The use of poly-
-lactide acid-based bioresorbable scaffolds is limited in daily clinical practice because of safety concerns and lack of physiological benefit. Magnesium-based bioresorbable scaffold ...(MgBRS) presents a short resorption period (<1 year) and have the potential of being thromboresistant and exhibiting early restoration of vasomotor function. To date, however, no randomized clinical trial has investigated the performance of MgBRS. Therefore, this study aimed to compare the in-stent/scaffold vasomotion between MgBRS and permanent metallic sirolimus-eluting stent (SES) at 12-month follow-up in ST-segment-elevation myocardial infarction patients.
This investigator-driven, multicenter, randomized, single-blind, controlled trial randomized ST-segment-elevation myocardial infarction patients 1:1 to SES or MgBRS at 11 academic centers. The primary end point was the rate of increase (≥3%) after nitroglycerin in mean lumen diameter of the in-stent/scaffold segment at 12 months with superiority of MgBRS over SES in the as-treated population. The main secondary end points included angiographic parameters of restenosis, device-oriented composite end point, their individual components, and device thrombosis rate. Besides, endothelial-dependent vasomotor response to acetylcholine (ie, endothelial function) was also assessed in a subgroup of patients (n=69).
Between June 2017 and June 2018, 150 ST-segment-elevation myocardial infarction patients were randomized (MgBRS, n=74; SES, n=76). At 1 year, the primary end point was significantly higher in the MgBRS arm (56.5% versus 33.8%;
=0.010). Conversely, late lumen loss was significantly lower in the SES group (in-segment: 0.39±0.49mm versus 0.02±0.27mm,
<0.001; in-device: 0.61±0.55mm versus 0.06±0.21mm;
<0.001). The device-oriented composite end point was higher in the MgBRS arm driven by an increase in ischemia-driven target lesion revascularization rate (1216.2% versus 45.2%,
=0.030). Definite thrombosis rate was similar between groups (11.4% in the MgBRS arm versus 22.6% in the SES group;
=1.0). Endothelial function assessment at device segment evidenced a more pronounced vasoconstrictive response to maximal dose of acetylcholine in the MgBRS arm (-8.3±3.5% versus -2.4±1.3% in the SES group,
=0.003).
When compared to SES, MgBRS demonstrated a higher capacity of vasomotor response to pharmacological agents (either endothelium-independent or endothelium-dependent) at 1 year. However, MgBRS was associated with a lower angiographic efficacy, a higher rate of target lesion revascularization, without thrombotic safety concerns.
URL: https://www.clinicaltrials.gov. Unique identifier: NCT03234348.
Aim
Use of a Bioresorbable Scaffolds (BRS) either in clinical practice or in the setting of an acute myocardial infarction (MI) is controversial. Despite an overall high rate of thrombosis, vascular ...healing response following BRS implantation tend to superiority as compared to metallic drug‐eluting stent in ST‐segment elevation myocardial infarction (STEMI) patients.
We sought to compare the in‐stent/scaffold vasomotion between metallic BRS and sirolimus eluting stent (SES) at 12‐month angiographic follow‐up in the setting of patients with STEMI treated by primary PCI.
Study design
This is an investigator‐driven, prospective, multicenter, randomized, single blind, two‐arm, controlled trial (ClinicalTrials.gov number: NCT03234348). This trial will randomize ~148 patients 1:1 to SES or BRS. Primary end‐point is the in‐stent/scaffold change in mean lumen diameter after nitroglycerin administration at 12‐month angiographic follow‐up. Besides, patient‐oriented combined endpoint of all‐cause death, any MI, and any revascularization, together with scaffold/stent thrombosis rate and device‐oriented endpoint of cardiac death, target vessel (TV)‐MI and TVR at 1 year will be also evaluated. Clinical follow‐up will be scheduled yearly up to 5 years.
Conclusion
This trial will shed light on the vascular vasomotion following BRS implantation in the complex scenario of STEMI.
