Study Confirms Lower Stent Thrombosis, MI Risks With Newer DES
Compared to early-generation drug-eluting stents (DES), new-generation DES carry lower long-term risks of stent thrombosis and myocardial infarction (MI) in patients receiving percutaneous coronary intervention (PCI), according to a registry study published online October 14, 2014, ahead of print in Catheterization and Cardiovascular Interventions.
Findings from 3-year follow-up highlight the superior safety profile of the latest DES, which were also as effective as their predecessors, write Luigi Vignali, MD, PhD, of Parma University Hospital (Parma, Italy), and colleagues.
|The researchers examined data from the REAL registry on all patients who underwent PCI with DES placement between January 1, 2007, and June 30, 2011, at 11 participating centers in northern Italy. A total of 2,775 patients received early-generation DES, and 2,557 received new-generation DES.|
|Early-generation DES included Cypher and Cypher Select (Cordis), Taxus Express and Taxus Liberté (Boston Scientific), and Endeavor (Medtronic). New-generation DES included Biomatrix (Biosensors), Endeavor Resolute (Medtronic), Nobori (Terumo), Optima (Sorin), Promus (Boston Scientific), and Xience (Abbott).|
At 3 years, new-generation DES were associated with reduced risks of MI and definite stent thrombosis compared with early-generation DES, but the rate of MACE (all-cause death, MI, and TVR) did not differ between the groups (table 1).
When looking only at events associated with ACS, the risks of MACE, TVR, and the composite of death and MI were lower with new-generation DES.
‘Real-World’ Data a Key Strength of Study
Several previously published clinical trials and meta-analyses have shown newer DES to have better safety profiles than the earlier generation, but the current study is one of the largest and longest to confirm this finding in everyday clinical practice, Dr. Vignali told TCTMD in a telephone interview. He also highlighted its use of propensity matching.
One drawback cited by the researchers is the low number of patients receiving DES with a bioresorbable polymer (8.3%) and polymer-free stents (0.6%). They note, too, that the pooling of several different new-generation DES into a single arm “is a major study limitation.”
Also in a telephone interview, Deepak Bhatt, MD, MPH, of Brigham and Women’s Hospital (Boston, MA) called the study findings “reassuring” and confirmatory.
“With the first-generation DES there was definitely more stent thrombosis than we saw with bare-metal stents, and even though the excess was very slight it was still a safety concern,” he said. “I think it is now clear the new-generation DES are as safe as BMS and are associated with a lower risk for repeat procedures.”
Dr. Bhatt noted that the use of BMS in the United States is now limited to patients perceived to be poor candidates for several months of dual antiplatelet therapy. He added, however, that even in this population, use of new-generation DES is increasing.
“The bottom line is these second-generation DES really are an advance,” he said.
Vignali L, Saia F, Belotti LMB, et al. New-generation drug-eluting stents reduce stent thrombosis and myocardial infarction: a propensity-score-adjusted analysis from the multicenter REAL registry. Cath Cardiovasc Interv. 2014;Epub ahead of print.
- The study was funded by the REAL registry group.
- Dr. Vignali reports no relevant conflicts of interest.
- Dr. Bhatt reports receiving research funding from Medtronic.