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Background: The ISCHEMIA trial (International Study of Comparative Health Effectiveness With Medical and Invasive Approaches) compared an initial invasive versus an initial conservative management strategy for patients with chronic coronary disease and moderate or severe ischemia, with no major difference in most outcomes during a median of 3.2 years. Extended follow-up for mortality is ongoing. Methods: ISCHEMIA participants were randomized to an initial invasive strategy added to guideline-directed medical therapy or a conservative strategy. Patients with moderate or severe ischemia, ejection fraction ≥35%, and no recent acute coronary syndromes were included. Those with an unacceptable level of angina were excluded. Extended follow-up for vital status is being conducted by sites or through central death index search. Data obtained through December 2021 are included in this interim report. We analyzed all-cause, cardiovascular, and noncardiovascular mortality by randomized strategy, using nonparametric cumulative incidence estimators, Cox regression models, and Bayesian methods. Undetermined deaths were classified as cardiovascular as prespecified in the trial protocol. Results: Baseline characteristics for 5179 original ISCHEMIA trial participants included median age 65 years, 23% women, 16% Hispanic, 4% Black, 42% with diabetes, and median ejection fraction 0.60. A total of 557 deaths accrued during a median follow-up of 5.7 years, with 268 of these added in the extended follow-up phase. This included a total of 343 cardiovascular deaths, 192 noncardiovascular deaths, and 22 unclassified deaths. All-cause mortality was not different between randomized treatment groups (7-year rate, 12.7% in invasive strategy, 13.4% in conservative strategy; adjusted hazard ratio, 1.00 [95% CI, 0.85–1.18]). There was a lower 7-year rate cardiovascular mortality (6.4% versus 8.6%; adjusted hazard ratio, 0.78 [95% CI, 0.63–0.96]) with an initial invasive strategy but a higher 7-year rate of noncardiovascular mortality (5.6% versus 4.4%; adjusted hazard ratio, 1.44 [95% CI, 1.08–1.91]) compared with the conservative strategy. No heterogeneity of treatment effect was evident in prespecified subgroups, including multivessel coronary disease. Conclusions: There was no difference in all-cause mortality with an initial invasive strategy compared with an initial conservative strategy, but there was lower risk of cardiovascular mortality and higher risk of noncardiovascular mortality with an initial invasive strategy during a median follow-up of 5.7 years. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT04894877.

Purpose This study aims to examine the prevalence and CAC distribution and to evaluate the association of each CAC classifications with major adverse cardiovascular event (MACE). Method This study was a retrospective observational cohort. We included patient aged above 35 years who underwent CAC testing. The absolute and age-sex specific percentile classification were categorized as 0, 1 to 10, 11 to 100, 101 to 400, and > 400 and 0, < 75th, 75th – 90th, and > 90th, respectively. The end point was MACE, including cardiovascular death, myocardial infarction, heart failure hospitalization, coronary artery revascularization procedures, and stroke. Multivariable Cox regression was used to estimate the hazard ratios. The discriminative performance between classification were compared using Harrell’s C-statistic. The agreement was assessed via Cohens’ Kappa. Result The study included 440 patients, with approximately 70% of Thai patients exhibiting a CAC score. CAC distributed higher in male than female and older than younger. Both CAC classification demonstrated the acceptable predictive performance. However, fair agreement was observed between classifications (Cohen’s kappa 0.51 95%CI 0.42–0.59). Within an absolute classification, the higher CAC could capture the higher hazard ratio more consistently across age-sex specific percentile level. In contrast, the association between MACE and the age-sex specific percentile classification was not consistent in all levels of the absolute CAC scale. Conclusion Both absolute and age-sex-specific percentile CAC scores showed acceptable performance in predicting MACE. However, it is likely that the classification of absolute CAC scores may be more appropriate for risk stratification in Thai clinical cohort.

