October 31st, 2013
Prolonged Dual Antiplatelet Therapy May Not be Necessary for Second-Generation Drug-Eluting Stents
Larry Husten, PHD
The precise duration of dual antiplatelet therapy (DAPT) following implantation of a drug-eluting stent (DES) has been the subject of considerable controversy. On the one hand, prolonged therapy may help prevent late stent thrombosis, which was particularly evident in first generation DESs. On the other hand, the risk of stent thrombosis may have diminished in newer generation drug-eluting stents, and prolonged DAPT is associated with a greater risk for bleeding complications and additional expense and management issues.
In the Optimized Duration of Clopidogrel Therapy Following Treatment With the Zotarolimus-Eluting Stent in Real-World Clinical Practice (OPTIMIZE) trial 3119 patients with stable CAD or a history of low-risk acute ACS who received a zotarolimus-eluting stent (Endeavor, Medtronic) were randomized to either short-term (3 months) or long-term (12 months) DAPT. The results of OPTIMIZE were presented at TCT 2013 in San Francisco and published online in JAMA.
At one year there were no significant differences between the groups. The primary endpoint — the composite of death, MI, stroke, or major bleeding — occurred in 6% of patients in the short-term group versus 5.8% of patients in the long-term group (risk difference 0.17, CI, -1.52 – 1.86, p=0.002 for noninferiority). Between 3 months and 1 year there was an identical 2.6% rate of events in both groups.
The rate of major adverse cardiac events (MACE: the composite of death, MI, emergent CABG, or target lesion revascularization) at one year was 8.3% in the short-term group versus 7.4% in the long-term group (hazard ratio 1.12, CI 0.87-1.45). Between 3 months and 1 year, the MACE rate was 5.3% versus 4.3% (p=ns).
The stent thrombosis rate at one year was 0.8% in both groups. Between 3 months and 1 year there were 4 events (0.3%) in the short-term group versus 1 event (0.1%) in the long-term group (p=0.18).
At one year there were 10 (0.6%) major bleeds in the short-term group versus 14 (0.9%) in the long-term group (p=0.41). Between 3 months and 1 year there were 3 (0.2%) major bleeding events in the short-term group versus 6 (0.4%) in the long-term group (p=0.31).
The results were consistent across important subgroups, including patients with diabetes, low-risk ACS patients, and patients with multivessel disease or bifurcation lesions.
One important caveat mentioned by the authors is that the trial was designed based on a higher anticipated event rate, 9% instead of the actual 6% that occurred in the trial. It is possible, then, that small but significant differences may not have been detected.
The results, say the authors, are consistent with previous trials showing that prolonged DAPT may not be necessary with other second-generation DESs.
The authors write that “although not specifically studied,” the results “may be especially relevant for patients at high risk of bleeding complications following PCI, such as the elderly and patients with a history of hemorrhagic events.”
Click here to read — and answer — several important questions from CardioExchange Editors Rick Lange and David Hillis that were triggered by the OPTIMIZE findings.
We’re closing comments on this news story, but encourage you to leave your thoughts at Rick and David’s post.
October 31st, 2013
EUROMAX Meets Primary Endpoint But Editorialist Raises Questions
Larry Husten, PHD
When started during transport to the hospital during a heart attack, bivalirudin (Angiox, Medicines Company) improves clinical outcomes and reduces major bleeding, though at the cost of a small but significant risk in stent thrombosis. The results of the European Ambulance Acute Coronary Syndrome (ACS) Angiography) Trial (EUROMAX) were presented on Wednesday by Phillippe Gabriel Steg at the TCT conference in San Francisco and published simultaneously in the New England Journal of Medicine.
A role for bivalirudin in primary PCI was established years ago in the HORIZONS-AMI trial, but clinical practice has evolved since then, including more prehospital treatment (especially in Europe), less use of glycoprotein IIb/IIIa inhibitors, and the advent of novel antiplatelet agents. EUROMAX, the investigators write, “was designed to determine whether [the] benefits of bivalirudin would persist in the contemporary setting.”
