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The association between body mass index (BMI) and major clinical events after acute coronary syndrome (ACS) remains controversial. We investigated the impact of BMI on major clinical events after ACS in a large individual patient data meta-analysis. Data on 81,553 patients from 45 different countries with ACS enrolled in 8 large randomized clinical trials were included, followed up for a median of 171 days. The mean age was 63.4 ± 11.7, 70% were male, and the mean BMI was 27.3 ± 4.7 kg/m2. Compared with upper–normal-weight participants (BMI 21.75 to 24.9 kg/m2, reference category), underweight participants (<18.5 kg/m2) had an increased risk of death (hazard ratio [HR] 1.35, 95% confidence interval [CI] 1.10 to 1.66, p = 0.004). Both overweight subcategories, BMI 25 to 27.5 kg/m2 (HR 0.81, 95% CI 0.75 to 0.89, p <0.001) and BMI 27.5 to 29.9 kg/m2 (HR 0.84, 95% CI 0.76 to 0.92, p <0.001), and type I obesity (30 to 34.9, HR 0.81, 95% CI 0.73 to 0.89, p <0.001) had a significantly lower mortality. Type II and III obesities were not significantly associated with mortality. Mortality was lowest at a BMI of 30.9 kg/m2. Compared with normal-weight patients, overweight and obese categories were related with a significantly lower risk of bleeding and refractory ischemia. Overweight patients had a lower risk of myocardial infarction, heart failure hospitalizations, and heart failure-related deaths. There were no associations between BMI and revascularization rates or stroke. In conclusion, underweight and normal-weight patients were associated with an increased mortality risk, bleeding, ischemia, and heart failure compared with those with higher BMI after ACS.

Background. Despite technological innovations and improvements in stents and devices, sex-related discrepancies are still reported in the outcomes after ST-segment elevation myocardial infarction (STEMI), depending on biological and sex-specific pathophysiological differences, which have not been completely understood. The aim of the present study was to provide real-world data on the prognostic role of sex among patients with STEMI, enclosed into a recent up-to-date international registry. Methods. The ISACS-STEMI COVID-19 is a large-scale retrospective registry, including STEMI patients treated with mechanical reperfusion between 1 March and 30 June, 2019 and 2020. Patients, treated in 109 centers across Europe, Latin America, Southeast Asia, and North Africa, were grouped according to sex. Primary endpoint: In-hospital mortality; secondary endpoints: Time delay, 30-day mortality, and postprocedural Thrombolysis In Myocardial Infarction (TIMI) 3 flow. Results. We included 16,083 patients, 24.3% females (54.3% hospitalized in 2019, 45.7% in 2020). Women with STEMI were older, more often diabetic and hypertensive (p < 0.001), with a higher prevalence of hypercholesterolemia (p = 0.02), longer ischemia time (p = 0.01), ambulance referral (p = 0.03) and cardiogenic shock at presentation (p = 0.05), but less frequently smokers, with a previous cardiovascular event (p < 0.001) or anterior STEMI (p = 0.03) as compared to males. Preprocedural TIMI 0 flow, multivessel disease, need for thrombectomy (p < 0.001 and p = 0.001, respectively), use of Glycoprotein IIbIIIa inhibitors or cangrelor, radial access and implantation of drug-eluting stents (p < 0.001, p < 0.001 and p = 0.001, respectively) were also more common in men. Impaired postprocedural epicardial reperfusion (TIMI flow 0–2) was observed more frequently in females as compared to males (10% vs. 7.2%; adjusted OR [95% CI] = 1.30 [1.13–1.49], p = 0.01). In-hospital mortality was 5.8%, significantly higher among women (8.3% vs. 5%, p < 0.001, adjusted HR [95% CI] = 1.26 [1.06–1.5], p = 0.01). Similar data were observed for 30-day mortality (10.3% vs. 6.2%, p < 0.001, adjusted HR [95% CI] = 1.22 [1.06–1.38], p = 0.007). Conclusions. Among STEMI patients being treated with the most updated standard of care for primary percutaneous coronary intervention, female sex is still associated with higher complexity and impaired prognosis, displaying suboptimal epicardial reperfusion and increased in-hospital and 30-day mortality.

