NATICK, Mass. and CHICAGO, March 29 /PRNewswire-FirstCall/ -- Boston Scientific Corporation (NYSE: BSX - News) today announced results from an analysis of 4,772 patients from its TAXUS ARRIVE 1 and 2 registries, designed to assess the performance of the TAXUS® Express2(TM) Paclitaxel-Eluting Coronary Stent System in real-world practice. The one-year pooled ARRIVE data confirmed the known higher mortality rate for diabetics versus non-diabetics with cardiovascular disease(1), but showed that the TAXUS Stent had similarly low rates of stent-related cardiac death, myocardial infarction (MI), stent thrombosis, and major cardiac events (MCE) across those two patient subsets. The study also showed similar rates of target vessel re-intervention (TVR) and TAXUS-related TVR in indicated patients(2) per the European Union (EU) label, whether or not they had diabetes. Analysis of the data was presented by D. Lynn Morris, M.D., at the SCAI Annual Scientific Sessions in Partnership with the ACC/i2 Summit in Chicago.

The pooled analysis included one-year data on 1,530 medication-requiring diabetic patients and 3,242 non-diabetic patients from the ARRIVE registry program. Due to significant disparity in baseline characteristics between diabetic and non-diabetic patients, propensity score analysis was used to allow for adjustment of baseline differences (other than the presence of diabetes) between the two groups.

The results showed diabetic patients had the well-known higher overall adjusted one-year mortality rate than patients without diabetes (3.7% vs. 2.3%, respectively, p=0.016), with the difference being driven by the cardiac death rate (2.3% vs. 1.2%, p=0.014), and reflecting the more advanced cardiac disease associated with diabetes. However, this difference was not related to the TAXUS Stent as the TAXUS Stent-related cardiac death rates at one-year were comparable in diabetics and non-diabetics, respectively (1.0% vs. 0.7%, p=0.29) in this patient population(2). Additionally, TAXUS Stent-related MCE rates (cardiac death, MI, and re-intervention) at one year were comparable (5.7% vs. 5.6%, p=0.80), as was the incidence of TAXUS Stent-related MI (1.6% vs. 1.2%, p=0.26), in both groups. Stent thrombosis at one year was low and showed no significant difference between diabetics and non-diabetics under Protocol definition (1.5% vs. 1.3%, p=0.59) or ARC Definite/Probable (1.7% vs. 1.2%, p=0.29). Unadjusted one-year rates of TAXUS Stent-related cardiac death, TAXUS Stent-related MCE, TAXUS Stent-related MI, and protocol-defined stent thrombosis showed no differences between the two populations (p-values of 0.30, 0.74, 0.31, and 0.65, respectively), suggesting that the safety profile is comparable for the two groups despite increased underlying risk in patients with diabetes.

Additionally, the ARRIVE analysis confirmed that the TAXUS Stent maintained comparable re-intervention rates in the diabetic and non-diabetic patient populations in ARRIVE 1 and 2. Rates of one-year TVR, whether adjusted or unadjusted, were similar between the patient groups (6.1% vs. 6.0%, p=0.80, adjusted). TAXUS Stent-related re-intervention of a target vessel (equivalent to target lesion revascularization, or TLR) was also similar between the patient groups (4.3% vs. 4.5%, p=0.70), despite the known higher risk for re-intervention in diabetic patients.

"The ARRIVE diabetic subset data demonstrated that the TAXUS Stent mitigated the adverse effect of diabetes as a risk factor for restenosis and repeat procedures in the patients studied," said Dr. Morris of the Albert Einstein Medical Center in Philadelphia, PA. "While the diabetic patients had more cardiac risk factors and co-morbidities than non-diabetics, the TAXUS- related cardiac death, MI and stent thrombosis in the ARRIVE 1 and 2 registries were similar in both groups, even without adjustment for risk factors."

