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There is limited data on the optimal revascularization strategy in patients with recurrent in-stent restenosis (R-ISR).To compare the long-term outcomes of patients treated with either a thin-strut drug-eluting stent (thin-DES) or a drug-eluting balloon (DEB) for R-ISR in a drug-eluting stent (DES).A multicenter DEB-DRAGON registry was used to retrospectively identify patients with R-ISR who received either a thin-DES or a DEB. Propensity score matching was applied to adjust for baseline differences. The primary outcome was target lesion revascularization (TLR).Out of 311 patients (mean age, 67 years; 63% male) with R-ISR, 86 (27.7%) were treated with a thin-DES and 225 (72.3%) with a DEB. Median follow-up was 2.6 years. TLR occurred in 18 (20.9%) patients who received thin-DES and 61 (27.1%) patients treated with DEB (hazard ratio [HR], 0.57; 95% confidence interval [CI], 0.33-0.98; log-rank P = 0.04). The difference remained significant in a propensity score-matched cohort of 57 patients treated with thin-DES and 57 patients treated with a DEB (17.5 vs. 33.3%, respectively; HR, 0.38; 95% CI, 0.17-0.86; P = 0.01). The risks of device-oriented adverse cardiac events and all-cause mortality were similar after thin-DES or DEB in both unadjusted and propensity score-matched cohorts. In a multivariable Cox proportional hazard model, the treatment with a thin-DES was an independent predictor of a TLR-free survival (HR, 0.33; 95% CI 0.13-0.84; P = 0.02).In patients with R-ISR implantation of a thin-DES is associated with a lower risk of repeated revascularization compared with angioplasty with a DEB.

Low operator and institutional volume are associated with poorer procedural and long-term clinical outcomes in the general population of patients treated with percutaneous coronary interventions (PCI).To assess the relationship between operator experience and procedural outcomes of patients treated with PCI and rotational atherectomy (RA).Data for conducting the current analysis were obtained from the national registry of percutaneous coronary interventions (ORPKI) maintained in cooperation with the Association of Cardiovascular Interventions (AISN) of the Polish Cardiac Society. The study covers data from January 2014 to December 2020.During the investigated period, there were 162 active CathLabs, at which 747,033 PCI procedures were performed by 851 operators (377 RA operators [44.3%]). Of those, 5188 were PCI with RA procedures; average 30 ± 61 per site/7 years (Me: 3; Q1-Q3: 0-31); 6 ± 18 per operator/7 years (Me: 0; Q1-Q3: 0-3). Considering the number of RA procedures annually performed by individual operators during the analyzed 7 years, the first quartile totaled (Q1: =2.57), the second (Q2: =5.57), and the third (Q3: =11.57), while the fourth quartile was (Q4: 11.57). The maximum number of procedures was 39.86 annually per operator. We demonstrated, through a nonlinear relationship with annualized operator volume and risk-adjusted, that operators performing more PCI with RA per year (fourth quartile) have a lower number of the overall periprocedural complications (p = 0.019).High-volume RA operators are related to lower overall periprocedural complication occurrence in patients treated with RA in comparison to low-volume operators.

Data regarding the duration of dual antiplatelet therapy (DAPT) in patients with drug-eluting stent restenosis (DES-ISR) treated with percutaneous coronary intervention (PCI) and drug-eluting balloons (DEB) or DES are not unambiguous.To evaluate the relationship between long-term outcomes and the length of DAPT in patients treated with PCI due to DES-ISR with DEB or DES.Overall, a total of 1,367 consecutive patients with DES-ISR, who underwent PCI with DEB or DES between 2008 and 2019 entered the study. The mean length of the follow-up was 1,298.7 ±794 days. We assessed study endpoints according to the duration of DAPT (≤ 3 vs.3 and ≤ 6 vs.6 months) before and after propensity score matching (PSM): stroke, target lesion revascularisation (TLR), target vessel revascularisation (TVR), myocardial infarction (MI), death and device oriented composite endpoints (DOCE). Kaplan-Meier estimates were created to differentiate long-term outcomes.Pairwise contrast analysis considering type of PCI (DES vs. DEB) and duration of DAPT (≤ 6 vs.6 months) before PSM revealed superiority of DES + DAPT6 months vs. DEB + DAPT6 months for DOCE (Treatment with DAPT in patients with DES-ISR is related to better long-term outcomes in the case of PCI with DES than DEB. DAPT6 months is related to the greater rate of strokes, independently of the type of treatment (DES and DEB) than DAPT ≤ 6 months.

Patients undergoing percutaneous coronary interventions (PCI) with rotational atherectomy (RA) have massively calcified coronary arteries and their prognosis differs between sexes.The aim of the study was to evaluate the trends in the percentage of sexes in the subsequent years, to compare demographic characteristics between men and women, and to identify factors associated with the risk of periprocedural complications and death.We analyzed data on 751 113 patients treated with PCI between 2014 and 2020 from the Polish National Registry of Percutaneous Coronary Interventions (ORPKI). We extracted data on 5 177 (0.7%) patients treated with RA of whom 3 552 (68.6%) were men. To determine risk factors of periprocedural complications and death, a multivariable analysis was performed.The proportion of PCIs involving RA increased between 2014 and 2020 (P0.001). Almost twice as many RA procedures were performed on men (68.55%), and that proportion did not change in the following years. The female patients were older (75.2 [8.3] vs. 70.5 [9.2] years; P0.001). When considering periprocedural complications, their overall rate (3.45% vs. 2.31%; P = 0.01) and death rate (0.68% vs. 0.17%; P = 0.006) were greater among women. Also, via multivariable analysis, female sex was found to be a risk factor for greater periprocedural mortality (P = 0.02) and overall complication rate (P = 0.007).The majority of patients treated with RA are men and sex-related distribution was stable during the analyzed period. Female sex is a risk factor for greater periprocedural complications and mortality in patients treated with RA.

