RECO 血流恢复装置与 Solitaire FR 取栓装置用于血管再通的随机对照研究（REDIRECT）：一项前瞻性随机对照临床试验。
RECO Flow Restoration Device Versus Solitaire FR With the Intention for Thrombectomy Study (REDIRECT): a prospective randomized controlled trial.
机构信息
1Department of Neurosurgery, The First People's Hospital of Changzhou/The Third Affiliated Hospital of Soochow University, Changzhou.
2Department of Neurology, Fuzhou General Hospital of Nanjing Military Command, Fuzhou.
出版信息
J Neurosurg. 2020 Jun 5;134(5):1569-1577. doi: 10.3171/2020.3.JNS193356. Print 2021 May 1.
OBJECTIVE
The RECO flow restoration (FR) device is a new stent retriever designed for rapid flow restoration in acute ischemic stroke (AIS) caused by large vessel occlusion (LVO). Here, the authors compared the efficacy and safety of the RECO device with the predicate Solitaire FR stent retriever.
METHODS
The RECO Flow Restoration Device Versus Solitaire FR With the Intention for Thrombectomy Study (REDIRECT) was a multicenter, prospective, open randomized controlled trial. Patients with acute LVO at 7 Chinese stroke centers participated in the study. The primary efficacy endpoint was defined as a modified thrombolysis in cerebral infarction (mTICI) reperfusion grade ≥ 2 within three passes. The primary safety endpoint comprised any serious adverse device effect, symptomatic intracerebral hemorrhage (sICH), and any serious adverse event (SAE; defined as cerebral palsy or death) within 24 hours after the procedure. The secondary efficacy endpoints consisted of functional independence (modified Rankin Scale score 0-2), procedure duration, and 90-day all-cause mortality.
RESULTS
Between January 2014 and August 2016, 67 patients were randomly allocated to the RECO group and 69 patients to the Solitaire FR group. The primary efficacy endpoint (mTICI grade ≥ 2 within three passes) was similar in the two treatment groups (91% vs 87%, respectively, p = 0.5861), and the rate of reperfusion with an mTICI grade 2b/3 was 87% versus 75% (p = 0.1272). There were no serious adverse device effects in any patient. The rates of sICH (1.5% vs 7.2%, p = 0.1027) and SAEs (6.0% vs 1.4%, p = 0.2050) within 24 hours after the procedure were similar in the two treatment groups. There was no significant difference in the rate of functional independence (63% vs 46%, p = 0.0609) or 90-day all-cause mortality (13% vs 23%, p = 0.1848) or in procedure duration (85.39 ± 47.01 vs 89.94 ± 53.34 minutes, p = 0.5986) between the two groups.
CONCLUSIONS
The RECO stent retriever is effective and safe as a mechanical thrombectomy device for AIS due to LVO. Clinical trial registration no.: NCT01983644 (clinicaltrials.gov).
目的
RECO 血流恢复（FR）装置是一种新型支架取栓器，旨在快速恢复因大血管闭塞（LVO）引起的急性缺血性脑卒中（AIS）的血流。在此，作者比较了 RECO 装置与预测 Solitaire FR 支架取栓器的疗效和安全性。
方法
RECO 血流恢复装置与 Solitaire FR 用于血管内血栓切除术的研究（REDIRECT）是一项多中心、前瞻性、开放、随机对照试验。7 家中国卒中中心的急性 LVO 患者参与了该研究。主要疗效终点定义为 3 次内改良脑梗死溶栓（mTICI）再灌注分级≥2 级。主要安全性终点包括任何严重的器械相关不良事件、症状性颅内出血（sICH）和任何 24 小时内的严重不良事件（SAE；定义为脑瘫或死亡）。次要疗效终点包括功能独立性（改良 Rankin 量表评分 0-2）、手术时间和 90 天全因死亡率。
结果
2014 年 1 月至 2016 年 8 月，67 例患者被随机分配至 RECO 组，69 例患者至 Solitaire FR 组。两组主要疗效终点（3 次内 mTICI 分级≥2 级）相似（分别为 91%和 87%，p=0.5861），mTICI 分级 2b/3 的再灌注率分别为 87%和 75%（p=0.1272）。两组均无严重的器械相关不良事件。术后 24 小时内 sICH（1.5% vs 7.2%，p=0.1027）和 SAE（6.0% vs 1.4%，p=0.2050）发生率相似。两组术后功能独立性（63% vs 46%，p=0.0609）和 90 天全因死亡率（13% vs 23%，p=0.1848）或手术时间（85.39±47.01 分钟 vs 89.94±53.34 分钟，p=0.5986）无显著差异。
结论
RECO 支架取栓器作为一种治疗 LVO 引起的 AIS 的机械血栓切除术装置是有效且安全的。临床试验注册号：NCT01983644（clinicaltrials.gov）。
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