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颈动脉支架置入术中单药与双联抗血小板治疗的疗效和安全性。

Efficacy and safety of single versus dual antiplatelet therapy in carotid artery stenting.

机构信息

Division of Vascular and Endovascular Surgery, Department of Surgery, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA.

Division of Vascular and Endovascular Surgery, Department of Surgery, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA; Department of Vascular Surgery, Erasmus University Medical Centre, Rotterdam, The Netherlands.

出版信息

J Vasc Surg. 2023 May;77(5):1434-1446.e11. doi: 10.1016/j.jvs.2022.12.034. Epub 2022 Dec 26.

Abstract

OBJECTIVE

Current guidelines recommend dual antiplatelet (AP) therapy (DAPT) before carotid artery stenting (CAS); however, the true clinical effect of single AP therapy vs DAPT is unknown. We examined the efficacy and safety of preoperative single AP therapy vs DAPT in patients who had undergone transfemoral CAS (tfCAS) or transcarotid artery revascularization (TCAR).

METHODS

We identified all patients who had undergone tfCAS or TCAR in the Vascular Quality Initiative database from 2016 to 2021. We stratified the patients by procedure and identified those who had received the following preoperative AP regimens: DAPT (acetylsalicylic acid [ASA] + P2Y12 inhibitor [P2Yi]), no AP therapy, ASA only, ASA + AP loading dose, P2Yi only, and P2Yi + AP loading dose. The AP loading dose was given within 4 hours of CAS. We generated propensity scores for each treatment regimen and assessed in-hospital outcomes using inverse probability weighted log binomial regression, with DAPT as the reference and adjusting for intraoperative protamine use. The primary efficacy outcome was a composite end point of stroke and death, and the primary safety outcome was access-related bleeding.

RESULTS

Of the 18,570 tfCAS patients, 70% had received DAPT, 5.6% no AP therapy, 10% ASA only, 8.0% ASA + AP loading dose, 4.6% P2Yi only, and 2.9% P2Yi + AP loading dose. The corresponding unadjusted rates of stroke/death were 2.2%, 6.8%, 4.1%, 5.1%, 2.4%, and 2.3%. After adjustment, compared with DAPT, the incidence of stroke/death was higher with no AP therapy (relative risk [RR], 2.3; 95% confidence interval [CI], 1.7-3.2), ASA only (RR, 1.6; 95% CI, 1.2-2.1), and ASA + AP loading dose (RR, 2.0; 95% CI, 1.5-2.7) but was similar with P2Yi only (RR, 0.99; 95% CI, 0.58-1.7) and P2Yi + AP loading dose (RR, 1.1; 95% CI, 0.49-2.5). Of the 25,459 TCAR patients, 81% had received DAPT, 2.0% no AP therapy, 5.5% ASA only, 3.5% ASA + AP loading dose, 4.9% P2Yi only, and 2.4% P2Yi + AP loading dose. The corresponding unadjusted rates of stroke/death were 1.5%, 3.3%, 3.3%, 2.9%, 1.2%, and 1.1%. After adjustment, compared with DAPT, the incidence of stroke/death was higher with no AP therapy (RR, 2.0; 95% CI, 1.2-3.3) and ASA only (RR, 2.2; 95% CI, 1.5-3.1), with a trend toward a higher incidence with ASA + AP loading dose (RR, 1.6; 95% CI, 0.99-2.6), and was similar with P2Yi only (RR, 0.98; 95% CI, 0.54-1.8) and P2Yi + AP loading dose (RR, 0.66; 95% CI, 0.27-1.6). No differences were found in the incidence of access-related bleeding between the treatment groups after tfCAS or TCAR.

CONCLUSIONS

Compared with DAPT, no AP therapy or ASA monotherapy was associated with higher rates of stroke/death after CAS and should be discouraged as unsafe practice. Meanwhile, P2Yi monotherapy was associated with similar rates of stroke/death. No differences were found in the incidence of bleeding complications, and adding an AP loading dose to ASA or P2Yi monotherapy within 4 hours of the procedure did not affect the outcomes. Overall, these findings support the current guidelines recommending DAPT before CAS but also suggest that P2Yi monotherapy might confer thromboembolic benefits similar to those with DAPT. However, an immediate preoperative AP loading dose might not provide additional thromboembolic benefits.

