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Posts Tagged ‘syntax trial’

On the heels of the SYNTAX study which evaluated the effectiveness of using stents to treat multiple blockages, a new journal article outlined the appropriateness of both PCI (stenting and angioplasty) and CABG (bypass surgery) has been published.

For the Full Guidelines – click here..

Here’s an early glimpse of the article’s main points – most of which reinforce guidelines we’ve known since the early 1980’s (but which were questioned during the height of the stent-enthusiasm.)

[As usual, my comments are in italics and brackets.]

Article Re-post:

Title:  ACCF/SCAI/STS/AATS/AHA/ASNC/HFSA/SCCT 2012 Appropriate Use Criteria for Coronary Revascularization Focused Update Date

Posted:  January 30, 2012

Authors:  Patel MR, Dehmer GJ, Hirshfeld JW, Smith PK, Spertus JA, on behalf of the American College of Cardiology Foundation Appropriate Use Criteria Task Force, Society for Cardiovascular Angiography and Interventions, Society of Thoracic Surgeons, American Association for Thoracic Surgery, American Heart Association, American Society of Nuclear Cardiology, Society of Cardiovascular Computed Tomography, American Society of Echocardiography, Heart Rhythm Society. Citation:  J Am Coll Cardiol 2012;Jan 30:[Epub ahead of print].

Comments (6)Related Resources Cardiosource Video News Update on Appropriate PCI

Cardiosource Video News PCI AUC, Hydration and Afib Ablation

Perspective: The following are 10 points to remember about this focused update on appropriate use criteria for coronary revascularization:

1. The writing group and technical panel felt that some quantification of coronary artery disease (CAD) burden, either by description or SYNTAX score, could be helpful to clinicians. Coronary artery bypass grafting (CABG) was rated as appropriate in all of the new clinical scenarios developed, whereas percutaneous coronary intervention (PCI) was rated as appropriate only in patients with two-vessel CAD with involvement of the proximal left anterior descending artery (LAD) and in patients with three-vessel disease with a low CAD burden. [This means that people with a lot of blackages or disease should not receive multiple stents – but should have bypass surgery instead.  The ‘syntax score’ is a rating system used by cardiologists to assign a number to the amount of blockage.  The higher the number, the more blockage.].

2. ST-segment elevation myocardial infarction (STEMI) ≤12 hours from onset of symptoms and revascularization of the culprit artery is rated as appropriate with a score of 9 (on a 1-9 scale). [in the middle of a heart attack, stenting is an appropriate treatment to open the blockage that is causing the heart attack.]

3. Revascularization in patients with one- or two-vessel CAD without involvement of the proximal LAD and no noninvasive testing performed is considered inappropriate.  [This says that You can’t just stent disease that isn’t causing a problem unless the disease is located in critical areas, or just take asymptomatic people to the cath lab.]

4. PCI is considered inappropriate for left main stenosis and additional CAD with intermediate to high CAD burden. [This artery is too important to risk treating with stents.  If this vessel were to have a stent thrombosis – the patient almost always dies.]

5. Revascularization is considered uncertain in unstable angina/NSTEMI and low-risk features (e.g., Thrombolysis in Myocardial Infarction [TIMI] score ≤2) for short-term risk of death or nonfatal MI, but appropriate for those with intermediate-risk features (e.g., TIMI score 3-4) and for those with high-risk features.

6. Appropriateness for PCI is uncertain for three-vessel CAD with intermediate to high CAD burden (i.e., multiple diffuse lesions, presence of chronic total occlusion, or high SYNTAX score), but CABG is appropriate.  [this means that this is still ‘under discussion.’]

7. PCI for isolated left main stenosis is now graded as uncertain. [see number 4.]

8. For patients with acute MI (STEMI or NSTEMI) and evidence of cardiogenic shock, revascularization of one or more coronary arteries is appropriate.

9. It should be noted that uncertain indications require individual physician judgment and understanding of the patient to better determine the usefulness of revascularization for a particular clinical scenario.  [not all treatments fit all patients].

10. The Appropriate Use Criteria writing group and technical panel favor the collaborative interaction of cardiac surgeons and interventional cardiologists heart team approach regarding revascularization decisions in complex patients or coronary anatomy, as recommended in the PCI guidelines. [We should work together to treat the patient, which kind of works against PCI without surgical backup.]

Author(s): Debabrata Mukherjee, M.D., F.A.C.C.

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The is no easy buttonA new headline in Reuters brings home this notion, “Many stent patients get re-hospitalized.”  While this article highlights the high rates of re-hospitalization – (1 in 6! in this study) it fails to mention one of potential culprits.  While the authors discuss increasing patient co-morbidities, they fail to address increasing burdens of coronary artery disease (CAD) in patients receiving stents.  This isn’t a new phenomenon – but the strategy of  multiple stent treatment is. 

