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Randomized Controlled Trial
. 2022 Oct 7;18(8):e647-e655.
doi: 10.4244/EIJ-D-22-00269.

Evolocumab for prevention of microvascular dysfunction in patients undergoing percutaneous coronary intervention: the randomised, open-label EVOCATION trial

Masaharu Ishihara  1 , Masanori Asakura  1   2 , Kiyoshi Hibi  3 , Kozo Okada  3 , Wataru Shimizu  4 , Hitoshi Takano  4 , Satoru Suwa  5 , Kenshi Fujii  6 , Yasuo Okumura  7 , Toshiaki Mano  8 , Kenichi Tsujita  9 , Masataka Igeta  10 , Rika Okamoto  11 , Shinichiro Suna  1   2
Affiliations
Randomized Controlled Trial

Evolocumab for prevention of microvascular dysfunction in patients undergoing percutaneous coronary intervention: the randomised, open-label EVOCATION trial

Masaharu Ishihara et al. EuroIntervention. .

Abstract

Statins have been shown to prevent microvascular dysfunction that may cause periprocedural myocardial infarction after percutaneous coronary intervention (PCI). Evolocumab has more potent lipid-lowering properties than statins. Aims: The aims of this study were to investigate whether evolocumab pretreatment on top of statin therapy could prevent periprocedural microvascular dysfunction. Methods: This study included 100 patients with stable coronary artery disease who were scheduled to undergo PCI and had high low-density lipoprotein cholesterol (LDL-C) under statin therapy. Patients were randomised to receive evolocumab 140 mg every 2 weeks for 2 to 6 weeks before PCI (evolocumab group: N=54) or not (control group: N=46). The primary endpoint was the index of microvascular resistance (IMR) after PCI. Troponin T was measured before and 24 hours after PCI. Results: Geometric mean LDL-C was 94.1 (95% confidence interval [CI]: 86.8-102.1) mg/dl and 89.4 (95% CI: 83.5-95.7) mg/dl at baseline, and 25.6 (95% CI: 21.9-30.0) mg/dl and 79.8 (95% CI: 73.9-86.3) mg/dl before PCI, in the evolocumab group and in the control group, respectively. PCI was performed 22.1±8.5 days after allocation. Geometric mean IMR was 20.6 (95% CI: 17.2-24.6) in the evolocumab group and 20.6 (95% CI: 17.0-25.0) in the control group (p=0.98). There was no significant difference in the geometric mean of post-PCI troponin T (0.054, 95% CI: 0.041-0.071 ng/ml vs 0.054, 95% CI: 0.038-0.077 ng/ml; p=0.99) and in the incidence of major periprocedural myocardial infarction between the 2 groups (44.4% vs 44.2%; p=1.00). Conclusions: Evolocumab pretreatment did not prevent periprocedural microvascular dysfunction in patients on modern medical management with statins.

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Conflict of interest statement

K. Tsujita received remuneration for lectures from Amgen K.K. All other authors have reported that they have no conflicts of interest to declare relevant to the contents of this paper.

Figures

Central illustration
Central illustration. Study design of the EVOCATION trial.
This study enrolled 100 patients with stable CAD who were scheduled to undergo PCI and had high LDL-C under a maximally tolerated statin dose. Patients randomised to the evolocumab group received subcutaneous injections of evolocumab 140 mg every 2 weeks before PCI for 2 to 6 weeks after allocation. The primary endpoint was IMR after PCI. CAD: coronary artery disease; IMR: index of microvascular resistance; LDL-C: low-density lipoprotein cholesterol; PCI: percutaneous coronary intervention
Figure 1
Figure 1. Box plot of IMR in the evolocumab group and the control group.
Median IMR was 17.6 (interquartile range [IQR], 12.3-32.2) in the 52 patients allocated to the evolocumab group and 18.0 (IQR, 12.6-31.9) in the 45 patients allocated to the control group. The rhombus indicates geometric mean value: 20.6 (95% confidence interval [CI]: 17.2-24.6) in the evolocumab group and 20.6 (95% CI: 17.0-25.0) in the control group (p=0.98). IMR: index of microvascular resistance; PCI: percutaneous coronary intervention
Figure 2
Figure 2. Box plot of cardiac troponin T 24 hours after PCI in the evolocumab group and the control group.
Median troponin T was 0.057 (interquartile range [IQR], 0.027-0.102) ng/ml in the 54 patients allocated to the evolocumab group and 0.045 (IQR, 0.023-0.117) ng/ml in the 43 patients allocated to the control group. The rhombus indicates geometric mean value: 0.054 (95% confidence interval [CI]: 0.041-0.071) ng/ml in the evolocumab group and 0.054 (95% CI: 0.038-0.077) ng/ml in the control group (p=0.99). PCI: percutaneous coronary intervention
Figure 3
Figure 3. Box plot of IMR in patients with PMI and those without PMI.
Median IMR was 23.3 (interquartile range [IQR], 12.9-42.8) in 42 patients with PMI and 16.3 (IQR, 12.4-25.5) in 54 patients without PMI. The rhombus indicates geometric mean value: 24.0 (95% confidence interval [CI]: 19.7-29.2) in patients with PMI and 18.5 (95% CI: 15.5-22.2) in those without PMI (p=0.056). IMR: index of microvascular resistance; PCI: percutaneous coronary intervention; PMI: periprocedural myocardial infarction
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