Study Raises Questions About Transfusions In PCI Patients Reply

A very large observational study raises important questions about the role of transfusions in PCI patients in the US.

In a study published in JAMA, researchers from Duke and Yale analyzed data from more than 2.25 million percutaneous coronary intervention (PCI) procedures at more than 1,400 hospitals. The data came from the CathPCI Registry, a large ongoing study that includes  a significant proportion of all cardiac catheterization procedures in the US.

The overall transfusion rate was 2.14% but there was a very wide variation in transfusion practice patterns, ranging from 0 to 13%….

….

Click here to read the full post on Forbes.

 

About these ads

FDA Advisory Panel Recommends Against Approval Of Cangrelor Reply

The FDA’s Cardiovascular and Renal Drugs Advisory Committee today recommended against the approval of cangrelor, the investigational new antiplatelet drug from the Medicines Company. In a 7-2 vote the panel first rejected an indication  for the reduction of thrombotic cardiovascular events including stent thrombosis in patients undergoing PCI.

The panel also voted unanimously to reject a second indication…

Click here to read the full post on Forbes.

 

 

FDA Reviewers Deliver Split Opinion On The Medicines Company’s Cangrelor Reply

FDA reviewers presented two dramatically different views of The Medicines Company’s investigational new drug cangrelor. One reviewer says the drug should not be approved without a new trial and even states that the CHAMPION trials “were conducted unethically” and should not be approved “on that fact alone.”  But two other reviewers recommend approval.

Click here to read the full post on Forbes.

 

Both Overuse And Underuse Explain Disparities In Heart Procedures Reply

A new study finds that groups who have often been found to receive less medical care– non-whites, women, and people without private insurance or who are from urban and rural areas– are less likely to undergo coronary revascularization. But the same study finds that this disparity may be in no small part due to the fact that these same groups are less likely to receive inappropriate procedures. The study, published online in the  Journal of the American College of Cardiologysuggests, therefore, that the apparent underuse of healthcare in some groups may be partly counterbalanced by overuse in other groups.

In an interview with CardioExchange, Chan said that although “we have come a long way in ensuring that care is delivered equitably and thoughtfully in the US… there is no doubt that underuse in certain populations remains a persistent and huge problem. For policymakers… it highlights the importance of thinking about differences in treatment in a more complex way– as due to underuse and also potential overuse. Therefore, the goal may be to narrow the gap in vulnerable populations in instances where treatment has clearly established benefit rather than assuming that the measured difference is entirely due to a disparity in care.” Chan also said the paper was consistent with the hypothesis that patients for whom physicians are paid more are more likely to undergo inappropriate procedures.

Click here to read the full story on Forbes.

 

 

 

 

 

Fibrinolysis May Benefit Late-Arriving STEMI Patients Reply

Although primary PCI has emerged as the best treatment for STEMI, most patients don’t receive this treatment within the early time frame when it is known to be most beneficial. Delay in presentation is one important factor. Another is that most patients don’t arrive at a PCI-capable hospital and cannot be transferred fast enough to a PCI hospital.

The STREAM (Strategic Reperfusion Early after Myocardial Infarction) trial was planned as a proof-of-concept study to assess whether fibrinolysis was a beneficial alternative in this difficult group. Results were presented at the ACC in San Francisco and published simultaneously in the New England Journal of Medicine.

Click here to read the full story on Forbes.

Cangrelor During PCI May Reduce Ischemic Events Reply

In the Cangrelor versus Standard Therapy to Achieve Optimal Management of Platelet Inhibition (CHAMPION PHOENIX) trial, the intravenous platelet inhibitor cangrelor was tested for its effect on ischemic events associated with PCI. Cangrelor is a potent, fast-acting and reversible  agent. Results of the trial were presented at the ACC in San Francisco and published simultaneously in the New England Journal of Medicine.

A total of 11,145 PCI patients were randomized to a bolus and infusion of cangrelor or to a loading dose of clopidogrel. A primary endpoint event — death, MI, ischemia-driven revascularization, or stent thrombosis at 48 hours — occurred in 4.7% of the cangrelor group versus 5.9% of the clopidogrel group (adjusted OR, 0.78; 95% CI, 0.66-0.93; P=0.005). The authors calculated that 84 patients would need to be treated with cangrelor instead of clopidogrel to prevent one primary endpoint event.

Note to readers: Don’t miss this fascinating post on CardioExchange in which CHAMPION PHOENIX co-chair Deepak Bhatt responds to questions raised by Rick Lange and David Hillis in their New England Journal of Medicine editorial.

Click here to read the full story on Forbes.

Are Most People With Complex Coronary Disease Getting The Best Treatment? 1

angiogram

The relative value of PCI (stents) and bypass surgery for the treatment of people with blocked coronary arteries has been a topic of intense interest and debate for more than a generation now. Over time, the less invasive and more patient-friendly (and less scary) PCI has become the more popular procedure, but the surgeons (who perform bypass surgery) and cardiologists (who perform the less invasive PCI) have argued furiously about which procedure is safest and will deliver the most benefit in specific patient populations. In general, the most complex cases require the more thorough revascularization provided by surgery, while the more simple cases do well with PCI and can therefore avoid the trauma of surgery. But the specific criteria have remained murky, and interventional cardiologists have aggressively sought to take on increasingly more complex cases.

Now, long term results from a highly influential trial comparing the two procedures offer what is likely the most definitive solution we are likely to have for a very long time. Five year results from the SYNTAX trial have now been published in the Lancet.

