Clinical trial NCT05291637: Posterior cerebraL ArTery Occlusion Study
Official title: Endovascular Therapy vs Medical Management of PosterIor Cerebral Artery Occlusion Stroke
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke, Acute Ischemic
Keywords: Posterior occlusion artery (PCA)
Intravenous thrombolysis (IVT)
Endovascular therapy (EVT)
Modified Rankin Scale (mRS)
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
Collaborators: name: Heidelberg University
First posted: 2022-03-22
Enrollment: 1282
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients identified from electronic health records who have undergone stroke medical management treatment from 1/01/2003 to 01/01/2022 and patients who have undergone EVT stroke treatment from 01/01/2015 - 01/01/2022.

Brief summary: For this retrospective study, the investigators will collect and analyze data of patients who presented with posterior artery occlusion and underwent mechanical thrombectomy (the type of endovascular stroke treatment) and intravenous thrombolysis (the type of non-endovascular stroke treatment).

The electronic health records will be queried for the demographic, medical history, and outcomes data of all patients with posterior cerebral artery occlusion who underwent mechanical thrombectomy, intravenous thrombolysis (IVT), or medical management.

Detailed description: The primary aims of the research are to evaluate, in patients presenting with posterior artery occlusion (PCA), whether favorable outcome would be superior for EVT compared to Medically Management (MM), inclusive of intravenous thrombolysis (IVT), as measured by:

* 90-day modified Rankin Scale (mRS) ordinal shift or
* decrease in NIH Stroke Scale/Score (NIHSS) by two points at 24 hours or at hospital discharge

The secondary aims are to evaluate in patients presenting with PCA occlusion, other outcome and safety metrics:

* 90-day functional independence, mRS 0-2
* 90-day excellent outcome, mRS 0-1
* Visual field recovery (none, partial, complete) by 90-days
* rate of reperfusion by modified thrombolysis in cerebral infarction (TICI) scale grade
* any intracranial hemorrhage
* symptomatic intracranial hemorrhage
* mortality

In subgroup analysis, the investigators aim to identify subgroups that may confer differential treatment benefit by:

* location of occlusion on the PCA segment (P1, P2, P3)
* NIHSS strata (0-6, 7-15,\>16)
* time from symptom onset to treatment (0 to \<6h vs 6-24h)
* posterior circulation (PC) Acute Stroke Prognosis Early Computed Tomography Score (ASPECTS)
* visual field defect on presentation

The investigators hypothesize that greater benefit in outcomes would be seen in EVT treated patients with higher NIHSS, more proximal PCA occlusion, higher PC ASPECTS scores, and shorter time from symptom onset to treatment.

Eligibility criteria: Inclusion Criteria:

* Had an ischemic stroke with isolated posterior cerebral artery occlusion (P1, P2, or P3 segments) and was medically managed or managed with EVT during the study time period.

Exclusion Criteria:

* Patient with documented basilar artery occlusion and concomitant PCA occlusion
* Patient with documented basilar artery occlusion, migration with secondary PCA occlusion

