Leibundgut Gregor, Nietlispach Fabian, Pittl Undine, Brunner-La Rocca Hanspeter, Kaiser Christoph A, Pfisterer Matthias E
Department of Cardiology, University Hospital Basel CH-4031, Switzerland.
Am Heart J. 2009 Aug;158(2):271-6. doi: 10.1016/j.ahj.2009.04.025.
The long-term safety of drug-eluting stents (DES) for the treatment of ST-segment elevation myocardial infarction (STEMI) is unclear and may differ from that in stable angina (stable) patients as noted in autopsy studies.
To assess this problem, 210 consecutive STEMI and 323 stable patients, randomized 2:1 to DES versus bare-metal stents (BMS), were followed up for 3 years for definite/probable stent thrombosis (ST) and cardiac death/myocardial infarction. Events occurring during the initial 6 months were separated from later events.
The 3-year rate of ST was 8.1% in STEMI vs 3.4% in stable patients (P = .02), with corresponding rates of 9.4% vs 2.9% (P = .01) for DES and of 5.6% vs 4.3% (P = .71) for BMS patients, respectively. This difference appeared only after 6 months: 4.6% in STEMI vs 1.7% in stable patients (P = .05) and in DES-treated patients (6.2% vs 2.0%, P = .05). Results of ST were paralleled by findings of clinical events, although here differences were less pronounced, but also seen only late after stenting. Thus, in STEMI patients, late events occurred more frequently after DES vs BMS implantation (11.6% vs 3.0%, P = .04), compared to results in stable patients (DES 6.4%, BMS 1.9%, P = .08).
In this pilot study, we observed an increased rate of late ST and a trend to more related clinical events in patients after stenting for STEMI vs for stable angina, particularly if treated with DES. This may explain outcome differences between results of pivotal trials in stable patients vs those of "real-world" patients.
药物洗脱支架(DES)用于治疗ST段抬高型心肌梗死(STEMI)的长期安全性尚不清楚,且可能与尸检研究中观察到的稳定型心绞痛(稳定型)患者不同。
为评估此问题,对210例连续性STEMI患者和323例稳定型患者进行了研究,这些患者按2:1随机分为DES组和裸金属支架(BMS)组,随访3年,观察明确/可能的支架血栓形成(ST)及心源性死亡/心肌梗死情况。将最初6个月内发生的事件与之后的事件分开统计。
STEMI患者3年ST发生率为8.1%,稳定型患者为3.4%(P = 0.02);DES组相应发生率为9.4%,BMS组为2.9%(P = 0.01);STEMI患者BMS组为5.6%,稳定型患者BMS组为4.3%(P = 0.71)。这种差异仅在6个月后出现:STEMI患者为4.6%,稳定型患者为1.7%(P = 0.05),DES治疗患者为6.2%,稳定型患者为2.0%(P = 0.05)。ST结果与临床事件结果相似,尽管此处差异不太明显,但也仅在支架置入后期出现。因此,与稳定型患者相比(DES为6.4%,BMS为1.9%,P = 0.08),STEMI患者DES植入后晚期事件发生率高于BMS植入后(11.6%对3.0%,P = 0.04)。
在这项初步研究中,我们观察到与稳定型心绞痛患者相比,STEMI患者支架置入后晚期ST发生率增加,且相关临床事件有增多趋势,尤其是接受DES治疗者。这可能解释了稳定型患者关键试验结果与“真实世界”患者结果之间的差异。