Statistics Related to Interventional Cardiology Procedures

Statistics Related to Interventional Cardiology Procedures
Order 5899092
Statistics Related to Interventional Cardiology Procedures
1 You are the director of a community-based catheterization laboratory that performs approximately 500
percutaneous coronary interventions (PCIs) per year.
As part of a quality improvement initiative, you have
introduced a PCI database into practice that collects information at the time of the procedure and
over the first year following discharge. One year ago,
you introduced a new drug-eluting stent into the
laboratory practice. It quickly became popular and
now accounts for approximately one third of the
procedures in the laboratory. One of your clinical
colleagues is concerned that there have been several recent cases of subacute stent thrombosis and
wonders if these events can be attributed to the new
stent. What is the most appropriate study design to
get information quickly in your practice setting that
might be useful in addressing the question posed by
your clinical colleague?
(A) Randomized clinical trial
(B) Case–control study
(C) Cohort study
(D) Nonrandomized observational registry
2 The Framingham Heart Study can best be described
as what type of clinical study?
(A) Randomized clinical trial
(B) Case–control study
(C) Cohort study
(D) Community intervention study
3 One of your patients, who has been postmenopausal
for several years and who suffered a non–ST-segment
elevation myocardial infarction (NSTEMI) 2 years
ago, asks you for a recommendation regarding
hormone replacement therapy (HRT) to lower her
risk of having a second heart attack. You review
the literature on this topic and find divergent study
results. Large observational databases such as the
Nurses’ Health Study suggest a very impressive
reduction in the risk of ischemic events in women
taking hormone therapies, but other data from large,
well-powered randomized trials suggest that there is
no benefit for this endpoint associated with HRT.
What do you do?
(A) Recommend HRT since the effect reported in
the observational studies is just too large to
ignore
(B) Recommend HRT, because although the benefits are not clear, it likely does not cause harm
(C) Recommend against HRT because she is currently asymptomatic
(D) Recommend against HRT because there is no
benefit seen in randomized controlled trials
(RCTs), including in women with previously
known ischemic heart disease
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Statistics Related to Interventional Cardiology Procedures
340 900 Questions: An Interventional Cardiology Board Review
4 The following are all surrogate endpoints measured
in recent clinical trials, except:
(A) Low-density lipoprotein (LDL) cholesterol levels
(B) High-density lipoprotein (HDL) cholesterol
levels
(C) TIMI (thrombolysis in myocardial infarction)
blood flow
(D) Systolic blood pressure
(E) Recurrent ischemia
5 Glycoprotein IIb/IIIa platelet inhibitors may be used
as adjunctive pharmacotherapy during PCI. As you
consider whether or not to use these therapies during
a procedure, you review the available data from
clinical studies. Eptifibatide has been shown to reduce
the risk of which of these clinical events significantly,
compared with placebo?
(A) All-cause mortality
(B) Cardiovascular mortality
(C) Bleeding
(D) Thrombocytopenia
(E) The composite of death, myocardial infarction
(MI), urgent revascularization, or thrombotic
bailout
6 You have been approached to help in the planning
of a multicenter study that will examine a potential
difference in the restenosis rate of two commonly
used drug-eluting stents. The plan is to conduct a
randomized controlled trial. As you begin discussions
with your colleagues and the study sponsor, the first
question that might arise is how many subjects will
be needed for an adequate experiment. Which factor
is not relevant to the ensuing scientific discussions?
(A) Anticipated event rate in the control group
(B) Estimated difference between the groups
(C) Amount of time required to complete enrollment
(D) Composition of the primary endpoint
7 A recently completed, randomized, active control
clinical trial comparing new drug A with old drug
B reports a 15% improvement with the new drug,
p = 0.06. What is the most appropriate interpretation of these results?
(A) Drug A is comparable to Drug B
(B) Drug A is definitely inferior to Drug B
(C) Drug A is not statistically superior to Drug B
(D) Drug A is statistically superior to Drug B
8 You are part of a proposed study’s steering committee
that has been charged with designing a clinical trial
to test whether new stent A is better than old stent B.
The new stent has many attractive design features
and your research group would like to be sure that
the study is large enough to definitively conclude
that stent A is truly superior to stent B if the rates
hypothesized are seen. Which component of sample
size calculation does this refer to?
(A) Type II error
(B) Type I error
(C) Number needed to treat (NNT)
(D) Study p value
9 In the following figure, which study demonstrates
superiority of Drug X over Drug Y?
Drug A better
MID
Study A
Study B
Study C
Study D
0
MID: Minimally important difference
1 2
MID
Drug B better
(A) Study A
(B) Study B
(C) Study C
(D) Study D
10 In the figure in Question 9, which study demonstrates
equivalence between Drug X and Drug Y?
(A) Study A
(B) Studies A and B
(C) Studies A and C
(D) Studies A, C, and D
11 In the figure in Question 9, which study demonstrates
noninferiority between Drug X and Drug Y?
(A) Study A
(B) Studies A and B
(C) Studies A and C
(D) Studies A, C, and D
12 For which of the following reason(s) is blinding (or
‘‘masking’’) in a clinical trial important?
(A) It helps prevent introduction of treatmentspecific biases
(B) It helps maintain objectivity in assessment of
clinical events
Statistics Related to Interventional Cardiology Procedures 341
(C) It preserves Type I error rate
(D) A and B
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