急性缺血性中風比較橋接治療與直接動脈內血栓移除術的安全性(使用統一定義的有症狀顱內出血)：系統性回顧和統合分析與試驗計劃書

Abstract

1.研究背景 在急性缺血性中風（AIS）中，大血管阻塞（LVO）為預後較差的一型。目前針對發病時間在 4.5 小時內的病人，常見的兩種治療策略為橋接治療（BT）與直接機械性血栓移除（dMT）。然而，兩者在安全性方面，尤其是症狀性顱內出血（sICH）風險是否有差異，尚未有一致結論。過去研究採用的 sICH 定義不一，也使得比較變得困難。 2.研究方法 本研究以系統性文獻回顧與統合分析方式，比較 dMT 與 BT 兩組在 sICH 發生率上的差異。僅納入報告中明確採用 SITS-MOST 或 Heidelberg 分類定義 sICH 的隨機對照試驗（RCT）。統計分析使用 RevMan 5.3 軟體進行風險比（RR）與 95% 信賴區間計算，並進行分組與敏感性分析，以評估定義對結果的影響。 3.研究結果 本研究總共納入六篇 RCT，涵蓋 2,334 位受試者。整體分析結果顯示，dMT 組的 sICH 發生率為 4.29%，BT 組為 4.95%，差異無統計顯著性（RR = 0.86, 95% CI: 0.60–1.25, P = 0.44）。依據不同 sICH 定義進行的亞組分析結果亦一致。功能預後（mRS 0–2）與 90 天死亡率兩組差異不明顯。 4.研究結論 這項統合分析結果顯示，當統一使用 SITS-MOST 或 Heidelberg 定義時，橋接治療（BT）與直接機械性血栓移除術（dMT）在症狀性顱內出血的發生率上並無顯著差異。此結果可為臨床在處理大血管阻塞型中風時，是否有必要常規給予靜脈血栓溶解治療，提供新的思考方向。不過，目前納入之隨機對照試驗數量有限，且樣本數偏少，仍無法完全排除統計偏誤與族群異質性的影響。因此，未來應規劃更具統計效力、使用標準化定義的大型臨床試驗，以明確評估兩種治療策略的安全性與療效，進一步優化急性缺血性中風的治療選擇。

1.Background Acute ischemic stroke (AIS) caused by large vessel occlusion (LVO) is often associated with poor outcomes. For patients presenting within 4.5 hours, bridging therapy (BT) and direct mechanical thrombectomy (dMT) are both widely used. However, whether one approach carries a higher risk of symptomatic intracranial hemorrhage (sICH) remains uncertain. A major challenge in comparing studies lies in the inconsistent definitions of sICH. 2.Method This meta-analysis included randomized controlled trials (RCTs) that reported sICH using standardized criteria—either the SITS-MOST or Heidelberg Bleeding Classification. We used RevMan 5.3 to calculate pooled risk ratios (RRs) and 95% confidence intervals (CIs), along with subgroup and sensitivity analyses to evaluate the robustness of findings under different definitions. 3.Results Six RCTs with a total of 2,334 patients were included. The pooled incidence of sICH was 4.29% in the dMT group and 4.95% in the BT group, showing no statistically significant difference (RR = 0.86, 95% CI: 0.60–1.25, P = 0.44). Subgroup analyses based on sICH definition yielded consistent results. The two groups also showed no significant differences in functional independence (mRS 0–2) or 90-day mortality. 4.Conclusion This meta-analysis demonstrated that, when using a standardized definition such as the SITS-MOST or Heidelberg Bleeding Classification, there is no statistically significant difference in the incidence of sICH between BT and dMT in patients with AIS. These findings challenge the necessity of routine intravenous thrombolysis prior to endovascular treatment in the context of large vessel occlusion and suggest that a direct approach may be equally safe in selected patients. However, current RCTs remain limited in number and sample size, and existing studies may be subject to variability in design, definitions, and patient selection. Therefore, further well-designed, adequately powered RCTs using standardized outcome definitions are needed to definitively compare the safety and efficacy of BT and dMT. Such evidence will be essential to inform clinical decision-making and improve prognosis for patients with AIS.