S. A. Banifatemeh, Parham Sadeghipour, M. Alemzadeh-Ansari, A. Fakhrabadi, Fereshteh Zolfaghari, A. Zahedmehr, B. Mohebbi, R. Kiani, Farshad Shakerian, A. Rashidinejad, Zahra Hosseini, A. Firouzi
{"title":"支架过大在初次经皮冠状动脉介入治疗患者中的作用。一项开放标签随机对照试验。","authors":"S. A. Banifatemeh, Parham Sadeghipour, M. Alemzadeh-Ansari, A. Fakhrabadi, Fereshteh Zolfaghari, A. Zahedmehr, B. Mohebbi, R. Kiani, Farshad Shakerian, A. Rashidinejad, Zahra Hosseini, A. Firouzi","doi":"10.23736/S0026-4725.20.05396-7","DOIUrl":null,"url":null,"abstract":"BACKGROUND\nIn patients with ST-segment-elevation myocardial infarction (STEMI), primary percutaneous coronary intervention (PPCI) is the treatment of choice. Stent undersizing might occur due to catecholamine release and coronary spasm. Although routine oversizing has been promising in several investigations, it has never been tested in randomized clinical trials. In this single-center open-label randomized clinical trial, we evaluated the role of stent oversizing in PPCI.\n\n\nMETHODS\nCandidates for PPCI were randomly divided into oversized and non-oversized groups. 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引用次数: 0
摘要
背景st段抬高型心肌梗死(STEMI)患者,首选经皮冠状动脉介入治疗(PPCI)。由于儿茶酚胺释放和冠状动脉痉挛,可能发生支架尺寸过小。尽管在几项研究中,常规的超大尺寸已经很有希望,但从未在随机临床试验中进行过测试。在这项单中心开放标签随机临床试验中,我们评估了支架过大在PPCI中的作用。方法将PPCI候选者随机分为超大组和非超大组。在超大组,根据定量冠脉分析得出的平均管腔直径,支架超大10%。主要复合终点定义为心肌梗死(TIMI)血流等级III的完全st段(STR)溶解和手术后溶栓的发生。结果研究人群122例,分为超大组(n = 61)和非超大组(n = 61)。两组最终的TIMI血流等级无显著差异。完全STR在非超大组稍有利(56.05±55.12 vs 64.64±23.28;P = 0.056)。肌钙蛋白比率、CK-MB比率和6个月随访结果(定义为靶病变血运重建、心力衰竭和心血管死亡)在两组之间具有可比性。结论:我们的研究表明,在随访期间,PPCI患者常规过大对st段溶解、最终TIMI流量以及硬心事件没有好处。
Role of stent oversizing in patients undergoing primary percutaneous coronary intervention. An open-labeled randomized controlled trial.
BACKGROUND
In patients with ST-segment-elevation myocardial infarction (STEMI), primary percutaneous coronary intervention (PPCI) is the treatment of choice. Stent undersizing might occur due to catecholamine release and coronary spasm. Although routine oversizing has been promising in several investigations, it has never been tested in randomized clinical trials. In this single-center open-label randomized clinical trial, we evaluated the role of stent oversizing in PPCI.
METHODS
Candidates for PPCI were randomly divided into oversized and non-oversized groups. In the oversized group, the stent was oversized by 10% according to the mean lumen diameter, retrieved from the quantitative coronary analysis. Primary composite endpoints were defined as the occurrence of complete total ST-segment (STR)resolution and postprocedural thrombolysis in myocardial infarction (TIMI) flow grade III.
RESULTS
The study population was comprised of 122 patients, allocated to the oversized group (n = 61) and the non-oversized group (n = 61). There was no significant difference between the 2 groups regarding the final TIMI flow grade. Complete STR was marginally more favorable in the non-oversized group (56.05 ± 55.12 vs 64.64 ± 23.28; P = 0.056). The troponin ratio, CK-MB ratio, and 6-month follow up outcome-defined as target lesion revascularization, heart failure, and cardiovascular death-were comparable between the 2 groups.
CONCLUSIONS
Our study showed that routine oversizing in patients undergoing PPCI had no benefit regarding ST-segment resolution and the final TIMI flow, as well as hard cardiac events, during the follow-up.