<< More coverage from TCT 2013
Top News From TCT 2013: Slideshow
Megan Brooks; Renee Allen; Shelley Wood; Tricia Ward; Allison Shelley; Darbe Rotach; Steve Stiles; Michael O'Riordan
November 14, 2013
San Francisco hosted TCT 2013: Transcatheter Cardiovascular Therapeutics 25th Annual Scientific Symposium. For the first time, all TCT registrants received tablets and a dedicated app to enhance the meeting experience. It's "our first salvo at redefining the conference experience for attendees," said Dr Gregg Stone, program chair for the meeting.
Key trials and presentations at the sessions included:
TRANSLATE-POPS: Free platelet-function tests boost use but don't
change outcome
LEVANT 2 and RIBS V: Results met with cautious
optimism and some caveats
DUTCH PEERS: Two third-generation DES
equally safe, effective
REPRISE II: Solid results for repositionable
TAVR device
FREEDOM: Insulin-treated diabetics benefit from
CABG
OPTIMIZE: Three months' DAPT okay after zotarolimus stent
Free Platelet-Function Tests Boost Utilization, Not
Outcomes
Physicians are far more apt to order the VerifyNow platelet
function test for their acute-MI patients when it's offered free of charge, but
it only modestly influences their choice of antiplatelet agent, according to the
TRANSLATE-POPS study. Presenter Dr Tracy Wang (Duke Clinical
Research Institute, Durham, NC) said US physicians appear to be "intellectually
interested" in these tests. But "we generally select an agent based on what we
think a patient needs and what we think a patient can afford or can take. So in
that setting, if the clinician's mind is already made up, introducing a test
isn't likely to change that decision very much, although it does move the needle
some, a small amount."
Two Drug-Eluting Balloon Studies Raise Hopes,
Questions
Two studies of drug-eluting balloons (DEB) were met with
cautious optimism—and some caveats. Promising six-month results from the
LEVANT 2 study of patients with stenotic femoropopliteal arteries treated
with the Lutonix (Bard) DEB or standard balloon angioplasty were reported by
Dr Kenneth Rosenfield (Massachusetts General Hospital, Boston,
MA), but some attendees were hoping for a glimpse at 12-month results. The
RIBS V trial presented by Dr Bernard Gersh (Mayo Clinic,
Rochester, MN) randomized patients with bare-metal stent restenosis to
paclitaxel-eluting balloon or everolimus-eluting stent treatment.
The primary end point of mean luminal diameter (MLD) at nine months was 2.36 mm
in the stent group and 2.01 mm in the DEB group (p<0.0001), with similar
findings for
"It Matters": Two Third-Gen DES Equivalent in DUTCH
PEERS
Two market-leading third-generation drug-eluting stents (DES),
Promus Element (Boston Scientific) and Resolute Integrity
(Medtronic), proved equally safe and effective in a rare, large-scale,
randomized, investigator-initiated trial. In an "all-comers" population, no
significant difference was seen between the zotarolimus- and
everolimus-eluting stents for target vessel failure at 12 months.
Commenting on the study, Dr Cindy Grines (Detroit Medical Center) said
she finds all of the new-generation stents "very flexible and deliverable" and
that these two, on the basis of this study, "seem reasonably equivalent."
Solid Results for Repositionable TAVR Device
A novel
second-generation transcatheter aortic-valve replacement (TAVR) device (Lotus,
Boston Scientific) significantly improves the mean aortic-valve pressure
gradient in patients with symptomatic and severe aortic stenosis, according to
the REPRISE II study results. Five of the 120 patients died from
cardiovascular causes by 30 days, and two patients had a disabling stroke. The
Lotus device differentiates itself from current competitors in that physicians
can reposition the valve before deployment as well as resheath and remove it if
necessary. It also has an adaptive seal designed to minimize the risk of
paravalvular leak. The Lotus valve has received CE Mark approval for use in
Europe but is still investigational in the US.