The SARS-CoV-2 infection is associated with an increased risk of thromboembolic complications.We aimed to compare patient characteristics, and 12-month clinical outcomes of myocardial infarction with non-obstructive coronary arteries (MINOCA) before and during the COVID-19 pandemic.We retrospectively analyzed data of 51,734 patients with acute myocardial infarction registered in the nationwide PL-ACS database in 2019 and 2020, finally including 3,178 MINOCA patients. We compared baseline characteristics, management strategies, and 12-month clinical outcomes of MINOCA patients before (2019) and during (2020) the COVID-19 pandemic.The MINOCA percentage was higher in 2019 than 2020 (6.3% vs. 5.9%, P = 0.03). The groups did not differ apart from the higher hypercholesterolemia rate before the pandemic (33.9% vs. 28.2%, P0.001). We observed in-hospital stroke more frequently during pandemic (0 vs. 0.3%, P = 0.01). However, other in-hospital complications were similar between groups. Most patients were discharged on aspirin (85.6%), beta-blocker (73.1%), angiotensin convertase enzyme inhibitor/angiotensin receptor blocker (70.2%), and statin (62.7%), but only 50.6% of patients received P2Y12 inhibitor. There was no statistical difference in 12-month all-cause mortality in patients with MINOCA before and during pandemic (total population 9.9%; 9.2% [2019] vs. 11.0% [2020], P = 0.09).We observed a lower percentage of MINOCA cases and higher in-hospital stroke rates in MINOCA patients during the COVID-19 pandemic. The possible association between worse clinical outcomes of MINOCA patients during the COVID-19 pandemic and thromboembolic complications of SARS-CoV-2 infection needs further evaluation.

Myocardial infarction with non-obstructive coronary arteries (MINOCA) as a relatively new disease entity distinguished from the group of acute coronary syndromes (ACS) is not a rare clinical problem and it requires in-depth diagnostics. MINOCA accounts for 5–10% of all ACS cases. MINOCA is most common between the ages of 50–60 and predominates in females. Coronary microvascular dysfunction and coronary vasospasm are among the potential mechanisms. The latest guidelines for the treatment of ACS in patients presenting without persistent ST-segment elevation emphasize the importance of searching for the causes of angina in patients with insignificant lesions in the coronary arteries by extending invasive diagnostics (e.g., acetylcholine provocation test) and using noninvasive diagnostics (e.g., CMR or SPECT). In the context of MINOCA, among the typical risk factors for coronary artery disease, arterial hypertension (HTN) seems to be the most important by inducing coronary microcirculation remodeling (mostly hypertrophy) and hence the narrowing of the lumen. Studies comparing patients with MINOCA and obstructive coronary artery disease (MI-CAD) in the context of risk factors, in particular HTN, were analyzed. In five out of nine analyzed studies, HTN occurred significantly more often in patients with MINOCA compared to patients with MI-CAD. The current pharmacotherapy recommendations focus on slowing the progression of coronary microvascular dysfunction (CMD), i.e., adequate treatment of risk factors and comorbidities, such as HTN. Therefore, it seems reasonable to conduct studies directly analyzing the relationship between HTN and MINOCA in order to improve diagnostics and establish appropriate pharmacotherapy that will improve prognosis.

Aim: In this preliminary study, we aimed to confirm the clinical utility and safety of the new noncompliant balloon catheter River NC® (Balton, Poland). Materials & methods: The primary study end point was to verify balloon diameters calculated in quantitative coronary angiography (QCA) to diameters prespecified by the manufacturer and obtained at given pressures in subjects undergoing percutaneous coronary interventions. Results: Forty-two subjects were enrolled (73.8% multivessel disease; 40.5% type B1 lesions; 100% device success). No clinically significant differences between expected balloon diameters and QCA were registered in predilatation (2.36 ± 0.11 mm vs 2.43 ± 0.07 mm) and postdilatation (3.18 ± 0.19 mm vs 3.21 ± 0.31 mm). Conclusion: Our study results suggest that the River NC balloon is effective and safe. In the QCA evaluation, River NC balloon obtained prespecified diameters and lengths at applied pressures. Study registration: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (UR.D.WM.DNB.109.2019).

The long-term outcomes of patients with myocardial infarction with non-obstructive coronary arteries (MINOCA) are still not well known. This study aimed to compare the characteristics and outcomes between MINOCA and STEMI patients in a 5-year follow-up. Between 2010 and 2015 we identified 3171 coronary angiography procedures performed due to acute coronary syndrome, from which 153 had a working MINOCA diagnosis, and the final diagnosis of MINOCA was ascribed to 112 (5.8%) patients. Additionally, we matched 166 patients with STEMI and obstructive coronary arteries as the reference group. In MINOCA patients (mean age of 63 years), there were more females (60% vs. 26%, p < 0.001), and patients presented most frequently with NSTEMI (83.9%). Patients with MINOCA had more frequent atrial fibrillation (22% vs. 5.4%, p < 0.001) and higher left ventricular ejection fraction (59 ± 10% vs. 54 ± 10%, p < 0.001) compared to STEMI patients. We observed only a trend for a higher rate of MACE in STEMI patients at 5 years (11.6% vs. 18.7%, HR 1.82, 95% CI 0.91–3.63, p = 0.09). In multivariable Cox regression, only beta-blocker use was a protective factor (a trend observed), with HR 0.33, 95% CI 0.10–1.15, p = 0.082 of future MACE. The outcomes of MINOCA and STEMI patients were comparable in the 5-year follow-up.

OBJECTIVE: This study aimed to investigate the efficacy and safety of convalescent plasma (CP) transfusion in a group of high-risk COVID-19 patients. METHODS: This prospective study included 204 patients from a single tertiary-care hospital, hospitalized with COVID-19, of whom 102 were treated with CP administration and standard care (PG) and 102 others who received standard care only (CG). The CG was selected from 336 hospitalized patients using the propensity-score matching (PSM) technique using age, MEWS score, and comorbidities. The primary outcome was mortality rate; secondary outcomes were the requirement of a ventilator, length of ventilator need, length of intensive care unit (ICU) stay, and length of overall hospital confinement. Additionally, parameters predicting death in COVID-19 patients were identified. RESULTS: Findings confirmed a significantly lower mortality rate in the PG versus the CG (13.7% vs. 34.3 %, p = 0.001) and a significant difference in the cumulative incidence of death between the two groups (p < 0.001). CP treatment was associated with lower risk of death (OR = 0.25 CI95 [0.06; 0.91], p = 0.041). There were no significant differences in ICU stay, ventilator time, and hospitalization time between the two groups. CONCLUSIONS: A significantly lower mortality rate was observed in the group of patients treated with CP. Age, presence of cardiac insufficiency, active cancer, a ventilator requirement, and length of hospitalization significantly increased the risk of death in both groups. Our study shows that CP affords better outcomes when administrated in the earlier stage of high-risk COVID-19 disease.

