Drug-Eluting Balloons and Drug-Eluting Stents in Diabetic Patients Undergoing Percutaneous Coronary Intervention Due to Restenosis-DM-Dragon Registry.

Background: The rate of in-stent restenosis (ISR) is decreasing; however, it is still a challenge for contemporary invasive cardiologists. Therapeutic methods, including drug-eluting balloons (DEBs), intravascular lithotripsy, excimer laser coronary atherectomy, and imaging-guided percutaneous coronary intervention (PCI) with drug-eluting stents (DES), have been implemented. Patients with diabetes mellitus (DM) are burdened with a higher risk of ISR than the general population. Aims: DM-Dragon is aimed at evaluating the clinical outcomes of ISR treatment with DEBs vs. DES, focusing on patients with co-existing diabetes mellitus. Methods: The DM-Dragon registry is a retrospective study comprising data from nine high-volume PCI centers in Poland. A total of 1117 patients, of whom 473 individuals had DM and were treated with PCI due to ISR, were included. After propensity-score matching (PSM), 198 pairs were created for further analysis. The primary outcome of the study was target lesion revascularization (TLR). Results: In DM patients after PSM, TLR occurred in 21 (10.61%) vs. 20 (10.1%) in non-diabetic patients, p = 0.8690. Rates of target vessel revascularization (TVR), target vessel myocardial infarction, device-oriented composite endpoint (DOCE), and cardiac death did not differ significantly. Among diabetic patients, the risk of all-cause mortality was significantly lower in the DEB group (2.78% vs. 11.11%, HR 3.67 (95% confidence interval, CI) [1.01-13.3), p = 0.0483). Conclusions: PCI with DEBs is almost as effective as DES implantation in DM patients treated for ISR. In DM-Dragon, the rate of all-cause death was significantly lower in patients treated with DEBs. Further large-scale, randomized clinical trials would be needed to support these findings.

Long-Term Outcomes Following Sirolimus-Coated Balloon or Drug-Eluting Stents for Treatment of In-Stent Restenosis.

BACKGROUND: Evidence suggests that drug-coated balloons may benefit in-stent restenosis (ISR) treatment. However, the efficacy of new-generation sirolimus-coated balloon (SCB) compared with the latest generation drug-eluting stents (DESs) has not been studied in this setting. METHODS: All patients in the EASTBORNE (The All-Comers Sirolimus-Coated Balloon European Registry) and DEB-DRAGON (DEB vs Thin-DES in DES-ISR: Long Term Outcomes) registries undergoing percutaneous coronary intervention for DES-ISR were included in the study. The primary study end point was target lesion revascularization at 24 months. Secondary end points were major adverse cardiovascular events, all-cause death, myocardial infarction, and target vessel revascularization at 24 months. Our goal was to evaluate the efficacy and safety of SCB versus thin-struts DES in ISR at long-term follow-up. RESULTS: A total of 1545 patients with 1679 ISR lesions were included in the pooled analysis, of whom 621 (40.2%) patients with 621 lesions were treated with thin-strut DES and 924 (59.8%) patients with 1045 lesions were treated with SCB. The unmatched cohort showed no differences in the incidence of target lesion revascularization (10.8% versus 11.8%; P=0.568); however, there was a trend toward lower rates of myocardial infarction (7.4% versus 5.0%; P=0.062) and major adverse cardiovascular events (20.8% versus 17.1%; P=0.072) in the SCB group. After propensity score matching (n=335 patients per group), there were no significant differences in the rates of target lesion revascularization (11.6% versus 11.8%; P=0.329), target vessel revascularization (14.0% versus 13.1%; P=0.822), myocardial infarction (7.2% versus 4.5%; P=0.186), all-cause death (5.7% versus 4.2%; P=0.476), and major adverse cardiovascular event (21.5% versus 17.6%; P=0.242) between DES and SCB treatment. CONCLUSIONS: In patients with ISR, angioplasty with SCB compared with thin-struts DES is associated with comparable rates of target lesion revascularization, target vessel revascularization, myocardial infarction, all-cause death, and major adverse cardiovascular events at 2 years.

Sex Differences in Fractional Flow Reserve Utilization.

