Multianalysis with optical coherence tomography and vasomotion in everolimus-eluting stents and everolimus-eluting biovascular scaffolds: the MOVES trial.

Aims: To compare endothelium-dependent vasomotor function and vascular healing 15 months after implantation of two new-generation drug-eluting stents and biovascular scaffolds (BVS). Methods and results: A total of 28 patients previously treated with a SYNERGY stent (bioabsorbable polymer everolimus-eluting stents (BP-EES)), a PROMUS stent (persistent polymer everolimus-eluting stents (PP-EES)) or an ABSORB (BVS) underwent control coronary angiography, 15 months after implantation, coupled with optical coherence tomography imaging and supine bicycle exercise. Intracoronary nitroglycerin was administered after exercise testing. Coronary vasomotor response was assessed using quantitative coronary angiography at rest, during supine bicycle exercise and after nitroglycerin. The primary end point was the percent change in mean lumen diameter compared with baseline. Secondary end points were strut coverage and apposition.There were no significant differences in vasomotor response between the three treatment groups. Patients with PP-EES showed significant vasoconstriction of the proximal peristent segment at maximum exercise (P=0.02). BP-EES (2.7%, 95% CI 0 to 5.5) and BVS (3.2%, 95% CI 0 to 6.7) showed less uncovered struts than PP-EES (12.1%, 95% CI 2.9 to 21.3, P=0.02 and 0.09, respectively). Complete strut apposition was more frequently seen with BP-EES (99.6%, 95% CI 99.2 to 100) than with BVS (98.9%, 95% CI 98.2 to 99.6, P=0.04) or PP-EES (95.0%, 95% CI 91.6 to 98.5, P=0.001). Conclusion: BVS and thin strut BP-EES have a reassuring vasomotion profile, suggesting minimal endothelial dysfunction 15 months after implantation.

Comparison of everolimus- and biolimus-eluting coronary stents with everolimus-eluting bioresorbable vascular scaffolds: Two-year clinical outcomes of the EVERBIO II trial.

BACKGROUND: Data from randomized controlled trials have shown that the ABSORB BVS is non-inferior to Cobalt Chromium everolimus-eluting stents at 2years. METHODS & RESULTS: The EVERBIO II trial (Comparison of Everolimus- and Biolimus-Eluting Coronary Stents with Everolimus-Eluting Bioresorbable Vascular Scaffold) is a single-center, assessor-blind, randomized controlled trial enrolling 240 patients with an allocation ration of 1:1:1 conducted at University and Hospital Fribourg, Switzerland. The studied devices were an everolimus-eluting persistent polymer stent (EES), a biolimus-eluting stent with bioabsorbable polymer (BES) and a fully bioresorbable vascular scaffold (BVS). Clinical end points collected at 9months, 12months, and 2years, were academic research consortium defined composites, device thrombosis and target-vessel revascularization. Clinical follow-up at 2years was available in 96% (N=77) of patients in the EES group, in 100% (N=80) in the BES and 99% (N=77) in the BVS group. The device-oriented composite end point of cardiac death, target-vessel myocardial infarction and target-lesion revascularization occurred in 13 (16%) patients treated with EES, in 7 (9%) patients treated with BES and in 16 (21%) patients treated with BVS. There was no significant difference when the metallic stents were compared to the BVS (p=0.12). There was one late scaffold thrombosis throughout the trial in the BVS group, and no definite stent thrombosis in either EES or BES treated patients. CONCLUSIONS: The current analysis shows no significant differences with regard to clinical outcomes at 2years between BVS and the best-in-class metallic DES. Event rates were numerically higher in BVS-treated patients. However, when BVS were compared to BES alone, the occurrence of device related adverse events was significantly increased.

Transcutaneous aortic valve implantation using the carotid artery access: Feasibility and clinical outcomes.

BACKGROUND: Transcarotid access is an alternative route for transcutaneous aortic valve implantation (TAVI) in patients with impossible transfemoral access. AIMS: We evaluated the safety, effectiveness and early and late clinical outcomes of CoreValve® implantation via the common carotid artery. METHODS: Eighteen patients (10 men, 8 women; mean age 84±5 years) at high surgical risk (mean EuroSCORE II 16±13%) with significant peripheral artery disease underwent TAVI via common carotid artery access under general anaesthesia. Mean aortic valve area was 0.64±0.13cm2 (0.36±0.07cm2/m2). RESULTS: At a mean follow-up of 605±352 days, two patients (11%) had died in hospital, on days 6 and 20, as a result of sepsis with multiorgan failure (n=1) or pneumonia (n=1). There were no perioperative deaths, myocardial infarctions or strokes. Perioperative prosthesis embolization occurred in one patient (6%), requiring implantation of a second valve. In-hospital complications occurred in four patients (23%): blood transfusion for transient significant bleeding at the access site in one patient (6%); permanent pacemaker implantation in two patients (11%); and pericardial drainage in one patient (6%). The rate of event-free in-hospital stay was 66%. Post-procedural echocardiography showed very good haemodynamic performance, with a mean gradient of 8±3mmHg. Moderate paravalvular leak was present in one patient (6%). Mean intensive care unit stay was 48±31h; mean in-hospital stay was 7±3 days. CONCLUSION: TAVI performed by transcarotid access in this small series of severely ill patients was associated with a low incidence of complications, which were associated with the procedure itself rather than the access route.