Here’s some of the perspective on this study from two very savvy cardiologists, Rick Lange and L. David Hillis. (These comments are extracted from their original publication in CardioExchange. Note that I work on CardioExchange, which is published by the New England Journal of Medicine.)

…The “bottom line” conclusions are:

  1. CABG should remain the standard of care for patients with complex lesions…
  2. For patients with 3-vessel disease considered to be less complex… PCI is an acceptable alternative.
  3. All the data from patients with complex multivessel CAD should be reviewed and discussed by a cardiac surgeon and an interventional cardiologist, after which consensus on optimal treatment can be reached.

But Lange and Hillis, while they seem to largely agree with the study findings, also cast doubt on whether most physicians are likely to pay attention to the study details. They wonder whether most hospitals actually live up to the standards in the study, which requires, for each patient, a review of each patient by the multidisciplinary heart team, and the calculation of a complex SYNTAX score to establish the precise degree of risk.

Okay, let’s be honest….

  1. In your hospital, in what percentage of patients with left main or 3 vessel CAD are all the data systematically reviewed and discussed by a “Heart Team”?
  2. Do you calculate SYNTAX on all patients with left main or 3 vessel disease, or do you usually just “guestimate” lesion complexity?

If Lange and Hillis’s suspicions are correct, many people with complex coronary lesions are not receiving the best possible care. Hmmm.

Are Cardiologists Worried About Being Accused Of Unnecessary PCI? 3

In the last week two cases highlighted, yet again, the continuing shift in standards regarding PCI. In his interventional cardiology blog on CardioExchange, Rick Lange asks cardiologists: Could You Be Accused of Doing Unnecessary PCI?

“Public confidence is eroding as the number of reports of physician suspensions and monetary penalties for unnecessary PCIs grow. Accordingly, patients are questioning use of PCI, even when it is indicated and advisable.”

….

“Have investigations into unnecessary stenting changed your interventional practice? How so?”

Ohio Hospital And Cardiology Group Pay $4.4 Million To Settle Charges Over Unnecessary PCIs 2

In 2006, Reed Abelson in the New York Times reported that the PCI rate in Elyria, Ohio was four times the national average. Now, six-and-a-half years later, the local hospital and cardiology group have agreed to pay $4.4 million to settle US allegations “that the hospital and the physicians “performed angioplasty and stent placement procedures on patients who had heart disease but whose blood vessels were not sufficiently occluded to require the particular procedures at issue.”

The leader of the cardiology group defends its quality of care and says it “settled this matter so we can put it behind us and move forward.”

Read my complete story about this on Forbes.

CABG Highly Cost Effective In Diabetics With Multivessel Disease Reply

In November the main results of the FREEDOM trial showed that diabetics with multivessel disease do better with CABG than PCI. Now the findings of the trial’s cost-effectiveness study, published online in Circulation, demonstrate that CABG is also highly cost-effective when compared with PCI.

Elizabeth Magnuson and colleagues  found that although CABG initially cost nearly $9,000 more than PCI ($34,467 versus $25,845), over the long term it was more cost effective. At five years, greater follow-up costs in the PCI group, in large part due to a greater number of  repeat revascularization procedures, reduced the difference so that CABG cost only $3,600 more than PCI. The researchers calculated that CABG had a lifetime cost-effectiveness of $8,132 per QALY (quality-adjusted life-year) gained, which is considered highly cost effective. The finding was consistent across a broad range of assumptions.

The authors concluded “that CABG provides not only better long-term clinical outcomes than DES-PCI but that these benefits are achieved at an overall cost that represents an attractive use of societal health care resources. These findings suggest that existing guidelines that recommend CABG for diabetic patients with multivessel CAD remain appropriate in current practice and may provide additional support for strengthening those recommendations.”

“With great concerns about escalating healthcare costs, it’s very important when setting policy to understand the benefits gained from additional expenditures over the long run,” said Magnuson, in an AHA press release. “This is especially true in cardiovascular disease where many interventions tend to be very costly up front.”

 

Missouri Board Issues Emergency Suspension Of Cardiologist Accused Of Implanting Unnecessary Stents Reply

A Missouri cardiologist who has been accused of unnecessarily implanting stents in six patients has been temporarily barred from seeing patients. The Missouri State Board of Registration for the Healing Arts, which licenses physicians and investigates and disciplines physicians in cases of accused misconduct, issued an emergency suspension of the cardiologist’s license to practice, according to a news report by Jeremy Kohler published in the St. Louis Post-Dispatch.

Cardiologist Randall E. Meyer, of Central Missouri Cardiology in Jefferson City, has filed documents disputing the charges. He can seek reinstatement on February 4 at an administrative hearing. According to the Post-Dispatch, this is the first time the board has issued an emergency suspension in a very long time. The action follows a 2011 Missouri law that expanded the board’s power to issue emergency suspensions.

The Jefferson City cardiologist is accused of placing 13 stents in the coronary arteries of a patient “that “for the most part, were not blocked,” according to the article. In another case, “he told a patient she would have died overnight without the three stents he put in, but records showed no significant disease.”

Four patients are suing Meyer for malpractice. These cases appear to provide the basis for some of the board’s accusations.

2012 In Review: A Bad Year For Conventional Wisdom 3

This was a really grim year for anyone who thought we had things pretty well figured out. Time and again conventional wisdom was thrown out the window. 2012 forced the cardiology community to reconsider what it thought it knew about HDL cholesterol, platelet function tests, aspirin resistance, triple therapy, IABP, and more.

