Big Study Looks At Length of Drug Treatment After Stent Implantation Reply

The advent of drug-eluting stents dramatically reduced the restenosis (reclogging) rate associated with bare-metal stents but prompted new concerns about the rare but potentially lethal complication of stent thrombosis (ST). Cardiologists have relied upon dual antiplatelet therapy to prevent ST but there has been considerable uncertainty and controversy about the ideal duration of therapy.

The Dual Antiplatelet Therapy (DAPT) trial was coordinated by the Harvard Clinical Research Institute as part of a large-scale collaboration with the FDA, stent manufacturers, and pharmaceutical companies…. The main results of the trial were presented on Sunday at the American Heart Association meeting in Chicago and published simultaneously in the New England Journal of Medicine.

Click here to read the full post on Forbes.

 

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Cardiology Group Withdraws ‘Choosing Wisely’ Recommendation Reply

In the end it wasn’t wisdom for the ages. The American College of Cardiology said today that it was withdrawing one of its five recommendations in the “Choosing Wisely” campaign.  In 2012 the ACC recommended that heart attack patients should have only their culprit artery unblocked. It said that patients and caregivers should question whether complete revascularization of all nonculprit lesions in heart attack patients should be performed.

The original recommendation was based on non-randomized studies suggesting that treating all significantly blocked vessels in heart attack patients could be harmful. “However,” the ACC now states, “over the last two years, new science has emerged showing potential improvements for some patients in their overall outcomes as a result of complete revascularization.”

Click here to read the full post on Forbes.

 

Fractional Flow Reserve Gains Support in Stable CAD and NSTEMI Reply

In recent years interventional cardiologists have started to use a new catheter technique, called fractional flow reserve (FFR), in an attempt to assess which blocked vessels might benefit from a stent. Two studies presented at the European Society of Cardiology meeting in Barcelona offered new support for FFR, which has been slowly but surely gaining traction in the interventional cardiology community.

Bernard De Bruyne presented 2-year results from the FAME 2 (Fractional flow reserve versus Angiography for Multivessel Evaluation 2) study (simultaneously published in the New England Journal of Medicine). FAME 2 was designed to find out whether PCI, with the help of FFR, can reduce the rate of hard endpoints in stable coronary artery disease compared to medical therapy. (FAME 2 was sponsored by St. Jude Medical, which makes  an FFR pressure wire. Another major player in the field is the Volcano Corporation.)

Click here to read the full post on Forbes.

 

Study Offers Reassurance About Newer Drug-Eluting Stents Reply

Drug-eluting stents (DES) have been viewed as a great advance over earlier stents and balloon angioplasty because they result in many fewer cases of restenosis. But enthusiasm for the first generation of DES was somewhat curbed due to reports of late stent thrombosis (ST), a rare but very dangerous complication. Now findings from a large ongoing registry study provide some reassurance about the long-term safety of the new generation of drug-eluting stents in patients with heart attacks (STEMI). The results are published  in the Journal of the American College of Cardiology.

SCAAR (Swedish Coronary Angiography and Angioplasty Registry) investigators analyzed data from 34,000 primary PCI patients who received a bare-metal stent, an old-generation DES, or a new-generation DES.

Click here to read the full post on Forbes.

 

Prescription Delay Following Stent Implantation Is a Common and Deadly Problem Reply

After receiving a stent, many patients delay or fail to fill their prescription for clopidogrel or another antiplatelet agent. Now, a study published in the Journal of the American Heart Association offers evidence that this problem is widespread and often leads to serious consequences.

Researchers analyzed data from all stent implantations performed in British Columbia from 2004 through 2006. In all, 15,629 stents were implanted: 3,599 patients received at least one drug-eluting stent (DES), and 12,030 received bare metal stents (BMS) alone. Nearly a third of the patients in each stent group did not fill their prescription within 3 days after leaving the hospital.

A delay of 3 or more days in filling a first prescription for clopidogrel after hospital discharge was associated with significant increases in the risk for death and readmission with MI at 2 years:

Click here to read the full post on Forbes.

 

New Study Lends Support For Alternative Heart Attack Treatment Strategy 2

It is generally agreed that the best treatment for heart attack patients is to immediately reperfuse the blocked artery with a stent. But many people live in areas where this strategy, known as primary PCI, is not available within the time frame when it produces the greatest benefit. Previous studies have found good short term outcomes in patients who receive a pharmaco-invasive strategy, in which patients first receive fibrinolytic therapy including a clot-busting drug and then later undergo angiography. Now long-term results from a large real-world study show that this strategy may be an acceptable alternative for some patients when immediate primary PCI is not available.

In a paper published in Circulation, French researchers report the 5 year mortality findings from nearly 1,500 STEMI patients enrolled in the 2005 cohort of FAST-MI (The French Registry on Acute ST-Elevation and Non–ST-Elevation Myocardial Infarction).

Click here to read the full post on Forbes.

 

Stents Lose In Comparisons With Surgery And Medical Therapy Reply

Despite the enormous increase in the use of stents in recent decades, there is little or no good evidence comparing their use to the alternatives of CABG surgery or optimal medical therapy in patients also eligible for these strategies. Now two new meta-analyses published in JAMA Internal Medicine provide new evidence that the alternatives to PCI remain attractive and that some of the growth in PCI may have been unwarranted.

Click here to read the full post on Forbes.

