Search Results (267)

(1) Background: Comparison of clinical outcomes between patients with moderate-severe aortic valve stenosis and those with mild or no aortic valve stenosis undergoing surgical revascularization for critical limb threating ischemia (CLTI). (2) Methods: Single center retrospective analysis of consecutive patients undergoing surgical lower limb revascularization with femoro-distal bypass for critical ischemia between 2016 and 2022. All patients were evaluated preoperatively by echocardiographic examination and divided into two cohorts: group A with moderate-severe aortic valve stenosis (AVA-cm² < or =1.5 cm²) and group B with mild or absent stenosis (AVA-cm² > 1.5 cm²). Primary outcomes were major limb amputation and mortality between the two groups. The rate of major cardiovascular events (stroke, myocardial infarction, sudden cardiac death) and change in “preoperative functional status” were the secondary outcomes. Descriptive statistics for continuous variables were performed by calculating means, standard deviation (SD) medians, and interquartile range (IQR) while, for categorical variables, frequencies and percentages were performed. Intergroup comparison tests, for continuous variables, were performed by t-test or corresponding nonparametric tests (Mann-Whitney test) while, for categorical variables, Chi-square test was used. Evaluation of cut-offs for the variable AVA-fx-cm², in terms of predictive of outcome outcomes, was calculated by ROC curves. Comparison between clinical and outcome variables was performed using logistic regression models. A total of 316 patients were analyzed and divided in two groups: 50 (16%) patients with moderate or severe aortic valve stenosis (group A) and 266 (84%) with no or mild aortic valve stenosis (AVA > 1.5 cm²). Patients in group A were significantly older than those in group B (78 years vs. 74 years, p value = 0.005); no other significant comorbidity differences were found between the two groups. The mean follow-up was 1178 days (SD 991 days; 2–3869 days). There were no statistically significant differences between group A and group B in terms of major amputation rate (20% vs. 16.5%; p = 0.895) and overall mortality (48.0% vs. 40.6%; p = 0.640). In the total cohort, the statistically significant variables associated with the major amputation were systemic perioperative complication (OR 5.83, 95% CI: 2.36, 14.57, p < 0.001), bypass-related complication within 30 days of surgery (OR 2.74, 95% CI: 1.17, 6.45, p = 0.020), surgical revascularization below the knee (OR 7.72, 95% CI: 1.53, 140.68, p = 0.049), and the presence of a previous cardiovascular event (OR 2.65, 95% CI: 1.14, 6.26, p = 0.024). In patients undergoing surgical revascularization for CLTI, no significant difference in major amputation rate and overall mortality was found between subjects with mild or no aortic valve stenosis and those with moderate/severe stenosis. As expected, overall mortality was higher in older patients with worse functional status. A significantly higher rate of limb amputation was found in those subjects undergoing subgenicular revascularization, early bypass failure, or previous cardiovascular event. Full article

Background: Despite advances in coronary artery disease (CAD) treatment, challenges persist, particularly in complex lesions. While percutaneous coronary intervention (PCI) is widely used, its outcomes can be affected by complications like restenosis. Optical coherence tomography (OCT), offering higher-resolution imaging than angiography, shows promise in guiding PCI. However, meta-analytical comparisons between OCT-guided and angiography-guided PCI remain limited. Methods: Databases, including PubMed, Scopus, Cochrane Library, and ClinicalTrials.gov, were queried through May 2025 to identify randomized controlled trials (RCTs) comparing OCT-guided PCI with angiography-guided PCI. Data were pooled using risk ratios (RRs) and mean difference (MD) with 95% confidence intervals (CIs) in a random-effects model. Results: Five RCTs involving 5737 patients (OCT: 2738 and angiography: 2999) were included. On pooled analysis, OCT-guided PCI was associated with a notable reduction in major adverse cardiovascular event (MACE) (RR: 0.71, p = 0.0001), cardiac mortality (RR: 0.43, p = 0.003), target lesion revascularization (TLR) (RR: 0.53, p = 0.007), and stroke (RR: 0.17, p = 0.02), compared to angiography-guided PCI. No significant differences were noted for all-cause mortality and myocardial infarction. Conclusions: In patients with complex coronary lesions, OCT-guided PCI reduces the risk of MACE, cardiac mortality, TLR, and stroke, compared to angiography-guided PCI only. This study supports incorporating advanced imaging techniques like OCT to improve clinical outcomes, especially in complex PCIs. Full article

