ESC血管重建指南编写组提前透露新变化

巴黎——欧洲心血管学会（ESC）和欧洲心胸外科学会（EACTS）联合工作组将在8月下旬发布修订后的血管重建指南。日前，该工作组在欧洲经皮心血管介入学会（EAPCI）年会上透露了新版指南的一些要点，包括对2010年版指南首次提出的心脏小组概念的新认可。

联合工作组共同主席、比利时列日大学医院的Philippe H. Kolh医生指出：“2010年版指南的一个重要之处是引入了心脏小组（Eur. Heart J. 2010;31:2501-55）。2010年时，心脏小组的概念还具有争议性，而现在这一概念已被广为接受。我们将进一步支持和强调心脏小组的重要性。”

Spencer B. King, III医生与Franz-Josef Neumann医生

新版指南还呼吁所有开展血管重建的医疗机构制订各自的方案，从而指导临床医生在处理常规病例时在经皮冠状动脉介入（PCI）和冠状动脉旁路移植术（CABG）之间作出合理选择。

联合工作组成员、苏黎世大学医院心脏急症门诊部主任Ulf Landmesser医生指出：“2010年版指南引起了一种误解，即所有患者都必须接受心脏小组的讨论。2014年版指南更清晰地指出，心脏小组应发展出针对不同类型患者的合理血管重建策略的制度性方案。因此，假如1例患者有单支血管病变，你可以实施PCI而不必等待心脏小组的决定。有希望的做法是，心脏小组将只需讨论决策难度大的复杂患者，而制度性方案则能够处理常规病例。”

联合工作组共同主席、瑞士伯尔尼大学医院心血管内科主任Stephan Windecker医生介绍称，一项新的meta分析的结果凸显了血管重建在改善冠状动脉疾病患者结局方面相对于单纯药物治疗的关键角色。这一结果在2014年尤其有意义，因为今年是首次成功实施CABG的50周年。

Windecker医生报告了对100项随机对照试验结果的分析，这些试验对93,553例患者进行了260,000患者-年的随访，比较了若干种血管重建与药物治疗。分析结果显示，与药物治疗相比，CABG使全因死亡率降低了20%，具有统计学差异；欧洲心肌血管重建协作组织（EMRC）成员报告的未发表数据显示，采用新一代药物洗脱支架可使全因死亡率显著降低25%以上。Windecker医生还指出，新版指南的所有推荐意见均获得了联合工作组成员的一致认可，这些成员包括比例相当的心脏外科专家、介入心脏病专家和非介入心脏病专家。

尽管Windecker医生多次强调目前透露的指南内容在夏季发表最终版本之前仍有修改的可能性，但本次会议仍凸显出了新版指南中若干项值得注意的其他新要素。

·对于患有左主冠状动脉疾病、SYNTAX评分介于23~32的患者使用PCI，推荐程度更新为Ⅱa类，即“应当考虑”类推荐意见，而在2010年版指南中仅为Ⅲ类。SYNTAX试验的5年结果显示“PCI和CABG在结局方面无差异，这是更新PCI推荐意见的主要原因”（Lancet 2013;381:629-38）。“指南给予了SYNTAX评分很高的权重。”

·德国Bad Krozingen大学心脏中心主任Franz-Josef Neumann医生指出，由于比伐卢定引起大出血的风险较低，在对非ST段抬高性心肌梗死（NSTEMI）患者实施PCI时，比伐卢定是唯一获得推荐在PCI术中或术后即刻使用的抗凝药物，而普通肝素仅被推荐用于无法使用比伐卢定的患者。

·但是对于接受直接PCI的ST段抬高性心肌梗死（STEMI）患者，普通肝素则是唯一获得无条件Ⅰ级推荐的抗凝药物，而比伐卢定仅获得了Ⅱa级推荐（即“应当考虑”）。这两种药物之所以会发生地位互换，在一定程度上是基于一项超大规模单中心研究（HEAT-PPCI）的尚未发表的结果。这项在利物浦开展的研究的结果已于今年3月在美国心脏病学会（ACC）年会上公布：普通肝素在28天结局方面优于比伐卢定。Neumann医生表示：“我非常高兴，并且对于HEAT-PPCI结果被指南采纳颇有些惊讶，因为毕竟这一结果尚未正式发表。我估计这项推荐意见将对临床实践产生很大影响。”

·对于STEMI或 NSTEMI患者，优选的抗血小板P2Y₁₂i抑制剂均为普拉格雷和替卡格雷，而氯吡格雷则被降级到仅在普拉格雷和替卡格雷无法使用时才被采用的后备药物。King医生指出：“我对于氯吡格雷跌出首选药物行列有些惊讶。鉴于新型支架的支架血栓发生率较低，美国医生倾向于坚持使用氯吡格雷，而欧洲的变化更大。”Neumann医生则持相反意见：“对于经过选择的病例，我们仍然明确声明支持氯吡格雷。该药仅限用于高危的急性冠脉综合征、STEMI患者，而指南对这类情况推荐使用新型药物。”

Kolh医生披露称接受了由阿斯利康和Braun提供的酬金，以及由Edwards提供的研究支持。Landmesser医生和King医生均无利益冲突披露。Windecker医生披露称与9家公司存在利益关系。Neumann医生披露称其所在机构接受了15家公司的研究资助。

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By: MITCHEL L. ZOLER, Cardiology News Digital Network

PARIS  – A joint European Society of Cardiology and European Association for Cardio-Thoracic Surgery task force that will publish revised revascularization guidelines in late August gave a sneak peak of some important elements of the revision, including renewed endorsement of and a refinement to the heart team concept that was first introduced in the prior, 2010 version of the guidelines.

