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Abstract Background Various devices and techniques have been used for plaque modification in the treatment of severe coronary artery calcification. This prospective, multicenter, randomized, open-label study aims to evaluate the safety and efficacy of cutting balloon angioplasty using a novel bioabsorbable polymer-coated everolimus-eluting coronary stent for treating various degrees of calcified coronary lesions. Methods We outline the trial design aimed at assessing whether the cutting balloon (Wolverine™) is non-inferior to the non-compliant balloon in treating patients with calcified lesions, encompassing both de novo and in-stent restenosis (ISR) lesions. We aim to enroll 250 patients who have undergone bioabsorbable polymer-coated everolimus-eluting coronary stent (Synergy™) implantation. The primary endpoint is the minimal stent cross-sectional area at the calcium site as determined by intravascular ultrasonography. The secondary endpoints include major adverse cardiac events and target lesion revascularization at 12 months, alongside procedural convenience and operator-centric parameters, such as the number of balloons used, procedure time, and total contrast medium volume used. Discussion In this study, we will evaluate the efficacy and safety of Wolverine™ and non-compliant balloon in patients with calcified coronary lesions and provide a rationale for which type of balloons will optimally modify calcium lesions. In addition, we will attempt to expand the indications of the cutting balloon for treating mild-to-severe calcified coronary lesions. As the scope of insurance coverage for cutting balloons remains limited in some countries, this study may provide evidence for extending insurance coverage to the treatment of de novo calcified and ISR lesions. Trial registration ClinicalTrials.gov NCT06177808. Registered on January 1, 2024. more...

Background This study compared the safety and effectiveness of paclitaxel/cilostazol–eluting Cilotax stents with those of everolimus-eluting stents in patients with acute myocardial infarction. Real-world data from the Korea Acute Myocardial Infarction Registry were examined. Methods A total of 5,472 patients with acute myocardial infarction underwent percutaneous coronary intervention with Cilotax stents (n = 212) or everolimus-eluting stents (n = 5,260). The primary end point was the 3-year rate of target lesion failure. The other end points were major adverse cardiovascular events (a composite of cardiac death, target vessel myocardial infarction, and ischemia-driven target lesion revascularization), target vessel revascularization, and stent thrombosis. A propensity score matching analysis was performed to adjust for potential confounders by using a logistic regression model; propensity score matching generated 2 well-balanced groups (Cilotax group, n = 180; everolimus-eluting stents group, n = 170; N = 350). After propensity score matching, baseline clinical characteristics were similar between the groups. Results After percutaneous coronary intervention, compared with the everolimus-eluting stents group, the Cilotax group more often had major adverse cardiovascular events (24.1% vs 18.5%; P = .042), myocardial infarction (8.0% vs 3.2%; P < .001), target lesion revascularization (8.0% vs 2.6%; P < .001), target vessel revascularization (11.3% vs 4.5%; P < .001), and stent thrombosis (4.7% vs 0.5%; P < .001) before matching. Even after matching, the Cilotax group had more frequent target lesion revascularization (9.4% vs 2.9%; P = .22) and stent thrombosis (5.6% vs 1.2%; P = .34). Conclusion In patients with acute myocardial infarction who underwent percutaneous coronary intervention, use of the Cilotax stent was associated with higher rates of target lesion revascularization, target vessel revascularization, and stent thrombosis than were everolimus-eluting stents. Use of the Cilotax dual drugeluting stent should be avoided in the treatment of myocardial infarction. more...

Abstract We introduce HAPPY (Hierarchically Abstracted rePeat unit of PolYmers), a string representation for polymers, designed to efficiently encapsulate essential polymer structure features for property prediction. HAPPY assigns single constituent elements to groups of sub-structures and employs grammatically complete and independent connectors between chemical linkages. Using a limited number of datapoints, we trained neural networks utilizing both HAPPY and conventional SMILES encoding of repeated unit structures and compared their performance in predicting five polymer properties: dielectric constant, glass transition temperature, thermal conductivity, solubility, and density. The results showed that the HAPPY-based network could achieve higher prediction R-squared score and two-fold faster training times. We further tested the robustness and versatility of HAPPY-based network with an augmented training dataset. Additionally, we present topo-HAPPY (Topological HAPPY), an extension that incorporates topological details of the constituent connectivity, leading to improved solubility and glass transition temperature prediction R-squared score. more...

