By Todd Neale, Staff Writer, MedPage Today
Published: February 10, 2011
Reviewed by Michael Thomas Mullen Jr, MD; Clinical Instructor of Vascular Neurology,


  • In this double-blinded study 5,599 patients with atrial fibrillation and at least one other risk factor for stroke were randomly assigned to aspirin or apixaban, a novel factor Xa inhibitor.
  • All patients in this study were considered unsuitable for treatment with warfarin.
  • Treatment with apixaban was associated with a significant reduction in stroke and systemic embolism without an increased risk of hemorrhagic complications.

 

LOS ANGELES — In patients with atrial fibrillation who can’t take vitamin K antagonist therapy, the experimental anticoagulant apixaban is superior to aspirin for preventing stroke or systemic embolism, final results of the AVERROES trial confirmed.

Through about one year of follow-up, the rate of stroke or systemic embolism was 1.6% per year in the apixaban group and 3.7% per year in the aspirin group (HR 0.45, 95% CI 0.32 to 0.62), according to Hans-Christoph Diener, MD, PhD, of University Duisburg-Essen in Germany.

The rate of death was lower among patients taking apixaban (3.5% versus 4.4% per year) but this did not reach statistical significance (P=0.07). There was a significant reduction in the risk of a first hospitalization for cardiovascular causes (12.6% versus 15.9% per year, P<0.001).

The rate of major bleeding — the primary safety endpoint — was not raised in the apixaban group (1.4% versus 1.2% per year; HR 1.13, 95% CI 0.74 to 1.75), Diener reported here at the American Stroke Association’s International Stroke Conference.

The findings, which confirm the initial results presented last year at the European Society of Cardiology meeting, were reported simultaneously online in the New England Journal of Medicine.

Diener and his colleagues noted in their paper that treating 1,000 patients for one year with apixaban rather than aspirin would prevent 21 strokes or systemic emboli, nine deaths, and 33 hospitalizations for cardiovascular causes, at the cost of two major bleeds.

“The net clinical benefit of apixaban in these patients was therefore substantial,” they wrote.

Some patients are not good candidates for vitamin K antagonist therapy for numerous reasons, including an unwillingness to comply with regular testing, a proven inability to maintain an INR within the therapeutic range, a moderate risk of stroke, or a refusal to receive the therapy.

Aspirin reduces the risk of stroke for patients with atrial fibrillation, and adding clopidogrel (Plavix) reduces the risk even further, but the combination increases the risk of major hemorrhage.

Diener and his colleagues evaluated apixaban — a novel factor Xa inhibitor — as a treatment option for patients with atrial fibrillation who cannot take vitamin K antagonist therapy.

The AVERROES trial randomized 5,599 patients to apixaban (5 mg twice a day) or aspirin (81 to 324 mg daily) at 522 centers in 36 countries; 37% of the patients were from North America or western Europe.

In addition to unsuitability for vitamin K antagonist therapy, all patients had at least one risk factor for stroke.

The trial was stopped prematurely by its data and safety monitoring board after a mean follow-up of 1.1 years because prespecified interim analyses identified a clear benefit for apixaban in reducing stroke or systemic emboli.

The treatment effects were consistent in various subgroups, including high-risk patients who had already had a stroke or a transient ischemic attack.

Although major bleeding was not significantly increased in the apixaban group, an on-treatment analysis that included only those events occurring within two days of permanent study drug discontinuation approached significance (1.4% versus 0.9% per year; HR 1.54, 95% CI 0.96 to 2.45).

“The on-treatment analysis may provide a more specific measure of the effect of therapy but does so at the risk of introducing potential bias,” the authors wrote.

There was no suggestion of an increase in intracranial bleeding — a feared complication of antithrombotic therapy, according to the researchers — in the apixaban group, with 11 cases in that group and 13 in the aspirin group.

“This finding, together with the report of a much lower risk of hemorrhagic stroke with dabigatran (Pradaxa) as compared with warfarin, indicates that reduction of intracranial bleeding will be one of the most important benefits of the newer oral antithrombotic drugs over vitamin K antagonist therapy,” Diener and his colleagues wrote.

Serious adverse events occurred less frequently in the apixaban group (22% versus 27%), a difference mostly driven by fewer events related to vascular disorders of the central nervous system.

 

The authors acknowledged that early termination of the trial could have inflated the measured benefit.

 

AVERROES was funded by Bristol-Myers Squibb and Pfizer.

Connolly reported receiving payment for serving on the boards of Boehringer Ingelheim, sanofi-aventis, Portola, and Merck, consulting fees from Boehringer Ingelheim, sanofi-aventis, Portola, and Merck, grant support on behalf of his institution from Boehringer Ingelheim, sanofi-aventis, Portola, and Bristol-Myers Squibb, and lecture fees from Boehringer Ingelheim, sanofi-aventis, and Portola.

