Drug-eluting stents (DES) showed no difference in real-world results compared with bare metal stents (BMS) for mortality and MI, for both on-label and off-label usage, according to a meta-analysis published online June 15 in Circulation. The study also compared the rates of target vessel revascularization (TVR).
The analysis, which included approximately 190,000 patients from 56 studies overall, was performed at the Cardiovascular Research Foundation (CRF). The researchers were led by Ajay J. Kirtane, MD, an interventional cardiologist at New Yok-Presbyterian Hospital/Columbia University Medical Center; and Gregg W. Stone, MD, immediate-past chairman of CRF and director of cardiovascular research and education at the Center for Interventional Vascular Therapy at New York-Presbyterian Hospital/Columbia University Medical Center; all in New York City.
Kirtane and Stone conducted two parallel meta-analyses examining DES versus BMS use in both randomized, controlled trials and in observational registry analyses. The overall analysis represents a systematic overview of "real-world" (comprising both on-label and off-label) DES use to date and incorporates an overview of both the published literature as well as several unpublished studies presented at major cardiovascular meetings.
"The findings from these parallel studies are striking," Stone said.
The first meta-analysis of 22 randomized trials included more than 9,000 patients with recent follow up from previously published trials.
"DES resulted in no overall differences in death and MI, with a greater than 50 percent decrease in subsequent TVR procedures," said Stone, adding that these findings are consistent with both on-label and off-label use of DES.
In the 34-study observational meta-analysis (involving more than 180,000 real-world patients), "DES resulted in significant 22 percent and 13 percent reductions in death and MI, respectively, with a similar reduction in TVR (46 percent) as in the randomized trials, even after adjustment for confounding variables," said 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; trials that were included were required to follow patients for at least one year, according to the authors.
Kirtane noted that these findings should help to reassure patients and physicians about the safety of DES in off-label use.
"One of the interesting aspects of this analysis is that it points to significant differences between results obtained from randomized trials and observational analyses. Nonetheless, even with the stated limitations of observational data, the bottom line from both randomized trials and observational analyses is consistent: we can reduce the need for repeat procedures and we do not appear to be harming patients with DES," Kirtane concluded.