急性 ST 段抬高型心肌梗死的早期冠状动脉愈合：载雷帕霉素洗脱支架与药物涂层球囊治疗金属裸支架后。PEBSI-2 光学相干断层成像随机研究。

Early coronary healing in ST segment elevation myocardial infarction: sirolimus-eluting stents vs. drug-coated balloons after bare-metal stents. The PEBSI-2 optical coherence tomography randomized study.

机构信息

Interventional Cardiology, Hospital Puerta de Hierro Majadahonda.

Interventional Cardiology, Hospital Clínico San Carlos, Madrid.

出版信息

Coron Artery Dis. 2021 Dec 1;32(8):673-680. doi: 10.1097/MCA.0000000000001038.

DOI:10.1097/MCA.0000000000001038

PMID:33826537

Abstract

OBJECTIVES

Drug-coated balloons (DCBs) have theoretical advantages over drug-eluting stents (DESs) to facilitate stent healing. We studied whether, in patients undergoing primary coronary interventions (pPCIs), a strategy of DCB after bare-metal stent improves early healing as determined by optical coherence tomography (OCT) compared with new-generation DES.

METHODS

pPCI patients were randomized (1:1) to treatment with new-generation sirolimus-eluting stents (DES group) or DCB-strategy. Vessel healing was assessed by OCT at 90 days.

RESULTS

Fifty-three patients were randomized (26 DES vs. 27 DCB). At 90 days, both strategies showed a low rate of uncovered struts (3.2 vs. 3.2%, P = 0.64) and a very high and similar rate of covered and apposed struts (96.6 vs. 96.1%, respectively; P = 0.58). However, DCB group had a significantly lower rate of major coronary evaginations (68 vs. 37%, P = 0.026), and more frequently developed a thin homogeneous neointimal layer (20 vs. 70.4%, P = 0.001) suggesting distinct superior healing at 3 months compared to DES.

CONCLUSIONS

In pPCI both, sirolimus-DES and DCB-strategy, provide excellent strut coverage at 3 months. However, DCB ensures more advanced and optimal stent healing compared to sirolimus-DES. Further research is needed to determine whether, in patients undergoing pPCI, DCB offers superior long-term clinical and angiographic outcomes than new-generation DES (NCT03610347).

摘要

目的

药物涂层球囊（DCB）在促进支架愈合方面具有优于药物洗脱支架（DES）的理论优势。我们研究了在接受直接经皮冠状动脉介入治疗（pPCI）的患者中，与新一代 DES 相比，裸金属支架（BMS）后使用 DCB 的策略是否能通过光学相干断层扫描（OCT）确定的早期愈合。

方法

pPCI 患者被随机（1:1）分为接受新一代西罗莫司洗脱支架（DES 组）或 DCB 策略治疗。使用 OCT 在 90 天时评估血管愈合情况。

结果

53 名患者被随机分组（DES 组 26 例，DCB 组 27 例）。90 天时，两种策略的无覆盖支架比例均较低（3.2%比 3.2%，P=0.64），且有很高且相似的覆盖和对合支架比例（分别为 96.6%和 96.1%，P=0.58）。然而，DCB 组主要冠状动脉外凸的发生率明显较低（68%比 37%，P=0.026），且更频繁地形成薄而均匀的新生内膜层（20%比 70.4%，P=0.001），提示与 DES 相比，在 3 个月时具有明显更好的愈合效果。

结论

在 pPCI 中，西罗莫司-DES 和 DCB 策略在 3 个月时均可提供出色的支架覆盖率。然而，与西罗莫司-DES 相比，DCB 可确保更先进和更理想的支架愈合。需要进一步的研究来确定在接受 pPCI 的患者中，DCB 是否比新一代 DES 提供更好的长期临床和血管造影结果（NCT03610347）。