Daily Archives: December 8, 2024
Retrospective Cohort Study: As-Needed Blood Pressure Medications Associated With Increased AKI and Other Adverse Outcomes in Hospitalized Veterans
8 Dec, 2024 | 21:34h | UTCBackground: Inpatient asymptomatic blood pressure (BP) elevations are common, and clinicians frequently use as-needed BP medications to rapidly lower BP values. However, there is limited evidence supporting this practice, and abrupt BP reductions may increase the risk of ischemic events, including acute kidney injury (AKI).
Objective: To examine whether as-needed BP medication use during hospitalization is associated with increased risk of AKI and other adverse outcomes compared to no as-needed use.
Methods: This retrospective cohort study used a target trial emulation and propensity score matching. Adults hospitalized for ≥3 days in non-ICU VA hospital wards from 2015-2020, who received at least one scheduled BP medication within the first 24 hours and had at least one systolic BP reading >140 mm Hg, were included. Patients were categorized into two groups: those receiving at least one as-needed BP medication (oral or IV) and those receiving only scheduled BP medications. The primary outcome was time-to-first AKI event. Secondary outcomes included a >25% drop in systolic BP within 3 hours and a composite of myocardial infarction (MI), stroke, or death.
Results: Among 133,760 veterans (mean age 71.2 years; 96% male), 21% received as-needed BP medications. As-needed BP medication use was associated with a 23% higher risk of AKI (HR=1.23; 95% CI, 1.18-1.29). The IV route showed a particularly pronounced AKI risk (HR=1.64). Secondary analyses indicated a 1.5-fold increased risk of rapid BP reduction and a 1.69-fold higher rate of the composite outcome (MI, stroke, death) among as-needed users.
Conclusions: In a large, national cohort of hospitalized veterans, as-needed BP medication use was associated with increased AKI risk and other adverse outcomes. These findings suggest that routine as-needed BP medication use for asymptomatic BP elevations may be harmful.
Implications for Practice: Clinicians should carefully reconsider the use of as-needed BP medications in the inpatient setting, especially in older individuals or those with significant cardiovascular risk. Given the lack of clear benefit and potential for harm, greater caution and potentially more conservative approaches are warranted.
Study Strengths and Limitations: Strengths include a large, nationally representative sample and robust analytic methods. Limitations include the retrospective design, potential residual confounding, and limited generalizability to non-veteran or surgical populations. While causal inferences cannot be made, the findings strongly support the need to question current practice.
Future Research: Prospective, randomized trials are needed to determine the optimal management of asymptomatic inpatient hypertension and to assess whether avoiding or reducing as-needed BP medication use improves clinical outcomes.
RCT: FFR-Guided PCI Plus TAVI is Non-inferior and Superior to SAVR Plus CABG in Patients With Severe Aortic Stenosis and Complex Coronary Disease
8 Dec, 2024 | 21:22h | UTCBackground: Patients with severe aortic stenosis frequently present with concomitant complex coronary artery disease. Current guidelines recommend combined surgical aortic valve replacement (SAVR) and coronary artery bypass grafting (CABG) as first-line therapy. However, transcatheter aortic valve implantation (TAVI) and fractional flow reserve (FFR)-guided percutaneous coronary intervention (PCI) have emerged as alternative treatments. Assessing their efficacy compared to SAVR plus CABG has been an unmet need.
Objective: To determine whether FFR-guided PCI plus TAVI is non-inferior and, if demonstrated, superior to SAVR plus CABG in patients with severe aortic stenosis and complex or multivessel coronary disease.
Methods: This international, multicenter, prospective, open-label, non-inferiority randomized controlled trial included patients aged ≥70 years with severe aortic stenosis and complex coronary disease who were deemed suitable for either percutaneous or surgical treatment by a Heart Team. Participants were randomized (1:1) to FFR-guided PCI plus TAVI or SAVR plus CABG. The primary endpoint was a composite of all-cause mortality, myocardial infarction, disabling stroke, clinically driven target-vessel revascularization, valve reintervention, and life-threatening or disabling bleeding at 1 year.
