Adam Janas

Left Main Stenting in Comparison With Surgical Revascularization: 10-Year Outcomes of the (Left Main Coronary Artery Stenting) LE MANS Trial

OBJECTIVES This study has reported 10-year clinical follow-up of patients enrolled in the prospective, randomized LE MANS (Left Main Stenting) trial. BACKGROUND The very long-term outcome after left main stenting in comparison with surgical revascularization remains unknown. METHODS In this prospective, multicenter trial, we randomly assigned 105 patients with unprotected left main coronary artery stenosis with low and medium complexity of coexisting coronary artery disease according to SYNTAX (Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery) score to percutaneous coronary intervention (PCI) with stenting (n = 52) or coronary artery bypass grafting (CABG) (n = 53). Drug-eluting stents were implanted in 35%, whereas arterial grafts to the left anterior descending artery were utilized in 81%. Currently, the mean long-term follow-up was collected at 9.8 ± 1.0 years. Follow up for all-cause mortality is complete, whereas the incidence of major adverse cardiovascular and cerebral events (MACCE) was reported from 90% of patients. Ambulatory follow-up was completed in 46 (43.9%) patients. RESULTS At 10 years, there was a trend toward higher ejection fraction in stenting when compared with surgery (54.9 ± 8.3% vs. 49.8 ± 10.3%; p = 0.07). The mortality (21.6% vs. 30.2%; p = 0.41) and MACCE (51.1% vs. 64.4%; p = 0.28) were statistically not different between groups; however, numerically the difference was in favor of stenting. Similarly, there was no difference in the occurrence of myocardial infarction (8.7 vs. 10.4%; p = 0.62), stroke (4.3 vs. 6.3%; p = 0.68), and repeated revascularization rates (26.1% vs. 31.3%; p = 0.64). The probability of very long-term survival up to 14 years was comparable between PCI and CABG (74.2% vs. 67.5%; p = 0.34; hazard ratio: 1.45, 95% confidence interval: 0.67 to 3.13); however, there was a trend toward higher MACCE-free survival in the PCI group (34.7% vs. 22.1%; p = 0.06; hazard ratio: 1.71, 95% confidence interval: 0.97 to 2.99). CONCLUSIONS In patients with unprotected left main coronary artery stenosis with low and medium complexity of coexisting coronary artery disease, stenting offers numerically, but statistically nonsignificant, favorable long-term outcome up to 10 years in terms of safety and efficacy outcome measures, therefore, constitutes an alternative therapy for CABG.

A Nuclear Magnetic Resonance Spectroscopy as a Method for Evaluation of In Vivo Poly-l-Lactide Biodegradation Kinetics From Stent-Polymer Matrices An Experimental Study Utilizing Porcine Model of In-Stent Restenosis

Objectives: We aimed to comprehensively evaluate poly-lactide polymer degradation and sirolimus release kinetics from a drug-eluting stent matrix in the in vivo setting using a nuclear magnetic resonance (NMR) method. Methods: In 22 domestic swine, 18 biodegradable polymer-only coated stents (BPSs) and 36 biodegradable polymer-coated sirolimus-eluting stents (BP-SES) were implanted in coronary arteries with 115% overstretch. The animals were sacrificed at 1, 3, 7, 14, 28, and 56 days following baseline procedures. Vessel segments with BPS were harvested to evaluate polymer degradation with a NMR method, whereas BP-SES to analyze sirolimus tissue uptake and retention. Additionally, 8 BP-SES were implanted for histological analysis for 90 days of follow-up. Results: The NMR showed a gradual absorption of the polymer over the 6 consecutive time points, from 5.48 µg of the polymer on the stent at 1-day follow-up, through 4.33 µg at 3 days, 3.16 µg at 7 days, 2.42 µg at 14 days, 1.92 µg at 28 days to 1.24 µg in the last day of the study. The curve of polymer degradation corresponds well with the pharmacokinetic profile of sirolimus eluted from its surface and measured at identical time points. In histopathology, at 90 days, complete healing and biocompatibility were reported. Conclusions: The utilization of NMR method for BP absorption kinetics evaluation is a useful tool, which may be widely adopted to test other biodegradable implants. Further, it may substantially improve their safety and efficacy by facilitating programmed polymer and drugs elution.

