To Örebro University

BACKGROUND: Physiologically guided revascularization improves clinical outcomes. The cutoff values for deferral with fractional flow reserve (FFR) and instantaneous wave-free ratio (iFR) are the same across all coronary arteries, despite differences in coronary flow patterns. The objective was to compare deferral rates using either FFR or iFR in the right coronary artery (RCA), left anterior descending artery (LAD), and left circumflex artery (LCx), and compare clinical outcomes in deferred lesions in the RCA, LAD, and LCx.

METHODS: Right coronary artery, LAD, and LCx lesions in the Swedish Web-System for Enhancement and Development of Evidence-Based Care in Heart Disease Evaluated According to Recommended Therapies registry that were evaluated using either FFR or iFR were included. The composite of major adverse cardiac events (MACE) within 5 years and the individual components of cardiovascular death, noncardiovascular death, myocardial infarction, target segment revascularization, and target vessel revascularization were analyzed.

RESULTS: In total, 33,241 lesions were included in the final analysis (RCA, 17.8%; LAD, 62.3%; and LCx, 19.9%). The median follow-up time was 3.4 years. The median age was 69 years, and 73.5% of patients were men. The deferral rates with iFR were 10.6% higher (P < .001) in all coronary arteries combined, 18.7% higher (P < .001) in the RCA, 9.5% higher in the LAD (P < .001), and 5.3% higher in the LCx (P = .007). No significant differences were observed in the MACE rate or its individual components at 5 years between the deferred FFR and iFR groups in any of the investigated vessels.

CONCLUSIONS: Instantaneous wave-free ratio demonstrated a higher deferral rate across all coronary arteries than those examined with FFR, which was especially pronounced in the RCA, without any associated increased risk of MACE.

BACKGROUND: Hemodynamically obstructive coronary plaques may contain more vulnerable plaque characteristics than nonobstructive lesions. OBJECTIVES: The authors aimed to assess whether pressure-wire-based physiologic indices in nonculprit lesions are associated with vulnerable plaque characteristics.

METHODS: In the PROSPECT II study, patients with recent myocardial infarction underwent coronary angiography and culprit lesion percutaneous coronary intervention plus combined near-infrared spectroscopy and intravascular ultrasound assessment of all 3 coronary arteries. Instantaneous wave-free ratio (iFR) or fractional flow reserve (FFR) measurements were performed in intermediate lesions with angiographic stenosis >40%.

RESULTS: Among 898 patients, 319 angiographically intermediate lesions in 275 patients had matched intravascular ultrasound/near-infrared spectroscopy and FFR/iFR measurements; 96 (30.1%) lesions were physiologically significant (FFR ≤0.80 or iFR ≤0.89) and 223 (69.9%) were not. Physiologically significant lesions, compared with those that were not, more likely had a minimal lumen area ≤4.0 mm2 (96.9% vs 83.9%), plaque burden ≥70% (92.7% vs 71.3%) and maximum lipid core burden index in any 4 mm segment of the lesion ≥324.7 (57.0% vs 45.4%). By multivariable analysis, lesion location in the left anterior descending artery, small minimal lumen area, and larger plaque burden were independently associated with physiologic significance, whereas maximum lipid core burden index in any 4 mm segment of the lesion was not.

CONCLUSIONS: In patients with recent myocardial infarction, angiographically intermediate but physiologically significant coronary lesions were more likely to have high-risk vulnerable plaque features compared with nonphysiologically significant stenoses. However, coronary lesions without physiological significance also had a moderate-to-high prevalence of high-risk plaque characteristics, which may explain the residual risk associated with conservative noninterventional management of these lesions. (Providing Regional Observations to Study Predictors of Events in the Coronary Tree II [PROSPECT II]; NCT02171065).

ST-elevation myocardial infarction (STEMI) triggers a significant inflammatory response. Sweat may offer a novel, non-invasive medium for monitoring inflammation. In this prospective study, we characterized the inflammatory signatures in plasma and sweat collected from the skin surface of two patient groups: (1) 18 STEMI patients immediately following percutaneous coronary intervention (exposure) and (2) six patients who underwent outpatient angiography without subsequent intervention (control). Levels of 92 biomarkers were measured using a high-throughput proteomic assay and reassessed after 4-6 weeks in STEMI patients. Adjusting for patient group, sweat biomarkers did not show significant changes over time. In plasma, hepatocyte growth factor and interleukin-6 showed a significant decrease from the acute phase to follow-up, adjusted for patient group. STAM binding protein was significantly higher in the sweat of STEMI patients compared to controls, adjusted for time effects. While sweat was less sensitive than plasma for detecting biomarker levels in the setting of STEMI, its longitudinal analysis via wearable sensors holds promise for detecting specific markers.Trial registration: The trial is registered on www.clinicaltrials.gov with the trial registration number NCT05843006.

