Five-Year Outcomes after PCI or CABG for Left Main Coronary Disease

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jope

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Looks like another hit on cardiac surgery volumes coming - this time in patients with left main disease. At our center, we already see a big decline in straight-forward CABG or surgical AVRs now and the acuity of the patients that do make it in for cardiac surgery is is becoming higher.


Abstract
BACKGROUND
Long-term outcomes after percutaneous coronary intervention (PCI) with contemporary drug-eluting stents, as compared with coronary-artery bypass grafting (CABG), in patients with left main coronary artery disease are not clearly established.
METHODS
We randomly assigned 1905 patients with left main coronary artery disease of low or intermediate anatomical complexity (according to assessment at the participating centers) to undergo either PCI with fluoropolymer-based cobalt–chromium everolimus-eluting stents (PCI group, 948 patients) or CABG (CABG group, 957 patients). The primary outcome was a composite of death, stroke, or myocardial infarction.
RESULTS
At 5 years, a primary outcome event had occurred in 22.0% of the patients in the PCI group and in 19.2% of the patients in the CABG group (difference, 2.8 percentage points; 95% confidence interval [CI], −0.9 to 6.5; P=0.13). Death from any cause occurred more frequently in the PCI group than in the CABG group (in 13.0% vs. 9.9%; difference, 3.1 percentage points; 95% CI, 0.2 to 6.1). In the PCI and CABG groups, the incidences of definite cardiovascular death (5.0% and 4.5%, respectively; difference, 0.5 percentage points; 95% CI, −1.4 to 2.5) and myocardial infarction (10.6% and 9.1%; difference, 1.4 percentage points; 95% CI, −1.3 to 4.2) were not significantly different. All cerebrovascular events were less frequent after PCI than after CABG (3.3% vs. 5.2%; difference, −1.9 percentage points; 95% CI, −3.8 to 0), although the incidence of stroke was not significantly different between the two groups (2.9% and 3.7%; difference, −0.8 percentage points; 95% CI, −2.4 to 0.9). Ischemia-driven revascularization was more frequent after PCI than after CABG (16.9% vs. 10.0%; difference, 6.9 percentage points; 95% CI, 3.7 to 10.0).
CONCLUSIONS
In patients with left main coronary artery disease of low or intermediate anatomical complexity, there was no significant difference between PCI and CABG with respect to the rate of the composite outcome of death, stroke, or myocardial infarction at 5 years. (Funded by Abbott Vascular; EXCEL ClinicalTrials.gov number, NCT01205776. opens in new tab.)

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Maybe, but a very large portion of interventional cardiologists aren’t comfortable doing left main PCI. From my limited experience it’s the ECMO guys that do them.
 
Looks like another hit on cardiac surgery volumes coming - this time in patients with left main disease. At our center, we already see a big decline in straight-forward CABG or surgical AVRs now and the acuity of the patients that do make it in for cardiac surgery is is becoming higher.


Abstract
BACKGROUND
Long-term outcomes after percutaneous coronary intervention (PCI) with contemporary drug-eluting stents, as compared with coronary-artery bypass grafting (CABG), in patients with left main coronary artery disease are not clearly established.
METHODS
We randomly assigned 1905 patients with left main coronary artery disease of low or intermediate anatomical complexity (according to assessment at the participating centers) to undergo either PCI with fluoropolymer-based cobalt–chromium everolimus-eluting stents (PCI group, 948 patients) or CABG (CABG group, 957 patients). The primary outcome was a composite of death, stroke, or myocardial infarction.
RESULTS
At 5 years, a primary outcome event had occurred in 22.0% of the patients in the PCI group and in 19.2% of the patients in the CABG group (difference, 2.8 percentage points; 95% confidence interval [CI], −0.9 to 6.5; P=0.13). Death from any cause occurred more frequently in the PCI group than in the CABG group (in 13.0% vs. 9.9%; difference, 3.1 percentage points; 95% CI, 0.2 to 6.1). In the PCI and CABG groups, the incidences of definite cardiovascular death (5.0% and 4.5%, respectively; difference, 0.5 percentage points; 95% CI, −1.4 to 2.5) and myocardial infarction (10.6% and 9.1%; difference, 1.4 percentage points; 95% CI, −1.3 to 4.2) were not significantly different. All cerebrovascular events were less frequent after PCI than after CABG (3.3% vs. 5.2%; difference, −1.9 percentage points; 95% CI, −3.8 to 0), although the incidence of stroke was not significantly different between the two groups (2.9% and 3.7%; difference, −0.8 percentage points; 95% CI, −2.4 to 0.9). Ischemia-driven revascularization was more frequent after PCI than after CABG (16.9% vs. 10.0%; difference, 6.9 percentage points; 95% CI, 3.7 to 10.0).
CONCLUSIONS
In patients with left main coronary artery disease of low or intermediate anatomical complexity, there was no significant difference between PCI and CABG with respect to the rate of the composite outcome of death, stroke, or myocardial infarction at 5 years. (Funded by Abbott Vascular; EXCEL ClinicalTrials.gov number, NCT01205776. opens in new tab.)

