Background:It is unclear whether more effective forms of thrombus removal than current aspiration catheters would lead to improved outcomes. We sought to evaluate the prognostic role of residual thrombus burden (rTB), after manual thrombectomy, in patients undergoing primary percutaneous coronary intervention with routine manual thrombectomy in the TOTAL trial (Thrombectomy Versus PCI Alone).Methods:This is a single-arm analysis of patients from the TOTAL trial who underwent routine manual aspiration thrombectomy. The rTB was quantified by an angiographic core laboratory using the Thrombolysis in Myocardial Infarction criteria and validated using existing optical coherent tomography data. Large rTB was defined as grade ≥3. The primary outcome was death from cardiovascular causes, recurrent myocardial infarction, cardiogenic shock, or new or worsening heart failure within 180 days.Results:Of 5033 patients randomized to routine thrombectomy, 2869 patients had quantifiable rTB (1014 [35%] had large rTB). Patients with large rTB were more likely to have hypertension, previous percutaneous coronary intervention, myocardial infarction, or Killip class III on presentation but less likely to have Killip class I. The primary outcome occurred more frequently in patients with large rTB, even after adjustment for known risk predictors (8.6% versus 4.6%; adjusted hazard ratio, 1.83 [95% CI, 1.34–2.48]). These patients also had a higher risk of cardiovascular death (adjusted hazard ratio, 1.83 [95% CI, 1.13–2.95]), cardiogenic shock (adjusted hazard ratio, 2.02 [95% CI, 1.08–3.76]), and heart failure (adjusted hazard ratio, 1.74 [95% CI, 1.02–2.96]) but not myocardial infarction or stroke.Conclusions:Large rTB is a common finding in primary percutaneous coronary intervention and is associated with increased risk of adverse cardiovascular outcomes, including cardiovascular death. Future technologies offering better thrombus removal than current devices may decrease or even eliminate the risk associated with rTB. This, potentially, can turn into a strategic option to be studied in clinical trials.Registration:URL: https://www.clinicaltrials.gov; Unique identifier: NCT01149044.

中文翻译：

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血栓切除术后残留血栓负担的预后作用：来自 TOTAL 试验的见解

背景：目前尚不清楚比目前的抽吸导管更有效的血栓清除形式是否会改善结果。我们试图在 TOTAL 试验（血栓切除术与仅 PCI）中评估手动血栓切除术后残余血栓负荷 (rTB) 在接受初次经皮冠状动脉介入治疗和常规手动血栓切除术的患者中的预后作用。方法：这是一项单臂分析接受常规手动抽吸血栓切除术的 TOTAL 试验患者的比例。rTB 由血管造影核心实验室使用心肌梗塞溶栓标准进行量化，并使用现有的光学相干断层扫描数据进行验证。大 rTB 定义为≥3 级。主要结局是心血管原因死亡、复发性心肌梗死、心源性休克、或在 180 天内出现新的或恶化的心力衰竭。结果：在随机接受常规血栓切除术的 5033 名患者中，2869 名患者有可量化的 rTB（1014 [35%] 有大 rTB）。大 rTB 患者更可能有高血压、既往经皮冠状动脉介入治疗、心肌梗死或 Killip III 级，但不太可能有 Killip I 级。主要结局发生在大 rTB 患者中的频率更高，即使在调整了已知的风险预测因子（8.6% 对 4.6%；调整后的风险比，1.83 [95% CI，1.34–2.48]）。这些患者还具有较高的心血管死亡风险（调整后的风险比，1.83 [95% CI，1.13-2.95]）、心源性休克（调整后的风险比，2.02 [95% CI，1.08-3.76]）和心力衰竭（调整后的风险比，1.74 [95% CI，1.02-2。96]），但不是心肌梗塞或中风。结论：大型rTB是初次经皮冠状动脉介入治疗中的常见发现，并且与心血管不良后果（包括心血管死亡）的风险增加有关。提供比当前设备更好的血栓清除的未来技术可能会降低甚至消除与 rTB 相关的风险。这可能会变成在临床试验中研究的战略选择。注册：URL：https://www.clinicaltrials.gov；唯一标识符：NCT01149044。提供比当前设备更好的血栓清除的未来技术可能会降低甚至消除与 rTB 相关的风险。这可能会变成在临床试验中研究的战略选择。注册：URL：https://www.clinicaltrials.gov；唯一标识符：NCT01149044。提供比当前设备更好的血栓清除的未来技术可能会降低甚至消除与 rTB 相关的风险。这可能会变成在临床试验中研究的战略选择。注册：URL：https://www.clinicaltrials.gov；唯一标识符：NCT01149044。