University of Western Australia, School of Surgery, Perth, Australia; Department of Vascular Surgery, Royal Perth Hospital, Perth, Australia.
Department of Vascular Surgery, Royal Perth Hospital, Perth, Australia.
Ann Vasc Surg. 2021 Aug;75:237-252. doi: 10.1016/j.avsg.2021.02.050. Epub 2021 Apr 5.
This study aims to assess the use of drug-coated balloon (DCB) in a large patient population under real-world conditions and, specifically, analyse the impact of diabetes mellitus on long term outcomes following DCB utilisation.
BIOLUX P-III is a prospective, international, multicentre, registry that was conducted at 41 centres. The present study is a 24-month subgroup analysis of patients with diabetes mellitus having infrainguinal lesions treated with the Passeo-18 Lux DCB. The primary endpoints were freedom from major adverse events (MAEs) within 6 months of intervention and freedom from clinically driven target lesion revascularisation (CD-TLR) within 12 months of intervention.
Of the 882 patients in the registry, 418 had diabetes (516 lesions). Most diabetics had concomitant hypertension (88.8%) and hyperlipidaemia (70.3%). Insulin dependence was observed in 48.8% of diabetics. Moreover, smoking (62.2%) and chronic renal insufficiency (41.9%) were also found to be common in this cohort. Chronic limb threatening ischemia (Rutherford class ≥4) was present in 53.1% of all patients. 22.9% of lesions were infrapopliteal, while 22.5% of lesions were treated for in-stent restenosis. The mean target lesion length was 85.6 ± 73.2 mm, and 79.4% of lesions were calcified (of which 17.9% were heavily calcified). Overall, device success was 99.7%. Freedom from MAEs was 90.5% (95% confidence interval (95% CI): 87.2-93.0) at 6 months, 85.4% (95% CI: 81.5-88.6) at 12 months and 80% (95% CI: 75.5-83.8) at 24 months. Freedom from CD-TLR was 95.9% (95% CI: 93.8-97.4), 91.6% (95% CI: 88.7-93.8), and 87.1% (95% CI: 83.5-89.9) at 6, 12, and 24 months, respectively. All-cause mortality at 24 months in diabetics was 16.0% (95% CI: 12.6-20.2), and major target limb amputation was 6.1% (95% CI: 4.1-8.9), which was significantly higher than in non-diabetics (8.4% (95% CI: 6.0-11.6), P = 0.0005 and 1.2% (95% CI: 0.5-2.9), P <0.0001, respectively). At 24 months, 82.0% of patients had improved by ≥1 Rutherford class.
Treatment of a real-world diabetic patient population with the Passeo-18 Lux DCB resulted in high efficacy and low complication rates, despite the fact that diabetic patients usually suffer from a multitude of concomitant comorbidities.
NCT02276313.
本研究旨在评估在真实世界环境下大量患者人群中使用药物涂层球囊（DCB）的情况，并特别分析糖尿病对 DCB 治疗后长期结果的影响。
BIOLUX P-III 是一项前瞻性、国际性、多中心注册研究，在 41 个中心进行。本研究是对患有下肢缺血性疾病且接受 Passeo-18 Lux DCB 治疗的糖尿病患者的 24 个月亚组分析。主要终点是干预后 6 个月内无重大不良事件（MAE）和干预后 12 个月内无临床驱动的靶病变血运重建（CD-TLR）。
在登记处的 882 名患者中，418 名患有糖尿病（516 处病变）。大多数糖尿病患者伴有高血压（88.8%）和高脂血症（70.3%）。48.8%的糖尿病患者依赖胰岛素。此外，在这一队列中还发现吸烟（62.2%）和慢性肾功能不全（41.9%）也很常见。所有患者中慢性肢体威胁性缺血（Rutherford 分级≥4）占 53.1%。22.9%的病变位于腘下，22.5%的病变是治疗支架内再狭窄。平均靶病变长度为 85.6±73.2mm，79.4%的病变有钙化（其中 17.9%为重度钙化）。总体而言，器械成功率为 99.7%。干预后 6 个月 MAE 无事件率为 90.5%（95%置信区间（95%CI）：87.2-93.0），12 个月为 85.4%（95%CI：81.5-88.6），24 个月为 80%（95%CI：75.5-83.8）。干预后 6、12 和 24 个月的 CD-TLR 无事件率分别为 95.9%（95%CI：93.8-97.4）、91.6%（95%CI：88.7-93.8）和 87.1%（95%CI：83.5-89.9）。24 个月时糖尿病患者的全因死亡率为 16.0%（95%CI：12.6-20.2），主要目标肢体截肢率为 6.1%（95%CI：4.1-8.9），明显高于非糖尿病患者（8.4%（95%CI：6.0-11.6），P=0.0005 和 1.2%（95%CI：0.5-2.9），P<0.0001）。24 个月时，82.0%的患者至少改善了 1 个 Rutherford 分级。
尽管糖尿病患者通常患有多种并存的合并症，但使用 Passeo-18 Lux DCB 治疗真实世界的糖尿病患者人群可获得高疗效和低并发症发生率。
NCT02276313。
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