Shammas Nicolas W, Shammas Gail A, Hahn Alex, Jerin Michael, Dippel Eric J, Winter Matthew
Midwest Cardiovascular Research Foundation, Cardiovascular Medicine, PC, Davenport, Iowa 52803, USA.
Cardiovasc Revasc Med. 2009 Jul-Sep;10(3):151-5. doi: 10.1016/j.carrev.2009.01.007.
The paclitaxel drug-eluting stent (Taxus, Boston Scientific) is FDA approved for treatment of coronary artery disease in simple, noncomplex coronary lesions. In this registry, we sought to investigate the procedural success and long-term outcomes of patients receiving the Taxus stent in the setting of acute ST-elevation myocardial infarction (STEMI) in a busy single-center interventional program.
This is a single-center retrospective analysis of prospectively collected in-hospital data with postdischarge follow-up achieved by phone calls and review of medical records. Data were audited by an independent monitor, and outcomes were adjudicated by an experienced interventional cardiologist. All patients with STEMI over the period of 2 years (2005 and 2006) with native de novo lesions who received the Taxus stent were included. Patients receiving bare metal stents were excluded. The primary outcome was the combined end point of cardiac death, recurrent nonfatal MI, and target lesion revascularization (TLR) on follow-up.
Of 198 patients included in this study, follow-up data were obtained in 172 (86.9%) patients. The mean age was 63+/-14.9 years. There were 59.1% males. Patients had the following cardiac risk factors: diabetes 20.7%, hypertension 60.6%, hyperlipidemia 87.8%, and current smoking 48%. In-hospital complications included death 5.1%, acute closure with stent thrombosis 1%, vascular complications 2.9%, and cardiogenic shock 6.6%. The mean follow-up period (days) was 317.3+/-239.3. The primary end point of cardiac death, nonfatal MI, and TLR was met in 12.4%. Individual end points on follow-up were cardiac death 2.5%, total death 4.9%, TLR 8.1%, target vessel revascularization 19.9%, stroke 1.2%, nonfatal MI 5%, and acute stent thrombosis 5.5% (definite 4.3%, probable 0.6%, possible 0.6%; Academic Research Consortium definition).
The use of the Taxus stent in acute STEMI is associated with a low postdischarge combined end point of cardiac death, nonfatal MI, and TLR and a definite/probable 4.9% in-stent thrombosis rate, which is within the reported range of data published in "real-world" registry.
紫杉醇药物洗脱支架(Taxus,波士顿科学公司)已获美国食品药品监督管理局批准,用于治疗简单、非复杂冠状动脉病变的冠状动脉疾病。在本注册研究中,我们试图在一个繁忙单中心介入项目中,调查急性ST段抬高型心肌梗死(STEMI)患者接受Taxus支架治疗的手术成功率和长期预后。
这是一项单中心回顾性分析,对前瞻性收集的住院数据进行分析,并通过电话随访和查阅病历进行出院后随访。数据由独立监测人员审核,结局由经验丰富的介入心脏病专家判定。纳入2005年和2006年这两年间所有STEMI且有原发新发病变并接受Taxus支架治疗的患者。排除接受裸金属支架的患者。主要结局是随访时心脏死亡、复发性非致死性心肌梗死和靶病变血运重建(TLR)的联合终点。
本研究纳入的198例患者中,172例(86.9%)获得随访数据。平均年龄为63±14.9岁。男性占59.1%。患者有以下心脏危险因素:糖尿病20.7%、高血压60.6%、高脂血症87.8%、当前吸烟者48%。住院并发症包括死亡5.1%、支架血栓形成致急性闭塞1%、血管并发症2.9%、心源性休克6.6%。平均随访期(天)为317.3±239.3。心脏死亡、非致死性心肌梗死和TLR这个主要终点的发生率为12.4%。随访时的个体终点为心脏死亡2.5%、全因死亡4.9%、TLR 8.1%、靶血管血运重建19.9%、卒中1.2%、非致死性心肌梗死5%、急性支架血栓形成5.5%(明确4.3%、很可能0.6%、可能0.6%;学术研究联盟定义)。
在急性STEMI中使用Taxus支架与出院后心脏死亡、非致死性心肌梗死和TLR的联合终点发生率低以及明确/很可能4.9%的支架内血栓形成率相关,这在“真实世界”注册研究报告的数据范围内。