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在 ST 段抬高型心肌梗死中通过手动血栓抽吸进行支架植入术的优化:来自 EXAMINATION 试验的结果。

Optimization in stent implantation by manual thrombus aspiration in ST-segment-elevation myocardial infarction: findings from the EXAMINATION trial.

机构信息

From the Cardiology Department, University Hospital Clinic, Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain (D.F.-R., A.R., S.B., V.M.-Y., M.M., M.S.); Cardiology Department, University Hospital of Bellvitge, Barcelona, Spain (A.C.); Cardiology Department, Hospital do Meixoeiro, Vigo, Spain (A.I.); Cardiology Department, University Hospital of Sant Pau, Barcelona, Spain (A.S.); Cardiology Department, University Hospital San Carlos, Madrid, Spain (R.H.-A.); Cardiology Department, Hospital General of Alicante, Alicante, Spain (V.M.); Cardiology Department, Erasmus MC, Thoraxcenter, Rotterdam, The Netherlands (M.V., P.W.S.); Cardiology Department, University Hospital Bolognini Seriate, Bergamo, Italy (M.T.); Cardiology Department, Amphia Ziekenhuis, Breda, The Netherlands (P.d.H.); Cardiology Department, Hospital Son Dureta, Palma de Mallorca, Spain (A.B.); and Cardiology Department, Hospital Juan Canalejo, A Coruña, Spain (N.V.).

出版信息

Circ Cardiovasc Interv. 2014 Jun;7(3):294-300. doi: 10.1161/CIRCINTERVENTIONS.113.000964. Epub 2014 May 27.

Abstract

BACKGROUND

Manual thrombus aspiration (TA) is effective to reduce the thrombus burden during primary percutaneous coronary intervention for ST-elevation myocardial infarction. The objective of this study is to assess the impact of manual TA on stent implantation during primary percutaneous coronary intervention.

METHODS AND RESULTS

Population of the EXAMINATION trial (n=1498) was divided into 2 groups according to the use of TA. Immediate angiographic results, primary patient-oriented end point (combination of all-cause death, myocardial infarction, and any revascularization) and secondary device-oriented end point (combination of cardiac death, target vessel myocardial infarction, and clinically driven target lesion revascularization), definite/probable stent thrombosis, and major/minor bleeding were evaluated at 2 years. A total of 976 (65.2%) patients were classified into TA group and 522 (34.8%) patients into nonthrombus aspiration group. Manual TA was most frequently used in patients with worse initial thrombolysis in myocardial infarction flow. The TA group received less number of stents implanted (1.35 ± 0.62 versus 1.45 ± 0.71, P = 0.005) with bigger size (3.25 ± 0.44 versus 3.11 ± 0.46 mm, P < 0.001) compared with the nonthrombus aspiration group. A higher rate of direct stenting (69.2% versus 43.3%, P < 0.001) with lower rate of postdilatation (13.0% versus 18.0%, P < 0.009) was also present in the TA group compared with the nonthrombus aspiration group. At 2-year follow-up, no differences in clinical end point were observed between groups.

CONCLUSIONS

Manual TA during primary percutaneous coronary intervention is associated with a higher rate of direct stenting, a lower rate of postdilatation, and larger and less stents in comparison with conventional primary percutaneous coronary intervention. Conversely, manual TA had no apparent impact on clinical outcomes at long-term follow-up.

CLINICAL TRIAL REGISTRATION

http://www.clinicaltrials.gov. Unique identifier: NCT00828087.

摘要

背景

在急性 ST 段抬高型心肌梗死的经皮冠状动脉介入治疗中,手动血栓抽吸(TA)可有效降低血栓负荷。本研究旨在评估手动 TA 对经皮冠状动脉介入治疗中支架植入的影响。

方法和结果

EXAMINATION 试验(n=1498)的人群根据 TA 的使用情况分为 2 组。立即进行血管造影结果、主要以患者为导向的终点(全因死亡、心肌梗死和任何血运重建的组合)和次要以器械为导向的终点(心脏死亡、靶血管心肌梗死和临床驱动的靶病变血运重建的组合)、确定/可能的支架血栓形成以及主要/次要出血在 2 年内进行评估。共有 976(65.2%)名患者被归入 TA 组,522(34.8%)名患者归入非血栓抽吸组。手动 TA 最常应用于初始心肌梗死溶栓血流较差的患者。TA 组植入的支架数量较少(1.35±0.62 个 vs. 1.45±0.71 个,P=0.005),支架尺寸较大(3.25±0.44 毫米 vs. 3.11±0.46 毫米,P<0.001)。与非血栓抽吸组相比,TA 组直接支架置入率更高(69.2% vs. 43.3%,P<0.001),后扩张率更低(13.0% vs. 18.0%,P<0.009)。在 2 年随访期间,两组间临床终点无差异。

结论

与常规经皮冠状动脉介入治疗相比,直接支架置入率更高,后扩张率更低,支架尺寸更大,支架数量更少,提示在急性 ST 段抬高型心肌梗死的经皮冠状动脉介入治疗中应用手动 TA。然而,长期随访中手动 TA 对临床结果似乎没有明显影响。

临床试验注册

http://www.clinicaltrials.gov。唯一标识符:NCT00828087。

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