RESUMEN
Blood pressure (BP) phenotypes, as determined by the consistency between office BP (OBP) and ambulatory BP (ABP) measurements, enhance risk assessment during pregnancy. However, diagnostic criteria for hypertension in pregnancy are based on data from non-pregnant populations regarding long-term cardiovascular risks. This study aimed to identify adverse pregnancy outcomes (APOs; including maternal/fetal outcomes)-related BP thresholds to refine risk assessment in pregnant women. We analyzed 967 high-risk pregnant women who underwent simultaneous OBP and ABP measurements at an average gestational age of 29.6 ± 8.0 weeks. All hypertension phenotypes were associated with an increased risk of maternal and fetal outcomes, except white coat hypertension, which showed no association with fetal outcomes. Using an XGBoost algorithm, the receiver operating characteristic (ROC) curve-derived daytime diastolic BP (DBP) thresholds of 81.5 mmHg for maternal and 82.5 mmHg for fetal outcomes were identified as the BP parameters most strongly linked to APOs. Incorporating these thresholds into the BP phenotype-based model improved the area under the curve for APOs and the net reclassification index for maternal and fetal outcomes. Decision curve analysis demonstrated a consistent positive net benefit after incorporating BP thresholds into the phenotype-based model for maternal and composite outcomes. In conclusion, in a Chinese pregnancy cohort, we identified daytime DBP as the most influential parameter for APOs, significantly enhancing the predictive performance of BP phenotype-based models. This study underscores the importance of ABP monitoring in high-risk pregnancies and the need for further research to establish optimal BP monitoring criteria for pregnancy.
RESUMEN
BACKGROUND: Direct oral anticoagulants (DOACs) reduce stroke risk in patients with device-detected atrial fibrillation (DD-AFib) but increase major bleeding risk. The time to benefit (TTB) and time to harm (TTH) are not well quantified. OBJECTIVE: The purpose of this study was to determine TTB and TTH in DOAC-treated patients with DD-AFib. METHODS: Studies were identified from PubMed searching until November 2023. The primary efficacy outcome was the time to the first stroke event, and the primary safety outcome was the time to the first major bleeding event. Pooled hazard ratio (HR) and its confidence interval (CI) were calculated through reconstructed patient-level data and study-level data. Weibull model and Markov chain Monte Carlo simulation were applied to determine time to specific absolute risk change thresholds. RESULTS: Two trials involving DOACs-NOAH-AFNET 6 (Non-vitamin K antagonist Oral anticoagulants in patients with Atrial High rate episodes) and ARTESiA (Apixaban for the Reduction of Thrombo-Embolism in Patients With Device-Detected Sub-Clinical Atrial Fibrillation)-were identified, which randomized 6548 adults with a mean age of >75 years and a median atrial high-rate episode duration ranging from 1.5 to 2.8 hours. DOACs decreased the risk of stroke (HR 0.67; 95% CI 0.50-0.90) but increased the risk of major bleeding (HR 1.57; 95% CI 1.21-2.04). A TTB of 2.67 years was needed to prevent 1 stroke per 100 DOAC-treated patients, while a TTH of 1.67 years was needed to observe 1 major bleeding. CONCLUSION: In elderly patients with low durations of DD-AFib, DOACs result in a delayed and restricted stroke-preventive benefit while posing an early-onset bleeding risk. Our findings offer new insights into the risk-benefit profile and provide clinicians an additional dimension to facilitate shared decision-making discussions with patients.
RESUMEN
Background: Low-dose colchicine has been shown to lower major adverse cardiovascular events (MACE) among those with cardiovascular disease (CVD). It remains unclear how long a CVD patient needs to live to potentially benefit from colchicine. Our study aimed to determine the time to benefit (TTB) of colchicine in individuals with CVD. Methods: Literature searches were performed in PubMed for the cardiovascular outcome trial of colchicine in patients with CVD until October 12, 2023. The primary outcome measured was MACE. Reconstructed individual participant data (IPD) and the stratified Cox proportional hazards model were used to calculate the hazard ratio (HR) and 95 % confidence interval (CI) to estimate the efficacy of colchicine, and Weibull survival curves were fitted to estimate TTB for specific absolute risk reduction (ARR) thresholds (0.002, 0.005, and 0.01). Results: Four trials randomizing 11,594 adults aged between 59.8 and 66.5 years were included (follow-up duration: 12-28.6 months). Compared with placebo, colchicine reduced the risk of MACE (HR 0.68, 95 % CI: 0.60 to 0.78) but had no impact on cardiovascular and all-cause mortality. A TTB of 11.0 months (95 % CI: 0.59 to 21.3) was estimated to be needed to prevent 1 MACE in 100-colchicine-treated patients. The TTB for acute coronary syndrome was similar compared to stable coronary artery disease (10.7 vs. 11.2 months for ARR = 0.010). Conclusions: By using reconstructed IPD, this pooled analysis demonstrated that colchicine was associated with reduced nonfatal MACE, and the TTB was approximately 11.0 months to prevent 1 MACE per 100 patients.