Several Trials Highlight DES Comparisons

MIAMI BEACH, FLA.—An overview of several large randomized trials shows results of comparisons significant differences in the outcomes between new-, next- and first-generation drug-eluting stents (DES).

In the first presentation, Pieter Smits, MD, PhD, of Maastad Hospital in Rotterdam, the Netherlands, discussed the latest results from the all-comer COMPARE I and II trials. In the single-center COMPARE I trial, the everolimus-eluting (EES); Xience V stent (Abbott Vascular; n = 897) was compared with the paclitaxel-eluting (PES); Taxus Liberté stent (Boston Scientific; n = 903). At 3 years, MACE (a composite of death, nonfatal MI and TVR) was higher with the PES vs. EES (18.4% vs. 12.3%) , as was incidence of definite stent thrombosis (4.9% vs. 1.4%). 

COMPARE II was a multicenter trial of 2,700 patients with a noninferiority design comparing EES (Xience/Promus) with a biolimus-eluting stent (BES, Nobori, Terumo) featuring a biodegradable polymer.

The difference in event rate was not statistically significant with the biodegradable polymer, and the noninferiority margin of 4% was met. There was no significant difference in the primary endpoint of cardiac death and nonfatal MI between the biolimus stent and the EES (5.2% vs. 4.8%; P=.69); rates of ARC-defined definite and definite/probable stent thrombosis were also similar. A pooled analysis of both trials showed no significant difference in TLR between stent groups, and stent thrombosis was fairly low.

Researchers concluded that superiority of EES remains over PES and significantly increases over time. The biodegradable polymer BES was also noninferior to the EES at 1-year follow-up. However, Smits said longer follow-up data are needed to see a potential long-term beneficial effect with BES.

RESOLUTE

Sigmund Silber, MD, of the Heart Center at the Isar in Munich, presented 3-year follow-up data from the RESOLUTE All-Comers study — an open-label, multicenter, noninferiority trial of patients with symptomatic CAD who were eligible for DES implantation. Researchers assigned patients to a zotarolimus-eluting stent (n=1,150; Resolute, Medtronic) or an EES (n=1,150; Xience V). The data suggest that EES and ZES are clinically equivalent, even after 3 years.

In a separate pooled analysis of the global REOLUTE clinical program involving more than 5,000 patients, researchers found that among 907 patients who interrupted or discontinued DAPT after 1 month, none experienced ARC-defined definite or probable stent thrombosis at 1-year follow-up. Silber said a randomized trial is required confirm the hypothesis.

LEADERS

On behalf of the LEADERS investigators, Patrick W. Serruys, MD, PhD, of Thoraxcenter in Rotterdam, the Netherlands, presented the final 5-year results of the all-comers trial, which compared the biolimus-A9-eluting stent (BES n = 1,700; BioMatrix Flex, Biosensors) with a sirolimus-eluting stent (SES n = 1,700; Cypher, Cordis/Johnson & Johnson).

At 5 years, researchers found nonsignificant differences between groups for the primary endpoint of cardiac death,MI, and TVR. At 2 years, there was impressive 74% risk reduction in very late definite stent thrombosis with BES, according to Serruys. In conclusion, Serruys said the biodegradable -polymer stent maintained noninferiority and improved long-term clinical outcomes when compared with SES through 5 years (P=.071).

“The LEADERS trial provides the first evidence of improved clinical outcomes vs. the ’gold standard’ first-generation SES,” he said. “These findings provide the basis for the proof of concept of biodegradable polymer DES.”