"Our extensive ARRIVE registries provide valuable insights into diabetic patients who are often at higher risk for mortality and repeat stenting procedures," said Paul LaViolette, Chief Operating Officer at Boston Scientific. "The ARRIVE data demonstrated that the TAXUS Stent neutralized diabetes as a risk factor for clinical restenosis in the patients studied."

The growing diabetic subset accounts for more than one-quarter of all coronary interventional procedures in the United States. Diabetes is generally associated with an increased risk of cardiovascular events and patients with diabetes are more likely than non-diabetic patients to require repeat procedures due to a higher incidence of restenosis following angioplasty and stenting.

The safety and effectiveness of the TAXUS Express Stent has not been established in patients with diabetes in the United States.

MINNEAPOLIS--(BUSINESS WIRE)--According to new data released today at the American College of Cardiology meeting, Medtronic?s Endeavor drug-eluting stent has a safety profile more commonly associated with a bare-metal stent, long considered a benchmark for stent safety. This latest extension to our pooled safety analysis of data from the ENDEAVOR clinical program nearly doubles the number of Endeavor patients followed to three years and therefore strengthens our confidence in the findings we presented previously,? explained Dr. Laura Mauri, chief scientific officer of the Harvard Clinical Research Institute, an interventional cardiologist at the Brigham and Women?s Hospital (both in Boston) and the lead author of the research. ?With more than 1,200 patients whose clinical follow-up now extends to three years, the Endeavor drug-eluting stent continues to be associated with low rates of stent thrombosis, myocardial infarction and cardiac death ? three key safety metrics ? compared to the Driver^® bare-metal stent. Importantly, there were no new stent thrombosis events among patients in either group.?

Launched by Medtronic (NYSE:MDT - News) in the United States in February, the Endeavor stent is designed to promote rapid, complete and functional healing of the endothelium so that late safety concerns are minimized. It features an advanced cobalt alloy in a modular architecture for excellent deliverability and conformability, the antiproliferative drug zotarolimus to moderate neointimal hyperplasia, and a highly biocompatible polymer called phosphorylcholine (PC) for rapid drug elution.

The independent analysis performed by Dr. Mauri and colleagues ? ?The Endeavor Zotarolimus-Eluting Stent in Patients with Native Coronary Artery Disease: Safety with 1,200 Patients Followed to Three Years? (2900-104) ? included a total of 2,132 Endeavor patients and 596 Driver patients. The following table presents the cumulative incidence of adverse safety events, as well as adherence to dual-antiplatelet therapy, in both groups to three years of follow-up:

Pooled safety analysis of ENDEAVOR clinical program to three years of follow-up
		Endeavor (n = 2,132)		Driver (n = 596)		p value (log rank)
Stent thrombosis (ARC? definite/probable) -- total year 1 -- total years 2 and 3		0.7% 0.6% 0.1%		1.5% 1.3% 0.2%		0.059
Myocardial infarction		2.7%		4.2%		0.045
Cardiac death		1.0%		2.4%		0.021
Cardiac death / myocardial infarction		3.5%		6.6%		0.001
Adherence to dual-antiplatelet therapy?? -- at one year -- at two years -- at three years		29.0% 13.5% 9.1%		29.0% 13.5% 9.1%		na

^? ARC = Academic Research Consortium; international group that developed standard definitions for stent thrombosis to use across all trials of drug-eluting stents

^?? among patients in ENDEAVOR I, II, II continued access (CA), and III

As summarized in the table, the rate of stent thrombosis (ARC definite/probable) before and after one year differed between the two groups, while adherence to dual-antiplatelet therapy was similar.

Originally presented at the Transcatheter Cardiovascular Therapeutics (TCT) meeting in October 2007, the pooled safety analysis is based on data from three of the ENDEAVOR clinical program?s single-arm studies (ENDEAVOR I, II continued access, and pharmacokinetics) and its three randomized controlled trials (ENDEAVOR II, III and IV). It now includes 2,050 Endeavor patients followed to one year, 1,287 followed to two years, and 1,217 to three.