Image courtesy of National Institutes of Health
Insulin-Treated Diabetics Benefit From CABG: FREEDOM
A
subanalysis of the FREEDOM trial, a study that showed a benefit of coronary
artery bypass graft (CABG) surgery over PCI in diabetic patients with
multivessel disease, confirmed that this benefit was maintained in
insulin-treated patients. For the insulin-dependent diabetic patients, the rate
of major adverse cardiac events was significantly higher than in patients not
treated with insulin, but the advantage in terms of clinical outcomes with CABG
over PCI was evident in both the insulin-dependent and
non–insulin-dependent diabetic patients, reported Dr Michael
Farkouh (Mount Sinai School of Medicine, New York).
Three Months' DAPT Noninferior to 12 With Zotarolimus
Stent
Three months of aspirin plus clopidogrel following PCI with
a zotarolimus-eluting stent (Endeavor, Medtronic) proved noninferior to
the recommended 12 months of dual antiplatelet therapy (DAPT) in the
OPTIMIZE study. Results from the 3000-patient trial were published in the
Journal of the American Medical Association to coincide with their
presentation by Dr Fausto Feres (Instituto Dante Pazzanese de
Cardiologia, São Paulo, Brazil) here at TCT 2013.
No Upside to Aggressive PCI in Intermediate Lesions?
A study tackling a
longstanding question of when to intervene in "intermediate" coronary lesions
raised eyebrows here by concluding that there is no benefit to a more aggressive
strategy using a cutoff of >50% vs a more conservative cutoff of >70%.
"The revascularization of angiographically intermediate lesion can be deferred
safely," concluded Dr Hyeon-Cheol Gwon (Samsung Medical Center, Seoul,
South Korea) based on a randomized study of 900 patients. The results were met
with some skepticism during a press conference and formal presentation.
FFR-CT and iFR Accurately Identify
Two studies show the
benefit of assessing the functional severity of the coronary lesion using new
twists on measuring fractional flow reserve (FFR) in patients with suspected
CAD. In one, researchers measured the instantaneous wave-free ratio (iFR), which
is a pressure-derived, adenosine-free measurement of coronary stenosis, and
reported that it successfully characterized the hemodynamic severity of more
than 90% of stenoses. In the other trial, FFR-CT accurately detected 81% of
coronary stenoses in patients with stable CAD compared with 64% of stenoses
detected with coronary angiography and 53% with CT alone.
Photo courtesy of Wikimedia
Bleed Risk Falls With Bivalirudin en Route to PCI for
STEMI
The 30-day risk of death or major bleeding fell significantly in
ST-elevation MI (STEMI) patients treated with bivalirudin (Angiomax, the
Medicines Company) compared with heparin, both started prior to hospital
arrival for primary PCI, in the EUROMAX study presented here by Dr
Philippe Gabriel Steg (Hôpital Bichat, Paris, France) and
simultaneously published in the New England Journal of Medicine. However,
there was an excess risk of stent thromboses with bivalirudin driven by events
in the acute phase, within 24 hours of PCI.
No Slam Dunk for Radial in Women: SAFE-PCI
A study testing radial-access PCI
in women failed to show that the radial approach reduced the risk of bleeding or
vascular complications. However, there was a reduction in the risk of bleeding
or vascular complications with radial access in the entire randomized cohort of
women, which included women undergoing PCI and those who underwent a diagnostic
cardiac catheterization. Lead investigator Dr Sunil Rao (Duke University
Medical Center, Durham, NC) said the results suggest radial-access PCI is a
reasonable option in women, although there should be an expectation that some
women will require conversion to femoral access.
Low Strokes, PVL With CoreValve TAVR in Extreme Risk
Trial
Use of the self-expanding Medtronic CoreValve transcatheter
aortic valve in the CoreValve Extreme Risk trial led to some of the
lowest stroke and paravalvular leak rates seen in any transcatheter aortic-valve
replacement (TAVR) study to date, investigators reported here. The study also
met its primary end point of reduction in all-cause death or major stroke; as
expected, however, use of the device was associated with pacemaker implantation
in more than one in five patients, reported Dr Jeffrey Popma (Beth Israel
Deaconess Medical Center, Boston, MA).
For more information:
