Abstract
Objective
The impact of true first‐pass effect (T‐FPE, achieving substantial recanalization with extended thrombolysis in cerebral infarction; eTICI 3 after 1 thrombectomy) and outcomes on acute ischemic stroke (AIS) with large ischemic core remains uncertain. We aimed to study the association between T‐FPE and outcomes in AIS patients with large core infarct through a real‐world multicenter study.
Methods
From a prospective multicentric registry, we collected the data of all consecutive acute stroke patients with a large ischemic core who underwent thrombectomy and compared the outcomes of patients who achieved T‐FPE and those who did not. In addition, we compared the outcomes of patients with different numbers of thrombectomy pass to identify the effectiveness of T‐FPE. Multivariate analysis was performed to determine the predictors of T‐FPE. The primary outcome was good functional outcome (modified Rankin Scale score; mRS 0–3) at 90 days. Safety outcomes included a 90‐day mortality and symptomatic intracerebral hemorrhage within 48 hours after thrombectomy.
Results
Between November 2021 and February 2023, 447 eligible patients at 38 stroke centers were enrolled. Out of 447 thrombectomy patients, T‐FPE was achieved in 102 individuals (22.8%). T‐FPE was significantly associated with a higher proportion of good functional outcome (mRS 0–3 at 3 months, OR 2.221, 95% CI 1.418–3.479, p < 0.001) and lower mortality than non‐T‐FPE patients (31.4% vs. 45.5%, p = 0.012). The occlusion sites and lower DBP were strong predictors of T‐FPE.
Interpretation
T‐FPE was associated with favorable outcomes at 90 days in AIS patients with a large ischemic core who underwent EVT.
Introduction
Previous randomized clinical trials have confirmed the efficacy and safety of endovascular thrombectomy (EVT) in selected patients with ischemic stroke caused by cerebral large‐vessel occlusion (LVO).1, 2, 3, 4, 5 However, according to current guidelines, patients with large infarctions, as determined by imaging selection criteria such as an Alberta Stroke Program Early Computed Tomography score (ASPECTS) value of 5 or lower, or individuals with a concordance between their clinical state and perfusion imaging within 6–24 h, are typically excluded from the criteria for thrombectomy procedures.6, 7
Recently, four groundbreaking stroke trials have shown the safety and efficacy of EVT combined with standard medical treatment (SMT) in patients with large ischemic burden compared with SMT alone.8, 9, 10, 11 What should be noted is that mortality and the proportion of poor outcomes remain high in AIS patients with a large ischemic core who underwent EVT.8, 9, 10, 11 Due to the fact that most patients with a large core infarction have experienced a longer onset‐to‐treatment time and more severe ischemic damage, the brain situation is more complex and dangerous than in patients with small to moderate infarct cores. Meanwhile, a greater degree of thrombus burden further reduces the likelihood of surgical success. 12 There are many aspects worth exploring regarding how to maximize the effective use of thrombectomy in patients with a large ischemic core infarct.13, 14, 15 In previous studies, achieving complete or near‐complete reperfusion has been linked to better clinical outcomes and reduced adverse effects.16, 17, 18, 19, 20 In a related study, patients with an ASPECTS of 2–5 who underwent successful recanalization were five times more likely to achieve a favorable 90‐day outcome compared to those with unsuccessful recanalization. 21 Besides, it has been proven that each additional thrombectomy results in a shorter thrombus length and an increased coefficient of friction leading to a lower rate of successful recanalization. 22 A previous study found that the number of recanalization attempts correlated with vessel wall enhancement and blood–cerebrospinal fluid barrier disruption, which showed a strong association with larger infarct volumes and worse functional outcomes. 23 Hence, achieving successful reperfusion is valuable, and fewer thrombectomy attempts imply superior reperfusion, leading to better functional outcomes. True first‐pass effect (T‐FPE), defined as achieving substantial recanalization (modified Thrombolysis in Cerebral Infarction; mTICI 3) with the first thrombectomy device pass, has been reported to be associated with favorable clinical outcomes in patients with anterior circulatory infarction.24, 25 However, the rate, effects, and predictors of T‐FPE on clinical outcomes in case of large core infarct population are presently unknown. It is crucial to explore the T‐FPE in acute stroke patients with large ischemic core underwent thrombectomy.
