公众和非介入心脏病学家需要知道DES的益处大于风险

Public, noninterventionalists, need to hear that DES benefits outweigh risks  

　　纽约，纽约州－2007年12月17日内科学年鉴上发表了药物洗脱支架(DES)安全有效性的前景一文，作者认为DES相对于裸金属支架(BMS)更加安全这一理念并未被除介入心脏病学界以外的公众接受。

　　“我想虽然介入心脏病学家对这一理念十分清楚，但到目前为止普通心脏病学家也许并不了解。” Allen Jeremias医生（Stony Brook大学医学中心，纽约）在接受Heartwire的采访时说道：“事实是钟摆在快速的摆来摆去。当我们刚开始写这篇文章时，DES正倍受追捧。我们所能做的是熟知所有的数据，尽量给出一个更加公正的科学的评价。当你客观的看待这些数据时我们发现实际上DES的效益远大于危害。”

　　在文章写作到出版的过程中，钟摆又向反方向摆了回去。他补充道：“如果让我们现在将文章重写，我想我们可能会给出更有力的结论，因为现在有许多证据证明与BMS相比DES能够拯救更多的生命。钟摆已经向DES回摆了，不仅因为它有效，而且因为它比BMS更好更安全。”

　　文章总结了2007中段以前发表的关于DES安全有效行的大部分数据，重点说明了DES的临床收益大于其增加支架内血栓的风险。Jeremias医生和另一位共同作者Ajay Kirtane医生（Columbia大学，纽约）同时也强调了抗血小板药物的提前中断是支架内血栓的一个重要诱因，接受PCI治疗并置入支架的患者必须要接受长期的不间断的抗血小板治疗。

Jeremias医生说：“如果你能够暂时忘掉支架内血栓（半标志性终点事件），将注意力集中到应该观察的死亡和心梗（硬指标终点事件）上，你会发现DES能够在4年内减少它们的发生。你或许可以争论我们还需要等上10年再下结论，但是当你看到这些数据，会有越来越多的证据证明DES不仅安全，而且比我们预想的要更有效。”

　　坏消息传的更远

　　对于每分钟都在关注DES喧闹发展进程的介入心脏病学家来说这已经不是什么是新消息了，但是Jeremias医生认为当关于DES的坏消息被广为传播时，那些有利结论的声音就被掩盖了。结论是：需要非介入心脏病学家和公众保持关注。

他说：“我们非常希望将一研究结果发表在综合医学杂志上而不是心内科杂志，因为这一消息真的应该让每个医学实践者了解，同样也应该让普通心脏病学家了解。从媒体的角度来说，他们更愿意报道那些骇人的消息，这些消息会有更多的人听到或读到，而那些更多的有利于DES的消息却少人关注。但是现在通过对现有数据的再分析，我想很难再将这些好消息掩盖，DES比1年前认为的更加安全，而且更加有利于患者。

　　Jeremias医生还强调，他并不是要掩盖目前已被广泛认知的晚期支架内血栓风险。他说：“DES支架内血栓依然是一个存在着的问题，它肯定能够得到解决。但是如果你观察最后的结果，DES能够减少死亡、心梗这些终点事件硬指标的发生率。

　　（北京安贞医院　苑飞　编译）

　　（来源：www.theheart.org）

Public, noninterventionalists, need to hear that DES benefits outweigh risks  

January 17, 2008   Shelley Wood

New York, NY - The authors of a Perspective on drug-eluting stent (DES) safety and efficacy appearing in the Annals of Internal Medicine next month and published online December 17, 2007 say they believe the message about the relative safety of DES as compared with bare-metal stents is not getting out beyond the interventional community .

"I think interventional cardiologists have followed the story and are quite well-informed, but the general cardiologists may not, at this point, be up to date," Dr Allen Jeremias (Stony Brook University Medical Center, NY) told heartwire. "The truth is, the pendulum has swung radically. When we first wrote this article, it was the height of the DES mania. What we tried to do was familiarize ourselves with the data and try to provide a more unbiased and scientific type of review. And what we found was that when you looked at the data objectively, in balance, DES are more favorable than harmful."

In the interim, between writing the Perspective and its publication, the pendulum has swung back to more strongly favor DES, he adds. "If we were to write the same article again today, I think we’d be even stronger in our conclusions, because now there is a lot of evidence that they do save lives as compared with bare-metal stents. The pendulum has really swung toward them being not only efficacious but also safer and better than bare-metal stents."

The Perspective summarizes much of the information published on DES safety and efficacy until mid-2007, in aggregate suggesting that a net clinical benefit of DES outweighs the risks associated with an increase in stent thrombosis. Jeremias and coauthor Dr Ajay Kirtane (Columbia University, New York) also emphasize that premature discontinuation of antiplatelet therapy "is an important trigger" for stent thrombosis and that patients undergoing PCI and stenting must clearly be candidates for long-term, uninterrupted antiplatelet therapy.

"If you forget stent thrombosis as a semisurrogate end point for a minute and focus really on death and MI, which are really the only hard end points we should look at, they are reduced at four years," Jeremias said. "You could argue that we should wait 10 years, but if you look at the data emerging, there is more and more evidence that those devices are not only safe but also more beneficial than we anticipated."

Bad news travels further

None of this is new news to interventional cardiologists who have followed the turbulent history of drug-eluting stents minute by minute, but Jeremias maintains that while the bad-news DES story was trumpeted from the hilltops, stories about the more reassuring results for the devices have been muffled. The result: noninterventionalists and the public remain concerned.

"We really wanted to publish this in a general medical journal rather than a cardiology journal, because this message really needs to come out to the general medicine practitioner and to general cardiologists as well," he says. "From the media’s perspective, it’s always more interesting to report alarming news, and more people will hear that or read that than they will news that is more in favor of these devices, because it makes a more interesting story. Now, I think it’s very hard to get the message out that after repeat analysis, the devices appear to be safer than anticipated a year ago and in fact might be of benefit to patients."

Jeremias emphasized that he is by no means playing down the now-accepted increased risk of late stent thrombosis. "Stent thrombosis with DES is a problem and can certainly be improved upon. However, if you look at the balance at the end of the day, in terms of hard outcomes, death and MI, they are reduced with DES."

责任编辑 刘瑞琦