In the past, patients with a heavy burden of CAD such as multiple lesions, long length lesions or strategically placed lesions affecting multiple vessels (such as left main disease or trifurcation lesions) were treated more definitively, with open heart surgery (aka ‘bypass surgery’).

However, in the last decade, cardiology has ‘pushed the envelope’ in an effort to treat more diffuse and severe disease with stents and other temporary measures.  Despite multiple research studies showing the shortfalls of this method (as discussed previously here at Cartagena Surgery) this strategy has proved wildly successful with the general public.  Why?

The answer is obvious:  stents are the ‘easy option.’  [compared to surgery].  Too bad one of the other options is death..

multiple stents aka a 'full metal jacket"

Will the latest research (and news headlines) heralding the shortcomings of stents for permanent treatment of serious disease end this trend?

Unlikely.  There is just too much money involved.. and human nature doesn’t change.  Preventable behaviors cause the vast majority of human disease, but our behaviors seldom change.   And people will always seek to press the ‘easy button’.  [note the date on the headline below…]

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As I delve further into the Syntax trial, (in preparation for a presentation at work):

Mark Midei was charged with another 175 counts of unneccessary stenting this week..

The Syntax trial is a great example of the ‘big lie’ of the easy fix – and the publicity spin, as explained on this blog by (what appears to be ) one of the last honest cardiologists..  As I slosh through reams and reams of printed articles, as well as on-line stories, and links to journals on the Syntax trial and the results – it becomes readily apparent – that it is almost impossible to find an honest, and unbiased report of actual syntax results (particularly since cardiologists are doing most of the writing.)  Cardiac surgeons – listen up!!  You know the truth about outcomes with stents versus cabg (surgery) – you see it every single day.. But stop sitting there smugly, and self-assuredly, so certain that the truth will out..

The truth is out, but it’s so muddied as to be unrecognizable.  Start writing your own research papers and defend yourself (and your patients) from this watershed of biased reporting.. Stenting is EASY but it’s NOT effective, and bypass surgery remains the standard of practice and the best treatment for longevity.. No propaganda can change that – but surgeons can’t lie back and rest on their laurels..

Dr.  DeMaio escapes..

and the most infamous cardiologist in America.

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By popular request from several readers – I have re-posted an article summarizing the 2010 Syntax trial results (3 year data in this on-going trial).  This article was originally published at www.theheart.com.  I have also posted the link to a blog discussing these results in context.. Please note the heavily biased language (in favor of stenting) in both of these re-posts. Hard to dismiss the results showing CAGB to be SO much better for patients and longevity, but it seems like several of the cardiologists quoted attempt to do exactly that.

Three-year SYNTAX results extend CABG advantage to intermediate-risk patients

Sep 13, 2010     Shelley Wood

Geneva, Switzerland – Three-year results for the landmark SYNTAX trial are bringing some clarity to a finding just hinted at—then strenuously debated—at the two-year mark: “intermediate-risk” patients with complex coronary disease by SYNTAX score are probably better off getting open-heart surgery than PCI with a Taxus paclitaxel-eluting stent, investigators say. Cumulative event rates also point to ongoing separation of event curves for both MI and even all-cause death, although the latter by no means was statistically significant at three years.

Dr A Pieter Kappetein (Erasmus Medical Center, Rotterdam, the Netherlands), who presented the three-year results at the European Association of Cardiothoracic Surgery 2010 Annual Meeting, called the findings in the intermediate-risk subgroup the “most remarkable” difference to emerge between the two- and three-year mark, although not necessarily surprising. Indeed, Dr Manuel J Antunes (University Hospital, Coimbra, Portugal), who discussed the two-year results after their presentation last year, predicted that between-group differences that were statistically different at year one would remain so and that differences that trended in favor of one group would reach statistical significance in due time.

Dr David Cohen (Saint Luke’s Mid America Heart Institute, Kansas City, MO), commenting on the results for heartwire, said he was not “particularly concerned” by the three-year results, which, he noted, were only marginally different from the two-year results and continue to be driven by a higher revascularization rate in the Taxus/PCI-treated patients. He did single out as “interesting” the “continued gradual separation of the curves for both MI and all-cause mortality” to year three.

“These findings may relate to a variety of factors, including very late stent thrombosis, progression of disease at unstented segments, or the more complete revascularization afforded by initial CABG in these highly complex patients.  Although I suspect that some of these late events might have been avoided with the current generation of drug-eluting stents [DES], which are safer than the paclitaxel-eluting stents used in SYNTAX, bypass surgery continues to set a very high standard for our patients.”

