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.

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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.”

 

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…

Appropriate Use Criteria for Revascularization Updated Reply

The ACC, AHA, and other organizations have released updated appropriate use criterial for coronary revascularization. The 2012 Appropriate Use Criteria for Coronary Revascularization Focused Update incorporates data from the SYNTAX trial on the indications for PCI and CABG in patients with symptomatic, multivessel disease, as well as data from the CathPCI registry.

Here are some of the key ratings:

  • PCI for low burden left main disease alone or with blockages in other arteries with a low disease burdenuncertain
  • PCI for intermediate or high burden left main disease: inappropriate
  • PCI for low burden three-vessel disease: appropriate
  • PCI for intermediate or high burden three-vessel disease: uncertain
  • CABG remains appropriate for patients with two vessel disease including the proximal LAD and all three vessel and left main disease.

Click here to read the press release from the ACC, AATS, and SCAI…