Endovascularintervention using mechanical thrombectomy (MT) and/or intravenous thrombolysis (IVT) for patients with acute large-vessel occlusion (LVO) remains the current standard of care for those who present with acute ischemic stroke (AIS).1,2Favorable functional outcomes in patients with LVO who receive MT have been shown to be independently associated with early recanalization.3However, early reocclusion at the same location or territory following successful MT remains a concern and is associated with poor outcomes. Select patients with incomplete revascularization, luminal irregularities, intracranial atherosclerotic disease, or underlying intracranial stenosis and/or dissection are considered at high risk for developing reocclusion.4–9The use of a stent retriever or catheter aspiration may lead to arterial wall injury, which can further increase the risk of reocclusion.10In other scenarios, such as tandem occlusion, where stent placement may be necessary, immediate initiation of antiplatelet agents is crucial to prevent stent occlusion.11–17In these high-risk individuals, periprocedural initiation of antiplatelet medication may be beneficial in maintaining vessel recanalization and preventing recurrent stroke.
Nonetheless, early initiation of antiplatelet therapy in MT patients is limited by a heightened concern for an increased risk of intracranial hemorrhage (ICH), especially in the setting of prior IVT. Additionally, current guidelines recommend delaying antiplatelet medication until 24 hours postprocedure for those treated with IVT unless there is a coexisting condition where antiplatelet treatment is known to provide significant benefit or lead to substantial risk if withheld.2This general guidance away from the early use of antiplatelet medication is based on inconclusive data. Although large trials that investigated this issue showed higher rates of ICH in patients treated with antiplatelet agents within 24 hours of IVT, recent evidence increasingly contradicts this notion. With advances in endovascular therapy, early initiation of antiplatelet therapy following MT has largely shown a favorable safety profile.18–23Therefore, clarification of the "safe" timing for initiation of antiplatelet therapy after MT is prudent and necessary. The limitation lies in the fact that the outcomes are often not stratified based on the type of treatment (endovascular treatment, medical management, or a combination) and the dosage, route, and type of antithrombotic agent vary, which makes it challenging to make direct inferences regarding the impact of these agents on patients undergoing MT.
In this study, we aimed to evaluate the safety and functional outcomes of antiplatelet use within 24 hours following MT with or without prior IVT use. We hypothesized that early antiplatelet therapy, by maintaining vessel recanalization, may be associated with improved functional outcome.
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Study Population
这篇文章是写选通后统计ement for cohort studies. After obtaining institutional review board approval and a waiver of consent, we performed a retrospective review of a prospectively maintained database at a single institution for consecutive patients presenting with AIS who subsequently received MT between 2016 and 2020. Adults who received MT regardless of prior IVT administration were included. Included patients were determined to have radiographic confirmation of an LVO and presented within 6 hours of symptom onset or met CT perfusion criteria if they presented more than 6 hours after symptom onset. Patients were stratified into two groups: 1) those who received at least one of the following antiplatelet medications within 24 hours of the procedure (early): aspirin, clopidogrel, ticagrelor, eptifibatide, or abciximab; and 2) those who received antiplatelet medication greater than 24 hours after MT (late).
Baseline Characteristics
Baseline patient demographics and comorbidities including stroke severity (initial evaluation using the National Institutes of Health Stroke Scale [NIHSS]), vascular risk factors, admission Alberta Stroke Program Early CT Score (ASPECTS), and pretreatment with IVT were collected.
Timing of Antiplatelet Treatment
MT was performed with the use of a stent retriever and/or direct catheter-based aspiration technique. Patients who underwent balloon angioplasty and stent placement prior to distal MT with subsequent immediate initiation of antiplatelet therapy (dual oral/rectal antiplatelet and/or eptifibatide/abciximab drip) were also included. The decision to initiate antiplatelet therapy in selected nonstent post-MT patients was determined at the discretion of the treating physician. In general, patients with underlying intracranial stenosis, arterial dissection, incomplete revascularization, tandem occlusion, and luminal irregularities on angiography were started on antiplatelet therapy within 24 hours. Patients who underwent angioplasty and/or stent placement were started on antiplatelet agents immediately following MT. Conversely, patients who received preoperative IVT were often started on antiplatelet treatment after 24 hours.