Comparison of Stenting and Surgical Revascularization Strategy in Non-ST Elevation Acute Coronary Syndromes and Complex Coronary Artery Disease (from the Milestone Registry)

The optimal revascularization strategy in patients with complex coronary artery disease and non-ST-segment elevation acute coronary syndromes is undetermined. In this multicenter, prospective registry, 4,566 patients with non-ST-segment elevation myocardial infarctions, unstable angina, and multivessel coronary disease, including left main disease, were enrolled. After angiography, 3,033 patients were selected for stenting (10.3% received drug-eluting stents) and 1,533 for coronary artery bypass grafting. Propensity scores were used for baseline characteristic matching and result adjustment. Patients selected for percutaneous coronary intervention (PCI) were younger (mean age 64.4±10 vs 65.2±9 years, p=0.03) and more frequently presented with non-ST-segment elevation myocardial infarctions (32.0% vs 14.5%, p=0.01), cardiogenic shock (1.5% vs 0.7%, p<0.01), and history of PCI (13.1% vs 5.5%, p<0.01) or coronary artery bypass grafting (10.6% vs 4.6%, p<0.01). European System for Cardiac Operative Risk Evaluation scores were higher in PCI patients (5.4±2 vs 5.2±2, p<0.01). Patients referred for coronary artery bypass grafting more often presented with triple-vessel disease and left main disease (82.2% vs 33.8% and 13.7% vs 2.4%, respectively, p<0.01). After adjustment, 929 well-matched pairs were chosen. Early mortality was lower after PCI before matching (2.1% vs 3.1%, p<0.01), whereas after balancing, there was no difference (2.5% vs 2.8%, p=0.62). Three-year survival was in favor of PCI compared with surgery before (87.5% vs 82.8%, hazard ratio 1.44, 95% confidence interval 1.2 to 1.7, p<0.01) and after (86.4% vs 82.3%, hazard ratio 1.33, 95% confidence interval 1.05 to 1.7, p=0.01). Stenting was associated with improved outcomes in the following subgroups: patients aged >65 years, women, patients with unstable angina, those with European System for Cardiac Operative Risk Evaluation scores>5, those with Thrombolysis In Myocardial Infarction (TIMI) risk scores >4, those receiving drug-eluting stents, and those with 2-vessel disease. In conclusion, in patients presenting with non-ST-segment elevation acute coronary syndromes and complex coronary artery disease, immediate stenting was associated with lower mortality risk in the long term compared with surgical revascularization, especially in subgroups at high clinical risk.

MynxGrip for Closure of Antegrade Puncture After Peripheral Interventions With Same-Day Discharge

Background: This was the first prospective study to assess the safety and efficiency of MynxGrip vascular closure device (VCD) in peripheral interventions with antegrade access. Methods and Results: We enrolled 66 consecutive patients from 1 center. All patients were discharged home on the day of procedure and were observed for adverse events at 1 and 30 days of follow-up. No major complications were observed. The rate of minor complications (conversion to manual or mechanical compression) was 7.6%. Postdischarge, 3% of patients experienced minor complications—small abscess, ipsilateral deep vein thrombosis. In 1 patient, a second VCD was deployed after device failure. The derived device failure rate was 5.9%. No patients required hospitalization. No late bleeding and no hematomas >6 cm were noted. The mean time to discharge was 4 hours and 5 minutes. Conclusion: The MynxGrip was safe and effective in sealing access sites after antegrade femoral artery puncture with same-day discharge.