While in the ambulance on their way to the hospital for a primary PCI, 2218 patients with ST-segment elevation myocardial infarction (STEMI) were randomized to either bivalirudin or a control strategy of either unfractionated or low-molecular-weight heparin with optional adjunctive IIb/IIIa inhibitors.
At 30 days, the rate of death or major bleeding not associated with CABG was significantly lower in the bivalirudin group compared with the control group:
- 5.1% vs. 8.5%, relative risk 0.60, CI 0.43 – 0.82, p=0.001
A similar reduction was observed in the secondary composite endpoint of death, reinfarction, or non-CABG major bleeding:
- 6.6% vs. 9.2%, RR 0.72, CI 0.54 – 0.96, p=0.02
There were no significant differences in mortality (2.9% and 3.1%) or reinfarction (1.7% and 0.9%), but bivalirudin therapy did result in a significant reduction in major bleeding:
- 2.6% vs. 6.0%; RR 0.43, CI 0.28 – 0.66, p<0.001
The chief drawback to bivalirudin was a significant increase in the rate of acute stent thrombosis:
- 1.1% vs. 0.2%, RR 6.11. CO 1.37 – 27.24, p=0.007
The entire difference between the groups in stent thrombosis occurred in the first 24 hours of treatment. It should be noted that a similar elevation in stent thrombosis was observed in the HORIZONS-AMI trial. The EUROMAX investigators reported that none of the acute stent thromboses were fatal. Two thirds of the patients with stent thrombosis had reinfarction, and all of them had ischemia-driven revascularization.
In an accompanying editorial, Shamir Mehta writes that EUROMAX is “a timely and important second randomized study evaluating bivalirudin in primary PCI.” However, he points out that the definition of major bleeding in the study “did not actually require the occurrence of overt clinical bleeding,” and there were no significant differences in TIMI major bleeding or GUSTO severe or life-threatening bleeding.
In his conclusion, Mehta raises question about the value of bivalirudin in the clinical setting:
Thus, the clearest findings in the two trials evaluating bivalirudin in primary PCI are that bivalirudin increases the risk of acute stent thrombosis while reducing bleeding complications. Whether there is a true mortality reduction with bivalirudin among patients with STEMI is much less certain, since the EUROMAX study did not show even a trend toward a reduction in this outcome.
Is the tradeoff of reduced procedural bleeding worth the increased risk of acute stent thrombosis? This depends on the relative incidence of major bleeding versus that of stent thrombosis and the association between these events and subsequent mortality and morbidity. Few observers would dispute that stent thrombosis is a serious, albeit infrequent, event that results in either reinfarction or death in most cases. On the other hand, major bleeding occurs more frequently but varies widely in severity, depending on how the term is defined. Severe bleeding is prognostically more important but far less frequent than less serious bleeding, which has little or no long-term importance. Thus, it is critical that clinicians weigh the relative importance of these events before selecting an antithrombotic strategy for their patients.
October 29th, 2013
Pivotal Results for Medtronic’s CoreValve
Larry Husten, PHD
Key data on what will likely be the second transcatheter aortic valve to gain approval in the U.S. were presented today at the Transcatheter Cardiovascular Therapeutics (TCT) 2013 Conference in San Francisco. Jeffrey Popma, co-principal investigator of the trial, presented the major results from the CoreValve U.S. Pivotal Trial in patients who were too ill or frail for traditional open heart surgery.
In an as-treated analysis of 471 patients (the intention-to-treat population was 487), the primary endpoint — the rate of death or major stroke at 1 year — was 25.5% (CI 21.6-29.4). This was 40.7% lower than the prespecified performance goal of 43% (p<0.0001) based on historical standards.
All-cause mortality was 7.9% at 30 days and 24% at 1 year. Cardiovascular mortality was 7.9% and 17.9%.
The rate of major stroke was 2.4% at 30 days and 4.1% at 1 year.
