Negative selection bias for women inclusion in a clinical trial.

INTRODUCTION: Despite the growing awareness towards the importance of adequate representation of women in clinical trials among patients treated with percutaneous coronary intervention (PCI), available evidence continues to demonstrate a skewed distribution of study populations in favour of men. METHODS AND RESULTS: In this pre-specified analysis from the MASTER DAPT screening log and trial, we aimed to investigate the existence of a negative selection bias for women inclusion in a randomized clinical trial. A total of 2847 consecutive patients who underwent coronary revascularization across 65 participating sites, during a median of 14 days, were entered in the screening log, including 1749 (61.4%) non-high bleeding risk (HBR) and 1098 (38.6%) HBR patients, of whom 109 (9.9%) consented for trial participation. Female patients were less represented in consented versus non-consented HBR patients (22% versus 30%, absolute standardized difference: 0.18) and among non-consented eligible versus consented eligible patients (absolute standardized difference 0.14). The observed sex gap was primarily due investigators' choice not to offer study participation to females because deemed at very high risk of bleeding and/or ischemic complications, and only marginally to a slightly higher propensity of females compared to males to refuse study participation. CONCLUSIONS: Female HBR patients undergoing PCI are less prevalent, but also less likely to participate in the trial than male patients, mainly due to investigators' preference.

Severity of Coronary Artery Disease by Friesinger Score Among Women With Acute Coronary Syndrome in a Tertiary Care Hospital in Bangladesh.

BACKGROUND: The chance of coronary artery disease (CAD) is much higher in women who have gone through menopause than in those who have not, owing to hormonal defense against atherosclerosis. More advanced CAD and several comorbidities were observed in postmenopausal women. Nevertheless, there is a paucity of information comparing the angiographic severity of acute coronary syndrome (ACS) in premenopausal and postmenopausal women of different ages. This research sought to determine the Friesinger score's use in evaluating the degree of CAD in premenopausal and postmenopausal women with ACS. METHODS: A total of 145 female patients with ACS were included in this cross-sectional observational research. Depending on the stage of menopause, they were categorized into two groups: group I (premenopausal) and group II (postmenopausal). The study examined the differences in clinical data and the severity of coronary angiographic features based on the Friesinger score between the premenopausal and postmenopausal ACS groups. RESULTS: A statistically significant difference (p = 0.001) was found in the mean age of premenopausal ACS patients, which was 41.53 ± 5.45 years, and postmenopausal ACS patients, which was 57.23 ± 7.45 years. Between the premenopausal group (31.4% vs. 17.1%; p = 0.04 and 31.4% vs. 15.7%; p = 0.002) and postmenopausal group (48.6% vs. 20%; p = 0.001), there was a greater prevalence of normal coronary angiography, single-vessel disease, and triple-vessel disease. Comparing the postmenopausal group to the premenopausal group, the high to intermediate Friesinger score (11-15) was found to be considerably higher (2.9% vs. 1.4%; 72.9% vs. 50%; p = 0.003). CONCLUSION: Prior to menopause, single-vessel disease and normal coronary angiography were more common, whereas postmenopausal individuals had triple-vessel disease. The postmenopausal group's CAD was found to be more severe than the premenopausal group's according to the Friesinger score used for severity evaluation.

Abbreviated or Standard Dual Antiplatelet Therapy by Sex in Patients at High Bleeding Risk: A Prespecified Secondary Analysis of a Randomized Clinical Trial.

