February 8th, 2012
(In)Appropriate PCI: An (In)Appropriate Critique?
Richard A. Lange, MD, MBA and L. David Hillis, MD
According to a recently published study by Chan and colleagues, only 50% of the PCIs performed for nonacute indications were classified as appropriate, according to appropriate use criteria (AUC); 38% were “uncertain,” and 12% were inappropriate.
In a new expedited publication, Marso and colleagues retort by expressing concerns with the “current” PCI AUC (see also our CardioExchange news coverage here). However, the AUC document they critique is the 2009 version and not the current 2012 updated version, which addresses many of their concerns, including:
- Acknowledging when PCI may be appropriate even without an improvement in symptoms;
- Incorporating fractional flow reserve (FFR) for identification of the culprit lesion; and
- Including bypass graft status in patients with previous CABG.
Nonetheless, some of the issues they raised were not addressed in the update, including:
- Lack of concordance between the AUC technical panel and the clinical cardiology community regarding PCI appropriateness designations;
- Overdependence on stress testing pre-PCI; and
- Reliability of the National Cardiovascular Data Registry (NCDR) for obtaining necessary data with which to assess PCI appropriateness.
Two recommendations of Marso and colleagues are quite controversial and deserve vetting, and we’d like to hear your opinion. The authors recommend that:
- PCI classification should be changed from inappropriate to uncertain in patients with Canadian Cardiovascular Society class I or II angina while taking 0 or 1 antianginal medication who have 1- or 2-vessel CAD without involvement of the proximal LAD and low-risk findings on noninvasive testing; and
- Preprocedural stress testing should not be required in patients with class II angina.
Do you agree?
February 8th, 2012
Two Different Perspectives on the CABG Versus PCI Message in ASCERT
Fred H Edwards, MD, MS, Richard A. Lange, MD, MBA and L. David Hillis, MD
At the recent meeting of the Society of Thoracic Surgeons (STS), Fred Edwards presented the high-risk subset of ASCERT (ACCF-STS Database Collaboration on the Comparative Effectiveness of Revascularization Strategies). CardioExchange Interventional Cardiology moderators Rick Lange and David Hillis posed the following questions to Edwards and Christopher White, the president of the Society for Cardiovascular Angiography and Interventions (SCAI).
Rick Lange and David Hillis (RL and DH): Given the limits of observational studies, are you concerned about how this study will be interpreted?
Edwards: All studies, whether observational or randomized, have limitations. This study is no exception. Since ASCERT is an observational study, well-accepted statistical analyses are used to minimize selection bias and to balance the clinical characteristics of the two treatment groups. An exhaustive statistical approach that included numerous analytic techniques was used to achieve excellent balance between the two groups so we could have an apples-to-apples comparison of survival.
We should be careful to interpret the results specifically for the high-risk subgroups presented. It would be a misinterpretation to conclude that the same results would necessarily be expected in other subgroups or in patients less than 65 years of age. With those caveats in mind, though, we can safely say that ASCERT confirmed a distinct survival advantage in surgical patients as compared to PCI patients having very similar clinical characteristics. As seen in numerous other observational studies and some randomized trials, the survival advantage for surgery increases with time.
We should mention that the overall results and the results of other important subgroups will be presented in about two months at the ACC Annual Meeting.
White: ASCERT was NOT meant or designed to directly compare “outcomes” for PCI vs CABG because of major biases in how the data were collected (i.e., registry and CMS administrative databases). The major limitation is that patients who were initially referred for CABG, but were refused surgery due to their concurrent illnesses or comorbidities, were often treated with PCI for symptomatic relief. Because these patients were much sicker than patients offered CABG, their mortality rate (during follow-up) was higher. This does not mean they died from their PCI; they probably died from their concurrent illnesses. ASCERT is weakened because patients were not randomized, and there was no intention-to-treat analysis as required by Level 1 evidence.
Well-balanced, well-done, prospective randomized trials comparing CABG to PCI — like SYNTAX — offer a much better opportunity to compare PCI and CABG. SYNTAX was an apples-to-apples comparison; ASCERT is an apples-to-oranges comparison.
What ASCERT tells us is that in our current practice, based on trials like SYNTAX, cardiologists are selecting appropriate patients for CABG, and this is resulting in good clinical outcomes for “real-world” patients.
RL and DH: Should this study change our practice? If so, how?