Radiation Exposure of the Operator During Coronary Interventions (from the RADIO Study).

We sought to compare operator radiation exposure during procedures using right femoral access (RFA), right radial access (RRA), and left radial access (LRA) during coronary angiography (CA) and percutaneous coronary intervention (PCI). Because of an increased incidence of long-term malignancy in interventional cardiologists, operator radiation exposure is of rising concern. This prospective study included all consecutive patients who underwent elective or emergency CA ± PCI from September 2014 to March 2015. The primary end point was operator radiation exposure, quantified as the ratio of operator cumulative dose (CD) and patient radiation reported as dose-area product (DAP) (CD/DAP). Secondary end points included CD, DAP, and fluoroscopy time (FT). Overall 830 procedures (457 CA [55%] and 373 PCI [45%]) were performed, 455 (55%) through RFA, 272 (33%) through RRA, and 103 (12%) through LRA. The CD/DAP was lower in RFA (0.09 µSv/Gycm(2) [0.02 to 0.20]) compared with RRA (0.47 µSv/Gycm(2) [0.25 to 0.75], p <0.001). The LRA showed lower CD/DAP compared with RRA (p <0.001). CD was significantly lower in RFA (3 µSv [1 to 7]) compared with RRA (12 µSv [6 to 29], p <0.001). The LRA showed lower CD compared with RRA (p <0.001). There were no significant differences in DAP among the 3 access sites. FT was similar for the 3 groups (RFA 7 ± 7, RRA 5 ± 5, LRA 6 ± 5 minutes, RFA vs RRA: p = 1, RFA vs LRA: p = 0.16, RRA vs LRA: p = 0.52). In conclusion, the use of RFA during CA ± PCI is associated with significantly lower operator radiation exposure compared with RRA. LRA is associated with significantly lower operator radiation exposure compared with RRA.

Vascular response to everolimus- and biolimus-eluting coronary stents versus everolimus-eluting bioresorbable scaffolds--an optical coherence tomography substudy of the EVERBIO II trial.

QUESTIONS UNDER STUDY: Head-to-head optical coherence tomography (OCT) data comparing metallic stents with bioresorbable vascular scaffolds (BVS) are lacking. This study assessed vascular healing at 9-month follow-up after implantation of everolimus- and biolimus-eluting stents (EES; BES) and everolimus-eluting BVS. METHODS: OCT was performed in 74 patients enrolled in the EVERBIO II (NCT01711931) trial (23 with EES: 26 lesions, 7 625 struts; 23 with BES: 26 lesions, 6 140 struts; 28 with BVS: 33 lesions, 10 891 struts). OCT images were acquired using the pullback and nonocclusive flushing technique and analysed offline. RESULTS: BVS demonstrated fewer uncovered struts per patient (12 ± 27 [3.8 ± 8.4%] vs 59 ± 55 [21.8 ± 13.7%] in the EES&BES group, p <0.001), and thicker neointimal hyperplasia (BVS 102 ± 44 µm vs EES&BES 66 ± 36 µm, p <0.01). There was no significant difference with regard to malapposed struts (2.1 ± 2.7% in the BVS vs 4.4 ± 8.8% in the EES&BES group, p = 0.41). In a predefined signal intensity scale, quantitative analysis of the "key component" (black) revealed lower intensity in BVS than EES&BES (14 ± 23% vs 13 ± 12%, p = 0.007). Intensity was lower in polylactide-containing stents (BVS&BES) than in EES (15 ± 19% vs 10 ± 10%, p <0.001). CONCLUSIONS: BVS has fewer uncovered struts and presents with a thicker neointimal coverage compared with EES&BES. It is not known whether this improved capping correlates with superior vascular healing. Polylactide-containing stents (BVS and BES) demonstrate lower peristrut intensity compared with EES.

Comparison of endothelium-dependent and -independent vasomotor response after abluminal biodegradable polymer biolimus-eluting stent and persistent polymer everolimus-eluting stent implantation (COMPARE-IT).

