Efficacy and safety of Intensive Blood Pressure Control in Ischemic Stroke Patients Following Endovascular Thrombectomy: A Update Meta-Analysis

doi:10.21203/rs.3.rs-4709726/v1

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Efficacy and safety of Intensive Blood Pressure Control in Ischemic Stroke Patients Following Endovascular Thrombectomy: A Update Meta-Analysis

https://doi.org/10.21203/rs.3.rs-4709726/v1

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Objective

This meta-analysis aimed to determine the potential benefits or effectiveness of intensive blood pressure management in ischemic stroke patients who have undergone endovascular thrombectomy (EVT) and make an effective update for the evidence.

Methods

We comprehensively searched all relevant studies published before May 23, 2024, using multiple databases, including Cochrane Library, Embase, PubMed, Web of Science, China National Knowledge Infrastructure (CNKI) and Wangfang. The primary outcome was 90 days functional independence (Modified Rankin Scale, mRS score = 0–2), while the secondary outcomes comprised 90-day mortality, 7-day mortality, symptomatic intracranial hemorrhage (sICH), complications and hemicraniectomy.

Results

17 studies with a total of 5825 patients were included. The primary outcome: 90 days functional independence, a significant difference between different blood pressure management (OR = 1.58, 95% CI [1.17, 2.13]) was observed, with obvious heterogeneity (I² = 83.20%, p < 0.01). The secondary outcomes: The significant difference were found in 90-day mortality (OR = 0.75, 95% CI [0.58, 0.99]), sICH (OR = 0.74, 95% CI [0.58, 0.95]), hemicraniectomy (OR = 0.42, 95% CI [0.22, 0.81]). No significant difference were found in 7-day mortality (OR = 0.88, 95% CI [0.49, 1.58]), complications (OR = 1.32, 95% CI [0.50, 3.50]). Subgroup analysis for the heterogeneity.

Conclusion

Our results suggested that more intensive blood pressure management may yield greater benefits in terms of patients' clinic outcomes. However, the results should be interpreted cautiously. Additionally, blood pressure target of SBP < 140 mmHg may provide fundamental insights for future randomized controlled trials.

Biological sciences/Neuroscience

Health sciences/Medical research

Blood pressure

Endovascular thrombectomy

Ischemic stroke

Meta-analysis

Intensive blood pressure

Stroke

Endovascular thrombectomy (EVT) is a reliable and effective intervention for individuals with acute ischemic stroke and notable vascular occlusion^1–3. Despite achieving successful reperfusion in approximately 80% of the cases, at least 50% of patients bear adverse consequences such as mortality or disability within 90 days^1,4,5.

A previous observational study has demonstrated that blood pressure is an independent factor influencing postoperative EVT patients⁶. Although numerous guidelines advocate maintaining blood pressure < 180/105 mmHg following EVT^7,8; however, several observational studies have demonstrated an association between elevated blood pressure and unfavorable prognosis^9,10. Notably, nearly 70% of institutions adopt lower targets for managing systolic blood pressure (SBP)¹¹. These divergent perspectives can be attributed to multiple factors. Elevated blood pressure might increase the risk of intracranial hemorrhage and malignant brain edema in stroke patients by increasing intracranial pressure and cerebral microvascular reperfusion injury in stroke patients^1,6,9. Conversely, hypotension maintenance might lead to the infarcted area’s progressive expansion due to inadequate reperfusion, thereby elevating the likelihood of stroke recurrence^1,5,10. Intensive blood pressure management refers to maintaining blood pressure at a lower level through appropriate treatment¹², which is different from the conservative blood pressure control strategies after EVT^7,8.

