Next-generation drug-eluting stents proved safer than their predecessors and their bare-metal cousins for rates of restenosis, stent thrombosis and subsequent death, flipping the tables on previous findings.
New results from Swedish Coronary Angiography & Angioplasty Registry data taken between Nov. 2006 and Oct. 2010 show that DES have finally taken the lead for safety in the stent arena.
An earlier SCAAR study, comparing DES with bare-metal stent outcomes during 2003 and 2004, found higher rates of stent thrombosis and death with DES, leading to an immediate decline in their use, according to a press release from the European Society of Cardiology.
Findings released in 2007, which added an additional 2 years’ worth of data to the original study, found flat risk between the 2 stent groups.
The latest results, published in the January issue of the ECS journal, are the first to find a reduction in mortality associated with use of DES over bare-metal stents, either in randomized trials or in SCAAR data, according to the release.
Next-gen DES had a 23% lower mortality risk than their predecessors and a 45% lower risk than BMS.
The SCAAR study also found that next-gen DES had a 38% lower risk of clinically meaningful restenosis and a 43% lower risk of stent thrombosis within 2 years of implantation, when compared with their predecessors.
That’s good new for modern stents, which have had a bit of bad press lately over concerns that their thinner, more flexible designs may make them more prone to shrinking or becoming deformed over time.
While an extremely rare phenomenon, studies detailing crumpling concerns led the FDA to require Boston Scientific (NYSE:BSX) to include the shrinkage risk in labeling for its newly cleared Promus Element DES, which was included in the SCAAR findings.
The registry observed more than 61,000 patients who received nearly 95,000 stent implantations in Sweden from Nov. 2006 to Oct. 2010. Researchers say there were no major changes in procedures for antithrombotics or antiplatelet therapies that might have had a heavy influence on the results during that time.
SCAAR is the world’s largest PCI registry with the longest track of follow-up data, according to the release.
The next-generation DES, including Medtronic’s (NYSE:MDT) Endeavor Resolute, Abbott’s (NYSE:ABT) Xience V and Xience Prime and Boston Scientific’s Promus and Promus Element, were the clear front-runners for all 3 risk categories when compared to older DES, which in turn bested bare-metal stents.
The study’s older-generation DES included Cordis Corp.’s Cypher and Cypher Select; Boston Scientific’s Taxus Express and Taxus Liberté; and Medtronic’s Endeavor. The BMS were not identified.