Cath Lab Digest

• Ninety percent of the survivors recovered native cardiac function and were discharged with their own hearts

^*Significant = statistically significant with p<0.05
^**Syed Al, et al. Cardiovasc Revasc Med 2010; 1191–1197.

Fully Bioresorbable Vascular Scaffold Technology Shows Positive Data at Six and Nine Months

Abbott announced positive nine-month results from the first 45 patients enrolled in the second stage of the ABSORB trial. At nine months, Abbott’s bioresorbable vascular scaffold (BVS) demonstrated strong results that remained consistent with the six-month data from the same 45-patient group, with the rate of major adverse cardiac events (MACE) unchanged at 4.4 percent and no reports of blood clots (thromboses). These results were presented during the TCT.

“I am impressed with how consistent the BVS data have been to date, as the nine-month data are compelling and supportive of earlier positive results,” said John Ormiston, MD, medical director at Mercy Hospital in Auckland, New Zealand, and co-principal investigator for the ABSORB trial. “In addition to the positive safety data we’ve seen to date, the late loss rate of 0.19 millimeters reported at six months is comparable to a metallic drug-eluting stent, and may address a limitation of metal stents by not leaving metal in the artery.”

Abbott also presented six-month results for all 101 patients enrolled in the second stage of the ABSORB trial. In this complete patient population, the MACE rate remained consistent, with a nominal increase from 4.4% at six months in the first 45 patients to 5.0% at six months in all 101 patients. There were no reports of blood clots in any of the 101 patients.

Patrick W. Serruys, MD, PhD, professor of interventional cardiology at the Thoraxcentre, Erasmus University Hospital, Rotterdam, the Netherlands, and principal investigator for the ABSORB trial, said, “The findings to date show that the device appears to effectively treat coronary artery disease with the possibility of restoring natural vessel function in a way that is not possible with permanent implants.”

Abbott’s BVS is under investigation in two clinical studies, ABSORB and ABSORB EXTEND, and is currently not available for sale anywhere in the world. The BVS is made of polylactide, a proven biocompatible material that is commonly used in medical implants such as resorbable sutures.

The ABSORB trial is a prospective, non-randomized (open label), two-phase study that enrolled 131 patients from Australia, Belgium, Denmark, France, the Netherlands, New Zealand, Poland and Switzerland. Key endpoints of the study include assessments of safety — MACE and treated-site thrombosis rates — at 30 days; six, nine, 12 and 24 months; with additional annual clinical follow up for up to five years, as well as an assessment of the acute performance of the bioresorbable vascular scaffold, including successful deployment of the system. Other key endpoints of the study include imaging assessments by angiography, intravascular ultrasound (IVUS), optical coherence tomography (OCT), and other state-of-the-art invasive and non-invasive imaging modalities at six, 12, 18, 24 and 36 months.

The ABSORB EXTEND trial is a single-arm study that is currently enrolling patients at up to 100 centers in Europe, Asia Pacific, Canada and Latin America. The trial will enroll approximately 1,000 patients, including patients with more complex coronary artery disease. Abbott’s bioresorbable technology delivers everolimus, an anti-proliferative drug.

Economic Model Suggests That the Use of Cypher in Diabetic Patients May Result in Substantial Cost Savings When Compared to Other DES

New analysis indicates that the broad use of Cypher^® sirolimus-eluting coronary stent in patients with diabetes would result in substantial cost savings, as compared to the use of everolimus-eluting stents (EES), paclitaxel-eluting stents (PES), or zotarolimus-eluting stents (ZES). According to this analysis, the cost reduction per diabetic patient treated with Cypher would range between $733 and $937, depending on the comparator drug-eluting stent (DES). When this analysis is extrapolated to an estimated 200,000 U.S. diabetics that undergo percutaneous coronary intervention (PCI) with DES implantation each year, the annual cost savings with Cypher would exceed $145 million vs. all three other DES (EES, PES, or ZES).

This study reflects the growing attention to Comparative Effectiveness Research, a focal issue in the recent health care reform debate. “This study adds to the large body of evidence assessing the economic value of drug-eluting stents,” said Ryan Saadi, MD, MPH, Worldwide Vice President of Health Economics and Strategic Pricing at Cordis. “It is unique in that it includes all relevant stents and predicts the actual costs for an entire population of patients, in this case diabetic patients that qualify under a fixed fee reimbursement system like Medicare. We look forward to presenting our analysis in other important patient sub-groups in the future.”