Long-Term Outcomes After Percutaneous Lower Extremity Arterial Interventions With Atherectomy vs. Balloon Angioplasty ― Propensity Score-Matched Registry ―

BACKGROUND The impact of endovascular revascularization of the lower extremity arteries with atherectomy (AT) compared with percutaneous transluminal angioplasty (PTA) is still unclear. Therefore, the aim of the study was to compare long-term outcomes after percutaneous PTA and AT in patients requiring endovascular revascularization.Methods and Results:This was a single-center, retrospective registry of obstructive and symptomatic PAD patients who underwent endovascular revascularization. PTA was performed in 215 patients, and AT in 204 (Silver Hawk, EV3, n=125; CSI 360°, n=66; Pathway Medical Technologies, n=13). There were no significant between-group differences in baseline characteristics except for increased CAD, dialysis and CLI prevalence in the PTA group. Following propensity score analysis 131 well-matched pairs were included in analysis. Bail-out stenting was more frequent in the reference group (PTA, 6.1% vs. AT, 0%; P=0.004). At 6- and 12-month follow-up there were no differences in TLR between the groups (PTA, 8.3% vs. AT, 5.3%; P=0.47; and PTA, 16.7% vs. AT, 13.7%; P=0.73, respectively). The difference was in favor of AT at 24-month follow-up (PTA, 29.0% vs. AT, 16.7%; P=0.05). No difference was observed in amputation rate (PTA, 0.7% vs AT, 1.5%; P=0.62). On Kaplan-Meier analysis there were no significant differences between groups in time to TLR, amputation or death. CONCLUSIONS AT was associated with lower risk of TLR, and this should be confirmed in randomized controlled trials.

Comparable vascular response of a new generation sirolimus eluting stents when compared to fluoropolymer everolimus eluting stents in the porcine coronary restenosis model

BACKGROUND Novel sirolimus eluting stents (SES) have shown non-inferior clinical outcomes when compared to everolimus eluting stents (EES), however only limited preclinical data have been published. Therefore, we evaluate vascular response of a new generation biodegradable polymer SES (BP-SES: Alex Plus, Balton) and fluoropolymer EES (EES: Xience Pro, Abbott) in the porcine coronary restenosis model. METHODS A total of 40 stents were implanted with 120% overstretch in coronaries of 17 domestic swine: 16 BP-SES, 16 EES and 8 bare metal controls (BMS). Following 28 and 90 days, coronary angiography and optical coherence tomography (OCT) was performed, animals sacrificed and stented segments harvested for pathological evaluation. RESULTS At 28 days neointimal thickness in OCT was lowest in the BP-SES when compared to EES and BMS (0.18 ± 0.1 vs. 0.39 ± 0.1 vs. 0.34 ± 0.2 mm, respectively; p = 0.04). There was no difference in the proportion of malapposed or uncovered struts, although protruding covered struts were more common in BP-SES (14.8 ± 10% vs. 4.1 ± 4% vs. 3.7 ± 6%; p = 0.03). In pathology, the lowest neointimal thickness was confirmed in BP-SES (p < 0.05). The inflammation score was significantly lower in BP-SES and EES when compared to BMS (0.24 ± 0.1 vs. 0.4 ± 0.1 vs. 0.77 ± 0.4; p < 0.01) whilst EES and BP-SES had higher fibrin scores than BMS (1.2 ± 0.4 vs. 1.3 ± 0.3 vs. 0.17 ± 0.2; p < 0.01). At 90 days neointimal coverage and thickness in OCT was comparable between groups and healing in histopathology was complete. CONCLUSIONS New generation, BP-SES show similar vascular healing and biocompatibility profile with marginally higher degree of restenosis inhibition, when compared to fluoropolymer EES in the porcine coronary restenosis model.

Dose-dependent vascular response following delivery of sirolimus via fast releasing, biodegradable polymer stent matrix: an experimental study in the porcine coronary model of restenosis.

