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Clinical Trial
. 2023 Feb 6;22(1):28.
doi: 10.1186/s12933-023-01744-4.

Safety of metformin continuation in diabetic patients undergoing invasive coronary angiography: the NO-STOP single arm trial

Mauro Chiarito #  1   2 , Jorge Sanz-Sanchez #  3   4 , Raffaele Piccolo  5 , Francesco Condello  1   2 , Gaetano Liccardo  1   2 , Matteo Maurina  1   2 , Marisa Avvedimento  5 , Damiano Regazzoli  1 , Paolo Pagnotta  1 , Hector M Garcia-Garcia  6 , Roxana Mehran  7 , Massimo Federici  8   9 , Gianluigi Condorelli  1   2 , Jose Luis Diez Gil  3 , Bernhard Reimers  1 , Giuseppe Ferrante  1   2 , Giulio Stefanini  10   11
Affiliations
Clinical Trial

Safety of metformin continuation in diabetic patients undergoing invasive coronary angiography: the NO-STOP single arm trial

Mauro Chiarito et al. Cardiovasc Diabetol. .

Abstract

Background: Despite paucity of data, it is common practice to discontinue metformin before invasive coronary angiography due to an alleged risk of Metformin-Associated Lactic Acidosis (M-ALA). We aimed at assessing the safety of metformin continuation in diabetic patients undergoing coronary angiography in terms of significant increase in lactate levels.

Methods: In this open-label, prospective, multicentre, single-arm trial, all diabetic patients undergoing coronary angiography with or without percutaneous coronary intervention at 3 European centers were screened for enrolment. The primary endpoint was the increase in lactate levels from preprocedural levels at 72-h after the procedure. Secondary endpoints included contrast associated-acute kidney injury (CA-AKI), M-ALA, and all-cause mortality.

Results: 142 diabetic patients on metformin therapy were included. Median preprocedural lactate level was 1.8 mmol/l [interquartile range (IQR) 1.3-2.3]. Lactate levels at 72 h after coronary angiography were 1.7 mmol/l (IQR 1.3-2.3), with no significant differences as compared to preprocedural levels (p = 0.91; median difference = 0; IQR - 0.5 to 0.4 mmol/l). One patient had 72-h levels ≥ 5 mmol/l (5.3 mmol/l), but no cases of M-ALA were reported. CA-AKI occurred in 9 patients (6.1%) and median serum creatinine and estimated glomerular filtration rate remained similar throughout the periprocedural period. At a median follow-up of 90 days (43-150), no patients required hemodialysis and 2 patients died due to non-cardiac causes.

Conclusions: In diabetic patients undergoing invasive coronary angiography, metformin continuation throughout the periprocedural period does not increase lactate levels and was not associated with any decline in renal function.

Trial registration: The study was registered at Clinicaltrials.gov (NCT04766008).

Keywords: Coronary angiography; Metformin; Metformin-associated lactic acidosis; Percutaneous coronary intervention.

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Conflict of interest statement

Dr. Garcia-Garcia reports the following institutional grant support: Biotronik, Boston Scientific, Medtronic, Abbott, Neovasc, Shockwave, Phillips, and Corflow. Dr. Mehran reports grants from Abbott Laboratories, AstraZeneca, Bayer, Beth Israel Deaconess, Bristol Myers Squibb, CSL Behring, DSI, Medtronic, Novartis Pharmaceuticals, OrbusNeich; personal fees from Abbott Laboratories, Boston Scientific, Medscape/WebMD, Siemens Medical Solutions, PLx Opco Inc/dba PLx Pharma Inc, Roivant Sciences, Sanofi, Medtelligence (Janssen Scientific Affairs), Janssen Scientific Affairs; other from Abbott laboratories, other from Abiomed, other from Bristol Myers Squibb, other from Claret Medical, other from Elixir Medical, other from The Medicines eCompany, other from Spectranetics/Philips/Volcano Corp, other from Watermark Research Partners; non-financial support and other from Regeneron Pharmaceuticals, Idorsia Pharmaceuticals Ltd. Dr. Reimers has received speaker honoraria from Boston Scientific. Dr. Stefanini reports a research grant from Boston Scientific and speaker or consulting fees from B. Braun, Biosensors, and Boston Scientific. All other authors report no relationships relevant to the contents of this paper to disclose.

Figures

Fig. 1
Fig. 1
Study flow chart. eGFR estimated glomerular filtration rate, LVEF left ventricular ejection fraction, PCI percutaneous coronary intervention
Fig. 2
Fig. 2
Cumulative curves reporting preprocedural and 72-h lactate levels and their difference. Cumulative curves depict the sum of the frequency of preprocedural, 72-h lactate levels and their difference for all patients
See this image and copyright information in PMC

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