BackgroundCoronary microcirculatory dysfunction is a meaningful factor in the development of ischemic heart disease. We investigated the relationship between coronary microvascular spasm and complete blood count indices.MethodsBetween 2010 and 2013, we performed acetylcholine test (AChT) in subjects with suspicion of angina evoked by epicardial coronary spasm or coronary microvascular spasm according to COVADIS criteria. We administered acetylcholine in increasing doses of 25, 50, and 75 μg into the right coronary artery and 25, 50, and 100 μg into the left coronary artery. Patients were followed up for 60 months.ResultsIn total, 211 patients (60.5 ± 7.8 years, 67.8% women) were included in the study. The AChT revealed angina due to epicardial coronary spasm in 99 patients (46.9%) and coronary microvascular spasm in 72 (34.1%). White blood cell (WBC), red blood cell distribution width (RDW), platelets (PLT), mean platelet volume (MPV), and platelet distribution width (PDW) values were significantly higher in patients with coronary microvascular spasm than in patients from the other two groups, i.e., epicardial coronary spasm and negative AChT. PDW showed the highest sensitivity (65%) and specificity (72%) at the cutoff value of 15.32% [area under the curve, 0.723; 95% confidence interval (CI) 0.64–0.83; P < 0.001]. Independent risk factors for coronary microvascular spasm diagnosis using AChT were as follows: female sex (OR, 1.199), PDW (OR, 2.891), and RDW (OR, 1.567).ConclusionPDW and RDW are significantly associated with the diagnosis of coronary microvascular spasm in patients undergoing AChT as well as with poor prognosis in such patients at 5 years.

Percutaneous coronary interventions (PCI) of bifurcation lesions poses a technical challenge with a high complication rate. Kissing balloon inflation (KBI) and proximal optimization technique (POT) are used to correct bifurcation carina after stenting. However, both may still lead to uncomplete strut apposition to the side branch (SB) lateral wall. Proposed herein, is a new stent-optimization technique following bifurcation stenting consisting of a combination of POT and KBI called proximal optimization with kissing balloon inflation (POKI).Bench and in-vivo evaluations were performed. For the bench visualization bifurcated silicone mock vessel was used. The POKI technique was simulated using a 3.5 mm POT balloon. For the in-vivo evaluation patients with angiographic bifurcation lesions in a native coronary artery with diameter ≥ 2.5 mm and ≤ 4.5 mm, SB diameter ≥ 2.0 mm, and percentage diameter stenosis (%DS) more than 50% in the main vessel (MV) were included. Provisional stenting was the default strategy.In total 41 vessels were evaluated. The target vessel was left main in 9 (22.0%) patients, left anterior descending artery - in 26 (63.4%), left circumflex artery - in 4 (9.8%) and right coronary artery - in 2 (4.9%). The predominant type of bifurcation was Medina 1-1-1 (61.8%). Baseline proximal MV DS% was 60.0 ± 23.7%, distal MV DS% - 58.8 ± 28.9% and SB DS% 53.0 ± 32.0%. The application of POKI was feasible in 41 (100%) of the vessels. Post-PCI residual DS at proximal MV was 11.5 ± 15.4%, distal MV - 6.6 ± 9.3%, and SB - 22.9 ± 28.5%. Both procedural and angiographic success was 100%.POKI is a novel stent-optimization technique for bifurcation lesions. It showed excellent feasibility and success rate both in bench and in-vivo evaluation.

Background: Optimal duration of dual antiplatelet therapy (DAPT) following percutaneous coronary intervention (PCI) of a bifurcation stenosis is still debated. We evaluated the impact of DAPT duration on clinical outcomes in all-comers patients undergoing bifurcation PCI included in the European Bifurcation Club (EBC) registry. Methods: We enrolled 2284 consecutive patients who completed at least 18 months follow-up. The cumulative occurrence of major adverse cardiac and cardiovascular events (MACCE), defined as a composite of overall-death, non-fatal myocardial infarction (MI), target vessel revascularization (TVR) and stroke were evaluated. Bleedings classified as Bleeding Academic Research Consortium (BARC) ≥3 were evaluated too. Results: Patients were divided into 3 groups: short DAPT (12-months, N.=1273). At 24 months follow-up MACCE-free survival was significantly lower in short DAPT patients (Log-Rank: 45.23, P for trend

Aims:The 2017 European Society of Cardiology guidelines for the management of ST-elevation myocardial infarction recommended assessing quality of care to establish measurable quality indicators in order to ensure that every ST-elevation myocardial infarction patient receives the best possible care. We investigated the quality indicators of healthcare services in Poland provided to ST-elevation myocardial infarction patients.Methods and results:The Polish Registry of Acute Coronary Syndromes is a nationwide, multicentre, prospective study of acute coronary syndrome patients in Poland. For the purpose of assessing quality indicators, we included 8279 patients from the Polish Registry of Acute Coronary Syndromes hospitalised with ST-elevation myocardial infarction in 2018. Four hundred and eight of 8279 patients (4.9%) arrived at percutaneous coronary intervention centre by self-transport, 4791 (57.9%) arrived at percutaneous coronary intervention centre by direct emergency medical system transport, and 2900 (37.2%) were transferred from non-percutaneous coronary intervention facilities. Whilst 95.1% of ST-elevation myocardial infarction patients arriving in the first 12 h received reperfusion therapy, the rates of timely reperfusion were much lower (ranging from 39.4% to 55.0% for various ST-elevation myocardial infarction pathways). The median left ventricular ejection fraction was 46% and was assessed before discharge in 86.0% of patients. Four hundred and eighty-nine of 8279 patients (5.9%) died during hospital stay. Optimal medical therapy is prescribed in 50–85% of patients depending on various clinical settings. Only one in two ST-elevation myocardial infarction patients is enrolled in a cardiac rehabilitation program at discharge. No patient-reported outcomes were recorded in the Polish Registry of Acute Coronary Syndromes.Conclusions:The results of this study identified areas of healthcare system that require solid improvement. These include direct transport to percutaneous coronary intervention centre, timely reperfusion, guidelines-based medical therapy (in particular in patients with heart failure), referral to cardiac rehabilitation/secondary prevention programs. Also, there is a need for recording quality indicators associated with patient-reported outcomes.

