SPIRIT II-IV: Reduced adverse events, improved efficacy for everolimus- vs. paclitaxel-eluting stents

Caixeta A. J Am Coll Cardiol Intv. 2010;3:1220-1228.
Kereiakes D. J Am Coll Cardiol Intv. 2010;3:1229-1239.

Two studies appearing in the Journal of the American College of Cardiology: Cardiovascular Interventions reported superior outcomes for everolimus-eluting stents when compared with paclitaxel-eluting stents, including reductions in target vessel revascularization and major adverse events, as well as improvements in clinical safety and efficacy.

In the studies, data were analyzed from two different SPIRIT trials, which were designed to clinically evaluate an everolimus-eluting stent (XIENCE V, Abbott Vascular) in the treatment of patients with de novo native coronary artery lesions.

SPIRIT II and III

The first analysis compared the 3-year rates of target vessel failure and major adverse cardiac events of everolimus-eluting stents vs. paclitaxel-eluting stents (Taxus Express, Boston Scientific) from the SPIRIT II and III trials. The overall study population included 1,302 patients from 93 international centers randomly assigned to either everolimus-eluting stents (n=892) or paclitaxel-eluting stents (n=410).

Adriano Caixeta, MD, PhD, and colleagues reported a lower 3-year rate with everolimus-eluting stents in both MI (3.8% vs. 6.7%; RR=0.56; 95% CI, 0.34-0.94) and target lesion revascularization (6.8% vs. 12.7%; RR=0.53; 95% CI, 0.37-0.77). Further, they reported sustained reductions with everolimus-eluting stents for both target vessel failure (13.7% vs. 19.5%; RR=0.70; 95% CI, 0.54-0.92) and major adverse cardiac events (9.1% vs. 16.3%; RR=0.56; 95% CI, 0.41-0.76).

According to the investigators, everolimus-eluting stents vs. paclitaxel-eluting stents resulted in significant and sustained reductions in target vessel failure and major adverse cardiac events at 3 years, which “is consistent with superior safety and efficacy of the [everolimus-eluting stent] platform.”

SPIRIT III and IV

Similarly, when researchers analyzed the outcomes from of the SPIRIT III and IV trials, the everolimus-eluting stent was shown to be superior.

The study included a combined population from both trials of 4,689 patients with de novo native coronary lesions who were randomly assigned 2:1 to receive either an everolimus-eluting stent (n=3,127) or a paclitaxel-eluting stent (n=1,562). One-year clinical outcomes were determined in patients with single- (n=3,823) vs. multiple-treated vessels (n=765), and in patients with single- (n=3,536) vs. multiple-treated (n=1,052) lesions.

Study data revealed that everolimus-eluting stents vs. paclitaxel-eluting stents led to reduced rates of target vessel MI (2.2% vs. 6.1%; P=.007) and ischemia-driven target lesion revascularization (4.2% vs. 8%; P=.04) among patients with multivessel disease. Likewise, for patients undergoing multi-lesion stenting, everolimus-eluting stent-treated patients also had reduced rates of target vessel MI (2.1% vs. 5.4%; P=.008) and ischemia-driven target lesion revascularization (3.7% vs. 7.4%, P=.01).

“[Everolimus-eluting stents] provided substantial clinical safety and efficacy benefits compared with [paclitaxel-eluting stents],” Dean J. Kereiakes, MD, and fellow researchers wrote. “Furthermore, the absolute benefit of [everolimus-eluting stents] vs. [paclitaxel-eluting stents] was directly proportional to the complexity of coronary artery disease as reflected by either the number of target vessels or lesions treated. These observations may have significant implications with respect to the optimal choice of revascularization strategy (percutaneous coronary intervention vs. CABG) in patients with multivessel coronary disease.” – by Brian Ellis

Taken together, these studies provide strong evidence that the second-generation everolimus stent is superior to the first-generation paclitaxel stent. With lower rates of both MI and revascularization, that makes a compelling story for the everolimus-eluting stent. The observation that the more complex patients derive even greater benefit from the everolimus stent is important and quite reassuring.

– Deepak L. Bhatt, MD
Cardiology Today Editorial Board

Disclosure: Dr. Bhatt reports receiving research grants from AstraZeneca, Bristol-Myers Squibb, Eisai, Sanofi-Aventis and The Medicines Company.

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