COMPARE: EES Maintains Advantage Over PES at 5 Years

An everolimus-eluting stent (EES) continues to show clinical benefit over a second-generation paclitaxel-eluting stent (PES) in an all-comers population through 5 years, according to final results from the COMPARE Trial published online July 22, 2015, ahead of print in JACC: Cardiovascular Interventions. 

Researchers led by Pieter C. Smits, MD, PhD, of Maasstad Ziekenhuis (Rotterdam, the Netherlands), randomized 1,800 patients undergoing elective or emergent PCI at their center to the Xience V EES (n = 897; Abbott Vascular) or Taxus Liberté PES (n = 903; Boston Scientific) between February 2007 and September 2008.

The previously reported 1-year results showed that EES lowered the risk of all-cause death, MI, or TVR (primary composite endpoint), with the difference driven by reductions in MI and TVR. Rates of TLR and definite/probable stent thrombosis also were lower with EES, but all-cause mortality did not differ between groups.

Similar findings were observed at 5 years (table 1).

Between-group differences were most apparent during the first 2 years of follow-up. Although the gap between the hazard curves of the primary endpoint for EES and PES appears to widen through the 5 years of follow-up, the curves for MI and TVR individually seem to progress in parallel after 3 and 2 years, respectively.

In landmark analysis, the rate of the primary endpoint remained lower in the EES arm from 1 to 5 years (12.9% vs 17.4%; P = .011), but rates of the individual components and of stent thrombosis—though numerically lower in the EES group—did not significantly differ between groups.

‘Reassuring’ Long-term Data

Citing the superior outcomes of EES compared with PES at 1 and 3 years, Dr. Smits told TCTMD in a telephone interview that “it is reassuring that we are still seeing superiority at 5 years.”

The advantage regarding the primary composite endpoint was seen in all analyzed subgroups, but there were trends toward greater absolute benefit with EES in women and patients with multivessel treatment (P for interaction = 0.05 and 0.08, respectively).

“The former finding potentially reflects the superiority of EES over PES in smaller vessels and more complex lesions, which are more prevalent in the female PCI population compared to the male PCI population,” the researchers write.

Even though the trial compared an EES to a stent that is now rarely used in clinical practice, the 5-year trial data are important, according to Ajay Kirtane, MD, SM, of NewYork-Presbyterian Hospital/Columbia University Medical Center (New York, NY).

“PES have been the benchmark in studies examining PCI as a whole, and many people have argued that PCI outcomes in those trials would have been better with the newer-generation stents,” he told TCTMD in a telephone interview. “This is supported by trials like COMPARE, which show demonstrable superiority with the newer-generation stents.”

David E. Kandzari, MD, of Piedmont Heart Institute (Atlanta, GA) agreed that COMPARE is a trial with a largely historical significance, but he added that the low event rates in the trial and in other studies of second-generation DES have implications for investigations of newer stent types.

“It is not clear that we can demonstrate improvement beyond the outcomes we are observing with everolimus-eluting stents, because the event rates are already so low,” he told TCTMD in a telephone interview. “The attractiveness of bioresorbable stent components is very intuitive, but it will be challenging to actually show a difference in outcomes with these new technologies.”   

Source: 
Smits PC, Vlachojannis GJ, McFadden EP, et al. Final 5-year follow-up of a randomized controlled trial of everolimus- and paclitaxel-eluting stents for coronary revascularization in daily practice: the COMPARE Trial. J Am Coll Cardiol Intv. 2015:Epub ahead of print. 

Disclosures:

• The COMPARE trial was funded by unrestricted grants from Abbott Vascular and Boston Scientific. 
• Dr. Smits reports receiving institutional research grants from Abbott Vascular, Boston Scientific, St. Jude Medical, and Terumo and lecture and travel fees from Abbott Vascular. 
• Dr. Kirtane reports receiving institutional research grants from Abbott Vascular, Abiomed, Boston Scientific, Eli Lilly, Medtronic, St. Jude Medical, and Vascular Dynamics. 
• Dr. Kandzari reports receiving research/grant support from Abbott Vascular, Biotronik, Boston Scientific, and Medtronic and serving as a consultant for Boston Scientific and Medtronic. 

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