Should I trust a study funded by a stent manufacturing company? ;)
 
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How about we look at 5, 10 and 15 years.
 
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Looks like another hit on cardiac surgery volumes coming - this time in patients with left main disease. At our center, we already see a big decline in straight-forward CABG or surgical AVRs now and the acuity of the patients that do make it in for cardiac surgery is is becoming higher.


Abstract
BACKGROUND
Long-term outcomes after percutaneous coronary intervention (PCI) with contemporary drug-eluting stents, as compared with coronary-artery bypass grafting (CABG), in patients with left main coronary artery disease are not clearly established.
METHODS
We randomly assigned 1905 patients with left main coronary artery disease of low or intermediate anatomical complexity (according to assessment at the participating centers) to undergo either PCI with fluoropolymer-based cobalt–chromium everolimus-eluting stents (PCI group, 948 patients) or CABG (CABG group, 957 patients). The primary outcome was a composite of death, stroke, or myocardial infarction.
RESULTS
At 5 years, a primary outcome event had occurred in 22.0% of the patients in the PCI group and in 19.2% of the patients in the CABG group (difference, 2.8 percentage points; 95% confidence interval [CI], −0.9 to 6.5; P=0.13). Death from any cause occurred more frequently in the PCI group than in the CABG group (in 13.0% vs. 9.9%; difference, 3.1 percentage points; 95% CI, 0.2 to 6.1). In the PCI and CABG groups, the incidences of definite cardiovascular death (5.0% and 4.5%, respectively; difference, 0.5 percentage points; 95% CI, −1.4 to 2.5) and myocardial infarction (10.6% and 9.1%; difference, 1.4 percentage points; 95% CI, −1.3 to 4.2) were not significantly different. All cerebrovascular events were less frequent after PCI than after CABG (3.3% vs. 5.2%; difference, −1.9 percentage points; 95% CI, −3.8 to 0), although the incidence of stroke was not significantly different between the two groups (2.9% and 3.7%; difference, −0.8 percentage points; 95% CI, −2.4 to 0.9). Ischemia-driven revascularization was more frequent after PCI than after CABG (16.9% vs. 10.0%; difference, 6.9 percentage points; 95% CI, 3.7 to 10.0).
CONCLUSIONS
In patients with left main coronary artery disease of low or intermediate anatomical complexity, there was no significant difference between PCI and CABG with respect to the rate of the composite outcome of death, stroke, or myocardial infarction at 5 years. (Funded by Abbott Vascular; EXCEL ClinicalTrials.gov number, NCT01205776. opens in new tab.)

How in the hell does this get published in NEJM?? This journal has become trash. The second sentence in the results is just not true. Your CI crossed 1. Death was equal, not higher in the PCI group.

Seriously, one of my residents would have caught this. And they let it slip in the abstract of a 2,000 patients RCT in the NEJM???
 
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How in the hell does this get published in NEJM?? This journal has become trash. The second sentence in the results is just not true. Your CI crossed 1. Death was equal, not higher in the PCI group.

Seriously, one of my residents would have caught this. And they let it slip in the abstract of a 2,000 patients RCT in the NEJM???

Except that crossing 0 would mean no statistical difference...
 