Diener reported receiving payment for serving on the boards of Abbott, AstraZeneca, Boehringer Ingelheim, CoAxia, D-Pharm, GlaxoSmithKline, Janssen-Cilag, Medtronic, MindFrame, Neurobiological Technologies, Novartis, sanofi-aventis, Servier, and Solvay, consulting fees from Abbott, AstraZeneca, Bayer Vital, Bristol-Myers Squibb, Boehringer Ingelheim, CoAxia, D-Pharm, Fresenius, GlaxoSmithKline, Janssen-Cilag, Knoll, Merck Sharpe and Dohme, Medtronic, MindFrame, Neurobiological Technologies, Novartis, Novo-Nordisk, Paion, Parke-Davis, Pfizer, sanofi-aventis, Sankyo, Schering-Plough, Servier, Solvay, Thrombogenics, Wyeth, and Yamaguchi, grant support on behalf of his institution from AstraZeneca, GlaxoSmithKline, Boehringer Ingelheim, Novartis, Janssen-Cilag, and sanofi-aventis, lecture fees from Abbott, AstraZeneca, Bristol-Myers Squibb, Bayer Vital, Boehringer Ingelheim, CoAxia, D-Pharm, GlaxoSmithKline, Merck Sharpe and Dohme, MindFrame, Neurobiological Technologies, Novartis, sanofi-aventis, Servier, Solvay, and Thrombogenics, payment from Boehringer Ingelheim and sanofi-aventis for manuscript preparation, and payment from Boehringer Ingelheim for developing educational presentations.

Their co-authors reported extensive relationships with industry. One of the authors is employed by Bristol-Myers Squibb.

 


Primary source: New England Journal of Medicine
Source reference:
Connolly S, et al “Apixaban in patients with atrial fibrillation” N Engl J Med 2011; DOI: 10.1056/NEJMoa1007432.

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AHA: Drug-Coated Balloons Expand PCI Options

Drug-eluting Balloons

On Drug-eluting Balloons

 

 

By Chris Kaiser, Cardiology Editor, MedPage Today
Published: November 18, 2011

 

 

ORLANDO — Drug-eluting balloons can be used in place of stenting in patients at high risk of bleeding, Mariusz Zadura, MD, explains in this exclusive InFocus report.

They are particularly useful for patients on warfarin, Zadura, of the Heart and Diabetes Center in Karlsburg, Germany, told cardiology editor Chris Kaiser.

When drug-eluting stents are implanted, dual antiplatelet therapy is contraindicated for 12 months; when balloons are deployed, antiplatelet therapy can begin a month later.

The balloons also offer a solution for bare-metal instent restenosis, Zadura said.

The authors reported they have no conflicts of interest.

 

Primary source: American Heart Association
Source reference:
Zadura, M, et al “Drug eluting balloon-PCI is an alternative to drug-eluting stents in patients with a high risk of bleeding complications” AHA 2011; Abstract 10265.

Additional source: American Heart Association
Source reference:
Zadura M, et al “Durg-Eluting Balloon-PCI is a New Terapeutic Option for Patients with In-Stent Restenosis in Bare Metal Stents” AHA 2011; Abstract 10244.

BIG CITY

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Re-engineering New York: More Than a Sci-Fi Dream?

 

http://www.nytimes.com/2011/11/20/nyregion/new-york-as-a-tech-hot-spot-is-it-just-a-sci-fi-dream.html?src=recg

 

 

At an urban-planning conference last week, Mary Ann Tighe, a prominent commercial real estate broker and glamorous presence in any room full of people who think about sewage flow, aligned herself against a certain strain of traditionalism. The most powerful woman in New York, according to a recent ranking by the business publisher Crain’s New York, Ms. Tighe lamented returning home from China to a skyline she now views only in the quaintest terms.

 

James Estrin/The New York Times

Cheni Yerushalmi, left, a founder of the Sunshine Bronx Business Incubator, chatting with his colleague Don’Angelo Bivens at the start-up center.

 

 

“I always think to myself, what a romantic 20th-century city,” Ms. Tighe told the audience. Implicit in her comment is the notion that to compete with Guangzhou we must look like Guangzhou. I suspect that this is a woman who doesn’t watch “Annie Hall” and get wistful.

Positioning New York for 21st-century global supremacy has been a preoccupation of the Bloomberg administration, and one central to the mayor’s vision of greatly expanding the technology sector by ratcheting up elite science education. The city is reviewing seven proposals from 17 universities and research institutions (Stanford and Cornell are among those that have forged alliances) bidding to create an applied sciences and engineering campus here — one that could spring up on Roosevelt Island or at the Brooklyn Navy Yard, among other potential locations. The city is offering land and up to $100 million in capital to achieve all this.

