scholarly journals Factors associated with early reperfusion improvement after intra-arterial fibrinolytics as rescue for mechanical thrombectomy

2021 ◽  
Vol 5 (1) ◽  
pp. 2514183X2110173
Author(s):  
Johannes Kaesmacher ◽  
Giovanni Peschi ◽  
Nuran Abdullayev ◽  
Basel Maamari ◽  
Tomas Dobrocky ◽  
...  

Objective: To identify factors associated with early angiographic reperfusion improvement (EARI) following intra-arterial fibrinolytics (IAF) after failed or incomplete mechanical thrombectomy (MT). Methods: A subset of patients treated with MT and IAF rescue after incomplete reperfusion included in the INFINITY (INtra-arterial FIbriNolytics In ThrombectomY) multicenter observational registry was analyzed. Multivariable logistic regression was used to identify factors associated with EARI. Heterogeneity of the clinical effect of EARI on functional independence (defined as modified Rankin Score ≤2) was tested with interaction terms. Results: A total of 228 patients (median age: 72 years, 44.1% female) received IAF as rescue for failed or incomplete MT and had a post-fibrinolytic angiographic control run available (50.9% EARI). A cardioembolic stroke origin (adjusted odds ratio (aOR) 3.72, 95% confidence interval (CI) 1.39–10.0) and shorter groin puncture to IAF intervals (aOR 0.82, 95% CI 0.71–0.95 per 15-min delay) were associated with EARI, while pre-interventional thrombolysis showed no association (aOR 1.15, 95% CI 0.59–2.26). The clinical benefit of EARI after IAF seemed more pronounced in patients without or only minor early ischemic changes (Alberta Stroke Program Early Computed Tomography Score (ASPECTS) ≥9, aOR 4.00, 95% CI 1.37–11.61) and was absent in patients with moderate to severe ischemic changes (ASPECTS ≤8, aOR 0.94, 95% CI 0.27–3.27, p for interaction: 0.095). Conclusion: Early rescue and a cardioembolic stroke origin were associated with more frequent EARI after IAF. The clinical effect of EARI seemed reduced in patients with already established infarcts. If confirmed, these findings can help to inform patient selection and inclusion criteria for randomized-controlled trials evaluating IAF as rescue after MT.

Stroke ◽  
2021 ◽  
Vol 52 (Suppl_1) ◽  
Author(s):  
Zachary Hubbard ◽  
Guilherme B Porto ◽  
Sami Al Kasab ◽  
Eyad Almallouhi ◽  
Alejandro M Spiotta ◽  
...  

Introduction: Patients with poor baseline images were excluded from most clinical trials so the data about whether these patients could benefit from MT remains unknown. In this study, we aim to investigate the safety and efficacy of MT in patients with large vessel occlusion (LVO) and large core infarct (LCI). Methods: The Stroke Thrombectomy and Aneurysm Registry (STAR) was interrogated. We included thrombectomy patients presenting with LVO within 24 hours and with a LCI as defined by Alberta Stroke Program Early CT Score (ASPECTS) < 6. Patients presenting within 6 hours of last known normal (LKN) were considered in the early window and patients presenting after 6 hours were considered in the late window. 90-day outcomes were assessed. We used a logistic regression model to assess the factors associated with good 90-day outcome in patients in the early and late windows. Results: 144 patients were included in this study (table). Median age was 69 and 92 (64%) patients were treated in the early MT window. ICA was the most common site of occlusion (48.6%) and ADAPT was used in 34.7%. Admission NIHSS was 17.5. Successful recanalization (TICI>2b) was achieved in 84.7% and median procedure time was 54 minutes. sICH hemorrhage was observed in 22 (15.3%). Median mRS was 4 at 90 days. Favorable outcome was observed in 41 patients (28.5%) and mortality occurred in in 59 (41%). There was no difference in 90-day functional outcome between patients in early and late windows. In patients presenting in the early window, age (aOR=0.905, p=0.0002) and baseline NIHSS (aOR=0.909, p=0.0423) were independently associated with 90-day outcome. In patients presenting in the late window, only age (aOR=0.934, p=0.0069) was independently associated with good outcome. Conclusion: More than one in four patients presenting with ASPECTS<6 may achieve functional independence at 90-day following MT. Patient age remains the main predictor of 90-day outcome in patients with low ASPECTS in both late and early windows.