Here, we aim to use data from a prospective, multicenter, nation‐wide registry to assess the impact of T‐FPE on efficacy and safety outcomes in patients with large core stroke, as well as its predictors. More importantly, we have delineated the characteristics of the T‐FPE population and conducted a comprehensive exploration of T‐FPE from various aspects, aiming to provide new vision to improve the efficacy of endovascular thrombectomy in acute ischemic stroke.
Methods
Patient population
Data came from an ongoing, prospective, observational, nationwide registry that enrolled all patients with acute large vessel occlusion within 24 hours of their last known well in China (URL: http://www.chictr.org.cn, Unique identifier: ChiCTR2100051664). All patients were enrolled in the registry between November 1, 2021 and February 8, 2023. The study protocol was approved by the ethics committee of the Xinqiao Hospital, Army Medical University, and all participating centers. Written informed consent from each patient was required for the registry but not for this analysis because we used anonymized clinical information obtained in routine clinical practice after the ethics committee review.
The inclusion criteria for this study were as follows: (1) an age at least 18 years old; (2) acute ischemic stroke due to anterior circulation large vessel occlusion, defined as occlusion of the internal carotid artery (ICA) or the M1 segment or M2 segment of the middle cerebral artery; (3) large ischemic core on NCCT (defined as an ASPECTS of 0 to 5); (4) symptom presentation within 24 h (the time metric of time last known well within 24 h was used instead if the presentation time was unavailable). Patients were excluded from the study in the case of (1) pre‐stroke mRS >2; (2) lack of follow‐up information on 90‐day outcomes; (3) serious or terminal illness. In this analysis, data from patients were included if they were treated with EVT and endovascular therapy, underwent thrombectomy with a stent retriever, or contact aspiration as the first‐line technique.
Data collection
Demographic variables, vascular risk factors, stroke severity (based on the National Institutes of Health Stroke Scale [NIHSS]), location of occlusion, workflow measures, and treatment information were prospectively recorded at the time of enrollment.
An independent core imaging laboratory evaluated all digital subtraction angiographies and imaging data include the baseline core infarct determined by the NCCT‐based ASPECTS, stroke etiology (based on the Trial of ORG10172 in Acute Stroke Treatment [TOAST] classification), and collateral status, ranging from grade 0 to grade 4 (according to the American Society of Interventional and Therapeutic Neuroradiology/Society of Interventional Radiology collateral grading system [ASITN/SIR]). The findings on baseline NCCT for the ASPECTS, baseline imaging for the occlusion site, angiographic outcomes and symptomatic intracranial hemorrhage (sICH) was diagnosed according to the Heidelberg Bleeding Classification were also assessed.
Angiographic data and procedural technique were evaluated to determine the T‐FPE in the MAGIC registry by using the following three criteria: (1) single pass/use of the device, (2) successful recanalization of the large vessel occlusion and its downstream territory (Extended Thrombolysis in Cerebral Infarction [eTICI] score 3), 25 and (3) no use of rescue treatment. Rescue treatment included remedial balloon angioplasty, stent implementation, and intraarterial drug administration. We identified cases according to the other following original definitions: the non‐T‐FPE group was defined by a final eTICI score of 0–2c or necessitating >1 pass or requiring adjunctive rescue therapy. The FPE group was defined as meeting all criteria for T‐FPE but achieving a eTICI score of 2b–3. The modified FPE group was defined on the basis of a final score of eTICI 2c/3 with 1 pass of the device and without any salvage treatment.