At our institution, performing physicians include three fellowship-trained neuroendovascular physicians with a combined experience of greater than 20 years.
Outcome Measurements
The primary outcome was safety as defined by symptomatic ICH (sICH) and all-cause inpatient mortality. Symptomatic ICH was defined as Heidelberg Bleeding Classification class 2 on postprocedural brain CT and/or MRI with an increase in NIHSS score of ≥ 4 points within 36 hours from treatment.24We collected periprocedural and postprocedural outcomes as follows: vessel recanalization, modified Rankin Scale (mRS) score at discharge, and functional independence at 30 days and 90 days. Vessel recanalization was determined immediately following MT and defined by the modified Thrombolysis in Cerebral Infarction (TICI) grade. Functional independence was defined as an mRS score ≤ 2.25
Statistical Analysis
We compared baseline patient demographics between early antiplatelet use (< 24 hours) and late antiplatelet use (> 24 hours). Continuous variables with normal and skewed distribution were analyzed using the unpaired t-test and Mann-Whitney U-test, respectively. The rates of ICH (symptomatic and asymptomatic), inpatient mortality, and functional independence between groups were analyzed using the chi-square test. The mRS scores were analyzed as ordinal data using the Mann-Whitney U-test. Multiple imputations were used to create complete data sets for missing data. Multivariable analysis was performed separately for each outcome variable while adjusting for early antiplatelet use, sex, preoperative IVT, and thrombectomy site; p values were 2-tailed and statistical significance was set at p < 0.05. All statistical analyses were performed using IBM SPSS version 28 (IBM Corp.).
Results
A total of 190 patients met igroups favored early antiplatelet therapy nclusion criteria, with 95 patients each in the early and late antiplatelet groups. Comparing the two groups, we found a significantly higher proportion of males (62.1% vs 37.9%, p < 0.001), lower preoperative IVT use (24.2% vs 75.8%, p < 0.001), and higher angioplasty (23.2% vs 2.1%, p < 0.001) and stent placement (20.0% vs 2.1%, p < 0.001) in the early group. A majority (90.5%) of patients underwent thrombectomy of the anterior circulation. Of these, 93 patients (97.9%) were in the late group and 79 (83.1%) in the early group. Of the 18 patients who underwent thrombectomy of the posterior circulation, 16 (16.8%) and 2 (2.1%) were in the early and late groups, respectively (Table 1).
Baseline characteristics of the study population by early versus late antiplatelet treatment
Early (<24 hrs) (n = 95) | Late (>24 hrs) (n = 95) | p Value | |
---|---|---|---|
Age, yrs | 70.07 ± 14.82 | 72.80 ± 15.11 | 0.211 |
Sex | <0.001 | ||
Male | 58 (61.1) | 36 (37.9) | |
Female | 37 (38.9) | 59 (62.1) | |
African American | 26 (27.4) | 33 (34.7) | 0.272 |
Hypertension | 74 (77.9) | 78 (82.1) | 0.468 |
Diabetes | 23 (24.2) | 21 (22.1) | 0.731 |
Hypercholesterolemia | 53 (55.8) | 50 (52.6) | 0.662 |
Atrial fibrillation | 28 (29.5) | 39 (41.1) | 0.095 |
当前吸烟者 | 17 (17.9) | 17 (17.9) | >0.99 |
Initial NIHSS | 15.20 ± 8.34 | 15.97 ± 6.51 | 0.480 |
Preop IVT | 23 (24.2) | 72 (75.8) | <0.001 |
Median ASPECTS (range) | 10 (1–10) | 10 (2–10) | 0.543 |
Antiplatelet | |||
Monotherapy | 62 (65.3) | ||
Dual therapy | 21 (22.1) | ||
Other* | 12 (12.6) | ||
Angioplasty | 22 (23.2) | 2 (2.1) | <0.001 |
Stent | 19 (20.0) | 2 (2.1) | <0.001 |
IA tPA | 8 (8.4) | 6 (6.3) | 0.579 |
TICI grade | 0.154 | ||
0 | 2 (2.1) | 9 (9.5) | |
1 | 0 (0) | 3 (3.2) | |
2a | 6 (6.3) | 6 (6.3) | |
2b | 28 (29.5) | 23 (24.2) | |
2c | 10 (10.5) | 9 (9.5) | |
3 | 49 (51.6) | 45 (47.4) | |
Thrombectomy site | <0.001 | ||
Anterior | 79 (83.2) | 93 (97.9) | |
Posterior | 16 (16.8) | 2 (2.1) |
IA = intra-arterial; tPA = tissue plasminogen activator.