Background: Peripheral endovascular intervention (PEVI) is routinely performed using standard-dose radiation (SDR), which is associated with elevated levels of radiation. No study has evaluated the outcomes of minimal-dose radiation (MDR) in PEVI. Methods: We performed a prospective observational study of 184 patients (65 ± 12 years) at an academic medical center from January 2019 to March 2020 (mean follow-up of 3.9 ± 3.6 months) and compared the outcomes of MDR (n = 24, 13.0%) and SDR (n = 160, 87.0%) in PEVI. Primary endpoints included air kerma, dose area product (DAP), fluoroscopy time, and contrast use. Secondary endpoints included all-cause mortality, cardiac mortality, acute myocardial infarction, acute kidney injury, stroke, repeat revascularization, vessel dissection/perforation, major adverse limb event, access site complications, and composite of complications. Results: For MDR (68 ± 10 years, mean follow-up of 4.3 ± 5.2 months), the primary endpoints were significantly less than SDR (65 ± 12 years, mean follow-up of 3.8 ± 3.2 months; p < 0.001). Regarding the secondary endpoints, one vessel dissection occurred using MDR, while 36 total complications occurred with SDR (p = 0.037). Conclusions: PEVI using MDR was safe and efficacious. MDR showed a significant decrement in radiation parameters and fluoroscopy time. Therefore, MDR can serve as an effective alternative for PEVI in acute or critical limb ischemia. Full article

Background/Objectives: Randomized studies of patients with unprotected left main coronary artery (ULMCA) disease involve highly selected populations. Therefore, we sought to investigate the 60-month event-free survival of consecutive patients undergoing ULMCA percutaneous coronary intervention (PCI) and determine the best risk score system and independent predictors of event-free survival. Methods: All patients who underwent ULMCA PCI at our center between 1 January 2007 and 31 December 2014 were included. The primary endpoint was the time to cardiac death, target lesion myocardial infarction, or target lesion revascularization (whichever came first) with a follow-up of 60 months. Results: A total of 513 patients (mean age 68 ± 12 years, 64% male, 157 elective, 356 acute) underwent ULMCA PCI. The 60-month incidence of events was 16.8% and 38.0% in elective and acute patients, respectively. There were significantly more events in the acute group during the first 6.5 months. Of the risk scores, the ACEF (AUC = 0.786) and SYNTAX II (AUC = 0.716) scores had the best predictive power in elective and acute patients, respectively. The SYNTAX score proved to be the least predictive in both groups (AUC = 0.638 and 0.614 in the elective and acute groups, respectively). Left ventricular function (hazard ratio (HR) for +10% 0.53 [95% CI, 0.38–0.75] and 0.81 [95% CI, 0.71–0.92] in elective and acute patients, respectively) and, in acute patients, access site (femoral vs. radial HR 1.76 [95% CI, 1.11–2.80]), hyperlipidemia (HR 0.58 [95% CI, 0.39–0.86]), and renal function (HR for +10 mL/min/1.73 m² higher GFR: 0.87 [95% CI, 0.78–0.97]) were independent predictors of event-free survival. Conclusions: Acute ULMCA PCI patients have worse prognosis than elective patients, having more events during the first 6.5 months. Besides anatomical complexity, clinical and procedural parameters determine the prognosis. Full article

Chronic total occlusions (CTOs), defined as complete coronary artery blockages persisting for over three months, are frequently encountered in up to 25% of coronary angiograms. Although percutaneous coronary intervention (PCI) for CTO remains technically challenging, advancements in guidewires, microcatheters, re-entry devices, and intravascular imaging, along with the expertise of specialized operators, have significantly improved procedural success rates, now exceeding 90% in expert centers. While recent evidence, such as the SYNTAX II study, emphasizes the importance of complete revascularization, over half of CTO cases continue to be managed conservatively with optimal medical therapy (OMT), partly due to the limited high-quality randomized evidence supporting revascularization. Observational studies have demonstrated that successful CTO-PCI is associated with improved angina relief, quality of life, left ventricular function, and possibly long-term survival. Extended observational follow-up, such as the Korean and Canadian registries, suggests long-term reductions in cardiac and all-cause mortality with CTO revascularization. However, randomized controlled trials (RCTs) have primarily shown symptomatic benefit, with no consistent reduction in major adverse cardiac events (MACE) or mortality, likely due to limited sample sizes, short follow-up, and treatment crossovers. Various strategies, including the hybrid algorithm, guide CTO interventions by balancing antegrade and retrograde techniques based on lesion complexity. Imaging modalities such as coronary CT angiography and intravascular ultrasound play a pivotal role in planning and optimizing these procedures. Future innovations, such as real-time fusion imaging of CCTA with coronary angiography, may enhance lesion visualization and guidewire navigation. While current guidelines recommend CTO-PCI in selected symptomatic patients with demonstrable ischemia or viable myocardium, the decision should be individualized, incorporating anatomical feasibility, comorbidities, patient preferences, and input from a multidisciplinary Heart Team. Looking ahead, adequately powered RCTs with extended follow-up are essential to determine the long-term clinical impact of CTO-PCI on hard outcomes such as mortality and myocardial infarction. Full article