Aims The aim of this study is to demonstrate the non-inferiority of the BiOSS LIM C sirolimus-eluting cobalt-chromium bifurcation dedicated stent against the XIENCE stent regarding the patient-oriented composite endpoint (POCE) at 12 months among patients with left main coronary artery disease (LMCA). Methods and results The POLBOS LM study is a single-arm, prospective, multicentre study enrolling 260 patients (SYNTAX score ≤32) with a pre-specified performance goal based on the results of the EXCEL trial with contemporary percutaneous coronary intervention (PCI) for LMCA disease. Patient enrolment will comply with objective inclusion criteria of diameter stenosis ≥50% in the LMCA based on off-line quantitative coronary angiography (QCA) analysed by an independent core laboratory using dedicated bifurcation QCA software. The BiOSS LIM C is used for the treatment of LMCA disease with the same specific technical classification as for the BiOSS LIM (modified MADS classification) and the stent implantation is optimised by using pre-specified intravascular ultrasound criteria. The primary endpoint is POCE (a composite of all-cause death, stroke, any myocardial infarction, and any revascularisation) at 12 months. Conclusions The POLBOS LM study will indicate the efficacy of the BiOSS LIM C stent with contemporary PCI for distal left main bifurcation lesions in comparison with the XIENCE stent from the recent EXCEL trial, as a performance index.

Cardiac tumors pose the uncommon group of disorders and most of them are metastases. They are generally localized in the left heart and may present with non-specific symptoms. Diagnosis may be often difficult due to the presence other heart diseases. The gold standard in diagnosing is non-invasive imaging. We present a case of a 77-year-old male admitted to our hospital due to flu symptoms, headaches and loss of weight in the last 2–3 weeks. The diagnostic process including computed tomography (CT) and magnetic resonance imaging revealed pathological contrast enhancement in the left parietal lobe, whereas subsequent transthoracic echocardiography disclosed a pathological oval mass 2.5 x 3.5 cm in the left heart suspected of a metastasis. Results of echocardiography turned the diagnostic process around and extended to bronchoscopy and abdominal CT. Finally, central left lung tumor with metastases to lungs, pleura, lymphoid nodes of the right hilar, left ventricle, left suprarenal gland and central nervous system was diagnosed.

The bifurcation optimization stent system (BiOSS) LIM (Balton, Warsaw, Poland) stent is a dedicated coronary bifurcation stent. Its unique construction is developed in accordance with the anatomy of the coronary bifurcations, thus eliminating the carina displacement as a mechanism of side branch ostium compromise. Since its development in 2008, the BiOSS stent underwent several changes with the latest version created of sirolimus eluting cobalt-chromium stent. Results from registries and randomized clinical trials showed that implantation of the BiOSS stent is safe and effective with comparable results for major adverse cardiovascular events (MACE) and target lesion revascularisation rates between the BiOSS and regular drug-eluting stent groups. This stent provides alternative for coronary bifurcation treatment, especially when there is a large difference in diameter between the main vessel and the main branch.

IntroductionPercutaneous coronary interventions (PCI) in bifurcations are still challenging and are associated with higher risks of periprocedural complications as well as restenosis and stent thrombosis. The aim of this paper was to summarize 12 months of clinical results of the prospective, first-in-man registry assessing the BiOSS LIM C stent (Balton, Poland).Material and methodsIn the prospective two-center registry we enrolled patients with non-ST-segment elevation acute coronary syndrome (NSTE-ACS) and stable coronary artery disease. Provisional T-stenting was the default treatment strategy. The primary endpoint was defined as the rate of cardiac death, myocardial infarction (MI) and clinically driven target lesion revascularization (TLR) in 12-month follow-up.ResultsThe study population consisted of 95 patients (mean age: 66.8 ±9.8 years, 17.9% were females). A BiOSS LIM C stent was implanted in the left main (LM) in 53 (55.8%) cases. There were 25.2% of patients with NSTE-ACS, 33.7% with diabetes, 90.5% with hypertension, and 53.7% had previous MI. The device success rate was 100%. An additional regular drug-eluting stent was deployed in the side branch in 18.9% of cases. Proximal optimization technique and final kissing balloon (FKB) technique were used in 53.7% and 30.5% of cases, respectively. MI type 4a was registered in 4 (4.2%) cases. At 12 months the MACE rate was 9.5%, cardiac death 1.1%, MI 2.1% and clinically driven TLR 6.3%. All incidents, apart from one TLR, appeared in the LM subgroup.ConclusionsOur registry might suggest that PCI using the BiOSS LIM C in coronary bifurcations is feasible and might be an option for percutaneous revascularization.

Background: Whereas the efficacy and safety of intravascular lithotripsy (IVL) have been confirmed in de novo calcified coronary lesions, little is known about its utility in treating stent underexpansion. This study aimed to investigate the impact of IVL in treating stent underexpansion. Methods and Results: Consecutive patients with stent underexpansion treated with IVL entered the multicenter IVL-Dragon Registry. The procedural success (primary efficacy endpoint) was defined as a relative stent expansion >80%. Thirty days device-oriented composite endpoint (DOCE) (defined as a composite of cardiac death, target lesion revascularization, or target vessel myocardial infarction) was the secondary endpoint. A total of 62 patients were enrolled. The primary efficacy endpoint was achieved in 72.6% of patients. Both stent underexpansion 58.5% (47.5–69.7) vs. 11.4% (5.8–20.7), p < 0.001, and the stenotic area 82.6% (72.4–90.8) vs. 21.5% (11.1–37.2), p < 0.001, measured by quantitative coronary angiography improved significantly after IVL. Intravascular imaging confirmed increased stent expansion following IVL from 37.5% (16.0–66.0) to 86.0% (69.2–90.7), p < 0.001, by optical coherence tomography and from 57.0% (31.5–77.2) to 89.0% (85.0–92.0), p = 0.002, by intravascular ultrasound. Secondary endpoint occurred in one (1.6%) patient caused by cardiac death. There was no target lesion revascularization or target vessel myocardial infarction during the 30-day follow-up. Conclusions: In this real-life, largest-to-date analysis of IVL use to manage underexpanded stent, IVL proved to be an effective and safe method for facilitating stent expansion and increasing luminal gain.