“The fact that nearly three-quarters of patients were alive and free of strokes at one year is remarkable, given the complex medical conditions and extreme frailty of this population,” said Popma in a Medtronic press release. “Not only do the results meet the CoreValve study’s safety and efficacy endpoints for patients at extreme risk for surgery, but the positive clinical outcomes and low complication rates set a high standard for what transcatheter valves can achieve.”
At 1 year, 90% of patients had a significant improvement in their heart failure symptoms (improvement in at least one NYHA Class) and highly significant changes in quality-of-life scores (27.4 points in the KCCQ scale).
The mean gradient of blood flow was 8.5 mm Hg at 30 days and 8.8 mm Hg at 1 year. Paravalvular leak rates were 11.5% at 30 days and 4.1% at 1 year. Patients with moderate paravalvular leaks did not have an increased risk of death compared with patients with lesser paravalvular leaks.
Major vascular complications occurred in 8.3% at 30 days and 8.5% at 1 year.
At 1 month, 22.2% of patients required a permanent pacemaker. These patients were not at increased risk for death.
Following the release of the trial results, Medtronic announced that the FDA said it would conduct separate reviews for the extreme-risk group studied in this arm of the trial and for the high-risk group (randomized to CoreValve or surgery) participating in a second arm of the trial. Medtronic said that that FDA has determined that it has sufficient information to conduct its review without the need for an advisory panel. The company said it anticipates FDA approval for the extreme-risk patient population by the end of 2014.
October 29th, 2013
Using CAC Scores to Determine the Best Candidates for a Polypill
Anita Vashi, MD, MPH
CardioExchange’s John Ryan interviewed Khurram Nasir about his research group’s JACC study, which examines whether the coronary artery calcium score (CAC) can be used to determine the target population for a polypill. Results show that patients with a CAC=0 had a very low event rate and high number needed to treat (NNT), whereas the majority of CVD events occurred in patients with a CAC of >100. The authors conclude that avoiding treatment in those with a CAC=0 could allow for a more selective use of the polypill within the population.
Ryan: In your study, you say that the NNT to see a benefit of a polypill in patients with a CAC>100, is ~20. How does this compare with using just clinical and laboratory parameters to decide whether to use the polypill?
Nasir: Across subgroups that met the inclusion and exclusion criteria based on the clinical and laboratory parameters for the four suggested polypill regimens, the NNT in five years to prevent one CVD event ranged from 36-57 and 55-85 for CHD, respectively.
Ryan: You argue that the NNT for a CAC=0 is possibly too high to make it worthwhile. Is there a way of predicting which patients with a CAC=0 will go on to have events that can be applied here?
Nasir: The basic hypothesis for this study stems from observation in a series of reports from our group including a large meta-analysis and retrospective and prospective studies that the absence of CAC confers a favorable prognosis with a very low event rate of ~1 per 1000 patient-years (~1% 10-year event rate). As confirmed in sensitivity analyses in the current study, even if the reduction in the relative risk were as high as 95%, the benefit would be minimal and the resultant NNT for 5 years to prevent a CVD event will be greater than 50 with polypill use. At the same, I do agree that with additional information and testing we may able to identify a subgroup among those with CAC=0 who will be at a relatively higher risk, however, the yield is likely to be minimal for the efforts and resources needed.
Ryan: What are your concerns about introducing CAC as a population-based screening tool?
Nasir: I would like to stress that the idea we are proposing is very different from “screening” with CAC testing, where the goals would be early detection and halting disease progression based on proven interventions, an approach that has its own pros and cons and can be extensively debated.
In this study, we emphasize a unique concept of “de-risking” individuals already deemed high risk enough to be considered for lifelong medications. As extensively demonstrated in the past and now in the current study, CAC testing has the unique ability to identify a sizeable proportion (nearly 50%) who have no signs of early atherosclerotic disease, an extremely low risk of incident CVD, and — as a result — an unacceptably high NNT to prevent one cardiac event.
