New ESC/EACTS Revascularization Guidelines Trim Back Use of Bivalirudin, DAPT

Shelley Wood

September 11, 2014

BARCELONA, SPAIN — As promised, the European Society of Cardiology (ESC) and the European Association of Cardiothoracic Surgery released new guidelines on myocardial revascularization at the European Society of Cardiology (ESC) 2014 Congress . In them are some some key departures in the use of which approaches and drugs to use and when[1]. The guidelines were also published online August 29, 2014 in the European Heart Journal.

As previously reported by heartwire , 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. Back in May, the writing group ESC chair, Dr Stephan Windecker (University Hospital Inselspital Bern, Switzerland), presented an early glimpse of some of the planned recommendations but cautioned at the time that these were not yet finalized. He and others presented the final document at the ESC meeting, highlighting a range of important changes.

Speaking with heartwire , Dr Jean-Philippe Collett (Hôpital Bichat-Claude Bernard, Paris, France), also on the writing group, highlighted some of the key differences from the 2010 guidelines relating to concomitant drugs.

A key change in the management of stable CAD, Collett said, was a reduction in the duration of dual antiplatelet therapy required for patients undergoing nonurgent/elective PCI.

"This has been shortened now, depending on what type of device is implanted," he said. Six months is recommended for drug-eluting stents (DES), especially first-generation DES, instead of the previously recommended six to 12 months. At least one month is recommended for bare-metal stents (class I). Also new, a shorter DAPT duration (less than six months) may be considered in patients with a high bleeding risk (class IIb) who receive newer-generation DES.

As well, clopidogrel pretreatment, which was "not recommended/may be harmful" in previous guidelines, has been "toned down" in the new guidance, Collett said, given a class IIb recommendation for patients with a high probability for significant CAD.

In non-ST-elevation ACS, Collett highlighted a change in guidance pertaining to GP IIb/IIIa inhibitors, which have been downgraded to a class III (do not use) in patients in whom the coronary anatomy is not known. The same recommendation was also given to prasugrel (Effient, Lilly/Daiichi Sankyo) pretreatment in this setting, based on the results of ACCOAST , he said.

In STEMI, the "major change" said Collett, is that bivalirudin has been downgraded from a class I to a IIa, based on HEAT PPCI and EUROMAX , and unfractionated heparin has been upgraded to a level of evidence 1c at a dose of 70-100 U/kg as monotherapy and 50-70 U/kg in patients in whom GP IIb/IIIa therapy is planned.

As well, prasugrel and ticagrelor (Brilinta, AstraZeneca) are the "preferred" P2Y12 inhibitors and are to be given "at the first point of contact" (class Ib), while clopidogrel is recommended only when prasugrel or ticagrelor are contraindicated or not available.

Heart Teams, Diabetic Patients, Acute HF, and More

Windecker's presentation highlighted a number of other changes, many of which he had also previewed at EuroPCR :

•  New recommendations dealing with the timing of patient information (ie, risk/benefit information as well as therapeutic consequences) prior to coronary angiography, as well as the need for a heart team to be involved in developing all institutional protocols relating to revascularization strategies.

•  Recommendations incorporating five-year results from the SYNTAX trial to inform the decision to do CABG vs PCI, as well as a table to help physicians calculate the SYNTAX score for their patients. That table includes a diagram that "weights" the different vessels for scoring purposes.

•  New guidelines specific to diabetic patients that include five-year results from BARI 2D , 10 years of follow-up from MASS II , and more recent results from the pivotal FREEDOM trial. CABG is now recommended over PCI in all patients with stable multivessel CAD who have an "acceptable" surgical risk (class I).

•  Recommendations specific to the management of patients with acute heart failure in the setting of ACS, including the downgrading of intra-aortic balloon pumps in patients with cardiogenic shock (now class III, that is, not recommended for "routine use"), although short-term mechanical circulatory support "may be considered" (class IIb).

•  Recommendations on the treatment of arrhythmias after revascularization as well as the decision making regarding patients who also need anticoagulation. New here is a class IIb recommendation for percutaneous closure of the left atrial appendage in certain settings. Collett also stressed the use of an algorithm that focuses first on cardioembolic risk, then bleeding risk, factoring in setting (acute or stable).

•  Recommendations for minimum PCI operator/hospital volumes: 75 per operator/400 per institution per year for the treatment of patients with ACS and 75/200 per year for patients with stable CAD.

Asked whether the sweeping document, 100 pages in total, may be too complex and detailed for physicians to consult on a regular basis, Collett said he disagreed. "I think that they are very user-friendly," he said. "They are consistent with the literature, they are really pragmatic, and they [deal] only with revascularization/stenting/interventions, and this was the purpose of the guidelines. So we've made it simple, and I think people will like it."

Windecker disclosed receiving speaker fees from AstraZeneca and Eli Lilly and research contracts to his institution from Biotronik and St Jude. Collett disclosed clinical research grants from Bristol-Myers Squibb, Sanofi, Eli Lilly, Guerbet Medical, Medtronic, Boston Scientific, Cordis, Stago, Centocor, Foundation of France, INSERM, the French Federation of Cardiology, and the French Society of Cardiology.

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