Title: Efficacy and Safety of Zotarolimus-Eluting and Sirolimus-Eluting Coronary Stents in Routine Clinical Care (SORT OUT III): A Randomised Controlled Superiority Trial
Topic: Interventional Cardiology
Date Posted: 3/15/2010
Author(s): Rasmussen K, Maeng M, Kaltoft A, et al., on behalf of the SORT OUT III Study Group.
Citation: Lancet 2010;Mar 15:[Epub ahead of print].
Clinical Trial: yes
Related Resources
Trial: Comparison of Zotarolimus-Eluting Stents and Sirolimus-Eluting Stents in Patients With Coronary Artery Disease (SORT OUT III)
Study Question: What is the safety and efficacy of the zotarolimus-eluting stent (ZES) compared with the sirolimus-eluting stent (SES) in patients with coronary artery disease who are receiving routine clinical care?
Methods: The authors performed a single-blind superiority trial comparing SES to ZES in all adult patients with chronic stable coronary artery disease or acute coronary syndromes undergoing percutaneous coronary intervention (PCI) at five high-volume centers in Denmark. Follow-up data were obtained from national administrative and health care registries. The primary endpoint was a composite of cardiac death, myocardial infarction, and target vessel revascularization events within 9 months. Intention-to-treat analyses were done at 9 and 18 months.
Results: The study randomized 1,162 patients to the ZES and 1,170 to a SES. The randomly allocated stent was implanted in 1,589 (98%) lesions allocated to the ZES and 1,569 (97%) lesions allocated to SES (p = 0.15). Six patients were lost to follow-up. All other patients were included in analyses at 30-day and 9-month follow-up. Eighteen-month follow-up was completed for 94% of the patients. At 9 months, patients treated with a ZES were more likely to have met the primary endpoint (6% vs. 3%; hazard ratio, 2.15; 95% confidence interval, 1.43-3.23; p = 0.0002). This difference was sustained at 18 months (10% vs. 5%; 2.19; 1.58-3.04; p < 0.0001). There was no difference in the all-cause mortality at 9 months (2% vs. 2%), whereas it was higher in the ZES patients at 18 months (4% vs. 3%; 1.03-2.50; p = 0.035).
Conclusions: The SES is superior to the ZES for patients undergoing PCI in routine clinical practice.
Perspective: Multiple studies have evaluated the relative efficacy and safety of a SES and a paclitaxel-eluting stent (PES), and most (but not all) of them suggest better outcomes with the SES. Data on comparative efficacy of the ZES and the everolimus-eluting stent (EES) are rather limited. The SPIRIT IV and COMPARE trials suggest that the EES is probably safer and more efficacious than the PES. The relative position of the ZES in the DES spectrum is harder to define. This trial suggests a lower rate of target lesion revascularization with SES that is not surprising since the SES has better anti-restenotic efficacy. The Endeavour III trial had demonstrated a late catch-up phenomenon with the SES, and longer-term follow-up of the SORT OUT III trial will be needed to establish the relative long-term safety and efficacy of ZES and SES. Hitinder S. Gurm, M.B.B.S., F.A.C.C
Title: Low Diagnostic Yield of Elective Coronary Angiography
Topic: Interventional Cardiology
Date Posted: 3/10/2010 4:00:00 PM
Author(s): Patel MR, Peterson ED, Dai D, et al.
Citation: N Engl J Med 2010;362:886-895.
Clinical Trial: No
Study Question: What is the diagnostic yield of coronary angiography among patients with coronary artery disease (CAD) in a contemporary national sample?
Methods: From January 2004 to April 2008, at 663 hospitals in the American College of Cardiology National Cardiovascular Data Registry, the authors identified patients without known CAD who were undergoing elective cardiac catheterization. The patients' demographic characteristics, risk factors, and symptoms and the results of noninvasive testing were correlated with the presence of obstructive CAD, which was defined as stenosis of 50% or more of the diameter of the left main coronary artery, or stenosis of 70% or more of the diameter of a major epicardial vessel.
Results: A total of 398,798 patients were included in the study. The median age was 61 years; 52.7% of the patients were men, 26% had diabetes, and 69.6% had hypertension. Noninvasive testing was performed in 83.9% of the patients. At catheterization, 149,739 patients (37.6%) had obstructive CAD. No CAD (defined as <20% of stenosis in all vessels) was reported in 39.2% of patients. Independent predictors of obstructive CAD included male sex (odds ratio [OR], 2.70; 95% confidence interval [CI], 2.64-2.76); older age (OR per 5-year increment, 1.29; 95% CI, 1.28-1.30); presence of insulin-dependent diabetes (OR, 2.14; 95% CI, 2.07-2.21); and presence of dyslipidemia (OR, 1.62; 95% CI, 1.57-1.67). Patients with a positive result on a noninvasive test were moderately more likely to have obstructive CAD than those who did not undergo any testing (41.0% vs. 35.0%, p < 0.001; adjusted OR, 1.28; 95% CI, 1.19-1.37).
Conclusions: The authors concluded that in this study, only a minority of patients without known coronary disease who underwent elective cardiac catheterization had obstructive CAD.
Perspective: This analysis of a contemporary national sample of patients suggests that only a minority of patients undergoing coronary angiography have obstructive CAD. The assessment of coronary stenosis was made by the interpreting/performing physician and it is possible that more stringent assessment may further lower the fraction of patients with obstructive CAD. It should also be noted that this study addresses only overutilization and not underutilization of coronary angiography in appropriate patients. However, it is obvious from this study that the current strategies used to make decisions for proceeding to coronary angiography, including clinical assessment and noninvasive testing, need substantial modification and improvement to increase the diagnostic yield of coronary angiography and prevent over- or underutilization to improve overall quality of patient care. Debabrata Mukherjee, M.D., F.A.C.C.