Heart Center, Satakunta Central Hospital, Pori, Finland; Department of Internal Medicine and Heart Center, Kuopio University Hospital and University of Eastern Finland, Kuopio, Finland.
Int J Cardiol. 2013 Sep 30;168(2):1214-9. doi: 10.1016/j.ijcard.2012.11.060. Epub 2012 Dec 3.
The TITAX-AMI randomized controlled trial demonstrated a better clinical outcome with titanium-nitride-oxide-coated bioactive stents (BAS) as compared with paclitaxel-eluting stents (PES) at 2-year follow-up, in patients with acute myocardial infarction (MI) undergoing early percutaneous coronary intervention (PCI). We sought to present the 5-year clinical outcome of the TITAX-AMI trial.
A total of 425 patients with acute MI were randomly assigned to receive either BAS (214), or PES (211). The primary endpoint was major adverse cardiac events (MACE): a composite of cardiac death, recurrent MI or ischemia-driven target lesion revascularization (TLR). Clinical follow-up was performed to 5 years.
The 5-year cumulative incidence of MACE was significantly lower in patients assigned to BAS as compared with those assigned to PES (16.4% versus 25.1%, respectively, p=0.03). Similarly, the 5-year rates of cardiac death and recurrent MI were significantly lower in patients assigned to BAS (1.9% versus 5.7%, and 8.4% versus 18.0%, p=0.04 and p=0.004, respectively). Yet, the rates of ischemia-driven TLR were similar between the two study groups (11.2% versus 10.9%, respectively, p=0.92). The rate of definite stent thrombosis (ST) was again significantly lower in patients assigned to BAS (0.9% versus 7.1%, respectively, p=0.001).
In the current prospective randomized TITAX-AMI trial, among patients presenting with acute MI who underwent early PCI, BAS achieved a better clinical outcome as compared with PES at 5-year follow-up, as reflected by lower cumulative rates of overall MACE, cardiac death, recurrent MI, and definite ST; yet, with statistically similar rates of ischemia-driven TLR.
TITAX-AMI 随机对照试验表明，在接受早期经皮冠状动脉介入治疗（PCI）的急性心肌梗死（MI）患者中，与紫杉醇洗脱支架（PES）相比，氮化钛涂层生物活性支架（BAS）在 2 年随访时具有更好的临床结局。我们旨在报告 TITAX-AMI 试验的 5 年临床结果。
共 425 例急性 MI 患者被随机分为 BAS 组（214 例）或 PES 组（211 例）。主要终点是主要不良心脏事件（MACE）：包括心脏死亡、再发 MI 或缺血驱动的靶病变血运重建（TLR）的复合终点。临床随访至 5 年。
与 PES 组相比，BAS 组患者的 5 年累积 MACE 发生率显著降低（分别为 16.4%和 25.1%，p=0.03）。同样，BAS 组患者的心脏死亡和再发 MI 发生率在 5 年内也显著降低（分别为 1.9%和 5.7%，8.4%和 18.0%，p=0.04 和 p=0.004）。然而，两组患者的缺血驱动 TLR 发生率相似（分别为 11.2%和 10.9%，p=0.92）。BAS 组患者的明确支架血栓形成（ST）发生率也显著降低（分别为 0.9%和 7.1%，p=0.001）。
在当前前瞻性随机 TITAX-AMI 试验中，在接受早期 PCI 的急性 MI 患者中，BAS 与 PES 相比，在 5 年随访时获得了更好的临床结局，表现为总体 MACE、心脏死亡、再发 MI 和明确 ST 的累积发生率较低；然而，缺血驱动 TLR 的发生率统计学上相似。
