Clinical trial NCT06953427: The Impact of Age on Short-term Post-thrombectomy Outcomes in Patients Aged 70 or Beyond With Acute Ischemic Stroke
Official title: The Impact of Age on Short-term Post-thrombectomy Outcomes in Patients Aged 70 or Beyond With Acute Ischemic Stroke
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Cerebral Ischemia
Endovascular Thrombectomy
Prognosis
Age Factors
Interventional Radiology
Elderly (Aged &gt;70)
Lead sponsor: Kuang Tien General Hospital
Sponsor class: OTHER
First posted: 2025-05-01
Enrollment: 94
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Single-center cohort of patients aged ≥70 years with AIS who underwent EVT at Kuang Tien General Hospital, Taichung, Taiwan.

Brief summary: A recent Cochrane systematic review of 18 randomized controlled trials (RCTs) comparing endovascular intervention-either mechanical thrombectomy or intra-arterial thrombolysis combined with medical treatment-to conservative medical treatment alone provided high-certainty evidence that endovascular intervention increases the likelihood of achieving a favorable functional outcome (modified Rankin Scale \[mRS\] score of 0-2) by 50% in patients with acute ischemic stroke (AIS).1 More recently, a cross-Atlantic RCT was conducted to determine whether endovascular therapy (EVT) plus medical care is superior to medical care alone in patients with acute proximal cerebral vessel occlusion in the anterior circulation and large infarcts, regardless of infarct size. The study confirmed a 63% increased odds of a favorable outcome with EVT plus medical care. In real-world registries of EVT for AIS due to large-vessel occlusion in the anterior circulation, approximately one-half of patients are aged 70 and older, while 13% to 39% are aged 80 and beyond. In patients aged 70 and beyond who are EVT-eligible, post-procedure mortality increases progressively with increasing age. A prospective European study found that each additional year of age was associated with an 8% decline in the likelihood of achieving a favorable functional outcome. In elderly patients, increasing age is more than just a number-it reflects a higher likelihood of significant medical comorbidities, polypharmacy, declining functional status, compromised nutritional status, and weakened immune function. Research on age as a predictor of EVT outcomes often compares elderly patients to much younger counterparts. However, contrasting post-EVT outcomes in older adults with those under 70 is neither realistic nor appropriate due to inherent differences in baseline health, comorbidities, and physiological resilience. Therefore, the investigators analyzed a prospectively registered cohort to assess whether age influences post-EVT functional outcomes, using septuagenarians as the control group.

Detailed description: This is a retrospective, single-center cohort study evaluating patients aged ≥70 years with AIS who underwent EVT at Kuang Tien General Hospital, Taichung, Taiwan. A registry has been established by the Department of Interventional Neuroradiology under the supervision by Dr. Pao-Sheng Yen. for patients who The stroke center is nationally accredited for its capability to evaluate and perform EVT for acute ischemic stroke emergencies. The study was approved by the Institutional Review Board (IRB) with an approval certificate numbered KTGH-11415, and informed consent was waived due to the retrospective nature of the study.

Eligibility criteria: Inclusion Criteria:

* Age ≥70 years
* Acute Ischemic Stroke due to large-vessel occlusion (LVO) confirmed by CT angiography or MR angiography
* underwent EVT within the standard treatment window
* available 3-month modified Rankin Scale (mRS) scores.

Exclusion Criteria:

* Premorbid mRS score \>2
* Poor imaging quality precluding assessment
* Lack of follow-up data.

Primary outcomes:
measure: Post-endovascular thrombectomy modified Thrombolysis in Cerebral Infarction (mTICI) reperfusion grade
timeFrame: Immediate post-thrombectomy
measure: Three-months post-EVT modified Rankin scale (mRS)
timeFrame: 3-months post-EVT
Secondary outcomes:
measure: Spontaneous intracerebral hemorrhage
timeFrame: Day 2 to Day 90 post-EVT
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Department of Interventional Neuro-Radiology, Kuang Tien General Hospital
Study officials:
affiliation: Kuang Tien General Hospital
name: Pao-Sheng Yen, MD
role: STUDY_DIRECTOR
References:
citation: 1. Roaldsen MB, Jusufovic M, Berge E, Lindekleiv H. Endovascular thrombectomy and intra-arterial interventions for acute ischaemic stroke. Cochrane Database Syst Rev. 2021 Jun 14;6(6):Cd007574. 2. Costalat V, Jovin TG, Albucher JF, et al. Trial of Thrombectomy for Stroke with a Large Infarct of Unrestricted Size. N Engl J Med. 2024 May 9;390(18):1677-89. 3. Zerna C, Rogers E, Rabi DM, et al. Comparative Effectiveness of Endovascular Treatment for Acute Ischemic Stroke: A Population-Based Analysis. J Am Heart Assoc. 2020 Apr 7;9(7):e014541. 4. Adcock AK, Schwamm LH, Smith EE, et al. Trends in Use, Outcomes, and Disparities in Endovascular Thrombectomy in US Patients With Stroke Aged 80 Years and Older Compared With Younger Patients. JAMA Netw Open. 2022 Jun 1;5(6):e2215869. 5. Enriquez BAB, Halling HK, Lund CG, et al. Exploring the Impact of Age and Pre-Stroke Modified Rankin Scale in Elderly Thrombectomy: A 15-Year Single-Center Experience. Cerebrovasc Dis Extra. 2024;14(1):125-33. 6. Groot AE, Treurniet KM, Jansen IGH, et al. Endovascular treatment in older adults with acute ischemic stroke in the MR CLEAN Registry. Neurology. 2020 Jul 14;95(2):e131-e9. 7. Zhai G, Song J, Yu N, et al. Predictors of Mechanical Thrombectomy for Anterior Circulation Emergent Large-Vessel Occlusion in the Older Adults. Clin Appl Thromb Hemost. 2023 Jan-Dec;29:10760296231184219. 8. Inoue M, Ota T, Hara T, et al. An Initial High National Institutes of Health Stroke Scale Score and Any Intracranial Hemorrhage Are Independent Factors for a Poor Outcome in Nonagenarians Treated with Thrombectomy for Acute Large Vessel Occlusion: The Tokyo/Tama-REgistry of Acute Endovascular Thrombectomy (TREAT) Study. World Neurosurg. 2022 Sep;165:e325-e30. 9. Ippen FM, Schregel K, Ungerer M, Feisst M, Ringleb PA, Gumbinger CK. Outcomes in elderly patients undergoing endovascular thrombectomy in association with premorbid Rankin Scale scores. Front Neurol. 2024;15:1418415. 10. Yen PS, Kok VC, Lin YH, Wu YT,