Primary outcomes:
measure: Change in stroke outcome based on modified Rankin Scale (mRS)
timeFrame: baseline, 90 days
measure: Change in NIH Stroke Score (NIHSS)
timeFrame: baseline, 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Miami
country: United States
facility: Miami Baptist Health
state: Florida
city: Atlanta
country: United States
facility: Emory University School of Medicine
state: Georgia
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
city: Camden
country: United States
facility: Cooper University Healthcare
state: New Jersey
city: Buffalo
country: United States
facility: University of Buffalo
state: New York
city: New York
country: United States
facility: Mount Sinai Health
state: New York
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Houston
country: United States
facility: UT Texas Medical Center
state: Texas
city: Helsinki
country: Finland
facility: Helsinki University Hospital
city: Berlin
country: Germany
facility: Charite Berlin
city: Bochum
country: Germany
facility: Universitätsklinikum Knappschaftskrankenhaus Bochum
city: Dresden
country: Germany
facility: University Clinics Dresden
city: Erlangen
country: Germany
facility: Universitätsklinikum Erlangen
city: Hamburg
country: Germany
facility: University Medical Center Hamburg-Eppendorf
city: Heidelberg
country: Germany
facility: Heidelberg University
city: Bologna
country: Italy
facility: IRCCS Istituto delle Scienze Neurologiche di Bologna
city: Lisboa
country: Portugal
facility: Egas Moniz Hospital
city: Lisbon
country: Portugal
facility: Centro Hospitalar Universitário de Lisboa Central
city: Barcelona
country: Spain
facility: Vall D'Hebron
city: Lausanne
country: Switzerland
facility: Lausanne University Hospital
state: Vaud
city: Basel
country: Switzerland
facility: University Hospital Basel
Study officials:
affiliation: Boston Medical Center, Neurology
name: Thanh N Nguyen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Heidelberg University Hospital, Neurology
name: Simon Nagel, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Herweh C, Abdalkader M, Nguyen TN, Puetz V, Schone D, Kaiser D, Chen CH, Jeng JS, Mohlenbruch MA, Ringleb PA, Nagel S. Mechanical Thrombectomy in Isolated Occlusion of the Proximal Posterior Cerebral Artery. Front Neurol. 2021 Jul 29;12:697348. doi: 10.3389/fneur.2021.697348. eCollection 2021.
citation: Berberich A, Finitsis S, Strambo D, Michel P, Herweh C, Meyer L, Hanning U, Strbian D, Abdalkader M, Nogueira RG, Puetz V, Kaiser DPO, Olive-Gadea M, Ribo M, Fragata I, Marto JP, Romoli M, Ringleb PA, Nguyen TN, Nagel S. Endovascular therapy versus no endovascular therapy in patients receiving best medical management for acute isolated occlusion of the posterior cerebral artery: A systematic review and meta-analysis. Eur J Neurol. 2022 Sep;29(9):2664-2673. doi: 10.1111/ene.15410. Epub 2022 Jun 17.
citation: Nguyen TN, Qureshi MM, Strambo D, Strbian D, Raty S, Herweh C, Abdalkader M, Olive-Gadea M, Ribo M, Psychogios M, Fischer U, Nguyen A, Kuramatsu JB, Haupenthal D, Kohrmann M, Deuschl C, Kuhne Escola J, Yaghi S, Shu L, Puetz V, Kaiser DPO, Kaesmacher J, Mujanovic A, Marterstock DC, Engelhorn T, Klein P, Haussen DC, Mohammaden MH, Abdelhamid H, Souza Viana L, Cunha B, Fragata I, Romoli M, Diana F, Virtanen P, Lappalainen K, Clark J, Matsoukas S, Fifi JT, Sheth SA, Salazar-Marioni S, Marto JP, Ramos JN, Miszczuk M, Riegler C, Jadhav AP, Desai SM, Maus V, Kaeder M, Siddiqui AH, Monteiro A, Masoud HE, Suryadevara N, Mokin M, Thanki S, Siegler JE, Khalife J, Linfante I, Dabus G, Asdaghi N, Saini V, Nolte CH, Siebert E, Meinel TR, Finitsis S, Mohlenbruch MA, Ringleb PA, Berberich A, Nogueira RG, Hanning U, Meyer L, Michel P, Nagel S. Endovascular Versus Medical Management of Posterior Cerebral Artery Occlusion Stroke: The PLATO Study. Stroke. 2023 Jul;54(7):1708-1717. doi: 10.1161/STROKEAHA.123.042674. Epub 2023 May 24.
citation: Strambo D, Michel P, Nguyen TN, Abdalkader M, Qureshi MM, Strbian D, Herweh C, Mohlenbruch MA, Raty S, Olive-Gadea M, Ribo M, Psychogios M, Fischer U, Nguyen A, Kuramatsu JB, Haupenthal D, Kohrmann M, Deuschl C, Kuhne Escola J, Demeestere J, Lemmens R, Vandewalle L, Yaghi S, Shu L, Puetz V, Kaiser DPO, Kaesmacher J, Mujanovic A, Marterstock DC, Engelhorn T, Requena M, Dasenbrock HH, Klein P, Haussen DC, Mohammaden MH, Abdelhamid H, Souza Viana L, Cunha B, Fragata I, Romoli M, Diana F, Hu W, Zhang C, Virtanen P, Lauha R, Jesser J, Clark J, Matsoukas S, Fifi JT, Sheth SA, Salazar-Marioni S, Marto JP, Ramos JN, Miszczuk M, Riegler C, Poli S, Poli K, Jadhav AP, Desai SM, Maus V, Kaeder M, Siddiqui AH, Monteiro A, Masoud HE, Suryadareva N, Mokin M, Thanki S, Alpay K, Ylikotila P, Siegler JE, Linfante I, Dabus G, Asdaghi N, Saini V, Nolte CH, Siebert E, Serrallach BL, Weyland CS, Hanning U, Meyer L, Berberich A, Ringleb PA, Nogueira RG, Nagel S. Endovascular Versus Medical Therapy in Posterior Cerebral Artery Stroke: Role of Baseline NIHSS Score and Occlusion Site. Stroke. 2024 Jul;55(7):1787-1797. doi: 10.1161/STROKEAHA.124.047383. Epub 2024 May 16.