BP-TARGET (Blood pressure target) was the pioneering randomized controlled trial (RCT) that targeted blood pressure management post-EVT and effectively controlled intensive blood pressure within the range of 100–129 mmHg¹³. However, its findings did not support the advantages of intensive blood pressure treatment modalities. Subsequently, a Chinese RCT, ENCHANTED2/MT (the second enhanced control of hypertension and thrombectomy study), was prematurely terminated due to adverse effects associated with intensive blood pressure management¹². Several meta-analyses have been initiated to discuss this issue. Ghozy¹⁴ et al included only four randomized controlled trials in their study, with significant risk of selection bias due to differing blood pressure management goals among the studies included. A meta-analysis of Multiple Observational Studies and Two Randomized Controlled Trials was constrained by a limited number of studies and substantial heterogeneity¹⁵. Consequently, with the gradual update of the latest evidence^16,17, clinical evidence regarding post-EVT blood pressure management has become increasingly contradictory. This study re-examined all previous research and updated the latest evidence accordingly.

The present meta-analysis was conducted per the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines¹⁸, adhering to established standards. PROSPERO Registration Number: CRD42022376706

Search strategy

We extensively searched multiple databases including Cochrane Library, Embase, PubMed, Web of Science, China National Knowledge Infrastructure (CNKI) and Wangfang to identify relevant studies published before May 23, 2024. The PubMed search strategy included the terms "ischemic stroke", "mechanical thrombectomy”, “endovascular thrombectomy”, “intraarterial thrombectomy”, “endovascular procedures”, and “blood pressure”. Additionally, we manually searched the references of selected studies and current field reviews to identify relevant literature. After Endnote software eliminated duplicate studies, the remaining articles were carefully reviewed, the complete search strategy in eTable1.

Selection criteria

The inclusion criteria were: (1) The studies that investigated multiple blood pressure and primarily focused on systolic blood pressure (SBP); (2) Those with at least one of the following outcome measures: 90 days functional independence (defined as modified rankin scale, mRS score = 0–2 ), 90-day mortality, 7-day mortality, sICH, complications (including malignant cerebral edema, hypotensive events or early neurological deterioration), and hemicraniectomy; (3) No language restrictions.

The exclusion criteria were: (1) Studies without intensive blood pressure, and (2) Meta-analyses, systematic reviews, case reports, editorials, animal experiments, letters, comments, and conference abstracts were excluded.

Data extraction and quality assessment

Two researchers (Zhou and Yang) independently screened the literature and extracted relevant data. Any discrepancies were resolved through discussion with a third researcher (Huang). The extracted data included authorship, publication date, study design, blood pressure target, sample size, and outcomes. RCTs were assessed using the Cochrane Risk of Bias Tool¹⁹ and the observational studies were evaluated by the Newcastle-Ottawa Scale (NOS)²⁰.

Statistical analysis

The statistical analysis was performed using StataMP (v.15) software. Dichotomous variables were represented by odds ratio (OR) and 95% confidence interval (CI). A p-value < 0.05 was considered statistically significant. The I² test was used to measure heterogeneity; an I² < 50% indicated high homogeneity and a fixed-effect model was employed. Furthermore, I² > 50% indicated lower homogeneity, and thus a random-effect model was utilized. Publication bias assessment was only performed in cases when the analysis included > 7 studies¹⁹. In assessing publication bias, a funnel plot, Egger's test, and meta-regression analysis were employed. The leave-one-out method for sensitivity analysis was conducted to assess result stability.

After comprehensively searching multiple databases and eliminating duplicate studies, we reviewed 1400 published studies based on their titles and abstracts. Among these, we examined entire texts of 79 studies and excluded those who lacked blood pressure target data. Eventually, 17 studies^{10,12,13,16,21–33} were included in this meta-analysis (Fig. 1), encompassing 5825 EVT patients. eTable 2 (supplement 1) presents a summary of the key characteristics of the included studies.

Risk of Bias

The RCTs and observational studies’ quality evaluation were illustrated in eFigure 1 and eTable 3 (supplement 1). The results of Begg’s test (p = 0.50) and Egger’s test(p = 0.12) show that p > 0.05, so there is no publication bias (eFigure 2, supplement 1). Meta-regression analysis showed no signifcant correlations between different blood pressure, country and year of publication. But with statistically significant differences were observed in different study type (p < 0.01) and sample size (p = 0.04), eFigure 3,4 (supplement 1). Funnel plot was used for assessing publication bias (eFigure 5, supplement 1). The leave-one-out method demonstrated that the overall effect size remained moderate and was not significantly influenced by any individual study, indicating the robustness of the findings (eFigure 6, supplement 1).

