Department of Medicine, University of Verona, Verona, Italy.
Am J Med. 2011 May;124(5):434-43. doi: 10.1016/j.amjmed.2010.11.027.
Prednisone at immunosuppressive doses after stenting has shown remarkable efficacy in reducing ischemic recurrences in nondiabetic patients with high post-procedural levels of C-reactive protein; the study aim was to compare the clinical outcome obtained in a control group of patients treated with bare metal stents versus 2 other study groups--bare metal stent plus oral prednisone or drug eluting stents--assuming similar optimal adjunctive medical treatment.
Five tertiary Italian hospitals enrolled 375 nondiabetic patients with coronary artery disease and no contraindications to dual antiplatelet treatment or corticosteroid therapy in a randomized, controlled study performed between 2007 and 2009. Patients were allocated into 3 study groups: bare metal stents (controls), bare metal stents followed by a 40-day prednisone treatment, or drug-eluting stents. The primary endpoint was the event-free survival of cardiovascular death, myocardial infarction, and recurrence of ischemia needing repeated target vessel revascularization at 1 year as adjudicated by an independent clinical events committee.
One-year follow-up was obtained in all patients. Patients receiving bare metal stents alone as compared to those treated with prednisone or drug-eluting stents had lower event-free survival; the primary endpoint was 80.8% in controls compared to 88.0% in the prednisone and 88.8% in the drug-eluting stent groups, respectively (P=.04 and .006).
Compared with bare metal stents alone, prednisone treatment after bare metal stents or drug-eluting stent implantation result in a better event-free survival at 1 year.
在支架置入术后给予免疫抑制剂量的泼尼松可显著降低 C 反应蛋白水平升高的非糖尿病患者的缺血性复发;本研究旨在比较接受裸金属支架治疗的对照组患者与另外 2 个研究组(裸金属支架联合口服泼尼松或药物洗脱支架)的临床结果,假设采用了类似的最佳辅助药物治疗。
2007 年至 2009 年期间,5 家意大利三级医院对 375 名患有冠状动脉疾病且无双重抗血小板治疗或皮质激素治疗禁忌证的非糖尿病患者进行了一项随机对照研究。患者被分配至 3 个研究组:裸金属支架(对照组)、裸金属支架加 40 天泼尼松治疗或药物洗脱支架。主要终点是心血管死亡、心肌梗死和需要再次血运重建的缺血复发的无事件生存,1 年时由独立临床事件委员会判定。
所有患者均获得了 1 年的随访。与接受泼尼松或药物洗脱支架治疗的患者相比,单独接受裸金属支架治疗的患者无事件生存率较低;主要终点在对照组中为 80.8%,在泼尼松组和药物洗脱支架组中分别为 88.0%和 88.8%(P=.04 和.006)。
与单独使用裸金属支架相比,裸金属支架置入后加用泼尼松或药物洗脱支架治疗 1 年后无事件生存率更好。