BackgroundData regarding management of patients with unprotected left main coronary artery in-stent restenosis (LM-ISR) are scarce.ObjectivesThis study investigated the safety and effectiveness of percutaneous coronary intervention (PCI) vs. coronary artery bypass grafting (CABG) for the treatment of unprotected LM-ISR.MethodsConsecutive patients who underwent PCI or CABG for unprotected LM-ISR were enrolled. The primary endpoint was a composite of major adverse cardiac and cerebrovascular events (MACCE), defined as cardiac death, myocardial infarction (MI), target vessel revascularization (TVR), and stroke.ResultsA total of 305 patients were enrolled, of which 203(66.6%) underwent PCI and 102(33.4%) underwent CABG. At 30-day follow-up, a lower risk of cardiac death was observed in the PCI group, compared with the CABG-treated group (2.1% vs. 7.1%, HR 3.48, 95%CI 1.01–11.8, p = 0.04). At a median of 3.5 years [interquartile range (IQR) 1.3–5.5] follow-up, MACCE occurred in 27.7% vs. 29.6% (HR 0.82, 95%CI 0.52–1.32, p = 0.43) in PCI- and CABG-treated patients, respectively. There were no significant differences between PCI and CABG in cardiac death (9.9% vs. 18.4%; HR 1.56, 95%CI 0.81–3.00, p = 0.18), MI (7.9% vs. 5.1%, HR 0.44, 95%CI 0.15–1.27, p = 0.13), or stroke (2.1% vs. 4.1%, HR 1.79, 95%CI 0.45–7.16, p = 0.41). TVR was more frequently needed in the PCI group (15.2% vs. 6.1%, HR 0.35, 95%CI 0.15–0.85, p = 0.02).ConclusionsThis analysis of patients with LM-ISR revealed a lower incidence of cardiac death in PCI compared with CABG in short-term follow-up. During the long-term follow-up, no differences in MACCE were observed, but patients treated with CABG less often required TVR.Visual overviewA visual overview is available for this article.Registrationhttps://www.clinicaltrials.gov; Unique identifier: NCT04968977.

Aims Patients at high bleeding risk (HBR) represent a prevalent subgroup among those undergoing percutaneous coronary intervention (PCI). Early aspirin discontinuation after a short course of dual antiplatelet therapy (DAPT) has emerged as a bleeding avoidance strategy. The aim of this study was to assess the effects of ticagrelor monotherapy after 3-month DAPT in a contemporary HBR population. Methods and results This prespecified analysis of the TWILIGHT trial evaluated the treatment effects of early aspirin withdrawal followed by ticagrelor monotherapy in HBR patients undergoing PCI with drug-eluting stents. After 3 months of ticagrelor plus aspirin, event-free patients were randomized to 12 months of aspirin or placebo in addition to ticagrelor. A total of 1064 (17.2%) met the Academic Research Consortium definition for HBR. Ticagrelor monotherapy reduced the incidence of the primary endpoint of Bleeding Academic Research Consortium (BARC) 2, 3, or 5 bleeding compared with ticagrelor plus aspirin in HBR (6.3% vs. 11.4%; hazard ratio (HR) 0.53, 95% confidence interval (CI) 0.35–0.82) and non-HBR patients (3.5% vs. 5.9%; HR 0.59, 95% CI 0.46–0.77) with similar relative (P interaction = 0.67) but a trend towards greater absolute risk reduction in the former [−5.1% vs. −2.3%; difference in absolute risk differences (ARDs) −2.8%, 95% CI −6.4% to 0.8%, P = 0.130]. A similar pattern was observed for more severe BARC 3 or 5 bleeding with a larger absolute risk reduction in HBR patients (−3.5% vs. −0.5%; difference in ARDs −3.0%, 95% CI −5.2% to −0.8%, P = 0.008). There was no significant difference in the key secondary endpoint of death, myocardial infarction, or stroke between treatment arms, irrespective of HBR status. Conclusions Among HBR patients undergoing PCI who completed 3-month DAPT without experiencing major adverse events, aspirin discontinuation followed by ticagrelor monotherapy significantly reduced bleeding without increasing ischaemic events, compared with ticagrelor plus aspirin. The absolute risk reduction in major bleeding was larger in HBR than non-HBR patients.

Objectives The aim of the DAPT-DRAGON registry was to asses long-term outcomes and the length of dual antiplatelet therapy (DAPT) in patients treated with percutaneous coronary intervention (PCI) due to drug-eluting stent in stent restenosis (DES-ISR) with drug-eluting balloons (DEB) or thin-DES. Background Data regarding the duration of DAPT in patients with DES-ISR treated with PCI is still undergoing research and observation, and the adequate duration of DAPT in this group of patients is not unambiguously sanctioned. Methods Overall, 1,367 consecutive patients with DES-ISR who underwent PCI with DEB or DES, were entered into the multi-center DAPT-DRAGON Registry (Fig. 1). The mean age was 66.7±9 years (70.5% males). The median follow-up was 3.3 years. There were 34.1% patients with chronic coronary syndrome, 35.2% with unstable angina, 2.9% with ST segment elevation myocardial infarction and 27.7% with non-ST segment elevation myocardial infarction (MI). We assessed selected study endpoints according to the duration of DAPT (≤3 vs. >3 months and ≤6 vs. >6 months), before and after propensity score matching (PSM): stroke, target lesion revascularization (TLR), target vessel revascularization (TVR), MI, death and device-oriented composite endpoints (DOCE). Results Among predictors of increased DOCE rate before PSM, we demonstrated: PCI with DEB vs. DES (p6 months) before PSM revealed superiority of thin-DES+DAPT >6 months vs. DEB+DAPT >6 months for DOCE (p3 months) had no significant influence on assessed long-term outcomes, while the percentage of stroke free survival was significantly lower in the group of patients with DAPT ≤6 months vs. >6 months (p=0.01; Fig. 2). Conclusions Long-term treatment with DAPT (>6 months) in patients with DES-ISR with DES implantation is related to better long-term outcomes in terms of lower rate of DOCE, TVR and TLR compared to PCI with DEB. DAPT >6 months is related to a greater rate of strokes, independently of the type of treatment (thin-DES and DEB) compared to DAPT ≤6 months. Funding Acknowledgement Type of funding sources: None. Figure 1Figure 2