BACKGROUND Fast releasing, rapamycin-eluting stents, although safe, showed inferior results with regard to inhibition of restenosis. AIM Therefore, we report vascular effects of a novel, biodegradable polymer stent matrix with elevated sirolimus dose and fast release kinetics (ed-frSES, Alex, Balton) in the porcine coronary in-stent restenosis model. METHODS A total of 19 stents were implanted with 120% overstretch in the coronary arteries of seven domestic pigs: seven ed-frSES with 1.3 μg/mm2 of sirolimus, eight frSES with 1 μg/mm2 of sirolimus, and eight bare metal stents (BMS). For the following 28 days, coronary angiography was performed, animals were sacrificed, and the stented segments harvested for histopathological evaluation. RESULTS In angiography at 28 days the late lumen loss was lowest in the elevated dose sirolimus eluting stent (SES) (ed-frSES: 0.20 ± 0.2 vs. frSES: 0.80 ± 0.5 vs. BMS: 0.96 ± 0.5 mm, p < 0.01). This was confirmed in the morphometric evaluation in histopathology as represented by a significant and dose-dependent decrease in the percentage area of stenosis (ed-frSES: 22.4 ± 12.7% vs. frSES: 35 ± 10.7% vs. BMS: 47.5 ± 12.5%, p < 0.01). There was no peri-strut inflammation in any of the groups. However, the endothelialisation score was numerically not meaningfully decreased in ed-frSES (ed-frSES: 2.93 vs. frSES: 3. vs. BMS: 3, p = 0.05). Signs of fibrin were also noted in ed-frSES (ed-frSES: 0.4 vs. frSES: 0 vs. BMS: 0, p = 0.05). CONCLUSIONS Sirolimus dose-dependent vascular response was reported. The elevated dose, fast releasing SES shows satisfactory vascular healing, similar to regular dose, fast release SES, with improved efficacy in restenosis inhibition.

Safety and feasibility of same-day early discharge after endovascular revascularization of lower extremities in elderly. SENIOR-ER registry

The aim of the study was to assess safety and feasibility of one‐day early discharge (ODD) after endovascular revascularization (ER) of lower extremities in elderly.

Temporal healing patterns and coverage dynamics after new Polish transcatheter PFO occluder implantation in a swine

BACKGROUND Although currently used devices for interventional closure of patent foramen ovale (PFO) are widely used due to the minimally invasive nature of this technique and high success rate, there is still a need to look for new materials and designs in order to improve the treatment outcomes. AIM To evaluate the safety, biocompatibility, temporal healing patterns, and coverage dynamics of the new Polish PFO occluder (Balton, Warsaw, Poland) in a swine model - an observation that may assist the decision with regard to its first-in-human use and duration of anticoagulation therapy. METHODS In total, 12 pigs were scheduled for 28-day (n = 6) and 90-day follow-up (n = 6). In each animal, using a standard femoral venous approach, one PFO occluder was implanted and subsequently, in order to verify device position stability, the Minnesota manoeuvre was performed. At follow-up, all devices underwent a comprehensive evaluation with the use of high-resolution radiography (Faxitron MX-20 system), scanning electron microscopy (SEM), and standard histopathological techniques. RESULTS All PFO occluders were implanted successfully with no complications. The Faxitron revealed that all nitinol portions of the frame appeared intact and breaks were not detected at both studied time points. Overall, the device appeared to be well deployed in the atrial septum. At 28 days the average neointimal coverage of the right side of the PFO occluder by SEM was 92%; while in contrast the left side had less coverage, at 63%. At 90 days, the coverage of the right side of the occluder was 96.8%, while the left side of the PFO occluder improved and had similar coverage of 93.3%. By histology the endothelialisation process was virtually complete at 90 days. At the early time-point the overall inflammatory infiltrate was moderate and subsequently it diminished and was only mild or occasionally moderate at 90-day follow-up. At both time points the inflammatory reaction was limited to the neointimal tissue surrounding the device. CONCLUSIONS Our study confirmed safety and good overall biocompatibility of the new Polish PFO occluder, which is comparable to other devices available on the market - an observation that supports the decision with regard to its first-in-human application. Neoendothelialisation was virtually completed at 90 days, suggesting that similarly to other widely used devices a minimum of three to six months of anticoagulation therapy should be recommended.

TCT-211 Local intravascular delivery of low-density-lipoprotein cholesterol causes increased neointimal thickening in the healthy porcine coronary model. Insights into development of model of atherosclerosis

Background: The preclinical studies of vascular response are limited due to lack of underlying disease. The available cholesterol diet based and genetic atherosclerotic models are not satisfactory ...