Our message is very clear: since risk factors and biomarkers cannot really rule out disease, they can only be used to raise risk estimates, and, thus, are inextricably tied to more treatment and unanticipated downstream effects. In this situation, prior to committing to lifelong therapies, the “Power of Zero”, irrespective of traditional baseline risk, provides an excellent opportunity to avoid over-treating and its associated risks. This strategy will allow us to focus on individuals with actual disease, among whom the majority of clinical events will occur, and potentially derive the highest yield from our preventive strategies.
Ryan: The polypill is intended for developing countries. Are you suggesting that they buy a lot of CT scanners?
Nasir: We do not dictate or advocate developing additional assets and infrastructures to cater to this specific need. This will not be an effective use of limited health care resources.
However, at the same time, we need to realize that the concept of a polypill is gaining significant interest in developed countries such as Canada and U.K., as well as in emerging markets such as China and India where we are experiencing an increased penetration of CT technologies in local health care systems.
Depending upon local situations, I think our findings do provide a potential framework to consider whether the added information based on CAC can used for shared decision making on how best to appropriately allocate resources.
While considering the role of CAC testing in these situations, individual stakeholders need to carefully weigh their respective health care systems’ needs, goals, and available resources. Among many important considerations are one’s ability to negotiate a reasonable cost of CAC testing, determine costs for lifelong medication/follow up visits/labs, issues of compliance, side effects of these combination pills, and the potential downstream implications of wider CAC testing.
However, one of the most important things that we seem to ignore and is currently hard to measure is “individual preference”: most of us will agree that we’d like to avoid exposure to unnecessary medications. There is a huge gap in our ability to grasp the importance of how patients (the most important stakeholder) perceive this issue, and can only be better understood by closely engaging them in these decision-making processes.
October 28th, 2013
Radiation Dose Linked to Cardiac Risk in Breast Cancer Patients
Larry Husten, PHD
In the past, cardiovascular risk has been linked to the radiation dose received by breast cancer patients. Now, a new study published in JAMA Internal Medicine attempts to calculate the cardiac risk of breast cancer patients today undergoing current radiotherapy protocols.
David J. Brenner and colleagues calculated the excess cardiac risk for 48 patients who received radiotherapy at New York University. They estimated the 20-year cardiac risk based on baseline risk and patient-specific mean cardiac radiation dose. Cardiac dose was significantly higher in patients with left-sided radiotherapy. These patients also received significantly higher doses if they were treated in the supine body position instead of the prone position. Position did not significantly have an impact on cardiac dose in patients who received right-side radiotherapy.
Patients with the highest baseline risk who had left-sided therapy treated in the supine position therefore had the highest amount of estimated radiotherapy-induced risk (3.52%, CI 1.47%-5.85%). By contrast, low-risk patients with right-sided radiotherapy had only a small increased risk (<0.1%).
The authors conclude that in patients at high baseline risk “radiotherapy-induced risks of major coronary events are likely to be reduced… by targeting baseline cardiac risk factors (cholesterol, smoking, hypertension), by lifestyle modification, and/or by pharmacological treatment.”
In an invited commentary, Carolyn Taylor and Sarah Darby write that the large variability in the cardiac risk associated with radiotherapy can provide “reassurance for the majority of women that their absolute risk of ischemic heart disease from breast cancer radiotherapy is likely to be small compared with the likely absolute benefit…” For some patients, however, a risk estimate may identify “the minority of women for whom the benefits of radiotherapy do not clearly outweigh the risks, including those for whom adequate coverage of the target tissue cannot be achieved without a high heart dose.”
October 28th, 2013
Selections from Richard Lehman’s Literature Review: October 28th
Richard Lehman, BM, BCh, MRCGP
CardioExchange is pleased to reprint this selection from Dr. Richard Lehman’s weekly journal review blog at BMJ.com. Selected summaries are relevant to our audience, but we encourage members to engage with the entire blog.
