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All GLG News Analyses Filed Under: Cardiology

Analyses are solely the work of the authors and have not been edited or endorsed by GLG.

Do Patients Finally have an Alternative to Anticoagulation for Afib?

April 5, 2009

GLG Expert Contributor

ACC: Device May Prevent Stroke in AF Patients | www.medpagetoday.com

1) Certain patient groups now have an option for non medical protection from thromboembolic events in afib; however patients most likely to benefit were not included in the trial. 2) Despite the success in noninferiority compared to warfarin, the device did have a twofold increase in periprocedural complications. 3) The most likely group of physicians to implant this device will be invasive electrophysiologists who perform afib ablation because of their vast experience with transeptal technique and knowledge of left atrial anatomy.

Good In Theory, But Not In Practice

April 5, 2009

GLG Expert Contributor

Novel Stent Fares Worse Than Bare Metal in STEMI Patients | www.tctmd.com

The concept of coating a stent with antibodies to proteins on the surface of endothelial progenitor cells (a somewhat more mature type of stem cells) is attractive in theory. The stem cells would accelerate the growth of endothelium over the stent and participate in healing of the vessel. Unfortunately, the concept did not prove to be viable in practice. This may be because it does not work, or because of the thrombus usually present in arteries of patients with myocardial infarction and the resultant inability of the stent to attract stem cells. Either way, this negative study will make it difficult to enroll patients in other studies with this stent.

Watchman trial: right device, wrong patient population.

April 3, 2009

GLG Expert Contributor

ACC: Device May Prevent Stroke in AF Patients | www.medpagetoday.com

1. Left atrial appendage is not the only source of systemic thromboemboli. Thrombi form in the rest of the left atrium and even in the ventricle. 2. The trial did not address issues of thrombogenicity of the device by itself. 3. "Pericardial effusion" was not an effusion, but a bleeding from the appendage after device was deployed. 4. The trial did not include population with contraindications to anticoagulation: instead comparing embolic stroke rates in patient with atrial fibrillation with contraindications to Coumadin with and without Watchman, the trial involved anticoagulated patients with and without the device and analyzed the rates of hemorrhagic stroke!!

Darusentan and Resistant Hypertension

April 2, 2009

GLG Expert Contributor

Phase III Study of Gilead's Darusentan for Resistant Hypertension Meets Primary Endpoints | investors.gilead.com

The most recent press release from Gilead Scienes, Inc. (Nasdaq: GILD) re: phase III study of Darusentan, a novel endothelin receptor antagonist, designed to control resistant hypertension. The effectiveness in controlling systemic blood pressure was found to be statistically significant. Incidence of anemia and liver toxicity did not seem to be significant. Frequency of peripheral edema was remarkable.

The Statin Revolution

March 31, 2009

GLG Expert Contributor

Study: Cholesterol drug lowers blood clot risk | hosted.ap.org

The statin drugs continue to show that they have new ways to treat a host of new illnesses. They are amazing drugs and I believe that they will help to lower future healthcare costs by preventing future diseases.

Does Genius-STEMI Trial Spell Trouble for Orbus-Neich Genous Stent?

March 31, 2009

GLG Expert Contributor

Novel Stent Fares Worse Than Bare Metal in STEMI Patients | www.tctmd.com

The device is a stent which is coated with antibodies for capture of endothelial progenitor cells.  It has been suggested that this could favor endothelialization and reduce restenosis, and previous studies predominantly enrolling non-MI patients showed promise for the technology.  The Genius-STEMI trial reported this week at ACC was a small single center trial, and found a higher rate of restenosis and revascularization with the experimental device than with the bare metal control.      

The Watchman prevents embolic stroke in non-valvular atrial fibrillation

March 30, 2009

GLG Expert Contributor

ACC: Device May Prevent Stroke in AF Patients | www.medpagetoday.com

Coumadin is prescribed to patients with atrial fibrillation because of the devastating effects of embolic stroke (coming from the heart), which in 80 year olds can be as high as 24% per year. Coumadinization is a tedious and tricky process wherein patients must have bloodwork frequently, avoid many types of other medications and vegetables, and  may have dangerous bleeding events. A device which could dramatically lower the risk of stroke to levels lower that coumadinization without the excess baggage of coumadin's restrictions would be a welcome addition to our armamentarium and I suspect would be highly utilized, especially at the advanced hospital centers that house cardiac catheterization laboratories.

AstraZeneca's (AZN) Cholesterol Lowering Drug Crestor Reduces Risk of Developing Venous Thromoembolism (VTE)

March 30, 2009

GLG Expert Contributor

Study: Cholesterol drug lowers blood clot risk | hosted.ap.org

Venous thromboembolism (VTE) [also called the economy class syndrome] is an important public health problem. Blood clots that develop in the deep veins of the body can travel to the lungs and be fatal. The JUPITER trial was presented at the American College of Cardiology (ACC) annual meeting currently underway in Orlando, FL and published concomitantly in the online version of the prestigious New England Journal of Medicine (http://content.nejm.org/cgi/content/full/NEJMoa0900241). The trial showed that apparently healthy patients who received Crestor instead of a placebo were 43% less likely to develop VTE and 23% less likely to develop Pulmonay emoblism (blood clot in the lungs). This suggests that Crestor has effects on the inflammatory mechanisms in the body in addition to its effects on lowering cholesterol.

Atritech's Watchman Atrial appendage closure device could be a useful alternative to warfarin in patients with Atrial Fibrillation.

March 29, 2009

GLG Expert Contributor

ACC: Device May Prevent Stroke in AF Patients | www.medpagetoday.com

The results of the PROTECT-AF trial were presented at the annual meeting of the American College of Cardiology (ACC) currently underway in Orlando, FL. This trial enrolled patients with Atrial fibrillation and compared warfarin with the Watchman device. The trial was designed as a non inferiority trial and the device was noted to be non inferior to warfarin for its primary end points of stroke and death and as expected the device group had lower rates of strokes caused by bleeding in the brain (hemorrhagic strokes).

Genous bio-engineered (endothelial cell capture) stent results presented at the American College of Cardiology Annual Meeting

March 29, 2009

GLG Expert Contributor

Novel Stent Fares Worse Than Bare Metal in STEMI Patients | www.tctmd.com

The Genous stent is a bio-engineered endothelial cell capture stent that has been projected as a "stent technology of the future". This stent was designed to decrease the rates of stent re-narrowing (in stent restenosis) and catastrophic closure of the stent (stent trombosis). The GENOUS trial (comparing this stent to an older generation cobalt-chromium non drug coated stent) was presented at the annual meeting of the American College of Cardiology (ACC) currently underway in Orlando. This showed the GENOUS stent performed much worse. While the mortality rates were similar in both groups, this trial raises significant safety concerns.

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