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Except that crossing 0 would mean no statistical difference...

If they are doing an rct and comparing the incidence of an outcome, it should be using relative risk. The CI for RR crossing 1 is not significant. They could be using a different statistic, but why tf would they do that?
 
If they are doing an rct and comparing the incidence of an outcome, it should be using relative risk. The CI for RR crossing 1 is not significant. They could be using a different statistic, but why tf would they do that?

The stats section, table 1, and limitations discussion address the reporting of outcomes. But the tldr version is there are issues with this study (see what sevo has already pointed out) and it isn't related to how the abstract is worded
 
How about we look at 5, 10 and 15 years.

You beat me to it. One of the most important points is that just because you get a stent and are on optimal med therapy doesn’t mean the CAD disease process stops entirely. In addition to the risk of ISR, all the arterial circulation distal to the stent can still become atherosclerotic.

Otoh, having LM dz and then getting an arterial LAD and CX bypass graft means you now have biologically active tissue well distal from the offending lesion which are providing a luxury blood supply and are secreting NO/antithrombotic mediators which keep the coronaries happy.
 
Still, most people would choose a stent over CABG if given a choice. Heck I would probably choose a stent (or a robo off-pump miniCAB.) There are cardiologists in my community who have been stenting left mains for over a decade now.
 
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The stats section, table 1, and limitations discussion address the reporting of outcomes. But the tldr version is there are issues with this study (see what sevo has already pointed out) and it isn't related to how the abstract is worded

They present CI and p-values in the same line. Reading this abstract just screams of Busch league.
 
Another one...


“Inclusion criteria:

Patients >20 years of age
Moderate to severe ischemia on noninvasive stress testing (nuclear ≥10% ischemia; echo ≥3 segments of ischemia; cardiac magnetic resonance ≥12% ischemia and/or ≥3 segments with ischemia; exercise treadmill test ≥1.5 mm ST depression in ≥2 leads or ≥2 mm ST depression in single lead at <7 METs with angina)


Exclusion criteria:

≥50% left main stenosis (from blinded computed tomography)
Advanced chronic kidney disease (estimated glomerular filtration rate <30 ml/min)
Recent myocardial infarction
Left ventricular ejection fraction <35%
Left main stenosis >50%
Unacceptable angina at baseline
New York Heart Association class III-IV heart failure
Prior PCI or CABG within last year


Among patients with stable ischemic heart disease and moderate to severe ischemia on noninvasive stress testing, routine invasive therapy failed to reduce major adverse cardiac events compared with optimal medical therapy. There was also no benefit from invasive therapy regarding all-cause mortality or cardiovascular mortality/myocardial infarction. One-third of subjects reported no angina symptoms at baseline. Routine invasive therapy was associated with harm at 6 months (increase in periprocedural myocardial infarctions) and associated with benefit at 4 years (reduction in spontaneous myocardial infarction). These results do not apply to patients with current/recent acute coronary syndrome, highly symptomatic patients, left main stenosis, or left ventricular ejection fraction <35%.“
 
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Also from the article...

Although the overall interpretation of this trial was negative, there were mixed findings with evidence for both harm and benefit. This signals that: 1) invasive therapy for stable ischemic heart disease patients needs to be carefully considered in the context of angina burden and background medical therapy, and 2) likelihood that optimal coronary revascularization can be achieved with low procedural complications.

Well, no ****! You mean we shouldn't be placing stents and operating on everyone with CAD regardless of symptoms?
 
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Btw, EXCEL is a trash study and the response has been highly controversial. Essentially, they combined periprocedural MI with late stage MI in the results, and the definition of periprocedural MI was such that CABG had a much higher periprocedural event rate (duh, there is more troponin leak after a CABG), whereas there were many more late stage MIs in the PCI group.

 
And there goes the future of coronary interventions as big moneymakers for hospitals. At least the second big study in the last couple of years supporting medical treatments (vs interventions).
 
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And there goes the future of coronary interventions as big moneymakers for hospitals. At least the second big study in the last couple of years supporting medical treatments (vs interventions).
I wish that would be true but i feel like that won't be the case. Too much benjamins on the table at this point.
 
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