Clinical outcomes
The primary outcome for the present study was the favorable outcome (modified Rankin Scale [mRS] score 0–3) at 90 days after the procedure. Secondary efficacy outcomes included the good outcome (mRS score 0–2) at 90 days and mRS score 0–4 at 90 days, as well as National Institutes of Health Stroke Scale (NIHSS) score at 24 h and 5–7 days (or discharge, if earlier). Safety outcomes included death within 90 days, symptomatic intracranial hemorrhage (sICH), procedural complications, and severe adverse events within 90 days.
Statistical analysis
All statistical analyses were performed using Statistical Product and Service Solutions (26th version; IBM Corporation, Armonk, New York, USA) and R (version 4.1.2; R Foundation, Vienna, Austria) with appropriate packages (R Foundation for Statistical Computing). Categorical and binary variables were compared utilizing the chi‐squared or Fisher exact tests, while continuous variables were assessed employing the Student t‐test (i.e., mean comparison) for variables exhibiting normal distributions, and the Mann–Whitney U‐test for variables lacking normal distributions. Continuous data variables were expressed as the median and interquartile range (IQR), and categorical variables were expressed as counts and percentages.
Logistic regression was used to determine the effect of T‐FPE versus other recanalization outcomes on clinical outcome at 90 days and to evaluate predictors of T‐FPE after adjustment for confounders. To further clarify the results of the impact of the number of passes on outcomes, binary logical analyses were also used to compare clinical outcomes across different numbers of passes.
Propensity score matching (PSM) methods were used to adjust for important prognostic factors to assess efficacy and safety outcomes between patients achieve T‐FPE and non‐T‐FPE. The propensity score was estimated using a multivariable logistic regression model, with hypertension, diabetes, baseline NIHSS, first‐line thrombectomy strategy, craniectomy, diabetes, and intravenous thrombolysis as covariates. We performed a 1:2 matching based on the nearest neighbor matching with a 0.2 caliper.
In the inversed probability of treatment weighting (IPTW) cohort, the treatment effect was assessed using the inverse probability‐weighted regression adjustment model, which incorporated the inverse propensity score for weighting each subject, and adjusted for the weighted regression coefficients to determine the mean predicted outcomes at the treatment level.
We conducted further research into the variability of treatment efficacy for the primary outcome among the following subgroups: age (≤65 vs. >65 years old), sex (female vs. male), hypertension (no vs. yes), baseline NIHSS score (≤17 vs. >17), IVT (no vs. yes), occlusion site, first‐line thrombectomy strategy, and stroke causative mechanism.
Results
Frequency and characteristics of T‐FPE
Of 745 patients registered in the MAGIC registry, 447 were analyzed in this study. The flowchart illustrating the selection of patients and the distribution of angiographic reperfusion results is presented in Figure 1. Overall, 102 of 447 patients (22.8%) achieved T‐FPE from the full cohort. In total, 143 of 388 patients (41.2%) achieved a final eTICI score of 2b–3 and 114 achieved a final eTICI score of 2c–3. The patients in both groups were of similar age (69 [58–80] vs. 69 [59–77]) years and had lower proportions of female (36.3% vs. 45.2%, p = 0.109) in the T‐FPE group. In T‐FPE patients, the median baseline NIHSS score was 14 (IQR, 9–20), the median ASPECTS was 9 (IQR, 8–10), the median initial systolic BP was 143 (IQR, 127–156), the median initial diastolic BP was 82 (IQR, 73–90), the median onset‐to‐imaging time was 267 (IQR, 164–389), and the median onset‐to‐puncture time was 355 (IQR, 239–485). The occluded vessel site was ICA in 24 patients (23.5%), M1 in 67 (65.7%), and M2 in 11 (10.8%). Nineteen patients (18.6%) underwent stent retriever (SR), 58 patients (56.9%) underwent contact aspiration (CA), and 25 patients (24.5%) underwent stent retriever combined with contact aspiration (SR + CA) as the first‐line thrombectomy (Table 1). In the T‐FPE group, patients had a significantly lower baseline diastolic blood pressure (82 [IQR, 73–90] vs. 87 [IQR, 76–98]; p = 0.020), a higher ASITN/SIR grade (26 of 102 [25.5%] vs. 46 of 345 [13.3%]; p = 0.004), and were more likely to present with a middle cerebral artery (67 of 102 [65.7%] vs. 143 of 345 [41.4%]).
