Trikalinos Thomas A, Alsheikh-Ali Alawi A, Tatsioni Athina, Nallamothu Brahmajee K, Kent David M
Institute for Clinical Research and Health Policy Studies, Tufts Medical Center, Boston, MA, USA.
Lancet. 2009 Mar 14;373(9667):911-8. doi: 10.1016/S0140-6736(09)60319-6.
Over the past 20 years, percutaneous transluminal balloon coronary angioplasty (PTCA), bare-metal stents (BMS), and drug-eluting stents (DES) succeeded each other as catheter-based treatments for coronary artery disease. We undertook a systematic overview of randomised trials comparing these interventions with each other and with medical therapy in patients with non-acute coronary artery disease.
We searched Medline for trials contrasting at least two of the four interventions (PTCA, BMS, DES, and medical therapy). Eligible outcomes were death, myocardial infarction, coronary artery bypass grafting, target lesion or vessel revascularisation, and any revascularisation. Random effects meta-analyses summarised head-to-head (direct) comparisons, and network meta-analyses integrated direct and indirect evidence.
61 eligible trials (25 388 patients) investigated four of six possible comparisons between the four interventions; no trials directly compared DES with medical therapy or PTCA. In all direct or indirect comparisons, succeeding advancements in percutaneous coronary intervention did not produce detectable improvements in deaths or myocardial infarction. The risk ratio (RR) for indirect comparisons between DES and medical therapy was 0.96 (95% CI 0.60-1.52) for death and 1.15 (0.73-1.82) for myocardial infarction. By contrast, we recorded sequential significant reductions in target lesion or vessel revascularisation with BMS compared with PTCA (RR 0.68 [0-60.0.77]) and with DES compared with BMS (0.44 [0.35-0.56]). The RR for the indirect comparison between DES and PTCA for target lesion or vessel revascularisation was 0.30 (0.17-0.51).
Sequential innovations in the catheter-based treatment of non-acute coronary artery disease showed no evidence of an effect on death or myocardial infarction when compared with medical therapy. These results lend support to present recommendations to optimise medical therapy as an initial management strategy in patients with this disease.
在过去20年中，经皮腔内球囊冠状动脉成形术（PTCA）、裸金属支架（BMS）和药物洗脱支架（DES）相继成为冠状动脉疾病的导管介入治疗方法。我们对比较这些干预措施彼此之间以及与非急性冠状动脉疾病患者药物治疗效果的随机试验进行了系统综述。
我们在Medline中检索了对比四种干预措施（PTCA、BMS、DES和药物治疗）中至少两种的试验。符合条件的结局指标包括死亡、心肌梗死、冠状动脉旁路移植术、靶病变或靶血管血运重建以及任何血运重建。随机效应荟萃分析总结了直接（头对头）比较，网络荟萃分析整合了直接和间接证据。
61项符合条件的试验（25388例患者）研究了四种干预措施之间六种可能比较中的四种；没有试验直接比较DES与药物治疗或PTCA。在所有直接或间接比较中，经皮冠状动脉介入治疗的相继进展在死亡或心肌梗死方面未产生可检测到的改善。DES与药物治疗间接比较的死亡风险比（RR）为0.96（95%CI 0.60-1.52），心肌梗死为1.15（0.73-1.82）。相比之下，我们记录到与PTCA相比，BMS使靶病变或靶血管血运重建有显著的相继降低（RR 0.68[0.60-0.77]），与BMS相比，DES使靶病变或靶血管血运重建有显著的相继降低（0.44[0.35-0.56]）。DES与PTCA在靶病变或靶血管血运重建方面间接比较的RR为0.30（0.17-0.51）。
与药物治疗相比，非急性冠状动脉疾病导管介入治疗的相继创新在死亡或心肌梗死方面未显示出有效果的证据。这些结果支持了当前将优化药物治疗作为该疾病患者初始管理策略的建议。
