in these clinical events on the basis of stent type. He
did note, “… event rates with latest-generation baremetal stents were lower than may be appreciated by
most interventional cardiologists and that rates of
stent thrombosis were low in both stent groups.”
Still, also as expected, second-generation DES
performed better than the latest generation of BMS
for target-lesion revascularization (5.3% vs. 10.3%,
respectively; p < 0.001), any revascularization, and
definite stent thrombosis.
Yet, Kaare Harald Bonaa, MD, PhD, Norwegian
University of Science and Technology, Trondheim,
Norway, who presented the data, said while DES
patients did have less need for a second revascularization procedure, it was not to the level interventionalists might have expected. In fact, he said,
“Thirty patients would need to be treated with DES
rather than with BMS to prevent one repeat revascularization.” Dr. Bonaa added, “Patients treated
with DES do not live longer and they do not live
better than patients treated with BMS.”
Where are we? Dr. Bates noted that secondgeneration DES are preferred in most clinical situations. Nevertheless, he wrote, BMS use remains an
important option in some patients, including those
with a large vessel diameter in whom restenosis
rates are low, those who cannot complete the longer
duration dual-antiplatelet therapy (DAPT) recommended for DES because of noncompliance or need
for noncardiac surgery, those who cannot pay for
DES or a longer duration of DAPT, and those at increased risk for bleeding (e.g., patients with recent
bleeding or a need for concomitant anticoagulation
therapy). – New England Journal of Medicine
Single Imaging Good, Hybrids Less So
For patients presenting with what might be coronary artery disease (CAD), a new study tackled
the tough topic of which noninvasive test is better?
Investigators conducted a head-to-head comparison
of the most commonly used noninvasive techniques
in the single-center PACIFIC trial, which stands for
(deep breath): Prospective Head-to-Head Comparison of Coronary CT Angiography, Myocardial Perfusion SPECT, PET, and Hybrid Imaging for Diagnosis
of Ischemic Heart Disease using Fractional Flow
Reserve as Index for Functional Severity of Coro-
TABLE 1
nary Stenoses. Just in case you were wondering
which tests were tested….
The first lesson: hybrid approaches don’t help:
diagnostic accuracy was not enhanced by either hybrid coronary computed tomography (CCTA)/single
photon emission CT (SPECT) or CCTA/positron
emission tomography (PET). The combos resulted
in an increase in false negatives although there was
a decrease in false positive results (p < 0.001). This
was disappointing news to the presenters who have
previously promoted two as being better than one:
specifically, CCTA/SPECT.1
Comparing these noninvasive tests to the gold
standard results, investigators showed that PET was
significantly more accurate (85%) for diagnosing
coronary ischemia compared to CCTA (74%;
p < 0.01) and SPECT (77%; p < 0.01). Sensitivity of
the noninvasive approaches was 87% for PET, 90%
for CCTA, and 57% for SPECT, whereas specificity
was 60%, 94%, and 84%, respectively.
“At present, there is little consensus about the
choice of noninvasive imaging modality, and European and U.S. guidelines do not advocate for any
one over another,” according to Ibrahim Danad,
MD, from VU University Medical Center, Amsterdam, the Netherlands who presented the findings.
“The vast majority of studies used invasive coronary angiography as a reference standard, which
may lead to erroneous interpretations. These data
represent the first comprehensive evaluation of
coronary artery disease and will help to guide the
clinician to choose the appropriate non-invasive test
for his or her patients.”
Consider Procedural Complexity When
Determining DAPT
Alongside other established clinical risk factors,
procedural complexity looms as an important
parameter to take into account in tailoring upfront
duration of DAPT.
This comes from an interesting study of almost
9,600 patients, using pooled patient-level data
from 6 randomized controlled trials. (Investigators
spanned the globe: United States, Italy, Spain,
the Netherlands, South Korea, and France.) Of
the pooled population, 1,680 (17.5%) patients
underwent complex PCI, defined as at least one of
NORSTENT: Select Clinical Events During up to 6 Years of Follow-up
DES
(n=4.504
BMS
(n=4,509)
HR
(95% CI)
Primary outcome*
16.6%
17.1%
0.98
(0.88 – 1.09)
0.66
Death from any cause
8.5%
8.4%
1.10
(0.94 – 1.29
0.22
Total MI
11.4%
12.5%
0.91
(0.80 – 1.03)
0.14
Any revascularization
16.5%
19.8%
0.76
(0.69 – 0.85)
< 0.001
Definite stent thrombosis
0.8%
1.2%
0.64
(0.82 – 1.18)
0.0498
* Composite of death from any cause and nonfatal spontaneous myocardial infarction.
BMS = bare-metal stent; DES = drug-eluting stent; HR = hazard ratio; MI = myocardial infarction.
28 CardioSource WorldNews: Interventions
p Value
the following features: 3 vessels treated, > 3 stents
implanted, > 3 lesions treated, bifurcation with 2
stents implanted, total stent length > 60 mm, or
chronic total occlusion. The primary efficacy endpoint was major adverse cardiac events (MACE),
defined as the composite of cardiac death, MI, or
stent thrombosis. The primary safety endpoint was
major bleeding.
Patients who underwent complex PCI were at
a substantially higher risk of ischemic events, in a
graded fashion, with increased procedural complexity (hazard ratio [HR]: 1.98; p < 0.0001) (FIGURE).
The risk was similar in magnitude to that of other
well-established clinical risk factors and tended to
be greater for progressively higher degrees of procedural com plexity.
In patients who underwent complex PCI, compared with a short period of DAPT (3 or 6 months),
long-term DAPT (>1 year) significantly reduced
the risk of cardiac ischemic events with a magnitude that, again, was greater for higher procedural
complexity (adjusted HR: 0.56 for longer DAPT).
Compared to the noncomplex PCI group, the p
value for interaction was 0.01.
The benefits of prolonged DAPT appeared to be
uniform across complex PCI components, DES generations, and clinical presentation. And, of course,
long-term DAPT was associated with an increased
risk of major bleeding that was irrespective of procedural complexity.
Currently, clinical decision making on upfront
DAPT intensity and duration after coronary stenting is predominantly made on the basis of clinical
ischemic and bleeding risk factors. Gennaro Giustino, MD, and colleagues are arguing that degree
of procedural complexity “substantially influences
future ischemic risk and identifies patients who
may benefit from longer or more intense antithrombotic therapies.” – Journal of the American College of
Cardiology
Time to Rethink ICDs in HF?
For primary prevention, implantable cardioverter–
defibrillators (ICDs) reduce the risk of premature
death among patients with left ventricular systolic
dysfunction after MI and among patients with
heart failure (HF) and reduced ejection fraction.
What about patients with HF who do not have
CAD?
The guidelines support ICDs in this setting,
although based on less robust evidence, for sure;
specifically, a meta-analysis of small trials involving
patients with nonischemic cardiomyopathy, as well
as subgroup analysis of patients with nonischemic
cardiomyopathy from larger trials.
A new study – more than twice the size as the
largest previous study – questions this approach.
The Danish Study to Assess the Efficacy of ICDs in
Patients with Non-ischemic Systolic Heart Failure
on Mortality (DANISH – conducted in Denmark,
of course), randomly assigned 1,116 patients with
nonischemic HF to conventional therapy or an ICD
plus conventional therapy. After a median of 5.6
years, ICD therapy was associated with a risk of
sudden cardiac death that was half that of conventional therapy, but the effect on overall mortality, the
primary endpoint of the trial, was not significant.
September/October 2016