Stroke ◽  
2017 ◽  
Vol 48 (suppl_1) ◽  
Author(s):  
Adnan Siddiqui ◽  
Donald Frei ◽  
Albert J Yoo ◽  
Ghita Soulimani ◽  
Hope Buell ◽  
...  

Introduction: A recent meta-analysis of four randomized controlled trials (RCTs) concluded that mechanical thrombectomy using Solitaire for large vessel ischemic stroke was effective with significantly reduced disability. Hypothesis: Our hypothesis was that treatment with the Penumbra Aspiration System and the novel 3D Stent Retriever would demonstrate similar angiographic and functional outcomes compared to use of Solitaire. Methods: The 3D trial was a RCT to compare the safety and effectiveness of the 3D Stent Retriever when used with the Penumbra Aspiration System (3D/PS) compared to the PS alone. Inclusion criteria for the 3D RCT included presentation with NIH Stroke Scale ≥ 8 and refractory to or not eligible for IV rtPA. Analysis compared reperfusion to mTICI 2b or 3 and functional independence (mRS 0-2 at 90 days) in a 3D Trial cohort with ASPECTS 8-10 vs the meta-analysis data reported by Campbell et al ( Stroke 2016). Results: One hundred four (104) of 198 patients met analysis criteria. Baseline ASPECTS (median [IQR]) were similar between the 3D Trial ASPECTS 8-10 cohort (3D/PS, PS, combined: 9 [8,10]) and Campbell group (9 [7,10]). Substantial reperfusion (mTICI 2b or 3) was experienced in 84.6% (44/52) of 3D/PS and 75.0% (39/52) of PS alone cases, similar to the Campbell group (76.6%). When both arms were pooled, results (79.8%) were also similar to Campbell. With regards to functional independence, both 3D cohorts and pooled trial results showed similar rates compared with Campbell (Figure). Conclusions: The novel 3D Stent Retriever + Penumbra System and the Penumbra Aspiration System alone showed similar reperfusion and functional outcomes compared to Solitaire.


Author(s):  
Yousif Eliya ◽  
Sera Whitelaw ◽  
Lehana Thabane ◽  
Adriaan A. Voors ◽  
Pamela S. Douglas ◽  
...  

Background: Trial steering committees (TSCs) steer the conduct of randomized controlled trials (RCTs). We examined the gender composition of TSCs in impactful heart failure RCTs and explored whether trial leadership by a woman was independently associated with the inclusion of women in TSCs. Methods: We systematically searched MEDLINE, EMBASE, and CINAHL for heart failure RCTs published in journals with impact factor ≥10 between January 2000 and May 2019. We used the Jonckheere-Terpstra test to assess temporal trends and multivariable logistic regression to explore trial characteristics associated with TSC inclusion of women. Results: Of 403 RCTs that met inclusion criteria, 127 (31.5%) reported having a TSC but 20 of these (15.7%) did not identify members. Among 107 TSCs that listed members, 56 (52.3%) included women and 6 of these (10.7%) restricted women members to the RCT leaders. Of 1213 TSC members, 11.1% (95% CI, 9.4%–13.0%) were women, with no change in temporal trends ( P =0.55). Women had greater odds of TSC inclusion in RCTs led by women (adjusted odds ratio, 2.48 [95% CI, 1.05–8.72], P =0.042); this association was nonsignificant when analysis excluded TSCs that restricted women to the RCT leaders (adjusted odds ratio 1.46 [95% CI, 0.43–4.91], P =0.36). Conclusions: Women were included in 52.3% of TSCs and represented 11.1% of TSC members in 107 heart failure RCTs, with no change in trends since 2000. RCTs led by women had higher adjusted odds of including women in TSCs, partly due to the self-inclusion of RCT leaders in TSCs.


Pharmaceutics ◽  
2020 ◽  
Vol 12 (11) ◽  
pp. 1113
Author(s):  
Seung-Yeon Jeong ◽  
Jung-Hwan Park ◽  
Ye-Seul Lee ◽  
Youn-Sub Kim ◽  
Ji-Yeun Park ◽  
...  