Introduction Considerable progress has been made in the treatment of coronary bifurcation stenosis. Anatomical characteristics of the lesion, however, fail to give information about the functional significance of the bifurcation stenosis. There is no study that systematically establishes the baseline functional significance of coronary stenosis and its effect on procedural and clinical outcomes. Methods Patients with significant angiographically bifurcation lesions defined as diameter stenosis >50% in main vessel and/or side branch were included. FFR was performed in main vessel (MV) and side branch (SB) before and after percutaneous coronary intervention (PCI). If FFR was ≤0.80 the lesion was considered functionally significant, and patients underwent PCI. For the group with FFR >0.80 – intervention was deferred. All patients were followed-up for vital status every 3 months. Cox regression analysis was performed to identify independent predictors of all-cause and cardiovascular death. The local ethics committee approved the study and patients signed informed consent for participation into registry. Results For mean follow-up of 38±18 months (median 40, IQR 23–55 months) all-cause mortality was numerically lower: 8.5% (n=7/82) in deferred group and 12.6% in stented group (n=11/76, p=0.387). The cardiac mortality was also numerically lower, but statistically not significant (9.8%, n=8/82 vs. 11.5%, n=10/88, p=0.714). On multivariate model, independent predictors were mitral regurgitation >1st degree – HR=1.778 (CI 1.100–2.874, p=0.019); dyslipidemia HR=0.765 (CI 0.594–0.985, p=0.038); hemoglobin concentration – HR=0.976 (CI 0.964–0.988, p Conclusion Baseline high-sensitive troponin T value is a strong predictor for both all cause and cardiac mortality in patients undergoing coronary bifurcation lesion PCI. Funding Acknowledgement Type of funding sources: Public hospital(s). Main funding source(s): Alexandrovska University Hospital

SARS-Cov-2 infection, due to inflammation processes, can affect autonomic nervous system and heart rate variability (HRV) even after disease. Previous studies showed significant changes in HRV parameters in severe (including fatal) infection of SARS-Cov-2. However, HRV analysis for the asymptomatic or mild-symptomatic Covid-19 patients have not been reported. In this study, we suggested that there is an influence of a SARS-Cov-2 infection on the HRV in such patients after weeks form disease.Sixty-five ECG Holter recordings from young (mean age 22.6 ± 3.4 years), physically fit male subjects after 4-6 weeks from the second negative test (considered to be the beginning of recovery) and twenty-six control male subjects (mean age 23.2 ± 2.9 years) were considered in the study. Night-time RR time series were extracted from ECG signals. Selected linear, frequency as well as nonlinear HRV parameters were calculated. We found significant differences in Porta’s symbolic analysis parameters V0 and V2 (p2 (p

OBJECTIVE The aim: We aimed to assess the feasibility and safety of performing balloon aortic valvuloplasty (BAV) with Valver balloon catheter (Balton, Poland) in adults with severe aortic stenosis as a bridge or palliative treatment. PATIENTS AND METHODS Materials and methods: We identified consecutive patients who underwent BAV procedures between May 2019 and March 2020 using Valver balloon catheters. Demographic data, medical history, and clinical characteristics were retrospectively collected in all study patients together with periprocedural data as well as 12-month follow-up data. RESULTS Results: We included 18 patients. The mean population age was 78.1±8.9 years, and women were 61.1%. The most common co-morbidities were arterial hypertension (88.9%), dyslipidemia (83.3%), and coronary artery disease (72.2%). The baseline mean aortic valve pressure gradient was 49.94±27.02 mmHg and the mean aortic valve area (AVA) was 0.65±0.20 cm2. In all cases, the procedure was performed from the femoral access via the 8F sheath. Two Valver balloon catheter sizes were used 18x40mm (33.3%) and 20x40mm (66.7%). Three periprocedural complications were observed, and none was associated with the Valver balloon catheter per se. The transthoracic echocardiography after the procedure revealed a decrease in the mean pressure gradient of 11.1±8.85 mmHg, and an increase in AVA of 0.21±0.19 cm2. At 12-month follow-up, the mortality rate was 38.9%. CONCLUSION Conclusions: BAV is a procedure increasingly performed in catheterization laboratories worldwide. This paper confirmed the relative safety of BAV with Valver balloon catheters in the modern era, showing a low incidence of valve and vascular complications.

Background: The side branch (SB) compromise after main vessel (MV) stenting remains a significant problem in coronary bifurcation treatment. Currently the two major hypotheses for the mechanism of SB compromise are carina shift from MV into the SB and plaque shift into the ostium of side vessel. It is proposed herein, SB ostial deformation leading to reshaping of the ostium from circle to ellipse is a third possible mechanism. In the current study, the theoretical effects and correlation of ostial deformation with fractional flow reserve (FFR) is explored. Methods: Based on angiographic measurements and theoretical analysis formulas, three different SB ostial areas using circular ostial shape assumption and elliptical ostial shape assumption were calculated. Three different types of ostial areas with FFR values after MV stenting in 49 patients from the FIESTA registry were compared and analyzed. Results: It was found that there is significant overestimation of stenosis severity when estimated by the circle formula, than with the ellipse formula — ASc vs. ASds with 25% ± 13%, p < 0.001, ASc vs. ASmld with 9% ± 10%, p < 0.001. The elliptical shape assumptions provide more accurate ostial area stenosis, which correlates better with FFR. This finding is more significant in less severe stenosis (< 70% area stenosis) than in a more severe one. Conclusions: A third possible mechanism of SB compromise after MV stenting of coronary bifurcation stenosis is elliptical ostial deformation at the ostium of SBs. The ostial area, calculated based on elliptical assumption correlates better with FFR, than area stenosis calculated with the traditional circular formula.