Edwards: The results of this study should encourage physicians to recognize the growing body of evidence showing that long-term survival is better with CABG than with PCI in most patient subsets. This survival advantage is becoming more evident each year. These ASCERT findings represent the world’s largest observational or “real world” CABG vs PCI study in high-risk patients. As such, it should prompt some reassessment of optimal revascularization strategy, not only by surgeons and cardiologists, but by primary care physicians as well.
I do not think ASCERT findings indicate that all high-risk patients should now be referred for CABG. The choice of revascularization is not dictated solely by long-term survival. There is more to it than that. Patient preference and quality of life expectations, for example, should be considered as well.
White: Absolutely not. ASCERT shows that the current selection process for CABG and PCI is yielding excellent results. If the process were changed — for example, if higher-risk patients received CABG — the outcomes of surgery would very likely worsen.
RL and DH: What should we tell our patients who are trying to decide between CABG and PCI and are aware of the results of this study?
Edwards: Some patients may conclude that the message of ASCERT is “surgery works better than stents.” We would do well to advise them that there is good evidence that long-term survival is better with surgery, but we also should note that there is an approximately 2% rate of in-hospital mortality with CABG compared with 1% with PCI. Complication rates, recovery time, and re-intervention rates should also be a central part of the conversation.
In most cases, surgeons should tell patients they need to also consult with a cardiologist. Likewise, cardiologists should refer patients for surgical consultation. In an ideal world, patients, surgeons, cardiologists and primary care physicians would all be talking to each other. The concept of a “heart team” of cardiologists and surgeons is a central part of the joint recommendations by STS and ACC on transcatheter valve replacement, and we believe that all coronary patients would benefit from a similar heart team approach. In fact, the newest guidelines published jointly by the ACC, AHA, and STS recommend a “heart team” approach for patients with complex coronary disease, so that patients have an opportunity to speak with both a surgeon and an interventionalist.
The highest priority for all of us in the medical profession is the patient — not our specialty, not our revenue, not our business model — just the patient. We must unwaveringly focus all our efforts on simply finding the best treatment for both the short-term and the long-term welfare of each of our patients.
White: Patients should understand that with clinical trials such as SYNTAX and FAME, their cardiologists have good comparative data on which to base their recommendation for medical therapy or revascularization (CABG or PCI). The ASCERT data suggest that cardiologists are properly selecting patients for CABG and PCI given the excellent real-world outcomes.
February 7th, 2012
Bleeding Problems Continue to Bedevil Merck’s Novel Antiplatelet Agent Vorapaxar
Larry Husten, PHD
In the large TRA-2P study of more than 26,000 patients with MI, ischemic stroke, or documented peripheral vascular disease, the novel antiplatelet agent vorapaxar significantly reduced the primary endpoint of CV death, MI, stroke, or urgent coronary revascularization. But treatment resulted in a significant increase in bleeding, including intracranial hemorrhage.
The fate of vorapaxar now appears to be uncertain, as the company said it will review data from the drug’s two large clinical trials with the investigators of the trials and external experts to inform the company’s next steps.
The full results of the TRA-2P (Thrombin Receptor Antagonist in Secondary Prevention of atherothrombotic ischemic events) trial are scheduled to be presented in March at the American College of Cardiology meeting. Merck today released the top-line results in a press release.
TRACER, the large ACS trial with vorapaxar, was terminated early last year due to similar safety concerns. As reported here last year, at the same time TRACER was stopped, the TRA-2P trial was modified. TRA-2P investigator Eugene Braunwald said that vorapaxar would be discontinued in patients who experienced a stroke prior to entry or during the trial because of an increase in intracranial hemorrhage in these patients.
February 6th, 2012
Women and ICDs: More Complications, Fewer Benefits
Larry Husten, PHD
After consulting an electrophysiologist, women are just as likely as men to receive an ICD but they suffer more complications and are less likely to benefit from the device, according to a new study from Canada published in the Annals of Internal Medicine.