Importance: Abbreviated dual antiplatelet therapy (DAPT) reduces bleeding with no increase in ischemic events in patients at high bleeding risk (HBR) undergoing percutaneous coronary intervention (PCI). Objectives: To evaluate the association of sex with the comparative effectiveness of abbreviated vs standard DAPT in patients with HBR. Design, Setting, and Patients: This prespecified subgroup comparative effectiveness analysis followed the Management of High Bleeding Risk Patients Post Bioresorbable Polymer Coated Stent Implantation With an Abbreviated vs Standard DAPT Regimen (MASTER DAPT) trial, a multicenter, randomized, open-label clinical trial conducted at 140 sites in 30 countries and performed from February 28, 2017, to December 5, 2019. A total of 4579 patients with HBR were randomized at 1 month after PCI to abbreviated or standard DAPT. Data were analyzed from July 1 to October 31, 2022. Interventions: Abbreviated (immediate DAPT discontinuation, followed by single APT for ≥6 months) or standard (DAPT for ≥2 additional months, followed by single APT for 11 months) treatment groups. Main Outcomes and Measures: One-year net adverse clinical events (NACEs) (a composite of death due to any cause, myocardial infarction, stroke, or major bleeding), major adverse cardiac or cerebral events (MACCEs) (a composite of death due to any cause, myocardial infarction, or stroke), and major or clinically relevant nonmajor bleeding (MCB). Results: Of the 4579 patients included in the analysis, 1408 (30.7%) were women and 3171 (69.3%) were men (mean [SD] age, 76.0 [8.7] years). Ischemic and bleeding events were similar between sexes. Abbreviated DAPT was associated with comparable NACE rates in men (hazard ratio [HR], 0.97 [95% CI, 0.75-1.24]) and women (HR, 0.87 [95% CI, 0.60-1.26]; P = .65 for interaction). There was evidence of heterogeneity of treatment effect by sex for MACCEs, with a trend toward benefit in women (HR, 0.68 [95% CI, 0.44-1.05]) but not in men (HR, 1.17 [95% CI, 0.88-1.55]; P = .04 for interaction). There was no significant interaction for MCB across sex, although the benefit with abbreviated DAPT was relatively greater in men (HR, 0.65 [95% CI, 0.50-0.84]) than in women (HR, 0.77 [95% CI, 0.53-1.12]; P = .46 for interaction). Results remained consistent in patients with acute coronary syndrome and/or complex PCI. Conclusions and Relevance: These findings suggest that women with HBR did not experience higher rates of ischemic or bleeding events compared with men and may derive particular benefit from abbreviated compared with standard DAPT owing to these numerically lower rates of events. Trial Registration: ClinicalTrials.gov Identifier: NCT03023020.

Optimal timing of influenza vaccination among patients with acute myocardial infarction - Findings from the IAMI trial.

Influenza vaccination reduces the risk of adverse cardiovascular events.The IAMI trial randomly assigned 2571 patients with acute myocardial infarction (AMI) to receive influenza vaccine or saline placebo during their index hospital admission. It was conducted at 30 centers in 8 countries from October 1, 2016 to March 1, 2020. In this post-hoc exploratory sub-study, we compare the trial outcomes in patients receiving early season vaccination (n = 1188) and late season vaccination (n = 1344).The primary endpoint wasthe composite of all-cause death, myocardial infarction (MI), or stent thrombosis at 12 months. Thecumulative incidence of the primary and key secondary endpoints by randomized treatment and early or late vaccination was estimated using the Kaplan-Meier method. In the early vaccinated group, the primary composite endpoint occurred in 36 participants (6.0%) assigned to influenza vaccine and 49 (8.4%) assigned to placebo (HR 0.69; 95% CI 0.45 to 1.07), compared to 31 participants (4.7%) assigned to influenza vaccine and 42 (6.2%) assigned to placebo (HR 0.74; 95% CI 0.47 to 1.18) in the late vaccinated group (P = 0.848 for interaction on HR scale at 1 year). We observed similar estimates for the key secondary endpoints of all-cause death and CV death. There was no statistically significant difference in vaccine effectiveness against adverse cardiovascular events by timing of vaccination. The effect of vaccination on all-cause death at one year was more pronounced in the group receiving early vaccination (HR 0.50; 95% CI, 0.29 to 0.86) compared late vaccination group (HR 0.75; 35% CI, 0.40 to 1.40) but there was no statistically significant difference between these groups (Interaction P = 0.335). In conclusion,there is insufficient evidence from the trial to establish whether there is a difference in efficacy between early and late vaccinationbut regardless of vaccination timing we strongly recommend influenza vaccination in all patients with cardiovascular diseases.

Impact of real-time optical coherence tomography and angiographic coregistration on the percutaneous coronary intervention strategy.

