A Medical Device Daily

A multicenter study unveiled at this year's annual meeting of the American College of Cardiology (Washington) in Chicago has found the cost savings of two leading non-invasive methods for detecting coronary artery disease (CAD) vary based on the patient's heart history. James Min, MD, cardiologist at New York Presbyterian/Weill Cornell (New York) presented the findings.

The study found that patients who underwent coronary computed tomographic angiography (CCTA), without a prior diagnosis of CAD, incurred costs $603 lower (per-patient average) than those who underwent myocardial perfusion imaging (MPI or SPECT). Both groups had equal clinical outcomes.

Patients with known CAD who underwent MPI incurred healthcare costs $2,451 lower (per patient) than CCTA patients with equal clinical outcomes, suggesting that CCTA may be a cost-efficient alternative in patients without a prior CAD diagnosis.

"This provides an initial foundation to suggest that CCTA may be used as a cost-efficient alternative to nuclear stress testing for evaluation of patients with suspected coronary artery disease," Min said.

In other news from the conference:

• Nine-month results from Elixir Medical's (Sunnyvale, California) Excella I Trial were presented by Alexandre Abizaid, MD, PhD, chief of coronary interventions at the Institute of Dante Pazzanese de Cardiologia (S o Paulo, Brazil). The Excella I Trial is a 15-patient first-in-man study of Elixir's Excella Novolimus-Eluting Coronary Stent System.

The four-month results from the study were presented last October at the 19th Annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium, and the eight-month angiographic follow-up demonstrated continued reduction in late lumen loss and neointimal hyperplasia formation.

In-stent late lumen loss was 0.31 ± 0.25 mm, neointimal volume obstruction was 6.0 ± 0.36%, and binary restenosis was zero percent. There were no MACE events or incidents of stent thrombosis through the nine-month clinical follow-up period.

The results "suggest that Excella may represent the next generation in drug-eluting stents by achieving the optimal clinical results using a lower drug dose and polymer load as compared to other currently available DES systems," said Abizaid.

"We believe the Excella Novolimus-Eluting Coronary Stent System will set the industry standard in achieving excellent clinical outcomes for patients," said Motasim Sirhan, Elixir CEO.

Based on the results, Elixir plans to initiate Excella II, a randomized trial that will recruit patients from Europe, New Zealand, and Brazil, comparing the Excella stent to a currently approved drug-eluting stent (DES).

• Boston Scientific (Natick, Massachusetts) reported favorable outcomes of one-year data from the company's Taxus IV and V randomized clinical trials in patients who received the Taxus Express Paclitaxel-Eluting DES compared to patients who received bare-metal stents (BMS).

These results add to the growing body of evidence that paclitaxel-eluting stents are clinically beneficial over BMS even in the treatment of large vessels (greater than 3.5 mm), which typically have reduced restenosis risk compared to smaller diameter vessels.

David Cox, MD, presented the Taxus IV and V results at the SCAI Annual Scientific Sessions in Partnership with the ACC/i2 Summit.

In an analysis of Taxus IV and V one-year clinical events, Cox reported that patients treated with the Taxus Stent had significant reductions in one-year revascularization rates in both large and small diameter vessels compared to BMS. Although the absolute magnitude of the efficacy benefit was reduced in large diameter vessels, the relative reduction compared to BMS was maintained.

"The risk for restenosis with BMS is generally decreased in large vessels, prompting some interventional cardiologists to choose BMS over DES in vessels larger than 3.5 mm. However, since larger vessels also surround significant amounts of heart muscle tissue, even small differences in clinical events between BMS and DES may be clinically relevant," said Cox.

• Long-term, follow-up data presented at the meeting suggest that patients who received the Cypher Sirolimus-eluting DES for blockage of a BMS were significantly less likely to need another procedure (target lesion revascularization or TLR) at three years, compared to patients who received brachytherapy.

In addition, there were no significant differences in safety endpoints, such as the rates of death, myocardial infarction, or stent thrombosis between the two treatment arms of this study.

The study, A Randomized Trial Comparing Sirolimus-Eluting Stent with Vascular Brachytherapy for the Treatment of In-Stent Restenosis Within Bare Metal Stents SISR), is a multi-center, randomized study of 384 patients from 26 academic and community health centers in the U.S. The original trial was designed for follow-up at nine months.

This longer-term, follow-up analysis focused on pre-specified safety endpoints, namely death, MI and stent thrombosis, as well as target lesion revascularization (TLR), an efficacy endpoint, to determine whether any new safety issues emerged and whether the major benefit of the Cypher Stent, namely reduction in TLR, was maintained.

Cordis (Miami Lakes, Florida), maker of the Cypher, sponsored the trial.