Values are presented as the number of patients (%) or mean ± SD unless stated otherwise. Boldface type indicates statistical significance.
More than 2 medications including eptifibatide and ticagrelor.
没有显示任何significan单变量分析t differences in sICH (p = 0.120), asymptomatic ICH (p = 0.092), or overall ICH (p = 0.498) between the two groups. Likewise, inpatient mortality did not differ significantly between groups (p = 0.281). The mRS score was significantly lower at discharge (p < 0.001), 30 days (p = 0.011), and 90 days (p = 0.024) in the early group. Functional independence was significantly higher in the early antiplatelet group at discharge (p = 0.015) and at 30 days (p = 0.006). No significant difference in functional independence was observed at 90 days (p = 0.102) between the two groups (Table 2).夫人的转移分布分数之间groups favored early antiplatelet therapy (Figs. 1–3).
Safety and clinical and functional outcomes by early versus late antiplatelet treatment: univariable analysis
Early (<24 hrs) (n = 95) | Late (>24 hrs) (n = 95) | p Value | |
---|---|---|---|
我 | 25 (26.3) | 21 (22.1) | 0.498 |
Symptomatic | 3 (3.2) | 8 (8.4) | 0.120 |
Asymptomatic | 22 (23.2) | 13 (13.7) | 0.092 |
Inpatient mortality | 16 (16.8) | 23 (24.2) | 0.281 |
Discharge | |||
mRS score* | 4 (0–6) | 5 (0–6) | <0.001 |
Functional independence | 29 (30.5) | 14 (14.7) | 0.015 |
30 days postop | |||
mRS score* | 4 (0–6) | 4.79 (0–6) | 0.011 |
Functional independence* | 21 (22.1) | 6 (6.3) | 0.006 |
90 days postop | |||
mRS score* | 4 (0–6) | 5.00 (0–6) | 0.024 |
Functional independence* | 27 (28.4) | 17 (17.9) | 0.102 |
Values are presented as the number of patients (%) unless stated otherwise. Boldface type indicates statistical significance. Functional independence is defined as mRS score ≤ 2.
Ordinal data are presented as median (range). No imputation was performed for mRS score on discharge. Imputations were performed for mRS score and functional independence at 30 and 90 days.
多变量分析表明,早期的蚂蚁iplatelet use was independently associated with significantly increased odds of achieving functional independence at discharge (OR 3.07, 95% CI 1.36–6.94; p = 0.007) and 30 days (OR 5.78, 95% CI 1.78–18.77; p = 0.004). Early antiplatelet use was not independently associated with increased odds of sICH (OR 0.59, 95% CI 0.14–2.55; p = 0.479) (Table 3).