90 days functional independence

16 studies with 5549 patients provided data on 90 days functional independence (mRS score = 0–2). A meta-analysis using a random-effects model indicated statistically significant differences in blood pressure management (OR = 1.58, 95% CI [1.17, 2.13]), with obvious heterogeneity (I² = 83.20%, p < 0.01), Fig. 2. Given the high heterogeneity and varying specific blood pressure values across the included studies, subgroup analyses were performed. Subgroup analyses revealed statistically significant differences in SBP < 140 mmHg (OR = 1.62, 95% CI [1.17, 2.24];I² = 74.20%, p < 0.01), with reduced heterogeneity noted, (eFigure 7, supplement 1). The lowest heterogeneity was observed when SBP was < 160 mmHg (OR = 2.23, 95% CI [1.65, 3.03]༛I² = 0%, p = 0.85). Due to different study types, subgroup analysis revealed that observational studies favored intensive blood pressure management (OR = 1.94, 95% CI [1.66, 2.28]). In contrast, results from randomized controlled trials (RCTs) showed the opposite effect (OR = 0.66, 95% CI [0.51,0.87]). Heterogeneity decreased in both subgroup classifications (I² = 18.20%, p = 0.27 and I² = 29.30%, p = 0.24), (eFigure 8, supplement 1).

90-day mortality

The results of 90-day mortality data were obtained from 15 studies encompassing 5051 patients. As seen in Fig. 3, Statistically significant difference in 90-day mortality was observed across different blood pressure management (OR = 0.77, 95% CI [0.59, 1.00]; I ² = 52.60%, p = 0.01) in a random-effect model analysis. The subgroup analysis exhibited there was no statistically significant difference in different blood pressure values, (eFigure 9, supplement 1). In subgroup analysis based on different study types, heterogeneity (observational studies, I ² = 34.30%, p = 0.12 VS. RCTs, I ² = 0%, p = 0.85) was reduced. Observational studies indicated that more intensive blood pressure management was beneficial for the 90-day survival rate of patients (OR = 0.63, 95% CI [0.48, 0.82]), (eFigure 10, supplement 1).

7-day mortality

The results of 7-day mortality data were obtained from 4 studies encompassing 2084 patients. No statistically significant difference in 7-day mortality was observed across different blood pressure management (OR = 0.88, 95% CI [0.49, 1.58]; I ² = 67.10%, p = 0.03) in a random-effect model analysis, Fig. 4. The subgroup with RCTs’ study type (OR = 1.36, 95% CI [0.87, 2.13]; I ² = 0%, p = 0.68) exhibited the lowest heterogeneity, (eFigure 11, supplement 1).

Symptomatic intracranial hemorrhage

The results of sICH data were obtained from 13 studies encompassing 4284 patients. As seen in Fig. 5, Statistically significant difference in sICH was observed across different blood pressure management (OR = 0.74, 95% CI [0.58, 0.95]; I ² = 33.70%, p = 0.11) in a fixed-effect model analysis. The subgroup with SBP < 140 mmHg (OR = 0.69, 95% CI [0.50, 0.97]; I ² = 27.50%, p = 0.20) exhibited that more intensive blood pressure management was beneficial for the sICH, (eFigure 12, supplement 1). In subgroup analysis based on different study types, heterogeneity (observational studies, I ² = 24.00%, p = 0.22 VS. RCTs, I ² = 0%, p = 0.78) was reduced, (eFigure 13, supplement 1).

Complications

The results of complications data were obtained from 6 studies encompassing 1602 patients. As seen in Fig. 6, no statistically significant difference in complications was observed across different blood pressure management (OR = 1.32, 95% CI [0.50, 3.50]; I ² = 70.80%, p < 0.01) in a random-effect model analysis. The subgroup with RCTs’ study type (OR = 3.42, 95% CI [1.43, 8.18]; I ² = 0%, p = 0.35) exhibited that less intensive blood pressure management was beneficial for the complications, (eFigure 14, supplement 1).