In recent years, a number of clinical trials have been published on the efficacy and safety of drug delivery using microneedles (MNs). This review aims to systematically summarize and analyze the current evidence including the clinical effect and safety of MNs. Three electronic databases, including PubMed, were used to search the literature for randomized controlled trials (RCTs) and clinical controlled trials (CCTs) that evaluated the therapeutic efficacy of MNs from their inception to 28 June 2018. Data were extracted according to the characteristics of study subjects; disorder, types, and details of the intervention (MNs) and control groups; outcome measurements; effectiveness; and incidence of adverse events (AEs). Overall, 31 RCTs and seven CCTs met the inclusion criteria. Although MNs were commonly used in skin-related studies, evaluating the effects of MNs was difficult because many studies did not provide adequate comparison values between groups. For osteoporosis treatment, vaccine, and insulin delivery studies, MNs were comparable to or more effective than the gold standard. Regarding the safety of MNs, most AEs reported in each study were minor (grade 1 or 2). A well-designed RCT is necessary to clearly evaluate the effectiveness of MNs in the future.


2009 ◽  
Vol 27 (24) ◽  
pp. 3938-3944 ◽  
Author(s):  
Christopher M. Booth ◽  
Aurélie Le Maître ◽  
Keyue Ding ◽  
Kristen Farn ◽  
Michael Fralick ◽  
...  

Purpose To assess the frequency, implications, and factors associated with reporting nonfinal analyses (NFAs) of randomized controlled trials (RCTs) as abstract publications. Methods We identified 138 consecutive reports of RCTs testing systemic therapy for lymphoma, breast, colorectal, or non–small-cell lung cancer published in six major journals between 2000 and 2004. We then searched proceedings of seven major cancer meetings, 1990 to 2004, for abstracts related to these publications which presented efficacy results. Articles and abstracts were compared for discordance in sample size, median follow-up, results, and conclusions. Abstracts were evaluated for statements explicitly noting or implying that results were not final. Factors associated with discordance were assessed by uni- and multivariate analyses. Results We identified 303 related abstracts; 197 were eligible. In 86 abstracts (44%), results were stated or implied to be NFA; this was explicitly stated in 41 (21%). The NFAs included 12 where accrual was ongoing. Discordance with article was found in 124 abstracts (63%) and was more common with NFAs (67 of 86 [78%] v 57 of 111 [51%]; P = .0001). When compared with articles, authors' conclusions were substantively different in 17 abstracts (10%). Factors most associated with data discordance were lymphoma trial (odds ratio [OR], 3.8; 95% CI, 1.5 to 10.8), cooperative group trial (OR, 2.8; 95% CI, 1.4 to 5.6), and presentation of a NFA (OR, 2.9; 95% CI, 1.5 to 5.8). Conclusion Meeting abstracts often include NFAs and are frequently discordant with subsequent article publication.


Stroke ◽  
2021 ◽  
Author(s):  
Johannes Kaesmacher ◽  
Mirjam Kaesmacher ◽  
Maria Berndt ◽  
Christian Maegerlein ◽  
Sebastian Mönch ◽  
...  

Background and Purpose: Proximal middle cerebral artery (MCA) occlusions impede blood flow to the noncollateralized lenticulostriate artery territory. Previous work has shown that this almost inevitably leads to infarction of the dependent gray matter territories in the striate even if perfusion is restored by mechanical thrombectomy. Purpose of this analysis was to evaluate potential sparing of neighboring fiber tracts, ie, the internal capsule. Methods: An observational single-center study of patients with proximal MCA occlusions treated with mechanical thrombectomy and receiving postinterventional high-resolution diffusion-weighted imaging was conducted. Patients were classified according to internal capsule ischemia (IC+ versus IC−) at the postero-superior level of the MCA lenticulostriate artery territory (corticospinal tract correlate). Associations of IC+ versus IC− with baseline variables as well as its clinical impact were evaluated using multivariable logistic or linear regression analyses adjusting for potential confounders. Results: Of 92 included patients with proximal MCA territory infarctions, 45 (48.9%) had an IC+ pattern. Longer time from symptom-onset to groin-puncture (adjusted odds ratio, 2.12 [95% CI, 1.19–3.76] per hour), female sex and more severe strokes were associated with IC+. Patients with IC+ had lower rates of substantial neurological improvement and functional independence (adjusted odds ratio, 0.26 [95% CI, 0.09–0.81] and adjusted odds ratio, 0.25 [95% CI, 0.07–0.86]) after adjustment for confounders. These associations remained unchanged when confining analyses to patients without ischemia in the corona radiata or the motor cortex and here, IC+ was associated with higher National Institutes of Health Stroke Scale motor item scores (β, +2.8 [95% CI, 1.5 to 4.1]) without a significant increase in nonmotor items (β, +0.8 [95% CI, −0.2 to 1.9). Conclusions: Rapid mechanical thrombectomy with successful reperfusion of the lenticulostriate arteries often protects the internal capsule from subsequent ischemia despite early basal ganglia damage. Salvage of this eloquent white matter tract within the MCA lenticulostriate artery territory seems strongly time-dependent, which has clinical and pathophysiological implications.


