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Interventional Cardiology
Research Review
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Issue 22 - 2015
Making Education Easy
In this issue:
Second-generation DES followed by
6- vs. 12-month DAPT
IVUS guidance to minimise PCI
contrast use
Hybrid revascularisation for
multivessel coronary artery disease
Clinical implications of NSTEMI with
occluded artery
Prasugrel + bivalirudin vs.
clopidogrel + heparin in STEMI
CABG vs. DES for isolated proximal
LAD disease
Device to narrow the coronary sinus
in refractory angina
Predicting side branch occlusion risk
in coronary bifurcation
Operator sleep deprivation and
PCI outcomes
Remote ischaemic conditioning
in STEMI
Abbreviations used in this issue:
CABG = coronary artery bypass graft; DAPT = dual antiplatelet therapy;
DES = drug-eluting stent; ECG = electrocardiography;
IVUS = intravascular ultrasound; LAD = left anterior descending;
LIMA = left internal mammary artery; LV = left ventricular;
MI = myocardial infarction; (N)STEMI = (non-)ST-segment elevation MI;
PCI = percutaneous coronary intervention; RCT = randomised controlled trial;
TIMI = thrombolysis in MI
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Welcome to issue 22 of Interventional Cardiology Research Review.
In this issue, the MOZART trial researchers have reported that IVUS-guided PCI was safe and associated with a marked
reduction in iodine contrast use compared with angiography alone. Other researchers reported that one quarter of their patients
with NSTEMI had an occluded culprit coronary artery, and that such patients were more likely to have hypercholesterolaemia,
ECG abnormalities, multivessel disease and LV dysfunction. Interesting research from the US found no evidence of adverse
outcomes when PCI was performed by operators with acute sleep deprivation due to performing procedures during the
previous night, but chronic sleep deprivation did appear to increase bleeding events.
Thank you for your comments, questions and suggestions – please keep them coming.
Kind Regards,
Associate Professor Craig Juergens
[email protected]
Second-generation drug-eluting stent implantation followed by 6- versus
12-month dual antiplatelet therapy
Authors: Colombo A et al.
Summary: Patients with stable or unstable angina or silent ischaemia undergoing revascularisation with ≥1 second-generation
DES were randomised to 6 months (n=682) or 12 months (n=717) of DAPT in the SECURITY noninferiority RCT.
The respective 6- and 12-month DAPT groups had: i) similar primary composite endpoint event rates (cardiac death, MI,
stroke, definite or probable stent thrombosis or BARC [Bleeding Academic Research Consortium] type 3 or 5 bleeding) at
12 months (4.5% and 3.7% [p<0.05 for noninferiority]); ii) similar main secondary composite endpoint event rates (primary
endpoint plus BARC bleeding type 2) at 12 months (5.3% vs. 4.0% [p=0.273]) and during 12–24 months (1.5% vs. 2.2%
[p=0.289]); and iii) similar definite or probable stent thrombosis rates at 12 months (0.3% vs. 0.4% [p=0.694]) and during
12–24 months (0.1% vs. 0% [p=0.305]).
Comment: Guidelines recommend DAPT for at least 12 months after DES implantation or for 6–12 months for those not
at high risk. Randomised trials have generally shown an increased bleeding risk with no significant reduction in major
adverse cardiac events with prolonged therapy. The current study assessed a shorter duration of therapy in patients
receiving a second-generation DES. This investigator driven, multicentre international study was stopped early due to
logistic and economic constraints. The majority of patients (61.6%) had stable angina and >97% of patients received
clopidogrel. Bleeding and major adverse cardiac events were similar, and the study suggested 6 months of therapy was
noninferior to 12 months in this low-risk cohort using Endeavour, Nobori, Biomatrix, Promus or Xience stents.
Reference: J Am Coll Cardiol 2014;64(20):2086–97
Abstract
Interventional Cardiology
Research Review
TM
Independent selection and review of the trials by Associate Professor Craig Juergens,
Interventional Cardiologist and Head of Cardiology,
Liverpool Hospital, Sydney.
403210.022, WL287191, June 2015
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a RESEARCH REVIEW publication
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Interventional Cardiology
Research Review
TM
Intravascular ultrasound guidance to minimize the use
of iodine contrast in percutaneous coronary intervention
Authors: Mariani J et al.
