Quality of Life After Percutaneous Coronary Intervention or Medical Therapy for Chronic Total Coronary Occlusions: EUROCTO and DECISION-CTO Meta-Analysis.

We evaluated the effect of PCI vs OMT in patients with a CTO and no concomitant coronary lesions in a post-hoc pooled analysis of 2 RCTs.

我们在2项随机试验的事后汇总分析中评估了CTOs患者且无并发冠状动脉病变时，PCI与OMT的治疗效果。

Methods

A total of 518 patients with a single CTO and no other significant coronary lesion were extracted from 2 RCTs, EUROCTO and DECISION-CTO, which had compared PCI vs OMT.

从两项随机对照试验EUROCTO和DECISION-CTO中提取了518名单一慢性完全闭塞（CTO）患者，这些患者没有其他显著的冠状动脉病变，试验比较了经皮冠状动脉介入治疗（PCI）与优化的药物治疗（OMT）的效果。

Randomization to PCI or OMT was 1:1 in DECISION and 2:1 in EUROCTO.

在DECISION试验中，患者被随机分为PCI组和OMT组，比例为1:1；而在EUROCTO试验中，比例为2:1。

The clinical status was assessed by the Seattle Angina Questionnaire (SAQ) at baseline and after 12 months, and clinical events were monitored for 3 years.

基线和12个月后通过西雅图心绞痛问卷（SAQ）评估临床状态，并监测3年的临床事件。

Results

PCI was successful in 92.2%.

经皮冠状动脉介入治疗（PCI）的成功率为92.2%。

On an intention-to-treatanalysis, PCI appeared to be superior to OMT for the change of angina frequency scores between baseline and follow-up (12.2 vs 8.6; P = 0.009), QoL (19.5 vs 11.3; P < 0.001), and the SAQ summary score (13.8 vs 8.5; P < 0.001).

在意向治疗分析中，与OMT相比，PCI在基线和随访期间心绞痛频率评分的变化（12.2 vs 8.6; P = 0.009）、生活质量（19.5 vs 11.3; P < 0.001）以及SAQ总结评分（13.8 vs 8.5; P < 0.001）方面似乎更优。

For physical limitation, the difference was just at the level of the Bonferroni correction for multiple tests (P = 0.01).

对于身体限制，差异仅在多重测试的Bonferroni校正水平上（P = 0.01）。

There was a wide variability of changes in SAQ scores.

SAQ评分的变化存在很大的变异性。

For QoL, the major determinant for a significant improvement was a low baseline score and the assignment to PCI, whereas gender, diabetes, or lesion complexity had no influence.

对于生活质量，主要的决定因素是低基线评分和被分配到经皮冠状动脉介入治疗（PCI），而性别、糖尿病或病变复杂性没有影响。

During a mean follow-up of 3.1 years, the clinical endpoints of cardiac death or nonfatal myocardial infarction were similar in both groups (OMT vs PCI: 2.7% vs 5.1%; P = 0.17).

在平均3.1年的随访期间，两组的心脏死亡或非致命性心肌梗死的临床终点相似（OMT组与PCI组：2.7%对5.1%；P=0.17）。

The rates of stroke or hospitalization for bleeding were similar, and only target lesion revascularizations were more frequent with OMT (18.8% vs 10.6%; P = 0.005).

中风或因出血住院的比率相似，仅靶病变血运重建在OMT组更为频繁（18.8%对10.6%；P=0.005）。

Conclusions

In this post-hoc analysis from 2 RCTs of patients with a single CTO and no significant concomitant lesion, PCI achieved better improvement in QoL, angina frequency, and the SAQ summary score than OMT with no signal of excess harm regarding clinical endpoints.

在这项针对单一慢性完全闭塞（CTO）且无显著共病病变患者的两项随机对照试验（RCTs）的事后分析中，经皮冠状动脉介入治疗（PCI）在改善生活质量、心绞痛频率和西雅图心绞痛问卷（SAQ）总评分方面，相较于优化药物治疗（OMT）取得了更好的效果，并且在临床终点方面没有显示出过度伤害的迹象。

(EUROCTO [Evaluate the Utilization of Revascularization or Optimal Medical Therapy for the Treatment of Chronic Total Coronary Occlusions; NCT01760083] and DECISION-CTO [Drug-Eluting Stent Implantation Versus Optimal Medical Treatment in Patients With Chronic Total Occlusion; NCT01078051]).

（EUROCTO研究[评估血管重建或最佳药物治疗用于治疗慢性完全冠状动脉闭塞；NCT01760083]和DECISION-CTO研究[药物洗脱支架植入与最佳药物治疗在慢性完全闭塞患者中的比较；NCT01078051]）。