 

FDA Spanks 23andMe, Grants Breakthrough Status To Factor Xa Inhibitor, and Approves Promus Premier Stent Reply

It was a busy morning at the FDA. Three new FDA actions may be of considerable interest in the cardiology universe:

FDA Halts 23andMe Personal Genome Test– The FDA sent a scathing letter to 23andMe ordering the company to stop selling its Personal Genome Service (PGS) test.   The FDA highlighted two cardiology-related uses of PGS as “particularly concerning,” including drug responses involving warfarin sensitivity and clopidogrel response.

FDA Grants Breakthrough Status To Factor Xa Inhibitor Antidote–

 …

FDA Approves Promus Premier Everolimus-Eluting Platinum Chromium Coronary Stent System–

Click here to read the full story on Forbes.

 

 Image representing 23andMe as depicted in Crun...

Image representing Portola Pharmaceuticals as ...

Surgery Preferable To Stents In Elderly People With Carotid Disease Reply

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.

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.

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.

Studies Examine Less Burdensome Dual Antiplatelet Regimens Reply

Two new studies published in the Journal of the American College of Cardiology offer hope but not, yet, compelling evidence to support less burdensome requirements for dual antiplatelet therapy (DAPT) after drug-eluting stent (DES) implantation.

In the first study, Spanish investigators followed 1,622 consecutive patients who received a drug-eluting stent (DES) for one year. They found that 10.6% of the DES patients interrupted at least one antiplatelet drug during the first year. Two-thirds (64.5%) of the  interruptions were temporary, lasting a median of 7 days. After discontinuation of therapy 4.1% of patients had an acute coronary syndrome (ACS), but this was not significantly different from the 5.5% rate of major cardiac events in patients who remained on DAPT.

The authors concluded that early discontinuation of DAPT “is not exceptional and is usually temporary. Although further knowledge about individual risk is desirable, our results suggest that discontinuation for a few days (median: 7 days) of DAT after the first month of DES implantation may be reasonably safe in terms of major cardiac events.”

In an accompanying editorial, Bernhard Witzenbichler points out several limitations of the study, and concludes that “the data can only suggest that a brief interruption of DAPT does not have a large impact on ischemic risk.”

In the second study, Korean investigators randomized 2,117 patients to receive either the Endeavor zotarolimus-eluting (ZES) stent plus 3 months of DAPT therapy or standard therapy, consisting of another DES with a full year of DAPT. There was no difference between the two groups in the primary endpoint (the composite of CV death, MI, stent thrombosis, TVR, or bleeding), which occurred in 4.7% of patients in each group, and there were no significant differences in any of the components of the endpoint. The authors concluded that the Endeavor ZES plus 3 month DAPT “could be safe and beneficial for the selected patients with coronary artery disease who may need to stop DAPT early after DES implantation.”
Click to continue reading…

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…

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…

Large Meta-Analysis Finds Very Low Thrombosis Rates for Xience Stent Reply

A large new meta-analysis published in the Lancet provides the best evidence yet that the cobalt-chromium everolimus eluting (CoCr-EES) stents  (Xience and Promus) have a significantly lower rate of stent thrombosis than bare-metal stents BMS) and other drug-eluting stents (DES).

Tullio Palmerini and colleagues analyzed data from 49 randomized trials comparing different stents in more than 50,000 patients.

Odds ratios for 1 year definite ST for CoCr-EES compared with:

  • BMS: 0·23, CI 0·13–0·41
  • paclitaxel-eluting stents: OR 0·28, CI 0·16–0·48
  • permanent polymer-based sirolimus-eluting stents: OR 0·41, CI 0·24–0·70
  • phosphorylcholine-based zotarolimu-seluting stents: OR 0·21, CI 0·10–0·44
  • compared with Resolute zotarolimus-eluting stents: OR 0·14, CI 0·03–0·47

The superiority of the CoCr-EES over BMS emerged within the first month, suggesting that the findings were not simply a reflection of longer duration of  dual antiplatelet therapy. At two years, the CoCr-EESs still had a lower rate of definite stent thrombosis than both bare-metal stents (OR 0·35, CI 0·17–0·69) and paclitaxel-eluting stents (OR 0·34, CI 0·19–0·62). Since concerns were first raised a number of years ago about the higher rate of stent thrombosis with drug-eluting stents, the new results, write the authors, “represent a paradigm shift.”<
In an accompanying comment, John Ormiston and Mark Webster point out that a meta-analysis should only "be regarded as hypothesis-generating," but write that "despite these limitations" the findings are "very reassuring." "CoCr-EES should be regarded as the standard against which future design improvements are compared."
Click here to read the Lancet press release…

FDA Approves Medtronic’s Resolute Drug-Eluting Stent for Treatment of CAD, Including Diabetics Reply

The FDA has approved the Medtronic Resolute zotarolimus-eluting stent for the treatment of coronary artery disease. The Resolute DES is approved for use in a wide variety of patients, including diabetics. The new stent uses the same drug-and-polymer combination as the popular Resolute Integrity DES. The Resolute clinical trial program enrolled more than 5,000 patients worldwide, a third of whom had diabetes.

“The Resolute Integrity DES offers several notable benefits, starting with outstanding deliverability, which means it’s exceptionally easy to navigate the stent on the delivery system through the coronary vasculature to the narrowed arterial segment that requires treatment,” said Martin B. Leon, a principal investigator of the RESOLUTE US clinical study, in a Medtronic press release. “Its approval by the FDA is based on the impressive performance of the Resolute DES in a wide variety of patients. With the device’s compelling combination of deliverability, efficacy and safety, not to mention that it is the first DES approved for patients with diabetes, the Resolute Integrity DES promises to gain rapid acceptance in cath labs nationwide.”
Click here to read the Medtronic press release…