Positive CvLPRIT Results Lead ACC to Change Guidelines

BARCELONA – Heart attack patients who had complete revascularization of all blocked arteries had better outcomes than those who had only the “culprit” artery unblocked, according to results from the CvLPRIT (Complete Versus Lesion-Only Primary PCI Trial) study.

The open label, randomized trial showed that among patients with acute ST-segment elevation myocardial infarction (STEMI), those who had stenting of significant coronary stenoses not responsible for the infarction as well as the infarct-producing lesion had a 55% reduction in major adverse cardiac events (MACE) at 1 year, compared with the group that had only the infarct-related artery treated. The results were presented at the annual congress of the European Society of Cardiology.

The positive results mirror the results of the PRAMI trial presented at last year’s ESC annual congress, and seem to be the tipping point for the American College of Cardiology to withdraw one of its Choosing Wisely recommendations, which had questioned any intervention beyond unblocking just the artery responsible for the heart attack.

“The newest findings regarding coronary revascularization are great examples of science on the move, and we are responding accordingly,” wrote ACC President Patrick T. O’Gara in a statement issued on Sept. 22, not too long after the results of CvLPRIT were presented.

Dr. Anthony Gershlick, who presented the results of CvLPRIT at ESC, also concluded that “this strategy may be needed to be considered for future STEMI guidelines committees.”

But the topic remains controversial, and not all experts agree that it’s time for a change in clinical practice.

Dr. Shamir R. Mehta of McMaster University in Hamilton, Ont., said that both the CvLPRIT and PRAMI trials are still relatively small to measure up to the results of large meta-analyses, which show that revascularization of nonculprit arteries at the time of primary percutaneous coronary intervention (PCI) could be associated with higher mortality rates.

“The important question is, was there a significant hazard with doing revascularization at a later time point, and unfortunately this trial was too small to answer that question,” Dr. Mehta said at ESC. Dr. Gershlick, of University Hospitals of Leicester NHS Trust in England, disagreed.

“One question for me was, if a clinician is presented with angiographically significant stenoses in a non–infarct-related artery, should these be treated on that admission?” said Dr. Gershlick in a press conference. He said although retrospective registry data suggest otherwise, the results of PRAMI showed a 65% reduction in MACE with total revascularization at the time of primary PCI.

For CvLPRIT, he and his colleagues randomized 296 heart attack patients to receive either revascularization of only the infarct-related artery (146 patients), or have complete revascularization at the time of primary PCI.

The primary endpoint was MACE, which is a composite of total mortality, recurrent myocardial infarction (MI), heart failure, and ischemia-driven revascularization at 12 months.

Patients were on average 65 years old and mostly male. More than 80% had stenoses of a non–infarct-related artery, and more than 70% were treated via the radial approach.

In the complete revascularization group, the non–infarct-related arteries were treated after the infarct-related artery during the same sitting or during the same hospital admission.

At 12 months, there was a 55% reduction in MACE among patients who had complete revascularization. All components of the composite endpoint also showed a decrease, although they didn’t reach significance, compared with the group that received stenting of only the infarct-related artery.

There also was a reduction in all-cause mortality, recurrent MI, heart failure, and repeat revascularization in the complete revascularization group.

In addition, there were no safety signals, Dr. Gershlick said.

The study had several limitations, including its small size, combined endpoint, and loss to follow-up.

Experts agreed that there’s a need for larger randomized trials, such as the COMPLETE trial, which is currently enrolling patients.

Dr. Gershlick and Dr. Mehta had no disclosures.