NEJM 24 Oct 2013 Vol 369
Thrombus Aspiration During STEMI (pg. 1587): This Swedish trial compared thrombus aspiration during myocardial infarction with conventional percutaneous intervention. It was based on the national comprehensive Swedish Coronary Angiography and Angioplasty Registry (SCAAR). “All 29 PCI centers in Sweden as well as 1 in Iceland and 1 in Denmark participated in the trial. During the study period, 11,709 patients with STEMI in Sweden and Iceland underwent PCI and were registered in SCAAR. Of these, 7012 were enrolled in the trial. An additional 247 patients were enrolled from the center in Denmark, for a total of 7259 patients…None of the patients who underwent randomization were lost to follow-up with respect to the primary end point.” How about that? From start to finish the trial took less than three years, and it proves conclusively that aspirating clot at the time of PCI for ST elevation MI makes no difference to mortality.
JAMA 23/30 Oct 2013 Vol 310
Effect of Statin Therapy on Mortality in Patients with Ventilator-Associated Pneumonia (pg. 1692): Statins do a great deal more than just lower cholesterol, and for all we know they prevent cardiovascular disease by an entirely different mechanism, though the degree to which they do is proportional to their lowering effect on LDL-C. In particular they show strong evidence of having an anti-inflammatory action, and some studies have suggested that they can reduce mortality in sepsis. In this trial, patients in 26 French ICUs with ventilator-associated pneumonia were randomized to simvastatin 60mg or placebo. By the time the trial had recruited 300 patients, it was stopped for futility. Statins are wonderful drugs, but they do not reduce mortality in this situation.
Association Between Influenza Vaccination and CV Outcomes in High-Risk Patients (pg. 1711): I move among sceptics, and I am not entirely convinced that influenza vaccination does anything much, but this meta-analysis suggests that it may reduce cardiovascular events in high-risk individuals. “A large, adequately powered, multicenter trial is warranted to address these findings and assess individual cardiovascular end points.” Yes indeed: and it could be done in a single flu season in the whole UK if we could just harness the same national database methods as that Swedish trial of thrombectomy in MI.
Linagliptin for Patients Aged 70 Years or Older with Type 2 Diabetes Inadequately Controlled with Common Antidiabetes Treatments: A Randomised, Double-Blind, Placebo-Controlled Trial (pg. 1413): You can tell what’s coming, can’t you? Yes, “inadequately controlled” here means a HbA1c greater than 7%: and linagliptin reduces this over 24 weeks with a “safety profile similar to placebo.” Fewer than 10% of participants had an initial HbA1c level above 9%, which is where I would say it may be rational to discuss adding treatment in this age group. The reporting of this Boehringer Ingelheim funded study reads very smoothly, as well it might: five of the six authors are employees of the company, while the sixth and principal author “has received honoraria for lectures and advisory work from Boehringer Ingelheim (the manufacturer of linagliptin).” Yes, and the accompanying editorial salves The Lancet’s conscience in accepting this paper by gently mentioning its defects while going on to bang a drum for the concept of “frailty” as a missing element in this study. The more I read about “frailty,” the more I’m convinced that it is just one more misleading label, aimed more at extending the academic literature than at helping patients. But that is another matter. Just file this paper as one more example of advertising unnecessary treatment under the guise of a randomized trial.
BMJ 26 Oct 2013 Vol 347
Should People at Low Risk of CVD Take a Statin? Statins for all? Yes, I would say, statins for all who really want them after full discussion of the harms and benefits. Just what these are is a matter for debate, and this article presents one side of that debate, pointing out possible under-reporting of harms and overstating of benefits to people at low risk. But I would have to go to the primary literature to be sure, because these authors clearly have a definite view on the message they think should be conveyed to “patients”. Yet having a risk of cardiovascular disease does not make anyone a patient: everyone has some risk, and we are talking here about free individuals. To consider that we as doctors should be “gatekeepers” in this situation is an affront to human rights. What we badly need is a better tool to share decision-making with those who come to us for advice on this issue, and James McCormack has recently come up with a very good and flexible web-based one. I’m going to spend a few days seeing if I can finesse it and perhaps develop an even simpler guide on one side of printed paper.
October 25th, 2013
FDA Approves Abbot’s MitraClip for Patients at Prohibitive Surgical Risk
Larry Husten, PHD
The FDA today approved Abbott’s catheter-based MitraClip device for patients with significant symptomatic degenerative MR who are at prohibitive risk for mitral valve surgery. The company said it would launch the device immediately in the United States. The device is the first percutaneous nonsurgical therapy approved for the treatment of mitral valve disease.
