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For patients with low-to-intermediate-risk multivessel disease, treatment with a second-generation everolimus-eluting stent (EES) not only provides superior angiographic results compared with a first-generation paclitaxel-eluting stent (PES), it also yields a low adverse event rate at 1 year, according to a 2-part study published online September 18, 2013, ahead of print in JACC: Cardiovascular Interventions.

For the EXECUTIVE trial, a team led by Flavio Ribichini, MD, of the University of Verona (Verona, Italy), enrolled 600 patients with 2- or 3-vessel CAD at 30 Italian centers between October 2008 and March 2010. Of this cohort, 200 patients were randomized to PCI with the Xience V EES (Abbott Vascular; Santa Clara, CA; n = 103) or the Taxus Liberté PES (Boston Scientific, Boston, MA; n = 97). The other 400 patients were assigned to a registry and received only EES.

In the randomized arm, the EES group received 313 stents in 263 lesions, while the PES group received 314 stents in 235 lesions. Baseline angiographic complexity as assessed by the Syntax score was low (12.7 ± 5.24), and clinical risk was intermediate (mean logistic EuroScore 4.79 ± 5.6) for both randomized arms and the registry cohort.

Xience Reduces Late Loss

In the randomized study, prespecified 9-month angiographic follow-up was obtained in 87% of the EES group and 79% of the PES group. In-stent late loss (primary endpoint) was lower with EES compared with PES in analyses of both single lesions (-0.027 ± 0.485 mm vs. 0.225 ± 0.507 mm; P for superiority = 0.0014) and all lesions (0.052 ± 0.513 mm vs. 0.238 ± 0.504; P for superiority = 0.0026).

Moreover, subgroup analyses showed consistent trends in favor of EES. The difference in in-stent late loss reached significance in patients with shorter lesions (≤ 15 mm; P = 0.001), 2-vessel disease (P = 0.019), or a higher EuroScore (≥ 6; P = 0.003) as well as those treated with a single stent per lesion (P = 0.001) and nondiabetic patients (P = 0.039).

At 30 days, the incidence of clinical events was low and similar between the 2 randomized arms (1% for EES and 2.2% for PES) and slightly higher in a group combining registry and randomized EES patients (4.7%; n = 503).

At 1 year, outcomes including MACE (all-cause death, MI, and ischemia-driven TVR; the registry primary endpoint), cardiac death, target vessel Q-wave MI, and Academic Research Consortium-defined possible stent thrombosis, were similar among the randomized EES and PES groups and the pooled EES group (table 1).

Table 1. One-Year Outcomes

a P = 0.30 for randomized EES vs. PES.

Most MIs were periprocedural, with very few spontaneous cases occurring during later follow-up.

The authors note that the current clinical results for EES “closely replicate” those seen in lower-risk populations in the SPIRIT III and IV and Resolute All-Comers trials.

“In the context of the data that we have clinically comparing these stents, I’m not sure this [study] adds to our knowledge base,” Jeffrey W. Moses, MD, of Columbia University Medical Center/Weill Cornell Medical Center (New York, NY), told TCTMD in a telephone interview. Whether EES are superior is “a pretty settled question,” he said. Moreover, “although the patients here are multivessel, look at their Syntax scores—only about 5% are over 22. They’re a routine PCI cohort, not the type of patients for whom stenting might be controversial.”

SYNTAX Dated

Dr. Moses suggested that the real question is: With most multivessel PCI now being performed with contemporary DES like Xience, are the outcomes obtained using first-generation PES in the SYNTAX trial relevant to the PCI vs. CABG issue anymore?

“I think the general consensus is that they are not,” he asserted, adding that “a lot of inferential data suggest that the outcomes for Xience or Resolute line up [with surgery]. But we don’t have any studies that really address that.”

Given the dated nature of SYNTAX, “my problem is in imputing its outcomes into guidelines,” Dr. Moses said. ”The surgical outcomes are the surgical outcomes, but DES outcomes have improved markedly over the past 5 or 6 years [since the trial].”

There are ample data from the COMPARE and SPIRIT trials showing differences in MACE between EES and PES, Dr. Moses observed. In the EXECUTIVE trial, the MACE rates, though not significantly different, are about one-third lower with Xience at 1 year. “Who knows what that advantage might be at 5 years,” he added. “If you impute that [PCI improvement] into the SYNTAX outcomes, then you’d have noninferiority to surgery,” he maintained. “But of course that’s speculative.”

Future results from the large ongoing EXCEL trial pitting PCI with Xience Prime (Abbott Vascular) against CABG in left main patients might provide some helpful data regarding the multivessel issue, Dr. Moses allowed. But he noted that that trial carries a Syntax score cutoff of 32, and since left main disease contributes heavily to the score, the overall technical complexity of the multivessel subgroup will be low.

“Frankly, I would have preferred that the money spent on EXCEL would instead have gone toward a multivessel trial,” Dr. Moses concluded. “That would have had implications for a broader group of patients.”

Study Details 

Baseline characteristics were well matched between the EES and PES groups in the randomized arm, and were similar to those of registry patients except for a higher prevalence of elevated troponin in the registry cohort. 

The most complete degree of revascularization was pursued; all patients had at least 2 suitable major vessels treated, with a planned maximum of 4 DES.

At 1 year, 74% of the randomized EES patients, 67% of the randomized PES patients, and 70% of registry (EES) patients remained on dual antiplatelet therapy.

 

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Source:
Ribichini F, Romano M, Rosiello R, et al. A clinical and angiographic study of the Xience V everolimus-eluting coronary stent system in the treatment of patients with multivessel coronary artery disease: The EXECUTIVE (EXecutive RCT: Evaluating Xience V in a Multi Vessel Disease) trial. J Am Coll Cardiol Intv. 2013;Epub ahead of print.

 

 

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