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"Thrombectomy - mortality"
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Mechanical thrombectomy in nonagenarians with acute ischemic stroke
by
Papanagiotou, Panagiotis
,
Maus, Volker
,
Leischner, Hannes
in
Age Factors
,
Aged, 80 and over
,
Brain Ischemia - diagnosis
2019
BackgroundMechanical thrombectomy (MT) is a safe and effective therapy for ischemic stroke. Nevertheless, very elderly patients aged ≥90 years were either excluded or under-represented in previous trials. It remains uncertain whether MT is warranted for this population or whether there should be an upper age limit.MethodsWe retrospectively reviewed 79 patients with stroke aged ≥90 years from three neurointerventional centers who underwent MT between 2013 and 2017. Good functional outcome was defined as modified Rankin scale (mRS) ≤2 and assessed at 90-day follow-up. Successful recanalization was graded by Thrombolysis in Cerebral Infarction Scale (TICI) ≥2 b. Feasibility and safety assessments included unsuccessful recanalization attempts (TICI 0), time from groin puncture to recanalization, symptomatic intracranial hemorrhage (sICH), mortality, and intervention-related serious adverse events.ResultsOnly occlusions within the anterior circulation were included. Median time from groin puncture to recanalization was 39 min (IQR 25–57 min). The rate of successful recanalization (TICI ≥2 b) was 69.6% (55/79). Good functional outcome (mRS ≤2) at 90 days was observed in 16% (12/75) of patients. In-hospital mortality was 29.1% (23/79) and increased significantly at 90 days (46.7%, 35/75; p<0.001). sICH occurred in 5.1% (4/79) of patients. No independent predictor for good functional outcome (mRS ≤2) at 90 days was identified through logistic regression analysis.ConclusionMT in nonagenarians leads to high mortality rates and less frequently good functional outcome compared with younger patient cohorts in previous large randomized trials. However, MT appears to be safe and beneficial for a certain number of very elderly patients and therefore should generally not be withheld from nonagenarians.
Journal Article
Intra-arterial tenecteplase after successful endovascular therapy (ANGEL-TNK): protocol of a multicentre, open-label, blinded end-point, prospective, randomised trial
by
Miao, Zhongrong
,
Liebeskind, David S
,
Luo, Gang
in
Anticoagulants
,
Blood pressure
,
Carotid arteries
2025
BackgroundDespite successful reperfusion after thrombectomy for large vessel occlusion (LVO) stroke, up to half of patients are dependent or dead at 3-month follow-up.The aim of the current study is to demonstrate safety and efficacy of administering adjunct intra-arterial (IA) tenecteplase in anterior circulation LVO patients who have achieved successful reperfusion defined as eTICI 2b50 to 3.MethodsANGEL-TNK is a multicentre, open-label, assessor-blinded endpoint, prospective randomised, controlled trial that will enrol up to 256 patients. Patients who meet inclusion criteria with anterior circulation LVO stroke and successful reperfusion will be randomised to receive IA tenecteplase or best medical management at 1:1 ratio.ResultsThe primary endpoint is a 90-day excellent outcome defined as modified Rankin Scale (mRS) 0–1. The primary safety endpoint is symptomatic intracranial haemorrhage within 48 hours from randomisation. Secondary endpoints include 90-day ordinal mRS, mRS 0–2, mRS 0–3, all-cause mortality and any intracranial haemorrhage.ConclusionIn patients with anterior circulation LVO stroke, the ANGEL-TNK trial will inform whether adjunct IA tenecteplase administered after successful thrombectomy reperfusion improves patient outcomes.Trial registration number NCT05624190.
Journal Article
IRIS, a randomised, double-blind, placebo-controlled trial of interleukin-6 receptor inhibition undergoing endovascular treatment in acute anterior circulation ischaemic stroke: study rationale and design
by
Wu, Chuanjie
,
Ji, Xunming
,
Zhou, Chen
in
Aged
,
Antibodies, Monoclonal, Humanized - adverse effects
,
Antibodies, Monoclonal, Humanized - therapeutic use
2025
RationaleNeuroprotective strategies based on reperfusion therapy hold substantial promise for acute ischaemic stroke (AIS). Preclinical research indicates that tocilizumab, an interleukin-6 receptor antagonist, can attenuate ischaemia-reperfusion damage by exerting anti-inflammatory and neuroprotective effects.AimTo determine tocilizumab’s efficacy and safety when combined with endovascular thrombectomy (EVT) in patients with acute anterior circulation large vessel occlusion (LVO).Sample size estimatesTo determine a 30% decrease in average infarct core volume comparing the intervention and historical control groups (mean increase of 18.7 mL (SD=9.7 mL) post-thrombectomy) via a two-sided test (alpha=0.05, power=80%), accounting for a 10% drop-out rate, we plan to recruit 108 participants.Methods and designThis trial is designed as a randomised, multicentre, double-blind, placebo-controlled trial. Patients will be randomly and evenly allocated to the tocilizumab or placebo groups.Study outcomesThe primary endpoint is the change in infarct core volume between baseline and 72 hours post-treatment. Secondary outcomes include the 90-day modified Rankin scale score (0–2, indicating functional independence). The key safety endpoints include 90-day mortality and symptomatic intracerebral haemorrhage within 72 hours after EVT.DiscussionAdministering tocilizumab within 24 hours of stroke as an adjunct to EVT may effectively reduce the infarct core volume for patients experiencing AIS with anterior circulation LVO, potentially improving functional outcomes in these patients.