Critical limb ischemia is associated with excessively high risk for cardiovascular events, including myocardial infarction and death. Additionally, in this patient population non-invasive evaluation of coronary artery disease is limited due to (1) inability of exercise testing, (2) frequent occurrence of balanced ischemia and (3) frequent occurrence of diffuse coronary calcification. Intentional Coronary Revascularization Versus Conservative Therapy in Patients Undergoing Peripheral Artery Revascularization Due to Critical Limb Ischemia trial (INCORPORATE trial) is a multicentric international randomized open label clinical trial. Trial will recruit patients, who underwent successful peripheral artery revascularization due to critical limb ischemia and randomize 1:1 to conservative medical therapy versus an immediate invasive strategy to investigate and treat coronary artery disease. The objective is to evaluate whether intentional invasive strategy with ischemia targeted reasonably complete coronary revascularization is superior as compared to conventional primarily conservative approach in terms of spontaneous myocardial infarction and overall survival at 12 months follow-up. The trial is registered at clinicaltrials.gov (NCT03712644).

Background: Considerable progress has been made in the treatment of coronary bifurcation stenosis. Anatomical characteristics of the vessel and lesion, however, fail to give information about the functional significance of the bifurcation stenosis. To the best of our knowledge, there is no study that systematically establishes the baseline functional significance of coronary stenosis and its effect on procedural and clinical outcomes.Methods: Patients with significant angiographic bifurcation lesions defined as diameter stenosis > 50% in main vessel and/or side branch were included. FFR was performed in main vessel (MV) and side branch (SB) before and after percutaneous coronary intervention (PCI). 169 patients from Fiesta study (derivation cohort) and 555 patients from prospective bifurcation registry (test cohort) were analyzed to validate angiographic prediction score (BFSS) used to determine the potentially functional significance of coronary bifurcation stenosis.Results: Bifurcation functional significance score (including the following parameters - SYNTAX ≥11, SB/MB BARI score, MV %DS ≥ 55%, MB %DS ≥ 65%, lesion length ≥25mm) with a maximum value of 11 was developed. A cut-off value of 8.5 was shown to give the best discriminatory ability – with accuracy 87% (sensitivity 77%, specificity 96%, pConclusion: An angiographic score (BFSS) with good discriminatory ability to determine the functional significance of coronary bifurcation stenosis was developed. The value for BFSS≥8.5 can be used as a discriminator to define groups with higher risk for all-cause and cardiac mortality. Also, we found that the smaller side branches pose greater mortality risk.

Considerable progress has been made in the treatment of coronary bifurcation stenosis. Anatomical characteristics of the vessel and lesion, however, fail to give information about the functional significance of the bifurcation stenosis. To the best of our knowledge, there is no study that systematically establishes the baseline functional significance of coronary stenosis and its effect on procedural and clinical outcomes. Patients with significant angiographic bifurcation lesions defined as diameter stenosis > 50% in main vessel and/or side branch were included. FFR was performed in main vessel (MV) and side branch (SB) before and after percutaneous coronary intervention (PCI). 169 patients from Fiesta study (derivation cohort) and 555 patients from prospective bifurcation registry (clinical effect cohort) were analyzed to validate angiographic prediction score (BFSS) used to determine the potentially functional significance of coronary bifurcation stenosis. Bifurcation functional significance score (including the following parameters—SYNTAX ≥ 11, SB/MB BARI score, MV %DS ≥ 55%, main branch (MB) %DS ≥ 65%, lesion length ≥ 25 mm) with a maximum value of 11 was developed. A cut-off value of 6.0 was shown to give the best discriminatory ability—with accuracy 87% (sensitivity 77%, specificity 96%, p

Although Slavic populations account for over 3.5% of world inhabitants, no centralized, open source reference database of genetic variation of any Slavic population exists to date. Such data are crucial for either biomedical research and genetic counseling and are essential for archeological and historical studies. Polish population, homogenous and sedentary in its nature but influenced by many migrations of the past, is unique and could serve as a good genetic reference for middle European Slavic nations.The aim of the present study was to describe first results of analyses of a newly created national database of Polish genomic variant allele frequencies. Never before has any study on the whole genomes of Polish population been conducted on such a large number of individuals (1,079).A wide spectrum of genomic variation was identified and genotyped, such as small and structural variants, runs of homozygosity, mitochondrial haplogroups and Mendelian inconsistencies. The allele frequencies were calculated for 943 unrelated individuals and released publicly as The Thousand Polish Genomes database. A precise detection and characterisation of rare variants enriched in the Polish population allowed to confirm the allele frequencies for known pathogenic variants in diseases, such as Smith-Lemli-Opitz syndrome (SLOS) or Nijmegen breakage syndrome (NBS). Additionally, the analysis of OMIM AR genes led to the identification of 22 genes with significantly different cumulative allele frequencies in the Polish (POL) vs European NFE population. We hope that The Thousand Polish Genomes database will contribute to the worldwide genomic data resources for researchers and clinicians.

The risk of ischemic events gradually decreases after acute coronary syndrome (ACS), reaching a stable level after 1 month, while the risk of bleeding remains steady during the whole period of dual antiplatelet treatment (DAPT). Several de-escalation strategies of antiplatelet treatment aiming to enhance safety of DAPT without depriving it of its efficacy have been evaluated so far. We hypothesized that reduction of the ticagrelor maintenance dose 1 month after ACS and its continuation until 12 months after ACS may improve adherence to antiplatelet treatment due to better tolerability compared with the standard dose of ticagrelor. Moreover, improved safety of treatment and preserved anti-ischemic benefit may also be expected with additional acetylsalicylic acid (ASA) withdrawal. To evaluate these hypotheses, we designed the Evaluating Safety and Efficacy of Two Ticagrelor-based De-escalation Antiplatelet Strategies in Acute Coronary Syndrome - a randomized clinical trial (ELECTRA-SIRIO 2), to assess the influence of ticagrelor dose reduction with or without continuation of ASA versus DAPT with standard dose ticagrelor in reducing clinically relevant bleeding and maintaining anti-ischemic efficacy in ACS patients. The study was designed as a phase III, randomized, multicenter, double-blind, investigator-initiated clinical study with a 12-month follow-up (ClinicalTrials.gov Identifier: NCT04718025; EudraCT number: 2020-005130-15).

