one year, and two years after surgery.
Ninety-four patients were enrolled, 47 in each group. There were no intra-operative complications. At M1, 16/47 early type II EL occurred (34%) in group A vs. 2/47 (4.3%) in group B (p < .001). At M6, 15/36 type II EL (41.7%) occurred in group A vs. 2/39 (4.26%) in group B (p < .001). At M12, 15/37 type II El (40.5%) occurred in group A vs. 5/35 (14.3%) in group B (p = .018). At 24 months, 8/32 type 2 El (25%) occurred in group A vs. 3/29 (6.5%) in group B (p = .19). Kaplan–Meier curves of survival free from EL and re-interventions were significantly in favour of group B (p < .001). Aneurysm sac volume decreased significantly in group B compared with group A at M6 (p = .081), at M12 (p = .004), and M24 (p = .001).
For selected patients at risk of EL, ASCE seems effective in preventing EL at one, six, and at 12 months. However, the difference was not statistically significant at 24 months. ASCE decreases the re-intervention rate two years after EVAR. A significantly faster aneurysm volume shrinkage was observed at one and two years following surgery. (SCOPE 1 trial: NCT01878240)</description><subject>Adult</subject><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Aneurysm</subject><subject>Aortic Aneurysm, Abdominal - therapy</subject><subject>Blood Vessel Prosthesis Implantation - methods</subject><subject>Combined Modality Therapy</subject><subject>Embolisation</subject><subject>Embolization, Therapeutic - methods</subject><subject>Endoleak</subject><subject>Endovascular</subject><subject>Endovascular Procedures - methods</subject><subject>Female</subject><subject>Follow-Up Studies</subject><subject>Humans</subject><subject>Kaplan-Meier Estimate</subject><subject>Life Sciences</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Prevention</subject><subject>Proportional Hazards Models</subject><subject>Prospective Studies</subject><subject>Reoperation - statistics & numerical data</subject><subject>Treatment Outcome</subject><issn>1078-5884</issn><issn>1532-2165</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2021</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp9kU1v1DAYhC0EoqXwBzggH6lEFn_HkbhEq4UirQQqizhajvNG9SqJFzsJ6oH_jsOWHjm91nhmDvMg9JqSDSVUvT9u4LikDSMsC3RDmH6CLqnkrGBUyaf5TUpdSK3FBXqR0pEQIimXz9EF51wwJfUl-v01hnQCN_kF3uFbO7Zh8AlafPgV8BbGKQI-RG97HDq8y7-LTW7ubcS3cLI-rnLdrKExe-oQJ-9wPcIc79OAf_jpDof494Z5wt-sw7uhCb1PdvJhfImedbZP8OrhXqHvH3eH7U2x__Lp87beF05wMRWloh23tC2tIKyRSkKlKts1ireNBqudqkRnidSq0RXrnNa0dBVhjjEqFan4Fbo-997Z3pyiH2y8N8F6c1PvzaoRIbmopFho9r49e08x_JwhTSYP4qDv7QhhToaJMm9c8XKtZWeryyOmCN1jNyVmRWSOZkVkVkSGUpMR5dCbh_65GaB9jPxjkg0fzgbIiyweoknOw-ig9TGDMm3w_-v_A8CRoiI</recordid><startdate>202102</startdate><enddate>202102</enddate><creator>Fabre, Dominique</creator><creator>Mougin, Justine</creator><creator>Mitilian, Delphine</creator><creator>Cochennec, Frederic</creator><creator>Garcia Alonso, Carlos</creator><creator>Becquemin, Jean-Pierre</creator><creator>Desgranges, Pascal</creator><creator>Allaire, Eric</creator><creator>Hamdi, Sarah</creator><creator>Brenot, Philippe</creator><creator>Bourkaib, Riyad</creator><creator>Haulon, Stephan</creator><general>Elsevier B.V</general><general>Elsevier</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope><scope>1XC</scope><scope>VOOES</scope></search><sort><creationdate>202102</creationdate><title>Prospective, Randomised Two Centre Trial of Endovascular Repair of Abdominal Aortic Aneurysm With or Without Sac Embolisation</title><author>Fabre, Dominique ; 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This prospective randomised two centre study (SCOPE 1: Sac COil embolisation for Prevention of Endoleak) compared the outcomes of standard EVAR in patients with AAA at high risk of type II endoleak (EL with EVAR with ASCE during the period 2014–2019.
Patients at high risk of type II EL were randomised to standard EVAR (group A) or EVAR with coil ASCE (group B). The primary endpoint was the rate of all types of EL during follow up. Secondary endpoints included freedom from type II EL related re-interventions, and aneurysm sac diameter and volume variation at two year follow up. Adverse events included type II EL and re-interventions. CTA and Duplex ultrasound scans were scheduled at 30 days, six months, one year, and two years after surgery.
Ninety-four patients were enrolled, 47 in each group. There were no intra-operative complications. At M1, 16/47 early type II EL occurred (34%) in group A vs. 2/47 (4.3%) in group B (p < .001). At M6, 15/36 type II EL (41.7%) occurred in group A vs. 2/39 (4.26%) in group B (p < .001). At M12, 15/37 type II El (40.5%) occurred in group A vs. 5/35 (14.3%) in group B (p = .018). At 24 months, 8/32 type 2 El (25%) occurred in group A vs. 3/29 (6.5%) in group B (p = .19). Kaplan–Meier curves of survival free from EL and re-interventions were significantly in favour of group B (p < .001). Aneurysm sac volume decreased significantly in group B compared with group A at M6 (p = .081), at M12 (p = .004), and M24 (p = .001).
For selected patients at risk of EL, ASCE seems effective in preventing EL at one, six, and at 12 months. However, the difference was not statistically significant at 24 months. ASCE decreases the re-intervention rate two years after EVAR. A significantly faster aneurysm volume shrinkage was observed at one and two years following surgery. (SCOPE 1 trial: NCT01878240)</abstract><cop>England</cop><pub>Elsevier B.V</pub><pmid>33342658</pmid><doi>10.1016/j.ejvs.2020.11.028</doi><tpages>9</tpages><oa>free_for_read</oa></addata></record> |
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| subjects | Adult Aged Aged, 80 and over Aneurysm Aortic Aneurysm, Abdominal - therapy Blood Vessel Prosthesis Implantation - methods Combined Modality Therapy Embolisation Embolization, Therapeutic - methods Endoleak Endovascular Endovascular Procedures - methods Female Follow-Up Studies Humans Kaplan-Meier Estimate Life Sciences Male Middle Aged Prevention Proportional Hazards Models Prospective Studies Reoperation - statistics & numerical data Treatment Outcome |
| title | Prospective, Randomised Two Centre Trial of Endovascular Repair of Abdominal Aortic Aneurysm With or Without Sac Embolisation |
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