Department of Cardiology, Cardiovascular Institute & Fu Wai Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College, Beijing 100037, China.
Chin Med J (Engl). 2009 Oct 5;122(19):2261-7.
In response to the increasing concern with the safety of the drug-eluting stent (DES), the present study aimed to evaluate the long-term safety and efficacy of DES used for a Chinese patient population.
All patients, who underwent an index elective percutaneous coronary intervention with an implantation of either DES or bare-metal stent (BMS) in a single institution from April 2004 to December 2006, were included in the analysis. A propensity-score matching technique was applied to adjust and to minimize the impact of confounding factors.
Overall, there were 1465 patients (20.2%) who had undergone an implantation of only BMS, and 5769 patients (79.8%) of only DES. The propensity-score matching technique set up 1321 pairs of patients for analysis. There were no significant differences between the rates of stent thrombosis (definite and probable) of the two groups (1.06% vs 1.21%, P = 0.8580). Although rates of mortality and myocardial infarction (MI) during the 2-year follow-up period had not differed significantly, rates of death/MI (3.0% vs 4.5%, P = 0.0263), target-lesion revascularization (TLR, 3.2% vs 8.5, P = 0.0001), target-vessel revascularization (TVR, 5.8% vs 9.5%, P < 0.0001) and any revascularization (10.0% vs 13.3%, P = 0.0066) were significantly lower for the DES group than for the BMS group. Among the patients in whom devices were implanted for off-label indications, the propensity-score matched rates of stent thrombosis, mortality, MI, and death/MI were not significantly different, while rates of TLR, TVR and any revascularization were significantly lower for the DES group than for the BMS group.
During the 2 years of follow-up post stenting, DES use is associated with lower rates of death/MI, TLR, TVR and any revascularization, compared with BMS, in propensity-score matched Chinese patient populations. In the setting of off-label usage, DES use is also associated with similar advantages.
鉴于对药物洗脱支架（DES）安全性的日益关注，本研究旨在评估 DES 在我国患者人群中的长期安全性和疗效。
所有患者于 2004 年 4 月至 2006 年 12 月在一家医疗机构接受了经皮冠状动脉介入治疗（percutaneous coronary intervention，PCI），并植入 DES 或金属裸支架（bare-metal stent，BMS），这些患者均被纳入分析。应用倾向评分匹配技术来调整和最小化混杂因素的影响。
总体而言，有 1465 例患者（20.2%）仅植入了 BMS，5769 例患者（79.8%）仅植入了 DES。倾向评分匹配技术共建立了 1321 对患者进行分析。两组支架血栓形成（明确和可能）的发生率无显著差异（1.06%比 1.21%，P = 0.8580）。虽然在 2 年随访期间死亡率和心肌梗死（myocardial infarction，MI）的发生率无显著差异，但死亡率/心肌梗死发生率（3.0%比 4.5%，P = 0.0263）、靶病变血运重建（target-lesion revascularization，TLR，3.2%比 8.5%，P = 0.0001）、靶血管血运重建（target-vessel revascularization，TVR，5.8%比 9.5%，P < 0.0001）和任何血运重建（10.0%比 13.3%，P = 0.0066）的发生率显著更低。对于因适应证外而植入器械的患者，支架血栓形成、死亡率、MI 和死亡率/心肌梗死发生率的倾向评分匹配率无显著差异，而 TLR、TVR 和任何血运重建的发生率显著更低。
在支架置入后 2 年的随访期间，与 BMS 相比，DES 在我国患者人群中的应用与死亡率/心肌梗死发生率、TLR、TVR 和任何血运重建的发生率较低相关。在适应证外使用的情况下，DES 的应用也具有类似的优势。
