| Literature DB >> 33722961 |
Brian T Jankowitz1, Ashutosh P Jadhav2, Bradley Gross3, Tudor G Jovin4, Abdulnasser A Alhajeri5, Justin F Fraser6, Ricardo A Hanel7, Eric Sauvageau8, Amin Aghaebrahim9, Donald Frei10, Richard Bellon10, David Loy11, Ajit S Puri12, Adel M Malek13, Ajith Thomas14, Gabor Toth15, Demetrius Klee Lopes16, R Webster Crowley17, Adam S Arthur18,19, John Reavey-Cantwell20, Eugene Lin21, Adnan H Siddiqui22, Michael J Alexander23, Ahmad Khaldi24, Geoffrey P Colby25, Justin M Caplan26, Sudhakar R Satti27, Aquilla S Turk28, Alejandro M Spiotta29, Richard Klucznik30, Danial K Hallam31, David Kung32, Michael T Froehler33, R Charles Callison34, Peter Kan35, Steven W Hetts36, Osama O Zaidat37.
Abstract
BACKGROUND: Stent-assisted coiling of wide-necked intracranial aneurysms (IAs) using the Neuroform Atlas Stent System (Atlas) has shown promising results.Entities:
Keywords: aneurysm; coil; stent
Mesh:
Year: 2021 PMID: 33722961 PMCID: PMC8785011 DOI: 10.1136/neurintsurg-2020-017115
Source DB: PubMed Journal: J Neurointerv Surg ISSN: 1759-8478 Impact factor: 5.836
Baseline characteristics of the ATLAS trial posterior circulation cohort
| Characteristics | Summary statistics (n=116) |
| Demographics | |
| Age | 60.2±10.5 |
| Female | 81.0% (94) |
| White | 91.4% (106) |
| Target aneurysm characteristics (site-reported) | |
| Aneurysm neck width (mm) | 4.7±1.7 |
| Aneurysm size (mm) | 7.1±3.0 |
| Dome:neck ratio | 1.2±0.3 |
| Parent vessel diameter proximal to the aneurysm neck (mm) | 2.9±0.6 |
| Parent vessel diameter distal to the aneurysm neck (mm) | 2.4±0.5 |
| Target aneurysm location | |
| Arising from the mid aspect of the PComA | 1 (0.9%) |
| Basilar apex | 88 (75.9%) |
| Basilar trunk | 7 (6.0%) |
| Superior cerebellar artery | 5 (4.3%) |
| Posterior inferior cerebellar artery | 5 (4.3%) |
| Vertebral artery | 5 (4.3%) |
| Vertebrobasilar junction | 2 (1.7%) |
| Other* | 3 (2.6%) |
Data are mean±SD, or n (%).
*Persistent trigeminal artery, fetal posterior cerebral artery, and posterior cerebral artery.
ATLAS, Assessment of Treatment with Lisinopril and Survival; PComA, posterior communicating artery.
Primary safety and efficacy endpoint rate through 12-month' follow-up (CEC adjudicated)
| Endpoint | Summary statistics | 95% CI | Performance goal | P value* |
| Primary efficacy endpoint† | 76.7% | (67.0% to 86.5%) | 50% | <0.001 |
| Primary safety endpoint | 5 (4.3%) | (1.4% to 9.8%) | 25% | <0.001 |
| Major ipsilateral stroke | 4 (3.4%) | (0.9% to 8.6%) | ||
| Neurologic death | 1 (0.9%) | (0.0% to 4.7%) |
*One-sided binomial exact test of success against the performance goal at 12 months (α=0.025).
†Multiple imputation for missing data.
CEC, Clinical Events Committee.
Secondary efficacy endpoints at 12-month follow-up
| Endpoint | Summary statistics (n=116) | 95% CI |
| Procedural technical success (per patient) | 116/116 (100.0%) | |
| Subjects with one stent implanted | 76/116 (65.5%) | |
| Subjects with two stents implanted | 40/116 (34.5%) | |
| Raymond-Roy class (core laboratory) | ||
| I | 81/95 (85.3%) | (76.5% to 91.7%) |
| II | 9/95 (9.5%) | (4.4% to 17.2%) |
| III | 5/95 (5.3%) | (1.7% to 11.9%) |
| 1 and 2 combined | 90/95 (94.7%) | (88.1% to 98.3%) |
| Recanalization (1) | 9/97 (9.3%) | (4.3% to 16.9%) |
| Any Raymond-Roy class change over time (core laboratory) | ||
| Same | 68/95 (71.6%) | (61.4% to 80.4%) |
| Better | 17/95 (17.9%) | (10.8% to 27.1%) |
| Worse | 10/95 (10.5%) | (5.2% to 18.5%) |
| Parent artery stenosis >50% (core laboratory) | 2/95 (2.1%) | (0.3% to 7.4%) |
| Incidence of stent migration (core laboratory) | 0/95 (0.0%) | (0.0% to 3.8%) |
| Incidence of re-treatment (site-reported) | 9/116 (7.8%) | (3.6% to 14.2%) |
Data are n (%).
*Recanalization is defined as Raymond score of 3 at 12 month visit or retreatment due to recanalization.
Secondary safety endpoints through 12-month follow-up
| Secondary safety endpoint | Summary statistics | 95% CI |
| New or worsening major ipsilateral stroke (CEC-adjudicated) | 4 (3.4%) | (0.9% to 8.6%) |
| Subarachnoid hemorrhage (CEC-adjudicated)* | 2 (1.7%) | (0.2% to 6.1%) |
| Aneurysm rupture (CEC-adjudicated)* | 1 (0.9%) | (0.0% to 4.7%) |
| Device-related serious adverse event (site-reported) | 11 (9.5%) | (4.8% to 16.3%) |
Data are n (%).
*One subject experienced a serious adverse effect (SAE) on postoperative day 1 that was site-reported as ‘vessel dissection related to subarachnoid hemorrhage (SAH)’ and possibly related to the device and was CEC-adjudicated as a major ipsilateral stroke, aneurysm rupture, and SAH’. This single event is therefore captured in four separate secondary endpoint categories (ie, new or worsening ipsilateral stroke, SAH, aneurysm rupture, and device-related SAE).
CEC, Clinical Events Committee.