CHICAGO--(BUSINESS WIRE)--Data showing strong clinical efficacy for Medtronic?s Endeavor^® drug-eluting stent were presented today at the American College of Cardiology meeting. Entitled ?One-Year Clinical and Angiographic Results in Diabetics from ENDEAVOR IV: A Randomized Comparison of the Endeavor Drug Eluting Stent System Versus Taxus in de novo Native Coronary Lesions? (2803-8) ? the presentation featured an analysis of 477 diabetic patients from the ENDEAVOR IV clinical study. ENDEAVOR IV is an ongoing head-to-head comparison of the Endeavor and Taxus stents in 1,548 patients. Below is a summary of the principal findings for the diabetic subset:

ENDEAVOR IV results at 12-month follow-up for diabetic patients
	Endeavor (n = 241)		Taxus (n = 236)
Overall mortality	0.0%		0.9%
Cardiac death	0.0%		0.0%
Myocardial infarction	0.9%		0.9%
Stent thrombosis	0.9%		0.4%
Target lesion revascularization (TLR)	6.9%		6.8%
Target vessel revascularization (TVR)	8.6%		9.4%
Target vessel failure (TVF)	8.6%		10.8%

The safety and effectiveness of the Endeavor stent have not been established in diabetic patients. Data would first require both FDA review and approval.

?Performance of drug-eluting stents in diabetic patients is scrutinized by doctors because diabetes complicates so many aspects of the angioplasty procedure. Achieving good efficacy is more difficult, and safety concerns are significantly increased.? said Dr. Jeffrey Popma, Director of Invasive Cardiovascular Services, Caritas Cardiovascular Center for the Caritas Saint Elizabeth?s Medical Center in Boston, and director of the core lab that performed the angiographic analysis for the entire ENDEAVOR clinical program, including ENDEAVOR IV.

Launched in the United States in February and now available in more than 120 countries worldwide, the Endeavor stent is indicated for improving coronary luminal diameter in patients with ischemic heart disease due to de novo lesions of length ≤ 27 mm in native coronary arteries with reference vessel diameters of ≥ 2.5 mm to ≤ 3.5 mm.

Impact of angiography on TLR reinforced

Also presented at the ACC scientific session were the findings of two other substudies from the ENDEAVOR IV clinical trial. One analysis ? ?The Impact of Mandatory Angiographic Follow-up on the One-Year Clinical and Angiographic Results From Endeavor IV: A Randomized Comparison of the Endeavor Drug Eluting Stent System vs. Taxus in De Novo Native Coronary Lesions? (2900-103) ? illustrated the artificial impact of routine angiography on revascularization rates. The first 328 enrolled ENDEAVOR-IV patients were selected to undergo angiography immediately post-procedure and again after eight months. These results were compared to the subsequent 1,200 patients in whom angiography was not performed. In patients receiving angiographic follow-up, the TLR rate at 12 months was 8.5 percent for Endeavor and 3.0 percent for Taxus but with no angiographic follow-up, the TLR rates were 3.6 percent for Endeavor and 3.3 percent for Taxus. These findings support the ARC recommendations that PCI clinical studies assess lesion characteristics with angiography only after the follow up required to assess the primary clinical endpoint.

Side-branch occlusion with Endeavor

A second sub-analysis ? ?The Fate of Side-Branches Among Patients Treated With Zotarolimus-Eluting and Paclitaxel-Eluting Stents: An ENDEAVOR-IV Substudy? (2901-19) ? looked at side-branch occlusion post-stenting. The analysis was conducted as doctors seek to explain the significantly increased rate of periprocedural MI with Taxus when compared to Endeavor observed in the ENDEAVOR IV clinical trial.

ENDEAVOR IV side-branch occlusion results
		Endeavor		Taxus		p value (log rank)
Side-branch occlusion post-stenting		2.2%		4.8%		p=0.032

The ENDEAVOR IV clinical trial was not prospectively designed to evaluate side-branch occlusions, so further study is warranted.