Derek MacFadden and colleagues analyzed data from 6021 patients treated at 18 ICD implantation centers in Canada; 21.4% of the patients were women. The rate of ICD implantation was similar in men and women, but women were more likely to have complications and less likely to receive appropriate shocks or antitachycardia pacing:
- Major complications by 45 days: OR 1.78 (CI 1.24 – 2.58, p=0.002)
- Major complications by 1 year: HR 1.91 (CI 1.48 – 2.47, p< 0.001)
- Receipt of appropriate ICD shock: HR 0.69 (CI 0.51 – 0.93, p= 0.015)
- Receipt of appropriate shock or antitachycardia pacing: HR 0.73 (CI 0.59 – 0.90, p=0.003)
The lower rate of appropriate ICD therapy for women “suggests that their baseline arrhythmic risk is lower under current primary and secondary prevention eligibility criteria,” write the authors.
In an accompanying editorial, Pamela Douglas and Lesley Curtis point out that there is “ample evidence” for sex-related differences in the epidemiology and biology of sudden death and arrhythmias, but the low enrollment of women in the major ICD trials “make it difficult to fully assess the value of ICDs in women.” They call for a “careful evaluation” of “the validity of applying a one-size-fits-all approach” to ICD usage.
February 6th, 2012
Selections from Richard Lehman’s Weekly Review: Week of February 6th
Richard Lehman, BM, BCh, MRCGP
CardioExchange is pleased to reprint selections 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.
Week of February 6th
JAMA 1 Feb 2012 Vol 307
483 Shock horror: Americans are not getting fatter. Brits like me can no longer console themselves that however bad the obesity epidemic may be in the UK, it will always be worse in the USA. Mind you, we are quite a way behind; and Americans still cherish their obesogenic environment by never serving portions that are less than twice the amount required. It’s just that nowadays in middle class circles it tends to contain a lot of unidentifiable greenery and some grated carrot. A plateau has been reached at every age group in the US, according to the latest figures from NHANHES. The 2010 obesity level was 17% overall in children and adolescents, and 36% in adults, with higher levels in black and Mexican Americans. The awful fact is that for those already obese, this is virtually irreversible by any non-surgical intervention, individual or societal.
Lancet 4 Feb 2012 Vol 379
453 I recommend the editorial on this study of cardiovascular magnetic resonance and single-photon emission computed tomography for diagnosis of coronary heart disease (CE-MARC). State-of-the-art cardiac MRI is pretty amazing at spotting coronary atheroma, and better than state-of-the-art CT (SPECT); but that is no reason to rush to adopt the new technology. Robert Bonow’s words have resonances far beyond cardiac imaging: “Enhanced diagnostic accuracy of CMR must be balanced against availability and cost-effectiveness, and there is a need for evidence of measurable improvements in patient outcomes. Diagnosis of coronary artery disease alone is not sufficient to determine the need for revascularisation. To show value, advances in imaging must be coupled with enhanced patient well-being or a reduction in unnecessary downstream testing and procedures.”
BMJ 4 Feb 2012 Vol 344
Three papers in this week’s BMJ examine the decline in mortality from myocardial infarction in European countries. The first is England, a part of the United Kingdom which was oddly missing from the European MONICA study in the 1980s and 1990s. This record linkage study shows an astonishing fall in standardized mortality from myocardial infarction of one half between 2002 and 2010. This is unevenly spread across England, as most things are, but in this case there is no evidence of a clear North/South divide. Nearly half of the drop is attributed to improved survival at 30 days. Most deaths from MI in England are now sudden deaths outside hospital.
In Denmark, a similar decline has occurred, but measured over 25 years rather than 8.
The investigators from Poland prefer to measure their halving of cardiac mortality from 1991: “Over half of the recent fall in mortality from coronary heart disease in Poland can be attributed to reductions in major risk factors and about one third to evidence based medical treatments” they conclude. By means of different kinds of modelling, they attribute this to “socioeconomic transformation”, i.e. liberation from the yoke of socialism. Perhaps we in England should attribute ours to Tony Blair, though I would rather not.
February 3rd, 2012
CMS Releases Details of Proposed National Coverage for TAVR
Larry Husten, PHD
On Thursday the Centers for Medicare & Medicaid Services (CMS) released a memo containing details of its proposed Medicare coverage for transcatheter aortic valve replacement (TAVR). The memo is a response to a formal request for national coverage determination (NCD) from the Society of Thoracic Surgeons (STS) and the American College of Cardiology (ACC). The memo will be open for public comment until March 3, after which a final determination will be made.
