Category Archives: Clinical Trials / Studies

March 20, 2013 · 7:13 pm

FDA Panel Decision on Mitraclip Approval: It’s Safe and “Sort of” Effective

MitraClip, manufactured by Abbott Vascular

MitraClip, manufactured by Abbott Vascular

Today’s Circulatory System Devices Panel of the Medical Devices Advisory Committee heard testimony from Abbott Vascular, surgeons, cardiologists and patients.

The indications for the MitraClip Clip Delivery System that were being discussed were “the percutaneous reduction of significant symptomatic mitral regurgitation (MR=3+) in patients who have been determined by a cardiac surgeon to be too high risk for open mitral valve surgery and in whom existing co-morbidities would not preclude the expected benefit from correction of the mitral regurgitation.”

In the end, the panel voted on three questions which relate to the approvability of the device, and the envelope goes to…well here are the votes: Continue reading →

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Filed under Clinical Trials / Studies, FDA, Meetings & Conferences, Patient Empowerment, Patients

January 28, 2013 · 12:47 pm

European Society of Cardiology: “Transradial Access Should Be 1st Choice for Angioplasty”

Transradial Wrist ApproachThis is very big news.

Today the European Association of Percutaneous Cardiovascular Interventions (EAPCI), the Acute Cardiovascular Care Association (ACCA) and the Working Group (WG) on Thrombosis of the European Society of Cardiology (ESC) published their joint consensus document on the radial approach to PCI, online ahead of print in EuroIntervention. Continue reading →

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Filed under Clinical Trials / Studies, Cost Effectiveness, Global Trends, Patient Experience, Patients, Transradial Approach

December 6, 2012 · 10:53 am

The Activated Patient Blog Launches

Partnering with informed patients is a central tenant of the newly released joint 2012 Guidelines For Diagnosis and Management of Patients with Stable Ischemic Disease, as well as SCAI’s consensus update on Ad-Hoc PCI. And new studies about angioplasty and stents are being presented regularly that call for shared decision-making: for example, the OVER study, showing that endovascular repair of abdominal aortic aneurysms with stent grafts is equivalent to open surgery, the FREEDOM study discussing the options for multivessel disease in diabetic patients, and FAME 2 for the treatment of stable heart disease with significant ischemia as measured by fractional flow reserve. Patient preference comes into play in all of these. Continue reading →

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Filed under ACC, Clinical Trials / Studies, FFR, Patient Empowerment, Patient Experience, Patients, Shared Decision-Making

December 2, 2012 · 7:27 pm

Fractional Flow (Chart) Reserve

Flow Chart from Ad Hoc PCI Consensus Statement

Click to enlarge flow chart

Best medical practices for angioplasty and stent placement are a moving target because no sooner than a guideline is published it can be changed by the results of a more recent study. And the SCAI Ad Hoc PCI Consensus Statement posted online just three days ago is no exception. Continue reading →

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Filed under FAME I / FAME II, FFR, Non-Invasive Testing, Optimal Medical Therapy

December 1, 2012 · 11:17 pm

Ad Hoc Angioplasty: The Patient Is On The Table

Cardiologist and patient in cath lab

Cardiologist talks to a patient “on the table” in cath lab

Something that is “on the table” is defined as an item that is “up for discussion.” And this week The Society for Cardiac Angiography and Interventions (SCAI) issued a consensus statement about the proper use of “ad hoc PCI” — and the patient was definitely on the table, up for discussion, part of the conversation.

Since we’re into definitions, ad hoc PCI is the scenario in which a diagnostic catheterization is followed in the same session by PCI (angioplasty and stents). And this is a common scenario: in New York State, for example, 80% of all angioplasties are done in the same session as the diagnostic angiogram, although the vast majority of these are emergency or primary angioplasties, where a patient in the midst of a heart attack (or close to it) is brought into the cath lab and the blockage is opened up, saving the heart muscle and possibly the patient’s life. Continue reading →

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Filed under COURAGE, FAME I / FAME II, FFR, Heart Attack, History, Optimal Medical Therapy, Patient Empowerment, Patients, Shared Decision-Making, Stent

November 27, 2012 · 6:03 pm

Stents, Trials and Studies: What’s in a Word?

What's In a Word?Today the editors of the HEART Group Journals, comprising the Journal of the American College of Cardiology and other participating cardiovascular publications, issued a “Statement on Matching Language to the Type of Evidence Used in Describing Outcomes Data.”

Although the title of the article may be a bit yawn-inducing, the editors deserve a kudo or two for attempting to clarify reporting on medical issues. Continue reading →

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Filed under ACC, Appropriate Use Criteria (AUC), Clinical Trials / Studies, Drug-Eluting Stents, FDA, Media Coverage, Patients

October 30, 2012 · 8:54 pm

The Question of Angioplasty in the Elderly

We just posted a report on the XIMA Trial which studied stents in octogenarians. The trial compared drug-eluting with bare-metal stents and the results are very interesting: while the trial didn’t find a difference in these two types of stents for the pre-specified composite endpoint of death, heart attack, revascularization, stroke and major bleeding…it did find significantly lower incidence of revascularization and heart attack in those patients who received the drug-eluting Xience stent.

But the real take-away from the XIMA Trial is that stenting and angioplasty in the elderly is safe and effective. Mortality from cardiac causes in this trial was 4% at one year, no matter which stent was used. Continue reading →

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Filed under Antiplatelet Medications, Bare Metal Stents, Clinical Trials / Studies, Drug-Eluting Stents, Heart Attack, Meetings & Conferences, Patients, Stent, Video