“All Comers” Study Tests Medtronic’s Resolute Integrity vs Boston’s Promus Element

As if you’ve not heard enough huff and puff about polymer coated drug eluting stents in the past week, right? Well, here’s one more from Medtronic. The company is trumpeting quite a landmark with the publication of a first head-to-head randomized controlled trial of “third-generation” durable-polymer drug-eluting stents for the treatment of coronary artery disease in an “all-comers” patient population. You can probably guess the outcome, but Resolute Integrity’s greater longitudinal strength doesn’t seem to play out in better target vessel failure stats.

Background

The study, imaginatively tagged DUTCH PEERS saw Medtronic’s Resolute Integrity drug-eluting stent (DES) pitched against the Promus Element DES from Boston Scientific Corp. in a randomised trial. One year results were presented at TCT 2013.

According to a Medtronic press release, the two devices performed similarly on all measures except longitudinal strength, which favored the Medtronic device.

The results, which included a pre-specified assessment of this important device characteristic, as well as being presented at TCT 2013, were simultaneously published by The Lancet. They show a statistically significant difference in longitudinal stent deformation (length-wise distortion or shortening of the device inside the artery after deployment) between the two devices at one year of follow-up (p=0.002): nine occurrences (1.0 percent) with the platinum-chromium Promus Element stent platform (n=905) vs. zero occurrences (0.0 percent) with the cobalt-alloy Resolute Integrity stent platform (n=905).

However, contrastingly the study found no statistically significant differences at one year between the Resolute Integrity and Promus Element stents on the composite primary endpoint of target vessel failure (6.1 percent vs. 5.2 percent, p=0.42). Individual components of TVF — cardiac death, target vessel myocardial infarction, and target vessel revascularization — were also low and similar in both groups. Additionally, the incidence of definite/probable stent thrombosis for both groups was similarly low (0.6 percent vs. 0.9 percent respectively, p=0.40), and there was no definite stent thrombosis in either group after three months following stent implantation.

This study has value as an “all-comers” stent studies, which include very few exclusion criteria to ensure applicability of their results to real-world clinical practice.

Investigator comments

“A potential trade-off with the novel, flexible designs of third-generation stent platforms was thought to be reduced longitudinal device stability,” said lead author and presenter Clemens von Birgelen, M.D., Ph.D., co-director of the Department of Cardiology at Thoraxcentrum Twente and professor of cardiology at the University of Twente in the Netherlands. “However, our study did not find such a trade-off with the Resolute Integrity DES.”

Source: Medtronic, Inc.