Summary: The MOZART trial randomised patients undergoing PCI (n=83) to angiographic
or IVUS guidance. Compared with angiography, IVUS-guided PCI was associated with a
significantly lower median total volume of contrast (20.0 vs. 64.5mL [p<0.001]) and a
significantly lower median contrast-creatinine clearance ratio (1.0 vs. 0.4 [p<0.001]), with
no between-group difference for in-hospital and 4-month outcomes.
Comment: Contrast-induced acute kidney injury is a potential complication of invasive
coronary procedures and is associated with significant morbidity and mortality. The volume
of contrast used is a major predictor of contrast-induced acute kidney injury and few
studies have attempted to address this issue. This small RCT shows that aggressive
use of IVUS can dramatically reduce contrast use. Lessons to be learned to reduce
contrast use for routine PCI strategies include rigorous preprocedure planning, use of
smaller catheters without side holes and the use of dilute contrast with smaller syringes.
All patients had to be suitable for IVUS guidance, the study was not blinded and was
not powered for clinical endpoints, but we should consider such strategies in patients at
high risk for contrast nephropathy.
Reference: JACC Cardiovasc Interv 2014;7(11):1287–93
Abstract
Hybrid revascularization for multivessel coronary
artery disease
Authors: Gąsior M et al.
Summary: Two hundred patients with multivessel coronary artery disease involving the LAD
artery and a >70% lesion in ≥1 other major epicardial vessel who were amenable to both
PCI and CABG and referred for conventional surgical revascularisation were randomised
1:1 to undergo hybrid coronary revascularisation or CABG. Among participants assigned
to hybrid coronary revascularisation, 93.9% completed the procedure with the remaining
6.1% converted to standard CABG. There was no significant between-group difference at
12 months for mortality, MI, major bleeding or repeat revascularisation, and no cerebrovascular
incidents were reported.
Comment: The most advantageous part of CABG is insertion of a LIMA graft to the LAD
artery, whilst the long-term efficacy of saphenous vein graft is inferior to DES patency.
This prospective, single-centre, randomised, open-label pilot study suggests a hybrid
strategy is feasible for patients with multivessel disease (mean syntax score 23). In the
hybrid group, the aim was to perform a minimally invasive direct coronary artery bypass
with LIMA to LAD artery followed by PCI to other vessels. This allowed assessment of
LIMA graft patency, and antiplatelet therapy was started after surgery. Larger studies
are needed to confirm this is a viable strategy for routine use.
Reference: JACC Cardiovasc Interv 2014;7(11):1277–83
Abstract
Non-ST elevation myocardial infarction with occluded
artery and its clinical implications
Authors: Soon K et al.
Summary: The prevalences and differences between NSTEMI with occluded versus patent
culprit arteries were explored in a retrospective group of 143 patients with NSTEMI who had
undergone inpatient coronary angiography and with 12 months of follow-up data. Compared
with patients with NSTEMI with a patent culprit artery, those with an occluded culprit artery
(n=34) had significantly higher rates of hypercholesterolaemia (85.3% vs. 64.2% [p=0.015]),
ST-depression abnormality on ECG (32.4% vs. 11.9% [p=0.008]), multivessel disease on
coronary angiogram (76.5% vs. 48.6% [p=0.004]) and LV dysfunction on echocardiogram
(75% vs. 48% [p=0.016]). A trend for a higher rate of HF within 12 months of discharge
was apparent among patients with NSTEMI with an occluded culprit artery, but death, MI,
revascularisation, arrhythmia and angina readmission rates did not differ significantly.
No correlation was evident between peak creatine kinase level and the timing of percutaneous
revascularisation in both groups.
Comment: Generally NSTEMI is thought to be due to incomplete occlusion of the
culprit artery as opposed to STEMI where complete occlusion is usually the case.
This single-centre, retrospective observational study conducted in a primary PCI centre
in Victoria showed that in 24% of NSTEMIs, the culprit artery was in fact occluded. This is
consistent with other studies, and clues included ECG changes showing ST depression
or T-wave inversion and impaired LV dysfunction. As would be expected, these patients
more often had multivessel disease and collaterals present. There was no evidence earlier
PCI resulted in less myocardial damage, although the numbers were probably too small
to confidently exclude this, and more research is needed to see if this is a viable strategy.