One device company, with a lot of help, did just about everything right when it introduced a radical, highly disruptive new technology. Another device company did just about everything wrong in handling a series of crises. The new generation oral anticoagulants continued to make gains– slowly– but also failed to achieve the early blockbuster success that some had thought they might achieve.

And it was another bad year for scientific integrity.

Conventional Wisdom Isn’t

Raising HDL cholesterol had to be great. Then the evidence arrived. Just last week HPS2-THRIVE put the final  nail in the niacin coffin. (I wonder what all the critics of AIM-HIGH have to say now?) And another CETP inhibitor bit the dust. The HDL hypothesis is far from dead, but any claim of benefit due to raising HDL will need to be rigorously demonstrated in a large, well-designed clinical trial.

Platelet function tests just had to be useful in guiding therapy. Then ARCTIC came along and blew a cold wind on the idea.

On a related note, many believed that testing for aspirin resistance might be a good idea. Then a paper in Circulation presented strong evidence that the entire concept of aspirin resistance might be a myth.

Triple therapy for PCI patients already receiving anticoagulation was standard clinical practice, endorsed by the guidelines. Now, after WOEST, we know that what we knew was wrong. Drop the aspirin.

Intraaortic balloon counterpulsation (IABP) has a class 1 recommendation for patients in cardiogenic shock following myocardial infarction for whom early revascularization is planned. Until IABP-SHOCK II was presented at the ESC and published in NEJM.

Depending on your perspective the FREEDOM trial either confirmed or denied conventional wisdom. We now know with near certainty that diabetics with multivessel disease have better outcomes with CABG than with PCI. An important lesson from an important trial.

Conventional wisdom had it that chelation therapy was worthless. The conventional wisdom may still be valid, but the NIH’s TACT trial means the debate will continue. It’s hard to imagine a satisfactory result to this controversy, despite the good intentions of the NIH and at least some of the TACT investigators. In general I support the concept of testing alternative therapies, especially if they gain traction in clinical practice, but it’s not clear yet whether we really learned anything from TACT (except that doing trials like this is extraordinarily hard). A trial like TACT should only be performed if it has a good chance of actually answering the big clinical question. Unfortunately, TACT didn’t do this.

TAVR: Bright Spot in a Dark Year

Click to continue reading…

FREEDOM Lends Strong Support To CABG For Diabetics With Multivessel Disease 3

Editor’s note: The embargo on FREEDOM was lifted early after a press release was published by mistake.)

Diabetics with multivessel disease do better with CABG than PCI, according to FREEDOM (Future Revascularization Evaluation in Patients with Diabetes Mellitus: Optimal Management of Multivessel Disease), a large NIH-sponsored study presented at the American Heart Assocation in Los Angeles and published simultaneously in the New England Journal of Medicine.

The study was designed to evaluate the  relative worth of the two revascularization procedures in diabetics with multivessel disease. Although many studies, including BARI, ARTS, CARDia, and SYNTAX, suggested that CABG was more effective than PCI in this population, PCI has remained a popular procedure in this group. Now, many experts agreed here in Los Angeles, FREEDOM may well dampen enthusiasm for PCI in this group.

In the trial, 1900 patients were randomized to either PCI with a drug-eluting stent or CABG. After followup for at least two years the primary outcome– the composite of death, nonfatal MI, or nonfatal stroke– occurred more often in the PCI group. There were more deaths and MIs in the PCI group but more strokes in the CABG group:

Here are the 5-year event rates:

Composite endpoint: 26.6% in the PCI group versus 18.7% in the CABG group (p=0.005)

  • Deaths: (16.3% versus 10.9%, p=0.049) but more strokes in the CABG group
  • MI: 13.9% versus 6%, p<0.001)
  • Stroke: 2.4% versus 5.2%, (p=0.03)

The results in favor of CABG were consistent across all the prespecified subgroups, including severity of disease as assessed by the SYNTAX score.

In an accompanying editorial, Mark Hltaky discussed the resistance of many cardiologists to accepting that CABG is superior to PCI in this patient population. Previous studies were dismissed because they were outdated, an argument that Hlatky labels “a catch-22, since long-term studies are needed to compare hard outcomes, but evidence from long-term studies may be ignored if therapies are evolving.” In particular, PCI advocates  have proposed that the use of drug-eluting stents would close the gap between PCI and CABG.

Now, he writes, 17 years after the NHLBI issued a clinical alert based on the results of the BARI trial, FREEDOM “provides compelling evidence of the comparative effectivesness of CABG versus PCI.”

He concludes:

“The results of the FREEDOM trial suggest that patients with diabetes ought to be informed about the potential survival benefit from CABG for the treatment of multivessel disease. These discussions should begin before coronary angiography in order to provide enough time for the patient to digest the information, discuss it with family members and members of the heart team, and come to an informed decision.”

At an AHA press conference, David O. Williams said that FREEDOM “provides meaningful information to help” cardiologists choose the best therapy for their patients and that it will cause “a definite change in practice.”

At the same press conference, Alice Jacobs said that FREEDOM might result in CABG receiving a class 1 recommendation in the guidelines. Now, she said, “one would think long and hard” about offering PCI to diabetics with multivessel disease.

