Long-term clinical outcomes following successful percutaneous coronary intervention in patients with extremely long coronary chronic total occlusion lesions.

BACKGROUND: Lesion length is related to worse clinical outcomes following percutaneous coronary intervention (PCI) for the treatment of chronic total occlusion (CTO). However, the data to confirm the association between extremely long lesions and clinical hard endpoints have been limited. Therefore, we investigated the impact of extremely long CTO lesions (≥50 mm, treated lesion length) on the long-term clinical outcomes following successful PCI. METHODS: A total of 333 consecutive patients with CTO who underwent successful PCI with drug-eluting stents (DESs) were allocated to either the extremely long or the short CTO group according to their CTO lesion length. The 5-year clinical outcomes were compared between the two groups. The incidence of myocardial infarction, cardiac death (CD), revascularization, and major adverse cardiovascular events (MACE) was higher in the extremely long CTO group. The 5-year clinical outcomes were analyzed using the Cox hazard ratio (HR) model. RESULTS: In the entire study population, the extremely long CTO lesion was an independent predictor for higher rate of revascularization, MACE, CD, or mortality. CONCLUSIONS: In our study, CTO patients with extremely long lesions (≥50 mm) who underwent successful PCI were associated with a higher risk of worse long-term clinical outcomes, including hard clinical endpoints such as CD and mortality even in the DESs era.

Effect of systolic dysfunction and elevated left ventricular end diastolic pressure on 3-year clinical outcomes in patients with atrial fibrillation.

OBJECTIVES: Systolic and diastolic dysfunctions are related to adverse clinical outcomes in patients with sinus rhythm. The aim of this study was to clarify the prognostic significance of systolic and diastolic dysfunctions in patients with persistent atrial fibrillation (AF). METHODS: We evaluated the data of 114 consecutive patients with persistent AF who underwent measurement of LVEDP at our hospital between March 1, 2011 and December 31, 2014. The patients were divided into two groups according to the left ventricular ejection fraction (LVEF): LVEF < 50 (reduced ejection fraction, REF group) and LVEF ≥50 (preserved EF, PEF group). The PEF group was further divided into two subgroups according to the left ventricular end-diastolic filling pressure (LVEDP): LVEDP > 15 mm Hg and LVEDP ≤ 15 mm Hg subgroups. The 3-year clinical outcomes were compared between the PEF and REF groups and the LVEDP ≥15 mm Hg and LVEDP < 15 mm Hg groups. RESULTS: During the 3-year follow-up period, the rate of heart failure (HF) hospitalization and incidence of AF with rapid ventricular rhythm (RVR) were higher in the REF group than in the PEF group. Multivariate analysis revealed that REF was the only significant predictor of HF hospitalization (hazard ratio, 4.71; 95% confidence interval, 1.48-15.02; p = 0.009). CONCLUSIONS: Our mid-term follow-up data demonstrated that systolic dysfunction was an important predictor of HF hospitalization in patients with AF. However, elevated LVEDP may not be associated with adverse mid-term clinical outcomes in patients without systolic dysfunction.

Early-Stage Vascular Response between Bare Metal Stent and Drug-Free Bioresorbable Vascular Scaffold in the Small-Sized Peripheral Artery: A Preclinical Study in Porcine Femoral Arteries.

