肝素涂层支架植入术与球囊血管成形术在特定冠心病患者中的随机对照研究（贝内斯特 II 试验）

Randomised comparison of implantation of heparin-coated stents with balloon angioplasty in selected patients with coronary artery disease (Benestent II).

作者信息

Serruys P W, van Hout B, Bonnier H, Legrand V, Garcia E, Macaya C, Sousa E, van der Giessen W, Colombo A, Seabra-Gomes R, Kiemeneij F, Ruygrok P, Ormiston J, Emanuelsson H, Fajadet J, Haude M, Klugmann S, Morel M A

机构信息

University Hospital Rotterdam Dijkzigt, Thorax Center, Rotterdam, The Netherlands.

出版信息

Lancet. 1998 Aug 29;352(9129):673-81. doi: 10.1016/s0140-6736(97)11128-x.

DOI:10.1016/s0140-6736(97)11128-x

PMID:9728982

Abstract

BACKGROUND

The multicentre, randomised Benestent-II study investigated a strategy of implantation of a heparin-coated Palmar-Schatz stent plus antiplatelet drugs compared with the use of balloon angioplasty in selected patients with stable or stabilised unstable angina, with one or more de-novo lesions, less than 18 mm long, in vessels of diameter 3 mm or more.

METHODS

827 patients were randomly assigned stent implantation (414 patients) or standard balloon angioplasty (413 patients). The primary clinical endpoint was event-free survival at 6 months, including death, myocardial infarction, and the need for revascularisation. The secondary endpoints were the restenosis rate at 6 months and the cost-effectiveness at 12 months. There was also one-to-one subrandomisation to either clinical and angiographic follow-up or clinical follow-up alone. Analyses were by intention to treat.

FINDINGS

Four patients (one stent group, three angioplasty group) were excluded from analysis since no lesion was found. At 6 months, a primary clinical endpoint had occurred in 53 (12.8%) of 413 patients in the stent group and 79 (19.3%) of 410 in the angioplasty group (p=0.013). This significant difference in clinical outcome was maintained at 12 months. In the subgroup assigned angiographic follow-up, the mean minimum lumen diameter was greater in the stent group than in the balloon-angioplasty group, (1.89 [SD 0.65] vs 1.66 [0.57] mm, p=0.0002), which corresponds to restenosis rates (diameter stenosis > or =50%) of 16% and 31% (p=0.0008). In the group assigned clinical follow-up alone, event-free survival rate at 12 months was higher in the stent group than the balloon-angioplasty group (0.89 vs 0.79, p=0.004) at a cost of an additional 2085 Dutch guilders (US$1020) per patient.

INTERPRETATION

Over 12-month follow-up, a strategy of elective stenting with heparin-coated stents is more effective but also more costly than balloon angioplasty.

摘要

背景

多中心随机对照的贝内斯特-II研究比较了肝素涂层的帕尔马-沙茨支架植入联合抗血小板药物治疗与单纯球囊血管成形术在特定患者中的疗效。这些患者患有稳定型或已稳定的不稳定型心绞痛，有一处或多处新发病变，病变长度小于18毫米，血管直径3毫米或以上。

方法

827例患者被随机分为支架植入组（414例）或标准球囊血管成形术组（413例）。主要临床终点为6个月时的无事件生存率，包括死亡、心肌梗死和再次血管重建的需求。次要终点为6个月时的再狭窄率和12个月时的成本效益。患者还被一对一地随机分为接受临床和血管造影随访或仅接受临床随访。分析采用意向性治疗。

结果

4例患者（支架组1例，血管成形术组3例）因未发现病变而被排除在分析之外。6个月时，支架组413例患者中有53例（12.8%）发生主要临床终点事件，血管成形术组410例患者中有79例（19.3%）发生（p = 0.013）。这种临床结局的显著差异在12个月时仍然存在。在接受血管造影随访的亚组中，支架组的平均最小管腔直径大于球囊血管成形术组（分别为1.89 [标准差0.65] 毫米和1.66 [0.57] 毫米，p = 0.0002），对应的再狭窄率（直径狭窄≥50%）分别为16%和31%（p = 0.0008）。在仅接受临床随访的组中，支架组12个月时的无事件生存率高于球囊血管成形术组（分别为0.89和0.79，p = 0.004），但每位患者的费用额外增加2085荷兰盾（1020美元）。