Outcomes after thrombus aspiration for ST elevation myocardial infarction: 1-year follow-up of the prospective randomised TOTAL trial
Outcomes after thrombus aspiration for ST elevation myocardial infarction: 1-year follow-up of the prospective randomised TOTAL trial
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DOI：
10.1016/s0140-6736(15)00448-1
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发表时间：
2016-01-09
期刊：
影响因子：
168.9
通讯作者：
Dzavik, Vladimr
中科院分区：
文献类型：
--
作者：
Jolly, Sanjit S.;Caims, John A.;Dzavik, Vladimr
两项大型试验报道了ST段抬高心肌梗死（STEMI）血栓抽吸后1年的相互矛盾的结果。在一项最大的血栓抽吸随机试验的1年随访中，我们旨在阐明长期益处，以帮助指导临床实践。方法STEMI患者常规抽吸ThrOmbecTomy联合PCI与PCI单独治疗的试验（TOTAL）是一项前瞻性、随机、在10732例STEMI患者中进行的常规手动血栓切除术与单纯经皮冠状动脉介入治疗（PCI）的对比研究。来自20个国家87家医院的合格成年患者（年龄≥ 18岁）入组，并在症状发作后12小时内随机（1：1）分配接受常规手动血栓切除术联合PCI或单独PCI。通过24 h计算机化中心系统进行排列区组随机化（区组大小可变），并按中心分层。参与者和研究者对治疗分配不设盲。试验在180天时，在心血管死亡、心肌梗死、心源性休克或心力衰竭的主要结局方面没有显示出差异。然而，结果显示ST段消退和远端栓塞的替代结局有所改善，但这一发现是否会转化为长期受益仍不清楚。在TOTAL研究的长期随访中，我们报告了1年时的主要结局（心血管死亡、心肌梗死、心源性休克或心力衰竭）和次要结局的结果。主要结局的分析是通过改良的意向治疗进行的，仅包括接受首次PCI的患者。该试验注册于ClinicalTrials.gov，编号NCT 01149044。结果在2010年8月5日至2014年7月25日期间，入组了10732例合格患者，并随机分配至血栓切除术后PCI组（n=5372）或单纯PCI组（n=5360）。在排除每组中未接受PCI的患者后（PCI+血栓切除术组337例，单纯PCI组331例），最终研究人群包括10 064例患者（5035例血栓切除术和5029例单纯PCI）。血栓切除术组5035例患者中有395例（8%）发生了1年时的主要结局，而单纯PCI组5029例患者中有394例（8%）发生了1年时的主要结局（风险比[HR] 1.00 [95% CI 0.87-1.15]，p=0.99）。血栓切除术组179例（4%）和单纯PCI组192/5029例（4%）患者在1年内发生心血管死亡（HR 0.93 [95% CI 0.76-1.14]，p=0.48）。60例患者在1年内发生了关键安全性结局卒中（1.2%），而单纯PCI组为36例（0.7%）（HR 1.66 [95%CI 1.10-2.51]，p=0.015）。解释STEMI PCI期间常规血栓抽吸并未降低长期临床结局，可能与卒中增加相关。因此，血栓抽吸不再被推荐为STEMI的常规策略。
Background Two large trials have reported contradictory results at 1 year after thrombus aspiration in ST elevation myocardial infarction (STEMI). In a 1-year follow-up of the largest randomised trial of thrombus aspiration, we aimed to clarify the longer-term benefits, to help guide clinical practice.Methods The trial of routine aspiration ThrOmbecTomy with PCI versus PCI ALone in Patients with STEMI (TOTAL) was a prospective, randomised, investigator-initiated trial of routine manual thrombectomy versus percutaneous coronary intervention (PCI) alone in 10 732 patients with STEMI. Eligible adult patients (aged >= 18 years) from 87 hospitals in 20 countries were enrolled and randomly assigned (1: 1) within 12 h of symptom onset to receive routine manual thrombectomy with PCI or PCI alone. Permuted block randomisation (with variable block size) was done by a 24 h computerised central system, and was stratified by centre. Participants and investigators were not masked to treatment assignment. The trial did not show a difference at 180 days in the primary outcome of cardiovascular death, myocardial infarction, cardiogenic shock, or heart failure. However, the results showed improvements in the surrogate outcomes of ST segment resolution and distal embolisation, but whether or not this finding would translate into a longer term benefit remained unclear. In this longer-term follow-up of the TOTAL study, we report the results on the primary outcome (cardiovascular death, myocardial infarction, cardiogenic shock, or heart failure) and secondary outcomes at 1 year. Analyses of the primary outcome were by modified intention to treat and only included patients who underwent index PCI. This trial is registered with ClinicalTrials.gov, number NCT01149044.Findings Between Aug 5, 2010, and July 25, 2014, 10 732 eligible patients were enrolled and randomly assigned to thrombectomy followed by PCI (n=5372) or to PCI alone (n=5360). After exclusions of patients who did not undergo PCI in each group (337 in the PCI and thrombectomy group and 331 in the PCI alone group), the final study population comprised 10 064 patients (5035 thrombectomy and 5029 PCI alone). The primary outcome at 1 year occurred in 395 (8%) of 5035 patients in the thrombectomy group compared with 394 (8%) of 5029 in the PCI alone group (hazard ratio [HR] 1.00 [95% CI 0.87-1.15], p=0.99). Cardiovascular death within 1 year occurred in 179 (4%) of the thrombectomy group and in 192 (4%) of 5029 in the PCI alone group (HR 0.93 [95% CI 0.76-1.14], p=0.48). The key safety outcome, stroke within 1 year, occurred in 60 patients (1.2%) in the thrombectomy group compared with 36 (0.7%) in the PCI alone group (HR 1.66 [95% CI 1.10-2.51], p=0.015).Interpretation Routine thrombus aspiration during PCI for STEMI did not reduce longer-term clinical outcomes and might be associated with an increase in stroke. As a result, thrombus aspiration can no longer be recommended as a routine strategy in STEMI.