|Slideshow | RESOLUTE International: Evaluation of The Resolute Stent in a ‘Real-World’ Patient Population|
|J. Belardi, F-J. Neumann, P. Widimský, A. Serra Peñaranda, on Behalf of the RESOLUTE International Investigators
WASHINGTON, D.C.--The Endeavor Resolute stent (Medtronic) was associated with a low clinical event rate, across all lesion and patient subgroups at one year, based on the open-label, real-world RESOLUTE International registry, presented at the 2010 Transcatheter Cardiovascular Therapeutics (TCT) annual conference. Alan C. Yeung, MD, told Cardiovascular Business News that the registry shows that the newer generation of stents can achieve “very good outcomes in contemporary clinical practice.”
The RESOLUTE International included 2,349 patients with symptomatic coronary artery disease eligible for drug-eluting stent (DES) implantation with no limitations on the number of lesions, number of vessels or lesion length, at approximately 100 sites, located outside of North America. At one year of clinical follow-up, the researchers followed out 2,287 patients (97.4 percent).
“The researchers were able to enroll the patient population very quickly,” says Yeung, indicating that the stent is commonly deployed outside of North America. Yeung, who is division chief and director of interventional cardiology at Stanford University Medical Center in Stanford, Calif., also is principal investigator of the U.S. Resolute trial, the results of which may be available in March 2011.
There was no angiographic follow-up, but 25 percent of patients were randomly assigned to 100 percent of data monitoring at enrollment. Therefore, according to Yeung, the data are a bit stronger than a typical registry.
Of this patient population, 30.5 percent had diabetes, which is “higher than most clinical trials, but reflective of a real-world population, says Yeung. Also, 77.8 percent were males with an average age of 63.5 years, 27 percent of whom had a prior MI and 29.6 percent of whom had a prior PCI procedure. Dual-antiplatelet therapy usage was confirmed in 91.3 percent of patients at one year.
Overall, 67.5 percent of the patients were deemed complex patients due to the lesion characteristics. Of the 2,349 patients enrolled in the registry, 3,147 lesions were treated. Yeung suggested the outcomes indicated the Resolute performs well in multivessel disease (20.6 percent of patients), which “is becoming more common in real-life clinical practice, and these patients often are not included in trials.”
He noted that the patients who received the Resolute stent had “good outcomes” with the 30-day primary endpoints of death and cardiac death both at 0.4 percent and target vessel MI at 2.6 percent. At one year, death was 2.3 percent and target vessel MI was 3.1 percent. For the combined endpoint of cardiac death plus target vessel MI, the outcomes were 2.8 percent at 30 days and 4.2 percent at one year.
Stent thrombosis rates also were “very low,” at 0.7 percent at 30 days and 0.9 percent at one year, Yeung said.
The researchers concluded that their results “support the generalizability of the RESOLUTE All Comers study results,” adding that the data are “robust as reflected by consistencies between monitored versus unmonitored patients.”
Moving forward with the zotarolimus-eluting Resolute platform, Yeung says the U.S. trial includes stent diameters of 2.25 mm to 3.5 mm, with a substudy of stent diameter of 4.0 mm, and another substudy of stents 38 mm in length—sizes and lengths which have to be examined with this platform. “At that point, the whole body of data will be helpful in looking ahead to see if the safety profile is improved with the unique polymer,” he concludes.