In the memo CMS proposes coverage for TAVR only if 5 conditions are met, including
- The use of an FDA-approved device for an FDA-approved indication,
- Evaluation of the patient by 2 cardiac surgeons,
- Performance of the procedure at an institution with sufficient surgical and interventional cardiology experience and expertise, including participation in a prospective national TAVR study and a commitment to the Heart Team concept,
- Performance by physicians with sufficient experience and expertise,
- The patient must be enrolled in, and the physician must participate in, a national TAVR registry that will track outcomes for at least five years after the procedure.
CMS also said it would provide coverage for patients enrolled in clinical trials that meet a long list of criteria. CMS recommended that coverage be denied for indications other than those specifically mentioned in the memo.
February 2nd, 2012
Study Explores Role of Periprocedural Dabigatran in AF Ablation
Larry Husten, PHD
As dabigatran becomes more widely used in AF patients, electrophysiologists are trying to figure out how to handle anticoagulation in patients taking the drug and for whom AF ablation is planned. In a new study published in the Journal of the American College of Cardiology, Dhanunjaya Lakkireddy and colleagues report on a multicenter, observational study of 290 patients who underwent an AF ablation procedure. Half the patients were taking periprocedural dabigatran and half were matched controls taking warfarin.
There were significantly more thromboembolic and bleeding complications in the dabigatran group than in the warfarin group:
- Thromboembolic complications: 3 with dabigatran versus none with warfarin (p=0.25)
- Major bleeding complications: 9 versus 1 (p=0.019)
- Composite of bleeding and thromboembolic complications: 16% versus 6% (p = 0.009)
In a multivariate analysis, dabigatran was an independent predictor of bleeding or thromboembolic complications (OR 2.76, CI 1.22 – 6.25; p = 0.01).
In an editorial comment, Bradley Knight writes that the study “at first… appears to suggest that dabigatran has no role periprocedurally in patients undergoing AF ablation.” Although “AF ablation should not be performed on nearly uninterrupted dabigatran, as it was used in this study,” Knight preserves hope for “other approaches that capitalize on the advantages of the new oral anticoagulants.”
February 2nd, 2012
The Biggest Opportunities for Cost Savings in Cardiology: Take II
Harlan M. Krumholz, MD, SM
In response to my recent post, we received some nice suggestions about where to eliminate waste in cardiovascular care. There were also some interesting concerns. We welcome more. Here are the suggestions that stood out:
- Seek to optimize medical therapy over stenting for some patients.
- More judicious use of imaging with stress tests.
- Avoid using biomarkers for ACS in circumstances where they are highly unlikely to modify your approach.
Let’s work with these suggestions. Since clinical decisions are made case by case — and each situation has its own nuance — how do we move the needle to decrease testing and treatment that does not provide any benefit? Can we become more specific about where there are opportunities? How would it work best? What would our community suggest?
And surely you have additional suggestions for areas where we can use fewer resources without compromising the care of patients (or even to improve it). Consider this a suggestion box for cardiology. Please share!
Comments are closed on this post, but please join the conversation at our news story on the ACC’s and the American Society of Nuclear Cardiology’s contributions to the Choosing Wisely initiative.
February 1st, 2012
Meta-Analysis Confirms Benefits of Statins in Women
Larry Husten, PHD
Although clinical trials have consistently found a beneficial effects for statins, some critics have questioned the strength of the evidence in women, who are often under-represented in clinical trials. A large new meta-analysis published in the Journal of the American College of Cardiology provides the best evidence yet that the relative reductions in events observed in men also occur in women, but doesn’t provide evidence about the absolute risk benefit in women.
William Kostis and colleagues analyzed data from 18 randomized trials of primary and secondary prevention, including 141,235 patients (40,275 women). The reduction in cardiovascular risk was similar for both sexes:
- Women: OR: 0.81, CI 0.75 – 0.89, p < 0.0001
- Men: OR: 0.77, CI: 0.71 – 0.83, p < 0.0001
All-cause mortality was also significantly reduced by statins in both sexes:
- Women: OR: 0.90, CI: 0.82 – 0.99, p = 0.0344
- Men: OR: 0.84, CI: 0.77 – 0.92, p = 0.0003
For women the effect on all-cause mortality did not achieve statistical significance in the secondary prevention trials, while for men the difference in mortality did not achieve significance in the primary prevention trials. However, investigators did not find a significant interaction by sex in these analyses.
The authors conclude that “statin therapy should be used in appropriate patients without regard to sex. It seems that, with respect to statin therapy, what is good for the gander is good for the goose.”
