Shelley Wood

May 21, 2014

PARIS, FRANCE — The European Society of Cardiology (ESC) and the European Association of Cardiothoracic Surgery are poised to release new guidelines on myocardial revascularization, a packed session here at EuroPCR 2014 heard today. The new guidelines, which update a 2010 document, will be presented in full at the upcoming ESC Congress in Barcelona later this year and published simultaneously in the European Heart Journal.

As such, Dr Stephan Windecker (University Hospital Inselspital Bern, Switzerland) said today, this first glimpse of the new recommendations should be considered a "teaser" and a "preview," with nothing being finalized or actionable until later this summer.

The new document has been three years in the making and incorporates important findings from a range of PCI and surgery trials that have been heralded as practice-changing in recent years.

Three Hot Topics

Today's preview session focused on just three areas where there are important new evidence-based recommendations, although the final document will be much more comprehensive, covering a much wider range of topics, Windecker stressed.

These three areas in particular—revascularization in stable artery disease, revascularization in diabetic patients, and choice of antithrombotic therapy in the setting of revascularization—are the topics "where there is new evidence and where there will be the most debate," session cochair Dr Philippe Kohl (University Hospital of Liège, Belgium) observed.

Of note, the writing group for the new guidelines comprised eight clinical cardiologists, nine interventional cardiologists, and eight cardiovascular surgeons, and they were "able to reach consensus on each recommendation," Windecker said.

That reflects a principle that is the cornerstone of the new draft guidance, Kohl emphasized: namely, the importance of the heart team in working collaboratively to agree on the best treatment strategy for any given patient.

"Guidelines are guidelines, but they are not written in stone," he said. So "having the local heart team discuss [each] patient is of utmost importance."

Stable Coronary Artery Disease Patients

Dr Ulf Landmesser (University Hospital, Zurich, Switzerland) presented some of the new recommendations that are planned for the stable-CAD section. Of note, this section is specifically for patients with stable disease in whom the decision has already been made to proceed with revascularization. The ESC has separate stable CAD guidelines that deal with the management of this patient group and their options, including medical management.

Landmesser pointed out that guideline writers had five-year results from the SYNTAX trial, which influenced their recommendations on multiple fronts, most notably for revascularization choice in patients with one-, two-, or three-vessel disease, depending on where the coronary disease is located. Included in the new guidelines, for example, is a diagram that can help physicians calculate the SYNTAX score in their patients before proceeding with a revascularization method.

Of note, he added, all of the recommendations include a little footnote indicating that the anatomical findings must be backed up by evidence of ischemia.

Revascularization in Diabetes

Next, Dr Lucia Torraca (Ospedali Rinuiti Ancona, Italy) reviewed the planned new guidance for diabetic patients, which now incorporates five-year results from BARI 2D , 10 years of follow-up from MASS II , and more recent results from the pivotal FREEDOM trial. She stressed that the new recommendations here almost uniformly cite a level of evidence "A" or "B," pointing to the concentration of high-quality studies of diabetic patients in recent years. Almost across the board, she noted, CABG is the class I recommendation for revascularization over PCI for diabetic patients.

Antithrombotic Drugs

The third and final sneak peek in today's session dealt with concomitant antithrombotic therapy; Dr Franz-Josef Neumann (Universitäts-Herzzentrum Freiburg-Bad Krozingen, Germany) walked the audience briskly through some of the new recommendations.

These include a downgrading of clopidogrel in the setting of stable coronary disease where there is a high probability of significant CAD—in this specific setting, recommendations for the use of clopidogrel now take a back seat to newer antiplatelet drugs.

In a key departure from previous guidelines, the new draft guidance, on the basis of the EXCELLENT and PRODIGY studies, recommend a reduced duration of dual antiplatelet therapy after drug-eluting stents—now six months, instead of six to 12. The draft guidelines also specify, however, that "more than six months" is preferable in patients at high ischemic risk and low bleeding risk.

On the basis of ISAR-REACT 3 , bivalirudin is now a class IIa(A) recommendation in patients at high risk of bleeding who are undergoing elective PCI after a 600-mg clopidogrel loading dose. In STEMI, however, the guidelines have been updated to include HORIZONS-AMI , EuroMAX , and HEAT-PPCI , such that recommendations to use bivalirudin have been downgraded slightly for patients undergoing primary PCI. The inclusion of HEAT-PPCI, which generated so much controversy when it was presented earlier this year, is particularly notable in that the study has not yet been published.

Dr Spencer King (Emory University, Atlanta, GA), one of the panelists for today's session, said he was "very pleased and sort of amazed that the HEAT-PPCI trial has jumped into your guidelines, and with your ability to act quickly. . . . That was a very interesting trial and will be impactful in the overall utilization [of bivalirudin]."

Also incorporated into the draft guidelines is the ACCOAST trial, which showed no benefit and possible harm with prasugrel pretreatment in the setting of NSTE-ACS, when the coronary anatomy is unknown. Prasugrel pretreatment in this scenario will be given a class IIIb (not recommended) in the 2014 document, Neumann said.

Staying Tuned

In his closing remarks, Windecker stressed again that the session was "meant to be a teaser" and that no one should act on any of the previewed recommendations until the final document is out at the end of the summer, since they may yet be revised. He encouraged attendees to make the trip to Barcelona to see the final guidelines presented in more detail at ESC 2014.

King, addressing the crowded audience, made the point that "a room on this subject, packed like this, sends a message: guidelines are no longer an academic exercise; we are all under observation by others who control the purse strings and other things." While guidelines are supposed to just be guidelines, "there is a growing perception that there is regulatory interest in this, and a responsibility to incorporate medical economics in what we do." To have an audience so interested in what as-yet-unfinished guidelines might recommend speaks to the broad level of interest in doing the right thing.

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