Background/Objectives: The aim of this study is to identify markers and develop a multifactorial model for characterizing extensive scar tissue after revascularization in patients with myocardial infarction (MI). Methods: A total of 123 patients with MI were examined. The patients underwent contrast-enhanced cardiac magnetic resonance imaging (MRI) with a 1.5 Tesla GE SIGNA Voyager (GE HealthCare, Chicago, IL, USA) on the 7th–10th days from the onset of the disease. At the first stage, we performed a comparative analysis and built a multifactorial model based on the examination results of 92 (75%) patients enrolled from April 2021 to October 2023. These patients formed the group used for model development, or the “modeling group”. The mass of the scar was calculated, including relative to the left ventricular (LV) myocardium mass (M_scar/LVMM, in %). Results: The first subgroup consisted of 36 (39%) patients with a large scar, denoted as “LS” (M_scar/LVMM > 20%). The second subgroup included 56 (61%) patients with a smaller scar, referred to as “SS” (M_scar/LVMM ≤ 20%). Logistic regression was used to identify independent factors affecting scar tissue size. A multifactorial model was created. This model predicts M_scar/LVMM > 20% on MRI. It uses readily available clinical parameters: high-sensitivity troponin I (HscTn I) and N-terminal pro B-type natriuretic peptide (NT-proBNP) levels, and LV relative wall thickness (RWT). We tested the multifactorial model on the “modeling group” (n = 31). The sensitivity was 63.6% and the specificity was 85.7%. Conclusions: These indicates the feasibility of its application in clinical practice. Full article

Myocardial infarction (MI) remains a leading cause of morbidity and mortality worldwide. While timely reperfusion therapies such as percutaneous coronary intervention (PCI) and thrombolysis are essential for salvaging ischemic myocardium, they can paradoxically exacerbate tissue injury through a process known as myocardial infarction reperfusion injury (MIRI). MIRI can contribute to up to 50% of the final infarct size, significantly diminishing the benefits of revascularization and leading to worsened cardiac outcomes. The pathophysiology of MIRI involves complex, interrelated mechanisms including oxidative stress, calcium overload, mitochondrial dysfunction, inflammatory responses, apoptosis, and dysregulated autophagy. Post-reperfusion recovery is further complicated by structural and functional abnormalities such as microvascular obstruction, endothelial dysfunction, and myocardial stunning. Clinically, distinguishing reperfusion injury from ischemic damage is challenging and often requires the use of sensitive biomarkers, such as cardiac troponins, alongside advanced imaging modalities. Although a range of pharmacological (e.g., antioxidants, calcium channel blockers, mitochondrial stabilizers, anti-inflammatory agents) and non-pharmacological (e.g., hypothermia, gene therapy, stem cell-based therapies) interventions have shown promise in preclinical studies, their clinical translation remains limited. This is largely due to the multifactorial and dynamic nature of MIRI. In this context, network pharmacology offers a systems-level approach to understanding the complex biological interactions involved in MIRI, facilitating the identification of multi-target therapeutic strategies. Integrating network pharmacology with omics technologies and precision medicine holds potential for advancing cardioprotective therapies. This review provides a comprehensive analysis of the molecular mechanisms underlying MIRI, examines the current clinical challenges, and explores emerging therapeutic strategies. Emphasis is placed on bridging the translational gap through validated, multi-target approaches and large-scale, multicenter clinical trials. Ultimately, this work aims to support the development of innovative and effective interventions for improving outcomes in patients with myocardial infarction. Full article