Background: The literature review shows that female patients are more frequently underdiagnosed or suffer from delayed diagnosis. Recognition of sex-related differences is crucial for implementing strategies to improve cardiovascular outcomes. We aimed to assess sex-related disparities in the frequency of fractional flow reserve (FFR)-guided procedures in patients who underwent angiography and/or percutaneous coronary intervention (PCI). Methods: We have derived the data from the national registry of percutaneous coronary interventions and retrospectively analyzed the data of more than 1.4 million angiography and/or PCI procedures [1,454,121 patients (62.54% men and 37.46% women)] between 2014 and 2022. The logistic regression analysis was conducted to explore whether female sex was associated with FFR utilization. Results: The FFR was performed in 61,305 (4.22%) patients and more frequently in men than women (4.15% vs. 3.45%, p < 0.001). FFR was more frequently assessed in females with acute coronary syndrome than males (27.75% vs. 26.08%, p < 0.001); however, women with chronic coronary syndrome had FFR performed less often than men (72.25% vs. 73.92%, p < 0.001). Females with FFR-guided procedures were older than men (69.07 (±8.87) vs. 65.45 (±9.38) p < 0.001); however. less often had a history of myocardial infarction (MI) (24.79% vs. 36.73%, p < 0.001), CABG (1.62% vs. 2.55%, p < 0.005) or PCI (36.6% vs. 24.79%, p < 0.001) compared to men. Crude comparison has shown that male sex was associated with a higher frequency of FFR assessment (OR = 1.2152-1.2361, p < 0.005). Conclusions: Despite a substantial rise in FFR utilization, adoption in women remains lower than in men. Female sex was found to be an independent negative predictor of FFR use.

Efficacy of Alirocumab, Evolocumab, and Inclisiran in Patients with Hypercholesterolemia at Increased Cardiovascular Risk.

Background and Objectives: Lowering low-density lipoprotein (LDL-C) levels is critical for preventing atherosclerotic cardiovascular disease, yet some patients fail to reach the LDL-C targets despite available intensive lipid-lowering therapies. This study assessed the effectiveness and safety profile of alirocumab, evolocumab, and inclisiran in lipid reduction. Materials and Methods: A cohort of 51 patients (median (Q1-Q3) age: 49.0 (39.5-57.5) years) was analyzed. Eligibility included an LDL-C level > 2.5 mmol/L while on the maximum tolerated dose of statin and ezetimibe, a diagnosis of familial hypercholesterolemia, or a very high risk of cardiovascular diseases following myocardial infarction within 12 months prior to the study. Follow-ups and lab assessments were conducted at baseline (51 patients), 3 months (51 patients), and 15 months (26 patients) after the treatment initiation. Results: Median initial LDL-C levels 4.1 (2.9-5.0) mmol/L, decreasing significantly to 1.1 (0.9-1.6) mmol/L at 3 months and 1.0 (0.7-1.8) mmol/L at 15 months (p < 0.001). Total cholesterol also reduced significantly compared to baseline at both intervals (p < 0.001). No substantial differences in LDL-C or total cholesterol levels were observed between 3- and 15-month observations (p > 0.05). No statistically significant differences were noted in cholesterol reduction among the alirocumab, evolocumab, and inclisiran groups at 3 months. The safety profile was favorable, with no reported adverse cardiovascular events or significant changes in alanine transaminase, creatinine, or creatine kinase levels. Conclusions: Alirocumab, evolocumab, and inclisiran notably decreased LDL-C and total cholesterol levels without significant adverse effects, underscoring their potential as effective treatments in patients who do not achieve lipid targets with conventional therapies.

Intentional coronary revascularization versus conservative therapy in patients after peripheral artery revascularization due to critical limb ischemia: the INCORPORATE trial.

OBJECTIVES: INCORPORATE trial was designed to evaluate whether default coronary-angiography (CA) and ischemia-targeted revascularization is superior compared to a conservative approach for patients with treated critical limb ischemia (CLI). Registered at clinicaltrials.gov (NCT03712644) on October 19, 2018. BACKGROUND: Severe peripheral artery disease is associated with increased cardiovascular risk and poor outcomes. METHODS: INCORPORATE was an open-label, prospective 1:1 randomized multicentric trial that recruited patients who had undergone successful CLI treatment. Patients were randomized to either a conservative or invasive approach regarding potential coronary artery disease (CAD). The conservative group received optimal medical therapy alone, while the invasive group had routine CA and fractional flow reserve-guided revascularization. The primary endpoint was myocardial infarction (MI) and 12-month mortality. RESULTS: Due to COVID-19 pandemic burdens, recruitment was halted prematurely. One hundred eighty-five patients were enrolled. Baseline cardiac symptoms were scarce with 92% being asymptomatic. Eighty-nine patients were randomized to the invasive approach of whom 73 underwent CA. Thirty-four percent had functional single-vessel disease, 26% had functional multi-vessel disease, and 90% achieved complete revascularization. Conservative and invasive groups had similar incidences of death and MI at 1 year (11% vs 10%; hazard ratio 1.21 [0.49-2.98]). Major adverse cardiac and cerebrovascular events (MACCE) trended for hazard in the Conservative group (20 vs 10%; hazard ratio 1.94 [0.90-4.19]). In the per-protocol analysis, the primary endpoint remained insignificantly different (11% vs 7%; hazard ratio 2.01 [0.72-5.57]), but the conservative approach had a higher MACCE risk (20% vs 7%; hazard ratio 2.88 [1.24-6.68]). CONCLUSION: This trial found no significant difference in the primary endpoint but observed a trend of higher MACCE in the conservative arm.

