The Feasibility and Long-Term Outcomes of the Crossboss/Stingray for Treating Coronary Chronic Total Occlusions Lesions with Distal Diffuse Disease Landing Zone.

BACKGROUND: The feasibility and long-term outcomes of the CrossBoss/Stingray for treating coronary chronic total occlusions (CTO) with distal diffuse disease landing zone remain unclear. METHODS: Consecutive CTO patients with distal diffuse lesions that underwent percutaneous coronary intervention by the CrossBoss/Stingray system at Xijing Hospital from April 2016 to October 2020, were included. Patients were analyzed by two groups according to the extent of stenosis in the distal landing zone: 50%-70% stenosis (moderate stenosis group) and >70% stenosis (severe stenosis group). The primary efficacy outcome was technical success, defined as the frequency of true lumen guidewire placement distal to the CTO. The composite endpoint of all-cause death, any stroke, or any revascularization was also explored. RESULTS: A total of 91 consecutive patients were included, with 32 patients in the moderate stenosis group and 59 patients in the severe stenosis group. The mean J-CTO score was 2.5 ± 1.1. The technical success rate was 79.1% (72/91) in the overall population and was similar between the 2 groups: 78.1% (25/32) and 79.7% (47/59) (p = 0.608). No coronary perforation occurred. With a median follow-up of 29 months (IQR: 53-92), the estimated rate of the composite endpoint of all-cause death, any stroke, or any revascularization was 50.4% (all-cause death: 16.6%, any stroke: 1.1%, any revascularization: 36.5%) in the overall population. No significant difference was observed in the rate of the composite endpoint between the moderate stenosis group and the severe stenosis group (45.1% vs. 54.3%, respectively, p = 0.797). CONCLUSIONS: In CTO lesions with distal diffuse disease landing zone, the technical success rates of CrossBoss/Stingray and the long-term clinical outcomes were not significantly different between the moderate stenosis group (50%-70%) and the severe stenosis group (>70%). However, the relatively high rate of long-term clinical outcomes, especially any revascularization, warrants further investigations on this indication in future studies.

One-year clinical results of the NANO registry: A multicenter, prospective all-comers registry study in patients receiving implantation of a polymer-free sirolimus-eluting stent.

OBJECTIVES: We aimed to evaluate the safety and efficacy of Nano+™ (Lepu Medical, Beijing, China) stent implantation in all-comer patients at the 1-year follow-up. BACKGROUND: The Nano+™ stent is a novel polymer-free sirolimus-eluting stent polymer that employs nanoporous stent surface technology to control drug-delivery. The Nano+™ stent is one of the most widely used drug-eluting stent (DES) in China. METHODS: A total of 2,481 consecutive patients were included in the multicenter and prospective NANO registry. In this study, the primary endpoint was target lesion failure (TLF) at 1-year follow-up, defined as a composite of cardiac death, target vessel nonfatal myocardial infarction (TV-MI), and clinically driven target lesion revascularization (TLR). The safety endpoint was the occurrence of definite or probable stent thrombosis (ST). RESULTS: Up to 40.2% of patients presented with acute myocardial infarction (AMI). A total of 63.9% of the 2,904 lesions were American College of Cardiology/American Heart Association (ACC/AHA) type B2 or C lesions. One-year follow-up data were available for 98.4% of patients. The 1-year rate of TLF was 3.1% with rates of 1.3, 1.8, and 0.4% for clinically driven TLR, cardiac death, and TV-MI, respectively. ST occurred in 0.4% of patients. Diabetes mellitus, AMI, left ventricular ejection fraction <40% and long lesions (>40 mm) were independent predictors of 1-year TLF. CONCLUSIONS: The 1-year clinical outcomes were excellent for Nano+™ polymer-free SES implantation in an all-comer patient population. Follow-up will be extended up to 5 years, to further elucidate the potential long-term clinical benefits. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov/. Unique identifier: NCT02929030.

A Randomized Comparison of the Healing Response Between the Firehawk Stent and the Xience Stent in Patients With ST-Segment Elevation Myocardial Infarction at 6 Months of Follow-Up (TARGET STEMI OCT China Trial): An Optical Coherence Tomography Study.

Background: The healing response of the Firehawk stent in patients with ST-segment elevation myocardial infarction (STEMI) remains unclear. Aim: We compared the vascular healing of a biodegradable polymer sirolimus-eluting stent (Firehawk) vs. a durable polymer everolimus-eluting stent (Xience) at 6 months after percutaneous coronary intervention (PCI) in patients with STEMI. Methods: In this prospective, multicenter, randomized, non-inferiority study, patients within 12 h of STEMI onset were randomized in a ratio of 1:1 to receive Firehawk or Xience stents. Optical coherence tomography (OCT) follow-up was performed 6 months after the index procedure and assessed frame by frame. The primary endpoint was the neointimal thickness (NIT) at 6 months evaluated by OCT. The safety endpoint was target lesion failure (TLF) at 12 months. Results: The Firehawk stent was non-inferior to the Xience stent in terms of the neointimal thickness (73.03 ± 33.30 µm vs. 78.96 ± 33.29 µm; absolute difference: -5.94 [one-sided 95% lower confidence bound: -23.09]; P non-inferiority < 0.001). No significant difference was observed between the Firehawk and Xience groups regarding the percentage of uncovered struts (0.55 [0.08, 1.32]% vs. 0.40 [0.21, 1.19]%, P = 0.804), the percentage of malapposed struts (0.17 [0.00, 1.52]% vs. 0.17 [0.00, 0.69]%, P = 0.662), and the healing score (1.56 [0.23, 5.74] vs. 2.12 [0.91, 3.81], P = 0.647). At 12 months, one patient in the Firehawk group experienced a clinically indicated target lesion revascularization. No other TLF events occurred in both groups. Independent risk factors of the NIT included body mass index, hyperlipidemia, B2/C lesions, thrombus G3-G5, thrombus aspiration, and postdilation pressure. Conclusion: In patients with STEMI, Firehawk was non-inferior to Xience in vascular healing at 6 months. Both stents exhibited nearly complete strut coverage, moderate neointimal formation, and minimal strut malapposition. Clinical Trial Number: NCT04150016.

