November 27, 2009 (London, UK) — A study comparing two revascularization strategies in diabetic patients with multivessel disease failed to show that PCI was noninferior to coronary artery bypass graft (CABG) surgery .
At one year, there was no significant difference in the primary composite end point of death, stroke, and MI. Repeat revascularization procedures were significantly higher among the PCI-treated patients and, as with the Synergy Between PCI With Taxus and Cardiac Surgery (SYNTAX) trial comparing CABG with PCI, there were more strokes among patients treated with surgery, although this difference was not statistically significant.
The results of the study, known as the Coronary Artery Revascularization in Diabetes (CARDIA) trial, are published online today in the Journal of the American College of Cardiology.
The results were first presented in Munich, Germany, at the European Society of Cardiology Congress 2008 and reported at that time. As noted then, the CARDIA study had planned to enroll 600 patients but missed this mark, and as a result was underpowered with just 510 patients.
"The CARDIA trial was underpowered for the primary composite outcome, but we believe that this outcome was more meaningful and consistent with other major cardiovascular therapy trials than the conventional MACCE [major adverse cardiovascular and cerebrovascular events] outcomes, which are driven by repeat revascularization," according to lead investigator Dr Akhil Kapur (London Chest Hospital, UK) and colleagues.
The researchers note that the event rate in the PCI arm was higher than predicted, likely because of the increased complexity of coronary disease in these patients; this trend was also observed in the SYNTAX trial, which was also reported. These higher-than-expected event rates need to be taken into account when other trials are designed, say researchers.
This is not the last comparison of PCI and CABG in diabetic patients with coronary artery disease. The National Heart, Lung, and Blood Institute FREEDOM trial, led by Dr Valentin Fuster (Mount Sinai School of Medicine, New York), is ongoing, although results are not expected until the end of 2011. Planned enrollment is approximately 2000 patients, and the primary end point is a composite of all-cause mortality, nonfatal myocardial infarction, and stroke at five years.
Kapur A, Hall RJ, Malik IS, et al. Randomized comparison of percutaneous coronary intervention with coronary artery bypass grafting in diabetic patients. J Am Coll Cardiol 2009; DOI: 10.1016/j.jacc.2009.10.014.
Heartwire from Medscape © 2009 Medscape, LLC
Cite this: CARDIA: PCI Fails Noninferiority Test vs CABG - Medscape - Nov 27, 2009.