Figure 1.
Flowchart of patient inclusion in the present study.
Table 1.
Comparison of baseline characteristics between the T‐FPE and non‐T‐FPE groups.
| Baseline characteristic | Total (n = 447) | T‐FPE (n = 102) | Non‐T‐FPE (345) | p VALUE |
|---|---|---|---|---|
| Age | 69 (59–78) | 69 (58–80) | 69 (59–77) | 0.309 |
| Sex (female) | 193 (43.2) | 37 (36.3) | 156 (45.2) | 0.109 |
| Medical history | ||||
| Hypertension | 262 (58.6) | 63 (61.8) | 199 (57.7) | 0.462 |
| Hyperlipidemia | 93 (20.8) | 18 (17.6) | 75 (21.7) | 0.371 |
| Diabetes | 64 (14.3) | 16 (15.7) | 48 (13.9) | 0.653 |
| Atrial fibrillation | 213 (47.7) | 41 (40.2) | 172 (49.9) | 0.086 |
| Smoking | 134 (30.0) | 30 (29.4) | 104 (30.1) | 0.887 |
| Clinical presentation | ||||
| Initial systolic BP a | 146 (128–163) | 143 (127–156) | 147 (128–164) | 0.250 |
| Initial diastolic BP a | 86 (75–96) | 82 (73–90) | 87 (76–98) | 0.020 |
| Baseline NIHSS score | 17 (14–21) | 17 (13–20) | 18 (14–21) | 0.136 |
| ASITN/SIR grade | 0.004 | |||
| 0 | 80 (17.9) | 9 (8.8) | 71 (20.6) | |
| 1 | 147 (32.9) | 33 (32.4) | 114 (33.0) | |
| 2 | 148 (33.1) | 34 (33.3) | 114 (33.0) | |
| 3 | 72 (16.1) | 26 (25.5) | 46 (13.3) | |
| Location of occlusion site | <0.001 | |||
| ICA | 193 (43.2) | 24 (23.5) | 169 (49.0) | |
| M1 | 210 (47.0) | 67 (65.7) | 143 (41.4) | |
| M2 | 44 (9.8) | 11 (10.8) | 33 (9.6) | |
| Stroke etiology | 0.441 | |||
| Large artery atherosclerosis | 121 (27.1) | 32 (31.4) | 89 (25.8) | |
| Cardioembolism | 267 (59.7) | 54 (52.9) | 213 (61.7) | |
| Other | 13 (2.9) | 3 (2.9) | 10 (2.9) | |
| Unknown | 46 (10.3) | 13 (12.7) | 33 (9.6) | |
| Treatment profile | ||||
| Intravenous thrombolysis | 116 (26.0) | 34 (33.3) | 82 (23.8) | 0.053 |
| Craniectomy | 46 (10.3) | 8 (7.8) | 38 (11.0) | 0.354 |
| Onset‐to‐imaging time, min | 287 (156–455) | 267 (164–389) | 303 (157–471) | 0.370 |
| Onset‐to‐puncture time, min b | 360 (237–536) | 355 (239–485) | 361 (236–570) | 0.484 |
| General anesthesia | 77 (17.2) | 21 (20.6) | 56 (16.2) | 0.306 |
| First‐line thrombectomy strategy | 0.970 | |||
| SR | 87 (19.5) | 19 (18.6) | 68 (19.7) | |
| CA | 251 (56.2) | 58 (56.9) | 25 (24.5) | |
| SR + CA | 109 (24.4) | 25 (24.5) | 84 (24.3) |
Values expressed as n/total n (%) unless otherwise indicated.
BP, blood pressure; CA, contact aspiration; ICA, internal carotid artery; IQR, interquartile range; mRS, modified Rankin Scale; NIHSS, National Institutes of Health Stroke Scale; non‐T‐FPE, non‐true first‐pass effect; SR, stent retriever; T‐FPE, true first‐pass effect.
