Medtronic’s new generation drug-eluting stents
By Gabriela Eriksen
At the German Congress of Cardiology, this March, Professor Sigmund Silber, of the Cardiology and Clinical Practice, in Munich, presented results from the Medtronic RESOLUTE clinical trial.
Professor Sigmund Silber
The data indicated a low number of adverse cardiac events and no protocol-defined stent thrombosis. The next-generation Medtronic Endeavor Resolute drug-eluting stent system with new BioLinx polymer is designed to address the special needs of patients who have complex medical conditions and is engineered to match the duration of drug delivery with the longer healing duration often required by these patients.
In clinical results at nine months, the Endeavor RESOLUTE trial showed no target lesion revascularisation (TLR), no target vessel revascularisation (TVR) and a major adverse cardiac event (MACE) rate of just 7.0%. Of the trial’s 130 patients, 129 (99.2%) received clinical follow-up, and 95 had angiographic follow-up. In-stent late lumen loss, the study’s primary endpoint, was 0.22 mm, while in-segment late loss was 0.12 mm. In-stent angiographic binary restenosis (ABR) was 1.0% percent and in-segment ABR was 2.1%.
‘What is most impressive about these results is that they occurred in a patient population with complex and challenging characteristics,’ said Professor Ian Meredith, of Monash Medical Centre and Monash University Melbourne, Australia, who was principal investigator of the trial. He noted that the average lesion length in the RESOLUTE trial was 15.5 mm and nearly 82% of enrolled patients were classified as having challenging B2/C lesions. ‘The RESOLUTE trial enrolled a high percentage of patients with lesions that are difficult to treat, including small vessels and long lesions, and these results are extremely promising. Zotarolimus continues to be a very potent drug in preventing restenosis while the new BioLinx polymer appears to be delivering the drug as intended.’
This article was published on 04/30/2008
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