Safety and functional outcomes: multivariable analysis, imputed data
OR | 95% CI | p Value | |
---|---|---|---|
sICH | |||
Early antiplatelet use | 0.59 | 0.14–2.55 | 0.479 |
Sex | 1.10 | 0.30–3.99 | 0.883 |
Preop tPA | 3.02 | 0.72–12.62 | 0.130 |
Thrombectomy site | 0.00 | 0.00–0.00 | 0.998 |
Asymptomatic ICH | |||
Early antiplatelet use | 1.77 | 0.76–4.10 | 0.185 |
Sex | 0.84 | 0.39–1.84 | 0.671 |
Preop tPA | 0.62 | 0.27–1.44 | 0.262 |
Thrombectomy site | 0.35 | 0.07–1.67 | 0.188 |
All ICH | |||
Early antiplatelet use | 1.38 | 0.65–2.91 | 0.401 |
Sex | 0.90 | 0.45–1.81 | 0.760 |
Preop tPA | 0.95 | 0.46–1.98 | 0.893 |
Thrombectomy site | 0.31 | 0.14–0.72 | 0.135 |
Discharge functional independence | |||
Early antiplatelet use | 3.07 | 1.36–6.94 | 0.007 |
Sex | 0.46 | 0.22–0.99 | 0.046 |
Preop tPA | 1.54 | 0.70–3.39 | 0.287 |
Thrombectomy site | 0.13 | 0.02–1.02 | 0.052 |
30-day functional independence | |||
Early antiplatelet use | 5.78 | 1.78–18.77 | 0.004 |
Sex | 0.92 | 0.32–2.61 | 0.868 |
Preop tPA | 2.06 | 0.66–6.48 | 0.215 |
Thrombectomy site | 0.62 | 0.11–3.38 | 0.579 |
90-day functional independence | |||
Early antiplatelet use | 2.00 | 0.87–4.57 | 0.101 |
Sex | 0.59 | 0.28–1.25 | 0.167 |
Preop tPA | 1.88 | 0.82–4.30 | 0.135 |
Thrombectomy site | 1.29 | 0.40–4.19 | 0.669 |
Boldface type indicates statistical significance. All covariates used in the model are listed above.
The mRS scores and functional independence were analyzed using imputed data. Functional independence was defined as mRS score ≤ 2.
Discussion
Our study evaluated the safety and functional outcomes of antiplatelet use within 24 hours of MT with or without prior IVT. Our results indicate that early initiation of antiplatelet therapy is associated with increased odds of functional independence without increased odds of developing sICH. Our findings challenge the current guideline that recommends delaying antiplatelet therapy until 24 hours for patients treated with IVT.2Rather, the data suggest that there may, in fact, be an observed beneficial effect in this population.
The resistance to early initiation of antiplatelet agents comes from the ARTIS (Antiplatelet Therapy in Combination With Recombinant t-PA Thrombolysis in Ischemic Stroke) and MR CLEAN-MED (Multicenter Randomized Clinical Trial of Endovascular Treatment for Acute Ischemic Stroke in the Netherlands Investigating the Effect of Periprocedural Medication) trials that showed a significant increase in rates of sICH and poor outcomes following initiation of antiplatelet agents within 24 hours of MT.23,26Of note, patients in the ARTIS trial were administered intravenous aspirin within 90 minutes of IVT and oral antiplatelet therapy within 24 hours.26Patients in the MR CLEAN-MED trial were administered intravenous aspirin after groin puncture. However, several studies in recent years have investigated the impact of oral antiplatelet agents in patients undergoing MT and demonstrated favorable results.
A notable study that was cited in the 2018 American Heart Association/American Stroke Association guideline2is a retrospective single-center study from South Korea27that compared 712 patients who were treated with antithrombotics within 24 hours of recanalization treatment with patients undergoing standard therapy (> 24 hours). Patients who received IVT only (34%), endovascular treatment only (32%), or a combination (34%) were included. The rate of sICH was 3.3% (n = 15) in the early group and 3.1% (n = 8) in the late group. However, this was not stratified by the type of recanalization. Our study design differs in that we only included patients who underwent MT (without or without preoperative IVT). Regardless, our rate of sICH is similar to their cohort, with 3 (3.2%) in the early group and 8 (8.4%) in the late group. On multivariable analysis, the South Korean study demonstrated that early antithrombotic initiation, including ultra-early (< 12 hours) initiation, was associated with decreased odds of any ICH, but it was not associated with sICH. Our analysis did not reveal an increased odds of ICH (symptomatic or asymptomatic) with early antiplatelet use.2,27Similar results were demonstrated in studies that evaluated antiplatelet treatment within 24 hours following IVT in patients requiring stent placement.9,20
Further evidence comes from a recent retrospective review of a multicenter stroke registry that evaluated early neurological deterioration and hemorrhagic transformation expansion among 842 patients with known postthrombolysis hemorrhagic infarction at 24 hours. Early antiplatelet therapy (24–48 hours post-IVT) was independently associated with favorable outcome and a lower risk of early neurological deterioration. Early antiplatelet use was not associated with hemorrhagic transformation expansion, highlighting the safety of early antiplatelet treatment in this population.28
Additional evidence of antiplatelet safety can be extrapolated from studies that evaluated patients who were on antiplatelet therapy prior to hospital admission. Subgroup analysis from various prospectively maintained registries, including the RESCUE (Recovery by Endovascular Salvage for Cerebral Ultra-Acute Embolism)–Japan Registry 2, MR CLEAN (Multicenter Collaboration for Endovascular Treatment of Acute Ischemic Stroke in the Netherlands), and ANGEL (Acute Ischemic Stroke Cooperation Group of Endovascular Treatment), did not find any association between prior antiplatelet therapy and risk of sICH.29–31Taken together, these studies indicate a favorable safety profile for early initiation of antiplatelet agents after MT and suggest that the risk of sICH in previous studies may be overestimated.
