CvLPRIT: Complete Revascularization Halves MACE Risk in STEMI Patients

BARCELONA, Spain—Patients with ST-segment elevation myocardial infarction (STEMI) who undergo percutaneous coronary intervention (PCI) in all blocked arteries have much better outcomes than those whose treatment focused solely on the culprit lesion, according to data from the CvLPRIT trial released September 1, 2014, at the European Society of Cardiology (ESC) Congress. 

Importantly, the difference becomes apparent within the first month, indicating that staged PCI could be risky, said study investigator Anthony H. Gershlick, MD, of the University Hospitals of Leicester NHS Trust, Glenfield Hospital (Leicester, England).

The findings follow those of the PRAMI trial, presented at last year’s ESC Congress, which also supported complete revascularization—a departure from current European and US guidelines that emphasize a more gradual approach to primary PCI. 

Methods
For the Complete versus Lesion only PRimary-PCI Trial (CvLPRIT) trial, Dr. Gershlick and colleagues randomized 297 STEMI patients presenting at 7 UK centers to receive revascularization that was infarct-only (n = 146) or complete (n = 150). In the latter group, the infarct-related artery underwent PCI first before treatment of any significantly blocked non-infarct-related arteries, ideally within the same procedure but at least during the index hospitalization.
Randomization was stratified by infarct site (anterior vs nonanterior) and symptom-onset-to-balloon time (more or less than 3 hours). Significant blockage was defined as > 70% on single view or > 50% on 2 views. 


Complete revascularization increased both procedure time (55 vs 41 minutes; P < .0001) and contrast volume (250 vs 190 mL; P < .0001) but did not raise the risk of contrast-induced nephropathy (2% in each group; P = .95).

Calculated by time to first event, the 12-month risk of MACE (primary endpoint; total mortality, recurrent MI, heart failure, and ischemia-driven revascularization) was 55% lower in the complete revascularization group (table 1). 

Table 1. Clinical Outcomes at 12 Months

 

Infarct-Only

(n = 146)

Complete

(n = 150)

HR (95% CI)

P Value

MACE

21.2%

10.0%

0.45

(0.24-0.84)

.009

All-Cause Mortality

4.1%

1.3%

0.32

(0.06-1.60)

.14

Recurrent MI

2.7%

1.3%

0.48

(0.09-2.62)

.39

Heart Failure

6.2%

2.7%

0.43

(0.13-1.39)

.14

Repeat Revascularization

8.2%

4.7%

0.55

(0.22-1.39)

.20

 

“Though the numbers are small, and therefore nonsignificant, [complete revascularization] does affect all components of the primary endpoint,” Dr. Gershlick noted in a press conference. “I want to emphasize that it’s not just repeat revascularization that drives the [difference].”

In addition, when calculated by total number of events reported, all-cause mortality and repeat revascularization both showed positive trends (P = .09 and .07, respectively).

Dr. Gershlick noted that the Kaplan-Meier curves for first events separated early. “When you think about discharging the patient and perhaps bringing them back another time [for staged PCI], you should take note of [these data],” he said, referring to a difference in MACE risk at 30 days (HR 0.45; 95% CI 0.19-1.04) nearly identical to that seen at 1 year. 

Two months later may miss the window for maximum benefit, Dr. Gershlick emphasized, suggesting that future guideline-writing committees take the CvLPRIT data into account.

Not Enough to Overturn the Status Quo

Commenting after Dr. Gershlick’s presentation, Shamir Mehta, MD, of Hamilton Health Sciences (Hamilton, Canada), praised CvLPRIT as a well-conducted trial but raised doubts regarding its findings.

Not only do they contrast with those of a large meta-analysis, he said, they also contradict prevailing ideas about the treatment of non-culprit lesions during primary PCI.

“There is agreement on both sides of the Atlantic… that this is a potentially harmful procedure,” he stressed, noting that the practice is relegated to Class III by the ACC/AHA and “discouraged” by the ESC.

Dr. Mehta cited 2 “major issues” that he says detract from CvLPRIT. As a small study, it has low statistical power and is vulnerable to the play of chance, he said, arguing also that revascularization is an unreliable measure of benefit in an open-label trial.  

Over 1,800 deaths were included in the meta-analysis, while PRAMI and CvLPRIT together counted only 23, Dr. Mehta pointed out.

“In my opinion this is not enough to change the guidelines and this should not be enough to change clinical practice. We need more randomized trials and fortunately there are several ongoing,” he concluded, citing the multinational COMPLETE trial of more than 4,000 patients.

 


Source:
Gershlick AH. Complete versus Lesion only PRimary-PCI Trial (CvLPRIT): treat the infarct-related artery only or all lesions? Presented at: European Society of Cardiology Congress; September 1, 2014; Barcelona, Spain.

 

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Disclosures
  • Dr. Gershlick reports no relevant conflicts of interest.

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