Eight missing values (1 in FPE).
Five missing values (1 in FPE).
Angiographic and clinical outcomes in T‐FPE versus non‐T‐FPE cohorts
The T‐FPE patients had significantly better 90‐day clinical outcomes than those in the non‐T‐FPE population (Fig. 2). The rate of good functional outcome (mRS score of 0–3) was significantly higher among T‐FPE patients compared with non‐T‐FPE patients (52.0% vs. 32.8%; odds ratio, 2.221 [95% CI, 1.418–3.479]; p < 0.001). Mortality was also significantly lower in the T‐FPE group compared with the non‐T‐FPE group (31.4% vs. 45.5%; odds ratio, 0.547 [95% CI, 0.343–0.875]; p = 0.012), and T‐FPE patients had significantly fewer NIHSS score at discharge compared to non‐T‐FPE patients (11 vs. 16; odds ratio, 0.005 [95% CI, 0.000–0.067]; p < 0.001). The incidence rates of hernia within 90 days were lower in the T‐FPE group than in the non‐T‐FPE group (16.7% vs. 33.3%; odds ratio, 0.400 [95% CI, 0.227–0.705]; p = 0.002). A significant effect of T‐FPE was still observed for the mRS score 0–4 (64.7% vs. 46.4%; odds ratio, 2.120 [1.341–3.351]; p = 0.001). The mRS score 0–2 is higher percentage and fewer patients occurred sICH in the T‐FPE group than in the non‐T‐FPE group, but this difference did not reach statistical significance. These differences remained a certain extent unchanged in multivariate analysis adjusted for prespecified confounders (Table 2). Figure 3 shows the subgroup analysis of all patients. Regardless of age, sex, hypertension, baseline NIHSS score, IVT, and stroke etiology, T‐FPE contributed independently to a 90‐day favorable functional outcome.
Figure 2.
Effect of FPE with different definitions on clinical outcomes. Clinical outcomes at 3 months follow‐up in true FPE versus non‐true FPE patients (A), modified FPE versus nonmodified FPE patients (B), and FPE versus non‐FPE patients (C). mRS indicates modified Rankin Scale.
Table 2.
Procedural time and clinical outcome of the T‐FPE versus non‐T‐FPE groups.
| Characteristic | Total (n = 447) | T‐FPE (n = 102) | Non‐T‐FPE (n = 304) | Unadjusted OR (95% CI) | p Value | PSM adjusted OR | p Value | IPTW Adjusted OR | p Value |
|---|---|---|---|---|---|---|---|---|---|
| Clinical outcome | |||||||||
| Score on mRS at 90 days (IQR) | 4 (3–6) | 3 (2–6) | 5 (3–6) | 0.521 (0.350–0.775) | 0.001 | 0.69 (0.47–1.01) | 0.054 | 0.64 (0.40–1.04) | 0.068 |
| mRS score at 90 days | |||||||||
| 0–4 | 226 (50.6) | 66 (64.7) | 160 (46.4) | 2.120 (1.341–3.351) | 0.001 | 1.49 (0.99–2.26) | 0.059 | 1.80 (0.94–2.71) | 0.084 |
| 0–3 | 166 (37.1) | 53 (52.0) | 113 (32.8) | 2.221 (1.418–3.479) | <0.001 | 1.65 (1.10–2.51) | 0.017 | 1.95 (1.17–3.27) | 0.011 |
| 0–2 | 100 (22.4) | 29 (28.4) | 71 (20.6) | 1.533 (0.927–2.536) | 0.096 | 1.28 (0.81–2.04) | 0.292 | 1.36 (0.77–2.41) | 0.293 |
| NIHSS score at discharge | 15 (9–30) | 11 (6–17) | 16 (9–35) | 0.005 (0.000–0.067) | <0.001 | 0.068 (0.007–0.71) | 0.025 | 0.027 (0.001–0.59) | 0.022 |
| Death at 90 days | 189 (42.3) | 32 (31.4) | 157 (45.5) | 0.547 (0.343–0.875) | 0.012 | 0.72 (0.47–1.10) | 0.133 | 0.74 (0.43–1.28) | 0.284 |
| Procedural complications | |||||||||
| sICH | 62 (13.9) | 10 (9.8) | 52 (15.1) | 0.612 (0.299–1.253) | 0.180 | 0.98 (0.64–1.49) | 0.914 | 0.97 (0.57–1.63) | 0.904 |
| Hernia | 132 (29.5) | 17 (16.7) | 115 (33.3) | 0.400 (0.227–0.705) | 0.002 | 0.66 (0.40–1.08) | 0.104 | 0.69 (0.36–1.33) | 0.265 |
PSM and IPTW were calculated using logistic regression analysis adjusted for atrial fibrillation, initial diastolic BP, ASITN/SIR grade, location of occlusion site, and intravenous thrombolysis.