Background: The use of optical coherence tomography (OCT) with angiographic coregistration (ACR) during percutaneous coronary intervention (PCI) for procedural decision-making is evolving; however, large-scale data in real-world practice are lacking. Aims: Our study aims to evaluate the real-time impact of OCT-ACR on clinician decision-making during PCI. Methods: Patients with angiographic diameter stenosis >70% in at least one native coronary artery were enrolled in the study. The pre- and post-PCI procedural strategies were prospectively assessed after angiography, OCT, and ACR. Results: A total of 500 patients were enrolled in the study between November 2018 and March 2020. Among these, data related to 472 patients with 483 lesions were considered for analysis. Preprocedural OCT resulted in a change in PCI strategy in 80% of lesions: lesion preparation (25%), stent length (53%), stent diameter (36%), and device landing zone (61%). ACR additionally impacted the treatment strategy in 34% of lesions. Postprocedural OCT demonstrated underexpansion (15%), malapposition (14%), and tissue/thrombus prolapse (7%), thereby requiring further interventions in 30% of lesions. No further change in strategy was observed with subsequent postprocedural ACR. Angiographic and procedural success was achieved in 100% of patients, and the overall incidence of major adverse cardiovascular events at 1 year was 0.85%. Conclusions: The outcomes reflect the real-time impact of OCT-ACR on the overall procedural strategy in patients undergoing PCI. ACR had a significant impact on the treatment strategy and was associated with better clinical outcomes at 1 year after index PCI. OCT-ACR has become a practical tool for improving outcomes in patients with complex lesions.

Assessment of subclinical left ventricular systolic dysfunction in patients with asymptomatic severe aortic stenosis with preserved left ventricular systolic function by three-dimensional speckle tracking echocardiography.

OBJECTIVES: Left ventricular dysfunction and remodeling can occur as a result of aortic valve stenosis (AS). Three-dimensional speckle tracking echocardiography (3D-STE) can detect early left ventricular myocardial dysfunction even before ejection fraction declines. The purpose of this study was to look at the relationship between various myocardial strain parameters measured by 3D-STE in asymptomatic severe AS patients from Bangladesh. METHODS: This study included 46 patients with asymptomatic severe AS but preserved LV systolic function (mean age 50.11 ± 12.66 years, LVEF 63.78 ± 3.95%, AS group) and 33 healthy subjects with no cardiovascular disease (mean age 48.21 ± 4.53 years, LVEF 65.15 ± 3.13%, control group). 3D-STE was used to measure left ventricular global myocardial strain parameters such as peak systolic longitudinal strain (PSLS), circumferential strain, radial strain, and area strain. RESULTS: The AS group had significantly thicker interventricular septum and posterior ventricular wall than the control group (1.49 ± .19 cm vs. .81 ± .09 cm, p < .001; 1.73 ± 1.71 cm vs. .81 ± .10 cm, p = .003, respectively.) In the AS group, the Indexed Aortic Valve Area (AVA) was significantly lower than in the control group. (.29 ± .10 vs. 2.03 ± .18, p < .001, respectively). In terms of LVEF (p = .102), left ventricular end diastolic volume (p = .075), or left ventricular end systolic volume (p = .092), no significant inter-group difference was found. However, global PSLS (-10.75 ± 2.27 vs. -16.42 ± 2.76, p < .001), circumferential strain (-14.26 ± 3.40 vs. -16.64 ± 2.56, p = .001), area strain (-22.70 ± 4.19 vs. -26.45 ± 9.90, p = .024) and radial strain (32.20 ± 8.77 vs. 41.00 ± 7.52, p < .001) in the AS group were significantly lower than in the control group. CONCLUSION: Our findings showed reductions in left ventricular global myocardial strains, particularly PSLS in patients suffering from asymptomatic severe AS in Bangladesh; this is consistent with other studies. Reduced area strain, detectable with 3D-STE, is also consistent with that pattern.

Complementary evidence on the performance of coronary stents generated by a randomized controlled trial and a worldwide registry.

