Pre-PCI evolocumab did not prevent microvascular dysfunction when added to statin therapy
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Pretreatment evolocumab did not lower risk for periprocedural microvascular dysfunction in patients undergoing elective PCI for stable CAD who were already on statin therapy for high LDL, researchers reported.
The results of the multicenter, randomized EVOCATION trial on the impact of evolocumab (Repatha, Amgen) on periprocedural microvascular damage in patients undergoing PCI were published in EuroIntervention.
“We found no difference in index of microvascular resistance after elective PCI in patients with stable CAD when evolocumab pretreatment was given on top of statin therapy compared to standard statin therapy,” Masaharu Ishihara, MD, PhD, of the department of cardiovascular and renal medicine at Hyogo College of Medicine in Hyogo, Japan, and colleagues wrote. “Troponin T levels 24 hours after PCI and the incidence of periprocedural MI were almost identical in the two study arms, despite a marked reduction of LDL-C in the evolocumab group.”
Research on the prevention of periprocedural MI has become of recent clinical interest, Ishihara and colleagues wrote.
Lipid-lowering statin therapy has plaque-stabilizing and anti-inflammatory properties, whereas evolocumab possesses strong lipid-lowering properties. Therefore, researchers compared whether the pretreatment with evolocumab on top of statin therapy reduced risk for periprocedural MI after elective PCI compared with statin therapy alone.
Researchers enrolled 100 patients with stable CAD and high LDL treated with statin therapy who were scheduled to undergo elective PCI. Participants were randomly assigned to evolocumab 140 mg every 2 weeks for 2 to 6 weeks before PCI or not.
The primary endpoint was post-PCI index of microvascular resistance, a measure of coronary microvascular function independent of the epicardial artery.
Mean LDL level at baseline was 94.1 mg/dL in the evolocumab group (95% CI, 86.8-102.1) and 89.4 mg/dL in the control group (95% CI, 83.5-95.7).
After trial allocation, mean LDL level in the evolocumab group was 25.6 mg/dL (95% CI, 21.9-30) and 79.8 mg/dL among controls (95% CI, 73.9-86.3).
PCI was performed on average 22.1 days after trial allocation.
Researchers reported that the average post-PCI index of microvascular resistance was similar in both arms, calculated as 20.6 in the evolocumab group (95% CI, 17.2-24.6) and 20.6 in the control group (95% CI, 17-25; P = .98).
Ishihara and colleagues observed no significant difference in geometric mean post-PCI troponin T (0.054 in both groups; P = .99) and incidence of periprocedural MI (evolocumab, 44.4%; control, 44.2%; P = 1).
“Although not rejecting a null hypothesis does not mean equivalence, it is still noteworthy that post-PCI index of microvascular resistance, post-PCI troponin T and the incidence of periprocedural MI were almost identical between the evolocumab group and the control group,” the researchers wrote. “These findings suggest that pretreatment with evolocumab 140 mg every 2 weeks for 2 to 6 weeks did not prevent periprocedural microvascular dysfunction and PMI in patients with stable CAD undergoing elective PCI.”
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