Ko Dennis T, Chiu Maria, Guo Helen, Austin Peter C, Goeree Ron, Cohen Eric, Labinaz Marino, Tu Jack V
Division of Cardiology, Schulich Heart Centre, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Ontario, Canada.
J Am Coll Cardiol. 2009 May 12;53(19):1773-82. doi: 10.1016/j.jacc.2009.01.059.
Our main objective was to evaluate the longer-term safety and efficacy of drug-eluting stents (DES) in off-label indications as compared with bare-metal stents (BMS).
DES are frequently implanted in patients with off-label indications. However, the longer-term safety and effectiveness of DES among patients with off-label indications are not well understood.
Propensity score matching analysis was performed in a population-based cohort that included 6,944 off-label and 9,126 on-label patients who received percutaneous coronary interventions (PCIs) in Ontario, Canada, between December 1, 2003, and March 31, 2006. Off-label indications were defined on the basis of clinical and procedural characteristics.
For patients with off-label indications, rates of repeat target vessel revascularization at 3 years were significantly lower among patients treated with DES compared with those treated with BMS (11.6% vs. 15.3%, p < 0.001). Myocardial infarction rates were not significantly different between patients treated with DES and BMS (p = 0.52). Mortality rates were significantly lower among off-label patients treated with DES compared with BMS at 3 years of follow-up (6.9% vs. 10.5%, p < 0.001). For patients with on-label indications, the use of DES was associated with significantly lower rates of target vessel revascularization, but composite rates of myocardial infarction or death were not significantly different from BMS.
For patients with off-label indications, DES implantation was associated with lower target vessel revascularization without an associated increase in longer-term risk of myocardial infarction or death compared with BMS.
我们的主要目的是评估药物洗脱支架（DES）在非标签适应症中的长期安全性和有效性，并与裸金属支架（BMS）进行比较。
DES经常被植入有非标签适应症的患者体内。然而，DES在有非标签适应症患者中的长期安全性和有效性尚未得到充分了解。
在一个基于人群的队列中进行倾向评分匹配分析，该队列包括2003年12月1日至2006年3月31日期间在加拿大安大略省接受经皮冠状动脉介入治疗（PCI）的6944例非标签患者和9126例标签适应症患者。非标签适应症根据临床和手术特征进行定义。
对于有非标签适应症的患者，与接受BMS治疗的患者相比，接受DES治疗的患者3年时的再次靶血管血运重建率显著更低（11.6%对15.3%，p<0.001）。DES治疗患者和BMS治疗患者之间的心肌梗死率无显著差异（p = 0.52）。在3年随访时，与BMS相比，接受DES治疗的非标签患者死亡率显著更低（6.9%对10.5%，p<0.001）。对于有标签适应症的患者，使用DES与显著更低的靶血管血运重建率相关，但心肌梗死或死亡的复合率与BMS无显著差异。
对于有非标签适应症的患者，与BMS相比，DES植入与更低的靶血管血运重建相关，且不会增加心肌梗死或死亡的长期风险。
