PTA and Stent Better Than PTA in Superficial Femoral Artery Disease

　　PTA联合支架置入的1年血管开通率和无靶病变血运重建（TLR）率更佳

       RESILIENT研究结果显示：在股浅动脉疾病且病变长度小于150mm的患者中，经皮腔内动脉成型术联合直接支架置入与单纯PTA相比更加有效而且不良反应更少。
 

　　Baptist心脏血管研究所的创始人及所长，迈阿密大学医学院放射学临床教授Barry T. Katzen医生指出：血管成型术对于较长的、钙化较重的病变效果不佳。但就手术主要不良心血管事件（MACE）、死亡和出血来说，PTA和PTA联合支架置入两者都十分安全。”

　　股动脉疾病

　　Katzen医生及其同事在全世界24个中心共入选206例有长度小于150mm的股浅动脉（SFA）和腘动脉近段病变的患者，患者被随机分配至PTA联合支架（LifeStent，Edwards LifeSciences）组（n=134）和单纯PTA组（n=72）。研究结果显示：在1年内PTA联合支架组患者的血管通畅率为80%，单纯PTA组仅为38%。PTA联合支架组患者的无TLR率为87%，而单纯PTA组仅为46%（如图）。

　　研究者发现PTA联合支架组中85.6%的病变（n=153）被认为病变处理成功（定义为平均残余狭窄小于30%），而单独PTA组仅有71.6%（n=81）。研究将手术成功定义为残余狭窄小于30%，同时没有围手术期并发症。依此标准PTA联合支架组手术成功率为85.1%，而单独PTA组仅有70.8%。

　　生活质量

　　Katzen医生说两组患者在围手术期和30日内没有发生死亡、卒中、心梗、急诊外科血管重建手术、血栓或肾功能衰竭发生。两组中各有两例患者接受了输血治疗，而在单纯PTA组有1例患者出现了明显的远端栓塞。研究者同时发现接受PTA联合支架治疗患者在6个月时生活质量明显提高，一些患者中这一优势一直持续到1年。

　　在单纯PTA组中，29例（40.2%）患者交叉到PTA联合支架组。其中11例是由于球囊扩张后出现严重影响血流的夹层，另外18例是由于残余狭窄大于30%。Katzen医生说：“在这些交叉到PTA联合支架组的患者中病变长度明显长于其他患者，并达到统计学差异。”

　　研究者在1年时共发现9例（2.9%）支架断裂，但是支架断裂并未引起再狭窄。

　　（首都医科大学附属安贞医院　苑飞　编译）

PTA and Stent Better Than PTA in Superficial Femoral Artery Disease

Significant difference in primary patency and freedom from TLR at one year favors PTA plus stent.
 
In patients with superficial femoral artery disease and lesions shorter than 150 mm, treatment with percutaneous transluminal angioplasty plus a primary stent was more effective with fewer adverse events than treatment with PTA alone, according to RESILIENT trial results.

Barry T. Katzen, MD, founder and medical director of the Baptist Cardiac and Vascular Institute and clinical professor of radiology at the University of Miami School of Medicine, said that the longer, more calcified lesions did not respond sufficiently to angioplasty.

“Both arms were extremely safe in terms of procedural major adverse cardiovascular events, death and bleeding. There was no significant difference between these acutely and at 30 days,” Katzen said.

Femoral artery disease

Katzen and colleagues enrolled 206 patients with superficial femoral artery (SFA) disease and proximal
popliteal lesions , 150 mm at 24 sites worldwide. They randomized 134 patients to PTA plus a LifeStent
(Edwards LifeSciences), and 72 patients to PTA alone.

At one year, there was an 80% primary patency rate in patients treated with PTA plus stenting, compared
with 38% in patients treated with PTA alone. Also at one year, 87% of the PTA-plus-stent group was
free of TLR, compared with 46% of the PTA-alone group (Figure).

 
Investigators found lesion success, meaning residual stenosis , 30%, in 85.6% of lesions in the PTA-plusstent group (n = 153) and in 71.6% of lesions in the PTA-alone group (n=81). They measured procedure success as residual stenosis , 30% and no periprocedural complications.

Based on these criteria, they found 85.1% procedure success in the PTA-plus-stent group and 70.8% success in the PTA-alone group.

Quality of life

Peri-procedure and at 30 days, there was no incidence of death, stroke, MI, emergent surgical revascularization, thrombosis or renal failure in either group of patients, Katzen said. Two patients in each group required transfusion, and one patient in the PTA-alone group had a significant distal embolization.

Investigators also found significant improvement in quality of life for patients in the PTA-plus-stent group at six months, with sustained and, in some cases, improved quality of life at 1 year, Katzen said.

In the PTA-alone arm of the trial, 29 patients (40.2%) crossed-over to the PTA-plus-stent group, Katzen said. Eleven of these patients crossed-over because of major flowlimiting dissection and 18 because of residual stenosis >30%.

“There was definitely an increase in lesion length that characterized this crossover group, and this reached statistical significance,” Katzen said. These patients also had significantly more lesion calcification.

Investigators identified 9 stent fractures (2.9%), but none of these fractures were associated with restenosis at 1 year.