A Medical Device Daily

Clinical investigators at yesterday's "Innovative Devices and Futuristic Therapies" session during the 20th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium, sponsored by the Cardiovascular Research Foundation (New York) reported 12-month follow-up data from the ATLANTA Trial. The trial was sponsored by CeloNova BioSciences (Newnan, Georgia) maker of the Catania stent. The results include zero percent thrombosis in patients discontinuing dual anti-platelet therapy after only 30 days.

The ATLANTA Trial is a first-in-man (FIM), prospective, single center, non-randomized, single-arm study involving 55 patients (76 lesions) treated with the Catania coronary stent system with NanoThin Polyzene surface modification for symptomatic ischemic heart disease due to de novo, obstructive lesions of native coronary arteries.

At 12 months, in an unusually complex FIM patient population, the results showed zero (0.0) percent stent thrombosis (Academic Research Consortium, or ARC-defined), death, myocardial infarction, stroke, or coronary artery bypass graft. Target lesion revascularization was 10.9% (only 3.6% clinically driven, 7.3% non-clinically driven), with a binary restenosis rate of 6.8% (five of 74 lesions analyzed at twelve months). Of note, all patients stopped dual anti-platelet therapy after 30 days, but continued aspirin (100 mg/d) throughout the 12-month period.

The acute angiographic and procedural success rate in the ATLANTA Trial was 100%. Independent core laboratories analyzed quantitative coronary angiography and intravascular ultrasound (IVUS) data for all patients immediately after stent implantation and at 6-month follow-up. Further analysis of 1,904 cross sections (19,028 struts) by investigators using Optimal Coherence Tomography at baseline and again at 6-month follow-up in a subset of 15 randomly selected patients revealed complete endothelialization and 99.5% stent strut coverage.

In other news from the TCT meeting:

•: St. Jude Medical (St. Paul, Minnesota) reported FDA and European CE mark approval of the Angio-Seal Evolution Vascular Closure Device.

The Angio-Seal Evolution device is designed to enable physicians to seal femoral artery punctures made during minimally invasive catheter-based procedures. Effectively sealing the puncture helps achieve hemostasis (cessation of bleeding) quickly, enabling the patient to walk and resume activities sooner.

The Angio-Seal Evolution platform features a delivery system that reduces the variability that can occur as physicians deploy and secure the Angio-Seal closure system. Consistent with its Angio-Seal predecessors, Angio-Seal Evolution achieves hemostasis through the deployment of an anchor, suture and collagen seal (each of which is bioabsorbable). The company said that with Evolution, however, single-handed deployment has been made possible for the first time, which enables physicians to more easily support the puncture site.

The device's automated collagen compaction system is said to ensure consistent compaction of the collagen against the exterior wall of the vessel reducing procedural variables. With fewer variables in device deployment, physicians gain greater control and consistency in achieving rapid, safe and reliable hemostasis for their patients.

"The Angio-Seal Evolution takes a major step forward by automatically compacting the collagen," said Robert Applegate, MD, Wake Forest University Baptist Medical Center, (Winston-Salem, North Carolina) "The confidence it provides physicians in closing the puncture in such a short period of time with such effectiveness is outstanding."

•: Data from an independent meta-analysis of Abbott Laboratories' (Abbott Park, Illinois) SPIRIT II and SPIRIT III randomized clinical trials demonstrated that the Xience V Everolimus eluting coronary stent system continues to deliver clinically significant benefits for patients compared to the Taxus paclitaxel-eluting coronary stent system out to two years. In this meta-analysis, which included patients from the U.S., Europe and Asia-Pacific, Xience V demonstrated clinical superiority to Taxus in the endpoints of target vessel failure (TVF) and major adverse cardiac events (MACE) at two years. Xience V also demonstrated significantly lower clinical events rates than Taxus in the key efficacy (target lesion revascularization) and safety (cardiac death or heart attack) components of MACE at two years. The results were presented by Gregg Stone, MD, principal investigator of the SPIRIT III trial. The meta-analysis of 1,302 patients from the SPIRIT II and SPIRIT III trials demonstrated several notable results for Xience V at two years:

A clinically significant 31% reduction in the risk of ischemia-driven Target Vessel Failure (TVF, cardiac events related to the treated vessel) compared to Taxus (10.4% for Xience V vs. 14.7% for Taxus). TVF is a composite clinical measure of safety and efficacy outcomes defined as cardiac death, heart attack (myocardial infarction or MI) or target vessel revascularization (TVR).

"With the subgroup analysis, we saw encouraging trends of lower event rates between one and two years for patients treated with Xience V compared to patients treated with Taxus, regardless of patient or lesion complexity," said John Capek, PhD., executive VP, Medical Devices, Abbott. "Even though the SPIRIT III trial was not designed for statistical comparisons in subgroups, these positive trends demonstrate that Xience V performs in a consistent manner and gives physicians confidence in Xience V as they consider what is the most effective treatment for their patients."

•: Research presented by Stephen Silberstein, MD, director of the Jefferson Headache Center at Thomas Jefferson University Hospital (Philadelphia) suggests that two-thirds of all chronic migraine sufferers have a hole in their heart or a right-to-left shunt. This leads to abnormal blood flow that bypasses the filtration process within the lungs and may be a significant contributor to chronic headache pain.

Silberstein's presentation was titled "First Report of Clinical Trial Results: The Prevalence of PFO in Patients with Chronic Migraine." In the study, 66% (86 of 131) of adult chronic migraine sufferers in the statistically valid research effort were found to have an abnormal right-to-left shunt of blood that travels to the left side of the heart without being properly filtered by the lungs. According to Silberstein, the most common form of RLS heart defects are patent foramen ovales (PFOs), a condition that previous research shows is typically found in 25% of all people.

According to Silberstein, not all PFOs cause clinical problems in patients; however, this new data may indicate that patients who suffer from chronic migraine have a higher prevalence on PFO vs. the general population.

"Instead, we found a correlation more than 2.6 times the expected results (86 patients). This is a very significant difference. In other words, it's highly likely there's a strong connection between PFO/RLS heart defects and chronic migraines. If our results are borne out in future research, such studies will suggest a fairly simple way to eliminate or reduce chronic migraine pain — close PFO defects."