BACKGROUND: Large-scale registries can provide valuable complementary data to randomized controlled trials (RCT) for the postmarketing evaluation of coronary stents, but their scientific relevance remains debated. METHODS: We sought to compare the evidence on the performance of a single coronary stent platform generated by the RCT for its regulatory approval and a well-conducted international registry. Patients treated with the Ultimaster coronary stent in the CENTURY II (CII-UM) trial (n = 551) were compared to patients in the real-world e-ULTIMASTER (e-UM) registry (n = 35,389). All major events were adjudicated by an independent clinical event committee in both studies. Propensity weighted analysis was used to balance baseline and procedural differences between the 2 populations. RESULTS: Coronary artery disease was more complex in e-UM compared to CII-UM, including more acute coronary syndromes, multivessel disease, left main, arterial, or venous grafts, and chronic total occlusions (P < .005 for all). At one-year follow-up and after excluding periprocedural myocardial infarction (MI) there was no statistically significant difference between CII-UM and e-UM regarding all-cause death (hazard ratio [HR] 0.55, 95% confidence interval [CI] 0.26-1.20, P = .14), cardiac death (HR 0.71, 95% CI 0.29-1.72, P = .45), target lesion failure (HR 1.18, 95% CI 0.78-1.78, P = .44), and target vessel MI (HR 0.76, 95% CI 0.24-2.38, P = .63). However, target vessel revascularization rate was significantly higher in CII-UM than in e-UM, HR 1.78, 95% CI 1.23-2.56, P = .002. CONCLUSIONS: A well-conducted large-scale registry can provide valuable complementary evidence to RCTs on the postmarket performance of new coronary stents, across a wider range of uses and various geographic areas.

Clinical impact of influenza vaccination after ST- and non-ST-segment elevation myocardial infarction - insights from the IAMI trial.

BACKGROUND: Influenza vaccination early after myocardial infarction (MI) improves prognosis but vaccine effectiveness may differ dependent on type of MI. METHODS: A total of 2,571 participants were prospectively enrolled in the Influenza vaccination after myocardial infarction (IAMI) trial and randomly assigned to receive in-hospital inactivated influenza vaccine or saline placebo. The trial was conducted at 30 centers in eight countries from October 1, 2016 to March 1, 2020. Here we report vaccine effectiveness in the 2,467 participants with ST-segment elevation MI (STEMI, n = 1,348) or non-ST-segment elevation MI (NSTEMI, n = 1,119). The primary endpoint was the composite of all-cause death, MI, or stent thrombosis at 12 months. Cumulative incidence of the primary and key secondary endpoints by randomized treatment and NSTEMI/STEMI was estimated using the Kaplan-Meier method. Treatment effects were evaluated with formal interaction testing to assess for effect modification. RESULTS: Baseline risk was higher in participants with NSTEMI. In the NSTEMI group the primary endpoint occurred in 6.5% of participants assigned to influenza vaccine and 10.5% assigned to placebo (hazard ratio [HR], 0.60; 95% CI, 0.39-0.91), compared to 4.1% assigned to influenza vaccine and 4.5% assigned to placebo in the STEMI group (HR, 0.90; 95% CI, 0.54-1.50, P = .237 for interaction). Similar findings were seen for the key secondary endpoints of all-cause death and cardiovascular death. The Kaplan-Meier risk difference in all-cause death at one year was more pronounced in participants with NSTEMI (NSTEMI: HR, 0.47; 95% CI 0.28-0.80, STEMI: HR, 0.86; 95% CI, 0.43-1.70, interaction P = .028). CONCLUSIONS: The beneficial effect of influenza vaccination on adverse cardiovascular events may be enhanced in patients with NSTEMI compared to those with STEMI.

Severity of Coronary Artery Diseases Among Pre- and Postmenopausal Women With Acute Coronary Syndrome: A Hospital-Based Study in Bangladesh.