Background Home blood pressure monitoring is currently a gold standard for guiding an adjustment of antihypertensive medications. According to the American Heart Association (AHA), the self-automated blood pressure (BP) measurement may represent accurate home BP. However, there is a limited data in real-world practice Objective To explore the accuracy of a self-automated BP measurement in representing the actual home BP monitoring, in comparison with a single spot-arm automated BP measurement, which is routinely used in the clinical setting. Methods We conducted a single center, randomized cross-over trial. At the Cardiology clinic, hypertensive patients aged between 18 and 80 years, who were able to perform self-automated BP measurement, were included in the study. The patients were categorized into two groups using different BP measurement methods: a self-automated BP measurement according to the AHA Recommendation 2017 and a single spot-arm automated BP measurement, and then crossed over to alternative methods. All participants were instructed to rest at least 5 minutes prior to undergo BP measurement in both methods. The data of BP measurements were subsequently compared with the standard home BP monitoring. Results Overall, 190 patients underwent randomization. Mean differences of systolic blood pressure (SBP) in the self-automated AHA measurement and the single spot-arm measurement, compared with the standard home BP monitoring, were 3.57 mmHg (95% confidence interval (CI); 1.39 to 5.74 mmHg) and 9.44 mmHg (95% CI; 7.03 to11.86 mmHg), respectively (P Conclusion The self-automated BP measurement according to the AHA Recommendation 2017 was more accurate than the single spot-arm automated BP measurement in representing the actual home BP monitoring and reduced the possibility of the white coat effect. Funding Acknowledgement Type of funding sources: None. Table 1

Supplemental Digital Content is available in the text., Background: Thrombotic events are reduced with cangrelor, an intravenous P2Y12 inhibitor. We sought to characterize the timing, number, and type of early events (within 2 hours of randomization) in CHAMPION PHOENIX (A Clinical Trial Comparing Cangrelor to Clopidogrel Standard of Care Therapy in Subjects Who Require Percutaneous Coronary Intervention). Methods: CHAMPION PHOENIX was a double-blind, placebo-controlled trial that randomized patients undergoing percutaneous coronary intervention to cangrelor or clopidogrel. For this analysis, we evaluated the efficacy of cangrelor in the first 2 hours postrandomization with regards to the primary end point (death, myocardial infarction, ischemia-driven revascularization, or stent thrombosis). Sensitivity analyses were performed evaluating a secondary, post hoc end point (death, Society of Coronary Angiography and Intervention myocardial infarction, ischemia-driven revascularization, or Academic Research Consortium definite stent thrombosis). Results: The majority of events (63%) that occurred in the trial occurred within 2 hours of randomization. The most common early event was myocardial infarction; next were stent thrombosis, ischemia driven revascularization, and death. In the first 2 hours after randomization, cangrelor significantly decreased the primary composite end point compared with clopidogrel (4.1% versus 5.4%; hazard ratio, 0.76 [95% CI, 0.64–0.90], P=0.002). Similar findings were seen for the composite end point of death, Society of Coronary Angiography and Intervention myocardial infarction, ischemia-driven revascularization, or Academic Research Consortium stent thrombosis at 2 hours (0.9% versus 1.6%; hazard ratio, 0.57 [95% CI, 0.40–0.80], P=0.001). Between 2 and 48 hours, there was no difference in the primary composite end point (0.6% versus 0.5%; odds ratio, 1.17 [95% CI, 0.71–1.93]; P=0.53). Early (≤2 hours of randomization) GUSTO (Global Use of Strategies to Open Occluded Coronary Arteries) moderate or severe bleeding events were infrequent, and there was no significant difference with cangrelor compared with clopidogrel (0.2% [n=10] versus 0.1% [n=4]; adjusted odds ratio, 1.41 [95% CI, 0.37–5.40]; P=0.62). Conclusions: The reductions in ischemic events and overall efficacy seen with cangrelor in CHAMPION PHOENIX occurred early and during the period of time in which patients were being actively treated with cangrelor. These findings provide evidence that supports the importance of potent platelet inhibition during percutaneous coronary intervention. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01156571.