Reference: Heart Lung Circ 2014;23(12):1132–40
Abstract
www.researchreview.com.au
20%
~20%
up
to
RISK of a recurrent
CV event in the first year*1,2
RISK of a recurrent CV event
in the subsequent 3 years*1
After a successful intervention, what
more can we do to protect them from
their underlying disease?
403210.022, WL287191, June 2015
a RESEARCH REVIEW publication
2
Interventional Cardiology
Research Review
TM
Prasugrel plus bivalirudin vs.
clopidogrel plus heparin in
patients with ST-segment elevation
myocardial infarction
Authors: Schulz S et al.
Summary: The BRAVE 4 trial randomised patients with
STEMI to undergo primary PCI with a prasugrel plus bivalirudin
or clopidogrel plus heparin strategy; the trial was terminated
early due to slow recruitment after 548 participants had been
enrolled. No difference was seen between the prasugrel plus
bivalirudin versus clopidogrel plus heparin strategies for the
30-day rate of the primary composite endpoint (death, MI,
unplanned revascularisation, stent thrombosis, stroke or bleeding;
15.6% vs. 14.5% [p=0.680]), the composite ischaemic endpoint
(death, MI, unplanned revascularisation, stent thrombosis or
stroke; 4.8% vs. 5.5% [p=0.894]) or bleeding (14.1% vs. 12.0%
[p=0.543]). The results across various subgroups were consistent.
Comment: Recent studies have cast doubt on the benefits
of bivalirudin over heparin during primary PCI. This study is
another to compare bivalirudin with unfractionated heparin,
but with differing antiplatelet agents. Notably the protocol
suggested terminating the bivalirudin infusion at the end of
the procedure and bailout glycoprotein IIb/IIIas use was low
(6.1% clopidogrel and 3.0% prasugrel groups [p=0.074]).
The access site was femoral in all but one patient. Whilst the
trial was stopped early due to slow recruitment, there were
no apparent differences between the treatment arms for
composite endpoints. Unlike other bivalirudin STEMI trials,
stent thrombosis was similar in both groups (1.1% bivalirudin
and 1.5% heparin arms) and bleeding rates were similar.
This suggests prasugrel may reduce stent thrombosis but
increase bleeding, although the study is underpowered to
draw definite conclusions.
Reference: Eur Heart J 2014;35(34):2285–94
Abstract
Coronary artery bypass graft surgery
versus drug-eluting stents for
patients with isolated proximal left
anterior descending disease
Authors: Hannan EL et al.
Summary: This research compared outcomes of patients
who underwent CABG and received DESs for isolated proximal
LAD artery disease over a 3-year period; 5340/6064 patients
received DESs, and they were propensity matched into 715
CABG and/or DES pairs to minimise selection bias. No significant
difference was seen for mortality alone or mortality, MI and/or
stroke, but CABG was associated with significantly fewer repeat
revascularisations (7.09% vs. 12.98% [p=0.0007]). A Cox
proportional analysis confirmed no significant differences in
the 3-year mortality rate (adjusted hazard ratio 1.14 [95%
CI 0.70–1.85]) and the 3-year mortality, MI and/or stroke
rate (1.15 [0.76–1.73]), and also confirmed the lower repeat
revascularisation rate (0.54 [0.36–0.81]).
Comment: There are at least nine RCTs comparing CABG
with PCI in patients with single-vessel LAD artery disease;
however, the total number of patients (n=1207) is modest
and all but one was before the DES era. This study used
New York State’s clinical registries to provide up-to-date
comparisons between these two modalities. There appear
to be no differences in mortality, MI and stroke between the
two groups, but a higher rate of subsequent revascularisation
in the stented group. Depending on the perceived difficulty
of PCI (chronic total occlusion, complex bifurcation) and
quality of the distal vessel for LIMA anastomosis and patient
comorbidities, a heart team approach may be ideal in
deciding which treatment is best for an individual patient.
Reference: J Am Coll Cardiol 2014;64(25):2717–26
Abstract
Efficacy of a device to narrow the coronary sinus in refractory angina
Authors: Verheye S et al.