Surgery remains the option of choice for most of the 4 million people in the U.S. with mitral regurgitation (MR), but in some patients the surgical risk is very high. “As cardiac surgeons, we see patients with severe mitral regurgitation who we can technically operate on but who are just too frail or sick to survive mitral valve surgery with a reasonable risk and quality of life,” said Michael Mack, director of Cardiovascular Surgery at Baylor Health Care System, in an Abbott press release. “With the MitraClip system, heart teams now have a catheter-based, less-invasive treatment option that can help patients who cannot withstand surgery regain their quality of life.”
Earlier this year, the FDA’s Circulatory System Devices advisory panel gave a tepid endorsement to MitraClip. The panel narrowly voted 5-3 in favor of the device, saying that the benefits outweighed the risks. Although panel members expressed doubts about the device’s efficacy, in the end many panel members were persuaded by the pleas of surgeons and patients asking for another option for the most difficult cases.
According to Abbott, whether a patient is at “prohibitive risk” due to the presence of one or more documented surgical risk factors will be determined by a heart team. Most patients who receive the MitraClip only need to stay in the hospital for 2-3 days.
Abbott said that more than 11,000 patients have now been treated with the MitraClip device. “Clinical data and real-world international experience, dating back to 2003, have consistently shown that the MitraClip is a safe and effective therapy for patients unable to undergo mitral valve surgery, providing meaningful improvements in quality of life that are sustained over time,” said Ted Feldman, director of the cardiac catheterization laboratory at NorthShore University HealthSystem in Evanston, Il. “It has allowed many of my patients to go from bed rest to a more active lifestyle shortly following treatment.”
The company said that it will continue to support two prospective, randomized trials evaluating the effect of the MitraClip on heart failure progression. Those trials are COAPT in the U.S. and RESHAPE-HF in Europe. Both are still enrolling patients.
October 24th, 2013
Surgery Preferable to Stents in Elderly People with Carotid Disease
Larry Husten, PHD
Age should play an important role in choosing a revascularization procedure for people with blocked carotid arteries, according to a new paper published in JAMA Surgery. Carotid endarterectomy surgery (CEA) is preferable to carotid artery stenting (CAS) in elderly people; for younger patients, the two revascularization procedures are broadly similar.
George Antoniou and colleagues analyzed data from 44 studies containing more than half a million CEA and 75,000 CAS procedures. In the CAS group, when compared to younger patients, elderly patients were at increased risk for stroke (odds ratio 1.56,CI 1.40-1.75). In the CEA group, the stroke results were “equivalent” in the older and younger groups (OR 0.94, CI 0.88-0.99). In the CEA group there was a small but statistically significant increase in the mortality rate in the older group compared with the younger group (0.5% versus 0.4%, OR 1.62, CI 1.47-1.77). No significant difference in mortality between the older and younger groups emerged in the CAS group. In both the CAS and the CEA groups, increased age was associated with a greater risk of adverse cardiac events.
The authors pointed out that over the course of time the differences in outcome between young and old patients has diminished in the CAS group, while remaining stable in the CEA group. They said the finding may be attributed to the learning curve and to improved CAS techniques. But the overall differences in the CAS group, they speculated, may be due to the more challenging anatomy in elderly patients.
The findings, write the authors, “suggest that careful consideration of a constellation of clinical and anatomic factors is required before an appropriate treatment of carotid disease in elderly patients is selected…. CEA is associated with improved neurologic outcomes compared with CAS in elderly patients, at the expense of increased perioperative mortality, whereas both procedures are associated with increased risk of adverse cardiac events in advanced age.”
In an accompanying editorial, R. Clement Darling expresses concern over the definition of the term “elderly,” since the cutoff in the studies varied from 80 down to 65. But whatever the definition, he concludes, “the bottom line is, CEA and CAS seem to work equally well in younger patients, in expert hands. However, in the ‘elderly’ (at any age), CEA has better outcomes with low morbidity, mortality, and stroke rate and remains the gold standard.”
