Magnesium-based resorbable scaffold vs permanent metallic sirolimus-eluting stent in patients with ST-segment elevation myocardial infarction: 3-year results of the MAGSTEMI randomised controlled trial.

BACKGROUND: The long-term safety and performance of magnesium-based bioresorbable scaffolds (MgBRS) in ST-segment-elevation myocardial infarction (STEMI) patients are uncertain. AIMS: The aim of this study was to report the 3-year clinical outcomes of the MAGSTEMI trial. METHODS: This investigator-driven, multicentre, randomised, single-blind, controlled trial randomised STEMI patients 1:1 to MgBRS or to permanent metallic sirolimus-eluting stents (SES) at 11 academic centres. The main secondary endpoints included device-oriented composite endpoints (DoCE) and patient-oriented composite endpoints (PoCE), their individual components, any bleeding, and device thrombosis rate. All endpoints were defined according to the Academic Research Consortium. Events were adjudicated by an independent committee. RESULTS: Three-year clinical follow-up was obtained in 142 (90.0%) patients. At 3-year follow-up, MgBRS were associated with a higher rate of DoCE than SES (13 [17.6%] vs 5 [6.6%], diff -11.0 [95% CI: -21.3 to -0.7]; p=0.038). This difference was driven by an increased incidence of DoCE within the first year of follow-up. In the landmark analysis, there was no difference between 1 and 3 years (0 [0.0%] vs 1 [1.4%]; p=1.000). The difference in the rate of DoCE was driven by a higher incidence of target lesion revascularisation (TLR) in the MgBRS group compared to SES (12 [16.2%] vs 4 [5.3%]; diff -10.9% [95% CI: -20.7 to -1.2]; p=0.030). The difference in TLR was observed during the first year, with no further differences observed between 1 and 3 years (0 [0.0%] vs 1 [1.4%]; p=1.000). CONCLUSIONS: At 3-year follow-up, MgBRS were associated with a higher rate of TLR, which was clustered within the first year, compared to SES.

Temporal Trends, Characteristics, and Outcomes of Infective Endocarditis After Transcatheter Aortic Valve Replacement

BACKGROUND: Procedural improvements combined with the contemporary clinical profile of patients undergoing transcatheter aortic valve replacement (TAVR) may have influenced the incidence and outcomes of infective endocarditis (IE) following TAVR. We aimed to determine the temporal trends, characteristics, and outcomes of IE post-TAVR. METHODS: Observational study including 552 patients presenting definite IE post-TAVR. Patients were divided in 2 groups according to the timing of TAVR (historical cohort [HC]: before 2014; contemporary cohort [CC]: after 2014). RESULTS: Overall incidence rates of IE were similar in both cohorts (CC vs HC: 5.45 vs 6.52 per 1000 person-years; P = .12), but the rate of early IE was lower in the CC (2.29‰ vs 4.89‰, P < .001). Enterococci were the most frequent microorganism. Most patients presented complicated IE (CC: 67.7%; HC: 69.6%; P = .66), but the rate of surgical treatment remained low (CC: 20.7%; HC: 17.3%; P = .32). The CC exhibited lower rates of in-hospital acute kidney injury (35.1% vs 44.6%; P = .036) and in-hospital (26.6% vs 36.4%; P = .016) and 1-year (37.8% vs 53.5%; P < .001) mortality. Higher logistic EuroScore, Staphylococcus aureus etiology, and complications (stroke, heart failure, and acute renal failure) were associated with in-hospital mortality in multivariable analyses (P < .05 for all). CONCLUSIONS: Although overall IE incidence has remained stable, the incidence of early IE has declined in recent years. The microorganism, high rate of complications, and very low rate of surgical treatment remained similar. In-hospital and 1-year mortality rates were high but progressively decreased over time.

ST-Segment Elevation Myocardial Infarction Following Transcatheter Aortic Valve Replacement.