Regarding the impact of antiplatelet agents on functional independence, studies have shown mixed results. Early antiplatelet initiation was not associated with favorable functional recovery at 3 months in the South Korean trial.27Studies that evaluated prior antiplatelet use, including the RESCUE-Japan Registry 2 and MR CLEAN trials, also failed to show any association with functional outcomes.28,29Even in studies in which early antiplatelet use demonstrated higher rates of successful vessel recanalization, it did not translate into significant functional independence.18This is in contrast to our findings that showed an independent association with early antiplatelet use and increased odds of achieving functional independence at discharge and 30 days. Similar benefits were also demonstrated among patients with known ICH post-IVT.28Although the current literature is inconclusive, recent studies have demonstrated a trend toward favorable functional outcomes.20,27,31进一步的诊所al trials are needed to definitively determine the role of antiplatelet agents in improving long-term functional outcomes following MT.
Our study has several limitations. This is a single-center retrospective study of prospectively collected data, which has an inherent selection bias. Preoperative IVT use was significantly lower in the early group, which could confound the response to early antiplatelet treatment. This was addressed by adjusting for preoperative IVT in our models. We also did not adjust for stenting or angioplasty in our models, as the rates of stenting and angioplasty were too low in the late group. We did not take into account preadmission antiplatelet or anticoagulant agent use, which could be a significant factor given the high prevalence of these agents in the general population. However, as referenced above, post hoc analysis of large registries did not demonstrate an association between prior antiplatelet therapy and risk of sICH.29–31There were missing data at the 30- and 90-day follow-ups, and the analysis was performed using multiple imputations with the assumption that the data were missing at random.32Finally, the incidence of sICH was low, which limited our ability to make a well-powered analysis in our logistic regression.33
Despite these limitations, our study favors the early initiation of antiplatelet agents in patients with AIS who undergo MT for LVO. Further studies are needed to clearly define indications for early antiplatelet use following MT.
Conclusions
Early antiplatelet initiation after MT in patients with AIS due to LVO was not associated with significantly increased odds of developing sICH. However, it may be associated with increased odds of improved postoperative functional outcomes. Early initiation of antiplatelet therapy may have a role in select patients.
Disclosures
The authors report no conflict of interest concerning the materials or methods used in this study or the findings specified in this paper.
Author Contributions
Conception and design: Alexander, Claus, Tong, Gabrail, Kelkar, Griauzde, Richards. Acquisition of data: Alexander, Claus, Garmo, Gabrail, Griauzde. Analysis and interpretation of data: Alexander, Claus, Tong. Drafting the article: Alexander, Claus, Griauzde. Critically revising the article: Alexander, Claus, Tong, Garmo, Kelkar, Griauzde, Richards. Reviewed submitted version of manuscript: Alexander, Claus, Tong, McCabe, Garmo, Kelkar, Griauzde, Soo, Richards. Approved the final version of the manuscript on behalf of all authors: Alexander. Statistical analysis: Tong. Study supervision: Tong.
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