Outcomes after percutaneous coronary interventions in diabetic patients are shadowed by the increased rate of recurrence compared with nondiabetic patients.
We conducted a multicenter, randomized ...trial to demonstrate the efficacy of sirolimus-eluting stents compared with standard stents to prevent restenosis in diabetic patients with de novo lesions in native coronary arteries. The primary end point of the trial was in-segment late lumen loss as assessed by quantitative coronary angiography at 9-month follow-up. The trial was stratified by diabetes treatment status. One hundred sixty patients were randomized to sirolimus-eluting stents (80 patients; 111 lesions) or standard stent implantation (80 patients; 110 lesions). On average, reference diameter was 2.34+/-0.6 mm, lesion length was 15.0+/-8 mm, and 13.1% of lesions were chronic total occlusions. In-segment late lumen loss was reduced from 0.47+/-0.5 mm for standard stents to 0.06+/-0.4 mm for sirolimus stents (P<0.001). Target-lesion revascularization and major adverse cardiac event rates were significantly lower in the sirolimus group (31.3% versus 7.3% and 36.3% versus 11.3%, respectively; both P<0.001). Non-insulin- and insulin-requiring patients demonstrated similar reductions in angiographic and clinical parameters of restenosis after sirolimus-eluting stent implantation. During the 9-month follow-up, stent thrombosis occurred in 2 patients after standard stent implantation. Conversely, this phenomenon was not seen in the sirolimus stent group.
This randomized trial demonstrated that sirolimus stent implantation is safe and efficacious in reducing both angiographic and clinical parameters of restenosis compared with standard stents in diabetic patients with de novo coronary stenoses.
The MAGSTEMI trial showed larger endothelium-independent vasodilatation with magnesium-based bioresorbable scaffolds (MgBRS) than with sirolimus-eluting stents (SES). However, restenosis was more ...frequent with MgBRS. The aims of this study were to compare the healing pattern between MgBRS and SES and to describe the main causes of restenosis, as assessed by optical coherence tomography (OCT).
Ninety-five consecutive patients from the randomised MAGSTEMI trial (MgBRS=48, SES=47) underwent OCT imaging at one year. Healing and bioresorption pattern were categorised into four groups: 1) indiscernible struts were observed in 33.3% versus 0% of patients (p<0.001); 2) struts integrated into the vessel wall in 22.9% versus 63.8% (p<0.001); 3) protruding struts in 37.5% versus 31.9% (p=0.568); and 4) protruding and malapposed struts in 6.3% versus 4.3% (p=0.663), respectively. MgBRS were not suitable for strut coverage analysis; SES presented with 5.6% uncovered struts. Scaffold discontinuities were observed in 10.4% and 0%, respectively (p=0.023). MgBRS presented smaller minimal lumen area (3.92±2.02 vs 6.31±1.71 mm²; p<0.001) and larger area stenosis (52.84±18.05 vs 25.02±14.58%; p<0.001). Scaffold measurements were only feasible in 50% of MgBRS, with the expansion index being smaller than in SES (0.58±0.16 vs 0.86±0.19; p<0.001). Scaffold collapse was observed in at least 50% of cases with MgBRS restenosis.
Both MgBRS and SES exhibited a low degree of neointima healing, but lumen dimensions were smaller with MgBRS at one year. Although the advanced bioresorption state of MgBRS hampers the assessment of scaffold collapse, this seems to be the main mechanism of restenosis. Future generations of MgBRS should increase and prolong the radial force.
NCT03234348
Introduction
Limited data are available regarding the evaluation of right ventricular (RV) performance in patients with aortic stenosis (AS) undergoing transcatheter aortic valve implantation (TAVI).
...Objective
To evaluate the prevalence of RV dysfunction in patients with severe AS undergoing TAVI and long‐term changes.
