Initial stent implantation for patients with stable coronary artery
disease is not associated with improved outcomes compared with initial medical
therapy for the prevention of death, nonfatal MI, unplanned revascularization
or angina, according to a meta-analysis of eight previously published clinical
trials.
Kathleen Stergiopoulas, MD, PhD, and David L. Brown, MD,
of Stony Brook University Medical Center, N.Y., conducted a systematic review
and meta-analysis of previous randomized clinical trials that compared initial
stent implantation and medical therapy vs. initial medical therapy alone. The
researchers’ search yielded eight trials conducted between 1997 and 2005
that enrolled 7,229 patients and followed them for a mean of 4 years. In the
trials, 3,617 patients were randomly assigned to initial stent implantation and
medical therapy and 3,612 were assigned to initial medical therapy alone.
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Kathleen Stergiopoulas
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“The significant finding of this analysis is that compared with a
strategy of initial medical therapy alone, coronary stent implantation in
combination with medical therapy for stable CAD is not associated with a
significant reduction in mortality, nonfatal MI, unplanned revascularization or
angina after a mean follow-up of 4.3 years,” the
researchers wrote.
Comparison of two initial strategies
Of the 649 deaths among patients in the trials, 8.9% occurred among
patients assigned to initial stent implantation and medical therapy compared
with 9.1% among patients assigned medical therapy alone (OR=0.98; 95% CI,
0.84-1.16). Nonfatal MI was reported in 8.9% of the initial stent
implantation/medical therapy groups vs. 8.1% of the medical therapy groups
(OR=1.12; 95% CI, 0.93-1.34). Unplanned revascularization was performed in
21.4% of the initial stent implantation/medical therapy groups vs. 30.7% of the
medical therapy groups (OR=0.78; 95% CI, 0.57-1.06). Data on angina were
available for 4,122 patients. Among those who underwent initial stent
implantation/medical therapy, 29% experienced persistent angina vs. 33% of
those who had initial medical therapy (OR=0.80; 95% CI, 0.60-1.05).
Mounting evidence
Stergiopoulas and Brown concluded that the findings of this
meta-analysis “support current recommendations for instituting optimal
medical therapy in patients with stable CAD rather than proceeding directly to
stent implantation.” According to their estimates, these results suggest
that three-quarters of patients with stable CAD can avoid
PCI if treated with initial medical therapy, for a lifetime
health care cost savings of $9,450 per patient.
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William E. Boden
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However, the researchers acknowledged that these data are in contrast to
two recent meta-analyses that found reductions in mortality and angina among
patients assigned to initial PCI.
In an accompanying editorial, William E. Boden, MD, of Samuel S.
Stratton VA Medical Center and Albany Medical Center, said that in light of
increasing health care costs “we certainly have abundant scientific
evidence to support a more selective, measured and balanced approach to the
initial management of stable ischemic heart disease, and one that promotes and
embraces optimal medical therapy for the majority of patients as a proven
alternative to revascularization.”
For more information:
Disclosure: Drs. Boden, Brown and Stergiopoulas report no
relevant financial disclosures.
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Ajay J. Kirtane
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This meta-analysis essentially amalgamates a number of studies that have
been previously published. As such, I do not feel that these results add to the
‘mounting evidence’ of PCI vs. medical therapy, as noted in the
editorial. The researchers and editorialists conclude that the benefit of PCI,
at least in terms of symptom relief, is not that great over initial optimal
medical therapy. That seems to be at odds with numerous previous studies of PCI
vs. medical therapy, and it is important to consider that a significant
proportion of patients in the medical therapy arms of the included trials
actually ‘crossed over’ to subsequent PCI for a failure of medical
therapy. In addition, the researchers stress that studies included in this
meta-analysis were conducted in the stent era only. However, while restricting
this analysis to only the stent era, very few patients were treated with
current optimal PCI (including drug-eluting stents and fractional flow
reserve-guided PCI) and the researchers also included a mixed bag of studies of
both stable CAD as well as post-infarction patients that I think further
confuses the issue.
Overall, physicians need to be very cognizant as to why we are treating
patients. Patients enrolled in clinical trials of PCI vs. medical therapy
represent only a small fraction of patients that we encounter in clinical
practice with stable CAD. If we are treating very symptomatic patients (or
those with severe CAD), they will do better with PCI, and this option should be
presented to them. On the other hand, there are many patients with minimal or
no symptoms who clearly should be offered up-front medical therapy. What is
important is open dialogue.
– Ajay J. Kirtane, MD, SM, FACC,
FSCAI
Assistant Professor of Clinical Medicine
Columbia
University
SCAI Spokesperson
Disclosure: Dr. Kirtane reports no relevant financial
disclosures.