Mandatory YouTube Link for this trial:

Click here to read the AHA press release…

PCI Utilization Lower In States With Public Reporting Of Outcomes Reply

In patients with acute MI, utilization of percutaneous coronary intervention (PCI) is lower in states that publicly report outcomes data, according to a new study published in JAMA. Despite the difference in utilization, however, there was no difference in mortality between reporting and nonreporting states.

Karen Joynt and colleagues used Medicare data to analyze PCI utilization and mortality in acute MI patients in three states with public reporting of PCI outcomes (New York, Massachusetts, and Pennsylvania) and other states in the same region without public reporting. The differences in utilization were greatest in patients at highest risk, who presented with ST-segment elevation MI (STEMI), cardiogenic shock, or cardiac arrest.

  • Overall unadjusted PCI rate: 37.7% for reporting states versus 42.7% for nonreporting states
  • Risk-adjust odds ratio: 0.82, CI 0.71-0.93, p=0.003)

Overall mortality did not differ between the reporting and nonreporting states (12.8% and 12.1%, respectively; adjusted OR 1.08 (CI 0.96-1.20], p=0.20), although there was a significant mortality difference in the STEMI subgroup (13.5% vs. 11.0%; OR 1.35, CI 1.10-1.66, p=0.004).

In Massachusetts, where outcomes reporting was initiated during the course of the study period, PCI utilization was at first no different from the other nonreporting states, but was significantly lower than nonreporting states after the change.

The authors offer two potential explanations for the findings:

…the foregone procedures were futile or unnecessary, and public reporting focused clinicians on ensuring that only the most appropriate procedures were performed. Alternatively, public reporting may have led clinicians to avoid PCI in eligible patients because of concern over the risk of poor outcomes.

The mortality findings, they write, suggest “that the foregone procedures might have been a mix of appropriate and inappropriate PCIs.”

In an accompanying editorial, Mauro Mosucci writes that the mortality finding may be due to “a conscious or unconscious ‘futility assessment’” in states with public reporting,” leading to “avoidance of PCI for patients who are less likely to benefit.” Alternatively, “public reporting might have resulted in a drive toward improved quality of care and improved outcomes in patients receiving PCI, offsetting the adverse effect of not performing PCI in high-risk patients.” Mosucci also points out that the data may be skewed because public reporting might result in “gaming” the coding of cases.

Click here to read the press release from JAMA…

FAME 2: Can FFR Save PCI From Medical Therapy? 1

Two sharply divergent views have developed about the value of fractional flow reserve (FFR) in PCI. FFR advocates think the new technology can help identify ischemic lesions that will benefit from PCI, thereby helping to salvage or enhance the reputation of PCI. FFR skeptics think that optimal medical therapy is still the preferred option for most patients with stable angina. Both sides find evidence to support their view in the FAME 2 (Fractional Flow Reserve versus Angiography for Multivessel Evaluation 2) trial presented at the ESC and published simultaneously in the New England Journal of Medicine.

The FAME 2 investigators sought to show that patients who had ischemic lesions as determined by FFR would benefit from the addition of PCI to the best available medical therapy. Patients with stable coronary artery disease under consideration for PCI underwent FFR. Patients who had at least one functionally significant lesion, defined as FFR < .80, were randomized to FFR-guided PCI plus medical therapy or medical therapy alone. Patients with no ischemic lesions were observed in a registry and received best medical therapy.

The trial was stopped early after enrollment of 1,220 patients (888 in the randomized portion and 441 to the medical therapy registry)– about half the number of intended patients– because of a significant reduction in the primary endpoint (the composite of death, MI or urgent revascularization) in the PCI group:

  • 4.3% in the PCI group versus 12.7% in the medical therapy group (HR for PCI 0.32, CI 0.19-0.53, p<0.001)
  • 3% of patients in the registry had a primary endpoint event

There was no difference between the groups in the rate of death or MI. The difference in the primary endpoint was driven entirely by the lower rate of urgent revascularization in the PCI group:

  • 0.7% in the PCI group versus 9.5% in the medical therapy group (HR 0.07, CI 0.02-0.22)

The FAME  2 investigators wrote that PCI was found to be beneficial in their trial, but not in previous trials like COURAGE, because of the demonstrated presence of ischemia in their randomized population. In addition, they noted that despite receiving the best medical therapy available, there were significantly more unplanned hospitalizations with urgent revascularizations in the medical therapy group.

A very different view of the trial is presented in an accompanying editorial by William Boden, the principal investigator of the COURAGE trial, who asks: “Which Is More Enduring– FAME or COURAGE?” The first FAME trial compared angiographic-guided PCI to FFR-guided PCI but did not include a COURAGE-type arm which received optimal medical therapy alone. FAME II was designed to address that question, writes Boden, but it should not be interpreted to mean that FFR-guided PCI is superior to optimal medical therapy. Boden makes the following points:

–There were few “hard” events in FAME 2 and urgent revascularization could be performed without objective evidence  of ischemia or positive biomarkers.

–Since the trial was unblinded, “investigators may have had a lower threshold for recommending revascularization” for patients in the medical group.

–Patients in the FFR group did not have noninvasive testing demonstrating ischemia, so some may have had preserved myocardial perfusion.

–Patients in FAME II were not at very high risk.

–The short followup period (mean followup of 7 months) did not leave enough time for the risk of restenosis to fully emerge.

Boden is highly critical of the early termination of the study, writing that it leaves “more questions than answers…. but the only enduring finding of the FAME 2 trial appears to be that  of a reduced short-term rate of unplanned revascularization with FFR-guided PCI, with little evidence of long-term, incremental benefit on prognostically important clinical outcomes.”