Stent failure (SF) is a complication of percutaneous coronary intervention (PCI). This study aimed to assess the relationship of the optical coherence tomography (OCT) determined cause of SF with time since stent implantation, treatment, and outcome. This retrospective study included patients who underwent an OCT evaluation for SF from January 2013 to July 2023. In-stent findings were evaluated on OCT including tissue proliferation, tissue type, underexpansion, thrombus, and multiple stent layers. The relationship between time to presentation, treatment, and outcome was assessed. Of the 309 patients who underwent an OCT-guided PCI for SF, tissue proliferation was present in 228 (74%) and absent in 81 (26%). Among patients with tissue proliferation, OCT commonly showed lipidic neointima (  = 122, 54%), thrombus (  = 81, 36%), and underexpansion (  = 71, 31%). In patients without tissue proliferation, OCT commonly identified underexpansion (  = 58, 72%), thrombus (  = 55, 68%), and uncovered struts (  = 37, 46%). The mean time to SF was 6.89 ± 5.88 years with tissue proliferation and 2.98 ± 3.75 years without (  < 0.001). Patients with tissue proliferation were more likely to be treated with repeat stenting (78% vs. 60%,  < 0.001). Lipidic neointimal tissue and >1 layer of stent were predictors of target SF recurrence during a median 3 years of follow-up. In a large series of OCT-guided treatments of SF, tissue proliferation was more common, occurred later after stent implantation, and was more likely to be treated with repeat stenting than no-tissue proliferation. Lipidic neointimal tissue and >1 layer of stent were significant predictors of target SF during follow-up.

Hypertension is the leading cause of cardiovascular disease globally. Despite proven benefits, hypertension control is poor. We hypothesised that a comprehensive approach to lowering blood pressure and other risk factors, informed by detailed analysis of local barriers, would be superior to usual care in individuals with poorly controlled or newly diagnosed hypertension. We tested whether a model of care involving non-physician health workers (NPHWs), primary care physicians, family, and the provision of effective medications, could substantially reduce cardiovascular disease risk. HOPE 4 was an open, community-based, cluster-randomised controlled trial involving 1371 individuals with new or poorly controlled hypertension from 30 communities (defined as townships) in Colombia and Malaysia. 16 communities were randomly assigned to control (usual care, n=727), and 14 (n=644) to the intervention. After community screening, the intervention included treatment of cardiovascular disease risk factors by NPHWs using tablet computer-based simplified management algorithms and counselling programmes; free antihypertensive and statin medications recommended by NPHWs but supervised by physicians; and support from a family member or friend (treatment supporter) to improve adherence to medications and healthy behaviours. The primary outcome was the change in Framingham Risk Score 10-year cardiovascular disease risk estimate at 12 months between intervention and control participants. The HOPE 4 trial is registered at ClinicalTrials.gov, NCT01826019. All communities completed 12-month follow-up (data on 97% of living participants, n=1299). The reduction in Framingham Risk Score for 10-year cardiovascular disease risk was −6·40% (95% CI 8·00 to −4·80) in the control group and −11·17% (−12·88 to −9·47) in the intervention group, with a difference of change of −4·78% (95% CI −7·11 to −2·44, p<0·0001). There was an absolute 11·45 mm Hg (95% CI −14·94 to −7·97) greater reduction in systolic blood pressure, and a 0·41 mmol/L (95% CI −0·60 to −0·23) reduction in LDL with the intervention group (both p<0·0001). Change in blood pressure control status (<140 mm Hg) was 69% in the intervention group versus 30% in the control group (p<0·0001). There were no safety concerns with the intervention. A comprehensive model of care led by NPHWs, involving primary care physicians and family that was informed by local context, substantially improved blood pressure control and cardiovascular disease risk. This strategy is effective, pragmatic, and has the potential to substantially reduce cardiovascular disease compared with current strategies that are typically physician based. Canadian Institutes of Health Research; Grand Challenges Canada; Ontario SPOR Support Unit and the Ontario Ministry of Health and Long-Term Care; Boehringer Ingelheim; Department of Management of Non-Communicable Diseases, WHO; and Population Health Research Institute. [Display omitted]

Cardiovascular disease is the leading cause of death throughout the world, with the majority of deaths occurring in low- and middle-income countries. Despite clear evidence for the benefits of blood pressure reduction and availability of safe and low-cost medications, most individuals are either unaware of their condition or not adequately treated. The primary objective of this study is to evaluate whether a community-based, multifaceted intervention package primarily provided by nonphysician health workers can improve long-term cardiovascular risk in people with hypertension by addressing identified barriers at the patient, health care provider, and health system levels. HOPE-4 is a community-based, parallel-group, cluster randomized controlled trial involving 30 communities (1,376 participants) in Colombia and Malaysia. Participants ≥50 years old and with newly diagnosed or poorly controlled hypertension were included. Communities were randomized to usual care or to a multifaceted intervention package that entails (1) detection, treatment, and control of cardiovascular risk factors by nonphysician health workers in the community, who use tablet-based simplified management algorithms, decision support, and counseling programs; (2) free dispensation of combination antihypertensive and cholesterol-lowering medications, supervised by local physicians; and (3) support from a participant-nominated treatment supporter (either a friend or family member). The primary outcome is the change in Framingham Risk Score after 12 months between the intervention and control communities. Secondary outcomes including change in blood pressure, lipid levels, and Interheart Risk Score will be evaluated. If successful, the study could serve as a model to develop low-cost, effective, and scalable strategies to reduce cardiovascular risk in people with hypertension.