Background: In the PROSPECT-II study, near infrared spectroscopy (NIRS) and intravascular ultrasound (IVUS) was used to characterize atherosclerotic plaques in the coronary arteries. NIRS-derived lipid core burden index (LCBI) and IVUS-derived plaque burden (PB) were able to identify plaques strongly associated with adverse cardiovascular events.

Aim: Our aim was to identify biomarkers associated with LCBI or PB in the coronary arteries.

Methods: 898 patients with recent myocardial infarction underwent percutaneous coronary intervention. Blood samples to analyze plasma levels of 179 proteins associated with cardiovascular disease were procured and a combined NIRS-IVUS catheter was used to analyze the coronary arteries. Adjusted linear regression models were calculated between the biomarkers and the outcomes of interest, adjusted for multiplicity testing. Kaplan-Meier survival curves of biomarkers divided by median were assessed with the log-rank test. Adjusted Cox proportional models were calculated for major adverse cardiovascular events.

Results: A total of 24 proteins were associated with PB and 28 proteins with LCBI. Eight of these biomarkers were associated with both increased pan-coronary LCBI and PB; IL-18R1, CSF-1, VEGFA, EN-RAGE, cathepsin D, PCSK9, transferrin receptor protein 1 and OPN. After adjusting for multiplicity, angiopoietin like 3 (ANGPTL3) retained its association with LCBI, and IL-18R1 and CSF-1 retained their association with PB.

Conclusion: We were able to identify distinct biomarker patterns associated with PB and LCBI. IL-18R1 and CSF-1 had a strong relationship with PB. ANGPTL3 was associated with lipid rich plaques but not with PB, supporting its role in lipid accumulation and development of vulnerable plaques.

BACKGROUND: Intravascular ultrasound (IVUS) guides deferral decision-making regarding the left main coronary artery (LMCA) and improves outcomes. Further studies regarding coronary physiology to guide revascularization in the LMCA are needed. Our aim was to evaluate the outcome of LMCA deferral using IVUS or coronary physiology via instantaneous wave-free ratio (iFR) or fractional flow reserve (FFR).

METHODS: Between January 2014 and February 2022, patients undergoing evaluation with either IVUS or coronary physiology in the LMCA were included from the SWEDEHEART registry. Exclusion criteria were a minimum luminal area < 6 mm2, iFR ≤ 0.89, FFR ≤ 0.80, ad hoc percutaneous coronary intervention of lesions in the LMCA, proximal left anterior descending artery, and proximal circumflex artery, planned elective revascularization, and planned valvular surgery. The primary outcome was major adverse cardiac events (MACE), defined as a composite of all-cause death, myocardial infarction, and unplanned revascularization. Kaplan-Meier event rates and multivariable Poisson regression were used for the statistical analyses.

RESULTS: Deferral of revascularization in the LMCA was performed in 1552 patients, 33.6 % with IVUS and 66.4 % with coronary physiology (iFR 11.3 % vs. FFR 55.0 %). The median follow-up time was 2.7 years. No significant difference was seen in MACE (IVUS 40.2 % vs. coronary physiology 35.5 %; adjusted RR: 1.18; 95 %CI: 0.97-1.44; p = 0.09). The results were consistent across all investigated subgroups. The rate of all-cause death was higher in the IVUS group (adjusted RR: 1.38; 95 %CI: 1.03-1.83; p = 0.03).

CONCLUSIONS: Deferral of coronary revascularization in LMCA lesions using IVUS or coronary physiology did not differ in our combined endpoint. We observed a higher risk of all-cause death using IVUS.

IMPORTANCE: Upper gastrointestinal bleeding is common after myocardial infarction.

OBJECTIVE: To determine whether routine screening for Helicobacter pylori infection during hospitalization for myocardial infarction reduces bleeding events and improves clinical outcomes.

DESIGN, SETTING, AND PARTICIPANTS: A nationwide, open-label, 2-period, 2-sequence, cluster randomized, crossover clinical trial using a clinical registry for study population definition and data collection merged with national Swedish health data registries. From November 17, 2021, through January 17, 2024, thirty-five Swedish hospitals grouped into 18 clusters were randomized to a sequence of 1 year with routine H pylori screening of all patients with acute myocardial infarction followed by a washout period of 2 months before crossing over to 1 year with usual care or vice versa. Patients were followed up until January 17, 2025.

INTERVENTION: Routine addition of H pylori screening by urea breath test to standard care in all patients hospitalized for myocardial infarction during the screening periods.

MAIN OUTCOME AND MEASURE: Upper gastrointestinal bleeding, analyzed by a negative binomial model in the intention-to-treat population.

