Influence of COURAGE trial on optimal medical therapy use small
Borden WB. JAMA. 2011;305:1882-1889.
During the years after the publication of the COURAGE trial results, few changes were observed in the practice patterns of optimal medical therapy use among patients with stable coronary artery disease undergoing percutaneous coronary intervention, according to a new study.
In 2007, Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation (COURAGE) data indicated that PCI and optimal medical therapy (OMT) did not improve survival or prevent MI in patients with stable CAD compared with OMT alone.
In the current analysis, researchers set out to find the influence of these results on clinical practice. The observational study featured 467,211 patients (37.1% before, 62.9% after COURAGE publication) with stable CAD undergoing PCI from the National Cardiovascular Data Registry between Sept. 1, 2005, and June 30, 2009. Researchers defined OMT as either being prescribed or having a documented contraindication to medicines, including antiplatelet agents, beta-blockers and statins.
Overall, 206,569 patients were treated with OMT before PCI and 303,864 were treated at discharge after PCI. Before the COURAGE trial, OMT before PCI was used in 43.5% of patients (n=75,381), whereas after the trial, it was used in 44.7% of patients (n=131,188). Additionally, OMT use at discharge after PCI was 63.5% before the COURAGE trial and 66% after the trial.
“Collectively, these findings suggest a significant opportunity for improvement and a limited effect of an expensive, highly publicized clinical trial on routine clinical practice,” the researchers wrote, later concluding that the results “support a call for innovations in how OMT is incorporated into interventional strategies and for improving the translation of clinical evidence into practice.” – by Brian Ellis
It is a paper of some interest. It would appear to be disappointing that the rates of OMT were low and little affected by COURAGE trial results. However, there are significant limitations beyond those reported. The institutions reporting were not constant. Also the purpose of the NCDR CathPCI database is primarily to examine PCI outcomes. The medications and contraindications to medications may not have been as complete or careful as one would hope. Also, while these patients did not have acute coronary syndromes, there may have been some urgency to their care, limiting ability to place patients on OMT prior to their procedures. We should be glad to see a 20% absolute increase in OMT after the procedure given that these patients generally have a length of stay of 1 day and are often not even formally hospital admissions. So, while we should not be complacent and need to do better, let us also not overestimate the problem
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Cardiac rehabilitation improved mortality in patients after PCI
Goel K. Circulation. 2011;doi:10.1161/CIRCULATIONAHA.110.983536.
Findings from a retrospective study have suggested that patients who participated in cardiac rehabilitation within 3 months of percutaneous coronary intervention had a decreased rate of mortality. However, rates of MI and revascularization were not influenced by participation.
“Our results provide supportive evidence for the decision by Centers for Medicare and Medicaid Services to cover cardiac rehabilitation in PCI patients and for the recommendations in clinical practice guidelines and performance measures that support cardiac rehabilitation for all PCI patients,” the researchers wrote.
In the study, investigators from the Mayo Clinic in Rochester, Minn., examined consecutive patients (n=2,395) from a prospectively collected registry who underwent PCI in Olmsted County, Minnesota. During the 3 months after PCI, 964 patients (40%) participated in at least one outpatient cardiac rehabilitation session.
During a median follow-up of 6.3 years, 503 deaths (199 cardiac-related), 394 MIs and 755 revascularization procedures were reported. Patients who took part in cardiac rehabilitation had a noted reduction in all-cause mortality by all three statistical techniques employed, including propensity score-matched analysis (HR=0.54), propensity score stratification (HR=0.53) and regression adjustment with propensity score in a 3-month landmark analysis (HR=0.55; P<.001 for all three). A trend toward a reduction in cardiac-related mortality among those participated was also reported; however, only propensity score stratification documented a significant reduction (P=.016).
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Mortality, adverse events found higher in patients with elevated biomarkers after nonemergent PCI
Feldman D. Catheter Cardiovasc Interv. 2011;doi:10.1002/ccd.22962.
Elevation of cardiac troponin I and troponin T among patients who underwent nonemergent percutaneous coronary intervention was predictive of long-term all-cause mortality and a composite of adverse events in a new study.
All patients (n=22,353) in the analysis were compiled from 22 studies published between 1998 and 2009 that reported on the prognostic effect of cardiac troponin I (cTnI) and troponin T (cTnT). All-cause mortality was defined as the study’s primary endpoint.
In all, post-PCI cTnT or cTnI was elevated in 32% of patients. During a mean follow-up of 17.7 months, the primary endpoint was noticeably higher for patients with cTnI or cTnT elevation after PCI compared with patients without cTnI or cTnT elevation (OR=1.45; 95% CI, 1.22–1.72). Similarly, the composite of adverse events of all-cause mortality and MI in patients with cTnI or cTnT elevation was also higher (OR=1.77; 95% CI, 1.48-2.11).
“Our meta-analysis supports the ACC/AHA recommendation to monitor cTn markers post-PCI as to assess long-term clinical outcomes and to identify patients with high-risk coronary artery features,” the researchers wrote. “Further studies are needed to determine if peri-procedural efforts to minimize cTn elevations and more intensive outpatient monitoring/treatment of patients with elevated cTn levels after nonemergent PCI will result in improved long-term outcomes.” – by Brian Ellis
Meta-analyses can be very valuable but can also be misleading. One of the major problems with almost all of the studies in this area is that they use a baseline value that with rare exception is markedly above the recommended cut off value of the 99th percentile. When one does this one ignores the prognostic significance of the baseline value and also fails to understand that the values are most often rising. Thus, the results post procedure are substantially more elevated. Some would say most of the increase is due the natural rise of the elevated baseline value and most often not the procedure. If one uses the 99th percentile value as to define normality at baseline, it turns out that most if not all of the prognostic significance resides in the baseline value and there is modest or perhaps no additional contribution of the post-intervention values either short- or long- term. Lack of attention to this critical metric has confounded all of the meta-analyses and most of the studies. If one uses the 99th percentile value to define a normal baseline as in the Prasad study, there is no additional prognostic value in the post-PCI values. Unfortunately, that is the only study that uses that value at baseline. Thus, one needs to consider this meta-analysis with great caution.