Radial artery spasms - angiographic morphology, risk factors and management.

Introduction: Radial artery is the preferred access for coronary interventions. However, the procedure is sometimes interrupted by a spasm which causes pain, prolongs the procedure, and can force the access crossover. Aim: To observe factors contributing to a symptomatic radial artery spasm. Material and methods: In this prospective study, we present results of 103 consecutive patients regarding radial artery spasm and angiographic image of the punctured artery. Angiography of the radial artery was performed in 70 (68.0%) patients. Potential risk factors for radial artery spasm were evaluated. Results: The overall incidence of the radial artery spasm was high - 25 (24.3%). Signs of spasm were present in 37.1% of radial artery angiographies before the procedure and 60.1% after, however, it did not always indicate a symptomatic spasm. Risk factors related to radial artery spasm included female sex (OR = 2.94, p = 0.02), failure of the first puncture attempt (OR = 3.12, p = 0.014) and use of non-hydrophilic sheath (OR = 9.56, p = 0.036). Radial artery narrowing at the tip of the sheath was also a risk factor for spasm (p = 0.022). No spasms were observed after hydrophilic sheath application (n = 13). The administration of a radial cocktail was not observed to significantly decrease the spasm odds. Conclusions: Risk factors for radial artery spasm include female sex and multiple puncture attempts. Hydrophilic sheath coating protects against radial artery spasm. Overall signs of a spasm in the angiography are common and do not imply a symptomatic spasm, which can be predicted by a tight narrowing at the tip of the sheath.

Implementation of Microcirculation Examination in Clinical Practice-Insights from the Nationwide POL-MKW Registry.

Background and Objectives: The assessment of coronary microcirculation may facilitate risk stratification and treatment adjustment. The aim of this study was to evaluate patients' clinical presentation and treatment following coronary microcirculation assessment, as well as factors associated with an abnormal coronary flow reserve (CFR) and index of microcirculatory resistance (IMR) values. Materials and Results: This retrospective analysis included 223 patients gathered from the national registry of invasive coronary microvascular testing collected between 2018 and 2023. Results: The frequency of coronary microcirculatory assessments in Poland has steadily increased since 2018. Patients with impaired IMR (≥25) were less burdened with comorbidities. Patients with normal IMR underwent revascularisation attempts more frequently (11.9% vs. 29.8%, p = 0.003). After microcirculation testing, calcium channel blockers (CCBs) and angiotensin-converting enzyme inhibitors were added more often for patients with IMR and CFR abnormalities, respectively, as compared to control groups. Moreover, patients with coronary microvascular dysfunction (CMD, defined as CFR and/or IMR abnormality), regardless of treatment choice following microcirculation assessment, were provided with trimetazidine (23.2%) and dihydropyridine CCBs (26.4%) more frequently than those without CMD who were treated conservatively (6.8%) and by revascularisation (4.2% with p = 0.002 and 0% with p < 0.001, respectively). Multivariable analysis revealed no association between angina symptoms and IMR or CFR impairment. Conclusions: The frequency of coronary microcirculatory assessments in Poland has steadily increased. Angina symptoms were not associated with either IMR or CFR impairment. After microcirculation assessment, patients with impaired microcirculation, expressed as either low CFR, high IMR or both, received additional pharmacotherapy treatment more often.

In-Hospital Levels of Circulating MicroRNAs as Potential Predictors of Left Ventricular Remodeling Post-Myocardial Infarction.

Background and Objectives: Biochemical and molecular regulation of both adaptive and pathological responses of heart tissue to ischemic injury is widely investigated. However, it is still not fully understood. Several biomarkers are tested as predictors of left ventricle (LV) remodeling after myocardial infarction (MI). The aim of this study was to assess the relationship between selected microRNAs (miRNAs) and LV function and morphology in patients after MI. Materials and Methods: Selected miRNAs related to heart failure were assessed in the acute phase of MI: miR-150-3p, miR-21-5p, miR-19b-3p, miR-155-5p, miR-22-5p. Echocardiography with 3D imaging was performed at baseline and after 6 months. Remodeling was defined as >20% increase in LV end-diastolic volume, whereas reverse remodeling was defined as >10% reduction in LV end-systolic volume. Results: Eighty patients entered the registry. Remodeling occurred in 26% and reverse remodeling was reported in 51% of patients. In the presented study, none of the analyzed miRNAs were found to be a significant LV remodeling predictor. The observed correlations between miRNAs and other circulating biomarkers of myocardial remodeling were relatively weak. Conclusions: Our analysis does not demonstrate an association between the analyzed miRNAs and LV remodeling in patients with MI.

