Am Heart J：血管内超声引导支架置入表现更优

　　意大利学者的一项研究表明，在复杂冠脉病变患者中，血管内超声（IVUS）引导药物洗脱支架（DES）置入优于血管造影。论文于2012年11月21日在线发表于《美国心脏杂志》（Am Heart J）。

　　此项随机、多中心、国际性、开放标签研究共纳入284例复杂冠脉病变患者，并对IVUS和血管造影引导DES置入进行了对比评估。受试者基线特征无显著差异。主要研究终点为术后病变最小管腔直径。次要终点由严重不良心脏事件（MACE）、目标病变血运重建、目标血管血运重建、心梗以及1、6、9、12和24个月时支架血栓形成。

　　结果显示，主要研究终点存在有利于IVUS组的显著统计学差异（P=0.0002）。住院期间未出现患者死亡、接受再次血运重建或发生Q波心梗。两组患者在非Q波心梗发生方面无显著差异。在临床随访24个月时，IVUS和血管造影组在累计MACE、心源性死亡、心梗、目标病变血运重建和目标血管血运重建方面仍无显著差异。IVUS组仅出现1例明确亚急性支架血栓形成。

A prospective, randomized trial of intravascular-ultrasound guided compared to angiography guided stent implantation in complex coronary lesions: The AVIO trial

Background

No randomized studies have thus far evaluated intravascular ultrasound (IVUS) guidance in the drug-eluting stent (DES) era. The aim was to evaluate if IVUS optimized DES implantation was superior to angiographic guidance alone in complex lesions.

Methods

Randomized, multicentre, international, open label, investigator-driven study evaluating IVUS vs angiographically guided DES implantation in patients with complex lesions (defined as bifurcations, long lesions, chronic total occlusions or small vessels). Primary study endpoint was post-procedure in lesion minimal lumen diameter. Secondary end points were combined major adverse cardiac events (MACE), target lesion revascularization, target vessel revascularization, myocardial infarction (MI), and stent thrombosis at 1, 6, 9, 12, and 24 months.

Results

The study included 284 patients. No significant differences were observed in baseline characteristics. The primary study end point showed a statistically significant difference in favor of the IVUS group (2.70 mm ± 0.46 mm vs. 2.51 ± 0.46 mm; P = .0002). During hospitalization, no patient died, had repeated revascularization, or a Q-wave MI. No difference was observed in the occurrence of non-Q wave MI (6.3% in IVUS vs. 7.0% in angio-guided group). At 24-months clinical follow-up, no differences were still observed in cumulative MACE (16.9%vs. 23.2 %), cardiac death (0%vs. 1.4%), MI (7.0%vs. 8.5%), target lesion revascularization (9.2% vs. 11.9%) or target vessel revascularization (9.8% vs. 15.5%), respectively in the IVUS vs. angio-guided groups. In total, only one definite subacute stent thrombosis occurred in the IVUS group.

Conclusions

A benefit of IVUS optimized DES implantation was observed in complex lesions in the post-procedure minimal lumen diameter. No statistically significant difference was found in MACE up to 24 months.