No drawback to immediate complete revascularization in ACS
Doing an immediate complete revascularization of coronary artery lesions is as safe as a staged complete revascularization approach in patients with acute coronary syndrome (ACS) and multivessel disease in the BIOVASC trial presented at ACC.23/WCC.
At 1 year of follow-up, there was no significant difference in the composite primary endpoint of all-cause mortality, any myocardial infarction (MI), unplanned ischaemia-driven revascularization, or cerebrovascular events between the two strategies. Patients had multiple benefits, with the composite primary outcome occurring in 7.6 percent of patients in the immediate complete revascularization group and in 9.4 percent of those in the staged revascularization group (p=0.0011 for non-inferiority; p=0.166 for superiority). [Lancet 2023;doi: 10.1016/S0140-6736(23)00351-3]
All-cause death was comparable between the immediate and staged complete revascularization groups (1.9 percent vs 1.2 percent, hazard ratio [HR], 1.56, 95 percent confidence interval [CI], 0.68–3.61; p=0.30). MI rate was lower for immediate revascularization vs the staged approach (1.9 percent vs 4.5 percent; HR, 0.41, 95 percent CI, 0.22–0.76; p=0.0045), so was the rate of unplanned ischaemia-driven revascularization (4.2 percent vs 6.7 percent; HR, 0.61, 95 percent CI, 0.39–0.95, p=0.030).
MIs in the staged group were not procedure-related events but spontaneous. Major bleeding (BARC 3 or 5) at 1-year post-index procedure was similar at 1.6 percent for immediate complete revascularization vs 0.9 percent for the staged procedure (HR, 1.73, 95 percent CI, 0.68–4.39; p=0.25).
Now or later
The study included 1,525 patients (mean age 65.5 years, 77.8 percent male) with ACS and multivessel disease, including STEMI or NSTEMI* and unstable angina. Of these, 764 underwent complete revascularization during the index procedure and 761 had complete revascularization performed within 6 weeks of the index PCI.
In the staged group, the nonculprit vessels were typically treated within 4–28 days.
Patients treated with immediate complete revascularization had a significantly shorter hospital stay than those treated with the staged approach (3 vs 4 days; p< 0.001), with relevant economic implications.
“Additionally, immediate complete revascularization offered reassurance that patients would not suffer a second heart attack while waiting for the second procedure,” said lead investigator Dr Roberto Diletti from Erasmus University Medical Center in Rotterdam, the Netherlands, at ACC.23/WCC 2023.
Do everything upfront
Interventional cardiologists are often divided on whether to fix all the blocked blood vessels in the heart – including the culprit lesions – upfront or make the patient come back for a second round of stenting.
The problem with staging procedures is that once culprit lesions are misidentified, patients might be sent home without fixing the blockage that is causing the ACS.
“The takeaway is that physicians shouldn’t be concerned about doing everything at once during the index procedures, especially if there is a two-vessel disease or easy lesions that can be treated in a short time with not a lot of contrast [agents],” Diletti said. “It is safe and feasible.”
Many catheter laboratories in the US are fixing all coronary lesions at once rather than bringing the patient back another day or week, but BIOVASC gives confidence that it is not inferior to go for the staged approach either, commented Dr David Moliterno from the University of Kentucky in Lexington, Kentucky, US, during a press conference.
“Yes, we can fix everything and leave no blockage behind.” But he cautioned that for some patients, this may not be appropriate. “I am talking about those with compromised renal function” in whom excessive amounts of contrast agents should be avoided. Operator fatigue is another factor to consider, he added.
Important trial, but questions remain
Discussant Dr Dipti Itchhaporia from Hoag Memorial Hospital Presbyterian, Newport Beach, California, US said BIOVASC is an important trial. Nevertheless, she questioned the “remarkably high” rate of MI in patients treated with the staged approach and the low rate of functional imaging used in the study.
Diletti said the operator may have misjudged the culprit lesion, or patients with ACS may have multiple unstable plaques, and treating the culprit lesion alone does not do the job. “We need to look at the data more thoroughly to better understand this. But in both scenarios, immediate complete revascularization would prevent these events.”
On the low rate of functional imaging, he said this reflected current European practice, yet acknowledged that “ this could have reduced our ability to detect the culprit lesion.”
Further fine-tuning warranted
In an accompanying commentary, Dr Tobias Pustjens from the Zuyderland Medical Centre, Heerlen, the Netherlands, and two other experts, said pursuing an immediate complete revascularization strategy, particularly during reduced hospital capacity and staff scarcity, not only benefits the patient but can safely reduce the pressure on healthcare systems. [Lancet 2023;doi.org/10.1016/S0140-6736(23)00403-8]
However, he said the possibility of coronary artery bypass grafting (CABG) should not be omitted, noting that CABG is still the treatment of choice in patients with diabetes or complex coronary artery disease.
“The findings move clinical practice forward from culprit-only to immediate complete revascularization strategy … However, further fine-tuning of this treatment strategy to substantiate a role for intracoronary physiology assessment, intracoronary imaging, and guidance of the heart team decision is needed.”