Comparative Quantitative Aortographic Assessment of Regurgitation in Patients Treated With VitaFlow Transcatheter Heart Valve vs. Other Self-Expanding Systems.

OBJECTIVES: To compare the quantitative angiographic aortic regurgitation (AR) of six self-expanding valves after transcatheter aortic valve replacement (TAVR). BACKGROUND: Quantitative videodensitometric aortography (LVOT-AR) is an accurate and reproducible tool for assessment of AR following TAVR. METHODS: This is a retrospective central core-lab analysis of 1,257 consecutive cine aortograms performed post-TAVR. The study included 107 final aortograms of consecutive patients who underwent TAVR with first-generation VitaFlow in four Chinese centers and 1,150 aortograms with five other transcatheter aortic valves (Evolut Pro, Evolut R, CoreValve, Venus A-Valve, and Acurate Neo). LVOT-AR analyses of these five valves were retrieved from a previously published pooled database. RESULTS: Among 172 aortograms of patients treated with VitaFlow, 107 final aortograms (62.2%) were analyzable by LVOT-AR. In this first in man eight cases necessitated a procedural valve in valve due to inappropriate TAVR positioning and severe aortic paravalvular regurgitation. In the VitaFlow group, the mean LVOT-AR of the intermediate aortograms was 7.3 ± 7.8% and the incidence of LVOT-AR >17% was 8.6%. The mean LVOT-AR of the final aortogram was 6.1 ± 6.4% in the VitaFlow group, followed by Evolut Pro (7.3 ± 6.5%), Evolut R (7.9 ± 7.4%), Venus A-valve (8.9 ± 10.0%), Acurate Neo (9.6 ± 9.2%), and lastly CoreValve (13.7 ± 10.7%) (analysis of variance p < 0.001). Post hoc 2-by-2 testing showed that CoreValve had significantly higher LVOT-AR compared with each of the other five THVs. No statistical difference in LVOT-AR was observed between VitaFlow, Evolut Pro, Evolut R, Acurate Neo, and Venus A-valves. The VitaFlow system had the lowest proportion of patients with LVOT-AR >17% (4.7%) (AR after the final aortograms), followed by Evolut Pro (5.3%), Evolut R (8.8%), Acurate Neo (11.3%), Venus A-valve (14.2%), and CoreValve (30.1%) (chi-square p < 0.001). CONCLUSION: Compared to other commercially available self-expanding valves, VitaFlow seems to have a low degree of AR and a low proportion of patients with ≥moderate/severe AR as assessed by quantitative videodensitometric angiography. Once the learning phase is completed, comparisons of AR between different transcatheter heart valves should be attempted in a prospective randomized trial.

12-Month clinical results of drug-coated balloons for de novo coronary lesion in vessels exceeding 3.0 mm.

The purpose of this observational study was to investigate the feasibility, initial safety, and efficacy of the SeQuent® Please DCB (B. Braun Melsungen, Germany) for patients with de novo coronary lesions in vessels exceeding 3.0 mm in a consecutive series of all comer percutaneous coronary intervention. A total of 120 patients (135 lesions) with de novo coronary lesions in vessels ≥ 3.0 mm treated with DCB were enrolled in this single-centre prospective observational study. The primary endpoint was target lesion failure (TLF), a composite endpoint of cardiac death, target vessel-myocardial infarction (TV-MI), and clinically driven target vessel revascularization (TLR) at 12 months. Safety endpoints included cardiac death, TV-MI, and definite target vessel thrombosis. 45.9% of the lesions were classified as complex (type B2/C). The reference vessel diameter was 3.09 ± 0.31 mm measured via quantitative coronary angiography analysis. Coronary dissections occurred in 42 patients (35.0%; Type A-B 14.1%; Type C 19.1%; Type D: 1.6%), two of which [1.6%; (type D dissection)] underwent bail-out stent implantation. 12-month follow-up was completed in 100% patients. The 12-month incidence of TLF was 3.4%. The clinically driven TLR occurred in four patients (3.4%). The incidence of TLR was low in patients without any detectable dissections, similar to those with dissections (3.8% vs. 2.5%; p = 0.146). No patient suffered cardiac death, TV-MI, or target vessel thrombosis. The study shows the feasibility, initial safety, and efficacy of coronary intervention using SeQuent® Please DCB for the treatment of patients with de novo lesion in vessels exceeding 3 mm. The study highlights that the coronary dissection (Type A-C) post DCB treatment occurs frequently but is safe at follow up.