Department of Internal Medicine, Cardiology and Intensive Care, General Hospital Braunau, Austria.
Atherosclerosis. 2010 Jun;210(2):503-9. doi: 10.1016/j.atherosclerosis.2009.12.003. Epub 2009 Dec 6.
Although drug-eluting stents (DES) reduce restenosis rates relative to bare-metal stents (BMS), recent reports have indicated that the use of DES may be associated with an increased risk of stent thrombosis. Our study focused on the effect of stent type on clinical outcomes in a "real world" setting.
889 patients undergoing percutaneous coronary intervention (PCI) with either DES (Cypher or Taxus; n=490) or BMS (n=399) were enrolled in a prospective single center registry. The outcome analysis covered a period of up to 3.2 years (mean 2.7 years+/-0.5 years) and was based on 65 deaths, 27 myocardial infarctions, 76 clinically driven target lesion revascularizations (TLR), and 15 angiographically confirmed cases of definite stent thrombosis and was adjusted for differences in baseline characteristics.
In total 1277 stents (613 BMS and 664 DES) were implanted in 1215 lesions. Despite a significantly different unadjusted death rate (10.1% and 5.1% in BMS and DES patients, respectively; p<0.05), the patient groups did not differ significantly in the risk of myocardial infarction during 2.7 years of follow-up. After adjustment for differences in baseline characteristics between groups, the difference in the cumulative incidence of death did not remain statistically significant (p=0.22). Target lesion revascularizations occurred significantly less frequently in patients with DES compared to individuals after BMS implantation (5.9% and 11.8% in patients with DES and BMS, respectively; p<0.05). The rate of angiographically confirmed stent thrombosis was 2.1% in patients with DES and 1.1% in BMS patients (p=0.31). There was a significantly lower unadjusted event rate (including deaths, myocardial infarction, target lesion revascularization, and stent thrombosis) in patients with drug-eluting stents than in those with bare-metal stents (16.4% and 25.8%, respectively), with 9.4 fewer such events per 100 patients (unadjusted hazard ratio [HR], 0.64; 95% confidence interval [CI], 0.46 to 0.87). After adjustment, the relative risk for all outcome events in patients with drug-eluting stents was 0.79 (95% CI, 0.67 to 0.95). However, the adjusted relative risk for death and myocardial infarction did not differ significantly between groups (adjusted relative risk in patients with drug-eluting stents 0.94 (95% CI, 0.77 to 1.37)).
In this real-world population, the beneficial effect of first generation DES in reducing the need for new revascularization compared with BMS extends to more than 2.5 years without evidence of a worse safety profile. The minor risk of stent thrombosis and myocardial infarction within this period after implantation of DES seems unlikely to outweigh the benefit of these stents.
虽然药物洗脱支架（DES）相对于裸金属支架（BMS）降低了再狭窄率，但最近的报告表明，DES 的使用可能与支架血栓形成的风险增加有关。我们的研究侧重于支架类型对“真实世界”环境中临床结果的影响。
889 名接受经皮冠状动脉介入治疗（PCI）的患者（DES：Cypher 或 Taxus；n=490）或 BMS（n=399）被纳入前瞻性单中心登记处。结果分析涵盖了长达 3.2 年（平均 2.7 年±0.5 年）的时间，并基于 65 例死亡、27 例心肌梗死、76 例临床驱动的靶病变血运重建（TLR）和 15 例经血管造影证实的明确支架血栓形成病例，根据基线特征的差异进行了调整。
共植入 1215 个病变部位的 1277 个支架（613 个 BMS 和 664 个 DES）。尽管未经调整的死亡率存在显著差异（BMS 和 DES 患者分别为 10.1%和 5.1%；p<0.05），但两组在 2.7 年的随访期间心肌梗死的风险没有显著差异。在调整组间基线特征差异后，死亡率的累积发生率差异不再具有统计学意义（p=0.22）。DES 组的靶病变血运重建发生率明显低于 BMS 组（DES 和 BMS 患者分别为 5.9%和 11.8%；p<0.05）。DES 组的经血管造影证实的支架血栓形成发生率为 2.1%，BMS 组为 1.1%（p=0.31）。DES 组的未调整事件发生率（包括死亡、心肌梗死、靶病变血运重建和支架血栓形成）明显低于 BMS 组（分别为 16.4%和 25.8%），每 100 例患者中减少 9.4 例此类事件（未调整的危险比[HR]，0.64；95%置信区间[CI]，0.46 至 0.87）。调整后，DES 组所有结局事件的相对风险为 0.79（95%CI，0.67 至 0.95）。然而，DES 组的死亡和心肌梗死的调整后相对风险无显著差异（DES 组患者的调整后相对风险为 0.94（95%CI，0.77 至 1.37））。
在这个真实世界的人群中，第一代 DES 降低再血管化需求的益处与 BMS 相比，超过 2.5 年无安全性恶化的证据。DES 植入后这段时间内支架血栓形成和心肌梗死的风险较小，似乎不会超过这些支架的益处。
