CARDION_Vol.13_No.1

Arterial calcium findings

on mammograms

can predict heart

disease risk

Sutureless AVR an option

for higher-risk patients

American College of

Cardiology 2016

Self-expanding TAVR bests

surgery based on 3-year

stroke and death risks

FIRE AND ICE trial called a

win for cryoablation of AF

PCSK9 inhibitor overcomes

muscle-related statin

intolerance

Stem cells show heart failure

benefits in phase II trial

IN THIS ISSUE

TAVR matches surgery in intermediate-risk

patients

BY MITCHEL L. ZOLER

Frontline Medical News

At ACC16, Chicago

ranscatheter aortic-valve replacement performed

as well as surgical-valve replacement in patients

with an intermediate mortality risk in a prospec-

tive, randomised trial with more than 2000 patients

followed for 2 years, the first randomised trial to

compare the efficacy and safety of transcatheter

aortic-valve replacement against surgical replace-

ment in patients who did not have a high mortality

risk.

The results “support TAVR [transcatheter aortic-

valve replacement] as an alternative to surgery in

intermediate-risk patients similar to those included

in this trial,” said Dr Craig R. Smith at the annual

meeting of the American College of Cardiology. The

findings from the Placement of Aortic Transcatheter

Valves (PARTNER) 2 cohort A trial “will increase

use of TAVR,” predicted Dr Smith, professor and

chairman of surgery at New York – Presbyterian

Hospital/Columbia University in New York.

Until now, TAVR had been compared with sur-

gical aortic-valve replacement in two prospective,

randomised trials that both enrolled either high-risk

or inoperable patients with severe aortic stenosis,

the PARTNER 1 trial that tested the original Sapien

TAVR system, and the US CoreValve High-Risk

Study that tested the original CoreValve system

(often now called CoreValve classic). The average

Society of Thoracic Surgeons (STS) operative risk

score of high-risk patients enrolled in PARTNER 1

was 11.8%, and the average risk score in patients en-

rolled in the CoreValve study was 7.3%. In contrast,

the design of PARTNER 2A specified that enrolled

patients have a STS risk score of 4–8%, a criterion

actually met by 81% of the enrolled patients, and

the average STS risk score of all patients enrolled

in PARTNER 2A was 5.8%.

Although US labelling for both the Sapien valve

and its later iterations, Sapien XT and S3, and for

CoreValve and its later iteration, Evolut R, specify

Continued on page 7.

Guideline update shortens minimum DAPT duration in CAD

BY AMY KARON

Frontline Medical News

From an American College of

Cardiology/American Heart

Association Focused Update

ew guidelines decrease the mini-

mum duration of dual-antiplate-

let therapy (DAPT) to as little

as 3 months after drug-eluting stent

placement in certain lower-risk pa-

tients with coronary artery disease.

The updated recommendations

harmonise and replace six other

guidelines, and apply to everoli-

mus and zotarolimus stents, not

Cypher or Taxus stents, said Dr

Eric R. Bates, who helped author

the American College of Cardiol-

ogy/American Heart Association

Focused Update. “The emphasis is

on balancing ischaemic risk versus

bleeding risk. The recommendations

give clinicians guideline coverage to

make personalised DAPT recom-

mendations,” he said in an interview.

The guidance reflects recent

evidence that shorter duration (3–6

months) of DAPT, compared with

the standard 12 months of therapy

does not increase the risk of stent

thrombosis and potentially lessens

bleeding risk in select patients.

Other studies of an additional 18

or 36 months of DAPT found a

decrease in the risk of MI and stent

thrombosis, at the cost of greater

risk of bleeding. Thus, the updated

guidelines call for “a thoughtful as-

sessment of the benefit-risk ratio,

integration of study data, and consid-

eration of patient preference” when

selecting duration of DAPT. “In

general, shorter-duration DAPT can

be considered for patients at lower

ischaemic risk with high bleeding

risk, whereas longer-duration DAPT

may be reasonable for patients at

higher ischaemic risk with lower

bleeding risk,” the authors wrote,

led by Dr Glenn N. Levine of Bay-

lor College of Medicine, Houston

(

J Am Coll Cardiol

2016 Mar 29.

doi: 10.1016/j.jacc.2016.03.512).

The recommendations define

DAPT as combination therapy with

aspirin and a P2Y12 receptor inhibi-

tor – that is, clopidogrel, prasugrel,

or ticagrelor. “When indicated,

ticagrelor and prasugrel have a Class

IIa preference over clopidogrel,”

Dr Bates said. The recommended

daily dose of aspirin is 81 mg (range,

75–100 mg), which is usually con-

tinued indefinitely, regardless of how

long patients receive dual therapy.

The shortened durations of dual-

antiplatelet therapy include several

scenarios. For elective percutaneous

coronary intervention, the for-

mer Class I recommendation for

12 months of DAPT has been re-

duced to 6 months, with a Class IIb

recommendation for either longer

treatment or shorter (3-month)

treatment, Dr Bates, professor

of medicine at the University of

Michigan Health System in Ann

Arbor, said. For patients with acute

coronary syndrome, the guidelines

retain the Class I recommendation

for 12 months of DAPT, but also

add a Class IIb recommendation for

longer or shorter (6 months) DAPT.

The guidelines also include a

new Class IIb recommendation for

12 months of DAPT started early

after coronary artery bypass graft

in patients with stable ischaemic

heart disease. This strategy “may

be reasonable to improve vein graft

patency” in these patients, the rec-

ommendations state.

The guidance clarifies previous

recommendations on the timing

of elective noncardiac surgery, and

assigns Class IIb support for consid-

eration of such surgeries starting 3

months after implantation of drug-

eluting stents, if the risks of delaying

surgery outweigh the expected risk

of stent thrombosis when it is neces-

sary to stop P2Y12 inhibitor therapy.

The recommendations now dis-

tinguish between B and C levels of

evidence to increase granularity, ac-

cording to Dr Bates. The document

updates recommendations on dura-

tion of DAPT across six previously

published guidelines – the 2011

ACCF/AHA/SCAI Guideline for

Percutaneous Coronary Intervention

(PCI); the 2011ACCF/AHA Guide-

line for CoronaryArtery Bypass Graft

Surgery; the 2012ACCF/AHA/ACP/

AATS/PCNA/SCAI/STS Guideline

for the Diagnosis and Management

of Patients With Stable Ischaemic

Heart Disease; the 2013ACC/AHA

Guideline for the Management of

ST-Elevation Myocardial Infarction;

the 2014 ACC/AHA Guideline for

Non-ST-Elevation Acute Coronary

Syndromes, and the 2014 ACC/

AHA Guideline on Perioperative

Cardiovascular Evaluation and

Management of Patients Undergo-

ing Noncardiac Surgery.

The extensive evidence review that

informed guideline development was

simultaneously reported by Dr John

Bittl at Munroe Regional Medical

Center in Ocala, Florida, and his

colleagues. The investigators synthe-

sised evidence from 11 randomised

controlled trials of more than 33,000

patients who received mainly newer

generation stents. They also reviewed

a randomised controlled trial of more

than 21,000 patients with stable

ischaemic heart disease who were