BACKGROUND: The clinical benefits and outcomes of the interventional treatment of small-sized infrapopliteal arteries using stent implantation remain uncertain. The aim of this study was to compare the safety and efficacy of drug-free bioresorbable vascular scaffold (BVS) with that of bare metal stent (BMS) in endovascular treatment of small-sized peripheral arteries. METHODS: In this study, drug-free BVS and BMS were used in eight porcine models. We compared the angiographic and histomorphometric findings in the two groups at 4 weeks. In each pig, BVS and BMS of adequate sizes were implanted in the small branch (<3 mm) of the femoral artery. Angiography, intravascular ultrasound (IVUS), and histomorphometric analysis were performed at 4 weeks. RESULTS: In the 4-week follow-up angiography and IVUS examination, the minimal luminal diameter was smaller and diameter stenosis was more severe in the BVS group. Histomorphometric findings indicated that the lumen area in the BVS group was smaller (0.34 ± 0.28 mm2 vs. 1.40 ± 0.52 mm2, P < 0.001), whereas the neointimal area (2.70 ± 1.28 mm2 vs. 1.76 ± 0.66 mm2, P = 0.013), area stenosis (85.18 ± 13.14 % vs. 54.99 ± 16.13 %, P < 0.001), inflammatory score (2.07 ± 0.861 vs. 28 ± 0.39, P = 0.003), and fibrin scores (1.24 ± 0.70 vs. 0.79 ± 0.72, P = 0.043) were significantly higher in the BVS group. The injury score was higher in the BMS group. In histopathologic findings, restenosis was mainly due to recoil and distortion of the scaffold in the BVS group. CONCLUSIONS: Compared with BMS, drug-free BVS was not feasible for small-sized peripheral arteries based on the angiographic, IVUS, and histomorphometric results primarily due to insufficient mechanical support.

Assessment of Cutting-Balloon Angioplasty with Novel Bioabsorbable Polymer-Coated Everolimus-Eluting Stent in Treating Calcified Coronary Lesions Guided by Intravascular Ultrasound (CUPID Trial): study design and protocol.

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.

Three-Year Clinical Outcomes With the Cilotax Dual Drug-Eluting Stent vs Everolimus-Eluting Stents in Patients With Acute Myocardial Infarction.

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.

Impact of cigarette smoking on long-term clinical outcomes in patients with coronary chronic total occlusion lesions.

Cigarette smoking is a significant risk factor for coronary artery disease. However, there is insufficient evidence regarding the long-term clinical effects of smoking in Asian populations with chronic total occlusion (CTO). This study aimed to assess the effects of smoking on 5-year (median follow-up period, 4.2 ± 1.5 [interquartile range, 4.06-5.0] years) clinical outcomes in patients with CTO lesions who underwent percutaneous coronary intervention (PCI) or medical treatment (MT). We enrolled 681 consecutive patients with CTO who underwent diagnostic coronary angiography and subsequent PCI or MT. The patients were categorized into smokers (n = 304) and nonsmokers (n = 377). The primary endpoint was major adverse cardiovascular events (MACE), including a composite of all-cause death, myocardial infarction, and revascularization over a 5-year period. Propensity score matching (PSM) analysis was performed to adjust for potential baseline confounders. After PSM analysis, two propensity-matched groups (200 pairs, n = 400) were generated, and the baseline characteristics of both groups were balanced. The smokers exhibited a higher cardiovascular risk of MACE (29.5% vs. 18.5%, p = 0.010) and non-TVR (17.5 vs. 10.5%, p = 0.044) than the nonsmokers. In a landmark analysis using Kaplan-Meier curves at 1 year, the smokers had a significantly higher rate of MACE in the early period (up to 1 year) (18.8% and 9.2%, respectively; p = 0.008) compared with the nonsmokers. The Cox hazard regression analysis with propensity score adjustment revealed that smoking was independently associated with an increased risk of MACE. These findings indicate that smoking is a strong cardiovascular risk factor in patients with CTO, regardless of the treatment strategy (PCI or MT). In addition, in the subgroup analysis, the risk of MACE was most prominently elevated in the group of smokers who underwent PCI.

Randomized clinical trial to compare the efficacy of self-expanding bare metal nitinol stent and balloon angioplasty alone for below-the-knee lesions following successful balloon angioplasty: 1-year clinical outcomes.

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).

Stenting versus balloon angioplasty alone in patients with below-the-knee disease: A propensity score-matched analysis.

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.

Impact of chronic total occlusion lesion length on six-month angiographic and 2-year clinical outcomes.

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.