Davaine Jean-Michel, Quérat Julien, Guyomarch Béatrice, Costargent Alain, Chaillou Philippe, Patra Philippe, Gouëffic Yann
CHU de Nantes, l'Institut du thorax, Service de Chirurgie Vasculaire, Nantes, France; Laboratoire de Physiopathologie de la Resorption Osseuse, Inserm UMR 957, Nantes, France.
CHU de Nantes, l'Institut du thorax, Service de Chirurgie Vasculaire, Nantes, France.
Ann Vasc Surg. 2014 Oct;28(7):1686-96. doi: 10.1016/j.avsg.2014.03.033. Epub 2014 Apr 4.
The 1-year results of the prospective register STELLA suggested that primary stenting of long femoropopliteal (FP) lesions (≥15-cm) was a sure and effective treatment. However, the long-term results of this technique remain unknown.
STELLA is a prospective monocentric register of patients treated for FP lesions ≥15-cm (Trans-Atlantic Inter-Society Consensus [TASC] C and D) by direct stenting (Flexstar(®), Bard). The patients with de novo atheromatous lesions were included between November 2008 and October 2009 when the guidewire had crossed the lesion. Restenoses were excluded. The follow-up was coordinated by a clinical research assistant. Clinical and ultrasound evaluation were carried out every 3 months for 12 months, then every 6 months up to 30 months. Restenosis was defined by an index of peak systolic velocity >2.4.
Among the 58 patients (62 limbs) included, 40.3% presented an effort ischemia and 59.7% a critical ischemia (CI). The mean age was 71 ± 12 years. The lesions were classified as TASC D in 37.1% of the cases. The median length of the stenting was 26 ± 18 cm. The average follow-up was 26.1 months (1-30). At 30 months, a complete follow-up was obtained in 55 patients (58 limbs). The rate of survival was 79.6%. Nine of the 11 patients deceased presented initially with CI. Death was in connection with CI in 2 cases. At the date of latest news, 98.3% of the patients were under antiaggregating treatment, 20% received antivitamin K treatment, 75% received statins, and 75% received angiotensin-converting-enzyme inhibitors. The rates of maintenance of the primary and secondary clinical improvement were 68.6 ± 6.0% and 82.6 ± 5.1% at 12 months and 65.1 ± 6.2% and 78.4 ± 5.6% at 30 months, respectively. The mean Rutherford index was 4.1 ± 1.0 in preoperative, 0.7 ± 1.2 at 12 months, and 0.6 ± 1.1 at 30 months (P < 0.001). Two major amputations were carried out at 9 and 28 months for patients initially with CI. The mean systolic pressure index was 0.6 ± 0.1 in preoperative and 1.0 ± 0.2 at 1-year and 0.9 ± 0.3 at 30 months (P < 0.001). The rates of primary and secondary patency were 66 ± 6.3% and 80.9 ± 9.5% at 12 months and 62.2 ± 6.6% and 77.2 ± 5.9% at 30 months, respectively. Between 0 and 12 months, 12 (19.3%) intrastent restenosis (ISR) were noted. One ISR was observed after 12 months. At the same period, we observed 11 and 1 target lesion revascularization, respectively.
In the long run, the primary stenting of long FP lesions (≥15-cm) is a safe and durable treatment. A strong clinical and ultrasound monitoring is indicated during the first year to maintain the clinical improvement.
前瞻性登记研究STELLA的1年结果表明，长段股腘（FP）病变（≥15厘米）的初次支架置入术是一种可靠且有效的治疗方法。然而，该技术的长期结果仍不明确。
STELLA是一项前瞻性单中心登记研究，纳入了通过直接支架置入术（Flexstar(®)，巴德公司）治疗≥15厘米FP病变（跨大西洋两岸血管外科学会共识 [TASC] C级和D级）的患者。2008年11月至2009年10月期间，当导丝穿过病变时，纳入新发动脉粥样硬化病变患者，排除再狭窄患者。随访由临床研究助理协调。在12个月内每3个月进行一次临床和超声评估，然后每6个月进行一次，直至30个月。再狭窄定义为收缩期峰值速度指数>2.4。
纳入的58例患者（62条肢体）中，40.3%表现为运动性缺血，59.7%为严重缺血（CI）。平均年龄为71±12岁。37.1%的病例病变分类为TASC D级。支架置入的中位长度为26±18厘米。平均随访时间为26.1个月（1 - 30个月）。30个月时，55例患者（58条肢体）获得了完整随访。生存率为79.6%。11例死亡患者中有9例最初表现为CI。2例死亡与CI相关。在最新消息日期，98.3%的患者接受抗聚集治疗，20%接受抗维生素K治疗，75%接受他汀类药物治疗，75%接受血管紧张素转换酶抑制剂治疗。12个月时主要和次要临床改善维持率分别为68.6±6.0%和82.6±5.1%，30个月时分别为65.1±6.2%和78.4±5.6%。术前平均卢瑟福指数为4.1±1.0，12个月时为0.7±1.2，30个月时为0.6±1.1（P<0.001）。最初患有CI的患者在9个月和28个月时分别进行了2次大截肢。术前平均收缩压指数为0.6±0.1，1年时为1.0±0.2，30个月时为0.9±0.3（P<0.001）。12个月时初次和二次通畅率分别为66±6.3%和80.9±9.5%，30个月时分别为62.2±6.6%和77.2±5.9%。0至12个月期间，发现12例（19.3%）支架内再狭窄（ISR）。12个月后观察到1例ISR。同期，分别观察到11例和1例靶病变血运重建。
从长远来看，长段FP病变（≥15厘米）的初次支架置入术是一种安全且持久的治疗方法。在第一年需要进行严格的临床和超声监测以维持临床改善。