Medicina ◽  
2020 ◽  
Vol 56 (7) ◽  
pp. 353
Author(s):  
Taek Min Nam ◽  
Ji Hwan Jang ◽  
Young Zoon Kim ◽  
Kyu Hong Kim ◽  
Seung Hwan Kim

Background and objective: Procedural thromboembolisms after mechanical thrombectomy (MT) for acute ischemic stroke has rarely been studied. We retrospectively evaluated factors associated with procedural thromboembolisms after MT using diffusion-weight imaging (DWI) within 2 days of MT. Materials and Methods: From January 2018 to March 2020, 78 patients with acute ischemic stroke who underwent MT were evaluated using DWI. Procedural thromboembolisms were defined as new cerebral infarctions in other territories from the occluded artery on DWI after MT. Results: Procedural thromboembolisms were observed on DWI in 16 patients (20.5%). Procedural thromboembolisms were associated with old age (73.8 ± 8.18 vs. 66.8 ± 11.2 years, p = 0.021), intravenous (IV) thrombolysis (12 out of 16 (75.0%) vs. 25 out of 62 (40.3%), p = 0.023), heparinization (4 out of 16 (25.0%) vs. 37 out of 62 (59.7%), p = 0.023), and longer procedural time (90.9 ± 35.6 vs. 64.4 ± 33.0 min, p = 0.006). Multivariable logistic regression analysis revealed that procedural thromboembolisms were independently associated with procedural time (adjusted odds ratio (OR); 1.020, 95% confidence interval (CI); 1.002–1.039, p = 0.030) and IV thrombolysis (adjusted OR; 4.697, 95% CI; 1.223–18.042, p = 0.024). The cutoff value of procedural time for predicting procedural thromboembolisms was ≥71 min (area under the curve; 0.711, 95% CI; 0.570–0.851, p = 0.010). Conclusions: Procedural thromboembolisms after MT for acute ischemic stroke are significantly associated with longer procedural time and IV thrombolysis. This study suggests that patients with IV thrombolysis and longer procedural time (≥71 min) are at a higher risk of procedural thromboembolisms after MT for acute ischemic stroke.


Circulation ◽  
2015 ◽  
Vol 132 (suppl_3) ◽  
Author(s):  
Aaqib H Malik ◽  
Yasir Akram ◽  
Senada S Malik

Introduction: Congestive heart failure (CHF) is associated with significant morbidity and mortality. Angiotensin-converting enzyme (ACE) inhibitors and angiotensin receptor blockers (ARBs) are proven to be beneficial for improved survival and better quality of life in Heart failure patients. Optimal dosing of these agents presents a challenging question till date and controversy still surrounds whether similar health benefits can be achieved through lower dosages of ACE inhibitors and ARBs. Our aim was to determine whether there is a significant mortality benefit in CHF patients who receive higher dosage of ACE inhibitors and ARBs compared to lower dosage. Methods: Medline Indexed and Non-indexed, Cochrane Central, CINAHL and PsychINFO were searched for randomized controlled trials (RCTs) published till date. All RCTs that compared the clinical impact of high versus low dosage of ACE inhibitors or ARBs in heart failure patients were identified. Two independent investigators assessed the studies against an a priori inclusion criteria and disagreements were resolved by mutual discussion. Results: We used reported event rates for all studies to compute cumulative odds ratio and p-value for mortality. Summary effects were estimated using random effects models in RevMan 5.2. Of 1610 potentially relevant studies, a total of 5 studies (9027 patients) met our inclusion criteria and had data available on mortality events. The pooled estimate of the included studies showed a statistically significant 10% reduction in mortality of CHF patients who received higher dosage of ACE inhibitor and ARBs. (Odds Ratio: 0.90; 95% confidence interval 0.82,0.99). Heterogeneity was tested and it showed no evidence of publication bias. Conclusions: In conclusion, our meta-analysis of RCTs shows that higher dosage of ACE inhibitors and ARBs have a clinically and statistically significant mortality benefit over lower dosage in the management of chronic heart failure patients.


