A Medical Device Daily

At the 19th edition of the Transcatheter Cardiovascular Therapeutics (TCT) conference, which got underway this weekend in Washington, the usual big trial and product announcements manifested themselves. The following is a sampling of some of the most interesting and newsworthy items.

Johnson & Johnson (J&J; New Brunswick, New Jersey)and Boston Scientific (Natick, Massachusetts) reported new safety data for DES that may help revive sales depressed by prior reports linking the devices to a higher risk of heart attacks.

About 1 in 5 patients who got J&J’s drug-coated Cypher stent — produced by its Cordis (Miami Lakes, Florida) unit — to clear a completely blocked artery had their clot recur within six months, less than half the rate for bare-metal devices in a separate trial, J&J said. Boston Scientific found its drug-coated Taxus stent was as safe after two years for the sickest heart patients as for those who were healthier.

Demand for drug-coated stents by U.S. doctors fell after researchers in September 2006 reported a link between the stents and potentially fatal clots. As a result, Boston Scientific said U.S. sales of Taxus fell 38% to $240 million in 3Q07. In that same time period J&J reported a 44% drop, to $185 million, for U.S. sales of Cypher.

In the J&J study, researchers reported that the Approaches to Chronic Occlusions with Sirolimus-eluting Stents (ACROSS-CYPHER) study met its primary endpoint, which was the assessment of angiographic restenosis at six-month follow-up.

Among 200 patients treated with the Cypher stent following successful reopening of a completely blocked coronary artery (chronic total occlusion), the likelihood of renarrowing of the treated segment (angiographic restenosis) was reduced by 65.6% compared with a pre-specified cohort of patients treated with a bare metal stent in the earlier Total Occlusion Study of Canada (TOSCA-1) trial. In the entire segment treated with balloon angioplasty and stents, the restenosis rate for the Cypher was 19% while the restenosis rate for the bare metal stent was 55.2%. Following risk adjustment, these differences translated into an 84% reduction in the primary endpoint. Further, restenosis occurring only within the Cyphert-treated area was 7.5%.

Among patients treated with the Cypher, at six months, there were no deaths, and myocardial infarction and target lesion revascularization occurred in 1% and 6% percent of patients, respectively. Overall major adverse cardiac events were similarly low, at 6.5%.

The reported stent thrombosis rate for the CYPHER^® Stent was 0% within 24 hours after stent implantation, 0% between 1 and 30 days after stent implantation; and 0.5 percent beyond 30 days after stent implantation.

`These data add to the unsurpassed volume of clinical evidence on the use of the Cypher stent in a variety of patients and lesion subsets, including these very complex chronically occluded vessels,’’ said lead study author David Kandzari, chief medical officer for Cordis, in a statement.

Kandzari is one of the principal investigators of the Cordis-sponsored study. Enrollment and six-month follow-up were completed before Kandzari joined Cordis. At the time, Kandzari was part of the faculty at Duke University Medical Center (Durham, North Carolina).

Boston Scientific reported two-year results from a registry of about 7,000 patients who got Taxus that confirmed low rates of adverse events found after one year.

The TAXUS ARRIVE 1 and 2 registries were designed to assess the performance of the Taxus Express2 Paclitaxel-eluting coronary stent system in “real-world” practice.

Nearly two-thirds of patients had complex medical problems such as diabetes, or unusually long and thick deposits clogging the blood vessels. Other patients had smaller, thinner blockages.

Overall death rates, including all sicker and healthier patients, fell to 2.2% in the second year from 3.5% in the first year of the study. Repeat procedures to unclog arteries declined to 2.5% in the second year from 5.1% in the first year.

The 2,054 patients with diabetes in the trial had higher death rates at two years, 8.3%, than the 4.6% experienced by non-diabetics, the study found. Reclogged arteries occurred in 3.2% of diabetics, compared with 2.3% for non-diabetics.

“ARRIVE represents the largest reported series of drug-eluting stent patients in selected high-risk subgroups,” said John Lasala, MD, PhD, professor of medicine, Washington University School of Medicine. “Considering the complexity of patients studied, the ARRIVE data indicate acceptable Taxus-related incidence rates observed at one year and favorable safety and performance at two years. The data show consistent outcomes in high-risk patient groups representing a broad spectrum of procedural complexity seen in real-world practice.”

In other TCT news:

• Elixir Medical (Sunnyvale, California), a developer of drug-eluting stent (DES) platforms for the treatment of cardiovascular disease, reported four-month results for Excella, a first-in-man clinical trial of the company’s Novolimus-eluting coronary stent.

Results were presented by Alexandre Abizaid, MD, PhD, chief of Coronary Interventions at the Institute Dante Pazzanese de Cardiologia (São Paulo, Brazil).

The company’s Novolimus system was effective in reducing lumen loss and neointimal hyperplasia at four-month angiographic follow-up in patients treated with the device. The in-stent late lumen loss was 0.15 ± 0.29 mm and the neointimal volume obstruction as measured by intravascular ultrasound (IVUS) was 2.7 ± 2.7%. There were no MACE events or incidents of stent thombosis reported through the four-month follow-up period. Acute device success was achieved in all patients.

“Elixir’s Novolimus-eluting stent looks promising as a next-generation drug-eluting stent system for the treatment of cardiovascular disease,” said Abizaid. “I look forward to long-term data in more complex patient groups to confirm these excellent results.”

The trial enrolled 15 patients with ischemic heart disease in Brazil having single de novo native coronary artery lesions. The primary endpoint of the study was in-stent late lumen loss at four months. Secondary endpoints include major adverse cardiac events (MACE). In addition, serial IVUS was performed on all patients at baseline and four-month follow-up.

Novolimus is a pharmacologic compound with anti-proliferative and immunosuppressive properties developed for drug-eluting stent therapy. The stent is coated with a durable polymer coating technology to control the release of Novolimus. The company’s stent system is designed to provide safety and efficacy with a substantially lower polymer load and lower drug dose than currently commercially available drug eluting stent systems.

• PLC Systems (Franklin, Massachusetts) reported that it will introduce the RenalGuard system at the TCT meeting.

RenalGuard is an investigational system and therapy that targets patients with compromised renal function who may be at risk for contrast-induced nephropathy, or CIN, when undergoing cardiovascular imaging procedures.

RenalGuard therapy is based on initial pre-clinical study data that suggests that initiating and maintaining high urine output during imaging procedures allows the body to rapidly eliminate toxins in contrast media, reducing their harmful effects.

The system is a fully-automated, real-time matched fluid replacement device intended for the at-risk segment of the millions of interventional cardiology and radiology patients undergoing these procedures.

The company noted that CIN is the third most common cause of in-hospital acute renal failure. It is associated with significant in-hospital mortality rates, and increases in long-term mortality rates, major in-hospital adverse cardiac events, and the risk of having to undergo renal dialysis therapy.