Category Archives: Clinical Trials / Studies

October 15, 2012 · 7:59 pm

TCT 2012 – Transcatheter Cardiovascular Therapeutics in Miami Beach

Miami Beach

The TCT will be held in Miami Beach, October 22-26, 2012

The Transcatheter Cardiovascular Therapeutics conference (TCT) is the largest U.S. meeting devoted to interventional cardiology (angioplasty, stents, and related procedures) and it starts next week. Organizers are predicting a new attendance record of over 12,000 cardiologists and associated healthcare professionals, as well as members of the device, imaging and pharmaceutical industries, venture capitalists, and press. Speaking of which, yes…I will be there and Angioplasty.Org will be reporting on late-breaking trials, new directions and innovative devices.

The annual  meeting is truly international: attendees will be traveling from 70 countries; in fact, this year more than two-thirds of the registrants hail from outside the United States. Continue reading →

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Filed under Clinical Trials / Studies, Cost Effectiveness, FDA, Global Trends, Heart Attack, High Blood Pressure, Intravascular Guidance, Meetings & Conferences, Stent, Transradial Approach

September 28, 2012 · 7:37 pm

Medtronic Launches Stent for Diabetics in India; Abbott Launches Absorb “Scaffold”

Medtronic’s Resolute Integrity zotarolimus-eluting stent

According to reports yesterday by the Mumbai Bureau of Pharmabiz, and confirmed today by MassDevice, Medtronic has launched its Resolute Integrity Drug-Eluting Stent (DES) in India for the treatment of coronary artery disease (CAD). The Resolute Integrity is the only stent approved by the FDA for use in diabetics, based on a large cohort of diabetic patients in the Resolute clinical program.

Diabetics historically have had higher adverse events when treated with PCI (angioplasty and stents) — but the data from the Resolute trials showed virtually no difference between diabetics and non-diabetics, leading the FDA to approve the indication. Continue reading →

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Filed under Clinical Trials / Studies, Diabetes, Drug-Eluting Stents, FDA, Global Trends, Stent

September 15, 2012 · 1:00 pm

Results of the ADVISE Registry Published

Artist rendition illustrating the iFR "Wave Free Period"

Artist illustration of the iFR “Wave Free Period”

As previously reported on Angioplasty.Org, a new method for the functional measurement of intracoronary pressures and the severity of blockages has been developed by researchers at Imperial College in London. One of the main advantages of this new method, called Instant Wave-Free Ratio™ (iFR), is that, unlike standard fractional flow reserve (FFR), it does not require injection of a vasodilator drug, such as adenosine, to induce stress on the heart. The result is that the procedure is more comfortable for the patient and potentially useable in clinical scenarios where vasodilation is not feasible, such as acute coronary syndromes, infarctions, unstable patients, patients with breathing problems; it may also be somewhat quicker, easier to use, and more cost-effective. Continue reading →

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Filed under Appropriate Use Criteria (AUC), Cost Effectiveness, FAME I / FAME II, FFR, Interviews, Intravascular Guidance, Stent

July 8, 2012 · 10:30 pm

Cost Effectiveness of Wrist Angioplasty from Japan

Patient exchange in cath lab at Kihara Cardiovascular Hospital in Japan

Patient exchange in cath lab at Kihara Cardiovascular Hospital in Japan

Earlier today I reported on an important study, published online first in Circulation: Cardiovascular Quality and Outcomes. The study fed the results from 14 radial vs. femoral trials (RIVAL et al) into the cost-benefit analysis machine at Penn Medicine’s Center for Evidence-based Practice (CEP).

And the results? The transradial wrist approach to catheter-based procedures (angiograms, stents, etc.) was less expensive ($275 per procedure) and resulted in two-thirds less complications than the femoral/groin approach. Continue reading →

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Filed under Clinical Trials / Studies, Cost Effectiveness, Japan, Patient Experience, Video

May 15, 2012 · 9:18 pm

FAME II: Should Fractional Flow Reserve (FFR) Be Mandatory?

Should Fractional Flow Reserve (FFR) Be Mandatory?Earlier today, the opening day of EuroPCR, Dr. Bernard De Bruyne presented preliminary results from the FAME II trial which tested the diagnostic power of Fractional Flow Reserve to guide PCI (stenting) of the coronary arteries. I wrote about FAME II back in January, when enrollment in the trial was halted for ethical reasons because the results of the ongoing FAME II trial were showing that the outcomes for stents in patients with stable angina were clearly superior to those in patients who were being treated with medications (a.k.a. Optimal Medical Therapy or OMT) alone. An independent Data Safety Monitoring Board advised that continuing the randomization would not change the findings and so, it was unethical to withhold the option of stents from this patient population. Continue reading →

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Filed under Appropriate Use Criteria (AUC), COURAGE, FAME I / FAME II, FFR

March 4, 2012 · 1:30 pm

Stent-Trek: The Next Generation

Starship Stenterprise

Starship Stenterprise

Yeah. I went there. Since everyone from Motley Fool to MassDevice to the Wall Street Journal feels the need to use “Stent Wars” (a pun that I originated on this website a decade ago) I’ve decided to go all TV. Actually, “The Next Generation” is also a more appropriate reference than the “Wars” moniker, because the story here is no longer so much about behemoth entities and dark lords battling each other for control of the universe (not that this aspect has gone away) but a story of refinement, sleeker technology and, yes, much more Data! And this past couple of weeks has seen some important developments in the next generation of stents that are positive for both patients and physicians. Continue reading →

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Filed under Antiplatelet Medications, Clinical Trials / Studies, FFR, High Blood Pressure, Innovators, Intravascular Guidance, IVUS, Meetings & Conferences, OCT

February 8, 2012 · 5:35 pm

Stents vs. Pills — Summer Re-run in February

Pills vs. StentI’m looking at this morning’s news and I’m seeing headlines like these: “Stents Overused in Stable Heart Patients” (WebMD), “Pills as good as stents for stable heart patients” (Reuters), “No Extra Benefits Are Seen in Stents for Coronary Artery Disease” (New York Times), and “Stents no better than pills for some heart patients” (MassDevice) — and I think I have time-traveled half a decade back to March 2007 when the results of the COURAGE study were presented at the American College of Cardiology Annual Meeting. Continue reading →

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Filed under Clinical Trials / Studies, COURAGE, Media Coverage, Stent