A strategy of complete revascularisation was superior to culprit lesion-only percutaneous coronary intervention (PCI) in reducing the risk of cardiovascular death or myocardial infarction (MI) in patients with ST-segment myocardial infarction (STEMI) and multivessel coronary artery disease, as well as reducing the risk of a composite of CV death, MI or ischaemia driven revascularisation.
Findings from the global COMPLETE study were presented today at the European Society of Cardiology Congress (ESC 2019; 31 August–4 September, Paris France), and simultaneously published in the New England Journal of Medicine (NEJM).
Shamir R Mehta (Population Health Research Institute, Hamilton, California, USA) presented the final results from the trial on behalf of the investigators. He said: “Patients undergoing primary PCI to the culprit lesion for STEMI are often found to have multivessel coronary artery disease, with one or more angiographically significant nonculprit lesions. There is uncertainty on how best to manage these nonculprit lesions—whether to routinely revascularise them with PCI, or to manage them conservatively with guideline directed medical therapy alone.”
COMPLETE was a randomised, comparative effectiveness study of complete versus culprit-only revascularisation strategies to treat multivessel disease after early percutaneous coronary intervention for ST-segment elevation myocardial infarction, in which researchers randomly assigned (1:1) patients with STEMI and multivessel CAD who had undergone successful culprit lesion only PCI to a strategy of either complete revascularisation with PCI of angiographically significant nonculprit lesions or to no further revascularisation. Randomisation was stratified according to the timing of nonculprit lesion PCI: performed either during the index hospitalisation, or after discharge from hospital, a decision that was made prior to randomisation. Mehta stressed that this was an “important caveat of the design of the trial”. And he added: “it is important to note that all patients received guideline directed medical therapy.”
The first co-primary outcome was a composite of cardiovascular (CV) death or MI; the second was a composite of CV death, MI or ischaemia-driven revascularisation. A key secondary outcome was CV death, new MI, ischaemia-driven revascularisation, unstable angina, and New York Heart Association (NYHA) class IV heart failure. Median follow-up was for three years, and the longest follow-up was for more than five years. Nonculprit lesions were located in the left anterior descending (LAD) artery for approximately 10% of cases and in the proximal LAD for about 40% of cases, in both groups.
Mehta said: “One of the most important parameters in the trial was that complete revascularisation was achieved in over 90.1% of patients who were allocated to the nonculpit lesion PCI arm. That means that they had a SYNTAX score of zero; there was no significant disease was left behind in that group.”
The first co-primary outcome occurred in 158 of 2,016 patients (7.8%) in the complete revascularisation group, and 213 of 2,025 (10.5%) in the culprit lesion only PCI group (hazard ratio [HR] 0.74, 95% confidence interval [CI] 0.6–0.91, p=0.004).
Mehta explained: “The number needed to treat to prevent one of these events over a period of three years is 37 patients. The main benefit occurs over the long-term, with continued divergence of the Kaplan-Meier curves [of the two cohorts]. A complete revascularisation strategy has an effect over long term events, similar what we have seen with CABG [coronary artery bypass graft] surgery 20 years ago.”
The second co-primary outcome occurred in 179 patients (8.9%) in the complete revascularisation group and 339 patients in the culprit lesion only group (HR 0.52, 95% CI 0.43–0.61, p<0.001). The benefit of complete revascularisation was consistently observed for both co-primary outcomes, regardless of the intended timing of the nonculprit lesion PCI (p=0.62 and p=0.27 for first and second co-primary outcomes, respectively). “There is absolutely no interaction, said Mehta, “meaning that it doesn’t matter whether it is performed early during the index hospitalisation, or later after discharge from hospital, the benefits on hard outcomes, CV death or MI, are preserved. And the reason for that might be because the benefits of complete revascularisation occurred over the long-term.”
He continued: “The biggest impact in terms of the reduction of the primary endpoint was a reduction in myocardial infarction. This reduction was a 32% highly significant risk reduction in myocardial infarction with a complete revascularisation strategy. In addition to this, ischaemia driven revascularisation was reduced and unstable angina was reduced. Cardiovascular and all-cause deaths were fewer in the complete revacularisation group than the culprit-only group … but the trial was not powered to detect reductions in these two endpoints.”
There were no significant differences in any of the safety outcomes.
Source CardiovascularNews
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