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支架内最小管腔面积在支架植入后 9 个月对 3 年靶病变血运重建无复发生存率的影响:来自 TAXUS IV、V 和 VI 试验的连续血管内超声分析。

Impact of in-stent minimal lumen area at 9 months poststent implantation on 3-year target lesion revascularization-free survival: a serial intravascular ultrasound analysis from the TAXUS IV, V, and VI trials.

机构信息

Cardiovascular Research Foundation, New York, NY, USA.

出版信息

Circ Cardiovasc Interv. 2008 Oct;1(2):111-8. doi: 10.1161/CIRCINTERVENTIONS.108.784660. Epub 2008 Sep 3.

DOI:10.1161/CIRCINTERVENTIONS.108.784660
PMID:20031665
Abstract

BACKGROUND

Intravascular ultrasound (IVUS) is used to assess intermediate lesions in native coronary arteries; minimum lumen area (MLA) <4.0 mm(2) is accepted as a cutoff for a significant stenosis. We evaluated the IVUS in-stent MLA at 9-month follow-up that best predicted subsequent target lesion revascularization (TLR)-free survival in patients from the TAXUS IV, V, and VI studies.

METHODS AND RESULTS

In the combined TAXUS IV, V, and VI randomized trials, 9-month IVUS was available in 635 patients (331 treated with paclitaxel-eluting stents [PES] and 304 treated with bare-metal stents [BMS]) who did not require TLR in the first 9 months postintervention and who were followed for 3 years. The in-stent MLA that best predicted 3-year TLR-free survival was determined. At 9-months follow-up, IVUS-measured in-stent MLA was 5.7 + or -2.3 mm(2) in the PES group and 4.8 + or - 2.3 mm(2) in the BMS group. Between 9 months and 3 years, TLR was required in 4.9% of patients who were treated with PES and 6.7% of patients who were treated with BMS. Multivariate analysis identified MLA at 9 months as a significant predictor of late TLR (hazard ratio, 0.63 [0.43-0.93]; P = 0.02). The ability of MLA to predict late TLR was further assessed using receiver operating characteristic analysis. MLA was found to be an acceptable discriminator for both PES (c = 0.7448) and BMS (c = 0.7329). Finally, the optimal thresholds of MLA that best predicted subsequent TLR-free survival were determined to be 4.2 mm(2) for PES and 4.0 mm(2) for BMS.

CONCLUSIONS

In the combined IVUS analysis of TAXUS IV, V, and VI, patients who did not require TLR within the first 9 months had a high subsequent TLR-free survival rate whether treated with PES or BMS. MLA measured by IVUS at 9 months predicted subsequent TLR with a cutoff similar to intermediate, de novo lesions in native coronary arteries.

摘要

背景

血管内超声(IVUS)用于评估原生冠状动脉中的中间病变;最小管腔面积(MLA)<4.0mm(2)被认为是显著狭窄的截止点。我们评估了 TAXUS IV、V 和 VI 研究中 9 个月随访时的 IVUS 支架内 MLA,以预测随后的靶病变血运重建(TLR)无复发生存率。

方法和结果

在 TAXUS IV、V 和 VI 联合随机试验中,635 例患者(331 例接受紫杉醇洗脱支架[PES]治疗,304 例接受裸金属支架[BMS]治疗)在干预后 9 个月内无需 TLR,随访 3 年。确定了预测 3 年 TLR 无复发生存率的最佳支架内 MLA。在 9 个月随访时,PES 组 IVUS 测量的支架内 MLA 为 5.7+或-2.3mm(2),BMS 组为 4.8+或-2.3mm(2)。在 9 个月至 3 年期间,PES 治疗的患者中有 4.9%需要 TLR,BMS 治疗的患者中有 6.7%需要 TLR。多变量分析确定 9 个月时的 MLA 是晚期 TLR 的显著预测因子(危险比,0.63[0.43-0.93];P=0.02)。使用受试者工作特征分析进一步评估了 MLA 预测晚期 TLR 的能力。发现 MLA 可作为 PES(c=0.7448)和 BMS(c=0.7329)的可接受判别器。最后,确定最佳的 MLA 阈值,以最佳预测随后的 TLR 无复发生存率,PES 为 4.2mm(2),BMS 为 4.0mm(2)。

结论

在 TAXUS IV、V 和 VI 的联合 IVUS 分析中,在最初 9 个月内不需要 TLR 的患者,无论接受 PES 还是 BMS 治疗,都有很高的后续 TLR 无复发生存率。9 个月时 IVUS 测量的 MLA 预测随后的 TLR 与中间病变、原生冠状动脉中新发病变的截止值相似。

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