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对于接受第二代药物洗脱支架治疗的无保护左主干狭窄患者,计划进行血管造影控制与临床随访的比较:来自 FAILS(第二代支架治疗左主干失败-第三组研究)的倾向评分匹配分析。

Planned angiographic control versus clinical follow-up for patients with unprotected left main stem stenosis treated with second generation drug-eluting stents: A propensity score with matching analysis from the FAILS (failure in left main with second generation stents-Cardiogroup III Study).

机构信息

Dipartimento di Scienze Mediche, Divisione di Cardiologia, Città della Salute e della Scienza, Turin, Italy.

Ospedale San Raffaele Milano, Italy.

出版信息

Catheter Cardiovasc Interv. 2018 Oct 1;92(4):E271-E277. doi: 10.1002/ccd.27408. Epub 2017 Nov 11.

DOI:10.1002/ccd.27408
PMID:29130573
Abstract

BACKGROUND

The value of angiographic follow-up in unprotected left main (ULM) stenting remains undefined.

METHODS

The FAILS-2 registry included consecutive patients presenting with a critical lesion of an ULM treated with second generation drug eluting stents in 6 centers from June 2007 to January 2015. Patients were stratified into two groups: those discharged with planned angiographic follow-up and those with clinical follow-up. MACE (Major Adverse Clinical Events, a composite end point of death, myocardial infarction, TLR, and ST) was the primary end point, while each component was a secondary endpoint Sensitivity analysis was performed for patients treated with a provisional or a two-stent strategy. A propensity score analysis was used to compare the outcomes in the two groups.

RESULTS

After multivariate adjustment, 220 patients per group were selected. Planned angiographic follow up was performed after a median of 7 (6-10) months. After 16 (14-21) months, rates of MACE were similar between the two groups (24 vs. 21%, P = 0.29) with lower rates of all cause and cardiovascular death in the angiographic control group (6 vs. 14%, P = 0.01 and 3 vs. 6%, P = 0.04) but with higher rates of TLR (15 vs. 5%, P < 0.001). The same trend was seen irrespective of the stent strategy.

CONCLUSION

planned angiographic control results in more TLR but may reduce mortality. These findings need to be confirmed by adequately powered randomized controlled trial.

摘要

背景

在未保护的左主干(ULM)支架置入后进行血管造影随访的价值仍未确定。

方法

FAILS-2 注册研究纳入了 2007 年 6 月至 2015 年 1 月期间在 6 个中心接受第二代药物洗脱支架治疗的 ULM 临界病变的连续患者。患者分为两组:计划进行血管造影随访的患者和进行临床随访的患者。主要终点是 MACE(主要不良临床事件,死亡、心肌梗死、TLR 和 ST 的复合终点),每个组成部分均为次要终点。对采用临时或双支架策略治疗的患者进行敏感性分析。采用倾向评分分析比较两组的结局。

结果

经过多变量调整后,每组选择 220 例患者。中位数为 7(6-10)个月时进行计划的血管造影随访。16(14-21)个月后,两组的 MACE 发生率相似(24%与 21%,P=0.29),但在血管造影对照组中全因死亡率和心血管死亡率较低(6%与 14%,P=0.01 和 3%与 6%,P=0.04),但 TLR 发生率较高(15%与 5%,P<0.001)。无论支架策略如何,均呈现出相同的趋势。

结论

计划进行血管造影控制可导致更多的 TLR,但可能降低死亡率。这些发现需要通过充分有力的随机对照试验来证实。

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