One-stage hybrid coronary revascularization for the treatment of multivessel coronary artery disease- Periprocedural and long-term results from the "HYBRID-COR" feasibility study.

Background: The constant growth of interest in hybrid coronary artery revascularization (HCR) is apparent. Yet, few studies report outcomes of the one-stage HCR. Consequently, the status of such procedures is not adequately supported in clinical guidelines. The aim of this study was to report the safety, feasibility, and long term-outcomes of the one-stage HCR. Methods and results: Patients were enrolled in the prospective one-stage hybrid coronary revascularization program (HYBRID-COR). They underwent a one-stage hybrid revascularization procedure while on double antiplatelet therapy (DAPT) with Ticagrelor: endoscopic atraumatic coronary artery bypass grafting (EACAB) for revascularization of the left anterior descending (LAD) artery and percutaneous intervention in non-LAD arteries with contemporary drug-eluting stents. The composite primary endpoint included MACCE (major adverse cardiac and cerebrovascular events: death, myocardial infarction, stroke, and repeated revascularization) in long-term observation. The study cohort consisted of 30 patients (68% male) with stable coronary artery disease (26.7%) and unstable angina (73.3%). Procedural success was 100%. No death, myocardial infarction (MI), or stroke were observed in the perioperative period. One patient (3.3%) required chest revision and blood transfusion due to surgical bleeding. Kidney injury was noted in two patients (6.6%). In a long-term follow-up (median; IQR: 4.25; 2.62-4.69 years), two patients (6.6%) underwent repeated revascularization and one patient (3.3%) died due to MI. The overall primary endpoint rate was 9.9%. Conclusion: One-stage hybrid revascularization, on DAPT, is a feasible, safe, and efficient way of achieving complete revascularization in selected patients. The complication rate is low and acceptable. Further randomized trials are required.

Neointimal hyperplasia of ultra-thin stents with microcrystalline sirolimus or durable polymer everolimus-eluting stents: 6- and 24-month results of the DESSOLVE III OCT study.

AIMS: The DESSOLVE III OCT substudy aimed to compare serially neointimal hyperplasia volume obstruction (%VO) between the thin-strut MiStent with early polymer elimination and nine-month sustained drug release from microcrystalline sirolimus and the durable polymer-coated everolimus-eluting XIENCE stent at six and 24 months after implantation. METHODS AND RESULTS: The efficacy endpoint was %VO, calculated as abluminal neointimal volume/stent volume. Thirty-six patients (MiStent 16 patients, 16 lesions; XIENCE 20 patients, 22 lesions) underwent serial OCT evaluation at both six and 24 months. At six months, mean abluminal %VO was significantly lower in the MiStent group than in the XIENCE group (14.54±3.70% vs 19.11±6.70%; p=0.011), whereas the difference in %VO between the two groups decreased at 24 months (20.88±5.72% vs 23.50±7.33%; p=0.24). There was no significant difference in percentage malapposed struts and percentage uncovered struts between the two groups at both time points. CONCLUSIONS: In the serial comparative OCT analysis of the MiStent versus the XIENCE, the MiStent showed a more favourable efficacy for preventing neointimal formation with comparable strut tissue coverage, as compared with the XIENCE at six months, but this difference in %VO decreased at 24 months so that the difference in neointima at 24 months was no longer significant.

Renal Artery Stenting Associated With Improvement in Renal Function and Blood Pressure Control in Long-Term Follow-Up.

BACKGROUND/AIMS: Clinical benefits of percutaneous treatment of renal artery stenosis (RAS) remain controversial. The aim of this study was to evaluate the effects of renal artery stenting on kidney function and blood pressure (BP) control in the log-term follow-up. Additionally angiographic follow up was performed in selected subgroup of patients. METHODS: The study was designed as international registry of 265 consecutive patients with RAS treated with renal artery stenting. The primary end-point of the study was the change in renal function and blood pressure at long-term follow-up as compared with baseline values. Evaluation of the renal function was based on estimated glomerular filtration rate (eGFR) with the use of the modification of diet in renal disease (MDRD) formula. RESULTS: All patients had clinical follow-up at the median time of 23.8 (interquartile range: 3-90) months during ambulatory visits. At follow-up eGFR improved in 53,9% of patients. These patients had lower pre-procedural systolic BP, more severe lesion type at baseline and lower diameter stenosis in control angiography. At follow up visits, SBP improvement was observed in 77,4% of patients. The average number of anti-hypertensive medications before the procedure and at follow up did not change significantly (2,70±1,0 vs 2,49±0,9, p=0,1). Restenosis rate based on control angiography performed at median time of 15 months was 12%. CONCLUSION: The results of the study suggest that interventional treatment of RAS may preserve renal function and improve blood pressure control at long-term follow-up.

Stenting and Adjunctive Delivery of Paclitaxel Via Balloon Coating Versus Durable Polymeric Matrix for De Novo Coronary Lesions: Clinical and Angiographic Results from the Prospective Randomized Trial.

