Alfonso Fernando, Zueco Javier, Cequier Angel, Mantilla Ramón, Bethencourt Armando, López-Minguez José R, Angel Juan, Augé José M, Gómez-Recio Manuel, Morís César, Seabra-Gomes Ricardo, Perez-Vizcayno María J, Macaya Carlos
Unidad de Hemodinámica, Servicio de Cardiología Intervencionista, Instituto Cardiovascular, University Hospital San Carlos, Ciudad Universitaria, Plaza de Cristo Rey, Madrid 28040, Spain.
J Am Coll Cardiol. 2003 Sep 3;42(5):796-805. doi: 10.1016/s0735-1097(03)00852-0.
This randomized trial compared repeat stenting with balloon angioplasty (BA) in patients with in-stent restenosis (ISR).
Stent restenosis constitutes a therapeutic challenge. Repeat coronary interventions are currently used in this setting, but the recurrence risk remains high.
We randomly assigned 450 patients with ISR to elective stent implantation (224 patients) or conventional BA (226 patients). Primary end point was recurrent restenosis rate at six months. Secondary end points included minimal lumen diameter (MLD), prespecified subgroup analyses, and a composite of major adverse events.
Procedural success was similar in both groups, but in-hospital complications were more frequent in the balloon group. After the procedure MLD was larger in the stent group (2.77 +/- 0.4 vs. 2.25 +/- 0.5 mm, p < 0.001). At follow-up, MLD was larger after stenting when the in-lesion site was considered (1.69 +/- 0.8 vs. 1.54 +/- 0.7 mm, p = 0.046). However, the binary restenosis rate (38% stent group, 39% balloon group) was similar with the two strategies. One-year event-free survival (follow-up 100%) was also similar in both groups (77% stent vs. 71% balloon, p = 0.19). Nevertheless, in the prespecified subgroup of patients with large vessels (> or =3 mm) the restenosis rate (27% vs. 49%, p = 0.007) and the event-free survival (84% vs. 62%, p = 0.002) were better after repeat stenting.
In patients with ISR, repeat coronary stenting provided better initial angiographic results but failed to improve restenosis rate and clinical outcome when compared with BA. However, in patients with large vessels coronary stenting improved the long-term clinical and angiographic outcome.
本随机试验比较了支架内再狭窄（ISR）患者再次置入支架与球囊血管成形术（BA）的疗效。
支架再狭窄是一项治疗挑战。目前在此情况下会进行重复冠状动脉介入治疗，但复发风险仍然很高。
我们将450例ISR患者随机分为选择性支架植入组（224例患者）或传统BA组（226例患者）。主要终点是6个月时的再狭窄复发率。次要终点包括最小管腔直径（MLD）、预先设定的亚组分析以及主要不良事件的复合指标。
两组的手术成功率相似，但球囊组的院内并发症更为常见。术后支架组的MLD更大（2.77±0.4 vs. 2.25±0.5 mm，p<0.001）。随访时，考虑病变部位后，支架置入后的MLD更大（1.69±0.8 vs. 1.54±0.7 mm，p = 0.046）。然而，两种策略的二元再狭窄率（支架组38%，球囊组39%）相似。两组的1年无事件生存率（随访率100%）也相似（支架组77% vs. 球囊组71%，p = 0.19）。尽管如此，在预先设定的大血管（≥3 mm）患者亚组中，再次置入支架后的再狭窄率（27% vs. 49%，p = 0.007）和无事件生存率（84% vs. 62%，p = 0.002）更好。
在ISR患者中，与BA相比，再次冠状动脉支架置入术可提供更好的初始血管造影结果，但未能改善再狭窄率和临床结局。然而，在大血管患者中，冠状动脉支架置入术改善了长期临床和血管造影结局。