In an accompanying editorial comment, Lori Mosca praises the meta-analysis but notes that it only treats “sex-specific relative risk benefit and not absolute benefit,” and that both are needed “to make informed clinical choices with regard to the use of statins for primary prevention.” She also notes that the meta-analysis did not provide any evidence about the relative safety of statins in women.
January 31st, 2012
Guiding TAVR into Clinical Practice
Steven Bailey, MD, Richard A. Lange, MD, MBA and L. David Hillis, MD
The ACC, AATS, SCAI, and STS have issued a critical consensus document to guide the use of transcatheter aortic valve replacement (TAVR) as it enters clinical practice in the U.S. (see also our CardioExchange news coverage here). CardioExchange Interventional Cardiology moderators Rick Lange and David Hillis posed the following questions to writing committee member Steven R Bailey, the Janey Briscoe Distinguished Professor of Medicine and Radiology and Chief of the Division of Cardiology at the University of Texas Health Science Center at San Antonio.
Rick Lange and David Hillis (RL and DH): Consensus guidelines are nothing new. Why are these getting so much publicity?
Steven Bailey: Guidelines now address two levels of clinical practice. The multisociety Clinical Practice Guidelines are based specifically upon peer reviewed studies that provide evidence on how to treat specific conditions or how to use specific modalities (STEMI, stable angina, echo, etc.). These recommendations are often population-based.
The Appropriate Use Criteria (AUC) are designed to provide assistance not only to specialists but also to the general physician who wants to understand how to use testing and procedures in specific patient scenarios. The AUC recommendations fall into three categories: Appropriate, when we have published information to support practice; Uncertain, when the procedure is commonly used in clinical practice but we do not have clear-cut information about its use in a specific scenario; and Inappropriate, when published data indicates possible harm. These guidelines serve as guideposts in areas that require further investigation.
The current document is an Expert Consensus statement, described by the ACC as follows:
Expert consensus documents are intended to inform practitioners, payers, and other interested parties of the opinion of the ACCF concerning evolving areas of clinical practice and/or technologies that are widely available or new to the practice community…These documents are evidence-based whenever possible but tend to be shorter than guidelines, as they are developed around a topic that is more narrowly focused, that is new or emerging, and for which a smaller body of evidence is available.
The interest is also driven by external groups (patients, payers, and other agencies) who have interests in how we provide care and what choices can be selected.
RL and DH: Transcatheter aortic valve replacement (TAVR) is heralded as “transformational.” Isn’t this a bit over the top?
Bailey: TAVR has transformed delivery of care for patients with valvular heart disease in two major ways. First, the proof of efficacy, in high-risk surgical patients as well as in patients who are not surgical candidates, sets the stage for evolution of this technology to smaller, more effective devices. This is similar to the evolution of surgical valves from the Hufnagel valve to the tissue valves we us today.
But perhaps the most important “transformation” has been in the development of a multidisciplinary team (cardiology, cardiothoracic surgery, echo, imaging, anesthesia, and geriatrics) to make decisions regarding the best care for individual patients.
RL and DH: Are you concerned that “real world” TAVR results won’t be as good as those reported in the PARTNER studies?
Bailey: We should expect that outcomes in “real world” patients may not be the same as in highly selected patients at the few experienced centers who participated in this pivotal study. The current process of only allowing the procedure at a limited number of centers, with state-of-the-art facilities and multidisciplinary teams who are actively assisted with patient selection and the initial procedures, will be very important in enabling the selection of those patients who are most likely to have outcomes similar to those seen in the PARTNER nonsurgical arm.
RL and DH: The data from all TAVR patients are supposed to be entered into a national database. Do you think this will be effective in assuring that TAVR is used appropriately?
Bailey: Follow-up of patients who receive TAVR is critically important to allow centers to compare their results to those seen regionally and nationally. It will not be the sole method for assuring appropriate use, but it is critical to ensuring accountability for outcomes.
RL and DH: The transcatheter valve alone will cost ≈$30,000. Is TAVR cost effective, especially since it is being used in an elderly population?
Bailey: The current cost analysis by Cohen et al. does suggest that the costs of TAVR, even in this elderly population, are consistent with costs that our society accepts for lifesaving and life-prolonging therapy such as dialysis. This becomes an important decision in each individual patient. Experience shows that these costs will likely decrease over time, resulting in a more favorable cost-effectiveness analysis.
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