September 1st, 2014
New Support For Complete Revascularization During Primary PCI
Larry Husten, PHD
Until recently, MI patients receiving emergency PCI would only have the culprit artery opened. Complete revascularization of non-infarct-related arteries was performed later. The conventional wisdom was that revascularization of non-infarct-related arteries could be dangerous. That wisdom began to change last year with the PRAMI trial, which found no evidence of harm and a suggestion of benefit in MI patients who underwent more complete revascularization.
Now a new study presented at the European Society of Cardiology meeting in Barcelona delivers additional support to the more liberal use of total revascularization during initial treatment. The CvLPRIT (The Complete versus Lesion-only Primary PCI Trial) was an open-label, randomized study comparing treatment of the infarct-related artery (IRA) only with complete revascularization in 296 acute MI patients.
At 12 months, there was a large and statistically significant reduction in the incidence of major adverse cardiac events in the group randomized to complete revascularization. Each of the endpoint components was also numerically lower in the complete revascularization arm:
- MACE: 21.2% in the IRA arm versus 10% in the complete revascularization arm, HR 0.45, CI 0.24-0.84, p=0.009
- Mortality: 4.1% versus 1.3%, HR 0.32, ).06-1.60, p=0.14
- Recurrent MI: 2.7% versus 1.3%, HR 0.48,, 0.09-2.62, p=0.39
- Heart failure: 6.2% versus 2.7%, HR 0.43, 0.13-1.39, p=0.14
- Repeat revascularization: 8.2% versus 4.7%, HR 0.55, 0.22-1.39, p=0.2
The benefits of complete revascularization emerged shortly after the index procedure and were apparent in the prespecified subgroups, including the number of significantly affected vessels, sex, and age.
The authors were encouraged by the fact that hard events were reduced in similar proportion to the softer endpoint of repeat revascularization. The result “suggests this strategy may need to be considered by future STEMI guideline committees,” they said.
The previous PRAMI trial had been criticized because of some trial design issues, said CvLPRIT investigator Anthony Gershlick. “As a result, PRAMI has not led to widespread changes in clinical practice, with IRA-only revascularization at P-PCI remaining by far the more common practice.”
In an interview, Eliot Antman said that he was particularly struck by the apparent lack of harm in the complete revascularization group, since it has been the fear of causing harm that has been the main reason not to perform more complete revascularization. Because of the small size of the trial and the small number of events, he was unsure whether the trial would be enough to change current guideline recommendations.
To view all of our coverage from the ESC meeting, go to our ESC.14 Headquarters page.
Yes.size is a problem. Also, if you take out the softer (and likely subjective) difference in repeat revascularization, there is likely no statistical significance. The problem is that knowing that a patient has “incomplete” revascularization will often increase future procedures. I am not sure how strict the revascularization criteria were, and how assiduously they were enforced.
Adding this new information from ESC from the CvLPRIT trial to the previously presented PRAMI data raises concern about the ACC’s Choosing Wisely initiative and the AUC guidelines that have listed non-culprit lesion angioplasty during primary PCI as inappropriate (or in the more recent parlance “rarely appropriate”).
The Choosing Wisely initiative was designed to help physicians and patient’s be confident about therapies that are clearly not indicated to avoid inappropriate testing or treatment and its subsequent potential for harm and unnecessary cost.
My concern when the Choosing Wisely initiative included the recommendation that not culprit intervention be avoided in its 5 point statement is that this practice is sometimes appropriate. However, the language of both choosing wisely and AUC suggests that it is never appropriate. Clearly with the presentation of these 2 data sets the practice of sometimes treating non-culprit lesions at the time of primary PCI should be reconsidered and changed to a category of “may be appropriate” and warranted. A change in the guidance for patient’s and physicians to a status of uncertain is required.
“#5 Don’t perform stenting of non-culprit lesions during percutaneous coronary intervention (PCI) for uncomplicated hemodynamically stable ST-segment elevation myocardial infarction (STEMI)”
(See the whole thing here – http://www.choosingwisely.org/doctor-patient-lists/american-college-of-cardiology/)