SPIRIT IV: Everolimus-eluting stent outperforms paclitaxel-eluting stent in patients without diabetes
Kereiakes D. J Am Coll Cardiol. 2010;56:2084-2089.
The latest results from the SPIRIT-IV trial have shown everolimus-eluting stents to produce superior clinical outcomes in patients without diabetes, despite both stents performing similarly in patients with diabetes.
“The SPIRIT IV trial confirms and extends the observation made in the SPIRIT III trial of a significant interaction between randomized stent type everolimus-eluting stent (Xience V, Abbott Vascular) vs. paclitaxel-eluting stent (Taxus Express, Boston Scientific) and the presence of diabetes on the primary composite safety-plus-efficacy clinical endpoint,” the researchers wrote.
The randomized, prospective, single blind study included 3,687 patients with up to three de novo native coronary artery lesions who received either an everolimus-eluting stent (n=2,458) or a paclitaxel-eluting stent (n=1,229). Clinical outcomes were analyzed in randomly assigned patients with (n=1,185) and without (n=2,498) diabetes.
One-year results indicated that among patients without diabetes, everolimus-eluting stent vs. paclitaxel-eluting stent reduced the primary endpoint of target lesion failure by 54% (3.1% vs. 6.7%; P<.0001) and major adverse CV events by 52% (3.2% vs. 6.7%; P<.0001). Use of everolimus-eluting stent also resulted in lower rates of the major secondary endpoints of ischemia-driven target vessel revascularization, as well as the composite occurrence of cardiac death or target vessel MI (P=.05).
However, among patients with diabetes, there were no statistically significant differences in outcomes at 1 year between randomly assigned stent types for both target lesion failure and major adverse CV events.
“These findings suggest the need for further studies to elucidate the mechanistic pathways underlying the poor prognosis of patients with diabetes mellitus, with a focus toward development of novel drugs and stents to improve outcomes in this high-risk patient cohort,” the researchers wrote.
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P-OM3: Prescription omega-3 no more effective than placebo for paroxysmal AF treatment
American Heart Association Scientific Sessions 2010
CHICAGO — Researchers of the P-OM3 trial have reported that prescription omega-3 was no more beneficial for patients with paroxysmal atrial fibrillation than placebo for the recurrence of symptomatic AF.
“The rationale for this study was that many of our patients do use fish oil products in various doses and preparations in the hope of preventing several CV endpoints,” researcher Peter Kowey, MD, with the Jefferson Medical College, Philadelphia, and a Cardiology Today Editorial Board member, said in a press conference. “There clearly has been equipoise in the area of AF with as many studies producing positive as those producing negative results.”
In the prospective, randomized, double-blind, placebo-controlled study, 663 patients (paroxysmal AF, (n=542; persistent AF, n=121) were assigned to either P-OM3 (Lovaza, GlaxoSmithKline) 4 g daily or placebo and treated for 24 weeks. Patients had no substantial structural heart disease and normal sinus rhythm at baseline and were recruited from 96 sites in the United States between November 2006 and July 2009. The primary outcome was the time to first recurrence of symptomatic AF (including flutter) in subjects with paroxysmal AF.
At the final follow-up in January of this year, there were no significant differences between treatment groups for recurrence of symptomatic AF in the following strata: paroxysmal (HR=1.15; 95% CI, 0.90-1.46), persistent (HR=1.64; 95% CI, 0.92-2.92), and paroxysmal and persistent combined (HR=1.22; 95% CI, 0.98-1.52). The secondary endpoints, including time to first onset of symptomatic AF (excluding flutter; P=.21) and first recurrence of symptomatic or asymptomatic AF or flutter (P=.33), also supported the primary outcome.
“I don’t think there is any ambiguity about the results in this trial [when] looking at patients with paroxysmal AF that the use of high doses of omega-3 fatty acids did not appear to have a significant effect on recurrence of AF,” Kowey told Cardiology Today. “This doesn’t apply to other populations or other CV disease, but I think we’ve put this issue to rest in this particular population.”
Kowey reports having consulted on an ad hoc basis for GlaxoSmithKline.
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