BACKGROUND: Postmenopausal women present with more severe coronary artery disease (CAD) in addition to multiple comorbidities. However, there are limited data available to compare the risk factors, clinical characteristics, and angiographic severity of CAD between pre- and postmenopausal women with the acute coronary syndrome (ACS). AIM: This study aimed to assess and compare the severity of CAD in pre- and postmenopausal women with ACS. METHODS: This cross-sectional observational study was conducted at the Department of Cardiology of NHFH RI. A total of 140 female patients with ACS were enrolled and then divided into Group I (premenopausal) and Group II (postmenopausal) on the basis of menopause history. Clinical data and coronary angiographic severity were compared between both groups. RESULTS: The mean age of the premenopausal group was 41.53 ± 5.45 years, and that of the postmenopausal group was 57.23 ± 7.45 years. Family history of premature CAD was significantly more common in the premenopausal group than in the postmenopausal group (35(50%) vs. 23(32.9%); p=0.017)). DM and smokeless tobacco were more prevalent in the postmenopausal group (48(68.6%) vs. 28(40%); p=0.001 and 14(20%) vs. 2(2.9%); p=0.002). Atypical presentation was more common in the premenopausal group (21(30%) vs. 9(12.9%); p=0.013). Most of the patients in both groups presented with unstable angina followed by NSTEMI and STEMI. Mean left ventricular ejection fraction was lower in the postmenopausal group than in the premenopausal group (50.71 ± 8.38% vs. 53.74 ± 7.46%; p=0.026). Normal coronary angiogram and single-vessel disease were more prevalent in the premenopausal group (22(31.4%) vs. 12(17.1%); p=0.04) and (22(31.4%) vs. 11(15.7%); p=0.002), whereas triple-vessel disease was more prevalent in the postmenopausal group (34(48.6% vs. 14(20%); p=0.001). The left anterior descending artery was the most commonly involved vessel in the postmenopausal group (67(95.7%) vs. 60(85.7%); p=0.04). Finally, the mean Gensini score was higher in the postmenopausal group than in the premenopausal group (56.1 ± 43.4 vs. 33.5 ± 36.9; p=0.001). CONCLUSION: Family history of premature CAD and atypical presentation were common in premenopausal ACS patients. DM and smokeless tobacco use were more prevalent in the postmenopausal group than in the premenopausal group. Normal coronary angiogram and single-vessel disease were more prevalent in the premenopausal group, and triple-vessel disease was more common in the postmenopausal group. CAD was more severe in the postmenopausal group.

Improve the Prevention of Sudden Cardiac Arrest in Patients With Post-Acute Myocardial Infarction.

Background: Implantable cardioverter-defibrillator (ICD) implantation to prevent sudden cardiac death (SCD) in post-myocardial infarction (MI) patients varies by geography but remains low in many regions despite guideline recommendations. Objectives: This study aimed to characterize the care pathway of post-MI patients and understand barriers to referral for further SCD risk stratification and management in patients meeting referral criteria. Methods: This prospective, nonrandomized, multi-nation study included patients ≥18 years of age, with an acute MI ≤30 days and left ventricular ejection fraction <50% ≤14 days post-MI. The primary endpoint was defined as the physician's decision to refer a patient for SCD stratification and management. Results: In total, 1,491 post-MI patients were enrolled (60.2 ± 12.0 years of age, 82.4% male). During the study, 26.7% (n = 398) of patients met criteria for further SCD risk stratification; however, only 59.3% of those meeting criteria (n = 236; 95% CI: 54.4%-64.0%) were referred for a visit. Of patients referred for SCD risk stratification and management, 94.9% (n = 224) attended the visit of which 56.7% (n =127; 95% CI: 50.1%-63.0%) met ICD indication criteria. Of patients who met ICD indication criteria, 14.2% (n = 18) were implanted. Conclusions: We found that ∼40% of patients meeting criteria were not referred for further SCD risk stratification and management and ∼85% of patients who met ICD indications did not receive a guideline-directed ICD. Physician and patient reasons for refusing referral to SCD risk stratification and management or ICD implant varied by geography suggesting that improvement will require both physician- and patient-focused approaches. (Improve Sudden Cardiac Arrest [SCA] Bridge Study; NCT03715790).

Interventions in the diagnosis and adoption of pacemaker therapy in sinus node dysfunction patients: Results from the IMPROVE Brady study.

AIMS: IMPROVE Brady assessed whether a process improvement intervention could increase adoption of guideline-based therapy in sinus node dysfunction (SND) patients. METHODS: /Results: IMPROVE Brady was a sequential, prospective, quality improvement initiative conducted in India and Bangladesh. Patients with symptomatic bradycardia were enrolled. In Phase I, physicians assessed and treated patients per standard care. Phase II began after implementing educational materials for physicians and patients. Primary objectives were to evaluate the impact of the intervention on SND diagnosis and pacemaker (PPM) implant. SF-12 quality of life (QoL) and Zarit burden surveys were collected pre- and post-PPM implant. A total of 978 patients were enrolled (57.7 ± 14.8 years, 75% male), 508 in Phase I and 470 in Phase II. The diagnosis of SND and implantation of PPM increased significantly from Phase I to Phase II (72% vs. 87%, P < 0.001 and 17% vs. 32%, P < 0.001, respectively). Pacemaker implantation was not feasible in 41% of patients due to insurance/cost barriers which was unaltered by the intervention. Both patient QoL and caregiver burden improved at 6-months post-PPM implant (P < 0.001). CONCLUSIONS: A process improvement initiative conducted at centers across India and Bangladesh significantly increased the diagnosis of SND and subsequent treatment with PPM therapy despite the socio-economic constraints.