BACKGROUND: There is limited comparative clinical data regarding the safety and efficacy profile of paclitaxel delivery via balloon versus stent-polymer matrix. In this study, we aimed to compare the clinical and angiographic results of two different methods of paclitaxel delivery among patients undergoing percutaneous coronary intervention (PCI) for single de novo coronary lesions. METHODS: A total of 202 patients undergoing PCI due to symptomatic heart disease and at least one significant coronary artery lesion were prospectively enrolled in a multicenter non-inferiority trial. Eligible patients were randomized to a revascularization with either a paclitaxel eluting stent (PES = Coroflex Please, B.Braun) or a bare metal stent (BMS) followed by a paclitaxel coated balloon (PCB) dilation (BMS = Coroflex + PCB = Sequent Please, B.Braun). Clinical follow-up was obtained at 9 months in all patients, whereas angiographic in a subset of 94 (46.5%) patients. RESULTS: The baseline characteristics were well balanced between groups. At 9 months, the primary endpoint of in-stent late lumen loss in BMS + PCB was comparable and non-inferior to PES (0.21 ± 0.5 vs. 0.30 ± 0.7 mm, respectively. P(non-inf) < 0.05). At 9 months, the incidence of MACE (7.0 vs. 6.9%, HR = 1, 95%CI: 0.3-2.8; P = 0.99), comprising the occurrence of myocardial infarction (4.9 vs. 3.0%, HR = 1.62, 95%CI: 0.4-6.5; P = 0.32), target lesion revascularization (6.9 vs. 5.0%, HR = 1.42, 95%CI: 0.4-4.4; p = 0.54) and stent thrombosis (4.9 vs. 3.0%, HR = 2.01, 95%CI: 0.5-7.4; P = 0.74) was comparable between BMS + PCB and PES, respectively. In the BMS + PCB group, thrombosis tended to occur within 30 days (3.9 vs. 1.0%; P = 0.38). CONCLUSIONS: Paclitaxel delivery via drug coated balloon or polymer-stent matrix achieved comparable angiographic and clinical results among patients with de novo coronary lesions. BMS + PCB revascularization was associated with a higher rate of stent thrombosis when compared to newer generation drug eluting stents, therefore, should be recommended as a bail-out for PCB alone angioplasty.

Vascular response and mechanical integrity of the new biodegradable polymer coated sirolimus-eluting PROLIM stent implanted in porcine coronary arteries.

BACKGROUND: Although durable polymer coated drug-eluting stents (DES) are standard care in percutaneous coronary interventions, new stent platforms employing biodegradable polymer based drug delivery are increasingly being used in clinical practice. AIM: To evaluate the short- (28 days) and medium-term (90 days) vascular effects of the new biodegradable polymer coated sirolimus-eluting stent - the PROLIM stent. METHODS: The objectives of the study were evaluated using standard angiographic and histological methods. In addition, the mechanical integrity of tested stents was assessed using Faxitron imaging. A total of 12 PROLIM stents, 11 biodegradable polymer only coated stents (BPCS), and 12 bare metal stents (BMS) were implanted in the coronary arteries of 16 female non-atheroslerotic domestic swine using an overstretch of 1.1:1.0. RESULTS: At 28 days, neointimal proliferation was significantly lower in the PROLIM and BMS stents compared to the BPCS stents (p ≤ 0.05). Interestingly, despite thin neointima found at this time in the PROLIM group, there was a further significant decrease in neointimal formation between 28 and 90 days (p = 0.04). Although a statistically bigger neointima was found in BPCS stents at 28 days compared to the PROLIM and BMS stents, there was a 50% decrease in the neointimal area at 90 days follow-up (p = 0.02) which reached the level seen in other groups. The endothelialisation was completed in all tested stents after 28 days. There was a significant increase of fibrin depositions in the PROLIM treated arteries at 28 days which were resorbed nearly completely at 90 days follow-up. At 28 days, the inflammatory response was found to be numerically higher in the BPCS stents (p = NS) compared to other tested groups. On the contrary, at 90 days follow-up when the degradation process of the polymer had been completed, the inflammatory reaction decreased substantially to the level seen in the PROLIM and BMS stents. Faxitron analysis of the stented arteries revealed no major abnormalities except for isolated strut fractures observed in the mid portions of two BMS stents and one BPCS stent. CONCLUSIONS: The PROLIM - a biodegradable polymer coated sirolimus-eluting stent - demonstrates very good short-term and medium-term angiographic and histological results. The lack of 'catch-up phenomenon', fast endothelialisation process, and minimal inflammatory reaction may contribute to favourable clinical outcomes using PROLIM stents.

The new Polish stent Chopin. Assessment of safety and efficacy in the treatment of de-novo coronary lesions using percutaneous angioplasty.

AIM: The aim of the present study was to assess the safety and efficacy of percutaneous coronary interventions (PCI) using the new Polish stent "Chopin" (Balton, Poland). METHODS: The study consisted of experimental and clinical parts. In the experimental phase, the new stent was implanted into 5 pigs and control coronary angiography as well as intracoronary ultrasonography (ICUS) were performed 30 days later. In the clinical phase, 101 patients (57% of males, mean age 55.6+/-10 years) with symptomatic coronary artery disease (CAD) with "de novo" coronary lesions (including 12% of patients with unstable angina and 19% with acute myocardial infarction [MI]) underwent stent implantation. The patients were followed for 6 months for the occurrence of cardiac events. Quantitative coronary angiography was performed at baseline and after 6 months. RESULTS: In total, we attempted to implant 107 stents, which resulted in the successful deployment of 106 stents to 105 coronary arteries. The mean diameter of the stents was 3.2+/-0.3 mm, and length - 15.4+/-2 mm. During a one month follow-up period no cardiac events were noted. During a 6-month follow-up no death or new MI were recorded. Repeated target vessel revascularisation due to recurrent angina and in-stent restenosis was required in 15 (15.5%) patients. Control coronary angiography was performed in 97 (96%) patients. Of 101 stents, angiographic restenosis (narrowing of dilated lesion by >50% of vessel lumen) was documented in 18.8% of cases. The mean late vessel lumen loss was 0.77+/-0.6 mm, and stenosis - 29.1+/-20%. The restenosis rate was significantly higher in patients with unstable angina rather than in those with stable angina or acute MI. CONCLUSIONS: Implantation of the new Polish stent "Chopin" during PCI is safe and effective.