Journal Article
Effectiveness and safety of bridging therapy and endovascular therapy in patients with large cerebral infarctions: from ANGEL-ASPECT
2025
Background and purposeThe benefits of thrombolytic therapy before endovascular thrombectomy in cases of acute ischaemic stroke, with a large infarction volume, remain unclear. This analysis aims to evaluate the effectiveness and safety of bridging therapy and endovascular therapy among patients with large cerebral infarctions.MethodsIn this post-hoc analysis of the multicentre prospective study of ANGEL-ASPECT (Acute Anterior Circulation Large Vessel Occlusive Patients with a Large Infarct Core), participants were divided into two groups: an endovascular therapy group and a bridging therapy group. The primary outcome was the modified Rankin Scale (mRS) score at 90 days. The primary safety outcome was symptomatic intracranial haemorrhage. Ordinal logistic regression was performed to compare the primary endpoint between the two groups. Subgroup analyses were conducted to further explore potential risk factors associated with the outcomes.Results122 patients were included, of whom 77 (63%) underwent endovascular therapy and 45 (37%) underwent bridging therapy. The median scores on mRS at 90 days of the bridging therapy group and the endovascular therapy group were 3 (2–5) and 4 (2–6), with no significant differences (common OR 1.36; 95% CI 0.71 to 2.61). Symptomatic intracranial haemorrhage was reported in three patients who were in the endovascular and bridging therapy groups (relative risk (RR) 1.71; 95% CI 0.36 to 8.12). The mortality between two groups did not differ (RR 0.75; 95% CI 0.37 to 1.54).ConclusionsOur study indicated that endovascular therapy alone might be a viable option for patients with large cerebral infarctions, displaying no noticeable disparity in outcomes compared with bridging therapy.
Journal Article
Two-year clinical follow-up of the Multicenter Randomized Clinical Trial of Endovascular Treatment for Acute Ischemic Stroke in The Netherlands (MR CLEAN): design and statistical analysis plan of the extended follow-up study
by
Dijkgraaf, Marcel G. W.
,
Majoie, Charles B. M.
,
Roos, Yvo B. W. E. M.
in
Aged
,
Aged, 80 and over
,
Biomedicine
2016
Background
MR CLEAN was the first randomized trial to demonstrate the short-term clinical effectiveness of endovascular treatment in patients with acute ischemic stroke caused by large vessel occlusion in the anterior circulation. Several other trials confirmed that endovascular treatment improves clinical outcome at three months. However, limited data are available on long-term clinical outcome. We aimed to estimate the effect of endovascular treatment on functional outcome at two-year follow-up in patients with acute ischemic stroke. Secondly, we aimed to assess the effect of endovascular treatment on major vascular events and mortality during two years of follow-up.
Methods
MR CLEAN is a multicenter clinical trial with randomized treatment allocation, open-label treatment, and blinded endpoint evaluation. Patients included were 18 years or older with acute ischemic stroke caused by a proven anterior proximal artery occlusion who could be treated within six hours after stroke onset. The intervention contrast was endovascular treatment and usual care versus no endovascular treatment and usual care. The current study extended the follow-up duration from three months to two years.
The primary outcome is the score on the modified Rankin scale at two years. Secondary outcomes include all-cause mortality and the occurrence of major vascular events within two years of follow-up.
Discussion
The results of our study provide information on the long-term clinical effectiveness of endovascular treatment, which may have implications for individual treatment decisions and estimates of cost-effectiveness.
Trial registration
NTR1804
. Registered on 7 May 2009;
ISRCTN10888758
. Registered on 24 July 2012 (main MR CLEAN trial);
NTR5073
. Registered on 26 February 2015 (extended follow-up study).
Journal Article
Aspiration thrombectomy and intracoronary tirofiban in ST-segment elevation myocardial infarction
by
Song, Z.-Y.
