On June 19th, 2010 Dr. Andrey Espinoza, MD FACC FSCAI was asked to present at the 2010 Live Symposium of Complex Coronary and Vascular Symposium Hosted by the Mount Sinai School of Medicine, NY, NY.
Dr. Espinoza presented a challenging case performed at Hunterdon Medical Center to a International Panel of Experts for discussion.

cccsymposium.org

June 18, 2010
Mark Crane
Adapted from Medscape Medical News-a professional news service of WebMD

AVERROES:
Apixaban in atrial fibrillation study stopped early for benefit

Washington, DC - In a surprise turnabout, coming the day after it had rejected the same measure, the US Senate reached a last-minute deal Friday to delay a planned 21.3% Medicare fee cut for six months. The legislation also provides a 2.2% payment increase.
Senate Majority Leader Harry Reid (D-NV) and Senate Minority Leader Mitch McConnell (R-KY) both said the compromise is "paid for" and won't affect the national deficit. Under Senate rules, the agreement was passed by "unanimous consent" without a roll-call vote.
The legislators took turns complimenting each other for a new spirit of cooperation. They'd used heated rhetoric to bash each other Thursday night after a $118-billion package for a six-month delay in the Medicare pay cuts plus a finance package that extended jobless benefits and provided $24 billion to states for their Medicaid programs failed to pass.
The new pact was brokered by Senate Finance Committee Chair Max Baucus (D-MT), who said the agreement was a "good omen" that the two parties could work together on the rest of the finance package in the future.
The last-minute agreement means that the pay cuts, which technically went into effect June 1, will be rescinded, and physicians will be paid the full amount of their Medicare fees. If the Senate hadn't acted, the cuts would have gone into effect today.
Medicare contractors were ready to start processing June claims at the reduced rate. But the Center for Medicare and Medicaid Services (CMS) was holding up the claims, anticipating that Congress would stop the reduction retroactively.
The House of Representatives must still pass the measure, and that's likely to happen Monday. The CMS acknowledges that the uncertainty about the fee cuts and delayed processing of Medicare claims may present cash-flow problems for some doctors. It expects the delays to be only a few days.
Medical groups are still upset that the "doc fix" is only for six months instead of a longer reprieve from threatened pay cuts.
"The reduction in payments, even if temporary, creates havoc for practices," the American College of Physicians said in a statement. "The situation is unacceptable, and the frustration and anger is understandable." It said doctors need stable and predictable payments and called for a permanent fix.
Even before the vote Thursday, the American Medical Association at its annual meeting in Chicago mocked Congress for failing to grapple with the pay issue, saying the "Senate fiddles as Medicare burns" and that a six-month reprieve was inadequate.
The Medicare pay-cut issue is the result of a decade-old formula, called the sustainable growth rate, set up by Congress to slow the growth in Medicare spending. Reimbursement rates for Medicare would have been trimmed on a yearly basis. But Congress has deferred the cuts nine times since 2003, almost always just days before planned cuts would take effect. Changing the formula wasn't included in the healthcare overhaul President Barack Obama signed into law in March.

June 11, 2010
Michael O'Riordan

AVERROES:
Apixaban in atrial fibrillation study stopped early for benefit

Princeton, NJ and New York, NY - The Apixaban versus Acetylsalicylic Acid to Prevent Strokes (AVERROES) trial, a study comparing the safety and effectiveness of apixaban (Pfizer/Bristol-Myers Squibb) and aspirin in patients with atrial fibrillation, has been stopped early after a predefined interim analysis by the independent data monitoring committee "revealed clear evidence of a clinically important reduction in stroke and systemic embolism".
Full data from the study are not yet available, although a company statement issued yesterday reported that the interim analysis demonstrated an acceptable safety profile for apixaban compared with aspirin.
The AVERROES trial is being coordinated by the research institute at McMaster University, in Hamilton, ON, and consisted of 5600 patients from 36 countries with all types of atrial fibrillation who were intolerant of or unsuitable for warfarin. The study began in September 2007, with patients randomized to 5 mg of apixaban or 81 to 324 mg of aspirin for up to 36 months or until the end of the study.
The primary efficacy outcome is the time from the first dose of the study drug to the first occurrence of ischemic stroke, hemorrhagic stroke, or systemic embolism. The secondary efficacy outcome includes the time to the first occurrence of ischemic stroke, hemorrhagic stroke, systemic embolism, MI, or vascular death.
Apixaban is an oral factor Xa inhibitor that is being tested in a number of different types of patients. In one phase 2 study, reported by heartwire, researchers showed that apixaban added to antiplatelet therapy in acute coronary syndrome patients resulted in a dose-dependent increase in bleeding and a trend toward a reduction in clinically relevant ischemic events. Another study, also reported by heartwire, showed that the drug missed its primary end point in patients undergoing knee surgery, failing to meet statistical criteria for noninferiority when compared with enoxaparin (Lovenox, Sanofi-Aventis) for the prevention of venous thromboembolism.
Full results from the AVERROES study will be published at a later date in a medical journal, according to company officials. It will be presented at the European Society of Cardiology 2010 Congress in Stockholm, Sweden.

