紫杉醇洗脱支架置入术后最小支架面积对 9 个月随访通畅率的影响：来自 TAXUS IV、V、VI 及 TAXUS ATLAS Workhorse、长病变、直接支架试验的血管内超声综合分析。
Impact of post-intervention minimal stent area on 9-month follow-up patency of paclitaxel-eluting stents: an integrated intravascular ultrasound analysis from the TAXUS IV, V, and VI and TAXUS ATLAS Workhorse, Long Lesion, and Direct Stent Trials.
机构信息
Cardiovascular Research Foundation and Columbia University Medical Center, New York, New York 10022, USA.
出版信息
JACC Cardiovasc Interv. 2009 Dec;2(12):1269-75. doi: 10.1016/j.jcin.2009.10.005.
OBJECTIVES
We investigated the predictive value of the intravascular ultrasound (IVUS) measured post-intervention minimum stent area (MSA) on 9-month follow-up paclitaxel-eluting stent (PES) patency compared with bare-metal stents (BMS).
BACKGROUND
Stent underexpansion is a strong predictor for restenosis after sirolimus-eluting stent implantation, but the implication of underexpansion in PES is still unknown.
METHODS
From the combined TAXUS IV, V, and VI and TAXUS ATLAS Workhorse, Long Lesion, and Direct Stent trials, 1,580 patients (PES 1,098, BMS 482) in IVUS substudies were analyzed. The MSA that best predicted angiographic in-stent restenosis (ISR) (% diameter stenosis > or =50%) was determined.
RESULTS
The post-intervention IVUS MSA was similar in PES and BMS (6.6 +/- 2.5 mm(2) vs. 6.7 +/- 2.3 mm(2), p = 0.92). At 9-month follow-up, ISR was lower in the PES group versus the BMS group (10% vs. 31%, p < 0.0001). Using multivariable logistic regression analysis, post-intervention IVUS MSA was the independent predictor of subsequent ISR in both the PES and BMS groups (p = 0.0002 for PES and p = 0.0002 for BMS). The ability of the post-intervention IVUS MSA to predict ISR was further assessed using receiver operating characteristic analysis. The post-intervention IVUS MSA was found to be a faithful discriminator between patients with and without ISR in both PES (c = 0.6382) and BMS (c = 0.6373). Finally, the optimal thresholds of post-intervention IVUS MSA that best predicted stent patency at 9 months were 5.7 mm(2) for PES and 6.4 mm(2) for BMS.
CONCLUSIONS
Post-intervention MSA measured by IVUS can predict 9-month follow-up stent patency after both PES and BMS implantation. (Randomized Trial Evaluating Slow-Release Formulation TAXUS Paclitaxel-Eluting Coronary Stents to Treat De Novo Coronary Lesions; NCT00301522) (Direct Stenting of TAXUS Liberté-SR Stent for the Treatment of Patients With de Novo Coronary Artery Lesions; NCT00371423) (A Study of the TAXUS Liberté Stent for the Treatment of Long De Novo Coronary Artery Lesions; NCT00371475) (A Study of the TAXUS Liberté Stent for the Treatment of de Novo Coronary Artery Lesions in Small Vessels; NCT00371748).
目的
我们研究了血管内超声（IVUS）测量的支架内最小管腔面积（MSA）在紫杉醇洗脱支架（PES）通畅性 9 个月随访中的预测价值，与裸金属支架（BMS）相比。
背景
支架扩张不足是西罗莫司洗脱支架植入后再狭窄的强烈预测因素，但扩张不足对 PES 的影响尚不清楚。
方法
来自联合 TAXUS IV、V 和 VI 以及 TAXUS ATLAS Workhorse、长病变和直接支架试验，对 IVUS 子研究中的 1580 例患者（PES 1098 例，BMS 482 例）进行了分析。确定了预测血管内再狭窄（ISR）（%直径狭窄> =50%）的最佳支架内 MSA。
结果
PES 和 BMS 的支架内 MSA 相似（6.6 +/- 2.5 mm^2 与 6.7 +/- 2.3 mm^2，p = 0.92）。在 9 个月的随访中，PES 组的 ISR 低于 BMS 组（10%比 31%，p < 0.0001）。使用多变量逻辑回归分析，支架内 MSA 是 PES 和 BMS 两组后续 ISR 的独立预测因素（PES 组 p = 0.0002，BMS 组 p = 0.0002）。使用受试者工作特征分析进一步评估了支架内 MSA 预测 ISR 的能力。发现支架内 MSA 在 PES（c = 0.6382）和 BMS（c = 0.6373）中均能准确区分有和无 ISR 的患者。最后，支架内 MSA 的最佳阈值为 5.7 mm^2 用于 PES 和 6.4 mm^2 用于 BMS，可预测 9 个月时的支架通畅率。
结论
IVUS 测量的支架内 MSA 可预测 PES 和 BMS 植入后 9 个月的支架通畅率。（随机试验评估紫杉醇洗脱冠状动脉支架治疗新发病变的慢释放配方；NCT00301522）（TAXUS Liberté-SR 支架直接治疗新发病变；NCT00371423）（TAXUS Liberté 支架治疗新发病变的长病变；NCT00371475）（TAXUS Liberté 支架治疗小血管新发病变；NCT00371748）。
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