Methods
Consecutive patients with severe AS undergoing TAVI from January 2016 to July 2017 were included. RV anatomical and functional parameters were analyzed: RV diameters, fractional area change, tricuspid annular plane systolic excursion (TAPSE), S‐wave tissue Doppler of the tricuspid annulus (RV‐S'TDI), global longitudinal strain (RV‐GLS), and free wall strain (RV‐FWS). Preprocedure and 1‐year echo were analyzed.
Results
Final population included 114 patients, mean age 83.63 ± 6.31 years, and 38.2% women. The prevalence of abnormal RV function was high, variable depending on the parameter that we analyzed, and it showed a significant reduction 1 year after TAVI implantation: 13.9% vs 6.8% (TAPSE < 17mm), P = .04; 26.3% vs 20% (fractional area change < 35%), P = .048; 41.2% vs 29.2% (RV‐S'TDI < 9.5cm/s), P = .04; 48.7% vs 39.5% (RV‐GLS > 20), P = .049; and 48.7% vs 28.9% (RV‐FWS > 20), P = .03. Significant differences were noted between patients with low‐flow (LF) vs normal‐flow (NF) AS in RV dysfunction prevalence as well as in RV function recovery which is less evident in LF compared with NF patients.
Conclusions
RV dysfunction is high among symptomatic AS patients undergoing TAVI, with variable prevalence depending on the echocardiographic parameter used.
Paravalvular aortic regurgitation (AR) after transcatheter aortic valve implantation (TAVI) is common, but the evaluation of its severity by two-dimensional (2D) transthoracic echocardiography (TTE) ...presents several constrains. The aim of this study was to assess the usefulness of a new methodology, using three-dimensional (3D) TTE, for better assessment of paravalvular AR after TAVI.
Two-dimensional and 3D TTE was performed in 72 patients, 5 months after TAVI, using the X5-1 PureWave microbeamforming xMATRIX probe. The position and severity of the paravalvular AR jets were described using 2D and 3D TTE, and a model was designed for paravalvular AR systematic location description. Vena contracta width was measured using 2D transthoracic echocardiographic views, and the planimetry of the vena contracta was assessed after the perfect alignment plane was obtained using the multiplanar 3D transthoracic echocardiographic reconstruction tool. AR volume was calculated as the difference between 3D TTE-derived total left ventricular stroke volume and right ventricular stroke volume estimated using 2D TTE. Diagnostic efficiency for moderate AR was assessed using receiver operating characteristic curve analysis.
Forty-three patients (57.4%) presented with AR; 10 (13.3%) had central AR, and 33 (44.0%) had paravalvular AR jets. Vena contracta widths were similar between patients with moderate and mild AR (2.1 ± 0.53 vs 1.9 ± 0.16 mm, P = .16), but vena contracta planimetry was larger in patients with moderate AR than in those with mild AR (0.30 ± 0.12 vs 0.09 ± 0.07 cm(2), P = .001). Vena contracta planimetry on 3D TTE was better correlated with AR volume than vena contracta width on 2D TTE (Kendall's τ = 0.82 P < .001 vs 0.66 P < .001). The areas under the receiver operating characteristic curves were 0.96 for vena contracta planimetry and 0.35 for vena contracta width.
This study proposes an alternative methodology for paravalvular AR assessment after TAVI. Using vena contracta planimetry on 3D TTE, an accurate methodology for paravalvular AR jet evaluation and moderate AR classification is described.