Duration of antiplatelet therapy after complex percutaneous coronary intervention in patients at high bleeding risk: a MASTER DAPT trial sub-analysis.

AIM: To assess the effects of 1- or ≥3-month dual antiplatelet therapy (DAPT) in high bleeding risk (HBR) patients who received biodegradable-polymer sirolimus-eluting stents for complex percutaneous coronary intervention (PCI) and/or acute coronary syndrome (ACS). METHODS AND RESULTS: In the MASTER DAPT trial, 3383 patients underwent non-complex (abbreviated DAPT, n = 1707; standard DAPT, n = 1676) and 1196 complex (abbreviated DAPT, n = 588; standard DAPT, n = 608) PCI. Co-primary outcomes at 335 days were net adverse clinical events [NACE; composite of all-cause death, myocardial infarction, stroke, and bleeding academic research consortium (BARC) 3 or 5 bleeding events]; major adverse cardiac or cerebral events (MACCE; all-cause death, myocardial infarction, and stroke); and Types 2, 3, or 5 BARC bleeding. Net adverse clinical events and MACCE did not differ with abbreviated vs. standard DAPT among patients with complex [hazard ratio (HR): 1.03, 95% confidence interval (CI): 0.69-1.52, and HR: 1.24, 95% CI: 0.79-1.92, respectively] and non-complex PCI (HR: 0.90, 95% CI: 0.71-1.15, and HR: 0.91, 95% CI: 0.69-1.21; Pinteraction = 0.60 and 0.26, respectively). BARC 2, 3, or 5 was reduced with abbreviated DAPT in patients with and without complex PCI (HR: 0.64; 95% CI: 0.42-0.98, and HR: 0.70; 95% CI: 0.55-0.89; Pinteraction = 0.72). Among the 2816 patients with complex PCI and/or ACS, NACE and MACCE did not differ and BARC 2, 3, or 5 was lower with abbreviated DAPT. CONCLUSION: In HBR patients free from recurrent ischaemic events at 1 month, DAPT discontinuation was associated with similar NACE and MACCE and lower bleeding rates compared with standard DAPT, regardless of PCI or patient complexity. CLINICAL TRIAL REGISTRATION: This trial is registered with ClinicalTrials.gov, number NCT03023020, and is closed to new participants, with follow-up completed.

Outcomes and regional differences in practice in a worldwide coronary stent registry.

OBJECTIVE: The primary objective was to assess the performance of a new generation thin-strut sirolimus-eluting coronary stent with abluminal biodegradable polymer in an all comer population. The secondary objective was to detail differences in contemporary percutaneous coronary intervention (PCI) practice worldwide. METHODS: e-Ultimaster was an all-comer, prospective, global registry (NCT02188355) with independent event adjudication enrolling patients undergoing PCI with the study stent. The primary outcome measure was target lesion failure (TLF) at 1 year, defined as the composite of cardiac death, target vessel myocardial infarction and clinically driven target lesion revascularisation. Data were stratified according to 4 geographical regions. RESULTS: A total of 37 198 patients were enrolled (Europe 69.2%, Asia 17.8%, Africa/Middle East 6.6% and South America/Mexico 6.5%) and 1-year follow-up was available for 35 389 patients (95.1%). One-year TLF occurred in 3.2% of the patients, ranging from 2% (Africa/Middle East) to 4.1% (South America/Mexico). In patients with acute coronary syndrome, potent P2Y12 inhibitors were prescribed in 48% of patients at discharge, while at 1 year 72% were on any dual antiplatelet therapy. Lipid-lowering treatment was administered in 80.9% and 75.5% of patients at discharge and 1 year, respectively. Regional differences in the profile of the treated patients as well as in PCI practice were reported. CONCLUSIONS: In this investigation with worldwide representation, contemporary PCI using a new generation thin-strut sirolimus-eluting coronary stent with abluminal biodegradable polymer was associated with low 1-year TLF across clinical presentations and continents. Suboptimal adherence to current recommendations around antiplatelet and lipid lowering treatments was detected.

Influenza Vaccination After Myocardial Infarction: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial.