IQR, interquartile range; mRS, modified Rankin Scale; NIHSS, National Institutes of Health Stroke Scale; sICH, symptomatic intracerebral hemorrhage.
Figure 3.
Subgroup analysis of favorable outcome. The forest plot shows the differences in the odds ratios for favorable outcomes at 90 days in the prespecified subgroups.
T‐FPE versus other recanalization outcome
We defined different levels of reperfusion into distinct groups (m‐FPE and FPE) to assess their respective efficacy and safety (Table 3; Fig. 2). The clinical outcome benefits persisted when comparing patients achieving FPE versus non‐FPE, and the differences were also statistically significant when comparing modified FPE to non‐modified FPE patients (Table 3). The mortality rate was notably lower in the T‐FPE group compared to other groups (31.4% in T‐FPE vs. 41.6% in any mTICI2b, 35.6% in any mTICI2c, 36.0% in TICI3 final with >1 pass, and 42.3% in the full study cohort, respectively; Table 3; Fig. 2). There also found the complication is less likely to occur with brain herniation.
Table 3.
Comparison of the clinical and angiographic outcomes in full study cohort, true FPE cohort, mFPE cohort, and FPE cohort.
| Full study cohort (n = 447) | T‐FPE (n = 102) | p value | p Value (Any mTICI3 vs. T‐FPE) | Modified FPE (n = 114) | p Value | p Value (Any mTICI2c/3 vs. M‐FPE) | FPE (n = 143) | p Value | p Value (Any mTICI2b‐3 vs. FPE) | |
|---|---|---|---|---|---|---|---|---|---|---|
| mRS score at 90 days | ||||||||||
| 0–4 | 226/447 (50.6%) | 66/102 (64.7%) | 0.001 | 0.118 | 72/114 (63.2%) | 0.002 | 0.187 | 89/143 (62.2%) | 0.001 | 0.011 |
| 0–3 | 166/447 (37.1%) | 53/102 (52.0%) | <0.001 | 0.364 | 57/114 (50.0%) | 0.001 | 0.580 | 67/143 (46.9%) | 0.004 | 0.060 |
| 0–2 | 100/447 (22.4%) | 29/102 (28.4%) | 0.096 | 0.675 | 32/114 (28.1%) | 0.091 | 0.430 | 37/143 (27.75) | 0.224 | 0.831 |
| NIHSS score at discharge | 15 (9–30) | 11 (6–17) | <0.001 | 0.066 | 11 (6–17) | <0.001 | 0.033 | 11 (7–20) | <0.001 | <0.001 |
| Death at 90 days | 189/447 (42.3%) | 32/102 (31.4%) | 0.011 | 0.457 | 37/114 (32.5%) | 0.014 | 0.590 | 48/143 (33.6%) | 0.011 | 0.115 |
| sICH | 170/447 (38.0%) | 37/102 (36.3%) | 0.677 | 0.961 | 39/114 (34.2%) | 0.330 | 0.584 | 49/143 (34.3%) | 0.261 | 0.201 |
| Hernia | 132/447 (29.5%) | 17/102 (16.7%) | 0.002 | 0.051 | 19/114 (16.7%) | <0.001 | 0.026 | 26 (18.2%) | <0.001 | 0.006 |
FPE, first‐pass effect; M‐FPE, modified first‐pass effect; mRS, modified Rankin Scale; mTICI, modified thrombolysis in cerebral infarction; NIHSS, National Institutes of Health Stroke Scale; OR, odds ratio; sICH, symptomatic intracerebral hemorrhage; T‐FPE, true first‐pass effect.
