ATLANTA—More research is needed on the relative costs and benefits of using drug-eluting stents (DES) versus bare-metal stents (BMS) in patients who have experienced a STEMI, according to the results based on the DEDICATION trial presented Tuesday at the ACC.10 conference. Slides»
Monday, March 15, 10:30 AM - 12:00 PM Each year at the ACC meeting, program planners pour through abstracts to include in the late-breaking clinical trials sessions. This year, they picked 30 abstracts out of more than 100 that were submitted. Many of the late-breaking selections promise to be game-changers. If you want to get a sense of what your future practice might look like, you need to sit in on this session.
Written by Justine Cadet
Washington, D.C.—Due to the variety of bleeding definitions used in clinical trials and the potential various outcomes on patients and clinical practice from different bleeding thresholds, Sunil V. Rao, MD, from Duke University Medical Center in Durham, N.C., argued that the time has come to arrive at a consensus definition of bleeding, at the Cardiovascular Research Technologies conference on Feb. 21.
Antiplatelet agent ticagrelor (Brilinta, AstraZeneca) reduces death rates without increasing bleeding compared with the current standard treatment of clopidogrel for heart attack patients, based on the PLATO-Invasive trial published online Jan. 13 in the Lancet. An accompanying commentary describes the introduction of ticagrelor as “a landmark event that should redefine the care of patients with acute coronary syndromes (ACS).”
To better study the efficacy of the Combo Bio-engineered Sirolimus Eluting Stent, OrbusNeich has announced that a clinical trial to evaluate the success of the stent is underway in patients with symptomatic, ischemic heart disease.
Orlando, Fla.—STEMI patients who received both aspirin and the new reversible oral antiplatelet drug ticagrelor (Brilinta; AstraZeneca) had few cardiac events and less mortality than patients on aspirin and the popular irreversible antiplatelet medication clopidogrel (Plavix; Bristol-Myers Squibb), based on the results of the PLATO STEMI trial, presented during Sunday’s late-breaking clinical trial session at the American Heart Association conference.
HORIZONS AMI, which studied 3,602 STEMI patients who underwent primary PCI after two years, continued to find a statistically significant superiority for initial treatment with bivalirudin alone compared with heparin plus GPIIb/IIIa inhibitors, and for drug-eluting stents over bare-metal stents. The study was presented during the late-breaking clinical trials at the 2009 Transcatheter Cardiovascular Therapeutics (TCT) conference in San Francisco on Sept. 25.
SAN FRANCISCO—Abbott’s Xience V stent demonstrates enhanced safety and efficacy compared with Boston Scientific’s Taxus Express without routine angiographic follow-up, according to the one-year clinical data of SPIRIT IV presented at the late-breaking clinical trials session on Wednesday at the Transcatheter Cardiovascular Therapeutics conference. However, both stents produced positive clinical outcomes.
The National Institute for Health and Clinical Excellence (NICE) has issued approval for the marketing of prasugrel (Efient in EU/Effient in U.S.) from Eli Lilly and Daiichi Sankyo, with a few limitations.
Prasugrel (Effient) significantly reduces the risk of cardiovascular events in patients with acute coronary syndromes after PCI regardless of whether or not a glycoprotein (GP) IIb/IIIa inhibitor is used, according to an analysis of the TRITON–TIMI 38 trial in the Aug. 18 issue of the Journal of the American College of Cardiology.