Background Borderline electrocardiograms represent a challenge in ST-segment elevation myocardial infarction (STEMI) management and are associated with inappropriate discharges and delays to ...intervention. Objectives To assess angiographic characteristics and outcomes of patients presenting with subtle ST-elevation (STE) myocardial infarction. Methods A total of 504 consecutive patients with suspected STEMI treated by systematic primary percutaneous coronary intervention were prospectively included. Subtle STE was defined as a maximal preinterventional STE of 0.1 to 1 mm. Angiograms were interpreted by investigators unaware of the electrocardiographic data. Results The proportion of patients with subtle STE was 18.3%, 86% of them presented with Thrombolysis In Myocardial Infarction flow grade 0/1 and 91% underwent percutaneous coronary intervention. Despite having smaller infarcts, subtle STE patients associated more frequent multivessel disease (57% vs 44%, P = .02) and larger delays to reperfusion. During a follow-up of 19.0 ± 4.9 months, the rates of death or reinfarction were similar among groups (10.0% vs 12.6%, P = .467). Subtle STE was not associated with better outcomes neither in univariate nor after adjustment in a multivariate analysis (adjusted hazard ratio 0.79, 95% CI 0.37-1.69, P = .546). Conclusions Subtle STEMI is frequent in clinical practice and is usually associated with acute total coronary occlusion. Therefore, it should be diagnosed and treated in the same expeditiously manner as marked STEMI.
Quantitative flow ratio (QFR) based on three-dimensional quantitative coronary angiography (3D-QCA) is a novel method to assess physiological functionality after treatment with stents. The current ...study aimed to evaluate the difference in physiological functionality nine months after implantation of a bioresorbable polymer-based sirolimus-eluting stent with an electrografting base layer (BuMA Supreme: B-SES) versus a durable polymer-based zotarolimus-eluting stent (Resolute: R-ZES).
The current post hoc analysis was performed in the PIONEER randomised trial (1:1 randomisation to B-SES 83 patients/95 lesions and R-ZES 87 patients/101 lesions). QFR was measured in stented vessels in both arms at preprocedural, post-procedural and nine-month angiography without pharmacologically induced hyperaemia (contrast QFR). At nine months, both the values of QFR distal to the stent (B-SES: 0.89±0.10 vs. R-ZES: 0.89±0.11, p=0.97) and the number of vessels with QFR ≤0.8 were not significantly different between the two groups (11.0% vs. 12.8%, p=0.72), while the in-stent binary restenosis rate was also comparable (3.7% vs. 3.5%, p=1.00). QFR gradient across the device (∆QFR) at nine months was also similar between the groups (B-SES: 0.03±0.04 vs. R-ZES: 0.03±0.07, p=0.95).
Quantitative flow assessment nine months after stenting did not differ between B-SES and R-ZES, despite a significant difference in in-stent late lumen loss.
Spontaneous coronary artery dissection (SCAD) and Takotsubo syndrome (TTS) constitute two relatively common nonatherosclerotic causes of acute coronary syndrome particularly frequent in women.
This ...study sought to compare the baseline clinical and angiographic characteristics and in-hospital outcomes of patients from two large prospective registries on SCAD and TTS (the prospective nation-wide Spanish SCAD Registry and a prospective single-center TTS registry).
A total of 318 SCAD and 106 TTS consecutive patients were included. Most patients in both groups (88%) were women. Patients in the TTS group were older 74 (interquartile range, IQR 67-81) vs. 53 years-old (IQR 47-60), P < 0.001 and presented a higher prevalence of cardiovascular risk factors. Precipitating triggers were more frequent in TTS (56% vs. 42%, P = 0.009) but emotional stress was more common in the SCAD group (25% vs. 15%, P = 0.037). TTS patients showed a reduced release of cardiac biomarkers but had more severe left ventricular dysfunction (ejection fraction <50%: 73% vs. 12%, P < 0.001). In-hospital major adverse cardiovascular events occurred more frequently in TTS patients (12% vs. 4.7%, P < 0.001). Notably, TTS patients showed more frequently congestive heart failure (10% vs. 0.6%, P < 0.001), atrial fibrillation (11% vs. 1%, P < 0.001) and had a higher all-cause in-hospital mortality (5.7% vs. 1.3%, P = 0.032).
TTS patients are older and present a higher prevalence of some cardiovascular risk factors than patients with SCAD. TTS is linked to a worse in-hospital prognosis with higher mortality.
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