Clinical outcomes in different thrombectomy pass
To further the association between T‐FPE and outcomes, we compared the outcomes of single versus multiple thrombectomy pass in selected patients. We selected patients with the modified thrombolysis in cerebral infarction up to 2b–3, and clinical outcomes were compared among different numbers of stent retriever alone, contact aspiration alone and stent combined with aspiration separately. The results demonstrate that the clinical prognostic outcomes got worse as the number of thrombectomy times increased (Table I in the Data Supplement).
Predictors of T‐FPE
The multivariate analysis included meaningful variables that were different between the T‐FPE and non‐T‐FPE groups (initial diastolic BP, ASITN/SIR grade, atrial fibrillation, first‐line thrombectomy strategy, stroke etiology, location of occlusion site and intravenous thrombolysis) and showed only DBP (OR, 0.980; 95% CI, 0.964–0.996; p = 0.013) and location of occlusion site (OR, 3.314; 95% CI, 1.950–5.633; p < 0.001) as significant independent predictors of T‐FPE (Table 4).
Table 4.
Independent predictors of true first‐pass effect.
| Predictors | OR (95% CI) | p Value |
|---|---|---|
| DBP | 0.980 (0.964–0.996) | 0.013 |
| Location of occlusion site | ||
| ICA | 1.00 (ref) | – |
| M1 | 3.314 (1.950–5.633) | <0.001 |
| M2 | 2.318 (1.020–5.268) | 0.045 |
| IVT | 1.550 (0.938–2.562) | 0.087 |
Calculated using a backward‐stepwise logistic regression analysis after handling missing values by multiple imputation; candidate predictors were initial diastolic BP, ASITN/SIR grade, atrial fibrillation, first‐line thrombectomy strategy, stroke etiology, location of occlusion site, and intravenous thrombolysis.
DBP, diastolic blood pressure; ICA, internal carotid artery and intravenous thrombolysis.
Discussion
Using the data from a prospective, multicenter registry, this study demonstrated that (1) the incidence of T‐FPE was 22.8% in patients with a large core infarct; (2) T‐FPE was associated with a higher proportion of favorable outcomes, a lower mortality and fewer procedural adverse events; (3) an eTICI grade of 3 was the target for vessel recanalization after thrombectomy; (4) the occlusion site and lower DBP were the predictors of T‐FPE.
Several studies have identified a negative association between the number of recanalization attempts and functional outcomes, particularly among patients presenting with small‐to‐moderate ischemic infarction upon admission.24, 25, 26, 27 Our data indicated that in patients with extensive baseline infarction, successful reperfusion was also linked to favorable functional outcomes. Notably, we found successful reperfusion at any attempt reduced the likelihood of death at 90 days compared to unsuccessful reperfusion. The study established a substantial correlation between successful reperfusion and favorable clinical outcomes in the large core infarction population, underscoring the importance of targeting eTICI3 attainment following thrombectomy in this specific cohort.
Both effectiveness and safety outcomes suggest a strong association between T‐FPE and improved clinical outcomes. The study also showed a significant correlation with clinical outcomes in other various defined groups (modified FPE and FPE). Finally, 25.5% and 32% of the patients in this study achieved modified FPE and FPE. The realization of T‐FPE was merely 22.8% in this study and was lower than that reported by Aubertin et al. (33.2%), 28 suggesting that there is significant a room for improvement.
