CONFIRM 注册研究的汇总分析：糖尿病患者行外周动脉疾病旋磨术治疗的安全性结局。

Pooled analysis of the CONFIRM registries: safety outcomes in diabetic patients treated with orbital atherectomy for peripheral artery disease.

机构信息

1 UCLA Medical Center, Los Angeles, California, USA.

出版信息

J Endovasc Ther. 2014 Apr;21(2):258-65. doi: 10.1583/13-4449MR.1.

DOI:10.1583/13-4449MR.1

PMID:24754286

Abstract

PURPOSE

To compare the acute outcomes of orbital atherectomy treatment in diabetic vs. non-diabetic patients with peripheral artery disease (PAD).

METHODS

The CONFIRM registry series contained 1842 diabetic patients (1111 men; mean age 70.6±10.2 years) with 2819 lesions and 1247 non-diabetic patients (732 men; mean age 72.9±10.7 years) with 1885 lesions. The composite rate of procedure-related complications, including dissection, perforation, slow flow, vessel closure, spasm, embolism, and thrombus formation, was analyzed for the diabetic and non-diabetic groups.

RESULTS

Diabetics were younger but had a higher prevalence of coronary artery disease (p<0.001), renal disease (p<0.001), hypertension (p<0.001), hyperlipidemia (p<0.001), and lower ankle-brachial index scores (p=0.007). Diabetics had more severe PAD (Rutherford category 4-6; p<0.001), longer lesions (p<0.001), more infrapopliteal lesions (58% vs. 46%, p<0.001), and more lesions with severe and moderate calcium (86% vs. 78%, p<0.001). Diabetic and non-diabetic patients had the same (21.8%) composite rate of procedure-related complications, as well as similar rates of dissection (11.4% vs. 10.8%, p=0.68), embolism (2.2% vs. 2.4%, p=0.67), and thrombus formation (1.3% vs. 1.1%, p=0.75). However, diabetics had lower rates of perforation (0.5% vs. 1.1%, p=0.03) and spasm (5.5% vs. 7.6%, p=0.005), but a higher rate of slow flow (5.0% vs. 3.5%, p=0.02) and a tendency toward increased vessel closure (1.7% vs. 0.9%, p=0.06).

CONCLUSION

Plaque modification with orbital atherectomy resulted in similar low procedure-related complication rates in both the diabetic and non-diabetic groups, despite diabetics having more unfavorable baseline clinical and lesion characteristics. This study suggests that orbital atherectomy is a safe and effective treatment modality in both the diabetic and the non-diabetic populations.

摘要

目的

比较糖尿病与非糖尿病外周动脉疾病（PAD）患者行眼眶动脉切除术的急性结局。

方法

CONFIRM 登记研究包含 1842 例糖尿病患者（1111 例男性；平均年龄 70.6±10.2 岁）和 2819 处病变，以及 1247 例非糖尿病患者（732 例男性；平均年龄 72.9±10.7 岁）和 1885 处病变。分析了糖尿病组和非糖尿病组中与手术相关的并发症（夹层、穿孔、血流缓慢、血管闭塞、痉挛、栓塞和血栓形成）的综合发生率。

结果

糖尿病患者更年轻，但冠心病（p<0.001）、肾病（p<0.001）、高血压（p<0.001）、高脂血症（p<0.001）和踝肱指数评分（p=0.007）更低。糖尿病患者 PAD 更严重（Rutherford 4-6 级；p<0.001），病变更长（p<0.001），更易发生腘下病变（58% vs. 46%，p<0.001），且严重和中度钙化病变更多（86% vs. 78%，p<0.001）。糖尿病和非糖尿病患者的与手术相关的并发症综合发生率相同（21.8%），夹层发生率（11.4% vs. 10.8%，p=0.68）、栓塞发生率（2.2% vs. 2.4%，p=0.67）和血栓形成发生率（1.3% vs. 1.1%，p=0.75）也相似。然而，糖尿病患者穿孔发生率（0.5% vs. 1.1%，p=0.03）和痉挛发生率（5.5% vs. 7.6%，p=0.005）更低，但血流缓慢发生率（5.0% vs. 3.5%，p=0.02）和血管闭塞发生率（1.7% vs. 0.9%，p=0.06）更高。