PCI and Quality of Life
Abstract & Commentary
By Jonathan Abrams, MD, Professor of Medicine, Division of Cardiology, University of New Mexico, Albuquerque. Dr. Abrams serves on the speaker's bureau for Merck, Pfizer, and Parke-Davis. This article originally appeared in the October 2008 issue of Clinical Cardiology Alert. It was edited by Michael H. Crawford, MD, and peer reviewed by Rakesh Mishra, MD. Dr. Crawford is Professor of Medicine, Chief of Clinical Cardiology, University of California, San Francisco, and Dr. Mishra is Assistant Professor of Medicine, Weill Medical College, Cornell University; Assistant Attending Physician, NewYork-Presbyterian Hospital. Dr. Crawford is on the speaker's bureau for Pfizer, and Dr. Mishra reports no financial relationships relevant to this field of study.
Source: Weintraub WS, et al. Effect of PCI on quality of life in patients with stable coronary disease. N Engl J Med. 2008;359:677-687.
Perhaps the most prominent cardiovascular report in 2007 was the publication of the COURAGE trial (N Engl J Med. 2007;356:1503-1516), which demonstrated the equality in major CV outcomes in randomized patients with stable CAD, most with angina, who were assigned PCI with optimal medical therapy (OMT) vs OMT alone, with a mean follow-up of 4.6 years. This second publication from the COURAGE investigators reports on multiple assessments of quality of life, particularly angina presence and severity, between the two groups over the study observation.
The COURAGE trial assigned 2,207 patients with chronic stable angina, who had at least single vessel disease, to PCI vs no PCI; both groups received a regimen of OMT. The major findings showed no difference in the primary end points of death or myocardial infarction over the course of the study.
In COURAGE, each group received appropriate medical therapy, including aspirin, a beta blocker, a nitrate, a statin, a calcium channel blocker, and lisinopril or losartan, as well as clopidogrel in the PCI cohort. Follow-up in COURAGE consisted of three-month assessments of quality of life (QOL) using a variety of health status measures, especially the Seattle Angina Questionnaire and the RAND-36 health survey. Each of these surveys contains multiple modules, with individual scores ranging between 1-100, using multiple descriptors of angina and QOL indices evaluated by the survey assessments.
The results demonstrated that both groups received prompt improvement of angina, more so with PCI, and especially in the group of participants who had the most severe angina status at baseline. The PCI cohort had more effective angina control and improved QOL, compared to OMT only, but the differences were modest and dissipated within 3-6 months, after which time the PCI and OMT cohorts alone were equivalent. More patients became angina free with PCI, but by two years, the groups were equivalent in this domain. For all domains in the Angina Questionnaire and RAND-36 surveys, early improvement was greater in the PCI-OMT cohort, but these differences were gone by 3-6 months. A greater proportion of the PCI group had clinically improved scores for physical function, angina frequency, and quality of life for six months after randomization; these differences were no longer significant by 12 months. Baseline values for all five Seattle Angina Questionnaire scores were lower for the 600 patients in the medical therapy group who required coronary revascularization within three months after randomization. Angina frequency improved from baseline to three months; a greater benefit from PCI was seen in the lowest group (most severe angina). There was no improvement in the highest third that had no baseline angina. Both groups improved in all domains, with some advantage of PCI over medical therapy at three months; the improved domain scores were in physical functioning, vitality, chest pain, and general health. Other comparisons favored PCI up to six months, but no longer at 12 months. In summary, the Seattle Angina Questionnaire results support a benefit of PCI over OMT alone in the first 12-24 months. They comment on the unexpected early improvement in the OMT-only group, suggesting that PCI "is not always essential for relief of stable angina symptoms." Low Seattle scores were seen in the severe chest pain group; there was no benefit in the patients with little to no baseline angina. In conclusion, chronic CAD patients will get relief from angina whether treated with PCI plus optimal medical therapy or with optimal medical therapy alone. An initial strategy of PCI relieved angina and improved self-assessed health status to a greater extent than an initial strategy of OMT alone for approximately 24 months.
This is a "good news" report which is straightforward with expected outcomes, concluding that PCI is not mandatory in chronic stable angina patients receiving excellent guideline supported medical therapy. This report, while filled with multiple statistics and analyses, is good news for all. Those who complained that PCI was given less favorable ratings when COURAGE was reported last year should relax. The current analysis supports PCI as being more effective over a longer period of time after the procedure as opposed to medical therapy only. This report confirms that PCI is most useful in subjects that have severe and/or frequent angina; chest pain-free patients with CAD did not benefit, as would be expected.
In conclusion, both PCI and intense medical therapy are effective in improving or relieving angina in stable CAD individuals. Medical therapy alone is effective and is as safe as PCI. PCI subjects had a greater degree and length of improvement in angina. Over time, the two groups blend together, perhaps due to advancing CAD. As noted when COURAGE was first released, there was no difference in the important outcomes of death or MI between the two strategies. Thoughtful and knowledgeable physicians need to know the COURAGE result and make treatment decisions with thought and care.
In an accompanying editorial, Peterson and Rumsfeld conclude, "The COURAGE trial redefines the contemporary roles of optimal medical therapy and PCI in the management of patients with stable angina ... both treatment strategies can have a profoundly positive effect on health care status ... Optimal medical therapy as first-line therapy, with PCI reserved for patients who do not have a response or who have severe baseline symptoms."1
1. Peterson ED, Rumsfeld JS. Finding the courage to reconsider medical therapy for stable angina. N Engl J Med. 2008;359:751-753.