The SYNTAX trial
As previously reported by heartwire, SYNTAX was an 1800-patient trial randomizing patients with left main coronary disease and/or three-vessel disease to either CABG or PCI using the Taxus DES. At one year, PCI failed to meet the prespecified margin of noninferiority against CABG, after the primary end point (major adverse cardiac and cerebral events [MACCE]) occurred significantly more often among PCI-treated patients than among CABG-treated patients, driven by repeat procedures in the PCI group. For the “harder” end point of death/stroke/MI, rates were almost identical between the two groups; the stroke rate was higher in the CABG-treated patients. Two-year results, presented at last year’s European Society of Cardiologymeeting, showed MACCE rates continuing to diverge, still driven by higher repeat-revascularization rates and a signal of increased MI among PCI-treated patients.-SW

At three years, 95% of the original cohort of 1800 patients was available for follow-up. Rates of the primary end point, MACCE, remained statistically lower in the CABG-treated patients, driven by the lower rates of repeat-revascularization procedures—just under 11% in the CABG-treated patients vs nearly 20% in the PCI/DES group. For the hard composite end point of all-cause death, stroke, and MI out to three years, there were no differences between groups.

Stroke, which at one year had significantly favored the DES-treated patients, was no different between the two groups by three years and nearly identical between years one and two and between two and three. MI rates, which had numerically favored the CABG-treated patients at one year and had reached statistical significance by the two-year mark, continued to be significantly lower in CABG group from year two to three and cumulatively were significantly lower in the CABG-treated patients over three years, with an absolute difference of 3.5%.

Cumulative event rates to three years

Cumulative event rate CABG (%) Taxus (%) p
MACCE 20.2 28.0 < 0.001
Death, stroke, MI 12.0 14.1 0.21
All-cause death 6.7 8.6 0.13
Stroke 3.4 2.0 0.07*
MI 3.6 7.1 0.002
Repeat revascularization 10.7 19.7 < 0.001
*Stroke rate between one and two years 0.6% vs 0.7% and between two and three years 0.5% vs 0.6%

For the analysis of outcomes according to baseline SYNTAX score—developed to characterize complex coronary vasculature in patients with high-risk left main and/or three-vessel disease—Kappetein reminded heartwire that at both one and two years, the lowest-risk patients by SYNTAX score (score of 0-22) had MACCE rates that were very similar for both CABG- and DES-treated patients. By contrast, in patients with the highest SYNTAX scores (>33), reflecting the most complex disease, the SYNTAX trial clearly showed that CABG was the best option. As such, surgeons and interventionalists have largely been in agreement that PCI is a reasonable option for the lowest-risk group, while surgery is the clear winner for the highest-risk patients.

In intermediate-risk patients (23-32), the two-year results showed a trend toward improved outcomes with CABG, but no statistically significant differences, leading some to argue that PCI could still be considered for patients with an intermediate SYNTAX score—particularly if they had left main disease, but not triple-vessel disease. The three-year MACCE results in these intermediate-risk patients, however, show that the event curves have continued to separate, reaching 27.4% for DES-treated patients and 18.9% for the CABG-treated patients, a difference that now reaches statistical significance (p=0.02).

What’s clear from these three-year results, Kappetein told heartwire, is that it is only the lowest-risk patients by SYNTAX score in whom both PCI and CABG can be considered to be reasonable options.

What MI type?

According to Kappetein, the increased MACCE rate in the intermediate-risk group was driven by repeat-revascularization procedures, but also by the uptick in MIs among PCI-treated patients. But he acknowledged that it is not yet clear what kinds of MIs are driving this difference. Of note, rates of stent thrombosis (4.5%) among PCI-treated patients at three years were not statistically different from the rates of symptomatic graft occlusion (3.5%), hinting that the MIs being counted were not being caused solely by late stent thrombosis.

Asked if the bulk of these MIs were periprocedural “enzyme leaks,” Kappetein said: “We don’t know that yet, but we need to look deeper into that.”

Cohen, for his part, stressed that the “enduring lesson” from SYNTAX is that revascularization for chronic, complex coronary disease needs to be individualized to coronary anatomy, comorbidities, and patient preferences.

“The real value of SYNTAX continues to be in helping to provide high-quality, objective information to inform these complex decisions,” he commented. “I do think that is an important yet often-unappreciated aspect of SYNTAX. We often focus too much on ‘winners’ and ‘losers.’ The real winner here is the patient.”

Cohen has received grants for clinical research from Abbott Vascular, Boston Scientific, Edwards Lifesciences, Eli Lilly, Daiichi Sankyo, and Medtronic; has served as an advisor or consultant for Eli Lilly, Medtronic, Cordis, Schering-Plough, and Merck; and served as a speaker or a member of a speakers’ bureau for Eli Lilly and the Medicines Company. Kappetein disclosed having no conflicts of interest.

 

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