Republished with permission from CardioExchange, a NEJM group publication.

Guest Post: Is It The Right Time To Introduce Real Supervision Into Medical Practice? 1

Editor’s Note: Dr. Schloss, the medical director of cardiac electrophysiology at Christ Hospital in Cincinnati, OH, originally submitted the following post as a comment on my previous post in which I compared HCA to Barclays and JP Morgan. I’d be very eager to hear responses from other physicians about this subject.

Is It The Right Time To Introduce Real Supervision Into Medical Practice?

by Dr. Edward J. Schloss

One thing hospitals and banks have in common is that the quality of their work is obscure and not easily measured by the consumer. Systematic abuses can go undetected without direct supervision and public reporting.

At least a banker’s work is directly supervised by their peers. In a hospital, there is no direct supervision on the actions of the doctors. It is quite easy to work alongside another doctor for years without really knowing how good or bad they are. Current quality measures are easily gamed and do not really measure what they are intended to measure. Any practicing physician will tell you that.

Because our patients are not able to evaluate the quality of their care and external quality metrics are so poor, I wonder if the time might be right to introduce real supervision into medical practice. In his excellent piece in the New Yorker this week, Atul Gawande spends some time discussing ICU doctor supervision via the electronic ICU system. It may be time to extend this type of “check and balance” system into more clinical arenas. Imagine a physician supervisor making rounds into cath labs and ORs, reviewing charts and interviewing MDs. This sort of thing would likely be resisted by many doctors, but would be a better way to pick up outliers than computerized checklists.

Now that most doctors are employees of hospital systems, it would be feasible to set up such a supervision system (assuming federal privacy rules don’t get in the way).

Why HCA Is Like Barclays And JP Morgan 3

Earlier this week the New York Times reported on a pattern of seriously deficient cardiac care at a number of hospitals owned by HCA. Understandably, the most common reaction is simple disgust over more bad cardiology behavior. After the Mark Midei case, after subsequent and even worse cases in Maryland, Pennsylvania, and elsewhere, the easy thing is to say that many cardiologists, and especially interventional cardiologists, are corrupt and greedy.

But the larger significance of the HCA story has not been generally understood.

The real problem at HCA wasn’t so simple. Yes, some interventional cardiologists may have been acting like teenagers on spring break, and many may well have been guilty of poor medical judgement, and in some cases much worse. But that’s not what’s at the root of the HCA case.

And the real problem at HCA wasn’t that the hospital had no mechanism to deal with bad cardiologists. In fact, as readers of the Times article discovered, HCA had all sorts of internal and external controls and reviews. Time after time these reviews worked as intended and correctly identified the problem at hand.

The real problem at HCA was that all the oversight in the world meant nothing compared to the bottom line, and that power and authority flowed with the money. The problem is best exemplified by one anecdote in the Times story about a doctor at one HCA hospital:

Dr. Prasad Chalasani… was highlighted by the hospital in a 2009 business plan as being the most profitable doctor at the facility. “Our leading EBDITA MD,” the plan described him. (Ebitda, or earnings before interest, taxes, depreciation and amortization, is a measure of corporate earnings.) Just a few months earlier, hospital executives had received an outside review that characterized Dr. Chalasani as too quick to perform catheterizations, often without first doing the stress tests necessary to determine whether a patient needed the invasive and costly test.

Another example, featured prominently in the Times article, is the story of a nurse whose contract was not renewed after he reported  that unnecessary procedures were being performed at his hospital, although an internal HCA investigation had substantiated his allegations.

Medical judgement, the needs of patients, the responsibility to payers: these were all secondary. Oversight was blown away like so many  autumn leaves. Time and again, HCA executives ignored the reports of their own investigations or failed to implement programs and systems that would prevent them from recurring.

Now I don’t mean to suggest that the bad actions of individual physicians should not be taken seriously But there will always be incompetence, and there will always be individuals who seek to game the system to get more than their fair share. The question is whether the encompassing system is designed to encourage or hinder that behavior. Problems may arise even in the strictest systems, but they probably won’t lead to a federal investigation.

I think the best way to understand HCA is to look at the banks, since in many respects HCA acted like Barclays or JP Morgan, two banks whose inner workings have been exposed by recent scandals.  I’m not a financial journalist by any means, but several clear lessons have emerged from these scandals.
Click to continue reading…

NY Times: HCA Concealed Significant Problems At Lucrative Cardiac Centers 6

Despite numerous internal reviews that turned up a widespread pattern of unnecessary cardiology procedures being performed at many of its hospitals, the giant HCA corporation did little to rein in the problem or to inform regulators, payers, or patients about the problem, according to an investigative report in the New York Times by Reed Abelson and Julie Creswell. The story was published less than a day after  the company disclosed that it was being investigated by the US Attorney’s office in Miami.

The Times recounts numerous instances in which the company discovered a problem at one of its hospitals but then acted to conceal the problem or to prevent its reoccurrence at other hospitals. In one case, a nurse’s contract was not renewed after he reported to the company that unnecessary procedures were being performed at Lawnwood Regional Medical Center in Fort Pierce, Florida, although an internal HCA investigation had substantiated the nurse’s allegations.

