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Meta-analysis: No benefit of initial PCI vs. medical therapy for stable CAD
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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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“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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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:
- Boden WE. Arch Intern Med. 2012;172:319-321.
- Stergiopoulos K. Arch Intern Med. 2012;172:312-319.
Disclosure: Drs. Boden, Brown and Stergiopoulas report no relevant financial disclosures.
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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.
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