Summary: This study evaluated a balloon-expandable, coronary sinus-reducing device in 104 patients with CCS (Canadian
Cardiovascular Society) class III/IV angina and myocardial ischaemia who were not suitable for revascularisation. The patients
were randomised to implantation of the device or to a sham procedure (control group). Compared with controls, a significantly
greater proportion of implant recipients had an improvement of ≥2 CCS angina classes at 6 months (35% vs. 15% [p=0.02]).
QOL (assessed using the Seattle Angina Questionnaire) also improved significantly in the treatment group compared with
the control group (p=0.03).
Comment: The worldwide prevalence of severe angina not amenable to revascularisation is rising, with few therapeutic
options available. This small multicentre study randomising patients over 3 years is a proof-of-concept trial examining
a novel implantable device in the coronary sinus. The exact mechanism of benefit is unclear, but is felt to be due to
recruitment of coronary collateral flow and follows on from a surgical technique described in 1954 that partially occluded
the coronary sinus. Whilst this study showed patients subjectively felt better, there was little objective evidence of
improvement, and larger studies will be needed to better define the role of this device.
Reference: N Engl J Med 2015;372(6):519–27
Abstract
An angiographic tool for risk prediction of side branch occlusion in
coronary bifurcation intervention
Authors: Dou K et al.
Summary: These researchers established the RESOLVE scoring system for evaluating the risk of side-branch occlusion
using data from 1545 consecutive patients undergoing coronary bifurcation intervention, including 1601 lesions treated
with a single-stent technique or main-vessel stenting first strategy; side-branch occlusion occurred in 118 lesions. The risk
model and scoring system was constructed, with incremental weights attributed to each component variable according
to its estimated coefficients, from 1200 lesions. The remaining 401 lesions were used for validation. Side-branch
occlusion after main-vessel stenting was defined as any decrease in TIMI flow grade or absence of side-branch flow after
main-vessel stenting. Multivariable analyses revealed six variables independently associated with side-branch occlusion risk
(C-statistic 0.80 [95% CI 0.75–0.85] with good calibration); good calibration was confirmed in the validation cohort (0.77
[0.69–0.86]). Side-branch occlusion rates in the validation cohort were 0.0%, 3.8% and 19.8% in low-, intermediate- and
high-risk groups, respectively (p<0.001).
Comment: The risk of side-branch occlusion is the most important factor in determining the approach to bifurcation
stenting. This study from Fuwai Hospital in Beijing examined a large number of consecutive patients to develop a
risk stratification tool to predict the risk of side-branch occlusion. The authors identified six variables, including
plaque distribution (same side as side-branch worse), main-vessel TIMI flow before stenting (0 worse), preprocedural
diameter stenosis of bifurcation core (≥70˚ worse), bifurcation angle (≥90˚ worse), diameter ratio between main
vessel/side branch (≥2 worse) and diameter stenosis of side branch before main-vessel stenting (≥90% worse).
There is little discussion about using side-branch protection, but the above variables may help to inform decisions
around use of such strategies.
Reference: JACC Cardiovasc Interv 2015;8(1_PA):39–46
Abstract
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Interventional Cardiology
Research Review
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Middle-of-the-night percutaneous coronary
intervention and its association with percutaneous
coronary intervention outcomes performed the
following day
Authors: Aronow HD et al.
Summary: This analysis of data from the US National Cardiovascular Data Registry
investigated the effects of sleep deprivation on in-hospital mortality and bleeding among
1,509,096 ‘daytime’ (7am to midnight) PCI procedures performed by 5014 operators.
Compared with nonsleep-deprived operators, procedures performed by operators who
had performed ≥1 ‘night-time’ PCI procedure (midnight to 7am) earlier that day (2.4%)
were not associated with any significant impact on mortality (adjusted odds ratio 1.02
[95% CI 0.94–1.12]) or bleeding (1.03 [0.98–1.08]), but chronic sleep deprivation
(>1 ‘night-time’ procedure during the prior 7 days) was associated with a significantly
greater likelihood of bleeding (1.19 [1.05–1.34]).
