Miketic S, Carlsson J, Tebbe U
Department of Internal Medicine II (Cardiology), Klinikum Lippe-Detmold, Detmold, Germany.
Am Heart J. 2001 Nov;142(5):E8. doi: 10.1067/mhj.2001.118744.
Coronary artery stents are used for the treatment of acute or threatening vessel occlusion complicating coronary angioplasty or for prevention of restenosis after angioplasty. The current randomized trial compared the procedural outcome and long-term patency of 2 different flexible stents in unselected lesion morphology.
The study population consisted of consecutive patients undergoing coronary angioplasty for symptomatic coronary artery disease followed by high-pressure stent implantation. The poststent treatment consisted of antiplatelet therapy. The primary hypothesis was an assumed restenosis rate of 30% in the group receiving NIR stents (Boston Scientific Europe SPRL, Parc Industriel de Petit-Rechain, Belgium) and a reduction of the restenosis rate (defined as >50% vessel diameter at follow-up) by 50% in the group undergoing J&J Crown stent (Cordis, Johnson & Johnson Interventional Systems, Warren, NJ) implantation: the restenosis rate and minimal luminal diameter at follow-up. Follow-up angiography was performed 6 months after the initial procedure.
A total of 203 patients were randomized to receive either the J&J Crown stent (n = 103) or the NIR stent (n = 100). The procedural success was similar in both groups (96.1% vs 99% in the NIR stent group, respectively; P =.19). There were 4 cases of crossover from the J&J Crown to the NIR stent group. In one patient, stent implantation of either stent model did not succeed. One patient died from fulminant pulmonary embolism. Restenosis, defined as >50% diameter stenosis at follow-up 5.8 +/- 1.3 months after the initial procedure occurred in 19 patients (18.4%) in the J&J Crown stent group compared with 22 patients (22.0%) in the NIR stent group (P =.42). There was a significantly higher rate of crossover from the J&J Crown stent to the NIR stent (3.9% vs 0%, respectively, P =.047), whereas reverse crossover did not occur. The one lesion in which NIR stent implantation was not successful had an extremely tortuous proximal part. This patient underwent only balloon angioplasty. Clinical events were rare during 6 months of follow-up and the incidence did not differ between both groups (nonfatal myocardial infarction: J&J Crown stent 1.0% vs 0% in the NIR stent group, P =.32; all-cause mortality: J&J Crown stent 1.0% vs 0% in the NIR stent group, P =.32).
There were no significant angiographic and clinical differences between the J&J Crown and NIR stents. Both stents had a similar procedural success rate, although the implantation of NIR stents was successful even in vessels in which previous attempts at J&J Crown stent placement had failed.
冠状动脉支架用于治疗冠状动脉成形术并发的急性或有威胁的血管闭塞，或预防血管成形术后再狭窄。当前的随机试验比较了两种不同的可弯曲支架在未选择病变形态中的手术结果和长期通畅率。
研究人群包括因症状性冠状动脉疾病接受冠状动脉成形术并随后进行高压支架植入的连续患者。支架植入后的治疗包括抗血小板治疗。主要假设是接受NIR支架（波士顿科学欧洲公司，比利时小雷尚工业园）的组中假设的再狭窄率为30%，而接受强生Crown支架（科迪斯，强生介入系统公司，新泽西州沃伦）植入的组中再狭窄率（定义为随访时血管直径缩小>50%）降低50%：随访时的再狭窄率和最小管腔直径。在初始手术后6个月进行随访血管造影。
总共203例患者被随机分配接受强生Crown支架（n = 103）或NIR支架（n = 100）。两组的手术成功率相似（NIR支架组分别为96.1%和99%；P = 0.19）。有4例患者从强生Crown支架组交叉到NIR支架组。1例患者中，两种支架模型的植入均未成功。1例患者死于暴发性肺栓塞。在初始手术后5.8±1.3个月的随访中，定义为直径狭窄>50%的再狭窄在强生Crown支架组的19例患者（18.4%）中发生，而在NIR支架组的22例患者（22.0%）中发生（P = 0.42）。从强生Crown支架交叉到NIR支架的发生率显著更高（分别为3.9%和0%，P = 0.047），而反向交叉未发生。NIR支架植入未成功的1处病变其近端极其迂曲。该患者仅接受了球囊血管成形术。在6个月的随访期间临床事件很少，两组之间的发生率无差异（非致命性心肌梗死：强生Crown支架组为1.0%，NIR支架组为0%，P = 0.32；全因死亡率：强生Crown支架组为1.0%，NIR支架组为0%，P = 0.32）。
强生Crown支架和NIR支架在血管造影和临床方面无显著差异。两种支架的手术成功率相似，尽管NIR支架即使在先前尝试植入强生Crown支架失败的血管中植入也成功。