October 23rd, 2013
Flu Vaccine May Help Prevent Cardiovascular Events
Larry Husten, PHD
A new meta-analysis published in JAMA offers the best evidence yet that the flu vaccine may help prevent cardiovascular events.
Jacob Udell and colleagues analyzed data from five published clinical trials in which 6469 patients were randomized to flu vaccination or placebo (or no treatment). People who received the flu vaccine were significantly less likely than controls to have a cardiovascular event (2.9% vs. 4.7%; RR 0.64, CI 0.48-0.86, p = 0.003). The protective effect was largely restricted to people who had had a recent acute coronary syndrome (ACS):
- RR for patients with recent ACS: 0.45 (CI 0.32-0.63)
- RR for patients without recent ACS: 0.94 (CI 0.55-1.61; P for interaction = 0.02).
Results were similar after inclusion of unpublished data. The authors calculated that 58 people would need to be vaccinated to prevent 1 major cardiovascular event.
The authors wrote that if their findings are correct, wider use of the flu vaccine could have a significant impact on cardiovascular disease:
If severe influenza-associated morbidity and mortality is in part due to acutely triggered ischemic cardiovascular events, and a vaccine preventing influenza could decrease the risk of cardiovascular events, then this therapy could address a sizable component of residual cardiovascular risk not addressed by current therapy and provide yearlong coverage through 1 simple inoculation.
They recommended that “an adequately powered multicenter trial” be performed “to confirm the efficacy of this low-cost, annual, safe, easily administered, and well-tolerated therapy.”
In an accompanying editorial, Kathleen Neuzil writes that more than half of people under the age of 65, and as many as one third of those over 65, don’t receive annual flu vaccines. She points out that “one of the most consistent and relevant findings of operational research is that recommendation for vaccination from physicians and other health care professionals is a strong predictor of vaccine acceptance and receipt among patients… all health care practitioners can recommend influenza vaccine to their patients.”
In an interview with JAMA reporter Mike Mitka, Udell said that the study offers “yet another reason why receiving influenza vaccine might be a beneficial thing to do. And those hospitalized with a heart attack should be vaccinated before they walk out the door so they don’t have care gaps that could be very dangerous.”
October 23rd, 2013
FDA Approves First New Atherectomy Device in 20 Years
Larry Husten, PHD
The FDA on Tuesday granted PMA approval to the Diamondback 360 Coronary Orbital Atherectomy System (OAS) for the treatment of severely calcified coronary arteries. Cardiovascular Systems, the manufacturer of the device, said that the OAS was the first new coronary atherectomy system to receive FDA approval in two decades. The company said it would begin a controlled launch of the device immediately, focusing initially on “a limited number of the top medical institutions in the United States.”
“Coronary calcium is undertreated in the cardiac cath lab. Having a user-friendly device available to effectively treat severe coronary calcium may increase the safety of CAD interventions for this difficult to treat population, while improving long-term patient prognoses,” said Gregg Stone, in a press release.
The FDA approval was based on results of the ORBIT II study, a prospective, single-arm, multicenter study that evaluated the safety and efficacy of the OAS system in patients with severely calcified coronary lesions. The company said that it was “the first study in history that sought approval for treating these lesions.” At 30 days, 89.8% of patients in the study were free of major adverse cardiac events, the primary outcome of the study.
Atherectomy, as cardiologists who have been around for a while will remember, has had a very long and torturous history in interventional cardiology. Although interventional cardiologists have been known for their ready adoption of new technology, it is unclear at this point how willing they will be to utilize a new atherectomy device.
Medtronic Launches Aspiration Catheter
In separate news, Medtronic yesterday announced the launch of its Export Advance aspiration catheter for coronary thrombus removal. The device was recently approved by the FDA. The company said the device features a pre-loaded stylet that “increases the deliverability and kink resistance of the new device while traversing the vasculature to reach the aspiration site.”
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