Category Archives: Clinical Trials / Studies

Status of the “Disappearing Stent” in Europe: It’s Complicated!

Last night news began circulating on Twitter that Abbott’s Absorb BVS (Bioresorbable Vascular Scaffold) was being withdrawn from the European market. This information was prompted by several physicians posting on Twitter a March 31 “Urgent Field Safety Notice/Physician Advisory” letter from Abbott addressed to “Valued Abbott Vascular Customer.”

A number of news sources, including this one, posted articles and tweets to the effect that the Absorb was being taken off the commercial markets and, as the letter stated, “Effective May 31, 2017, the device will only be available in clinical register setting at select sites/institutions that will play a pivotal role in the monitoring of this technology until Summer 2018 at which time the situation will be reviewed.”

This morning Abbott reacted to this initial flurry of reports that they had “pulled the Absorb” with some clarification: specifically that the Absorb is NOT being pulled from the market and still retains the CE Mark. An Abbott spokesperson told Angioplasty.Org, “Absorb will continue to be commercially available in Europe through the registries.”

But the relationship, as they say on Facebook, is complicated.

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Filed under ACC, Antiplatelet Medications, Bioresorbable Stents/Scaffolds, Business & Industry, Clinical Trials / Studies, Europe, Stent, Stent Thrombosis

Interventional Cardiology Late-Breakers at ACC.17

Washington Convention Center

Over the next three days, a voluminous amount of data will be presented, shared, and debated among an estimated 18,000 attendees of the annual meeting of the American College of Cardiology, this year held in Washington, DC.

While the meeting covers the whole spectrum of cardiology and heart-related issues, there are a number of studies and late breaking clinical trials specific to the subspecialty of interventional cardiology. Continue reading

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Filed under ACC, Bioresorbable Stents/Scaffolds, Clinical Trials / Studies, FAME I / FAME II, FFR, Heart Attack, iFR, Intravascular Guidance, Meetings & Conferences

NORSTENT: Drug-Eluting Stents – Doing What They’re Supposed To

Coronary StentsAt this week’s annual European Society of Cardiology Congress in Rome, an important randomized clinical trial on stents was presented by Professor Kaare H. Bønaa, MD, PhD of the Clinic for Heart Disease, St. Olav’s University Hospital in Trondheim, Norway. Called NORSTENT, short for the “Norwegian Coronary Stent Trial,” this was the largest stent trial ever conducted, with 9,013 patients followed for six years. That’s serious! Continue reading

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Filed under Antiplatelet Medications, Back to the Future, Bare Metal Stents, Clinical Trials / Studies, Cost Effectiveness, Diabetes, Drug-Eluting Stents, Europe, Global Trends, Media Coverage, Meetings & Conferences, Patient Experience, Patients, Stent, Stent Thrombosis

AimRADIAL Masterclass V + FFR Workshop in Budapest

budapest_palaceOn September 22-23, 2016, the 5th Advanced International Masterclass on the Transradial Approach will be held in Budapest, Hungary. And this year, AimRADIAL will be preceded on September 21 by a one-day comprehensive workshop covering all aspects of Fractional Flow Reserve (FFR) from the basic principles and set-up in the cath lab, to the differences between FFR, iFR, and CFR, a comprehensive review of the clinical study data so far, and finally a look at future modalities, like FFR-CT (although the title of that talk by Dr. Nick Curzen is “FFR-CT: the future is now“). Continue reading

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Filed under Angiograms, Cardiac CT, FAME I / FAME II, FFR, Global Trends, iFR, Medical Education, Meetings & Conferences, Patient Experience, Transradial Approach

COURAGE: Does 15-Year Data Have Any Clinical Relevance?

pills_vs_stent_140sqThis past week saw publication of an update to the 2007 COURAGE trial which compared optimal medical therapy (OMT) to stenting (PCI) as the initial management strategy for stable coronary artery disease. (Please note the phrase “initial management strategy.” This will not be the last time you see it in this post.)

Appearing in the New England Journal of Medicine and titled “Effect of PCI on Long-Term Survival in Patients with Stable Ischemic Heart Disease,” this study, performed by Dr. Steven P. Sedlis and other COURAGE trial investigators, is described as “an extended survival analysis to examine the potential long-term survival benefit from initial PCI among the patients with stable ischemic heart disease who were followed for up to 15 years after initial enrollment in the COURAGE trial.”

This new analysis concluded: “…we did not find a difference in survival between an initial strategy of PCI plus medical therapy and medical therapy alone in patients with stable ischemic heart disease.” This also was the finding of the original COURAGE trial at five years. Continue reading

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Filed under Appropriate Use Criteria (AUC), Bare Metal Stents, Clinical Trials / Studies, COURAGE, Drug-Eluting Stents, FAME I / FAME II, FFR, Intravascular Guidance, IVUS, OCT, Optimal Medical Therapy, Stent

iFR and iFR Scout to be Featured in Live Case from Hammersmith

Dr. Justin Davies discusses value of using physiology-guided PCI

Dr. Justin Davies discusses value of using physiology-guided PCI

If you’ve been wondering what iFR (Instant wave-Free Ratio) is, how it works, how it compares to FFR (Fractional Flow Reserve) and, most importantly, how it affects clinical outcomes, then click here to register for a free, online, interactive live case being done on Monday, April 13, 2:30pm-3:30pm London Time, 9:30am-10:30am New York Time).

Interactive: that means you can ask questions!

Dr. Justin E Davies, interventional cardiologist at Imperial College NHS Trust, and developer of iFR, will be performing and guiding the worldwide audience through a live complex PCI multivessel case, using physiology to guide his procedure. Continue reading

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Filed under FAME I / FAME II, FFR, Global Trends, iFR, Imaging, Intravascular Guidance, Medical Education, Meetings & Conferences, Stent

Plavix and Aspirin After Stent: 8 Years Later – Is Longer Better?

plavix_and_stentNo one thought it would take quite so long to get this information, but in just a couple hours results from the Dual Antiplatelet Therapy (DAPT) Study will be presented at the American Heart Association Scientific Sessions 2014. The question to be answered: Is there a benefit to extending dual antiplatelet therapy (aspirin plus a thienopyridine, such as clopidogrel/Plavix, prasugrel/Effient, etc.) beyond one year after stenting?

This is a question asked back in 2006, during a special two-day FDA hearing, convened to discuss all known issues with drug-eluting stents and prompted by the “ESC firestorm” over the problems of increased incidence of late stent thrombosis in drug-eluting stents. (See “Problems Resurface with Drug-Eluting Stents” – September 9, 2006.) Continue reading

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Filed under Antiplatelet Medications, Bare Metal Stents, Clinical Trials / Studies, Drug-Eluting Stents, Global Trends, Meetings & Conferences, Optimal Medical Therapy, Stent Thrombosis