Nonculprit-lesion PCI in patients with STEMI and multivessel disease: do we now have a COMPLETE answer?

Reported from the European Society of Cardiology ESC Congress 2019 in Paris

Several randomized trials in the past have indicated a possible benefit of complete revascularization in patients with STEMI and multivessel disease (MVD) treated with primary PCI. However, the evidence was burdened by the small size of the previous trials and/or lack of power to assess hard endpoints such as death and new MI. 

The COMPLETE trial, which included 4041 patients, was designed to answer exactly this question – whether the strategy of complete revascularization leads to a reduction in the rate of cardiovascular (CV) death or new MI.

The answer we received today by Dr. Shamir R. Mehta, who presented the main results at the ESC’s 1st Hot line session, was positive – complete revascularization resulted in a significant reduction of CV death or new MI at the median follow-up of 3 years (7.8% vs. 10.5%, in the complete vs. the culprit-lesion-only group, respectively, HR 0.74, p=0.004, number needed to treat 37). The individual rate of new MI was significantly reduced (5.4% vs. 7.9%, HR 0.68, 95%CI 0.53–0.86), whereas the rates of CV death were similar (2.9% vs. 3.2%). Of note, cardiogenic shock patients were not enrolled in this study.

Timing of non-culprit lesion PCI

According to a prespecified analysis, the timing of non-culprit lesion PCI did not significantly impact the outcomes, i.e. the results remained consistent if nonculprit PCI was performed after the initial hospitalization for STEMI (median of 23 days), as opposed to performing it within the initial hospitalization (median of 1 day). This being said, it may be important to keep in mind that, per protocol, non-culprit PCI was to be performed by not later than 45 days.

Non-culprit lesions: a closer look

In the light of the overall positive results of complete revascularization, the question for our community may now be whether to routinely perform non-culprit PCI in patients with STEMI and MVD. To this end, 2 important points from the COMPLETE trial may be highlighted.

First, complete revascularization, defined as residual SYNTAX score of zero, was achieved in 90% of the cases, but the mean baseline SYNTAX score was 16 (and 7 after PCI of the culprit lesion), potentially suggesting lower complexity of nonculprit lesion PCI.
Of note, the previously conducted EXPLORE trial, which investigated nonculprit CTO PCI in patients with STEMI showed no apparent benefit of complete revascularization, with even a signal of more cardiac death at 4 years (Elias J, et al., Heart. 2018 Sep;104(17):1432-1438).

Secondly, FFR has been used in less than 1% of the lesions, thus potentially leaving out the question of how to proceed in patients with angiographically more intermediate lesions (in the COMPLETE trial, close to 60% of the non-culprit stenoses were deemed to be >80% on angiography).

In summary, the COMPLETE trial seems to provide solid evidence for the clinical benefit of complete revascularization in STEMI patients with MVD, but more data may be needed to better understand the impact of nonculprit PCI complexity and angiographically intermediate nonculprit lesions.

The presentation of the trial was complemented by the comment of Prof. Stephan James (Uppsala), who concluded that complete revascularization in STEMI patients with MVD should be performed at a staged procedure.

The manuscript was published simultaneously in the NEJM.

Watch this short interview of Luis Ortega-Paz providing a summary of COMPLETE randomized clinical trial:

View the results of this #CardioTwitter poll on whether COMPLETE will change STEMI practice

Will you change your practice in STEMI pts after the COMPLETE trial?@ESC_Journals@PCRonline@sbrugaletta@Ortega_Paz@SABOURETCardio@s_gati

— Elad Asher (@AsherElad) September 6, 2019