摘要

目的

目前的指南建议在颈动脉支架置入术(CAS)前进行双联抗血小板(AP)治疗(DAPT);然而,单一 AP 治疗与 DAPT 的真实临床效果尚不清楚。我们研究了术前单一 AP 治疗与 DAPT 在接受经股动脉 CAS(tfCAS)或经颈动脉血运重建术(TCAR)的患者中的疗效和安全性。

方法

我们从 2016 年至 2021 年在血管质量倡议数据库中确定了所有接受 tfCAS 或 TCAR 的患者。我们按手术方式对患者进行分层,并确定了以下术前 AP 治疗方案的患者:DAPT(乙酰水杨酸[ASA]+P2Y12 抑制剂[P2Yi])、无 AP 治疗、ASA 单药、ASA+AP 负荷剂量、P2Yi 单药和 P2Yi+AP 负荷剂量。AP 负荷剂量在 CAS 前 4 小时内给予。我们为每个治疗方案生成倾向评分,并使用逆概率加权对数二项式回归评估住院期间的结局,以 DAPT 为参照,并调整术中使用鱼精蛋白。主要疗效终点是卒中和死亡的复合终点,主要安全性终点是与通路相关的出血。

结果

在 18570 例 tfCAS 患者中,70%接受了 DAPT,5.6%无 AP 治疗,10%ASA 单药,8.0%ASA+AP 负荷剂量,4.6%P2Yi 单药,2.9%P2Yi+AP 负荷剂量。未调整的卒中和死亡率分别为 2.2%、6.8%、4.1%、5.1%、2.4%和 2.3%。调整后,与 DAPT 相比,无 AP 治疗(相对风险[RR],2.3;95%置信区间[CI],1.7-3.2)、ASA 单药(RR,1.6;95%CI,1.2-2.1)和 ASA+AP 负荷剂量(RR,2.0;95%CI,1.5-2.7)的卒中和死亡率发生率更高,但 P2Yi 单药(RR,0.99;95%CI,0.58-1.7)和 P2Yi+AP 负荷剂量(RR,1.1;95%CI,0.49-2.5)的发生率相似。在 25459 例 TCAR 患者中,81%接受了 DAPT,2.0%无 AP 治疗,5.5%ASA 单药,3.5%ASA+AP 负荷剂量,4.9%P2Yi 单药,2.4%P2Yi+AP 负荷剂量。未调整的卒中和死亡率分别为 1.5%、3.3%、3.3%、2.9%、1.2%和 1.1%。调整后,与 DAPT 相比,无 AP 治疗(RR,2.0;95%CI,1.2-3.3)和 ASA 单药(RR,2.2;95%CI,1.5-3.1)的卒中和死亡率发生率更高,ASA+AP 负荷剂量呈升高趋势(RR,1.6;95%CI,0.99-2.6),与 P2Yi 单药(RR,0.98;95%CI,0.54-1.8)和 P2Yi+AP 负荷剂量(RR,0.66;95%CI,0.27-1.6)相似。在 tfCAS 或 TCAR 后,各组间与通路相关的出血并发症发生率无差异。

结论

与 DAPT 相比,无 AP 治疗或 ASA 单药治疗与 CAS 后卒中和死亡的发生率较高相关,不应作为不安全的治疗方法。同时,P2Yi 单药治疗与卒中和死亡的发生率相似。与通路相关的出血并发症发生率无差异,在手术前 4 小时内给予 ASA 或 P2Yi 负荷剂量不会影响结局。总的来说,这些发现支持目前建议在 CAS 前进行 DAPT 的指南,但也表明 P2Yi 单药治疗可能与 DAPT 具有相似的血栓栓塞获益。然而,AP 负荷剂量的即刻应用可能不会提供额外的血栓栓塞获益。

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