IMPORTANCE: Shortened dual antiplatelet therapy followed by potent P2Y12 receptor inhibitor monotherapy reduces bleeding without increasing ischemic events after percutaneous coronary intervention (PCI). OBJECTIVE: To explore sex differences and evaluate the association of sex with outcomes among patients treated with ticagrelor monotherapy vs ticagrelor plus aspirin. DESIGN, SETTING, AND PARTICIPANTS: This was a prespecified secondary analysis of TWILIGHT, an investigator-initiated, placebo-controlled randomized clinical trial conducted at 187 sites across 11 countries. Study participants included patients who underwent successful PCI with drug-eluting stents, were planned for discharge with ticagrelor plus aspirin, and who had at least 1 clinical and at least 1 angiographic feature associated with high risk of ischemic or bleeding events. Data were analyzed from May to July 2020. INTERVENTIONS: At 3 months after PCI, patients adherent to ticagrelor and aspirin without major adverse event were randomized to either aspirin or placebo for an additional 12 months along with ticagrelor. MAIN OUTCOMES AND MEASURES: The primary end point was Bleeding Academic Research Consortium (BARC) type 2, 3, or 5 bleeding at 12 months after randomization. The primary ischemic end point was a composite of death, myocardial infarction, or stroke. RESULTS: Of 9006 enrolled patients, 7119 underwent randomization (mean [SD] age, 63.9 [10.2] years; 5421 [76.1%] men). Women were older (mean [SD] age, 65.5 [9.6] years in women vs 63.4 [10.3] years in men) with higher prevalence of chronic kidney disease (347 women [21.2%] vs 764 men [14.7%]). The primary bleeding end point occurred more often in women than men (hazard ratio [HR], 1.32; 95% CI, 1.06-1.64; P = .01). After multivariate adjustment, incremental bleeding risk associated with female sex was no longer significant (adjusted HR, 1.20; 95% CI, 0.95-1.52; P = .12). Ischemic end points were similar between sexes. Ticagrelor plus placebo vs ticagrelor plus aspirin was associated with lower risk of BARC type 2, 3, or 5 bleeding in women (adjusted HR, 0.62; 95% CI, 0.42-0.92; P = .02) and men (adjusted HR, 0.57; 95% CI, 0.44-0.73; P

Aims The aim of this study was to assess the impact of chronic kidney disease (CKD) on the safety and efficacy of ticagrelor monotherapy among patients undergoing percutaneous coronary intervention (PCI). Methods and results In this prespecified subanalysis of the TWILIGHT trial, we evaluated the treatment effects of ticagrelor with or without aspirin according to renal function. The trial enrolled patients undergoing drug-eluting stent implantation who fulfilled at least one clinical and one angiographic high-risk criterion. Chronic kidney disease, defined as an estimated glomerular filtration rate (eGFR) Conclusion Among CKD patients undergoing PCI, ticagrelor monotherapy reduced the risk of bleeding without a significant increase in ischaemic events as compared with ticagrelor plus aspirin.

Background The wide variation in bifurcation anatomy has generated an ongoing search for stents explicitly designed for coronary bifurcations, and to date, results have been underachieved. Methods The POLBOS I and POLBOS II were international, multicentre, randomized, open-label, controlled trials. Patients were randomly assigned to BiOSS Expert (in POLBOS I, biodegradable polymer eluting paclitaxel)/BiOSS LIM (in POLBOS II, biodegradable polymer eluting sirolimus) stent implantation or regular drug-eluting stent (rDES) deployment. A provisional T-stenting strategy was the default treatment option. The primary endpoint of this pooled data study was the cumulative rate of major adverse cardiovascular events (MACE) consisting of cardiac death, myocardial infarction (MI) and target lesion revascularization (TLR). Telephone follow-up was performed annually up to 72 months. (ClinicalTrials.gov Identifier: POLBOS I-NCT02192840, POLBOS II-NCT02198300). Results The total study population consisted of 445 patients, 222 patients in the BiOSS group and 223 patients in the rDES group. The follow-up rate was 93.7% in the BiOSS group and 91.9% in the rDES group. At 72 months, there was no significant difference between BiOSS and rDES groups regarding MACE (25.7% vs 25.1%, HR 1.06, 95% CI 0.73-1.52), cardiac death (3.1% vs 4.0%, HR 0.94, 95% CI 0.43-2.34), MI (3.6% vs 4.9%, HR 0.76, 95% CI 0.32-2.89), TLR (18.9% vs 16.1%, HR 1.17, 95% CI 0.75-1.83) and stent thrombosis rates (0.9% vs 0.5%, HR 1.21, 95CI 0.75-2.09). Conclusions At the 6-year follow-up, clinically significant clinical events did not differ between BiOSS stents and rDES.

Background: Data regarding the use of percutaneous coronary intervention with drug-eluting balloons (DEB) versus thin-strut drug-eluting stents (thin-DES) for treating DES in-stent restenosis in everyday clinical practice is scarce. Our goal was to evaluate the efficacy and safety profile of DEB versus thin-DES in DES in-stent restenosis. Methods: Consecutive patients with DES in-stent restenosis who underwent percutaneous coronary intervention between 2008 and 2019 entered the multicenter DEB-DRAGON Registry with a follow-up of 3 years. Patients who received DEB at the index procedure (n=557, 49.9%) were compared with those who received thin-DES (n=560, 50.1%). Results: Analysis of the unmatched cohort revealed lower rates of target lesion revascularization (9.1% versus 13.6%; hazard ratio [HR], 0.58 [95% CI, 0.41–0.83], P =0.003), target vessel revascularization (11.8% versus 16.7%; HR, 0.62 [95% CI, 0.45–0.84], P =0.003) and device-oriented composite end point, defined as a composite of cardiac death, target lesion revascularization, and target vessel myocardial infarction (12.7% versus 16.0%; HR, 0.69 [95% CI, 0.50–0.94], P =0.018) in the thin-DES group compared with the DEB group. The incidence of cardiac death, target vessel-myocardial infarction, and myocardial infarction were similar in both groups. However, after propensity score matching, there were no significant differences in target lesion revascularization (11.2% versus 11.2%; HR, 0.91 [95% CI, 0.55–1.51], P =0.707), target vessel revascularization (13.4% versus 14.2%; HR, 0.86 [95% CI, 0.55–1.36], P =0.523), and device-oriented composite end point (14.2% versus 14.2%; HR, 0.91 [95% CI, 0.58–1.42], P =0.667) between the thin-DES and DEB group, respectively. Conclusions: This analysis of a real-life registry revealed similar long-term outcomes of thin-DES and DEB in DES in-stent restenosis regarding target lesion revascularization, myocardial infarction, cardiac death, and device-oriented composite end point. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT04415216.