The Times gained access to internal HCA reviews which found that, for an extended period from 2002 until 2010, “some cardiologists at several of its hospitals in Florida were unable to justify many of the procedures they were performing” and, “in some cases, the doctors made misleading statements in medical records that made it appear the procedures were necessary.”
Click to continue reading…

Drug-Eluting Stents Often Used In Patients At Low Risk Of Restenosis 2

The chief advantage of drug-eluting stents (DES) over bare-metal stents is that they significantly reduce the risk of restenosis. The chief disadvantages of DES are their greater cost and the requirement for prolonged dual antiplatelet therapy after DES implantation.

In a study published in Archives of Internal Medicine,  Amit Amin and colleagues analyzed data from 1.5 million PCI procedures included in the National Cardiovascular Data Registry (NCDR) CathPCI registry to assess whether a higher risk for target vessel revascularization (TVR) is associated with greater DES use and to estimate the economic impact of lower DES use in patients who are at low risk for TVR.

The authors calculated that 43.0% of patients were at low risk for TVR, 43.8% were at moderate risk, and 13.2% were at high risk. DES was used 73.9% of the time in the low risk group (TVR risk <10%), 78.0% in the moderate risk group (TVR risk 10-20%), and 83.2% in the high risk group (TVR risk >20%). According to the investigators, cutting DES use by half in low-risk patients would lower US health care costs by $205 million each year, at the cost of an increase in the overall TVR rate of 0.5%.

The authors concluded that “a strategy of lower DES use among patients at low risk of TVR could present an important opportunity to reduce health care expenditures while preserving the vast majority of their clinical benefit.”

In an invited commentary, Peter W. Groeneveld writes that “the use pattern of DES during the past 9 years illustrates how far away the system is from consistently embracing value-based medical decision making, and it also enumerates the many barriers and inertial practices in US health care that must be surmounted to reach economic sustainability.”

Click here to read the Archives press release…

No Benefit Found For Exercise Echocardiography In Asymptomatic Patients Following CABG Or PCI 1

Routine exercise echocardiography in asymptomatic patients after revascularization does not lead to better outcomes, according to a new study published in Archives of Internal Medicine. Although guidelines generally discourage the practice, post-revascularization stress tests are still commonly performed.

Serge Harb and colleagues performed exercise echocardiography on 2,105 patients following CABG surgery or PCI and followed them for a mean of 5.7 years. 13% of the subjects were found to have ischemia. One-third of these underwent repeat revascularization. Nearly half (49%) of the patients without ischemia on the initial test underwent further exercise testing. Overall, 17% of patients in the study underwent repeat revascularization. However, revascularization had no significant impact on mortality.

Mortality was higher in patients who had ischemia at any time than in patients with no ischemia (8% versus 4.1%, p=0.03). However, the authors reported that “clinical and stress testing findings, but not echocardiographic features, were associated with both all-cause and cardiac mortality.” This finding, according to the authors, suggests “that risk evaluation could be obtained from a standard exercise test rather than exercise echocardiography.”

The authors write that “careful consideration is warranted before the screening of asymptomatic patients is considered appropriate at any stage after revascularization.”

In an accompanying commentary, Mark Eisenberg writes that the study makes “a compelling argument that routine periodic stress testing in asymptomatic patients following coronary revascularization is of little clinical benefit.”

Click here to read the press release from Archives…

Revascularization In New York State: High Questionable Rates For PCI But Not CABG Reply

A large study looking at real world usage of elective coronary artery bypass surgery (CABG) and stenting (PCI) in New York State finds that nearly two-thirds of PCI procedures have inappropriate or uncertain indications. By contrast, 90% of CABG procedures were deemed appropriate and 1.1% inappropriate.

In a paper published in the Journal of the American College of Cardiology, Edward Hannan and colleagues analyzed data  from NY State patients who received CABG or PCI in 2009 and 2010 and applied appropriate use criteria (AUC) from the ACC, the AHA, and other organizations. (The study only included patients without an acute coronary syndrome (ACS) or previous CABG, as these indications have not generally been the subject of previous concern. By contrast, a large, controversial study last year, that found a significant percentage of nonacute PCIs were performed for inappropriate or uncertain indications, included patients both with and without ACS.)

Here are the main findings of the study:
Click to continue reading…

Meta-Analysis Compares Drug-Eluting and Bare-Metal Stents for Primary Angioplasty Reply

A new meta-analysis comparing drug-eluting stents (DES) and bare-metal stents (BMS) in patients with myocardial infarction has provoked opposing take-away messages from an author of the study and an editorialist. The authors emphasize the reduction in target-vessel revascularization (TVR) associated with DES, but the editorialist focuses on several potential DES weaknesses suggested by the study.

In the paper, published in Archives of Internal Medicine, members of the Drug-Eluting Stent in Primary Angioplasty (DESERT) Cooperation pooled patient data from more than 11 clinical trials in which more than 8,600 patients were randomized to either sirolimus-eluting or paclitaxel-eluting stents or BMS.  After a mean follow-up of 1201 days, DES was associated with a significant reduction in TVR but there were no significant differences in death, reinfarction, or stent thrombosis (ST):

  • TVR: 12.7% for DES vs 20.1% for BMS, HR 0.57, CI 0.50-0.66, p<.001
  • Mortality: 8.5% vs 10.2%, HR 0.85, CI 0.70- 1.04, p = .11
  • Reinfarction: 9.4% vs 5.9%, HR 1.12, CI 0.88-1.41, p = .36
  • Stent thrombosis: 5.8% vs 4.3%, HR 1.13, CI 0.86-1.47, p = .38

However, after two years there was a significant increase in the risk of stent thrombosis associated with the DES group (HR 2.81, CI 1.28-6.19, p=0.04).