Results: Among 172 enrolled patients, 91 were assigned to FFR-guided PCI plus TAVI and 81 to SAVR plus CABG. At 1 year, the primary endpoint occurred in 4% of patients in the PCI/TAVI group versus 23% in the SAVR/CABG group (risk difference –18.5%; 90% CI –27.8 to –9.7; p<0.001 for non-inferiority; p<0.001 for superiority). The difference was driven mainly by lower all-cause mortality (0% vs 10%, p=0.0025) and reduced life-threatening bleeding (2% vs 12%, p=0.010).
Conclusions: In patients with severe aortic stenosis and complex coronary artery disease, FFR-guided PCI plus TAVI was non-inferior and in fact superior to SAVR plus CABG at 1 year, predominantly due to lower mortality and serious bleeding events.
Implications for Practice: These findings suggest that a percutaneous strategy may be a viable and potentially preferable alternative to surgery in selected patients. Nevertheless, given this is the first trial of its kind, cautious interpretation is advised, and routine adoption should await further corroboration.
Study Strengths and Limitations: Strengths include a randomized, multicenter design and standardized endpoint assessment. Limitations involve early trial termination resulting in a smaller sample size and the use of a single TAVI device type, limiting generalizability.
Future Research: Larger trials with longer follow-up, evaluation of other TAVI prostheses, and broader patient populations are needed to validate these findings and determine the optimal patient selection criteria.
Prospective Cohort: Combined CRP, LDL Cholesterol, and Lipoprotein(a) Levels Predict 30-Year Cardiovascular Risk in Women
8 Dec, 2024 | 20:58h | UTCBackground: Current 10-year risk models do not fully capture lifetime cardiovascular disease (CVD) risk. Inflammation, low-density lipoprotein (LDL) cholesterol, and lipoprotein(a) are distinct pathways associated with atherosclerosis. While their value in predicting 5- to 10-year cardiovascular risk is established, data on their combined long-term predictive utility, particularly over three decades in women, are limited.
Objective: To determine whether a single baseline measurement of high-sensitivity C-reactive protein (CRP), LDL cholesterol, and lipoprotein(a) provides additive and independent predictive value for 30-year cardiovascular outcomes in initially healthy women.
Methods: This prospective cohort study included 27,939 initially healthy U.S. women (mean age, 54.7 years) from the Women’s Health Study, enrolled between 1992 and 1995. Baseline levels of high-sensitivity CRP, LDL cholesterol, and lipoprotein(a) were measured. Participants were followed for 30 years for a first major adverse cardiovascular event (myocardial infarction, coronary revascularization, stroke, or cardiovascular death). Adjusted hazard ratios (HRs) for each biomarker’s quintiles were estimated, as well as combined models including all three biomarkers simultaneously.
Results: Over 30 years, 3,662 first major cardiovascular events occurred. Higher baseline quintiles of CRP, LDL cholesterol, and lipoprotein(a) were each associated with elevated 30-year risk. Compared to the lowest quintile, adjusted HRs for the top quintile were 1.70 (95% CI, 1.52–1.90) for CRP, 1.36 (95% CI, 1.23–1.52) for LDL cholesterol, and 1.33 (95% CI, 1.21–1.47) for lipoprotein(a). Each marker contributed independently, and models incorporating all three showed the greatest risk discrimination. Participants with all three biomarkers in the highest quintile had a HR of 2.63 (95% CI, 2.16–3.19) for the primary endpoint.
Conclusions: A single combined baseline assessment of high-sensitivity CRP, LDL cholesterol, and lipoprotein(a) strongly predicted CVD events over 30 years. These findings suggest extending beyond traditional 10-year estimates to identify long-term risk, reinforcing the need for early prevention strategies addressing multiple biological pathways.
Implications for Practice: Measuring these three biomarkers early may inform more personalized, prolonged preventive efforts. While lowering LDL cholesterol remains foundational, addressing inflammation and lipoprotein(a) could further optimize long-term CVD prevention. Nonetheless, caution is advised before embracing new interventions lacking robust long-term data.
Study Strengths and Limitations: Strengths include the extended 30-year follow-up, a large, well-characterized cohort, and standardized biomarker assessments. Limitations include a predominantly White, female population, limiting generalizability. Single-time-point biomarker measurements and evolving statin use over time add complexity. Despite these constraints, the study underscores the multifactorial nature of long-term CVD risk.
Future Research: Further investigations should evaluate targeted interventions on inflammation and lipoprotein(a), potentially through long-term clinical trials and more diverse populations. Such research could clarify the benefits of a multimodal risk-reduction strategy.