It is unclear why high body mass index (BMI) is associated with a lower risk of death in patients with cardiovascular disease (CVD). We hypothesized that the impact of higher BMI varies by the patient’s baseline risk of death. We analyzed data from 14 prospective studies conducted by us in 50 countries of 170,470 patients: 22.8% without CVD, 29.4% with stable CVD and 47.8% with acute coronary syndromes (ACS). Compared with overweight (BMI 25 to 29.9 kg/m2), normal weight (BMI 20 to 24.9 kg/m2), and underweight (BMI < 20 kg/m2) were associated with higher mortality in all cohorts. Compared with overweight, the risk of death among those with obesity (BMI ≥ 30 kg/m2) varied depending on the population studied: HR (95% confidence interval) in those without CVD, with stable CVD, and with ACS were 1.20 (1.01 to 1.45; p = 0.04), 1.08 (1.02 to 1.15; p = 0.01), and 1.01 (0.93 to 1.10; p = 0.72), respectively. The BMI associated with lowest mortality increased as cohort risk increased (no-CVD 27.2 kg/m2, stable CVD 28.1 kg/m2, and ACS 30.9 kg/m2; p <0.001). Within each cohort, the optimal BMI value was higher in the high-risk subgroup. In the ACS cohort, low-risk patients had an optimal BMI value of 29.1 kg/m2 while in the high-risk group higher BMI was associated with lower risk of death (interaction-p <0.001). In conclusion, between and within cohorts of people without CVD, stable CVD, and ACS, higher BMI was associated with lower risk of death in higher risk groups. The benefits of increased body fat (i.e., increased caloric reserve) may counteract the hazards in high-risk groups, suggesting an alternative explanation of the obesity paradox.

In elderly (75 years or older) patients living in Latin America with severe symptomatic aortic stenosis candidates for transfemoral approach, the panel suggests the use of transcatheter aortic valve implant (TAVI) over surgical aortic valve replacement (SAVR). This is a conditional recommendation, based on moderate certainty in the evidence (⨁⨁⨁Ο).This recommendation does not apply to patients in which there is a standard of care, like TAVI for patients at very high risk for cardiac surgery or inoperable patients, or SAVR for non-elderly patients (eg, under 65 years old) at low risk for cardiac surgery. The suggested age threshold of 75 years old is based on judgement of limited available literature and should be used as a guide rather than a determinant threshold.The conditional nature of this recommendation means that the majority of patients in this situation would want a transfemoral TAVI over SAVR, but some may prefer SAVR. For clinicians, this means that they must be familiar with the evidence supporting this recommendation and help each patient to arrive at a management decision integrating a multidisciplinary team discussion (Heart Team), patient’s values and preferences through shared decision-making, and available resources. Policymakers will require substantial debate and the involvement of various stakeholders to implement this recommendation.

Coronary artery perforation is one of the most common and feared complications of chronic total occlusion (CTO) percutaneous coronary intervention (PCI). We evaluated the utility of the recently presented OPEN-CLEAN (Coronary artery bypass graft, Length of occlusion, Ejection fraction, Age, calcificatioN) perforation score in an independent multicenter CTO PCI dataset. Of the 2,270 patients who underwent CTO PCI at 7 centers, 150 (6.6%) suffered coronary artery perforation. Patients with perforations were older (69 ± 10 vs 65 ± 10, p <0.001), more likely to be women (89% vs 82%, p = 0.010), more likely to have history of previous coronary artery bypass graft (38% vs 20%, p <0.001), and unfavorable angiographic characteristics such as blunt stump (64% vs 42%, p <0.001), proximal cap ambiguity (51% vs 33%, p <0.001), and moderate-severe calcification (57% vs 43%, p = 0.001). Technical success was lower in patients with perforations (69% vs 85%, p <0.001). The area under the receiver operating characteristic curve of the OPEN-CLEAN perforation risk model was 0.74 (95% confidence interval 0.68 to 0.79), with good calibration (Hosmer–Lemeshow p = 0.72). We found that the CTO PCI perforation risk increased with higher OPEN-CLEAN scores: 3.5% (score 0 to 1), 3.1% (score 2), 5.3% (score 3), 7.1% (score 4), 11.5% (score 5), 19.8% (score 6 to 7). In conclusion, given its good performance and ease of preprocedural calculation, the OPEN-CLEAN perforation score appears to be useful for quantifying the perforation risk for patients who underwent CTO PCI.

