- 作者：Anouar Belkacemi ; MD鈦?/sup> ; Pierfrancesco Agostoni ; MD ; PhD鈦?/sup> ; Hendrik M. Nathoe ; MD ; PhD鈦?/sup> ; Michiel Voskuil ; MD ; PhD鈦?/sup> ; ChunLai Shao ; MD鈦?/sup> ; Eric Van Belle ; MD ; PhD鈦?/sup> ; Thierry Wildbergh ; MD鈦?/sup> ; Luigi Politi ; MD&dagger ; ; Pieter A. Doevendans ; MD ; PhD鈦?/sup> ; Giuseppe M. Sangiorgi ; MD&dagger ; ; Pieter R. Stella ; MD ; PhD鈦?/sup> ; P.Stella@umcutrecht.nl
- 关键词：angioplasty ; drug-eluting balloon ; myocardial infarction ; STEMI ; stent
- 刊名：Journal of the American College of Cardiology
- 出版年：2012
- 期刊代码：201_07351097
- 类别：med
- 出版时间：19-26 June, 2012
- 卷：59
- 期：25
- 页码：2327-2337
- 文件大小：656 K
Objectives
The goal of this study was to compare angiographic, intravascular imaging, and functional parameters, as well as the clinical outcomes of patients treated with drug-eluting balloon (DEB) plus bare-metal stent (BMS) versus BMS versus drug-eluting stent (DES) for ST-segment elevated acute myocardial infarction (STEMI).Background
Concerns remain regarding the long-term safety of DES in STEMI. DEB could provide an attractive alternative in order to achieve potentially similar effectiveness but limiting the long-term hazards related to late-acquired stent malapposition and thus stent thrombosis.
Methods
In this randomized, international, 2-center, single-blinded, 3-arm study, STEMI patients were randomly assigned to group A: BMS; group B: DEB plus BMS; or group C: DES after successful thrombus aspiration. The primary endpoint was 6-month angiographic in-stent late-luminal loss. Secondary endpoints were in-stent binary restenosis, major adverse cardiac events (MACE: cardiac death, myocardial infarction, target vessel revascularization). In a subgroup of patients, stent (mal)apposition (by optical coherence tomography) and endothelial function (by acetylcholine infusion) was assessed.
Results
Overall, 150 patients were randomized. Procedural success was achieved in 96.7%. In groups A, B, and C, respectively, late-luminal loss was 0.74 卤 0.57 mm, 0.64 卤 0.56 mm, and 0.21 卤 0.32 mm (p < 0.01); binary restenosis was 26.2%, 28.6%, and 4.7%(p = 0.01); and MACE rates were 23.5%, 20.0%, and 4.1%(p = 0.02), respectively. The median percentage [25th to 75th interquartile range] of uncovered and malapposed stent struts per lesion was 0 [0 to 0.35], 2.84 [0 to 6.63], and 5.21 [3.25 to 14.5] (p < 0.01). Significant paradoxical vasoconstriction was seen in groups B and C.
Conclusions
In STEMI patients, DEB followed by BMS implantation failed to show angiographic superiority to BMS only. Angiographic results of DES were superior to both BMS and DEB. Moreover, DEB before implantation induced more uncovered and malapposed stent struts than BMS, but less than after DES. (Drug-Eluting Balloon in Acute Myocardial Infarction [DEB-AMI]; )