2016 ◽  
Vol 82 (2) ◽  
pp. 95-101 ◽  
Author(s):  
Anirudh Kohli ◽  
Edward Chao ◽  
Daniel Spielman ◽  
Dordaneh Sugano ◽  
Abhishek Srivastava ◽  
...  

The ability to return to work (RTW) postinjury is one of the primary goals of rehabilitation. The modified Rankin Scale (mRS) is a validated simple scale used to assess the functional status of stroke patients during rehabilitation. We sought to determine the applicability of mRS in predicting RTW postinjury in a general trauma population. The trauma registry was queried for patients, aged 18 to 65 years, discharged from 2012 to 2013. A telephone interview for each patient included questions about employment status and physical ability to determine the mRS. Patients who had RTW postinjury were compared with those who had not (nRTW). Two hundred and thirty-four patients met the inclusion criteria. Of these, 171 (72.5%) patients RTW and 63 (26.7%) did nRTW. Patients who did nRTW were significantly older, had longer length of stay and higher rates of in-hospital complications. Multivariate analysis revealed that older patients were less likely to RTW (odds ratio = 0.961, P = 0.011) and patients with a modified Rankin score ≤2 were 15 times more likely to RTW (odds ratio = 14.932, P < 0.001). In conclusion, an mRS ≤2 was independently associated with a high likelihood of returning to work postinjury. This is the first study that shows applicability of the mRS for predicting RTW postinjury in a trauma population.


Author(s):  
F. Flottmann ◽  
N. van Horn ◽  
M. E. Maros ◽  
R. McDonough ◽  
M. Deb-Chatterji ◽  
...  

Abstract Background and Purpose A Thrombolysis in Cerebral Infarction (TICI) score of 3 has been established as therapeutic goal in endovascular therapy (EVT) for acute ischemic stroke; however, in the case of early TICI2b reperfusion, the question remains whether to stop the procedure or to continue in the pursuit of perfection (i.e., TICI 2c/3). Methods A total of 6635 patients were screened from the German Stroke Registry. Patients who underwent EVT for occlusion of the middle cerebral artery (M1 segment), with final TICI score of 2b/3 were included. Multivariable logistic regression was performed with functional independence (modified Rankin Scale, mRS at day 90 of 0–2) as the dependent variable. Results Of 1497 patients, 586 (39.1%) met inclusion criteria with a final TICI score of 2b and 911 (60.9%) with a TICI score of 3. Patients who achieved first-pass TICI3 showed highest odds of functional independence (Odds ratio [OR] 1.71, 95% confidence interval [95% CI] 1.18–2.47). Patients who achieved TICI2b with the second pass (OR 0.53, 95% CI 0.31–0.89) or with three or more passes (OR 0.44, 95% CI 0.27–0.70) had significantly worse clinical outcomes compared to first-pass TICI2b. TICI3 at the second pass was by trend better than first-pass TICI2b (OR 1.55, 95% CI 0.98–2.45), but TICI3 after 3 or more passes (OR 0.93, 95% CI 0.57–1.50) was not significantly different from first-pass TICI2b. Conclusion First-pass TICI2b was superior to TICI2b after ≥ 2 retrievals and comparable to TICI3 at ≥ 3 retrievals. The potential benefit in outcome after achieving TICI3 following further retrieval attempts after first-pass TICI2b need to be weighed against the risks.


Sign in / Sign up

Export Citation Format

Share Document