Abbott (NYSE:ABT) kept up the pressure on Boston Scientific Corp. (NYSE:BSX) at a high-profile cardiology conference, releasing data from a pair of studies it says show that its Xience V drug-eluting stent is better than Boston Scientific’s competing Taxus.
Two-year data from the head-to-head trials of the paclitaxel-eluting Taxus against the everolimus-eluting Xience stent showed that more patients treated with BSX’s stent developed late-stent thrombosis. The data were presented in Washington, D.C., at the annual Transcatheter Cardiovascular Therapeutics conference.
In one trial, the Spirit IV study, nearly three-quarters of the patients in both arms were still on dual antiplatelet therapy after two years. But in the other trial, the Compare study, only 15 percent of the Taxus arm and 11 percent of the Xience arm were receiving that therapy after the two-year mark. The Compare results showed no statistically significant difference between the two arms after a year, when 70 percent of all subjects were still on the DAP therapy. But after two years, the data show, there was a 77 percent reduction in late stent thrombosis in the Xience arm.
"Xience is superior, and clinicians should be aware of the long-term risk with the Taxus stent," Dr. Dean Kereiakes of Ohio Heart Health Center in Cincinnati told MedPage Today. Physicians should be aware that patients implanted with the Taxus stent should stay on the DAP therapy for more than a year, Kereiakes added.
"I think the polymer and the thicker struts of the first generation [Taxus] stents set up an inflammatory reaction and that may be what is happening," he said.
Dr. Antonio Colombo of New York Presbyterian Hospital called the low thrombosis rates in the Spirit IV trial "almost unrealistically low," according to MedPage Today.
Abbott wasn’t the only company looking to make waves at the conference. Medical device industry players large and small are busy hawking the results of clinical trials and touting new products — or new versions of older products. Here’s a look at some of the initial releases from the conference. TCT 2010 is slated to run through Sept. 25.
- Abiomed
- Uspella registry results: Abiomed Inc. (NSDQ:ABMD) reported the latest results from its Uspella registry of 352 patients treating with its Impella 2.5 cardiac assist device. Patients treated for prophylactic revascularization showed a 17 percent improvement of left ventricular ejection fraction; a 61 percent reduction in patients classified as having New York Heart Assn. Class 4 heart failure; a 25 percent reduction in the target population for implantable cardiac defibrillators; and low rates of mortality (3.9 percent) and major adverse cardiac events (8.2 percent).
Patients who received Impella support before an angioplasty procedure showed a nearly 60 percent reduction in mortality. Ninety percent of survivors recovered "native cardiac function" and were discharged with their own hearts.
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- Uspella registry results: Abiomed Inc. (NSDQ:ABMD) reported the latest results from its Uspella registry of 352 patients treating with its Impella 2.5 cardiac assist device. Patients treated for prophylactic revascularization showed a 17 percent improvement of left ventricular ejection fraction; a 61 percent reduction in patients classified as having New York Heart Assn. Class 4 heart failure; a 25 percent reduction in the target population for implantable cardiac defibrillators; and low rates of mortality (3.9 percent) and major adverse cardiac events (8.2 percent).
- OrbusNeich
- Six-month data from the Perfect Stent trial: This 120-patient trial compared patients treated with OrbusNeich’s Genous bio-engineered R stent and B. Braun Inc.’s paclitaxel-coated balloon versus patients treated with the Genous stent alone. Six months after the procedures, in-stent late loss was 0.34mm for subjects treated with both devices, compared with 0.88mm for the group treated with the stent alone. No stent thrombosis was reported for either arm of the study; both groups received three months of DAP therapy. Rates of target lesion revascularization and MACE were lower in the investigational group compared to the control group.
“We are very encouraged by the good clinical and safety outcomes seen in patients treated with a combination of a paclitaxel-coated balloon and pro-healing technologies with only three months of dual antiplatelet therapy,” said principal investigator Dr. Jochen Woehrle of the University of Ulm, Germany. “This study supports the company’s development efforts with the Combo Stent.”
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- Six-month data from the Perfect Stent trial: This 120-patient trial compared patients treated with OrbusNeich’s Genous bio-engineered R stent and B. Braun Inc.’s paclitaxel-coated balloon versus patients treated with the Genous stent alone. Six months after the procedures, in-stent late loss was 0.34mm for subjects treated with both devices, compared with 0.88mm for the group treated with the stent alone. No stent thrombosis was reported for either arm of the study; both groups received three months of DAP therapy. Rates of target lesion revascularization and MACE were lower in the investigational group compared to the control group.
- Biosensors International Group Ltd.
- Eight-month Care II study results: Patients implanted with the Sparrow drug-eluting stent, designed to be the smallest-profile stent in the world, showed average in-stent late loss of 0.29mm, compared with 0.86mm for patients treated with the Sparrow bare-metal stent and 0.99mm in patients treated with Medtronic Inc.’s (NYSE:MDT) MicroDriver BMS. Rates MACE were 6.25 percen for the Sparrow DES, 14.3 percent for the Sparrow BMS and 26.7 percent for the MicroDriver.
"The CARE II eight-month results demonstrate the efficacy and safety of the Sparrow drug-eluting stent system in small coronary arteries, and suggest that its guidewire-like delivery mechanism and less traumatic stent expansion characteristic may improve outcomes in small vessels," said principal investigator Dr. Alexandre Abizaid of the Instituto Dante Pazzanese de Cardiologia in Sao Paulo, Brazil.
Read more - Three-year results from the Leaders trial: This trial, comparing the biolimus A9-eluting BioMatrix Flex stent with Johnson & Johnson (NYSE:JNJ) subsidiary Cordis Corp.’s Cypher Select stent, showed similar MACE rates after three years. Patients at risk for heart attack (ST elevation myocardial infarction), however, showed a 9.6 percent MACE rate in the BioMatrix arm and a 20.7 percdent rate in the Cypher arm.
"These further follow-up results from LEADERS confirm that the BioMatrix Flex stent continues to be safe and effective three years after implantation in an all-comers population, reflecting patients treated in routine clinical practice," said Patrick Serruys of the Erasmus Medical Center in the Netherlands.
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- Eight-month Care II study results: Patients implanted with the Sparrow drug-eluting stent, designed to be the smallest-profile stent in the world, showed average in-stent late loss of 0.29mm, compared with 0.86mm for patients treated with the Sparrow bare-metal stent and 0.99mm in patients treated with Medtronic Inc.’s (NYSE:MDT) MicroDriver BMS. Rates MACE were 6.25 percen for the Sparrow DES, 14.3 percent for the Sparrow BMS and 26.7 percent for the MicroDriver.
- PLC Systems Inc.
- Mythos RenalGuard trial update: This 157-patient trial examined the use of the RenalGuard system to prevent contrast-induced nephropathy in angioplasty patients with chronic kidney disease. Patients at high risk for renal failure who were treated with the system while undergoing imaging procedures developed CIN at a 69 percent lower rate than those treated beforehand with overnight hydration.
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- Mythos RenalGuard trial update: This 157-patient trial examined the use of the RenalGuard system to prevent contrast-induced nephropathy in angioplasty patients with chronic kidney disease. Patients at high risk for renal failure who were treated with the system while undergoing imaging procedures developed CIN at a 69 percent lower rate than those treated beforehand with overnight hydration.
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