This prospective, multicenter, randomized study aimed to compare the 1-year clinical outcomes after primary stenting with self-expanding bare metal nitinol stent (SENS) and plain old balloon angioplasty (POBA) in patients with critical limb ischemia (CLI) and below-the-knee (BTK) lesions. Overall, 119 patients with CLI and BTK lesions were randomized to POBA alone (POBA group, 61 patients) or primary stenting with SENS (stenting group, 58 patients) after achieving acceptable POBA results in target BTK lesions. Clinical outcomes including amputation and revascularization rates were prospectively compared for 1 year. After 1 year, similar incidence rates of individual clinical endpoints, including cardiac death (6.5% vs. 5.1%, p > 0.999), myocardial infarction (1.6% vs. 0.0%, p > 0.999), repeat revascularization (19.6% vs. 18.9%, p = 0.922), target lesion revascularization (13.1% vs. 17.2%, p = 0.530), and amputation (4.9% vs. 0.0%, p = 0.244), were observed. POBA appeared to have acceptable treatment outcomes compared with primary stenting with SENS after 1 year in CLI patients with BTK lesions undergoing percutaneous transluminal angioplasty (PTA). more...

Percutaneous transluminal angioplasty (PTA) is considered an effective treatment in patients with critical limb ischemia (CLI). However, the long-term durability of below-the-knee (BTK) PTA is known to be limited. This study sought to compare the 1-year clinical outcomes following stenting versus balloon angioplasty alone in BTK lesions. This study included 357 consecutive patients (400 limbs, 697 lesions) with BTK lesions who underwent PTA from September 2010 to December 2016. All enrolled patients were treated either by stenting (stent group; 111 limbs of 102 patients) or plain old balloon angioplasty (POBA group; 289 limbs of 255 patients). Stent group includes both primary and provisional stenting. Angiographic outcomes, procedural success, complications, and clinical outcomes were compared between the two groups up to 1 year. After propensity score matching (PSM) analysis, 56 pairs were generated, and the baseline and angiographic characteristics were balanced. The procedural success and complications were similar between the two groups; however, the incidence of procedure-related perforation was higher in the POBA group than in the stenting group [5(11.9%) vs.1 (0.9%), P = 0.009]. Six- to 9-month computed tomography or angiographic follow-up showed similar incidences of binary restenosis, primary patency, and secondary patency. In the 1-year clinical follow-up, there were similar incidences of individual hard endpoints, including mortality, myocardial infarction, limb salvage, and amputation rate, with the exception of target extremity revascularization (TER), which tended to be higher in the stenting group than in the POBA group [21 (20.8%) vs. 11 (10.9%), P = 0.054]. Although there was a trend toward a higher incidence of TER risk in the stenting group, stent implantation, particularly in bail-out stenting seemed to have acceptable 1-year safety and efficacy compared to POBA alone in patients undergoing BTK PTA. more...

