SORT OUT IV: Xience Holds Edge Over Cypher for Preventing Stent Thrombosis

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In patients with stable coronary artery disease (CAD), everolimus-eluting stents (EES) are noninferior to sirolimus-eluting stents (SES) at 2-year follow-up, according to a study published online September 5, 2012, ahead of print in the Journal of the American College of Cardiology. The multicenter trial also showed less stent thrombosis with the next-generation device.

Nine-month results of the SORT OUT IV (Scandinavian Organization for Randomized Trials with Clinical Outcome IV) trial, presented in November 2011 at the Transcatheter Cardiovascular Therapeutics scientific symposium in San Francisco, CA, indicated that EES are as safe and effective as SES.

For the study, researchers led by Lisette Okkels Jensen, MD, PhD, of Odense University Hospital (Odense, Denmark), randomized 2,774 patients with 3,584 lesions to receive either Xience V/Promus EES (n = 1,390; Abbott Vascular, Boston Scientific) or Cypher Select+ SES (n = 1,384; Cordis, Bridgewater, NJ) from August 2007 to June 2009.

At 2 years, the composite primary endpoint of cardiac death, MI, Academic Research Consortium-defined definite stent thrombosis, and clinically indicated TVR was comparable between the stents, as were additional patient-related (all death, all MI, or any revascularization) and stent-related (cardiac death, target vessel MI, or symptom-driven TLR) composites. However, definite stent thrombosis occurred less with EES (table 1).

Table 1. Clinical Outcomes at 2 Years

 
Distinct Safety Advantage Still Not Clear

In a telephone interview with TCTMD, Ajay J. Kirtane, MD, SM, of Columbia University Medical Center (New York, NY) called the results “very reassuring” but said the safety of EES must be clarified. “There does seem to be a trend that emerges out to 2 years with regard to less definite stent thrombosis, but we need to see with longer term follow-up whether that advantage is maintained or further accentuated,” he commented.

David E. Kandzari, MD, of the Piedmont Heart Institute (Atlanta, GA), agreed regarding the follow-up duration, suggesting that at least 5-year data would be needed in order to determine the existence of a divergence in safety or efficacy.

However, he told TCTMD in a telephone interview that it is still unclear whether “the continued improved outcomes of more contemporary PCI are really a function of newer generation drug-eluting stents or something else.” For example, approaches to statin and antiplatelet therapy as well as stenting techniques have changed, Dr. Kandzari said.

So far, he commented, “no study has really demonstrated that [Xience] is clearly superior in every way. That’s not to say we’d go back to using the Cypher stent, but it raises the issue that the outcomes have been very good with the [earlier device], and that makes me think that there’s probably more to it.”

The Last of Cypher?

One looming question is whether a trial testing Cypher holds any relevance now that SES are off the market.

Dr. Kandzari predicted SORT OUT IV would be one of Cypher’s last appearances in a research setting. Trials tend to “use commercial market leaders as the control,” he said, suggesting that “Xience, Promus, and Resolute stents will now be our new comparators.” Demonstrating superiority against Xience is “going to be very challenging,” Dr. Kandzari added. 

But Dr. Kirtane still characterized Cypher as a “reasonable comparison.”

At the time the study was designed, [Cypher] was the most efficacious first-generation stent that we had,” he continued. “So in that respect, this benchmarks the Xience data to the best form of the predicate technology. That’s important because if we just move forward and only compare within other realms, then it’s difficult to know how much better this is than what we had previously.”

Looking forward, Dr. Kirtane also pointed to the soon to be released results of the FREEDOM trial comparing CABG and PCI using first-generation stents in diabetic patients with multivessel disease. “Data from trials like this that compare everolimus and sirolimus, potentially showing a late advantage of these newer stent types, are going to be very important in order to put those other data in perspective,” he concluded.

 

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Source:
Jensen LO, Thayssen P, Christiansen EH, et al. 2-year patient related versus stent-related outcomes: The SORT OUT IV (Scandinavian Organization for Randomized Trials with Clinical Outcome IV) trial. J Am Coll Cardiol. 2012;Epub ahead of print.

 

 

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• EES Compared Favorably with SES In Two Pivotal Trials