ENDEAVOR IV is evaluating 1,548 patients at 80 clinical centers in the United States, with a primary endpoint of Target Vessel Failure (TVF) at nine months and a secondary endpoint of Major Adverse Cardiac Events (MACE) at 30-days. The principal investigator is Dr. Martin B. Leon of Columbia University Medical Center and the Cardiovascular Research Foundation in New York.

ENDEAVOR IV is evaluating 1,548 patients at 80 clinical centers in the United States, with a primary endpoint of Target Vessel Failure (TVF) at nine months and a secondary endpoint of Major Adverse Cardiac Events (MACE) at 30-days. The principal investigator is Dr. Martin B. Leon of Columbia University Medical Center and the Cardiovascular Research Foundation in New York.

The Endeavor drug-eluting stent is made of a cobalt alloy and is built on the same platform as Medtronic?s popular Driver bare metal stent, which features a unique modular architecture designed to enhance deliverability. In addition to the cytostatic drug zotarolimus, Endeavor is coated with phosphorylcholine (PC) technology, a polymer designed to simulate the outside surface of a red blood cell and mimic the structure of the natural cell membrane. The combination of these components is designed to contribute to rapid, complete and functional healing of the endothelium.

CHICAGO, March 31 /PRNewswire-FirstCall/ -- Data presented today from Abbott's SPIRIT II clinical trial demonstrated continued positive clinical results for the XIENCE(TM) V Everolimus Eluting Coronary Stent System out to two years, including an observed 40 percent reduction in major adverse cardiac events (MACE) and an observed 44 percent reduction in vessel retreatment (ischemia-driven target lesion revascularization, TLR) compared to the TAXUS® paclitaxel-eluting coronary stent system. The two-year results from the SPIRIT II trial were presented at the SCAI Annual Scientific Sessions in Partnership with ACC i2 Summit.

SPIRIT II is a 300-patient randomized clinical trial, which was conducted in Europe and Asia Pacific to support the launch of XIENCE V outside the United States. In SPIRIT II, XIENCE V demonstrated the following key results:

 

    -- In an analysis of major adverse cardiac events (MACE), XIENCE V
       demonstrated an observed 40 percent reduction in MACE compared to
       TAXUS at two years (6.6 percent for XIENCE V vs. 11.0 percent for
       TAXUS). MACE is an important clinical measure of patient outcomes,
       defined as cardiac death, heart attack (myocardial infarction or MI),
       or ischemia-driven target lesion revascularization.

    -- XIENCE V demonstrated an observed 44 percent reduction in
       ischemia-driven target lesion revascularization (TLR driven by lack of
       blood supply) compared to TAXUS at two years (3.8 percent for XIENCE V
       vs. 6.8 percent for TAXUS).

    -- Rates of definite/probable stent thrombosis under the Dublin/Academic
       Research Consortium (ARC) definition were 0.9 percent for XIENCE V and
       1.4 percent for TAXUS at two years. The ARC definition of late-stent
       thrombosis was developed to eliminate variability in the definitions
       across various drug eluting stent trials.

"In clinical endpoints such as major adverse cardiac events, retreatment and heart attack, patients treated with XIENCE V in the SPIRIT II clinical trial continue to fare better than patients treated with TAXUS out to two years," said Patrick W. Serruys, M.D., Ph.D., Professor of Interventional Cardiology at Thoraxcentre, Erasmus University Hospital, Rotterdam, and principal investigator of the SPIRIT II clinical trial, who presented the results today. "XIENCE V is performing as we would expect a next-generation drug eluting stent should over the long term, specifically on the important clinical endpoint of MACE. The low rate of MACE with XIENCE V compared to TAXUS was present at 6 months, one year and now at two years in the SPIRIT II trial."

