冠状动脉球囊血管成形术联合临时支架置入与直接支架置入的最佳选择（OCBAS）：即时及长期随访结果

Optimal coronary balloon angioplasty with provisional stenting versus primary stent (OCBAS): immediate and long-term follow-up results.

作者信息

Rodríguez A, Ayala F, Bernardi V, Santaera O, Marchand E, Pardiñas C, Mauvecin C, Vogel D, Harrell L C, Palacios I F

机构信息

Cardiac Unit Otamendi/Anchorena Hospital, Buenos Aires, Argentina.

出版信息

J Am Coll Cardiol. 1998 Nov;32(5):1351-7. doi: 10.1016/s0735-1097(98)00388-x.

DOI:10.1016/s0735-1097(98)00388-x

PMID:9809947

Abstract

OBJECTIVE

This study sought to compare two strategies of revascularization in patients obtaining a good immediate angiographic result after percutaneous transluminal coronary angioplasty (PTCA): elective stenting versus optimal PTCA. A good immediate angiographic result with provisional stenting was considered to occur only if early loss in minimal luminal diameter (MLD) was documented at 30 min post-PTCA angiography.

BACKGROUND

Coronary stenting reduces restenosis in lesions exhibiting early deterioration (>0.3 mm) in MLD within the first 24 hours (early loss) after successful PTCA. Lesions with no early loss after PTCA have a low restenosis rate.

METHODS

To compare angiographic restenosis and target vessel revascularization (TVR) of lesions treated with coronary stenting versus those treated with optimal PTCA, 116 patients were randomized to stent (n=57) or to optimal PTCA (n=59). After randomization in the PTCA group, 13.5% of the patients crossed over to stent due to early loss (provisional stenting).

RESULTS

Baseline demographic and angiographic characteristics were similar in both groups of patients. At 7.6 months, 96.6% of the entire population had a follow-up angiographic study: 98.2% in the stent and 94.9% in the PTCA group. Immediate and follow-up angiographic data showed that acute gain was significantly higher in the stent than in the PTCA group (1.95 vs. 1.5 mm; p < 0.03). However, late loss was significantly higher in the stent than the PTCA group (0.63+/-0.59 vs. 0.26+/-0.44, respectively; p=0.01). Hence, net gain with both techniques was similar (1.32< or =0.3 vs. 1.24+/-0.29 mm for the stent and the PTCA groups, respectively; p=NS). Angiographic restenosis rate at follow-up (19.2% in stent vs. 16.4% in PTCA; p=NS) and TVR (17.5% in stent vs. 13.5% in PTCA; p=NS) were similar. Furthermore, event-free survival was 80.8% in the stent versus 83.1% in the PTCA group (p=NS). Overall costs (hospital and follow-up) were US $591,740 in the stent versus US $398,480 in the PTCA group (p < 0.02).

CONCLUSIONS

The strategy of PTCA with delay angiogram and provisional stent if early loss occurs had similar restenosis rate and TVR, but lower cost than primary stenting after PTCA.

摘要

目的

本研究旨在比较经皮腔内冠状动脉成形术（PTCA）后即刻血管造影结果良好的患者的两种血运重建策略：选择性支架置入术与优化PTCA。仅当PTCA血管造影术后30分钟记录到最小管腔直径（MLD）早期丢失时，才认为临时支架置入术取得了良好的即刻血管造影结果。

背景

冠状动脉支架置入术可降低成功PTCA后24小时内MLD出现早期恶化（>0.3 mm，早期丢失）的病变的再狭窄率。PTCA后无早期丢失的病变再狭窄率较低。

方法

为比较冠状动脉支架置入术治疗的病变与优化PTCA治疗的病变的血管造影再狭窄和靶血管血运重建（TVR）情况，将116例患者随机分为支架置入组（n = 57）和优化PTCA组（n = 59）。在PTCA组随机分组后，13.5%的患者因早期丢失（临时支架置入）转而接受支架置入术。

结果

两组患者的基线人口统计学和血管造影特征相似。在7.6个月时，整个人口中96.6%进行了随访血管造影研究：支架置入组为98.2%，PTCA组为94.9%。即刻和随访血管造影数据显示，支架置入组的急性增益显著高于PTCA组（1.95对1.5 mm；p < 0.03）。然而，支架置入组的晚期丢失显著高于PTCA组（分别为0.63±0.59对0.26±0.44；p = 0.01）。因此，两种技术的净增益相似（支架置入组和PTCA组分别为1.32±0.3对1.24±0.29 mm；p = 无显著性差异）。随访时的血管造影再狭窄率（支架置入组为19.2%，PTCA组为16.4%；p = 无显著性差异）和TVR（支架置入组为17.5%，PTCA组为13.5%；p = 无显著性差异）相似。此外，支架置入组的无事件生存率为80.8%，PTCA组为83.1%（p = 无显著性差异）。总体费用（住院和随访）支架置入组为591,740美元，PTCA组为398,480美元（p < 0.02）。