Comment: In order to offer a 24/7 primary PCI service, cardiologists need to be on
call and may need to perform procedures in the ‘middle of the night’ (defined here as
between midnight and 7am). In other settings, such extended work hours are associated
with poor psychomotor performance. This paper used the CathPCI registry to examine
outcomes of sleep-deprived versus nonsleep-deprived operators, and suggests that whilst
it occurs infrequently (2.4%), there appears to be no adverse signal. Whilst representing
the largest published analysis of interventional cardiologist fatigue and patient safety,
there are a number of limitations including exactly how much rest each operator got,
whether more complex cases were rescheduled and how often more rested nurses or
fellows may have helped avert potential errors of judgment.
Reference: JACC Cardiovasc Interv 2015;8(1_PA):49–56
Abstract
Remote ischemic conditioning reduces myocardial
infarct size and edema in patients with ST-segment
elevation myocardial infarction
Authors: White SK et al.
Summary: Patients with STEMI with TIMI flow grade 0 (n=197) received remote ischaemic
conditioning with four 5-minute cycles of upper arm cuff inflation/deflation or an uninflated
cuff placed on the upper arm for 40 minutes (controls) prior to primary PCI in this RCT.
Compared with controls, remote ischaemic conditioning was associated with a significant
27% reduction in MI size (18.0% vs. 24.5% [p=0.009]), a lower 24-hour high-sensitivity
troponin T level (2296 vs. 2736 ng/L [p=0.037]), and reduced extent of myocardial oedema
on T2-mapping cardiac magnetic resonance (28.5% vs. 35.1% [p=0.003]) with lower mean
T2 values (68.7 vs. 73.1 msec [p=0.001]), precluding the use of cardiac magnetic resonance
oedema imaging for estimating the at-risk area. When cardiac magnetic resonance-independent
coronary angiography jeopardy scores were used to estimate the at-risk area, remote ischaemic
conditioning was associated with a significant improvement in the myocardial salvage index
(0.42 vs. 0.28 [p=0.03]).
Comment: Despite the increasing prevalence of primary PCI, significant morbidity and
mortality of STEMI remains, which may relate to reperfusion injury. Remote ischaemic
conditioning has emerged as a potential low cost and safe intervention, which may have
therapeutic benefit. This randomised single-centre study examined a surrogate MI endpoint
and suggested benefit of remote ischaemic conditioning. Patients were randomised on
arrival to hospital to remote ischaemic conditioning or control. The remote ischaemic
conditioning protocol consisted of a standard blood pressure cuff placed on the upper
arm and inflated to 200mm Hg and left inflated for 5 minutes. It was then deflated for 5
minutes and the cycle repeated a total of four times prior to primary PCI. The results are
intriguing and a large multicentre RCT powered for hard cardiac endpoints is now needed.
Reference: JACC Cardiovasc Interv 2015;8(1_PB):178–88
Abstract
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POST-MI PATIENTS
REMAIN AT HIGH AND
1-4
PERSISTENT RISK
20%
~20%
up
to
RISK of a recurrent
CV event in the first
year*1,2
RISK of a recurrent
CV event in the
subsequent 3 years*1
After a successful intervention, what
more can we do to protect them from
their underlying disease?
*The APOLLO HELICON analysis was a retrospective cohort study that included
108,315 patients from a national Swedish registry with a primary diagnosis of acute
MI between July 2006 and June 2011. The primary endpoint was risk for non-fatal
MI, non-fatal stroke, or cardiovascular death. The cumulative 1 year incidence of
the primary endpoint was 18.3%. In patients who were event free at 1 year, the
cumulative incidence of the primary endpoint was 20% after the following 3 years.1
On the basis of pooled data (Framingham Heart Study, Atherosclerosis Risk in
Communities Study, and National Heart, Lung, and Blood Institute), the American
Heart Association reported that 19% of men and 26% of women aged ≥45 years will
die within 1 year after a first MI.2
Reference 1. Jernberg T et al. Eur Heart J 2015: doi:10.1093/eurheartj/ehu505.
2. Mozaffarian D et al. Circulation 2015;131(4):434–441. 3. Nakatani D et al. Circ J
2013;77:439–446. 4. Kikkert WJ et al. Am J Cardiol 2014;113:229–235. AstraZeneca
Pty Ltd. ABN 54 009 682 311. 5 Alma Road, North Ryde NSW 2113. Medical Information:
1800 805 342. www.astrazeneca.com.au, 403210.022, WL287191, June 2015.
a RESEARCH REVIEW publication
© 2015 RESEARCH REVIEW
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