,
Dai, S.-P.
,
Geng, T.
in
Cardiology
,
China - epidemiology
,
Combined Modality Therapy - mortality
2016
Aim
Primary percutaneous coronary intervention is the most effective treatment for patients with ST-segment elevation myocardial infarction (STEMI). This study aimed to investigate whether the combination of aspiration thrombectomy with intracoronary tirofiban treatment can result in smaller infarcts and better patient prognosis compared with aspiration thrombectomy alone.
Patients and methods
In all, 150 patients with STEMI underwent primary percutaneous coronary intervention. Group A received aspiration thrombectomy and group B received a combination treatment of aspiration thrombectomy with intracoronary tirofiban. The endpoint was major adverse cardiovascular events, including myocardial (re)infarction, cardiovascular death, and target vessel revascularization.
Results
The clinical characteristics of the groups were not significantly different (
p >
0.05). The percentage of patients whose thrombolysis in myocardial infarction (TIMI) myocardial perfusion grades were less than 3 was significantly higher for group B than for group A (13.9 vs. 3.8 %,
p
= 0.029). The infarct size on cardiac magnetic resonance imaging was significantly different between groups (
p
= 0.036). At 6 months after the operation, the echocardiography results were better for patients in group B than for those in group A (
p
= 0.024 and
p
= 0.016, respectively). The frequency of bleeding complications and major adverse cardiac events of the groups were not significantly different (
p >
0.05).
Conclusion
Aspiration thrombectomy with intracoronary tirofiban in patients with STEMI is safe and effective. For cases with a large angiographic thrombus burden, tirofiban did not increase the rate of bleeding complications or major adverse cardiovascular events.
Journal Article
Rapid learning curve for Solitaire FR stent retriever therapy: evidence from roll-in and randomised patients in the SWIFT trial
by
Levy, Elad I
,
Budzik, Ronald
,
Jahan, Reza
in
Aged
,
Aged, 80 and over
,
Brain Ischemia - diagnosis
2016
BackgroundIn light of recent positive trial data for endovascular therapy in acute ischemic stroke (AIS), stent retriever use by practitioners without prior experience with these devices may become more common.ObjectiveTo assess the safety and efficacy of thrombectomy for AIS using Solitaire for patients treated in the roll-in period of the Solitaire With the Intention For Thrombectomy (SWIFT) trial, which represented the first clinical use of the device for these interventionalists.MethodsProspectively collected demographic, clinical, and angiographic data on patients treated in the initial roll-in and subsequent randomized phases of the SWIFT study were collected and analyzed. Key statistical analyses were validated by an independent external statistician.ResultsPatients in the roll-in period achieved equivalently high rates of reperfusion (55%) compared with those treated with the device in the randomized phase (61%). Rates of adverse events were comparable (13% vs 9%). Rates of good neurological outcome were equivalent between the roll-in and randomized patients treated with Solitaire (63% vs 58%). Including the roll-in patients strengthened the conclusions of the study, that reperfusion rates without symptomatic hemorrhage with Solitaire were greater than with Merci (59% vs 24%, p<0.001).ConclusionsThrombectomy in AIS using the Solitaire stent retriever device can be performed safely and effectively when used by experienced neurointerventionalists without previous experience with the device.Trial registration numberThe SWIFT study is registered with ClinicalTrials.gov, number NCT 01054560.
Journal Article
Thrombus Aspiration in ThrOmbus containing culpRiT lesions in Non-ST-Elevation Myocardial Infarction (TATORT-NSTEMI): study protocol for a randomized controlled trial
by
Eitel, Ingo
,
Scheller, Bruno
,
Pfeiffer, Dietrich
in
Biomedicine
,
Care and treatment
,
Clinical Protocols
2013
Background
Current guidelines recommend thrombus aspiration in patients with ST-elevation myocardial infarction (STEMI); however, there are insufficient data to unequivocally support thrombectomy in patients with non-STEMI (NSTEMI).
Methods/Design
The TATORT-NSTEMI (Thrombus Aspiration in ThrOmbus containing culpRiT lesions in Non-ST-Elevation Myocardial Infarction) trial is a prospective, controlled, multicenter, randomized, open-label trial enrolling 460 patients. The hypothesis is that, against a background of early revascularization, adjunctive thrombectomy leads to less microvascular obstruction (MO) compared with conventional percutaneous coronary intervention (PCI) alone, as assessed by cardiac magnetic resonance imaging (CMR) in patients with NSTEMI. Patients will be randomized in a 1:1 fashion to one of the two treatment arms. The primary endpoint is the extent of late MO assessed by CMR. Secondary endpoints include early MO, infarct size, and myocardial salvage assessed by CMR as well as enzymatic infarct size and angiographic parameters, such as thrombolysis in myocardial infarction flow post-PCI and myocardial blush grade. Furthermore, clinical endpoints including death, myocardial re-infarction, target vessel revascularization, and new congestive heart failure will be recorded at 6 and 12 months. Safety will be assessed by the incidence of bleeding and stroke.