In a small subset of patients in the SPIRIT II trial, in-stent imaging results were evaluated at two years. In this 117-patient subset, the angiographic in-stent late loss rate was 0.33 mm for XIENCE V and 0.34 mm for TAXUS at two years. In-stent late loss is a measure of vessel renarrowing within the margins of the stent.

"At any given point in time, across both the pivotal SPIRIT II and SPIRIT III clinical trials, XIENCE V consistently reduces observed MACE rates by 40 percent or more compared to TAXUS," said Charles Simonton, M.D., FACC, FSCAI, divisional vice president, Medical Affairs and chief medical officer, Abbott Vascular. "The single-digit MACE rate seen with XIENCE V out to two years is encouraging data for interventionalists as they look for ways to improve patient outcomes with next-generation drug eluting stents."

XIENCE V was launched in Europe and other international markets in late 2006. XIENCE V is an investigational device in the United States and Japan, and is currently under review for approval by the U.S. Food and Drug Administration.

Abbott also supplies a private-label version of XIENCE V to Boston Scientific called the PROMUS(TM) Everolimus-Eluting Coronary Stent System. PROMUS is designed, studied and manufactured by Abbott and supplied as part of a distribution agreement between the two companies.

CHICAGO--(BUSINESS WIRE)--Long-term, follow-up data presented today suggest that patients who received the CYPHER^® Sirolimus-eluting Coronary Stent for blockage of a bare metal stent were significantly less likely to need another procedure (target lesion revascularization or TLR) at three years compared to patients who received brachytherapy. In addition, there were no significant differences in safety endpoints, such as the rates of death, myocardial infarction (MI), or stent thrombosis between the two treatment arms of this study.

These data were presented at the Society for Cardiovascular Angiography and Interventions (SCAI) Annual Scientific Sessions in Partnership with American College of Cardiology (ACC) i2 Summit during the 57^th Annual Scientific Sessions.

The SISR Trial (A Randomized Trial Comparing Sirolimus-Eluting Stent with Vascular Brachytherapy for the Treatment of In-Stent Restenosis Within Bare Metal Stents) is a multi-center, randomized study of 384 patients from 26 academic and community health centers in the United States. The original trial was designed for follow-up at nine months. This longer-term, follow-up analysis focused on pre-specified safety endpoints, namely death, MI and stent thrombosis, as well as target lesion revascularization (TLR), an efficacy endpoint, to determine whether any new safety issues emerged and whether the major benefit of the CYPHER^® Stent, namely reduction in TLR, was maintained. Cordis Corporation sponsored the trial.

?These data continue to favor the CYPHER^® Stent compared to radiation therapy in these patients with complex coronary artery disease,? said David R. Holmes Jr., M.D., Principal Investigator and Professor of Medicine, The Mayo Clinic College of Medicine, Rochester, MN. ?Neither treatment modality in this study was associated with any new safety issues or concerns.? Dr. Holmes also serves as an advisory board member to the company?s e-SELECT registry, which is being conducted outside the United States.

At three years, 81 percent of patients who received the CYPHER^® Stent were free from a TLR compared to 71.6 percent of patients receiving brachytherapy (p=0.018). For target vessel revascularization, the survival free rates were 78.2 percent for the CYPHER^® Stent and 68.8 percent for the brachytherapy arm (p=0.022).

The stent thrombosis rates, as defined as definite and probable per the Academic Research Consortium (ARC) definitions, were not significantly different (3.7 percent for the CYPHER^® Stent vs. 2.6 percent for brachytherapy; p=0.606).

Although three year rates of target vessel failure (the CYPHER^® Stent, 75.1 percent; brachytherapy, 67.9 percent; p=0.067) and major adverse cardiac events, also known as MACE, were both improved with the CYPHER^® Stent, this did not reach statistical significance, likely reflecting progression of coronary artery disease at sites other than the original location of bare metal stent restenosis. Rates of MACE were 75.5 percent for the CYPHER^® Stent and 70.5 percent for brachytherapy (p=0.186).