|
Written by Justine Cadet
ATLANTA—The Endeavor stent was found to be inferior to the Cypher stent in routine clinical care patients at 18-month follow-up, according to the all comers SORT OUT III trial presented Monday at the late breaking clinical trials session during the 59 th American College of Cardiology (ACC) conference. Slides»
In many hospitals, the cath lab is the hub around which the practice of cardiology revolves. With our increasingly aging population and epidemic rise in diabetes and obesity, interventional cardiologists are performing more and more coronary interventions. To ensure efficacy and efficiency in the cath lab, physicians must focus on a broad range of areas, including devices, drugs, patient selection and protocols. All of these topics must be considered because a chain is only as strong as its weakest link. Drug-eluting stents (DES) have proved their worth compared to bare-metal stents in terms of improved restenosis rates. Questions still exist, however, regarding stent thrombosis. In addition, newer generation DES, coupled with new drugs and drug regimens, have made significant progress in reducing adverse events during and after PCI. But cardiologists want to know which DES and which drug regimen are best for their patients? The amount of research being conducted around improving the safety and efficacy of PCI is staggering. Even more impressive, however, is the careful consideration that interventionalists give to the emerging data. ACC.10, which kicks off Saturday in Atlanta, in conjunction with the i2 Summit, is chock full of educational sessions and late-breaking trials piloted by experts trying to determine how best to interpret the latest evidence. Attendees will no doubt hear disagreement, but they also will be treated to thoughtful analyses, robust discussions and honest deliberation. The basis of the next-generation of best practices will be defined. The late-breaking trials alone are worth the price of admission. Most of these trials are comparative studies, pitting one therapy against another. For example, the PLATO trial compared ticagrelor with clopidogrel in patients undergoing CABG. Other trials examine various management strategies for diabetics, intense versus less intense blood pressure control and various atrial fibrillation treatment approaches. In the past few years, there have been dramatic advances in PCI techniques, devices, and medications, with no sign that these will slow down. Guidelines published by the ACC, in conjunction with other societies, are continually being updated as new approaches supplant the old. Within the last few years, changes to guidelines include: • Updated recommendations on using anti-clotting medications, such as clopidogrel, low molecular-weight heparin and bivalirudin, before, during and after PCI; • A recommendation that embolic protective devices be used during PCI or peripheral arterial interventions; and • A recommendation for early follow-up of patients who have PCI of the left main coronary artery. Interventional cardiologists can expect to find many sessions at ACC.10 that will help them improve their daily practice. What's good for the patient is also good for the practice. With decreasing reimbursement and payment increasingly tied to performance, incorporating the latest cutting-edge research into one's practice will go a long way toward ensuring patient safety and practice efficiency. For educational session and late-breaking trial locations as well as other details, consult the session program onsite or visit ACC10.ACC.org. To download a pdf of conference sessions, click here. Click here to download the program to a mobile device or click here from within your mobile browser to download directly. You also can download the final program to your Ebook reader here. Cardiovascular Business News will help you navigate ACC.10. To get our daily news updates of education sessions from ACC.10 delivered to your inbox or mobile device, be sure you're signed up for Cardiovascular Business News at CardiovascularBusiness.com.
Written by Justine Cadet
Washington, D.C.—David J. Cohen, MD, director of cardiovascular research at St. Luke’s Mid America Heart Institute in Kansas City, Mo., evaluated the economics of drug-eluting stents (DES) versus bare-metal stents (BMS), along with what has recently changed in clinical practice to influence their costeffectiveness, during a session on Feb. 22 at the annual conference of the Cardiovascular Research Technologies.
The everolimus-eluting stent is better than the second-generation paclitaxel-eluting stent (Taxus Liberte, Boston Scientific) in unselected patients undergoing PCI in terms of safety and efficacy, concluded the COMPARE trial that was published Jan. 7 in Lancet. Based on these findings, the authors suggest that paclitaxel-eluting stents should no longer be used in everyday clinical practice.
Orlando, Fla.—The new, reversible antiplatelet drug cangrelor was not superior over clopidogrel in reducing the composite of death, MI or ischemic revascularization 48 hours after PCI, nor did the investigative drug prove superior over placebo for combined endpoint of MI, all-cause mortality and revascularization. Yet, the drug may have some benefits for stent thrombosis. Two randomized, controlled trials demonstrated these results, which were presented Sunday at the American Heart Association late breaking clinical trials session.
The Harvard Clinical Research Institute (HCRI) has reported that the first patients have been enrolled in the DAPT [dual-antiplatelet therapy] Study, marking the official initiation of the four-year clinical trial to investigate the duration of dual-antiplatelet therapy following drug-eluting stent (DES) implantations.
The long-awaited SPRIT IV one-year results, presented at the recent Transcatheter Cardiovascular Therapeutics (TCT) conference in San Francicso, for Abbott’s Xience V drug-eluting stent (DES) over Boston Scientific’s Taxus DES found a stent thrombosis rate of 0.29 percent, which surprised even Chuck Simonton, Abbott’s chief medical officer.
SAN FRANCISCO—A two-year dual-antiplatelet regimen with aspirin and clopidogrel can prevent the occurrence of very late stent thrombosis after PCI with drug-eluting stents (DES), according to the TYCOON (Two-Year ClOpidOgrel Need) registry presented at the annual Transcatheter Cardiovascular Therapeutics (TCT) meeting this week.
Stenting unprotected left main coronary artery disease (CAD) is feasible, offering a good long-term outcome, and using drug-eluting stents (DES) improves outcomes, according to the LE MANS Registry in the Journal of the American College of Cardiology.
Abbott has expanded its XIENCE V USA post-approval study designed to evaluate the safety and effectiveness of its Xience V everolimus-eluting coronary stent in a real-world clinical setting out to five years. The expansion allows for more than 2,000 patients from the XIENCE V trial to cross over into the Dual Anti-Platelet Therapy (DAPT) trial.
|