Definition and anatomical description of the left atrial appendage neck.

The left atrial appendage (LAA) is well known as a source of cardiac thrombus formation. Despite its clinical importance, the LAA neck is still anatomically poorly defined. Therefore, this study aimed to define the LAA neck and determine its morphometric characteristics. We performed three-dimensional reconstructions of the heart chambers based on contrast-enhanced electrocardiography-gated computed tomography scans of 200 patients (47% females, 66.5 ± 13.6 years old). The LAA neck was defined as a truncated cone-shaped canal bounded proximally by the LAA orifice and distally by the lobe origin and was present in 98.0% of cases. The central axis of the LAA neck was 14.7 ± 2.3 mm. The mean area of the LAA neck walls was 856.6 ± 316.7 mm2 . The LAA neck can be divided into aortic, arterial (the smallest), venous (the largest), and free surfaces. All areas have a trapezoidal shape with a broader proximal base. There were no statistically significant differences in the morphometric characteristics of the LAA neck between LAA types. Statistically significant differences between the sexes in the main morphometric parameters of the LAA neck were found in the central axis length and the LAA neck wall area. The LAA neck can be evaluated from computed tomography scans and their three-dimensional reconstructions. The current study provides a complex morphometric analysis of the LAA neck. The precise definition and morphometric details of the LAA neck presented in this study may influence the effectiveness and safety of LAA exclusion procedures.

Prognosis of patients with renal failure one year following non-ST-segment elevation myocardial infarction treated with percutaneous coronary intervention.

OBJECTIVE: Kidney failure is highly prevalent in patients with non-ST-elevation myocardial infarction (NSTEMI). The aim of the study was to evaluate the prognostic significance of baseline renal function regarding in-hospital and 1-year mortality among patients with NSTEMI and treated with percutaneous coronary intervention (PCI). METHODS: Data were obtained from the Polish Registry of Acute Coronary Syndromes (PL-ACS) and included 47,052 NSTEMI patients treated with PCI between 2017 and 2021. The cumulative incidence of all-cause mortality during the 1-year follow-up was presented using the Kaplan-Meier curves. The multivariable Cox regression model was created to adjust the relationship between eGFR (as a spline term) and all-cause mortality for potential confounders. RESULTS: After considering the exclusion criteria, 20,834 cases were evaluated, with a median eGFR of 72.7 (IQR 56.6-87.5) mL/min/1.73 m2. The median age was 69 (62-76) years. The study comprised 4,505 patients with normal (90-120), 10,189 with mild (60-89), 5,539 with moderate (30-59), and 601 with severe eGFR impairment (15-29). Lower eGFR was associated with worse baseline clinical profile and longer in-hospital delay to coronary angiography. There was a stepwise increase in the crude all-cause death rates across the groups at 1 year. The Cox regression model with a spline term revealed that the relationship between eGFR and the risk of death at 1 year was non-linear (reverse J-shaped), and the risk was the lowest in patients with eGFR∼90 mL/min/1.73 m2. CONCLUSIONS: There is a J-curve relationship between the eGFR value and 1-year all-cause mortality in patients with NSTEMI and treated with PCI.

Anticoagulation for Atrial Fibrillation in Acute Coronary Syndrome Survivors Reduces Major Cardiovascular Events and Mortality.

The prevalence of atrial fibrillation (AF) in acute coronary syndrome (ACS) patients is increasing. Data on outcomes of anticoagulation in ACS patients with AF are lacking.The aim of our study was to investigate the prevalence of stroke, myocardial infarction, bleeding complications, and all-cause mortality in this population.PL-ACS and AMI-PL registries gather an all-comer population of ACS patients in Poland, exceeding half a million records. We have selected ACS survivors with concomitant AF on admission, divided them into subgroups with regard to the administered anticoagulation, and followed up with them for a 12-month period (n = 13,973). Subsequently, groups were propensity score matched for age, sex, ejection fraction, diabetes, heart failure, renal impairment, and type of ACS.The study population was divided with regard to the administration of anticoagulation. Anticoagulation was prescribed in 2,466 patients (17.6%). The (D)OAC+ patients were younger; however, comorbidities were more prevalent in this group. The 12-month follow-up showed that the (D)OAC+ patients had significantly lower rates of all-cause mortality, myocardial infarction, and ischemic stroke, with no significant increase in bleeding events. After matching, the study groups consisted of 2,194 patients each and showed no differences in baseline characteristics. The outcomes of the 12-month observation were similar to the findings before matching.This all-comer national registry analysis shows that the use of guideline-recommended therapy and anticoagulation in ACS survivors with AF is associated with a lower rate of all-cause mortality, recurrent myocardial infarction, and ischemic stroke.