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Observational Study
. 2023 Feb 24;21(1):71.
doi: 10.1186/s12916-023-02781-2.

SGLT-2 inhibitors and in-stent restenosis-related events after acute myocardial infarction: an observational study in patients with type 2 diabetes

Raffaele Marfella #  1   2 , Celestino Sardu #  3 , Nunzia D'Onofrio  4 , Carlo Fumagalli  3 , Lucia Scisciola  3 , Ferdinando Carlo Sasso  3 , Mario Siniscalchi  5 , Ludovica Vittoria Marfella  3 , Davide D'Andrea  5 , Fabio Minicucci  5 , Giuseppe Signoriello  6 , Arturo Cesaro  7 , Maria Consiglia Trotta  8 , Chiara Frigé  9 , Francesco Prattichizzo  10 , Maria Luisa Balestrieri  4 , Antonio Ceriello  9 , Paolo Calabrò  7 , Ciro Mauro  5 , Luca Del Viscovo  4 , Giuseppe Paolisso  3   11
Affiliations
Observational Study

SGLT-2 inhibitors and in-stent restenosis-related events after acute myocardial infarction: an observational study in patients with type 2 diabetes

Raffaele Marfella et al. BMC Med. .

Abstract

Background: No study evaluated the incidence of intra-stent restenosis (ISR)-related events in patients with type 2 diabetes (T2DM) and acute myocardial infarction (AMI) treated or not with sodium/glucose cotransporter 2 inhibitors (SGLT2i).

Methods: We recruited 377 patients with T2DM and AMI undergoing percutaneous coronary intervention (PCI). Among them, 177 T2DM were treated with SGLT2 inhibitors before PCI. The primary outcome was major adverse cardiovascular events (MACE) defined as cardiac death, re-infarction, and heart failure related to ISR. In patients without ISR, minimal lumen area and minimal lumen diameter were assessed by coronary CT-angiography at 1-year follow-up.

Results: Glycemic control was similar in SGLT2i-treated patients and never SGLT2i-users. The incidence of ISR-related MACE was higher in never SGLT2i-users compared with SGLT2i-treated patients, an effect independent of glycemic status (HR = 0.418, 95% CI = 0.241-0.725, P = 0.002) and observed also in the subgroup of patients with HbA1c < 7% (HR = 0.393, 95% CI = 0.157-0.984, P = 0.027). In patients without the event, the stent patency was greater in SGLT2i-treated patients compared with never SGLT2i-users at 1-year follow-up.

Conclusions: SGLT2i treatment in T2DM is associated with a reduced incidence of ISR-related events, independently of glycemic control.

Keywords: Glycemic control; Major adverse cardiovascular events; Restenosis; SGLT-2 inhibitors; Type 2 diabetes.

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Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
STROBE diagram
Fig. 2
Fig. 2
A 1-year HbA1c mean levels in never SGLT2i users (n = 200) and current SGLT2i users (N = 177), boxplots display the median, 25th, and 75th percentiles, range, and extreme values. B Intra-stent restenosis rate during 1-year follow-up in never SGLT2i users (n = 200) and current SGLT2i users (N = 177), *P < 0.05 vs never SGLT2i users. C, D Minimum lumen diameter (MLD) and minimal luminal area (MLA) of treated coronary by coronary CT angiography at 1-year follow-up in never SGLT2i users (n = 156) and current SGLT2i users (N = 159) without intra-stent restenosis-related events, *P < 0.05 vs never SGLT2i users. Boxplots display the median, 25th, and 75th percentiles, range, and extreme values
Fig. 3
Fig. 3
A Time-dependent MACE risk analysis, adjusted for admission HbA1c, 1-year HbA1c levels, age, hypertension, cigarette smoking, BMI, HDL, LDL-cholesterol levels, triglycerides, antithrombotic, and lipid-lowering and glucose-lowering therapies according to Cox regression analysis, along with the relative HR, 95% confidence interval, and P values for all the covariates used for the adjustment (table). B Time-dependent MACE risk analysis, adjusted for admission, age, hypertension, cigarette smoking, BMI, HDL LDL-cholesterol levels, triglycerides, antithrombotic, and lipid-lowering and glucose-lowering therapies according to Cox regression analysis, in never SGLT2i users (n = 118, 59%) and current SGLT2i users (N = 107, 60%) with good glycemic control (1-year HbA1c mean < 7%), along with the relative HR, 95% confidence interval, and P values for all the covariates used for the adjustment (table)
Fig. 4
Fig. 4
A Time-dependent cardiovascular death risk analysis, adjusted for admission HbA1c, 1-year HbA1c levels, age, hypertension, cigarette smoking, BMI, HDL, LDL-cholesterol levels, triglycerides, antithrombotic, and lipid-lowering and glucose-lowering therapies according to Cox regression analysis. B Time-dependent acute coronary syndrome risk analysis, adjusted for admission HbA1c, 1-year HbA1c levels, age, hypertension, cigarette smoking, BMI, HDL, LDL-cholesterol levels, triglycerides, antithrombotic, and lipid-lowering and glucose-lowering therapies according to Cox regression analysis. C Time-dependent heart failure risk analysis, adjusted for admission HbA1c, 1-year HbA1c levels, age, hypertension, cigarette smoking, BMI, HDL, LDL-cholesterol levels, triglycerides, antithrombotic, and lipid-lowering and glucose-lowering therapies according to Cox regression analysis. D Time-dependent cardiovascular death risk analysis, adjusted for age, hypertension, cigarette smoking, BMI, HDL, LDL-cholesterol levels, triglycerides, antithrombotic, and lipid-lowering and glucose-lowering therapies according to Cox regression analysis in never SGLT2i users (n = 118, 59%) and current SGLT2i users (N = 107, 60%) with good glycemic control (1-year HbA1c mean < 7%). E Time-dependent acute coronary syndrome risk analysis, adjusted for age, hypertension, cigarette smoking, BMI, HDL, LDL-cholesterol levels, triglycerides, antithrombotic, and lipid-lowering and glucose-lowering therapies according to Cox regression analysis in never SGLT2i users (n = 118, 59%) and current SGLT2i users (N = 107, 60%) with good glycemic control (1-year HbA1c mean < 7%). F Time-dependent heart failure risk analysis, adjusted for age, hypertension, cigarette smoking, BMI, HDL, LDL-cholesterol levels, triglycerides, antithrombotic, and lipid-lowering and glucose-lowering therapies according to Cox regression analysis in never SGLT2i users (n = 118, 59%) and current SGLT2i users (N = 107, 60%) with good glycemic control (1-year HbA1c mean < 7%)
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