BACKGROUND: Observational and small, randomized studies suggest that influenza vaccine may reduce future cardiovascular events in patients with cardiovascular disease. METHODS: We conducted an investigator-initiated, randomized, double-blind trial to compare inactivated influenza vaccine with saline placebo administered shortly after myocardial infarction (MI; 99.7% of patients) or high-risk stable coronary heart disease (0.3%). The primary end point was the composite of all-cause death, MI, or stent thrombosis at 12 months. A hierarchical testing strategy was used for the key secondary end points: all-cause death, cardiovascular death, MI, and stent thrombosis. RESULTS: Because of the COVID-19 pandemic, the data safety and monitoring board recommended to halt the trial before attaining the prespecified sample size. Between October 1, 2016, and March 1, 2020, 2571 participants were randomized at 30 centers across 8 countries. Participants assigned to influenza vaccine totaled 1290 and individuals assigned to placebo equaled 1281; of these, 2532 received the study treatment (1272 influenza vaccine and 1260 placebo) and were included in the modified intention to treat analysis. Over the 12-month follow-up, the primary outcome occurred in 67 participants (5.3%) assigned influenza vaccine and 91 participants (7.2%) assigned placebo (hazard ratio, 0.72 [95% CI, 0.52-0.99]; P=0.040). Rates of all-cause death were 2.9% and 4.9% (hazard ratio, 0.59 [95% CI, 0.39-0.89]; P=0.010), rates of cardiovascular death were 2.7% and 4.5%, (hazard ratio, 0.59 [95% CI, 0.39-0.90]; P=0.014), and rates of MI were 2.0% and 2.4% (hazard ratio, 0.86 [95% CI, 0.50-1.46]; P=0.57) in the influenza vaccine and placebo groups, respectively. CONCLUSIONS: Influenza vaccination early after an MI or in high-risk coronary heart disease resulted in a lower risk of a composite of all-cause death, MI, or stent thrombosis, and a lower risk of all-cause death and cardiovascular death, as well, at 12 months compared with placebo. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02831608.

Safety and effectiveness of percutaneous coronary intervention using rotational atherectomy and new-generation drug-eluting stents for calcified coronary artery lesions in patients with chronic kidney disease.

AIM: Coronary artery calcification is an important factor influencing revascularisation outcomes in patients with chronic kidney disease (CKD). Lesion preparation using rotational atherectomy (RA) may help adequately modify calcified plaques and facilitate the achievement of optimal clinical outcomes in these patients. In this study, we assessed the safety and effectiveness of percutaneous coronary intervention (PCI) using RA followed by new-generation drug-eluting stent (DES) implantation in patients with CKD and calcified coronary artery disease (CAD). METHODS AND RESULTS: From November 2014 to October 2019, a total of 203 patients with calcified CAD who underwent RA followed by second- or third-generation DES implantation at our centre were included in the study. Mild, moderate, and severe CKD was present in 38%, 55.5%, and 6.5% of the patients, respectively. Diffused coronary calcifications were present in 85%. Procedural success was 97.5% with minimal periprocedural complications. In-stent restenosis occurred in one patient (0.5%); major adverse cardiovascular and cerebrovascular events were reported in 22 patients (10.8%); cardiac death occurred in eight patients during follow-up. CONCLUSION: Percutaneous coronary intervention using RA followed by second- or third-generation DES implantation is feasible and safe with high procedural success and low in-stent restenosis in CKD patients with calcified coronary lesions.

May Measurement Month 2019: an analysis of blood pressure screening results from Bangladesh.

According to the Non-communicable disease Risk Factors Survey of 2018, more than one-fifth (21.0%) of adults aged 25 years or older have hypertension and one-third of the adults did not have their blood pressure (BP) measured in their lifetime in Bangladesh. The National Heart Foundation of Bangladesh participated in May Measurement Month (MMM) 2017 and 2018 as well as this 2019 as a part of a global initiative aimed at raising awareness of high BP and to act as a temporary solution to the lack of screening programmes worldwide. This opportunistic screening of voluntary participants aged ≥18 years was carried out from May to July 2019. Data were collected from 100 screening sites in 16 districts in Bangladesh. BP measurement, the definition of hypertension, and statistical analysis followed the MMM protocol. Data on 24 941 individuals were analysed. Among the participants, 12 658 (50.8%) were female. After multiple imputation, 6990 (28.0%) had hypertension. Among the 6990 participants with hypertension, 5007 (71.6%) were on antihypertensive medication and 5331 (76.3%) were aware of having hypertension. Among 6990 participants with hypertension, 3217 (46.0%) had controlled BP (<140/90 mmHg) and among the participants with hypertension and on antihypertensive medication, 64.2% had controlled BP. Opportunistic BP screening can identify significant numbers of people with raised BP and thus assist in the prevention of cardiovascular diseases.