Background: Chronic mitral regurgitation (MR) is categorized into primary and secondary MR (SMR). While primary MR arises from structural abnormalities of the mitral valve apparatus, SMR is a consequence of cardiac remodeling, typically due to heart failure or atrial fibrillation. Management strategies differ significantly, with primary MR requiring direct valvular intervention and SMR necessitating a comprehensive approach incorporating guideline-directed medical therapy (GDMT), revascularization, and resynchronization strategies. The MitraClip, a transcatheter edge-to-edge repair (TEER) device, has emerged as a recommended intervention for symptomatic severe SMR despite optimal GDMT. Objectives: This study aims to evaluate national trends in MitraClip placements in the U.S. from 2016 to 2021 and to assess 90-day readmission events following the procedure. Additionally, we analyze patient and socioeconomic factors associated with heart failure readmissions post-MitraClip placement to optimize patient selection criteria. Methods: The study utilized data from the National Inpatient Sample (NIS) for the years 2016–2021 and the National Readmissions Database (NRD) for 2021. Patients who underwent MitraClip placement were identified using ICD-10 code 02UG3JZ. We stratified the population based on demographics, hospital resource utilization, and comorbidities. Index admissions were classified based on the presence or absence of heart failure remissions within 90 days post-procedure. Statistical analyses, including ANOVA and logistic regression, were conducted to identify factors associated with readmissions. Results: MitraClip utilization demonstrated a rising trend from 2016 to 2021, with total annual procedures increasing from 869 to 2488. Mean patient age remained stable at 76–79 years, with a nearly equal sex distribution. In-hospital mortality remained low (1–3%) throughout the study period. A steady increase in hospital charges was observed, alongside a decline in the mean length of stay. Analysis of 4918 index admissions for MitraClip placement in 2021 identified 780 total readmissions within 90 days, with 206 (26.4%) attributed to heart failure. Factors significantly associated with increased risk of heart failure readmissions included atrial fibrillation (OR 3.77, CI 1.82–4.23), pulmonary hypertension (OR 3.96, CI 1.49–5.55), and chronic lung disease (OR 1.91, CI 1.32–2.77). Conclusions: The increasing adoption of MitraClip underscores its growing role in managing SMR. However, heart failure readmissions remain a significant concern. Identifying high-risk patient profiles can refine selection criteria and enhance post-procedural management strategies to improve clinical outcomes. Further research is needed to optimize patient selection and refine risk stratification for MitraClip interventions. Full article

Minimally invasive coronary artery bypass grafting (MI-CABG) has emerged as a transformative approach to coronary revascularization, offering reduced morbidity, faster recovery and improved cosmesis compared to conventional coronary artery bypass grafting (CABG). Performed without full sternotomy and commonly without cardiopulmonary bypass (CPB), MI-CABG encompasses a variety of techniques. These procedures present unique challenges for the anesthesiologist, necessitating a tailored perioperative strategy. This review explores the anesthetic management of MI-CABG, focusing on preoperative assessment, intraoperative techniques, and postoperative care. Preoperative evaluation emphasizes cardiac, respiratory, and vascular considerations, including suitability for one-lung ventilation (OLV) and the impact of comorbidities. Intraoperatively, anesthesiologists must manage hemodynamic instability, ensure effective OLV, and maintain normothermia. Postoperative strategies prioritize multimodal analgesia, early extubation, and rapid mobilization to leverage the benefits of a minimally invasive approach. By integrating surgical and anesthetic perspectives, this review underscores the anesthesiologist’s pivotal role in navigating the physiological demands of MI-CABG. As techniques evolve and experience grows, a comprehensive understanding of these principles will enhance the safety and efficacy of MI-CABG, making it a viable option for an expanding patient population. Full article

