Washington Hospital Cardiologist Conducting Clinical Trials of 'Bioresorbable' Artery Implants
Since the end of May, cardiologist Ash Jain, M.D., has been conducting clinical trials of the world's first "bioresorbable," drug-eluting "scaffold" implants for coronary artery disease.
Drug-eluting (also called drug-coated) coronary stents that are currently the standard of care are metal-mesh tubes that prop open a blocked artery to the heart and slowly release drugs to help keep the blood vessel from re-closing. Unlike metal stents - which are permanent implants - the Absorb? bioresorbable vascular scaffold (BVS) is made of a naturally dissolvable material that is commonly used in medical implants such as dissolving sutures. Absorb is referred to as a "scaffold" to indicate that it is a temporary structure, rather than a permanent implant.
Trials of the implants are being conducted at 30 centers nationwide. The randomized, controlled trial will enroll approximately 2,250 patients.
Dr. Jain was among the first to be chosen for participation in the trials because of his extensive experience in conducting various clinical trials of other stents. He has been involved in several previous clinical trials of heart procedures using stents that are coated with medications to inhibit the buildup of plaque in the arteries. A cardiologist on the medical staff at Washington Hospital for 20 years, Dr. Jain serves as medical director of the hospital's Stroke Program and Invasive Vascular Imaging. He also is medical co-director of Cardiac Care Services and the Vascular Services Program.
Nationwide data indicate drug-coated stents have cut the rate of plaque re-building dramatically.
"Various studies show that patients with significant coronary artery disease who are treated only with balloon angioplasty have a 30 to 35 percent rate of blockage recurrence called restenosis," Dr. Jain notes. "Patients who received stents without drug coatings had a 15 to 20 percent rate of restenosis. In studies of stents coated with drugs, the rate of recurrence was only 5 to 7 percent."
The new implants open the clogged artery and restore blood flow to the heart in the same way metallic stents do. Starting at about 9 months, however, the new implant begins dissolving into the blood vessel over a period of several months, allowing the vessel to resume a more natural function and movement because it is free of a permanent metallic implant.
"The new stents have already been tested and approved for use in Europe and parts of Asia and Latin America," says Dr. Jain. "The trials for more than five years in other countries have shown that the performance of the new stents is as good as other drug-eluting stents, with the added advantage of being resorbed into the body. There have been no unusual complications with the new stents, and the rates of restenosis are similar to those of metallic stents."
Patients who would be considered for participation in the clinical trials include anyone with significant coronary arterial blockage who would be a candidate for other types of stents. So far, Dr. Jain has enrolled eight patients in the trial.
"We have had a 100 percent success rate with the Absorb implants, with no complications," he notes.
"Heart disease is the number one killer of men and women in the United States, and these new stents could revolutionize treatment of heart disease and advance the options for patient care," says Dr. Jain. "Clinical trials are one of the greatest ways to stay on top of best practices, and I am committed to pursuing treatments that could benefit patients in our community."
Health Care for the Community
Washington Hospital's Heart Program, including the state-of-the-art digital vascular imaging laboratories, serves more than 3,500 adult cardiac, vascular and electrophysiology patients annually. To learn more about cardiac care at Washington Hospital, visit www.whhs.com/heart.
To find a cardiologist near you, visit www.whhs.com/physicians or for more information regarding the new stent clinical trials contact Community Relations at (510) 791-3417.