Latebreaking data from SPIRIT IV, a largescale multicenter study of nearly 4,000 patients in the U.S., shows that an everolimuseluting stent demonstrated enhanced safety and efficacy in the treatment of de novo native coronary artery lesions when compared to a paclitaxeleluting stent, and showed that “low late loss” may be achieved with drugeluting stents without sacrificing safety.

Unlike similar prior studies (SPIRIT FIRST, SPIRIT II and SPIRIT III), the SPIRITIV trial was powered for superiority for clinical endpoints without angiographic follow up.

The trial also examined the differences in performance of the two stents in patients with diabetes.

“The results with the everolimus stent demonstrate enhanced safety and efficacy compared to the paclitaxel stent in this largescale study without routine angiographic followup and sets a new standard for eventfree survival after [implantation of a drugeluting stent],” said principal investigator Gregg W. Stone, MD, immediate past chairman of CRF, professor of medicine at Columbia University Hospital and Director of Cardiovascular Research and Education at the Center for Interventional Vascular Therapy at NewYorkPresbyterian Hospital/Columbia University Medical Center.

Results of the study were presented at the 21st annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium, sponsored by the Cardiovascular Research Foundation (CRF).

The primary endpoint of the trial was target lesion failure (TLF) at one year, a composite measure of cardiac death, target vessel heart attack or ischemiadriven target lesion revascularization (TLR). Major secondary endpoints of the trial were TLR at one year, and a composite of cardiac death or target vessel heart attack at one year.

For the everolimus stent, TLF at one year was 4.2 percent, and for the paclitaxeleluting stent, TLF was 6.8 percent, a significant 38 percent reduction.

At oneyear, ischemiadriven TLR was 2.5 percent for the everolimus stent and 4.6 percent for the paclitaxel stent, a significant 45 percent reduction.

The composite rates of cardiac death or target vessel myocardial infarction through one year were not statistically different with the 2 stents (2.2 percent for the everolimus stent and 3.2 percent for the paclitaxel stent). The rates of stent thrombosis, however, were significantly reduced with the everolimus stent compared to the paclitaxeleluting stent (0.3 percent vs. 1.1 percent respectively).

The results were consistent regardless of lesion length, vessel size and the number of lesions treated. However, in the diabeticpatient subgroup, the study found a comparable rate of TLF with both stents, whereas in patients without diabetes, the everolimus stent reduced TLF by 53 percent compared to the paclitaxeleluting stent.

“Outcomes in patients with diabetes may still be improved, and should represent an area of focus for future development of novel drugs and enhanced stent design,” Dr. Stone said.

Source
Judy Romero