冠状动脉支架置入术与球囊血管成形术治疗初次球囊血管成形术后再狭窄的比较。再狭窄支架研究组。

Coronary-artery stenting compared with balloon angioplasty for restenosis after initial balloon angioplasty. Restenosis Stent Study Group.

作者信息

Erbel R, Haude M, Höpp H W, Franzen D, Rupprecht H J, Heublein B, Fischer K, de Jaegere P, Serruys P, Rutsch W, Probst P

机构信息

Department of Cardiology, University of Essen, Germany.

出版信息

N Engl J Med. 1998 Dec 3;339(23):1672-8. doi: 10.1056/NEJM199812033392304.

DOI:10.1056/NEJM199812033392304

PMID:9834304

Abstract

BACKGROUND

Intracoronary stenting reduces the rate of restenosis after angioplasty in patients with new coronary lesions. We conducted a prospective, randomized, multicenter study to determine whether intracoronary stenting, as compared with standard balloon angioplasty, reduces the recurrence of luminal narrowing in restenotic lesions.

METHODS

A total of 383 patients who had undergone at least one balloon angioplasty and who had clinical and angiographic evidence of restenosis after the procedure were randomly assigned to undergo standard balloon angioplasty (192 patients) or intracoronary stenting with a Palmaz-Schatz stent (191 patients). The primary end point was angiographic evidence of restenosis (defined as stenosis of more than 50 percent of the luminal diameter) at six months. The secondary end points were death, Q-wave myocardial infarction, bypass surgery, and revascularization of the target vessel.

RESULTS

The rate of restenosis was significantly higher in the angioplasty group than in the stent group (32 percent as compared with 18 percent, P= 0.03). Revascularization of the target vessel at six months was required in 27 percent of the angioplasty group but in only 10 percent of the stent group (P=0.001). This difference resulted from a smaller mean (+/-SD) minimal luminal diameter in the angioplasty group (1.85+/-0.56 mm) than in the stent group (2.04+/-0.66 mm), with a mean difference of 0.19 mm (P=0.01) at follow-up. Subacute thrombosis occurred in 0.6 percent of the angioplasty group and in 3.9 percent of the stent group. The rate of event-free survival at 250 days was 72 percent in the angioplasty group and 84 percent in the stent group (P=0.04).

CONCLUSIONS

Elective coronary stenting was effective in the treatment of restenosis after balloon angioplasty. Stenting resulted in a lower rate of recurrent stenosis despite a higher incidence of subacute thrombosis.

摘要

背景

冠状动脉内支架置入术可降低新发冠状动脉病变患者血管成形术后再狭窄率。我们进行了一项前瞻性、随机、多中心研究，以确定冠状动脉内支架置入术与标准球囊血管成形术相比，是否能降低再狭窄病变管腔狭窄的复发率。

方法

共有383例至少接受过一次球囊血管成形术且术后有临床及血管造影再狭窄证据的患者，被随机分配接受标准球囊血管成形术（192例患者）或使用帕尔马兹-施查茨支架进行冠状动脉内支架置入术（191例患者）。主要终点是6个月时血管造影显示的再狭窄证据（定义为管腔直径狭窄超过50%）。次要终点是死亡、Q波心肌梗死、搭桥手术以及靶血管血运重建。

结果

血管成形术组的再狭窄率显著高于支架置入组（分别为32%和18%，P = 0.03）。血管成形术组27%的患者在6个月时需要进行靶血管血运重建，而支架置入组仅为10%（P = 0.001）。这种差异是由于血管成形术组的平均（±标准差）最小管腔直径（1.85±0.56 mm）小于支架置入组（2.04±0.66 mm），随访时平均差异为0.19 mm（P = 0.01）。亚急性血栓形成在血管成形术组为0.6%，在支架置入组为3.9%。血管成形术组250天时无事件生存率为72%，支架置入组为84%（P = 0.04）。