COMPLETE revascularization reduces death and recurrent MI risk

Revascularization of more than just the culprit lesion in patients with ST-elevation myocardial infarctions could significantly reduce their risk of cardiovascular death or myocardial infarction, according to results of the COMPLETE trial, presented at the annual congress of the European Society of Cardiology.

The report, simultaneously published online in the New England Journal of Medicine, detailed the outcomes of COMPLETE (the Complete versus Culprit-Only Revascularization Strategies to Treat Multivessel Disease after Early PCI for STEMI), a study in 4,041 patients who had experienced an ST-elevation myocardial infarction (STEMI), who had multi-vessel coronary artery disease, and who had undergone successful percutaneous coronary intervention of the culprit lesion.

Participants were randomized either to complete revascularization of all angiographically significant nonculprit lesions, or to no further revascularization, and were followed for a median of 3 years.

Of the patients who underwent complete revascularization, 7.8% experienced either cardiovascular death or another myocardial infarction, compared with 10.5% of those who only had revascularization of the culprit lesion, representing a significant 26% reduction (P = .004) in the incidence of this composite coprimary outcome.

The decrease in events was driven by a significant 32% reduction in the incidence of new myocardial infarction – particularly non-STEMI, new STEMI, and myocardial infarction type 1 – in the complete revascularization group, with only a 7% reduction in the incidence of death from cardiovascular causes.

With the second coprimary outcome of a composite of cardiovascular death, myocardial infarction, or ischemia-driven revascularization, this was seen in 8.9% of patients in the complete revascularization group compared with 16.7% of patients with the culprit-lesion-only group; a significant 49% reduction in incidence (P less than .001).

The authors calculated that 37 complete revascularizations would need to be performed to prevent one incidence of cardiovascular death or myocardial infarction. To prevent cardiovascular death, myocardial infarction, or ischemia-driven revascularization, the number needed to treat was 13.

The timing of complete revascularization did not appear to affect the benefits of the procedure, which were consistent among patients who underwent complete revascularization during their index hospitalization and in those who underwent the procedure after hospital discharge. Investigators had to specify before randomization whether the patient would undergo complete revascularization during the index hospitalization or after discharge but within 45 days.

The study also did not find any significant differences between the two groups in the risks of major bleeding, stroke, or stent thrombosis. However, the complete revascularization group did experience a nonsignificant 59% higher odds of contrast-associated acute kidney injury, which was attributed to the nonculprit lesion revascularization in seven patients in the complete revascularization group.

Dr. Shamir R. Mehta, of the Population Health Research Institute at McMaster University, Ontario, and coauthors noted that previous trials of complete-revascularization strategies in patients with STEMI were smaller and had included revascularization as part of a composite primary outcome.

“In the absence of a reduction in irreversible events such as cardiovascular death or new myocardial infarction, the clinical relevance of performing early nonculprit-lesion PCI in all patients with multivessel coronary artery disease to prevent later PCI in a smaller number of those patients is debatable,” they wrote. “We have now found that routine nonculprit-lesion PCI with the goal of complete revascularization confers a reduction in the long-term risk of cardiovascular death or myocardial infarction.”

No patients with cardiogenic shock were enrolled in the study, so the results could not be extrapolated to that patient group.

 

In an accompanying editorial, Dr. Lars Kober and Dr. Thomas Engstrøm, of the department of cardiology at Rigshospitalet at the University of Copenhagen, wrote that until now, there had been a lack of evidence that complete revascularization could reduce hard outcomes such as death and recurrent myocardial infarction (N Engl J Med. 2019 Sep. 1. doi: 10.1056/NEJMe1910898).

However, they said, given the findings of this study, it might now be appropriate to recommend complete revascularization for patients such as those enrolled in the study.

“Better selection of high-risk patients may also refine the determination of who is most likely to benefit from complete revascularization,” they wrote.

COMPLETE was supported by the Canadian Institutes of Health Research, with additional support from AstraZeneca, Boston Scientific, and the Population Health Research Institute. Two authors declared support from AstraZeneca and Boston Scientific during the conduct of the study, and eight declared personal fees, funding, and grants from the pharmaceutical industry outside the study. One author declared employment with Medtronic, unrelated to the submitted work.

Both editorial authors declared grants and personal fees, including from the study supporters.

SOURCE: Mehta S et al. N Engl J Med. 2019 Sep. 1. doi: 10.1056/NEJMoa1907775.

