使用Stentys自贴附冠状动脉支架治疗由分叉罪犯病变引起的ST段抬高型心肌梗死患者的一年临床结局：APPOSITION III研究结果

One-Year Clinical Outcomes of Patients Presenting With ST-Segment Elevation Myocardial Infarction Caused by Bifurcation Culprit Lesions Treated With the Stentys Self-Apposing Coronary Stent: Results From the APPOSITION III Study.

作者信息

Grundeken Maik J, Lu Huangling, Vos Nicola, IJsselmuiden Alexander, van Geuns Robert-Jan, Wessely Rainer, Dengler Thomas, La Manna Alessio, Silvain Johanne, Montalescot Gilles, Spaargaren René, Tijssen Jan G P, de Winter Robbert J, Wykrzykowska Joanna J, Amoroso Giovanni, Koch Karel T

机构信息

Department of Cardiology, Academic Medical Center, Cardiac Catheterization Laboratory, Room B2-125, Meibergdreef 9, 1105 AZ Amsterdam, the Netherlands.

出版信息

J Invasive Cardiol. 2017 Aug;29(8):253-258.

PMID:28756418

Abstract

OBJECTIVE

To investigate outcomes in patients with ST-segment elevation myocardial infarction (STEMI) after treatment with the Stentys self-apposing stent (Stentys SAS; Stentys S.A.) for bifurcation culprit lesions.

BACKGROUND

The nitinol, self-expanding Stentys was initially developed as a dedicated bifurcation stent. The stent facilitates a provisional strategy by accommodating its diameter to both the proximal and distal reference diameters and offering an opportunity to "disconnect" the interconnectors, opening the stent toward the side branch.

METHODS

The APPOSITION (a post-market registry to assess the Stentys self-expanding coronary stent in acute myocardial infarction) III study was a prospective, multicenter, international, observational study including STEMI patients undergoing primary percutaneous coronary intervention (PCI) with the Stentys SAS. Clinical endpoints were evaluated and stratified by bifurcation vs non-bifurcation culprit lesions.

RESULTS

From 965 patients included, a total of 123 (13%) were documented as having a bifurcation lesion. Target-vessel revascularization (TVR) rates were higher in the bifurcation subgroup (16.4% vs 10.0%; P=.04). Although not statistically significant, other endpoints were numerically higher in the bifurcation subgroup: major adverse cardiac events (MACE; 12.7% vs 8.8%), myocardial infarction (MI; 3.4% vs 1.8%), and definite/probable stent thrombosis (ST; 5.8% vs 3.1%). However, when postdilation was performed, clinical endpoints were similar between bifurcation and non-bifurcation lesions: MACE (8.7% vs 8.4%), MI (1.2% vs 0.7%), and definite/probable ST (3.7% vs 2.4%).

CONCLUSIONS

The use of the Stentys SAS was safe and feasible for the treatment of bifurcation lesions in the setting of primary PCI for STEMI treatment with acceptable 1-year cardiovascular event rates, which improved when postdilation was performed.

摘要

目的

研究采用Stentys自膨式支架（Stentys SAS；Stentys公司）治疗分叉罪犯病变的ST段抬高型心肌梗死（STEMI）患者的预后。

背景

镍钛诺自膨式Stentys最初是作为一种专用分叉支架开发的。该支架通过使其直径适应近端和远端参考直径，并提供“断开”互连器的机会，向侧支开放支架，从而促进一种临时策略。

方法

APPOSITION（一项评估Stentys自膨式冠状动脉支架在急性心肌梗死中的上市后注册研究）III研究是一项前瞻性、多中心、国际性观察性研究，纳入了使用Stentys SAS进行直接经皮冠状动脉介入治疗（PCI）的STEMI患者。临床终点根据分叉与非分叉罪犯病变进行评估和分层。

结果

在纳入的965例患者中，共有123例（13%）被记录为患有分叉病变。分叉亚组的靶血管血运重建（TVR）率较高（16.4%对10.0%；P=0.04）。虽然无统计学意义，但分叉亚组的其他终点在数值上更高：主要不良心脏事件（MACE；12.7%对8.8%）、心肌梗死（MI；3.4%对1.8%）和明确/可能的支架血栓形成（ST；5.8%对3.1%）。然而，当进行后扩张时，分叉病变和非分叉病变的临床终点相似：MACE（8.7%对8.4%）、MI（1.2%对0.7%）和明确/可能的ST（3.7%对2.4%）。