The findings, write the authors,

provide strong evidence of the beneficial effects of SES and PES during primary PCI in STEMI. With follow- up as late as 6 years, a robust and sustained decrease in TVR was noted with use of these DES. Although the rates of late reinfarction and ST progressively increased, with the difference becoming statistically significant after 2 years in patients receiving SES and PES, the HR for mortality, while not significantly different between DES and BMS, favored DES.

Click to continue reading, including a comment from Gregg Stone…

ASCERT Observational Study Finds Long Term Advantage for CABG Over PCI in High Risk Cases Reply

A very large observational study finds that long-term mortality in high risk patients is lower after bypass surgery than after PCI. The results, which were previously revealed in January at the annual meeting of the Society of Thoracic Surgeons (STS), were presented in final form at the American College of Cardiology by William Weintraub and published simultaneously in the New England Journal of Medicine.

ASCERT (ACCF-STS Database Collaboration on the Comparative Effectiveness of Revascularization Strategies) is an NHLBI-funded study based on linked data from the STS, the ACC, and CMS administrative data. The study population included patients 65 or older with 2 or 3 vessel disease who underwent CABG or PCI in the period from 2004 through 2007. 189,793 patients were followed in the study; 103,549 received PCI and 86,244 underwent CABG. Median followup was 2.67 years.

1 year adjusted mortality:

  • 6.2% for CABG versus 6.55% for PCI (RR 0.95, CI 0.90-1.00)

4 year adjusted mortality:

  • 16.4% versus 20.8% (RR 0.79, CI 0.76-0.82)

The findings, the authors said, were consistent with data from both previous observational and randomized trials. But, they acknowledged, “the potential remains for unmeasured confounders to have influenced the findings.”

In an accompanying editorial, Laura Mauri writes that “it is plausible that, in patients with diffuse atherosclerosis, CABG reduces the risk of fatal myocardial infarction more effectively than does focal treatment.” But she expressed skepticism that CABG could be shown to be better in two-vessel disease or in patients with three-vessel disease with focal lesions. ASCERT also does not reflect either the recent advances in PCI technology or the “modern PCI strategies” which reserve PCI for ischemic lesions, she writes.

Observational studies can provide valuable information “but there is no substitution for randomized trials to eliminate selection bias between treatments.” Mauri concludes: “we must … continue to give priority to randomized trials on the most salient questions regarding treatment strategy.”

Study Supports PCI Without Onsite Surgical Backup Reply

Here’s a great example of genuine medical progress: 10% of the first 50 patients who received balloon angioplasty from the developer of the procedure, Andreas Grüntzig, required emergency bypass surgery. By 2002 only 0.15% of PCI patients required emergency surgery, leading many to believe that surgical backup was no longer necessary.

Now a large new study provides strong evidence that PCI can in fact be performed safely and effectively at hospitals without surgical backup. In a presentation at the American College of Cardiology and published simultaneously in the New England Journal of Medicine. Thomas Aversano and colleagues in the Cardiovascular Patient Outcomes Research Team (C-PORT) report  the results of a trial that randomized 18,867 patients to undergo PCI at hospitals with or without surgical backup.

  • 6 week mortality was 0.9% at hospitals without surgical backup versus 1% at hospitals with surgical backup, which was well within the predefined margin of noninferiority of a 0.4% difference in risk (p=0.004).
  • The 9-month composite rate of death, Q-wave MI, or target-vessel revascularization was 12.1% and 11.2%, which met the predefined margin of noninferiority of a 1.8% difference in risk (p=0.05).

The authors noted that high risk patients were excluded from the study, raising the possibility that the study population may differ from the general PCI population.

“The study shows that under certain circumstances, non-primary angioplasty can be performed safely and effectively at hospitals without on-site cardiac surgery,” said Aversano, in an ACC press release.

At an ACC press conference, Aversano discussed the potential impact of the study and warned against interpreting the study as an open invitation to implement PCI without surgical backup:

It doesn’t say you ought to go out and do this and expand it willy nilly, that was not the purpose of this project… These hospitals did not simply buy stents and start doing angioplasty. They went through a formal development program.

 

Meta-Analysis Finds No Advantages for PCI Over Medical Therapy in Stable Patients Reply

Patients with stable coronary artery disease (CAD) today do no better with stents than with medical therapy, according to a new meta-analysis published in the Archives of Internal Medicine. Kathleen Stergiopoulos and David Brown identified 8 trials with 7,229 patients comparing stents to medical therapy in which stents were used in the majority of PCI cases. ”By limiting the analysis to studies in which stent implantation was the predominant form of PCI,” they explained, their meta-analysis “compares contemporary versions of PCI and medical therapy. The exclusion of studies using balloon angioplasty as the primary form of PCI shifted the years of enrollment forward by almost a decade during which time optimal medical therapy evolved to the current regimen that includes aspirin, β-blockers, ACE-inhibitors (or angiotensin receptor blockers) and statins.”

After a mean followup of 4.3 years, there were no significant differences between the stent and medical therapy groups:

  • Death: 8.9% for PCI versus 9.1% for medical therapy (OR 0.98, CI 0.84-1.16)
  • Nonfatal MI: 8.9% versus 8.1% (OR 1.12,CI 0.93-1.34)
  • Unplanned revascularization: 21.4% versus 30.7% (OR 0.78, CI 0.57-1.06)
  • Persistent angina: 29% versus 33% (OR 0.80; CI 0.60-1.05)

The authors write that their study “suggests that up to 76% of patients with stable CAD can avoid PCI altogether if treated with optimal medical therapy, resulting in a lifetime savings of approximately $9450 per patient in health care costs.”