It is also providing us with an invitation to imagine what New York would look and feel like as a kind of mid-Atlantic Silicon Valley. Is it even possible to mastermind such a world?

The city already has tech enclaves around Union Square and most notably now in Dumbo, Brooklyn. But of course there are reasons to remain skeptical of any future evolution. “Regions around the world have tried for decades to replicate the Silicon Valley experience, without success,” AnnaLee Saxenian, a professor of urban planning and dean of the School of Information at the University of California, Berkeley, told me. “There are also world-class technical universities all over that don’t generate ongoing commercial innovation and economic growth.” (And research generally, in the aggregate, loses money, as some economists will tell you.)

At the same time, Northern California’s Silicon Valley, Boston’s Route 128 and Austin, Tex., have all emerged as technology centers through some combination of major universities, Cold War government research money and proximity to venture capital. New York doesn’t have much in the way of military-financed research and development, but as a major medical center it has hundreds of millions of dollars flowing to it from the National Institutes of Health. James Parrott is an economist who now focuses on issues affecting New York State, but he wrote his dissertation on the emergence of Route 128’s tech corridor and he is optimistic about the city’s plan. “It is a model anyone would follow,” he said.

The mythology, and partial truth, of Silicon Valley is that genius was birthed in so many attached garages. In New York we don’t have garages, we have underground labyrinths that take $400 a month from us to park a car 10 blocks away from our apartments. But we do have places for businesses to grow, once we think about New York as a city that extends beyond Upper and Lower Manhattan.

The South Bronx, for instance. The soon-to-open Sunshine Bronx Business Incubator seems like an apt model for what could come. It occupies part of a floor in the 420,000-square-foot BankNote Building, a former currency-printing plant in Hunt’s Point, which was erected in 1909 and is virtually impossible to describe without sounding like a Corcoran brochure. It has clean lines, high ceilings, enormous windows, sweeping views of the Robert F. Kennedy Bridge and the city beyond, and it is fairly easy to get to, transportation being key to the blossoming of any tech hub.

After an application process and for $195 a month, technology entrepreneurs and other self-employed workers can join Sunshine and avail themselves of a mod, meticulous office space with video-conferencing facilities, open desks, private cubicles, conversation areas, healthy vending-machine snacks, continuing education, camaraderie. The model is a co-operative, and the point is to help people foster allegiances both within their fields and outside them, so that the guy working on a software start-up has ready access to the intellectual property lawyer, who, in turn, can easily find someone to develop her Web site. Those considered to be lacking the correct spirit of fraternity face being expelled.

The Bronx site was opened in part with a modest investment from the city’s Economic Development Corporation. The rest came from Sunshine, whose founders, Cheni Yerushalmi, an Israeli immigrant, and his Iraqi best friend, Joseph Raby, have been running similar sites in NoHo and TriBeCa. The company has helped give rise to Zipmark, a mobile and online payment company; the Vitamin Creek, an online supplier of nutritional supplements, and Atlassian, a $600 million software company; it also owns a retreat for its members (called “shiners”) in Vermont. Given the warehouse stock, the city sees the southern part of the Bronx as a place where tech businesses (and coworking particularly) could really flourish.

Beyond that, though, it is the city’s goal to create a whole population of engineers, men and women whose skills could serve all manner of industries. After the financial crisis, Seth Pinsky, president of the Economic Development Corporation, told me: “We went out to hundreds of people through the city and we asked one simple question. We said, ‘Put resources to the side; what would have the most dramatic impact on our economic competiveness?’ ” Over and over again, the answer was engineering talent. Mr. Pinsky, for his part, would like to see New York become a center for rapid prototyping, which involves the development of sophisticated machinery that serves, essentially, as a three-dimensional printer for product models.

And what if it did? What if legions of engineers lived among us? What would they wear? Where would they eat? What kind of space would they take up in our imagination? Would we ever get to a point, say, where the Engineer Living in Fieldston was as much of a cliché as the Writer Living in Brooklyn, the Editor Eating at Michael’s, the Fund Manager in the Fifth Avenue Apartment?

“New York just doesn’t feel like an engineering town,” a friend, a native and astute observer of the city’s culture, remarked to me recently. I wanted to disagree, but in truth, I couldn’t.

E-mail: bigcity@nytimes.com

This article has been revised to reflect the following correction:

Correction: November 19, 2011

An earlier version of this article mistated the fee that technology entrepreneurs and other self-employed workers pay to use the facilities at Sunshine Bronx Business Incubator. It is $195.