"One of the most important aspects of the 2010 guidelines was the introduction of the heart team (Eur. Heart J. 2010;31:2501-55) said Dr. Philippe H. Kolh. "In 2010, the heart team concept was still controversial, but I think now it is well accepted. We are further supporting and emphasizing the importance of the heart team," he said of the revised guidelines that will be released in August, during a session that previewed selected parts of the new guidelines at the annual congress of the European Association of Percutaneous Cardiovascular Interventions, an organization that also collaborated on the guidelines.

The revision also calls on each institution where operators perform revascularization to establish local protocols to guide the choice in routine cases between percutaneous coronary interventions (PCIs) or coronary artery bypass grafting (CABG), said Dr. Kolh, a cardiac surgeon at University Hospital in Liège, Belgium, and cochairman of the guideline-writing panel.

"The 2010 guidelines produced a misconception that every patient needs to be discussed by a heart team; the 2014 revision makes it clear that the heart team should develop institutional protocols for appropriate revascularization strategies for different types of patients. So if a patient has single-vessel disease, you can go ahead and do PCI and not wait for a heart-team decision," said Dr. Ulf Landmesser, professor and head of the acute cardiology clinic at University Hospital, Zurich, and a member of the 2014 panel. "Hopefully, it will now be clear that the heart team only needs to discuss complex patients that involve difficult decisions, and that institutional protocols can handle routine cases," Dr. Landmesser said.

The revision comes at a time when "the competition today is not so much between CABG and PCI; the more burning question is who should have revascularization, and how do patients get to the cath lab," noted Dr. Spencer B. King III, an interventional cardiologist at St. Joseph’s Medical Group in Atlanta who was invited to the session to comment on the new revision.

Results from a new meta-analysis highlight the critical role of revascularization relative to medical therapy alone in improving outcomes of patients with coronary artery disease. This finding is especially relevant in 2014, because it marks the 50th anniversary of the launch of revascularization with the first successful CABG performed, observed Dr.  Stephan Windecker, professor and chief of cardiology at University Hospital in Bern, Switzerland, and cochairman of the guidelines-writing panel.

He presented an analysis of results from 100 randomized, controlled trials that compared some form of revascularization against medical therapy in 93,553 randomized patients followed for more than 260,000 patient-years. The results showed that CABG cut the rate of all-cause mortality by 20%, compared with medical therapy, a statistically significant difference, and that treatment with new-generation drug-eluting stents produced a significant reduction of more than 25%, according to an as-yet unpublished report by members of the European Myocardial Revascularization Collaborative. Dr. Windecker also noted that all the recommendations in the new revision were approved with 100% consensus by the panel, which included cardiac surgeons, interventional cardiologists, and noninterventional cardiologists in equal numbers.

The session highlighted several other notable new elements in the revised guidelines, although Dr. Windecker stressed several times during the session that everything presented remained pending until the final version is released later this summer. The changes include:

• An "upgrade" of the recommendation for PCI use in patients with left main disease and a SYNTAX score of 23-32 to a IIa, "should be considered" class recommendation, boosted from class III "not recommended" status in 2010. Five-year outcomes from the SYNTAX trial showed "no difference in outcomes between PCI and CABG, a major reason to upgrade the recommendation for PCI," said Dr. Landmesser (Lancet 2013;381:629-38). "The guidelines put a lot of weight on SYNTAX score."

• When performing PCI in patients with non–ST-elevation myo cardial infarction (NSTEMI), bivalirudin (Angiomax) is recommended exclusively as the anticoagulant to use during and immediately following PCI – with unfractionated heparin recommended only for patients who cannot receive bivalirudin – based on bivalirudin’s proven reduced risk for causing major bleeds, said Dr. Franz-Josef Neumann, professor and director of the University Heart Center in Bad Krozingen, Germany.

• But for patients with ST-elevation MI (STEMI) undergoing primary PCI, unfractionated heparin received the only unqualified, level I recommendation for anticoagulation, with bivalirudin receiving a level IIa, "should be considered" recommendation. This repositioning of the two options occurred, based to some extent on yet unpublished results from a very large, single-center study in Liverpool, HEAT-PPCI, reported at the annual meeting of the American College of Cardiology meeting in March that showed unfractionated heparin outperformed bivalirudin for 28-day outcomes, Dr. Neumann said. "I was very pleased and sort of amazed that results from HEAT-PPCI jumped into the guidelines, and it’s not even published yet. That [recommendation] will have an impact, I suspect," commented Dr. King.

• For patients with either STEMI or NSTEMI, the preferred antiplatelet P2Y₁₂ inhibitors are prasugrel (Effient) and ticagrelor (Brilinta), with clopidogrel reduced to a back-up role "only when prasugrel or ticagrelor are not available," said Dr. Neumann. "I was a little surprised that clopidogrel has fallen off the charts. With the new stents having a low stent thrombosis rate, U.S. physicians tend to stick with clopidogrel; there has been more of a shift in Europe," commented Dr. King. "For elective cases, we still have a clear statement in favor of clopidogrel," countered Dr. Neumann. "It is only for higher risk, acute coronary syndrome and STEMI patients where the guidelines recommend the new agents."

Dr. Kolh said that he has received honoraria from Astra Zeneca and Braun, and research support from Edwards. Dr. Landmesser said that he had no disclosures. Dr. King said that he had no disclosures. Dr. Windecker said that he had received honoraria from, had been a consultant to, or had been a speaker for nine companies and had received research grants from seven companies. Dr. Neumann said that his institution had received research grants from 15 companies.