Hospitalized patients with COVID-19 pneumonia have high rates of morbidity and mortality. To assess the efficacy of colchicine in hospitalized patients with COVID-19 pneumonia. The Estudios Clínicos Latino América (ECLA) Population Health Research Institute (PHRI) COLCOVID trial was a multicenter, open-label, randomized clinical trial performed from April 17, 2020, to March 28, 2021, in adults with confirmed or suspected SARS-CoV-2 infection followed for up to 28 days. Participants received colchicine vs usual care if they were hospitalized with COVID-19 symptoms and had severe acute respiratory syndrome or oxygen desaturation. The main exclusion criteria were clear indications or contraindications for colchicine, chronic kidney disease, and negative results on a reverse transcription-polymerase chain reaction test for SARS-CoV-2 before randomization. Data were analyzed from June 20 to July 25, 2021. Patients were assigned in a 1:1 ratio to usual care or usual care plus colchicine. Colchicine was administered orally in a loading dose of 1.5 mg immediately after randomization, followed by 0.5 mg orally within 2 hours of the initial dose and 0.5 mg orally twice a day for 14 days or discharge, whichever occurred first. The first coprimary outcome was the composite of a new requirement for mechanical ventilation or death evaluated at 28 days. The second coprimary outcome was death at 28 days. A total of 1279 hospitalized patients (mean [SD] age, 61.8 [14.6] years; 449 [35.1%] women and 830 [64.9%] men) were randomized, including 639 patients in the usual care group and 640 patients in the colchicine group. Corticosteroids were used in 1171 patients (91.5%). The coprimary outcome of mechanical ventilation or 28-day death occurred in 160 patients (25.0%) in the colchicine group and 184 patients (28.8%) in the usual care group (hazard ratio [HR], 0.83; 95% CI, 0.67-1.02; P = .08). The second coprimary outcome, 28-day death, occurred in 131 patients (20.5%) in the colchicine group and 142 patients (22.2%) in the usual care group (HR, 0.88; 95% CI, 0.70-1.12). Diarrhea was the most frequent adverse effect of colchicine, reported in 68 patients (11.3%). This randomized clinical trial found that compared with usual care, colchicine did not significantly reduce mechanical ventilation or 28-day mortality in patients hospitalized with COVID-19 pneumonia. ClinicalTrials.gov Identifier: NCT04328480.

Cardiovascular disease (CVD) is the leading cause of death worldwide. The need to address CVD is greatest in low- and middle-income countries where there is a shortage of trained health workers in CVD detection, prevention, and control. Based on the growing evidence that many elements of chronic disease management can be shifted to nonphysician health care workers (NPHW), the HOPE-4 (Heart Outcomes Prevention and Evaluation Program) aimed to develop, test, and implement a training curriculum on CVD prevention and control in Colombia, Malaysia, and low-resource settings in Canada. Curriculum development followed an iterative and phased approach where evidence-based guidelines, revised blood pressure treatment algorithms, and culturally relevant risk factor counseling were incorporated. Through a pilot-training process with high school students in Canada, the curriculum was further refined. Implementation of the curriculum in Colombia, Malaysia, and Canada occurred through partner organizations as the HOPE-4 team coordinated the program from Hamilton, Ontario, Canada. In addition to content on the burden of disease, cardiovascular system pathophysiology, and CVD risk factors, the curriculum also included evaluations such as module tests, in-class exercises, and observed structured clinical examinations, which were administered by the local partner organizations. These evaluations served as indicators of adequate uptake of curriculum content as well as readiness to work as an NPHW in the field. Overall, 51 NPHW successfully completed the training curriculum with an average score of 93.19% on module tests and 84.76% on the observed structured clinical examinations. Since implementation, the curriculum has also been adapted to the World Health Organization's HEARTS Technical Package, which was launched in 2016 to improve management of CVD in primary health care. The robust curriculum development, testing, and implementation process described affirm that NPHW in diverse settings can be trained in implementing measures for CVD prevention and control. •Trained nonphysician health workers can help control the rising burden of CVD.•A culturally relevant, evidence-based training curriculum was implemented.•Fifty-one health workers completed the training in Colombia, Malaysia, and Canada.•Training curriculum has been adapted to the WHO's Global HEARTS initiative.