RESULTS: A total of 18 466 patients (median age, 71 years [IQR, 61-79], 13 138 males [71%]) with myocardial infarction were followed up: 9245 during the screening periods and 9221 during the nonscreening periods. At admission, 2284 during the screening periods and 2275 during the nonscreening periods (both 24.7%) reported proton pump inhibitor use. During screening periods, 6480 patients (70%) had undergone testing, of those 1532 (23.6%) tested positive for H pylori. After a median follow-up of 1.9 years, 299 patients in the screening group (incidence rate, 16.8 events per 1000 person-years; cumulative hazard at 3 years, 4.1%) and 336 in the usual care group (incidence rate, 19.2 events per 1000 person-years; cumulative hazard at 3 years, 4.6%) experienced the primary end point of upper gastrointestinal bleeding (rate ratio [RR], 0.90; 95% CI, 0.77-1.05; P = .18). Predefined nonmultiplicity adjusted subgroup analyses showed a heterogeneous intervention effect; for no anemia (RR, 0.98; 95% CI, 0.80-1.21), mild anemia (RR, 0.64; 95% CI, 0.42-0.98), and moderate to severe anemia (RR, 0.44; 95% CI, 0.23-0.87; P for interaction = .03).

CONCLUSIONS AND RELEVANCE: Among unselected patients with acute myocardial infarction, routine H pylori screening did not significantly reduce the risk of upper gastrointestinal bleeding.

TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT05024864.

BACKGROUND: The role of Helicobacter pylori (H. pylori) screening and eradication on reducing upper gastrointestinal bleeding (UGIB) complications after acute myocardial infarction (MI) is uncertain. The HELicobacter Pylori screening to prevent gastrointestinal bleeding in patients with acute MI (HELP-MI SWEDEHEART) trial aims to determine whether systematic H. pylori screening compared to usual care reduces UGIB, mortality, and cardiovascular outcomes after MI.

METHODS: A cluster randomized, crossover, registry-based clinical trial using SWEDEHEART as trial platform for study population definition and source for data collection in combination with nationwide Swedish health data registries. Thirty-five Swedish hospitals, organized into 18 clusters based on percutaneous coronary intervention networks, were randomized to either routine H. pylori screening for adults with acute type-1 MI or usual care. After one year, a 2-month blanking period was followed by a crossover to the alternate allocation for one year. The trial enrolment was concluded after one additional year of registry-based follow-up. The primary endpoint is UGIB. Secondary endpoints include all-cause death, cardiovascular death, readmission for MI, stroke, or heart failure. Endpoints will be reported combined (Net Adverse Clinical Events; Major Adverse Cardiac or Cerebrovascular Events) and separately. The primary analysis will include all available follow-up time corresponding to a maximum follow-up time of 3 years and 2 months.

CONCLUSION: HELP-MI SWEDEHEART aims to determine the utility of routine H. pylori screening to reduce UGIB and improve cardiovascular outcomes after MI. By integrating national registry follow-up data with a pragmatic trial design, it has the potential to provide evidence for the effect of the implementation of routine H. pylori screening as part of acute MI care.

TRIAL REGISTRATION: ClinicalTrials.gov, NCT05024864.

BACKGROUND AND AIMS: COVID-19 is an independent risk factor for cardiovascular disease. We investigated undiagnosed COVID-19 and its effect on recurrent adverse cardiovascular events among patients with acute myocardial infarction (AMI).

METHODS: We enrolled patients with either ST-segment elevation (STEMI) or non ST-segment elevation myocardial infarction (NSTEMI) presenting at the National Institute of Cardiovascular Disease, Dhaka, from June 28 to August 11, 2020. Nasopharyngeal swabs were collected for SARS-CoV-2 testing by rRT-PCR at enrolment. We followed all patients from admission until February 7, 2021, before the COVID-19 vaccination in Bangladesh, to register clinical endpoints (all-cause death, new AMI, heart failure, or new revascularization). Demographic information, cardiovascular risk factors, and clinical data were registered. Incidence rate (IR) per 100 person-years follow-up was calculated for clinical endpoints. Poisson regression was employed to estimate the incidence rate ratio (IRR) for SARS-COV-2 infection, adjusting for age.

RESULTS: We enrolled 280 patients with a mean age of 54.5 ( ± SD,11.8) years, and 78.6% were males. Of them, 12.9% had undiagnosed SARS-CoV-2 infection and were diagnosed with STEMI (n = 140, 50.0%) and NSTEMI (n = 140, 50.0%). We found that the IR per 100 person-years of all cause death was 35.2, 95% CI: 25.6 to 48.5; recurrent AMI was 18.5, 95% CI: 12.1 to 28.2; heart failure was 6.7, 95% CI: 3.3 to 13.5; and revascularization was 23.5, 95% CI: 16.1 to 34.3. Patients with COVID-19 had numerically higher IRRs for heart failure (2.40, 95% CI: 0.47 to 12.09, p = 0.290) and revascularization (1.11, 95% CI: 0.37 to 3.3, p = 0.853) compared to those without COVID-19, though these differences were not statistically significant.

CONCLUSION: This study provides updated data on undiagnosed cases among AMI patients during the first wave of the COVID-19 pandemic. Our findings emphasize the need for further research to explore the impact of COVID-19 on AMI patients in resource-limited settings like Bangladesh.