Background/Objectives: Polymer-free drug-eluting stents (PF-DESs) aim to mitigate long-term adverse effects associated with polymer-based platforms. However, clinical comparisons with biodegradable polymer DESs (BP-DESs) remain limited. The objective of this review is to assess the efficacy and safety of PF-DESs versus thin-struts (<100 μm) BP-DESs in patients undergoing percutaneous coronary intervention (PCI). Methods: We conducted a systematic review and meta-analysis of randomized controlled trials (RCTs) comparing PF-DESs and BP-DESs in adults undergoing PCI. PubMed, Embase, and CENTRAL were searched up to 1 February 2025. A random-effects model was used to calculate pooled risk ratios (RR) or mean differences (MD) with 95% confidence intervals (CI). Outcomes included myocardial infarction (MI), all-cause and cardiac death, target lesion revascularization (TLR), stent thrombosis, and angiographic/OCT parameters. Subgroup and sensitivity analyses were conducted for outcomes with high heterogeneity (I² > 50%). Results: Nine RCTs (n = 9597) were included. At 12 months, no significant differences were found between PF-DESs and BP-DESs for TLR (RR 1.51; 95% CI: 0.83–2.75), MI, or stent thrombosis. At 24 months, MI and all-cause death were similar between groups. A subgroup analysis showed lower cardiac death with the BioFreedom stent (RR 0.57; 95% CI: 0.35–0.90), not observed in non-BioFreedom devices. No significant differences were detected in angiographic or OCT outcomes, though heterogeneity was high. Conclusions: PF-DESs and BP-DESs demonstrated comparable clinical performance. The observed benefit in cardiac death with BioFreedom may reflect device-specific effects and merits further investigation. Full article

Surgical myocardial revascularization, regardless of the technique used, causes ischemia–reperfusion injury (IRI) in the myocardium mediated by inflammation and degradation of the endothelial glycocalyx (EG). We investigated the difference between on-pump and off-pump techniques in terms of the concentration of proinflammatory interleukin (IL)-18 and the EG degradation products syndecan-1 and hyaluronic acid measured by ELISA in the peripheral and cardiac circulation during open heart surgery and in the early postoperative period. The concentration of IL-18, C-reactive protein (CRP), and cardiac troponin T (cTnT) and the leukocyte count increased statistically significantly in revascularized patients at 24 and 72 h after revascularization compared to the beginning of the procedure and was always statistically significantly higher in on-pump patients. Syndecan-1 and hyaluronic acid only increased in on-pump patients 24 and 72 h after revascularization. IL-18 correlated positively with syndecan-1 and CRP only in the pump setting and with the number of leukocytes in both revascularization regimens 24 and 72 h after the surgery. cTnT and hyaluronic acid did not correlate with IL-18. Our results suggest that IL-18 plays an important role in the early inflammatory response in patients during open heart surgery and in the early postoperative period, leading to additional damage to the EG, while it is probably not responsible for myocardial necrosis. It could serve as a biomarker to identify high-risk patients and as a therapeutic target to reduce inflammation and EG degradation. In addition, measurement of IL-18 could help improve the treatment, recovery, and outcomes of patients after heart surgery. Full article

Coronary microvascular disease (CMVD) is not an uncommon complication after acute myocardial infarction (AMI), independent of prompt revascularization. It is a serious yet underdiagnosed disease that has a major impact on patient outcomes. Even when the infarct-related artery is successfully revascularized, a significant percentage of patients still have compromised microvascular circulation, which is linked to higher cardiovascular mortality and hospitalization for heart failure. The well-known invasive methods, such as the index of microvascular resistance (IMR) and the coronary flow reserve (CFR), have been considered as gold standards. However, they are constrained by their hazards and complexity. Non-invasive techniques, such as echocardiography Doppler for CFR assessment, positron emission tomography (PET), cardiac magnetic resonance imaging (CMR), and some other techniques provide alternatives, but their accessibility, cost and implementation during the peri-AMI period raise obstacles to their wider use. This review highlights both invasive and non-invasive modalities as it examines the diagnostic methods and prognostic significance of CMVD development early after AMI. Enhancing long-term results in this high-risk population requires a thorough understanding of pathophysiology and a commitment to larger diagnostic and prognostic studies for CMVD. Full article