Hemicraniectomy

The results of hemicraniectomy data were obtained from 4 studies encompassing 1415 patients. As seen in Fig. 7, statistically significant difference in hemicraniectomy was observed across different blood pressure management (OR = 0.42, 95% CI [0.22, 0.81]; I ² = 0%, p = 0.47) in a fixed-effect model analysis. The subgroup with SBP < 140 mmHg (OR = 0.34, 95% CI [0.17, 0.70]; I ² = 0%, p = 0.77) exhibited that more intensive blood pressure management was beneficial for the hemicraniectomy, (eFigure 15, supplement 1).

This study aimed to assess the safety and efficacy of intensive blood pressure management strategies on the clinical outcomes of ischemic stroke patients post-EVT. To our knowledge, this systematic review and meta-analysis represented the comprehensive investigation into post-thrombectomy blood pressure control following acute ischemic stroke, encompassing all observational studies and randomized controlled trials (RCTs). Our study included comprehensive assessment of both primary and secondary study outcomes, which were discordant with previous meta-analyses results^14,34,35. We conducted pre-planned subgroup analyses due to the inclusion of different study types simultaneously. Additionally, we performed a thorough assessment of publication bias, which was not undertaken in previous meta-analyses.

Study Characteristics

Firstly, our study predominantly supported more intensive blood pressure management for the primary outcome of 90-day functional independence. Interestingly, this year saw the almost simultaneous publication of three nearly consistent meta-analyses^14,36, each including the same four RCTs. Their findings, incorporated into our subgroup analysis, favored less intensive blood pressure management, contrary to previous research conclusions¹⁵. This discrepancy may be attributed to uncontrolled confounding bias in observational studies^31–33. Secondly, in secondary outcomes including 90-day mortality, symptomatic intracranial hemorrhage (sICH), and hemicraniectomy, our study results similarly indicated that more intensive blood pressure management benefits patient clinical outcomes. This aligns with previous research findings¹⁵. Lastly, it was noteworthy that heterogeneity in the studies warranted caution in interpreting our results. Despite employing methods such as subgroup analysis to explore sources of heterogeneity, further randomized controlled trials are needed for validation. We recommend SBP < 140 mmHg as a threshold, rather than more intensive blood pressure management strategies such as SBP < 120 mmHg¹².

More Clinical Evidence

The management of blood pressure following endovascular thrombectomy (EVT) for acute ischemic stroke has long been a contentious issue³⁷. Currently, both the European Stroke Organization and the American Stroke Association recommend maintaining post-EVT blood pressure below 180/105 mmHg^7,8, yet they acknowledged a lack of robust clinical evidence supporting this guideline. Due to this absence of empirical data and consensus, there exists considerable variation in clinical practice regarding post-EVT blood pressure management³⁸. A survey conducted in Canada among stroke specialists indicated that 72.5% of respondents perceived a lack of guidelines with practical relevance, highlighting the uncertainty surrounding optimal blood pressure control³⁸. Consequently, the inaugural BP-TARGET RCT was initiated in 2021, suggesting that intensive blood pressure management was a viable approach¹³. Previous meta-analysis³⁶ had demonstrated a U-shaped relationship between blood pressure variability (BPV) and patient prognosis and indicated that excessively high or low BPV did not lead to favorable clinical outcomes. Another meta-analysis proposed a specific target value for blood pressure management and suggested that maintaining SBP < 140 mmHg may yield superior benefits. However, the incorporation of observational studies and RCTs led to selection bias and compromised the research findings¹⁵.

