"The TAXUS registries confirm the outstanding performance of the TAXUS stent system in diabetic subsets, patients requiring multiple stents and other highly complex cases," said Dr. Russell. "When viewed in combination with data from our TAXUS clinical trials, the results paint a remarkably consistent picture of TAXUS as a safe and highly efficacious treatment for patients with coronary artery disease."
The ARRIVE peri-approval registry has enrolled nearly 2,600 consecutive patients at 50 sites in the United States and features the Company's TAXUS® Express2™paclitaxel-eluting coronary stent system. (A peri-approval registry includes patients who are enrolled before and after a product is approved.) ARRIVE was initiated in cooperation with the U.S. Food and Drug Administration (FDA) and is the first TAXUS registry in the United States.
The six-month clinical findings from ARRIVE demonstrated safety based on a site-reported TAXUS related cardiac adverse event rate of 4.3 percent (106/2,477), including site-reported TAXUS related cardiac death, myocardial infarction and reintervention of the target vessel. The registry reported a stent thrombosis rate of 1.7 percent (angiographically confirmed thrombotic events and all deaths less than six months without obvious cause). ARRIVE reported a 95 percent follow-up at six months.
Consecutive enrollment in ARRIVE has yielded a very diverse patient population involving patients receiving multi-vessel stenting (17 percent), left main stenting (3 percent), stenting of total occlusions (2 percent), stenting of bifurcated lesions (8 percent), stenting of saphenous vein grafts (6 percent) and stenting of in-stent restenonic lesions (7 percent). Ten percent of patients presented with an acute myocardial infarction. For the diabetic population overall, the TAXUS- related cardiac adverse event rate was 5.4 percent and the need for repeat procedures was 3.1 percent.
"ARRIVE has produced exceptional 'real-world' results from patients who were consecutively enrolled in the registry, which more closely resembles the patients that we see in our day-to-day practice," said John Lasala, M.D., Ph.D., of Barnes-Jewish Hospital and Washington School of Medicine in St. Louis and Co-Principal Investigator of ARRIVE. "Given this highly complex patient population, the results from ARRIVE are quite extraordinary. Of particular note are the outstanding data derived from ARRIVE's diabetic patient population, which represent 31 percent of those enrolled in the registry."
The ARRIVE registry enrolled patients at low-, medium- and high-volume community-based health centers in the United States.
Enrollment has commenced in the ARRIVE 2 registry program, which plans to enroll 5,000 patients at approximately 60 centers in the United States. The program is designed to collect and analyze 'real-world' safety and clinical outcomes data from the TAXUS Express2 paclitaxel-eluting stent system in the treatment of patients with coronary artery disease.
The Milestone II registry was designed as a follow-up to the Milestone I registry (which evaluated usage patterns of the Express2™ bare-metal stent system) to assess the TAXUS paclitaxel-eluting stent system. On a global basis, the registry has enrolled 3,688 patients at 164 centers in 31 countries. The Company today announced that the excellent global safety and efficacy data reported at six months extends to 12 months, including physician usage patterns.
Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices whose products are used in a broad range of interventional medical specialties. For more information, please visit: www.bostonscientific.com.
This press release contains forward-looking statements. The Company wishes to caution the reader of this press release that actual results may differ from those discussed in the forward-looking statements and may be adversely affected by, among other things, risks associated with clinical trials, the regulatory approval process, commercialization of new technologies, third party intellectual property and other factors described in the Company's filings with the Securities and Exchange Commission.