BACKGROUND: Drug-eluting stents (DES) have been associated with local endothelial dysfunction in the segments proximal and distal to the stent (peristent segments) and increased thrombotic risk in long term follow-up. Little data exists on endothelial function post-implantation of new DES with biodegradable polymer. The aim of our study was to compare the local endothelial function assessed by exercise induced coronary vasomotion after implantation of a biolimus A9-eluting stent with biodegradable polymer (BES) with an everolimus-eluting stent with durable polymer (EES). METHODS: Coronary vasomotion was evaluated with quantitative coronary angiography at rest and during supine bicycle exercise in nine patients with EES and thirteen patients with BES, 16 months after stent implantation. Mean luminal diameter of the stent, peristent segments, and of a control vessel were determined at rest, during exercise, and after the administration of nitroglycerine. RESULTS: The control vessel showed exercise-induced vasodilatation in both groups (EES: +6.4±5.5%, p=0.07; BES: +7.8±10.1%, p=0.07). Vasomotion in the stented vessel segment was abolished. There was exercise-induced vasoconstriction in both groups in the segments proximal (EES: -9.6±4.5%; p=0.03; BES: -4.3±5.4%, p=0.02) and distal to the stent (EES: -3.2±9.3%; p=0.41, BES -8.6±8.0%, p<0.01). Sublingual nitroglycerin was associated with maximal vasodilatation of the peristent segments in both groups. CONCLUSION: Alike DES with durable polymer, stents with a biodegradable polymer are associated with exercise-induced paradoxical coronary vasoconstriction of the peristent segments. This data suggests that endothelial dysfunction after DES implantation is not primarily caused by the durability of the polymer coating.

Optical Coherence Tomography Findings in Bioresorbable Vascular Scaffolds Thrombosis.

BACKGROUND: Everolimus-eluting bioresorbable vascular scaffolds have been developed to improve late outcomes after coronary interventions. However, recent registries raised concerns regarding an increased incidence of scaffold thrombosis (ScT). The mechanism of ScT remains unknown. METHODS AND RESULTS: The present study investigated angiographic and optical coherence tomography findings in patients experiencing ScT. Fifteen ScT (14 patients, 79% male, age 59±10 years) occurred at a median of 16 days (25%-75% interquartile range: 1-263 days) after implantation. Early ScT (<30 days) occurred in 8 cases (53%). Possible causal factors in these patients included insufficient platelet inhibition in 2 cases and procedural factors (scaffold underexpansion, undersizing, or geographical miss) in 4 cases. No obvious cause could be found in 2 early ScT. In late (>1 month) and very late (>1 year) ScT (respectively, 5 and 2 cases), 5 scaffolds showed intimal neovessels or marked peristrut low-intensity areas. Scaffold fractures were additionally found in 2 patients, and scaffold collapse was found in 1 patient with very late ScT. Extensive strut malapposition was the presumed cause for ScT in 1 case. One scaffold did not show any morphological abnormality. Thrombectomy specimens were analyzed in 3 patients and did not demonstrate increased numbers of inflammatory cells. CONCLUSIONS: The mechanisms of early ScT seem to be similar to metallic stents (mechanical and inadequate antiplatelet therapy). The predominant finding in late and very late ScT is peristrut low-intensity area.

Comparison of everolimus- and biolimus-eluting coronary stents with everolimus-eluting bioresorbable vascular scaffolds.

BACKGROUND: The first CE-approved bioresorbable vascular scaffold (BVS) is effective at treating simple lesions and stable coronary artery disease, but it has yet to be assessed versus the best-in-class drug-eluting stents (DES). OBJECTIVES: This study sought to compare the performance of a BVS with that of everolimus-eluting stents (EES) and biolimus-eluting stents (BES) in all-comer patients. METHODS: The EVERBIO II (Comparison of Everolimus- and Biolimus-Eluting Stents With Everolimus-Eluting Bioresorbable Vascular Scaffold Stents II) trial was a single-center, assessor-blinded study of 240 patients randomly assigned in a 1:1:1 ratio to EES, BES, or BVS. The only exclusion criterion was a reference vessel diameter >4.0 mm, which precluded treatment with BVS. The primary endpoint was angiographic late lumen loss (LLL) at 9 months. Secondary endpoints included patient-oriented major acute coronary events (MACE) (death, myocardial infarction [MI], and any revascularization), device-oriented MACE (cardiac death, MI, and target lesion revascularization), and stent thrombosis at the 9-month clinical follow-up. RESULTS: Follow-up angiography was performed in 216 patients (90.7%) at 9 months. In-stent LLL was similar between patients treated with BVS (0.28 ± 0.39 mm) and those treated with EES/BES (0.25 ± 0.36 mm; p = 0.30). Clinical outcomes were similar at 9 months: the patient-oriented MACE rate was 27% in BVS and 26% in the EES/BES group (p = 0.83) and the device-oriented MACE rate was 12% in BVS and 9% in the EES/BES group (p = 0.6). CONCLUSIONS: New-generation metallic DES (EES/BES) were not superior to BVS in terms of angiographic LLL and clinical outcomes. (Comparison of Everolimus- and Biolimus-Eluting Stents With Everolimus-Eluting Bioresorbable Vascular Scaffold Stents [EVERBIO II]; NCT01711931).