Largest Ever Analysis Of DES Data Demonstrates Safety, Efficacy In On-and-off-label Use

The analysis--which includes approximately 180,000 patients from 52 studies--was performed by a team of researchers led by Ajay J. Kirtane, MD, Assistant Professor of Clinical Medicine and an interventional cardiologist at NewYork-Presbyterian Hospital/Columbia University Medical Center, and Gregg W. Stone, MD, Chairman of CRF and Professor of Medicine at Columbia University Medical Center and Director of Cardiovascular Research and Education at the Center for Interventional Vascular Therapy at NewYork-Presbyterian Hospital.

Drs. Kirtane and Stone conducted two parallel meta-analyses examining DES vs. BMS use in both randomized, controlled trials and in observational registry analyses. The overall analysis represents the largest systematic overview of "real-world" (comprising both on-label and off-label) DES use to date and incorporates an updated overview of both the published literature as well as the most recent data from several unpublished studies presented in the last year.

"The findings from these parallel studies are striking," said Dr. Stone.

The meta-analysis of 22 randomized trials included more than 9000 patients with recent follow-up from previously published trials. According to the results, "DES resulted in small non-significant reductions in death and MI, with a greater than 50% decrease in subsequent TVR procedures," said Dr. Stone, adding that these findings are consistent with both on-label and off-label use of DES.

And in the 30-study registry meta-analysis (involving more than 170,000 "real-world" patients), "DES resulted in significant 20% and 11% reductions in death and MI, respectively, with a similar reduction in TVR (47%) as in the randomized trials, even after adjustment for confounding variables," said Dr. Stone. "These data are reassuring that DES are safe and effective for a wide-range of patients that are able to take dual antiplatelet therapy for at least one year."

The findings were consistent and robust across a variety of study designs and even in trials incorporating longer-term follow-up; trials that were included were required to follow patients for at least one year.

Dr. Kirtane remarked that these findings should help to reassure patients and physicians about the safety of DES in off-label use.

"Even with the stated limitations of registry data, the bottom line from both randomized trials and observational analyses is consistent: we can reduce the need for repeat procedures and we clearly are not harming patients with DES," he added.