Revascularization of more than just the culprit lesion in patients with ST-elevation myocardial infarctions could significantly reduce their risk of cardiovascular death or myocardial infarction, according to results of the COMPLETE trial, presented at the annual congress of the European Society of Cardiology.

The report, simultaneously published online in the New England Journal of Medicine, detailed the outcomes of COMPLETE (the Complete versus Culprit-Only Revascularization Strategies to Treat Multivessel Disease after Early PCI for STEMI), a study in 4,041 patients who had experienced an ST-elevation myocardial infarction (STEMI), who had multi-vessel coronary artery disease, and who had undergone successful percutaneous coronary intervention of the culprit lesion.

Participants were randomized either to complete revascularization of all angiographically significant nonculprit lesions, or to no further revascularization, and were followed for a median of 3 years.

Of the patients who underwent complete revascularization, 7.8% experienced either cardiovascular death or another myocardial infarction, compared with 10.5% of those who only had revascularization of the culprit lesion, representing a significant 26% reduction (P = .004) in the incidence of this composite coprimary outcome.

The decrease in events was driven by a significant 32% reduction in the incidence of new myocardial infarction – particularly non-STEMI, new STEMI, and myocardial infarction type 1 – in the complete revascularization group, with only a 7% reduction in the incidence of death from cardiovascular causes.

With the second coprimary outcome of a composite of cardiovascular death, myocardial infarction, or ischemia-driven revascularization, this was seen in 8.9% of patients in the complete revascularization group compared with 16.7% of patients with the culprit-lesion-only group; a significant 49% reduction in incidence (P less than .001).

The authors calculated that 37 complete revascularizations would need to be performed to prevent one incidence of cardiovascular death or myocardial infarction. To prevent cardiovascular death, myocardial infarction, or ischemia-driven revascularization, the number needed to treat was 13.

The timing of complete revascularization did not appear to affect the benefits of the procedure, which were consistent among patients who underwent complete revascularization during their index hospitalization and in those who underwent the procedure after hospital discharge. Investigators had to specify before randomization whether the patient would undergo complete revascularization during the index hospitalization or after discharge but within 45 days.

The study also did not find any significant differences between the two groups in the risks of major bleeding, stroke, or stent thrombosis. However, the complete revascularization group did experience a nonsignificant 59% higher odds of contrast-associated acute kidney injury, which was attributed to the nonculprit lesion revascularization in seven patients in the complete revascularization group.

Dr. Shamir R. Mehta, of the Population Health Research Institute at McMaster University, Ontario, and coauthors noted that previous trials of complete-revascularization strategies in patients with STEMI were smaller and had included revascularization as part of a composite primary outcome.

“In the absence of a reduction in irreversible events such as cardiovascular death or new myocardial infarction, the clinical relevance of performing early nonculprit-lesion PCI in all patients with multivessel coronary artery disease to prevent later PCI in a smaller number of those patients is debatable,” they wrote. “We have now found that routine nonculprit-lesion PCI with the goal of complete revascularization confers a reduction in the long-term risk of cardiovascular death or myocardial infarction.”

No patients with cardiogenic shock were enrolled in the study, so the results could not be extrapolated to that patient group.

 

In an accompanying editorial, Dr. Lars Kober and Dr. Thomas Engstrøm, of the department of cardiology at Rigshospitalet at the University of Copenhagen, wrote that until now, there had been a lack of evidence that complete revascularization could reduce hard outcomes such as death and recurrent myocardial infarction (N Engl J Med. 2019 Sep. 1. doi: 10.1056/NEJMe1910898).

However, they said, given the findings of this study, it might now be appropriate to recommend complete revascularization for patients such as those enrolled in the study.

“Better selection of high-risk patients may also refine the determination of who is most likely to benefit from complete revascularization,” they wrote.

COMPLETE was supported by the Canadian Institutes of Health Research, with additional support from AstraZeneca, Boston Scientific, and the Population Health Research Institute. Two authors declared support from AstraZeneca and Boston Scientific during the conduct of the study, and eight declared personal fees, funding, and grants from the pharmaceutical industry outside the study. One author declared employment with Medtronic, unrelated to the submitted work.

Both editorial authors declared grants and personal fees, including from the study supporters.

SOURCE: Mehta S et al. N Engl J Med. 2019 Sep. 1. doi: 10.1056/NEJMoa1907775.

