Das Tony S, McNamara Thomas, Gray Bruce, Sedillo Gino J, Turley Brian R, Kollmeyer Kenneth, Rogoff Michael, Aruny John E
Cardiology & Interventional Vascular Associates, Presbyterian Heart Institute, 7150 Greenville Avenue, Suite 500, Dallas, TX 75231, USA.
J Endovasc Ther. 2009 Apr;16(2 Suppl 2):II19-30. doi: 10.1583/08-2652.1.
To report the 12-month follow-up data from the prospective 16-center Below-the-Knee (BTK) Chill Trial, which examined the use of primary cryoplasty for BTK occlusive disease in patients with critical limb ischemia (CLI).
The trial included 108 patients (77 men; mean age 73 +/- 11 years, range 41-101) with CLI (Rutherford categories 4-6) involving 111 limbs with 115 target infrapopliteal lesions. Angiographic inclusion criteria were reference vessel diameter > or = 2.5 mm and < or = 5.0 mm and target lesion stenosis > or = 50%. The primary study endpoints were acute technical success (the ability to achieve < or = 50% residual stenosis and continuous inline flow to the foot) and absence of major amputation of the target limb at 6 months. Secondary endpoints were serious adverse events specifically related to use of primary cryoplasty and absence of major amputation of the target limb at 1, 3, and 12 months.
Acute technical success was achieved in 108 (97.3%) of treated limbs, with only 1 clinically significant dissection (> or = type C) and 2 residual stenoses >50%; stent placement was required following cryoplasty in only 3 (2.7%) procedures. At 6 months and 1 year, major amputation was avoided in 93.4% (85/91) and 85.2% (69/81) of patients, respectively. Through 1 year, 21% (17/81) of patients underwent target limb revascularization. Rates of major amputation and death at 1 year were 0% for limbs of patients with initial Rutherford category 4; 11.4% and 0%, respectively, for initial category 5; and 40.0% and 31.8% for initial category 6. One-year rates of major amputation and death were 20.4% and 8.8%, respectively, for diabetics, versus 4.0% and 10.7% for non-diabetics. At 1 year, major amputation occurred in 16.7% (2/12) of limbs that were expected to be amputated at the time of treatment.
Cryoplasty therapy is a safe and effective method of treating infrapopliteal disease, providing excellent results and a high rate of limb salvage in patients with CLI. Study outcomes through 1 year support the use of cryoplasty as a primary treatment option for patients with CLI secondary to BTK occlusive disease.
报告前瞻性16中心膝下（BTK）低温治疗试验的12个月随访数据，该试验研究了原发性低温成形术在严重肢体缺血（CLI）患者的BTK闭塞性疾病中的应用。
该试验纳入了108例患者（77例男性；平均年龄73±11岁，范围41 - 101岁），患有CLI（卢瑟福分级4 - 6级），累及111条肢体，有115个目标腘下病变。血管造影纳入标准为参考血管直径≥2.5 mm且≤5.0 mm，目标病变狭窄≥50%。主要研究终点为急性技术成功（实现残余狭窄≤50%且足部持续直线血流的能力）以及6个月时目标肢体无大截肢。次要终点为与原发性低温成形术使用特别相关的严重不良事件以及1、3和12个月时目标肢体无大截肢。
108条（97.3%）治疗肢体实现了急性技术成功，仅1例具有临床意义的夹层（≥C型）和2例残余狭窄>50%；仅3例（2.7%）手术在低温成形术后需要放置支架。在6个月和1年时，分别有93.4%（85/91）和85.2%（69/81）的患者避免了大截肢。至1年时，21%（17/81）的患者接受了目标肢体血管重建。初始卢瑟福分级4级患者的肢体1年时大截肢率和死亡率均为0%；初始分级5级患者分别为11.4%和0%；初始分级6级患者分别为40.0%和31.8%。糖尿病患者的肢体1年时大截肢率和死亡率分别为20.4%和8.8%，而非糖尿病患者分别为4.0%和10.7%。在1年时，预计治疗时会截肢的肢体中有16.7%（2/12）发生了大截肢。
低温成形术治疗是治疗腘下疾病的一种安全有效的方法，在CLI患者中能提供优异的结果和较高的肢体挽救率。1年的研究结果支持将低温成形术作为BTK闭塞性疾病继发CLI患者的主要治疗选择。
