美国纽约哥伦比亚大学医学中心Gregg W. Stone医生，报告了来自HORIZONS AMI支架组的最新数据。在这一组当中，研究人员评估了12个月的2个主要终点：缺血引起的有效靶病变重建有效性，以及主要心脏不良事件（包括全因死亡、再梗塞、支架血栓或中风）的安全性。主要的次要终点是13个月时的双支血管造影再狭窄。

      应用Taxus支架治疗的患者，发生缺血性靶病变重建率要显著低于接受Express支架的患者（见图1），而MACE水平在两组当中则是相当的（图2）。

      支架血栓率，参照学术研究协会（ARC）的定义，在12个月Taxus和Express之间是相当的（3.1%对3.4%）。
1204位患者进行了血管造影随访，显示在Taxus组当中，每个病变的二元再狭窄百分率明显地低于Express组(10.0% 对 22.9%; P<0.0001)。

      Stone医生说“Taxus紫杉醇洗脱支架与裸金属Express支架在心肌梗死患者中的长期安全性和有效性的比较将由继续进行的HORIZONS AMI试验的5年患者随访来决定。”

      美国波士顿Brigham和妇女医院 David P. Faxon医生说到，HORIZONS AMI是一个极其重要的试验。除了强调该试验的许多强势之外，Faxon还列举了一些尚未回答的问题。

       Faxon说，最重要的当然是我们应当真正理解这项研究在有效节省开销方面的意义，尤其是在当今我们所听到的经济危机当中。

抗凝治疗组
      上周三（10月15日）公布的HORIZONS AMI的第二个重要结果是由同样来自美国纽约哥伦比亚大学医学中心的Roxana Mehran博士公布的1年药物群组的试验结果，该结果是今年早些时候发布的30天结果的延伸。

      最初参与研究的95%的患者被囊括入一年随访当中：比伐卢定组1696例，肝素联合GP抑制剂组1702例。
两个主要终点为出血和净临床不良事件（包括严重出血以及诸如死亡、再栓塞、中风和靶病变重建的主要心血管事件）。主要的次要终点是MACE。

      1年期随访的时候，临床不良反应在比伐卢定组要明显的低（见图3）；比伐卢定的严重出血是5.8%，肝素是9.2%(P<0.0001)；而MACE在两组当中都是11.9%。

      两组当中1年期支架血栓发生率是接近的，比伐卢定3.5%，肝素加GP是3.2%。进一步的分析表明在30天和1年中，药物与支架种类之间都没有相互作用。

      此外，在比伐卢定组当中1年期全因死亡率有1.4个百分点的明显降低 (P=0.029) 。“HORIZONS AMI 最终显示了在心肌梗死患者当中直接进行PCI手术之后预防出血性并发症导致了更高的早期和晚期生存率，因此对于行介入治疗的患者选择最佳的药物和技术以最小化出血对于强化结果来说是非常重要的。”Mehran说到。

      美国波士顿Brigham和妇女医院Deepak L. Bhatt博士在评论时段提问到，为什么在快速围手术期之后早期出血的降低会转变成死亡率和再栓塞的降低。

      Bhatt回答到，抛开这其中的机制不提，不能争论死亡率降低的问题。我相信这个试验为直接PCI的抗凝护理规定了一个新的标准。

(医心评论：孟祥飞 译  陆卫 校）

HORIZONS AMI One-Year Follow-up: Less Ischemic TLR with Taxus DES
  
By TCT Daily Staff

Investigators revealed long-term outcomes Wednesday from the HORIZONS AMI trial, the largest study to focus on the optimal use of stents and anticoagulation therapy in patients with STEMI.

The randomized, multicenter trial compared bivalirudin to heparin plus a GP IIb/IIIa inhibitor in 3,602 STEMI patients. Of these patients, 3,000 were eligible for randomization, in a 3:1 ratio, to either Taxus paclitaxel-eluting stents or Express bare-metal stents.

Gregg W. Stone, MD, of Columbia University Medical Center, New York, presented the first data released from the HORIZONS AMI stent cohort. In this group, researchers assessed two primary endpoints at 12 months: ischemia-driven TLR for efficacy and major adverse cardiac events (a composite of all-cause death, reinfarction, stent thrombosis, or stroke) for safety. The major secondary endpoint was binary angiographic restenosis at 13 months.

Patients treated with a Taxus stent had significantly less ischemic TLR than those treated with an Express stent (see Figure 1), and MACE levels were equivalent between both treatment groups (see Figure 2 ).

Stent thrombosis rates, defined as ARC definite or probable, also were comparable at 3.1% for Taxus and 3.4% for Express at 12 months.

Angiographic follow-up was available for 1,204 patients, and showed that percent binary restenosis per lesion was significantly lower in the Taxus group than in the Express group (10.0% vs. 22.9%; P<0.0001).

"The long-term safety and efficacy profile of paclitaxel-eluting Taxus stents compared to bare-metal Express stents in STEMI will be determined by the ongoing five-year follow-up of patients randomized in the HORIZONS AMI trial," Stone said.

David P. Faxon, MD, of Brigham and Women’s Hospital in Boston, said that HORIZONS AMI is a "critically important trial." In addition to highlighting the trial’s many strengths, Faxon also listed several questions that remain unanswered.

"Most importantly, of course, we need to really understand what the cost effectiveness of this strategy is, particularly in today’s economic crisis that we’ve been hearing about," Faxon said.

Anticoagulant therapy cohort

In a second installment of HORIZONS AMI results Wednesday, Roxana Mehran, MD, of Columbia University Medical Center, New York, announced one-year outcomes from the pharmacologic cohort that extended the trial’s initial 30-day results, which were published earlier this year.

Over 95% of patients in the original study population were included in the one-year follow-up: 1,696 in the bivalirudin group and 1,702 in the heparin-plus-GP inhibitor group.

The two primary endpoints were major bleeding and net adverse clinical events (composite of major bleeding or major cardiovascular events including death, reinfarction, stroke, and TLR). The main secondary endpoint was MACE.

At one-year follow-up, net adverse clinical events were significantly lower in the bivalirudin group (see Figure 3); major bleeding was 5.8% with bivalirudin vs. 9.2% with heparin, (P<.0001); and the MACE rate was 11.9% in both groups.

One-year stent thrombosis rates were similar at 3.5% for bivalirudin and 3.2% for heparin-plus-GP inhibitor.

Further analyses showed no interaction between drug and stent type for clinical outcomes at either 30 days or one year.

In addition, there was a significant 1.4% reduction in all-cause mortality at one year with bivalirudin (P=.029) "HORIZONS AMI has finally demonstrated that the prevention of hemorrhagic complications after primary PCI in STEMI results in improved early and late survival, so optimal drug selection and technique to minimize bleeding are essential to enhance outcomes for patients undergoing interventional therapies," Mehran said.

Deepak L. Bhatt, MD, of Brigham and Women’s Hospital in Boston, asked during a comment period why a reduction in early bleeding would translate to a reduction in mortality and reinfarction after that immediate periprocedural period.

"Regardless of the underlying mechanism, one cannot argue with a reduction in mortality. I believe that this trial defines a new standard of care for anticoagulation in primary PCI," Bhatt said.