Summary
The TATORT-NSTEMI trial has been designed to test the hypothesis that thrombectomy will improve myocardial perfusion in patients with NSTEMI and relevant thrombus burden in the culprit vessel reperfused by early PCI.
Trial registration
The trial is registered under
http://www.clinicaltrials.gov
:
NCT01612312
.
Journal Article
Systematic review and meta-analysis of current rates of first pass effect by thrombectomy technique and associations with clinical outcomes
by
Abbasi, Mehdi
,
Kadirvel, Ramanathan
,
Fitzgerald, Seán
in
Aged
,
Bias
,
Brain Ischemia - diagnostic imaging
2021
BackgroundFirst pass effect (FPE) in mechanical thrombectomy is thought to be associated with good clinical outcomes.ObjectiveTo determine FPE rates as a function of thrombectomy technique and to compare clinical outcomes between patients with and without FPE.MethodsIn July 2020, a literature search on FPE (defined as modified Thrombolysis in Cerebral Infarction (TICI) 2c–3 after a single pass) and modified FPE (mFPE, defined as TICI 2b–3 after a single pass) and mechanical thrombectomy for stroke was performed. Using a random-effects meta-analysis, we evaluated the following outcomes for both FPE and mFPE: overall rates, rates by thrombectomy technique, rates of good neurologic outcome (modified Rankin Scale score ≤2 at day 90), mortality, and symptomatic intracerebral hemorrhage (sICH) rate.ResultsSixty-seven studies comprising 16 870 patients were included. Overall rates of FPE and mFPE were 28% and 45%, respectively. Thrombectomy techniques shared similar FPE (p=0.17) and mFPE (p=0.20) rates. Higher odds of good neurologic outcome were found when we compared FPE with non-FPE (56% vs 41%, OR=1.78) and mFPE with non-mFPE (57% vs 44%, OR=1.73). FPE had a lower mortality rate (17% vs 25%, OR=0.62) than non-FPE. FPE and mFPE were not associated with lower sICH rate compared with non-FPE and non-mFPE (4% vs 18%, OR=0.41 for FPE; 5% vs 7%, OR=0.98 for mFPE).ConclusionsOur findings suggest that approximately one-third of patients achieve FPE and around half of patients achieve mFPE, with equivalent results throughout thrombectomy techniques. FPE and mFPE are associated with better clinical outcomes.
Journal Article
Outcomes of stent retriever thrombectomy in basilar artery occlusion: an observational study and systematic review
by
Eldesouky, Islam
,
Rabilloud, Murielle
,
Sivan-Hoffmann, Rotem
in
Humans
,
Life Sciences
,
Retrospective Studies
2016
BackgroundBasilar artery occlusion (BAO) remains one of the most devastating subtypes of stroke with high mortality and poor outcome. Early recanalisation is the most powerful predictor of favourable outcome in patients with stroke, and may be improved with mechanical thrombectomy using stent retriever devices. However, the benefit in functional outcome and safety of stent retrievers are not yet well known. The aim of this study was to assess efficacy and safety profiles of stent retriever thrombectomy in BAO patients with stroke.MethodsWe analysed data retrospectively from our consecutive clinical series and conducted a systematic review and meta-analysis of all previous studies of stent retriever thrombectomy in BAO patients with stroke between November 2010 and April 2014.ResultsFrom March 2010 to March 2013, 22 patients with acute BAO were treated with a Solitaire stent retriever in our series. Favourable outcome was significantly associated with younger age and distal BAO. The literature search identified 15 previous studies involving a total of 312 subjects. In the meta-analysis, including our series data, the recanalisation rate (Thrombolysis In Cerebral Infarction (TICI) score ≥2b) reached 81% (95% CI 73% to 87%). The rate of symptomatic intracranial haemorrhage was 4% (95% CI 2% to 8%), favourable outcome (modified Rankin Scale (mRS) ≤2 at 3 months) was found in 42% (95% CI 36% to 48%) and mortality rate was 30% (95% CI 25% to 36%).ConclusionsStent retriever thrombectomy is a safe treatment modality for patients with stroke presenting with BAO. Although the stent retrievers showed a good recanalisation rate, there are currently no randomised clinical trials to assess its clinical efficacy in comparison with the reference treatment.
Journal Article