BACKGROUND:Successful management of chronic total occlusion (CTO)by percutaneous coronary intervention (PCI) is known to be associated with better clinical outcomes than failed PCI. However, whether angiographic and clinical outcomes following PCI for long CTO lesions differ from those following PCI for short CTO lesions in the drug eluting stent (DES) era remains unknown. We therefore investigated whether CTO lesion length can significantly influence6-month angiographic and 2-year clinical outcomes following successful CTO PCI. METHODS AND RESULTS:A total of 235 consecutive patients who underwent successful CTO intervention were allocated into either the long or short CTO group according to CTO lesion length. Six-month angiographic and 2-year clinical outcomes were then compared between the 2groups. We found that baseline clinical characteristics were generally similar between the 2 groups. Exceptions were prior PCI, which was more frequent in the long CTO group, and bifurcation lesions, which were more frequent in the short CTO group. Apart from intimal dissection, which was more frequent in the long than short CTO group, in-hospital complications were also similarly frequent between the 2groups. Furthermore, both groups had similar angiographic outcomes at 6 months and clinical outcomes at 2 years. However, the incidence of repeat PCI(predominantly target vessel revascularization),was higher in the long than short CTO group, with our multivariate analysis identifying long CTO as an important predictor of repeat PCI (odds ratio, 4.26;95% confidence interval, 1.53-11.9; p = 0.006). CONCLUSION:The safety profile, 6-month angiographic, and 2-year clinical outcomes of CTO PCI were similar between patients with long and short CTO. However, there was a higher incidence of repeat PCI in long CTO patients despite successful PCI with DESs. more...

Background There are limited data comparing long-term clinical outcomes between first-generation (1G) and second-generation (2G) drug-eluting stents (DESs) in patients who underwent successful percutaneous coronary intervention (PCI) for coronary chronic total occlusion (CTO) lesion. Methods A total of 840 consecutive patients who underwent PCI with DESs for CTO lesion from January 2004 to November 2015 were enrolled. Finally, a total of 324 eligible CTO patients received 1G-DES (Paclitaxel-eluting stent or Sirolimus-eluting stent, n = 157) or 2G-DES (Zotarolimus-eluting stent or Everolimus-eluting stent, n = 167) were enrolled. The clinical endpoint was the occurrence of major adverse cardiac events (MACE) defined as all-cause death, recurrent myocardial infarction (re-MI), total repeat revascularization [target lesion revascularization (TLR), target vessel revascularization (TVR), and non-TVR]. We investigated the 5-year major clinical outcomes between 1G-DES and 2G-DES in patient who underwent successful CTO PCI. Results After propensity score matched (PSM) analysis, two well-balanced groups (111 pairs, n = 222, C-statistic = 0.718) were generated. Up to the 5-year follow-up period, the cumulative incidence of all-cause death, re-MI, TLR, TVR and non-TVR were not significantly different between the two groups. Finally, MACE was also similar between the two groups (HR = 1.557, 95% CI: 0.820-2.959, P = 0.176) after PSM. Conclusions In this study, 2G-DES was not associated with reduced long-term MACE compared with 1G-DES following successful CTO revascularization up to five years. [ABSTRACT FROM AUTHOR] more...

Background In real practice, two or more antihypertensive drugs are needed to achieve target blood pressure. We investigated the comparative beneficial actions of combination therapy of renin-angiotensin system inhibitors (RASI), with calcium channel blockers (CCB) over CCB monotherapy on the development of new-onset diabetes mellitus (NODM) in Korean patients during four-year follow-up periods. Methods A total of 3208 consecutive hypertensive patients without a history of diabetes mellitus who had been prescribed CCB were retrospectively enrolled from January 2004 to December 2012. These patients were divided into the two groups according to the additional use of RASI (the RASI group, n = 1221 and the no RASI group, n = 1987). Primary endpoint was NODM, defined as a fasting blood glucose ≥ 126 mg/dL or hemoglobin A1c ≥ 6.5%. Secondary endpoint was major adverse cardiac events (MACE) defined as total death, myocardial infarction (MI) and percutaneous coronary intervention (PCI). Results After propensity score-matched (PSM) analysis, two propensity-matched groups (939 pairs, n = 1878, C-statistic = 0.743) were generated. The incidences of NODM (HR = 1.009, 95% CI: 0.700-1.452, P = 0.962), MACE (HR = 0.877, 95% CI: 0.544-1.413, P = 0.589), total death, MI, PCI were similar between the two groups after PSM during four years. Conclusions The use of RASI in addition to CCB showed comparable incidences of NODM and MACE compared to CCB monotherapy in non-diabetic hypertensive Korean patients during four-year follow-up period. However, large-scaled randomized controlled clinical trials will be required for a more definitive conclusion. [ABSTRACT FROM AUTHOR] more...