Previous studies have shown that repeated recanalization attempts, resulting from direct vessel wall injury during retrieval and aspiration maneuvers, may have harmful effects.29, 30 Additionally, each thrombectomy maneuver increases the risk of distal embolization due to clot fragmentation, potentially leading to worse functional outcomes after multiple attempts.31, 32 In our study, we evaluated various surgical approaches, including SR, CA, and SR + CA, and compared the impact of varying numbers of recanalization attempts on outcomes within these three scenarios. The data from this study, across the three surgical groups, further underscored the significance of minimizing the number of thrombectomy attempts needed to achieve successful revascularization.
This study offers new insights into EVT for large ischemic strokes, highlighting the critical question of optimizing achieve T‐FPE as an important prognostic factor in this vulnerable subgroup. In our study, it was found that occlusion sites in M1 and M2 were easier to achieve T‐FPE compared to ICA. More middle cerebral artery occlusions (76.5% vs. 51.0%) and fewer internal carotid artery occlusions (23.5% vs. 49.0%) were present in the T‐FPE group. After stratifying by different occlusion site, compare the prognosis of patients undergoing different surgical methods, suggesting that contact aspiration may be more favorable than stent thrombectomy in achieving FPE in large ischemic core populations (Table II in the Data Supplement). It can be explained by the fact that the stent thrombectomy in patients with large core infarcts would be more likely to result in endothelial damage and distal embolization compared to aspiration. Our data also revealed that patients with lower initial diastolic blood pressure had a significantly higher chance of achieving T‐FPE; this is a new finding “has not” reported before. It is reasonable to speculate that the initial diastolic blood pressure may influence the vascular state as well as the blood flow velocity associated with achieving T‐FPE.
Limitations
This study has several limitations. First, due to variations in the training of surgical operators across different centers, there were differences in the selection of surgical methods, which impacted the outcomes of thrombectomy procedures. Second, only Chinese patients were included, which may limit the generalizability.
Conclusions
T‐FPE was achieved in 22.8% of patients with large core stroke and was associated with a significantly better clinical outcome and a lower mortality. Occlusion site and lower DBP were strongly independent predictors of T‐FPE.
Author Contributions
Dr Qingwu yang had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. Concept and design: Shitao Fan, Changwei Guo, Jiacheng Huang, Zhouzhou Peng, Fengli Li, Qingwu yang. Acquisition, analysis, or interpretation of data: Shitao Fan, Changwei Guo, Jiacheng Huang, Zhouzhou Peng, Chengsong Yue, Jie Yang, Linyu Li, Dongjing Xie, Nizhen Yu, Shihai yang, Xiaolei shi, Dahong Yang, Fengli Li, Qingwu Yang. Drafting of the manuscript: Shitao Fan, Changwei Guo, Jiacheng Huang, Zhouzhou Peng, Fengli Li, Qingwu yang. Critical revision of the manuscript for important intellectual content: Shitao Fan, Fengli Li, Qingwu Yang. Statistical analysis: Shitao Fan. Supervision: Qingwu yang.
Funding Information
This study was funded by National Natural Science Foundation of China (No. 400 82271349), Academic Excellence Program (2022XKRC003), and Talent Incubation Program (2022YQB011).
Conflict of Interest
All authors declare that they have no conflicts of interest.
Supporting information
Data S1.
Acknowledgments
We thank all study participants for their contribution to the study and the research staff at all the participating hospitals.
Funding Statement
This work was funded by National Natural Science Foundation of China grant 82271349; Academic Excellence Program grant 2022XKRC003; Talent Incubation Program grant 2022YQB011.
Contributor Information
Fengli Li, Email: lifengli01@yeah.net.
Qingwu Yang, Email: yangqwmlys@163.com.
Data Availability Statement
Anonymized data will be shared to qualified investigators whose proposal of data use has been approved by the corresponding author and the MAGIC investigators.
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Associated Data
This section collects any data citations, data availability statements, or supplementary materials included in this article.
Supplementary Materials
Data S1.
Data Availability Statement
Anonymized data will be shared to qualified investigators whose proposal of data use has been approved by the corresponding author and the MAGIC investigators.