糖尿病患者使用含可生物降解聚合物的第三代药物洗脱支架：5年随访

Third generation drug eluting stent (DES) with biodegradable polymer in diabetic patients: 5 years follow-up.

作者信息

Wiemer Marcus, Stoikovic Sinisa, Samol Alexander, Dimitriadis Zisis, Ruiz-Nodar Juan M, Birkemeyer Ralf, Monsegu Jacques, Finet Gérard, Hildick-Smith David, Tresukosol Damras, Novo Enrique Garcia, Koolen Jacques J, Barbato Emanuele, Danzi Gian Battista

机构信息

Department of Cardiology and Intensive Care Medicine, Johannes Wesling University Hospital, Ruhr University Bochum, Hans-Nolte-Str. 1, 32429, Minden, Germany.

Clinic for Cardiology, Clinical Center of Serbia, School of Medicine, University of Belgrade, Belgrade, Serbia.

出版信息

Cardiovasc Diabetol. 2017 Feb 10;16(1):23. doi: 10.1186/s12933-017-0500-3.

OBJECTIVE

To report the long-term safety and efficacy data of a third generation drug eluting stent (DES) with biodegradable polymer in the complex patient population of diabetes mellitus after a follow-up period of 5 years.

BACKGROUND

After percutaneous coronary intervention patients with diabetes mellitus are under higher risk of death, restenosis and stent thrombosis (ST) compared to non-diabetic patients.

METHODS

In 126 centers worldwide 3067 patients were enrolled in the NOBORI 2 registry, 888 patients suffered from diabetes mellitus (DM), 213 of them (14%) being insulin dependent (IDDM). Five years follow-up has been completed in this study.

RESULTS

At 5 years, 89.3% of the patients were available for follow-up. The reported target lesion failure (TLF) rates at 5 years were 12.39% in DM group and 7.34% in non-DM group; (p < 0.0001). In the DM group, the TLF rate in patients with IDDM was significantly higher than in the non-IDDM subgroup (17.84 vs. 10.67%; p < 0.01). The rate of ST at 5 years was not different among diabetic versus non-diabetic patients or IDDM versus NIDDM. Only 10 (<0.4%) very late stent thrombotic events beyond 12 months occurred.

CONCLUSIONS

The Nobori DES performed well in patients with DM. As expected patients with DM, particularly those with IDDM, had worse outcomes. However, the very low rate of very late stent thrombosis in IDDM patients might have significant clinical value in the treatment of these patients. Clinical trial registration ISRCTN81649913; http://www.controlled-trials.com/isrctn/search.html?srch=81649913&sort=3&dir=desc&max=10.

目的

报告在糖尿病复杂患者群体中使用可生物降解聚合物的第三代药物洗脱支架（DES）5年随访期后的长期安全性和有效性数据。

背景

与非糖尿病患者相比，经皮冠状动脉介入治疗后的糖尿病患者死亡、再狭窄和支架血栓形成（ST）风险更高。

方法

全球126个中心的3067例患者纳入了NOBORI 2注册研究，888例患者患有糖尿病（DM），其中213例（14%）为胰岛素依赖型（IDDM）。本研究已完成5年随访。

结果

5年时，89.3%的患者可供随访。报告的5年时靶病变失败（TLF）率在DM组为12.39%，在非DM组为7.34%；（p<0.0001）。在DM组中，IDDM患者的TLF率显著高于非IDDM亚组（17.84%对10.67%；p<0.01）。5年时ST发生率在糖尿病患者与非糖尿病患者之间或IDDM患者与非IDDM患者之间无差异。仅发生了10例（<0.4%）超过12个月的极晚期支架血栓形成事件。

结论

Nobori DES在DM患者中表现良好。正如预期的那样，DM患者，尤其是IDDM患者，预后较差。然而，IDDM患者极低的极晚期支架血栓形成率在这些患者的治疗中可能具有重要的临床价值。临床试验注册号ISRCTN81649913；http://www.controlled-trials.com/isrctn/search.html?srch=81649913&sort=3&dir=desc&max=10 。