Revascularization of more than just the culprit lesion in patients with ST-elevation myocardial infarctions could significantly reduce their risk of cardiovascular death or myocardial infarction, according to results of the COMPLETE trial, presented at the annual congress of the European Society of Cardiology.

The report, simultaneously published online in the New England Journal of Medicine, detailed the outcomes of COMPLETE (the Complete versus Culprit-Only Revascularization Strategies to Treat Multivessel Disease after Early PCI for STEMI), a study in 4,041 patients who had experienced an ST-elevation myocardial infarction (STEMI), who had multi-vessel coronary artery disease, and who had undergone successful percutaneous coronary intervention of the culprit lesion.

Participants were randomized either to complete revascularization of all angiographically significant nonculprit lesions, or to no further revascularization, and were followed for a median of 3 years.

Of the patients who underwent complete revascularization, 7.8% experienced either cardiovascular death or another myocardial infarction, compared with 10.5% of those who only had revascularization of the culprit lesion, representing a significant 26% reduction (P = .004) in the incidence of this composite coprimary outcome.

The decrease in events was driven by a significant 32% reduction in the incidence of new myocardial infarction – particularly non-STEMI, new STEMI, and myocardial infarction type 1 – in the complete revascularization group, with only a 7% reduction in the incidence of death from cardiovascular causes.

With the second coprimary outcome of a composite of cardiovascular death, myocardial infarction, or ischemia-driven revascularization, this was seen in 8.9% of patients in the complete revascularization group compared with 16.7% of patients with the culprit-lesion-only group; a significant 49% reduction in incidence (P less than .001).

The authors calculated that 37 complete revascularizations would need to be performed to prevent one incidence of cardiovascular death or myocardial infarction. To prevent cardiovascular death, myocardial infarction, or ischemia-driven revascularization, the number needed to treat was 13.

The timing of complete revascularization did not appear to affect the benefits of the procedure, which were consistent among patients who underwent complete revascularization during their index hospitalization and in those who underwent the procedure after hospital discharge. Investigators had to specify before randomization whether the patient would undergo complete revascularization during the index hospitalization or after discharge but within 45 days.

The study also did not find any significant differences between the two groups in the risks of major bleeding, stroke, or stent thrombosis. However, the complete revascularization group did experience a nonsignificant 59% higher odds of contrast-associated acute kidney injury, which was attributed to the nonculprit lesion revascularization in seven patients in the complete revascularization group.

Dr. Shamir R. Mehta, of the Population Health Research Institute at McMaster University, Ontario, and coauthors noted that previous trials of complete-revascularization strategies in patients with STEMI were smaller and had included revascularization as part of a composite primary outcome.

“In the absence of a reduction in irreversible events such as cardiovascular death or new myocardial infarction, the clinical relevance of performing early nonculprit-lesion PCI in all patients with multivessel coronary artery disease to prevent later PCI in a smaller number of those patients is debatable,” they wrote. “We have now found that routine nonculprit-lesion PCI with the goal of complete revascularization confers a reduction in the long-term risk of cardiovascular death or myocardial infarction.”

No patients with cardiogenic shock were enrolled in the study, so the results could not be extrapolated to that patient group.

 

In an accompanying editorial, Dr. Lars Kober and Dr. Thomas Engstrøm, of the department of cardiology at Rigshospitalet at the University of Copenhagen, wrote that until now, there had been a lack of evidence that complete revascularization could reduce hard outcomes such as death and recurrent myocardial infarction (N Engl J Med. 2019 Sep. 1. doi: 10.1056/NEJMe1910898).

However, they said, given the findings of this study, it might now be appropriate to recommend complete revascularization for patients such as those enrolled in the study.

“Better selection of high-risk patients may also refine the determination of who is most likely to benefit from complete revascularization,” they wrote.

COMPLETE was supported by the Canadian Institutes of Health Research, with additional support from AstraZeneca, Boston Scientific, and the Population Health Research Institute. Two authors declared support from AstraZeneca and Boston Scientific during the conduct of the study, and eight declared personal fees, funding, and grants from the pharmaceutical industry outside the study. One author declared employment with Medtronic, unrelated to the submitted work.

Both editorial authors declared grants and personal fees, including from the study supporters.

SOURCE: Mehta S et al. N Engl J Med. 2019 Sep. 1. doi: 10.1056/NEJMoa1907775.