Nagasaki Harbor Medical Center, Nagasaki, Japan.
Tosei General Hospital, Seto, Japan.
Am J Cardiol. 2014 Jun 15;113(12):1986-9. doi: 10.1016/j.amjcard.2014.03.040. Epub 2014 Apr 1.
The frequency of radial artery occlusion was compared between patients receiving 4Fr versus 6Fr transradial coronary interventions (TRIs) in an open-label randomized trial (ClinicalTrials.gov identifier: NCT00815997). The primary outcome measure was radial artery occlusion on the day after TRI. The secondary outcome measures were the procedural success, major advanced cardiac events, access site-related complications, procedural times, fluoroscopy times, and contrast dye usage. A total of 160 patients were included. The procedure was successful in 79 of 80 patients (99%) in both groups. Whereas the 4Fr group showed no access site-related complications, the 6Fr developed 5 (6%), including 3 radial artery occlusions and 2 bleedings (1 radial artery perforation and 1 massive hematoma; p = 0.02). Although the radial artery occlusion rate was lower in the 4Fr versus the 6Fr groups, the difference was not significant (0% vs 4%, p = 0.08). The mean hemostasis time was significantly shorter in the 4Fr than in the 6Fr groups (237 ± 105 vs 320 ± 238 minutes, p = 0.007). In conclusion, these findings suggest that 4Fr TRI may become a less invasive alternative to 6Fr TRI in treating coronary artery diseases.
在一项开放标签随机试验(ClinicalTrials.gov 标识符:NCT00815997)中,比较了接受 4Fr 与 6Fr 经桡动脉冠状动脉介入治疗(TRI)的患者之间桡动脉闭塞的频率。主要结局指标为 TRI 后第 1 天的桡动脉闭塞。次要结局指标为手术成功率、主要心脏不良事件、入路相关并发症、手术时间、透视时间和造影剂使用。共纳入 160 例患者。两组患者的手术均成功,分别为 80 例中的 79 例(99%)。4Fr 组无入路相关并发症,6Fr 组出现 5 例(6%),包括 3 例桡动脉闭塞和 2 例出血(1 例桡动脉穿孔和 1 例大出血;p=0.02)。尽管 4Fr 组的桡动脉闭塞率低于 6Fr 组,但差异无统计学意义(0%比 4%,p=0.08)。4Fr 组的止血时间明显短于 6Fr 组(237±105 比 320±238 分钟,p=0.007)。总之,这些发现表明,4Fr TRI 可能成为治疗冠状动脉疾病的一种比 6Fr TRI 侵入性更小的替代方法。