Tetteroo E, van der Graaf Y, Bosch J L, van Engelen A D, Hunink M G, Eikelboom B C, Mali W P
Department of Radiology, University Hospital Utrecht, Netherlands.
Lancet. 1998 Apr 18;351(9110):1153-9. doi: 10.1016/s0140-6736(97)09508-1.
Percutaneous transluminal angioplasty (PTA) is a safe, simple, and successful treatment for intermittent claudication caused by iliac-artery occlusive disease. Primary stent placement has been proposed as more effective than PTA. We compared the technical results and clinical outcomes of two treatment strategies-primary placement of a stent across the stenotic segment of the iliac artery, or primary PTA followed by selective stent placement when haemodynamic results were inadequate.
We randomly assigned 279 patients with intermittent claudication, recruited from departments of vascular surgery, either to direct stent placement (group I, n=143) or primary angioplasty (group II, n=136), with subsequent stent placement in case of a residual mean pressure gradient greater than 10 mm Hg across the treated site. The main inclusion criterion was intermittent claudication on the basis of iliac-artery stenosis of more than 50%, proven by angiography. All patients had a clinical assessment before intervention and at 3, 12, and 24 months. Clinical success was defined as improvement of at least one clinical category. Secondary endpoints were initial technical results, procedural complications, cumulative patency as assessed by duplex ultrasonography, and quality of life.
In group II, selective stent placement was done in 59 (43%) of the 136 patients. The mean follow-up was 9.3 months (range 3-24). Initial haemodynamic success and complication rates were 119 (81%) of 149 limbs and 6 (4%) of 143 limbs (group I) versus 103 (82%) of 126 limbs and 10 (7%) of 136 limbs (group II), respectively. Clinical success rates at 2 years were 29 (78%) of 37 patients and 26 (77%) of 34 patients in groups I and II, respectively (p=0.6); however, 43% and 35% of the patients, respectively, still had symptoms. Quality of life improved significantly after intervention (p<0.05) but we found no difference between the groups during follow-up. 2-year cumulative patency rates were similar at 71% versus 70% (p=0.2), respectively, as were reintervention rates at 7% versus 4%, respectively (95% CI -2% to 9%).
There were no substantial differences in technical results and clinical outcomes of the two treatment strategies both at short-term and long-term follow-up. Since angioplasty followed by selective stent placement is less expensive than direct placement of a stent, the former seems to be the treatment of choice for lifestyle-limiting intermittent claudication caused by iliac artery occlusive disease.
经皮腔内血管成形术（PTA）是治疗髂动脉闭塞性疾病所致间歇性跛行的一种安全、简单且成功的方法。有人提出初次支架置入比PTA更有效。我们比较了两种治疗策略的技术结果和临床结局——在髂动脉狭窄段直接置入支架，或先行PTA，当血流动力学结果不佳时再选择性置入支架。
我们从血管外科招募了279例间歇性跛行患者，随机分为直接支架置入组（I组，n = 143）或初次血管成形术组（II组，n = 136），若治疗部位残余平均压力梯度大于10 mmHg，则随后置入支架。主要纳入标准是经血管造影证实髂动脉狭窄超过50%所致的间歇性跛行。所有患者在干预前及干预后3、12和24个月进行临床评估。临床成功定义为至少一个临床类别有所改善。次要终点为初始技术结果、手术并发症、经双功超声评估的累积通畅率及生活质量。
在II组的136例患者中，59例（43%）进行了选择性支架置入。平均随访时间为9.3个月（范围3 - 24个月）。初始血流动力学成功率和并发症发生率分别为I组149条肢体中的119条（81%）和143条肢体中的6条（4%），以及II组126条肢体中的103条（82%）和136条肢体中的10条（7%）。I组和II组在2年时的临床成功率分别为37例患者中的29例（78%）和34例患者中的26例（77%）（p = 0.6）；然而，分别仍有43%和35%的患者有症状。干预后生活质量显著改善（p < 0.05），但随访期间两组之间无差异。2年累积通畅率相似，分别为71%和70%（p = 0.2），再次干预率分别为7%和4%（95%CI -2%至9%）。
两种治疗策略在短期和长期随访中的技术结果和临床结局均无实质性差异。由于先行血管成形术再选择性置入支架比直接置入支架费用更低，因此前者似乎是髂动脉闭塞性疾病所致限制生活方式的间歇性跛行的首选治疗方法。