Background: While early risk stratification in STEMI is essential, the threat of cardiogenic shock (CS) persists after revascularization due to reperfusion injury and evolving instability. However, risk prediction in later phases—after revascularization—is less explored, despite its importance in guiding intensive care decisions. This study evaluates machine learning (ML) models for dynamic risk assessment in interventional cardiology and cardiac intensive care unit (CICU) phases, where timely detection of deterioration can guide treatment escalation. Methods: We retrospectively analyzed clinical and procedural data from 158 patients diagnosed with STEMI complicated by cardiogenic shock, treated between 2019 and 2022 at the Cardiology Department of the University Emergency Hospital of Bucharest, Romania. Machine learning models—Random Forest (RF), and Quadratic Discriminant Analysis (QDA)—were developed and tested specifically for the interventional cardiology and CICU phases. Model performance was evaluated using area under the receiver operating characteristic curve (ROC-AUC), accuracy (ACC), sensitivity, specificity, and F1-score. Results: In the interventional phase, RF and QDA achieved the highest accuracy, both reaching 87.50%. In the CICU, RF and QDA demonstrate the best performance, reaching ACCs of 0.843. QDA maintained consistent performance across phases. Relevant predictors included reperfusion strategy, TIMI flow before percutaneous coronary intervention (PCI), Killip class, creatinine, and Creatine Kinase Index (CKI)—all parameters routinely assessed in STEMI patients. These models effectively identified patients at risk for post-reperfusion complications and hemodynamic decline, supporting decisions regarding extended monitoring and ICU-level care. Conclusions: Predictive models implemented in advanced STEMI phases can contribute to dynamic, phase-specific risk reassessment and optimize CICU resource allocation. These findings support the integration of ML-based tools into post-PCI workflows, enabling earlier detection of clinical decline and more efficient deployment of intensive care resources. When combined with earlier-stage models, the inclusion of interventional and CICU phases forms a dynamic, end-to-end risk assessment framework. With further refinement, this system could be implemented as a mobile application to support clinical decisions throughout the STEMI care continuum. Full article

Background/Objectives: Despite the potential benefits, intravascular imaging for guiding percutaneous coronary intervention (PCI) remains underutilized. Recent trials have provided new data, prompting a need for updated insights. This study aimed to perform a comprehensive meta-analysis to compare the clinical outcomes of intravascular imaging-guided PCI versus angiography-guided PCI, thereby evaluating the relative effectiveness of these two guidance strategies in improving patient outcomes. Methods: PubMed, Cochrane Library, Embase and Clinicaltrials.gov databases were systematically searched from inception till 25 November 2024. Randomized clinical trials (RCTs) comparing intravascular imaging with coronary angiography in patients undergoing complex PCI were included. Statistical analysis was conducted using a random effects model to calculate pooled risk ratios with 95% confidence intervals (CI). Results: In this meta-analysis of 21 studies involving 18,043 patients, intravascular image-guided PCI significantly reduced the risk of all-cause mortality by 24%, cardiac mortality by 63%, MACE by 35%, target vessel myocardial infarction by 32%, stent thrombosis by 42%, target vessel revascularization by 45%, target lesion revascularization by 34% and myocardial infarction by 22% compared to angiography-guided PCI. There was no significant difference in bleeding events. Conclusions: Intravascular imaging significantly reduces cardiac events, all-cause mortality and revascularization rates in PCI patients. These findings support its broader adoption and potential updates to clinical guidelines. Full article

Background/Objectives: We sought to confirm the performance and safety of the Pantera Lux paclitaxel-coated balloon (pDCB) when used as per the instructions for use at a single high-volume center. Methods: In this retrospective analysis, 386 consecutive patients were categorized into three groups: the treatment of drug-eluting stent in-stent restenosis (DES-ISR) lesions (n = 191), bare-metal stent in-stent restenosis (BMS-ISR) lesions (n = 127), and de novo lesions (n = 68). The primary endpoint at 12 months was target-lesion revascularization (TLR). Secondary endpoints were device success, target-vessel myocardial infarction (TV-MI), and cardiac death. Results: The baseline characteristics were balanced between the groups, with a median age of 71.3 years, 25% being female, 32% being diabetic. The majority presented with chronic coronary syndrome (82.9%). Type C lesions were more often observed in the DES-IRS group as compared with the BMS-IRS and de novo groups (15.6% vs. 7.9% vs. 7.4%, p < 0.001). Cutting balloons were more often used in the DES-IRS group (41.0% vs. 19.7% vs. 1.5%, p < 0.001). The residual stenosis rate was 7.6% vs. 3.3% vs. 7.3% (p = 0.002). The TLR at 12 months was 8.9% vs. 2.4% vs. 1.5% (p = 0.013). Device success was achieved in 98.8% vs. 98.5% vs. 100% of cases (p = 0.8). TV-MI occurred in 3.2% vs. 0.8% vs. 1.5% (p = 0.5) and cardiac death in 2.6% vs. 0.0% vs. 2.9% (p = 0.13) in DES-IRS vs. BMS-IRS vs. de novo lesions. Conclusions: In this single-center observation, we confirmed the safety and efficacy of the Pantera Lux paclitaxel-coated balloon for the treatment of DES-IRS, BMS-IRS, and de novo lesions with low TLR rates at 12 months. Full article