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替格瑞洛与氯吡格雷用于股腘动脉紫杉醇洗脱支架植入患者的比较:一项使用频域光学相干断层扫描的随机试验研究

Ticagrelor versus clopidogrel in patients undergoing implantation of paclitaxel-eluting stent in the femoropopliteal district: A randomized pilot study using frequency-domain optical coherence tomography.

作者信息

Ducci Kenneth, Liistro Francesco, Porto Italo, Ventoruzzo Giorgio, Angioli Paolo, Falsini Giovanni, Vergallo Rocco, Bolognese Leonardo

机构信息

Cardio-Neuro-Vascular Department, Ospedale S. Donato, Arezzo, Italy.

Cardio-Neuro-Vascular Department, Ospedale S. Donato, Arezzo, Italy.

出版信息

Int J Cardiol. 2020 Apr 1;304:192-197. doi: 10.1016/j.ijcard.2020.01.024. Epub 2020 Jan 15.

Abstract

OBJECTIVES

Aim of this study was to evaluate different response in platelet reactivity and vessel healing using high-resolution frequency-domain optical coherence tomography (FD-OCT) in patients with femoropopliteal artery disease treated with ZILVER PTX drug eluting stents (DES), and randomly assigned to clopidogrel or ticagrelor for 12 months.

BACKGROUND

The optimal antithrombotic regimen for long-term management of patients with peripheral artery disease (PAD) after revascularization is poorly defined and often extrapolated from trials performed on patients undergoing percutaneous coronary intervention.

METHODS

In this single center randomized trial 40 patients with femoropopliteal artery disease treated with ZILVER PTX DES stents, were randomized to Ticagrelor (T) + Aspirin for 3 months, subsequently continuing Ticagrelor alone for another 9 months or Clopidogrel (C) + Aspirin for 3 months, subsequently continuing Clopidogrel alone for 9 months. Platelet reactivity via the P2Y12 pathway was evaluated at baseline and at 3 months follow-up, angiographic and FD-OCT follow-up along the entire stented segment was performed at 12 months.

RESULTS

No significant difference between T and C group was found concerning net percentage volume obstruction (29.7% ± 17.6% vs. 31.2% ± 10.7%; p = 0.78). FD-OCT at 12 months showed a high percentage of uncovered stent struts in both groups: 24.2% ± 32.8% in the T group vs 15.3% ± 15.8% in the C group (p = 0.4). Mean values of platelet reactivity units (PRU) at 3 month follow-up were 81 ± 72 in the T group and 200 ± 61 in the C group (p < 0.001).

CONCLUSIONS

Significantly higher platelet reactivity remains in patients treated with clopidogrel as compared to ticagrelor 3 months after PTA and stent implantation. Ticagrelor does not reduce neointimal proliferation in patients treated with DES in the femoropopliteal district as compared with clopidogrel. A large amount of uncovered stent struts at 12-month follow-up was found in these patients regardless of the antiplatelet treatment assumed.

摘要

目的

本研究旨在使用高分辨率频域光学相干断层扫描(FD - OCT)评估接受ZILVER PTX药物洗脱支架(DES)治疗的股腘动脉疾病患者在血小板反应性和血管愈合方面的不同反应,并随机分配接受氯吡格雷或替格瑞洛治疗12个月。

背景

外周动脉疾病(PAD)患者血管重建后长期管理的最佳抗血栓治疗方案尚不明确,且常从经皮冠状动脉介入治疗患者的试验中推断而来。

方法

在这项单中心随机试验中,40例接受ZILVER PTX DES支架治疗的股腘动脉疾病患者被随机分为替格瑞洛(T)+阿司匹林治疗3个月,随后单独继续使用替格瑞洛9个月,或氯吡格雷(C)+阿司匹林治疗3个月,随后单独继续使用氯吡格雷9个月。在基线和3个月随访时评估通过P2Y12途径的血小板反应性,在12个月时对整个支架段进行血管造影和FD - OCT随访。

结果

在净百分比体积阻塞方面,T组和C组之间未发现显著差异(29.7%±17.6%对31.2%±10.7%;p = 0.78)。12个月时的FD - OCT显示两组中未覆盖支架支柱的比例都很高:T组为24.2%±32.8%,C组为15.3%±15.8%(p = 0.4)。3个月随访时血小板反应性单位(PRU)的平均值在T组为81±72,在C组为200±61(p < 0.001)。

结论

与替格瑞洛相比,经皮腔内血管成形术(PTA)和支架植入3个月后,接受氯吡格雷治疗的患者血小板反应性显著更高。与氯吡格雷相比,替格瑞洛在股腘区接受DES治疗的患者中并未减少新生内膜增殖。无论采用何种抗血小板治疗,在这些患者12个月随访时均发现大量未覆盖的支架支柱。

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