In an accompanying editorial, William Boden writes that “the inescapable fact is that it is increasingly harder to justify use of PCI solely for angina relief in such patients — especially as an initial approach to management, and if medical therapy has not been first instituted (or if efforts to optimize pharmacologic treatment in those treated initially medically are not undertaken).”

Boden responds to the failure of clinical trials like BARI-2D and his own COURAGE trial to effect change in clinical practice:

While physicians outwardly worship at the altar of evidence-based medicine, in reality, we more often tend to practice selective evidence-based medicine by adopting and embracing those trials and studies with results that reinforce our existing clinical practice preferences or biases, while we ignore or disdain the results of studies with results that are unpopular, conflict with our existing clinical practice beliefs, or collide with the conventional wisdom.

Archives editor Rita Redberg places the study in the journal’s “Less Is More” category and writes that, despite the evidence, “fewer than half of Americans with stable CAD who undergo stent placement have received medical therapy first.”

Here is the press release from Archives:

Study Suggests No Benefit Associated With Stent Implantation Compared to Initial Medical Therapy for Stable Coronary Disease

CHICAGO—A meta-analysis of eight previously published clinical trials suggests that initial stent implantation for patients with stable coronary artery disease is not associated with improved outcomes compared with initial medical therapy for prevention of death, nonfatal heart attacks, unplanned revascularization or angina, according to a study published in the Feb. 27 Archives of Internal Medicine, one of the JAMA/Archives journals. The article is part of the journal’s Less is More series.

While percutaneous coronary intervention (PCI) reduces death and nonfatal myocardial infarction (MI, heart attack) in acute coronary syndrome settings, its role in treating stable coronary artery disease (CAD) “remains controversial,” the authors write in their study background.

Kathleen Stergiopoulos, M.D., Ph.D, and David L. Brown, M.D., of Stony Brook University Medical Center, New York, conducted a meta-analysis of previous randomized clinical trials that compared initial coronary stent implantation and medical therapy with initial medical therapy alone. Eight trials that enrolled 7,229 patients between 1997 and 2005 were included. Of those patients, 3,617 were randomized to receive stent placement and medication therapy and 3,612 were randomized to receive medication therapy alone.

“The significant finding of this analysis is that compared with a strategy of initial medical therapy alone, coronary stent implantation in combination with medical therapy for stable CAD is not associated with a significant reduction in mortality, nonfatal MI, unplanned revascularization or angina after a mean (average) follow-up of 4.3 years,” the researchers comment.

They explain their results are in contrast to two recent meta-analyses that found reductions in mortality and angina (discomfort, tightness or heaviness in the chest) in patients assigned to initial PCI. They suggest that an aspect of the current study may explain the difference.

“By limiting the analysis to studies in which stent implantation was the predominant form of PCI, this meta-analysis, for the first time that we know of, compares contemporary versions of PCI and medical therapy. The exclusion of studies using balloon angioplasty as the primary form of PCI shifted the years of enrollment forward by almost a decade during which time optimal medical therapy evolved to the current regimen that includes aspirin, β-blockers, ACE-inhibitors (or angiotensin receptor blockers) and statins,” they note.

Of the total 649 deaths among the 7,229 patients in the trials, 322 occurred among 3,617 patients in the stent groups (8.9 percent) and 327 occurred among 3,612 patients in the medical therapy groups (9.1 percent). Nonfatal MI was reported in 323 of 3,617 patients in the stent groups (8.9 percent) compared with 291 of 3,612 patients in the medical therapy groups (8.1 percent.) Unplanned revascularization was performed in 774 of 3,617 stent patients (21.4 percent) and 1,049 of 3,420 medical therapy patients (30.7 percent).

Data on angina were available for 4,122 patients. Among the initial stent implantation patients, 597 of 2,070 experienced persistent angina (29 percent) compared with 669 of 2,052 medical therapy patients (33 percent).

“In the context of controlling rising health care costs in the United States, this study suggests that up to 76 percent of patients with stable CAD can avoid PCI altogether if treated with optimal medical therapy, resulting in a lifetime savings of approximately $9,450 per patient in health care costs,” the authors conclude.

Commentary: Mounting Evidence for Lack of Percutaneous Coronary Intervention in Stable Heart Disease

In an invited commentary, William E. Boden, M.D., of the Samuel S. Stratton VA Medical Center, Albany, N.Y., writes: “What is the practicing clinician to take away from the present study in the context of other published meta-analyses? First, the totality of evidence does not support any demonstrable clinical benefit for PCI in patients with stable CAD in terms of reducing death, nonfatal MI, hospitalization for ACS (acute coronary syndrome), need for unplanned revascularization and a durable, sustained effect on angina relief.”

He continues: “Finally, given the spiraling health care costs that we have witnessed in the United States over the past decade, and the financial burden this places on our existing health care system, businesses and health care consumers, we certainly have abundant scientific evidence to support a more selective, measured and balanced approach to the initial management of SIHD (stable ischemic heart disease) and one that promotes and embraces optimal medical therapy for the majority of patients as a proven alternative to revascularization.”
(Arch Intern Med. 2012;172[4]:312-319172[4]:319-321)