PRESS RELEASE from
The Society for Cardiovascular Angiography and Interventions
May 26, 2010

SCAI Statement on the
NEJM Study Showing Carotid Stenting is as Safe
and Effective as Carotid Surgery in Patients
at Risk for Stroke

Carotid Revascularization Endarterectomy vs. Stenting Trial (CREST), published in The New England Journal of Medicine this week, found carotid artery stenting (CAS) is equally safe and as effective as carotid endarterectomy (CEA) for stroke prevention. The study is the largest and most rigorous randomized stroke prevention trial ever undertaken, and its findings are the strongest evidence to date for clinical equality and long-term durability (out to four years) of both.

• The overall safety and efficacy of the two procedures, based on the combined primary endpoint of stroke, heart attack and death, was largely the same, with equal benefits for both men and for women, and for patients who had previously had a stroke and for those who had not. There were also some notable differences. Investigators found:
  
  
• An especially noteworthy finding: CREST showed no significant differences between surgery and stents for the incidence of major or disabling stroke. The incidence of minor strokes (so-called mini-strokes) was higher for CAS; by definition, these were largely resolved shortly after the procedure. Patients treated with CEA, on the other hand, were twice as likely to suffer a heart attack (2.3 percent for surgery vs. 1.1 percent for stenting).
  
  
• This is an extremely important finding with significant implications for patients. Perioperative heart attacks after vascular surgery, including CEA, have been linked to a four times higher risk of dying during follow up (Landesberg G et al. J Amer Coll Cardiol 2003;42:1547-54). In contrast, the symptoms caused by minor strokes, as defined in the study, were those that resolved within 30 days.
  
  
• Improvement in training techniques for both vascular surgeons and interventional cardiologists contributed to the better outcomes for patients in both arms of the CREST trial, compared with previous European trials, which allowed inexperienced operators to be tutored during stent placement. In CREST, both the surgeons and the interventionalists underwent screening to ensure adequate training and experience before they were permitted to enroll patients.
  
  
• The age of the patient made a difference - younger patients generally did better with stents, older patients generally did better with surgery. For patients 69 years and younger, stenting results were superior to surgical results; the younger the patient, the larger the stenting benefit. Conversely, for patients older than 70, surgical results were slightly better than stenting; the older the patient, the larger the surgery benefit.
  

The authors of the editorial accompanying the CREST study rightly conclude: "... given the lack of significant difference in the rate of long-term outcomes [for CAS and CEA], the individualization of treatment choices is appropriate." Currently, however, only high-risk patients who are not good candidates for surgery are able to receive a CAS procedure. SCAI believes the CREST data should convince the Centers for Medicare and Medicaid Services (CMS) to reopen its coverage decision to give patients an opportunity to choose their procedure and allow physicians to tailor treatments for the best possible outcome. The evidence now strongly supports "individualizing" treatment and offering stent coverage so more patients who may benefit from this safe, effective and less-invasive treatment have access to it.

REMARKS FROM SCAI LEADERS

"CREST represents a landmark trial. The most important finding is that both strategies - CAS and CEA - produce excellent results in patients at risk for stroke, and carry similarly low procedural risk," said Kenneth Rosenfield, M.D., FSCAI, an interventional cardiologist and section head for Vascular Medicine and Intervention at Massachusetts General Hospital. "There was no difference in major stroke between surgery and stenting. There were more heart attacks with surgery and more minor strokes with stenting. But, with a minor stroke, the symptoms are usually subtle and resolve relatively quickly - within 30 days. Fortunately, major disabling stroke, which can significantly impact a patient's quality of life, occurred very infrequently in both treatment arms. In fact, complications were very infrequent for both treatments. These results indicate that patients who need their carotid artery opened will now have two options, stenting or surgery; the decision between these two must be individualized based on the patient's preference, age, medical condition, and anatomic suitability for CAS and CEA."
"The CREST data demonstrate the safety and efficacy of carotid artery stenting, reinforcing that this option should be available to more patients. We encourage the Centers for Medicare and Medicaid Services (CMS) to reopen its coverage decision on carotid stenting so more patients may benefit from a less-invasive option," said Christopher White, M.D., FSCAI, chairman, Department of Cardiology, and director of the Ochsner Heart & Vascular Institute, Ochsner Medical Center in New Orleans, and president-elect of the Society for Cardiovascular Angiography and Interventions. "Physicians should have the option to individualize treatment, given this data, to meet the varying needs of our patients."
"The CREST data suggest a larger group of patients, especially younger patients, are good candidates for carotid stenting. As stroke is a major cause of death in the United States, trials such as CREST add to our body of knowledge on how to best treat patients to address their individual needs so they may lead full and productive lives," said Larry S. Dean, M.D., FSCAI, president of the Society for Cardiovascular Angiography and Interventions, director of the University of Washington Medicine Regional Heart Center and professor of Medicine and Surgery at the University of Washington School of Medicine.

Upcoming Cases on the Endovascular Forum:
Endovascular Forum Original Interactive Cases

Use of Combined Atherectomy and Stenting to Treat a Complex Distal Anastomotic Vein Graft Stenosis and De Novo Popliteal Artery
Andrey Espinoza, MD, FACC, FSCAI
Medical Director, Cardiac Catheterization Laboratory
Hunterdon Cardiovascular Associates
Hunterdon Medical Center
Flemington, NJ, USA

www.endovascular.org