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Absolute treatment effects-i.e. numbers needed to treat (NNTs)-of novel antidiabetic drugs for cardiovascular outcomes have not been comprehensively evaluated. We aimed to perform a meta-analysis of digitalized individual patient outcomes to display and compare absolute treatment effects.Individual patient time-to-event information from Kaplan-Meier plots of cardiovascular mortality (CM) and/or hospitalization for heart failure (HHF) endpoints from cardiovascular outcome trials (CVOTs) evaluating dipeptidyl peptidase-4 (DPP-4) inhibitors, glucagon-like peptide-1 (GLP-1) receptor agonists, and sodium glucose transporter 2 (SGLT2) inhibitors vs. placebo were digitalized using WebPlotDigitizer 4.2 and the R code of Guyot et al.; Weibull regression models were generated, validated, and used to estimate NNT for individual trials; random-effects meta-analysis generated Meta-NNT with 95% confidence intervals. Sixteen CVOTs reported time-to-event information (14 in primary diabetes and 2 in primary heart failure populations). Thirteen studies including 96 860 patients were meta-analysed for CM: At the median follow-up of 30 months, Meta-NNTs were 178 (64 to ∞ to -223) for DPP-4 inhibitors, 261 (158 to 745) for GLP-1 receptor agonists, and 118 (68 to 435) for SGLT2 inhibitors. Ten studies including 96 128 patients were meta-analysed for HHF: At the median follow-up of 29 months, estimated Meta-NNTs were -644 (229 to ∞ to -134) for DPP-4 inhibitors, 441 (184 to ∞ to -1100) for GLP-1 receptor agonists, and 126 (91 to 208) for SGLT2 inhibitors. SGLT2 inhibitors were especially effective for HHF in primary heart failure populations [Meta-NNT 25 (19 to 39)] vs. primary diabetes populations [Meta-NNT 233 (167 to 385)] at 16 months of follow-up.We found only modest treatment benefits of GLP-1 receptor agonists and SGLT2 inhibitors for CM and HHF in primary type 2 diabetes mellitus populations. In primary heart failure populations, SGLT2 inhibitor benefits were substantial and comparable in efficacy to established heart failure medication.

Risk factor control of diabetes mellitus (DM) and especially dyslipidemia remains unsatisfactory in patients with atherosclerotic cardiovascular disease (ASCVD). We aimed to analyze the knowledge of low-density lipoprotein cholesterol (LDL-C) and glycated hemoglobin (HbA1c) treatment goals, subjective level of information, and information needs in very high-risk patients with ASCVD.ASCVD patients (n = 210; 75 ± 9 years; 71.4% male; 89.5% coronary disease) with DM (96.7% type 2) completed a questionnaire assessing knowledge of HbA1c and LDL-C treatment goals and subjective level of information and information needs on disease-related topics of DM and ASCVD. Serum LDL-C and HbA1c were measured.HbA1c goal (7.0% in 60.6%) was attained more frequently than LDL-C goal (70 mg/dl in 39.9%; p .01). Significantly more participants named the correct goal for HbA1c compared to LDL-C (52.9% vs. 2.4%; p .01). Subjective levels of information were higher and information needs were lower for DM than for ASCVD (p .01 for all topics). No associations of knowledge of treatment goals and level of information with the attainment of treatment goals for HbA1c and LDL-C were found. However, in multivariate regression, higher levels of education were associated with knowledge of treatment goals (HbA1c: odds ratio [OR] 1.32, 95% confidence interval [CI] 1.01-1.72, p = .04; LDL-C: OR 2.32, 95% CI 1.07-5.03; p = .03).In very high-risk patients with ASCVD, a deficit of knowledge of treatment goals to control dyslipidemia exists when compared to DM, patients felt significantly better informed for topics of DM than for ASCVD and display higher information needs for topics of ASCVD.

Patient safety is one of the most important issues in healthcare. High-risk percutaneous coronary interventions (HR-PCIs) offer well-established treatment options for patients with complex coronary artery disease and multiple comorbidities. Whether process standardization using standard operating procedure (SOP) management and checklists improves HR-PCI is still unknown.This retrospective study analyzed procedural characteristics, in-hospital outcomes, and length of hospital stay in patients who received HR-PCI in a German heart center 12 months before the introduction of process standardization using SOP management-the SOP (-) group-and after the introduction of process standardization using SOP management-the SOP (+) group. A total of 192 patients were included, with 77 patients in the SOP (-) group and 115 patients in the SOP (+) group. The mean age in the SOP (-) group was 72.0 ± 10.2 years and 81.8% were male; mean age in the SOP (+) group was 75.2 ± 10.4 years and 68.7% were male. Acute kidney events were significantly lower in the SOP (+) group than in the SOP (-) group (7.0% vs 10.4%; P=.04). Bleeding was the most common adverse event and significantly lower in the SOP (+) group than in the SOP (-) group (13.1% vs 31.2%, respectively; Plt;.01). There were trends toward shorter length of hospital stay in the SOP (+) group compared with the SOP (-) group (9.3 ± 6.4 days vs 10.9 ± 7.3 days, respectively; P=.10) and days of hospital stay in the intensive care unit (3.7 ± 4.0 days vs 4.7 ± 4.3 days; P=.07). SOP management was independently associated with shorter length of hospital stay in multivariate regression analysis.This retrospective study shows significantly better quality of care measures after the introduction of process standardization techniques using SOP management in HRPCIs, with a lower risk of adverse outcomes and shorter length of hospital stay.

Background Bempedoic acid (BA) is a novel oral low-density lipoprotein cholestrol (LDL-C) lowering drug. Its efficacy and safety for clinical outcomes in high cardiovascular risk patients remains unknown. Objectives and methods A systematic review was performed and randomized controlled trials (RCTs) of BA vs. placebo in high cardiovascular risk patients reporting clinical efficacy and safety outcomes were included in a meta-analysis. Cumulative odds ratios (OR) and mean differences with 95% confidence intervals (CI) were reported as summary statistics. Results Six RCTs with a total of 3,956 patients and follow-ups of four to 52 weeks were identified. There was no difference in MACE (OR 0.84; CI 0.61, 1.15), all-cause mortality (OR 2.37; CI 0.80, 6.99) and cardiovascular mortality (OR 1.66; CI 0.45, 6.04) for BA vs. placebo. BA showed beneficial trends for nonfatal myocardial infarction (OR 0.57; CI 0.32, 1.00) and was associated with a lower risk of new-onset or worsening of diabetes mellitus (OR 0.68; CI 0.49, 0.94) and non-coronary revascularization (OR 0.41; CI 0.18, 0.95), but higher risk of gout (OR 3.29; CI 1.28, 8.46) and a trend for worsening of renal function (OR 4.24; CI 0.98, 18.39) and muscular disorders (OR 2.60; CI 1.15, 5.91). Conclusion Bempedoic acid in high cardiovascular risk patients showed no significant effects on major cardiovascular outcomes in short-term follow-up. Unfavourable effects on muscular disorders, renal function and the incidence of gout sound a note of caution. Hence, further studies with longer-term follow-up are needed to clarify the risk/benefit ratio of this novel therapy. Funding Acknowledgement Type of funding sources: None.