Interceptor plus filter as safe and effective as currently approved alternatives in SVG lesions

　　（AMETHYST试验：应用Interceptor plus远端保护装置与其他远端保护装置的患者，其MACE发生率相似。）

　　AMETHYST 试验结果显示，应用冠脉Interceptor filter远端保护装置治疗的大隐静脉桥血管病变（SVG），在30天的安全性上不劣于已批准的其他远端血栓保护装置。

　　辛辛那提The Christ Hospital心脏中心的Dean J. Kereiakes博士公布了AMETHYST试验的最新临床试验结果：Interceptor plus（美敦力）远端血栓保护装置与目前在美国市场销售的其他远端保护装置相比，具有相似的安全性。

　　高危患者

　　Kereiakes博士称，Interceptor组的设备成功率（即良好的输送、展开、回撤）是90.5%，而对照组是93.8%。临床成功率（即所用的装置输送、展开、回撤后而无医院内MACE发生）Interceptor组是84.4%，对照组是89.6%。两组在设备成功率和临床成功率上无统计学差异。

　　因为在30天应用远端血栓保护装置治疗并同步实行PCI术的患者整体MACE发生率小，Kereiakes博士认为值得进一步研究。

　　AMETHYST试验筛选了800名患有SVG的患者。具有多种高风险疾病，如糖尿病、高血压、不稳定心绞痛、以及血脂异常等的患者也被纳入研究。患者以2：1的比例随机分为Interceptor plus组（30天随访率为97.9%）和对照组（30天随访率为97.4%）。对照组使用Guardwire（美敦力）或Filterwire（波士顿科学）远端保护装置。研究的主要终点：30天内MACE发生率（死亡，心肌梗死，及再次血运重建）。

　　分析

　　来自苏黎世Hirslanden 心脏中心的Gabor sutsch博士，在谈到对AMETHYST试验的看法时强调，该试验还需要更多的高危患者使用Interceptor plus的治疗资料。

　　Sutsch说这个试验成功地减少了PCI并发症，研究者针对高危患者的治疗也将被推荐，希望能进一步减少MACE的发生率。“（研究者）仍不能防止并发症的发生及完全消除MACE”Sutsch说，“也许需要采取其他的措施，包括近端保护、复合装置或者辅助治疗。”

Interceptor Plus Filter as Safe and Effective asCurrently Approved Alternatives in SVG Lesions

AMETHYST: Major adverse cardiovascularevent rate similar among patients treated with Interceptor fi lter and other approved devices.

The Interceptor Plus coronary filter system is non-inferior with regard to safety at 30 days when compared with currently approved distal embolic protection devices in saphenous vein graft SVG lesions, according to results of the AMETHYST trial.

The Interceptor fi lter (Medtronic) had a similar safety profi le to several distal embolic protection devices currently on the U.S. market. At 30 days, the Interceptor device showed noninferiority to control devices with regard to major adverse events (Figure).

AMETHYST results were presented by Dean Kereiakes, MD, from Christ Hospital in Cincinnati and coprincipal investigator.

High-risk patients

According to Kereiakes, the rate of device success — defi ned as delivery, deployment and retrieval of the assigned device — was 90.5% in the Interceptor group and 93.8% in the control group.

Clinical success — defi ned as delivery, deployment, and retrieval of the assigned device with no in-hospital MACE — was 84.4% in the Interceptor group and 89.6% for the control group. The differences in device and clinical success success were not statistically significant.

Kereiakes said the results indicated that overall, MACE at 30 days in patients treated with distal embolic protection devices appears to be less frequent in contemporary PCI practice and may merit further study.

AMETHYST included 800 patients with SVG disease and a high cardiovascular risk profi le. Patients  with various high-risk comorbid conditions, including diabetes, arterial hypertension, unstable angina and dyslipidemia, were recruited for the study.

Patients were randomized 2:1 to treatment with the Interceptor Plus filter or a control distal embolic protection device. The control devices were GuardWire (Medtronic) or FilterWire (Boston Scientifi c).

The study’s primary endpoint was defi ned as MACE (death, MI, or repeat revascularization) at 30 days.
Thirty-day clinical follow-up was available for 97.9% of patients treated with the Interceptor PLUS fi lter and 97.4% of patients treated with the control devices.

Analysis

Gabor Sutsch, MD, from the Hirslanden Heart Center in Zurich, offered his perspective on the AMETHYST trial.
Sutsch stressed that more information regarding treatment with the Interceptor fi lter in high-risk patients was still needed.

“This trial represents another successful effort to reduce the undesired high incidence of PCI-related complications,” Sutsch said.

He said the researchers were to be commended for their treatment of high-risk patients and hoped the risk of MACE could be further reduced.“[The researchers were] still not able to abolish complications and eliminate major adverse cardiovascular events completely,” Sutsch said.“Further steps are required and additional measures — including proximal protection, combination devices, or adjunctive treatment — may need to be examined.”