Clinical Presentation, Management and In-Hospital Outcome of Healthcare Personnel With COVID-19 Disease.

Objective Healthcare personnel (HCP) are undoubtedly one of the major frontline fighters in the coronavirus disease 2019 (COVID-19) pandemic. Therefore, it comes as no surprise that many HCP have become infected by COVID-19 globally. The infection of HCP has received great attention in social media and is frequently reported from different parts of the world. However, there are few scientific reports addressing this aspect of the COVID-19 pandemic. The aim of this study was to evaluate the characteristics of clinical presentation, treatment, and outcome of COVID-19 infection among the HCP of our setting. Methods This cross-sectional study was performed in the National Heart Foundation Hospital & Research Institute of Bangladesh from April 29 to July 20, 2020. HCP employed in this hospital who experienced fever or respiratory symptoms or came in close contact with COVID-19 patients at home or their workplace were included in this study. The presence of COVID-19 disease was confirmed by real-time reverse transcriptase-polymerase chain reaction on nasopharyngeal samples. A total of 394 HCP were sampled and 139 had a positive corona test. Structured interviews were conducted to document symptoms for all HCP with confirmed COVID-19. Data analysis was performed in July 2020. Results Out of 1,409 HCP, 139 subjects tested positive for COVID-19. Among the HCP, infection rate was 9.86%. The mean age of the study population was 34.08±11.11 years (range: 20-69 yrs), of whom 82 (59%) were female. Most of this cohort were nurses (56 [40.3%]) and physicians (25 [18%]), and the remaining 58 (41.7%) were other staff. The mean duration of onset of symptoms to test was 2.89±2.07 days. The most common symptoms were fever (84.2%), fatigue (56.1%), cough (54%), body ache (39.6%), headache, and anosmia (38.8%). Most subjects had mild disease (125 [93%]), three (2.1%) of the HCP had moderate disease and one (0.7%) had severe disease. Ten of the HCP (7.2%) were asymptomatic. Most of them were treated either by ivermectin plus azithromycin or ivermectin plus doxycycline. Only 20 (14.4%) of the HCP were hospitalized, while others were treated either in home isolation (59.7%) or in institutional isolation (25.9%). Recovery was almost uneventful except one healthcare worker who died. Conclusion Most HCP had mild symptoms and a few of them were asymptomatic also. HCP with mild COVID-19 symptoms may be treated in home or institutional isolation. As they are a vulnerable group for infection, providing adequate protection to HCP is absolutely mandatory to safeguard them from this pandemic.

May Measurement Month 2018: an analysis of blood pressure screening results from Bangladesh.

Elevated blood pressure (BP) is a growing burden worldwide, leading to over 10 million deaths each year. According to Non-communicable disease (NCD) Risk Factors Survey Bangladesh 2010, one-fifth (21.9%) of adults aged 25 years or more have hypertension. Almost one-third of the adult population did not have their BP measured in their lifetime in Bangladesh. National Heart Foundation of Bangladesh participated in May Measurement Month (MMM) 2018 as a part of a global initiative aimed at raising awareness of high BP and to act as a temporary solution to the lack of screening programmes nationally. An opportunistic cross-sectional survey of volunteers aged ≥18 years was carried out in May 2018. Blood pressure measurement, the definition of hypertension and statistical analysis followed the MMM protocol. Data were collected from 10 screening sites in 9 districts in Bangladesh. A total of 5208 individuals were screened during MMM18. After multiple imputation, 1750 (33.6%) had hypertension. Among the 1750 participants with hypertension, 1312 (75.0%) were aware of having hypertension. Among those that were not on antihypertensive medication, 15.2% were hypertensive and among those that were on antihypertensive medication 33.6% had uncontrolled hypertension. The present study showed that opportunistic screening can identify significant numbers of people with raised BP. A periodic public health programme at a national level needs to be initiated to increase hypertension detection and control rates and thus for prevention of cardiovascular diseases.