Simultaneously, multiple studies had indicated that higher systolic blood pressure values were detrimental to functional recovery outcomes in stroke patients^39,40, potentially influenced by successful reperfusion. Following successful reperfusion, the blood pressure target should be adjusted to mitigate reperfusion injury and facilitate penumbra recovery⁴¹. However, the recommended management target of 180/105 mmHg lacks valid evidence, and the adjustment of the appropriate blood pressure target based on individual patient factors (like reperfusion degree, overall hemodynamic state, and infarct area) remains uncertain^7,8,41. Previous observational studies had demonstrated that lower postoperative blood pressure values were associated with improved patient prognosis^42,43. However, the ENCHANTED2/MT trial has provided additional evidence suggesting limited impairment when SBP<120 mmHg, leading to early termination due to poor 90-day mRS scores. Since this blood pressure management goal is uncommon in current clinical practice, this can also define a minimum target value for blood pressure management goals in future RCTs^12,15. Although our analysis revealed that standard blood pressure management yields greater benefits, the intensive blood pressure modality’s target values were inconsistent across different trials (BP-TARGET < 130 mmHg¹³; ENCHANTED2/MT<120 mmHg¹²; BEST-Ⅱ<140 or 160 mmHg²¹, and OPTIMAL-BP < 140 mmHg¹⁶). Thus, establishing a unified target value for intensive blood pressure management is a challenge. Furthermore, studies had suggested that greater blood pressure variability (BPV ) post-EVT correlated with poorer prognosis⁴⁴, prompting debate on the necessity of targeting blood pressure control to minimize variability. The relationship between the reperfusion degree and BPV is of significant interest and can be determined by the mTICI scores. Previous studies have presented conflicting views on these findings. Some researchers argue that BPV in successful reperfusion patients (mTICI ≥ 2B) was closely associated with poor outcomes^45,46, while another study suggested that this association was the strongest in inadequate recanalization patients (mTICI < 2B)⁴⁷. Although our results were extensive, many confounding factors needed consideration. For example, in Yang et al.'s study¹², blood pressure control post-EVT was maintained for 72 hours, whereas in other studies it was for 24 hours. Discussions regarding antihypertensive medications were also not standardized^12,16,21. Additionally, the locations of vessel occlusion in acute ischemic stroke varied, including anterior circulation occlusions, large vessel occlusions, among others^24,25,29.

Limitations

Our study has several limitations. Firstly, we included both observational studies and a limited number of RCTs, which introduced potential risk of biases. Secondly, some secondary outcomes had insufficient study inclusion and inadequate sample sizes. Lastly, we did not fully incorporate patients undergoing successful reperfusion following acute ischemic stroke treated with endovascular thrombectomy. Therefore, further large-scale, multicenter randomized controlled trials are needed to further investigate these aspects.

Declaration of Competing Interest

None.

Funding

No funding

Author Contribution

Yitao Zhou and Huijie Yang: Study Conceptualization; Data curation; Conducting research and design; data analysis; composing the initial draft, final approval.Yangbin Zhou: Data curation; Formal analysis; data analysis; composing the initial draft, final approval.Menglu Wang: Formal analysis; data analysis; Writing - review & editing; final approval.Ganying Huang: Study Conceptualization; Project administration; Conducting research and design; data analysis; Supervision; Writing - review & editing; final approval.

Data Availability

All data can be found in articles and supplementary materials.

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No competing interests reported.

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26 Jul, 2024
Editor invited by journal
15 Jul, 2024
Submission checks completed at journal
15 Jul, 2024
First submitted to journal
09 Jul, 2024

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Efficacy and safety of Intensive Blood Pressure Control in Ischemic Stroke Patients Following Endovascular Thrombectomy: A Update Meta-Analysis

Status:

Version 1

Abstract

Objective

Methods

Results

Conclusion

Figures

Introduction

Methods

Search strategy

Selection criteria

Data extraction and quality assessment

Statistical analysis

Results

Risk of Bias

90 days functional independence

90-day mortality

7-day mortality

Symptomatic intracranial hemorrhage

Complications

Hemicraniectomy

Discussion

Study Characteristics

More Clinical Evidence

Limitations

Conclusion

Declarations

Declaration of Competing Interest

Funding

Author Contribution

Data Availability

References

Additional Declarations

Supplementary Files

Status:

Version 1