BACKGROUND: Among patients with acute coronary syndrome following transcatheter aortic valve replacement (TAVR), those presenting with ST-segment elevation myocardial infarction (STEMI) are at highest risk. OBJECTIVES: The goal of this study was to determine the clinical characteristics, management, and outcomes of STEMI after TAVR. METHODS: This was a multicenter study including 118 patients presenting with STEMI at a median of 255 days (interquartile range: 9 to 680 days) after TAVR. Procedural features of STEMI after TAVR managed with primary percutaneous coronary intervention (PCI) were compared with all-comer STEMI: 439 non-TAVR patients who had primary PCI within the 2 weeks before and after each post-TAVR STEMI case in 5 participating centers from different countries. RESULTS: Median door-to-balloon time was higher in TAVR patients (40 min [interquartile range: 25 to 57 min] vs. 30 min [interquartile range: 25 to 35 min]; p = 0.003). Procedural time, fluoroscopy time, dose-area product, and contrast volume were also higher in TAVR patients (p < 0.01 for all). PCI failure occurred more frequently in patients with previous TAVR (16.5% vs. 3.9%; p < 0.001), including 5 patients in whom the culprit lesion was not revascularized owing to coronary ostia cannulation failure. In-hospital and late (median of 7 months [interquartile range: 1 to 21 months]) mortality rates were 25.4% and 42.4%, respectively (20.6% and 38.2% in primary PCI patients), and estimated glomerular filtration rate <60 ml/min (hazard ratio [HR]: 3.02; 95% confidence interval [CI]: 1.42 to 6.43; p = 0.004), Killip class ≥2 (HR: 2.74; 95% CI: 1.37 to 5.49; p = 0.004), and PCI failure (HR: 3.23; 95% CI: 1.42 to 7.31; p = 0.005) determined an increased risk. CONCLUSIONS: STEMI after TAVR was associated with very high in-hospital and mid-term mortality. Longer door-to-balloon times and a higher PCI failure rate were observed in TAVR patients, partially due to coronary access issues specific to the TAVR population, and this was associated with poorer outcomes.

Clinical Outcomes After Implantation of Polyurethane-Covered Cobalt-Chromium Stents: Insights from the Papyrus-Spain Registry.

BACKGROUND/PURPOSE: The main indication of covered stents (CS) is coronary artery perforation (CAP), but, they have been increasingly used in other scenarios. Data on the long-term follow-up of CS is limited, and no studies have been conducted specifically using new-generation polyurethane-covered cobalt-chromium Papyrus CS. PURPOSE: to evaluate the clinical outcomes after hospital discharge of Papyrus CS and to compare their outcome after implantation in CAP or coronary artery aneurysms (CAA). METHODS/MATERIALS: We evaluated the baseline clinical characteristics, lesion subsets, procedural features and the outcomes after initial discharge of Papyrus CS implanted in 17 high-PCI-volume centers. RESULTS: 127 Papyrus CS were implanted in 108 patients (68 ±â€¯1 years; 82.8% male) admitted for stable coronary disease (32.3%), NSTEMI (42.4%) or STEMI (25.3%). The number of CS per patient was 1.2 ±â€¯0.6 (diameter: 3.5 ±â€¯1.7 mm; length: 18.5 ±â€¯3.7 mm). Angiographic success rate was 96%. CS diameter was larger in CAA (CAP:3.04 ±â€¯0.5 mm vs CAA:4.1 ±â€¯2.7 mm; p = .022). Intracoronary imaging techniques were used more frequently in CAA (p < .0001). After a mean follow-up of 22 ±â€¯16 months, the major cardiovascular adverse events (MACE) rate was 7.1% [cardiac death: 2%, Myocardial infarction: 5%, Target Lesion Revascularization: 5% and Stent Thrombosis (ST): 3%]. MACE rate was similar in CAP (7.7%) and CAA (7.1%) (p = .9). However, CAA showed a higher ST rate (CAP: 0% vs CA: 7.1%; p = .04). CONCLUSION: After hospital discharge, clinical outcomes after Papyrus CS implantation are acceptable (considering the clinical scenario and compared with other treatment alternatives) with no significant differences in the MACE rate between those implanted in CAA or in CAP. However, CAA group showed a higher ST rate.

Spontaneous coronary artery dissection and Takotsubo syndrome: comparison of baseline clinical and angiographic characteristics and in-hospital outcomes.

BACKGROUND: Spontaneous coronary artery dissection (SCAD) and Takotsubo syndrome (TTS) constitute two relatively common nonatherosclerotic causes of acute coronary syndrome particularly frequent in women. METHODS: 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). RESULTS: 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). CONCLUSION: 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.

Acute Kidney Injury After Percutaneous Edge-to-Edge Mitral Repair.

BACKGROUND: In catheter-based procedures, acute kidney injury (AKI) is a frequent, serious complication ranging from 10% to 30%. In MitraClip (Abbott Vascular, Santa Clara, California), a usually contrast-free procedure, there is scarce data about its real incidence and impact. OBJECTIVES: This study aimed to evaluate incidence, predictive factors, and midterm outcomes of AKI in patients with significant mitral regurgitation (MR) undergoing transcatheter valve repair with MitraClip. METHODS: A total of 721 patients undergoing MitraClip were included. AKI was defined as an absolute or a relative increase in serum creatinine of >0.3 mg/dl or ≥50%, respectively, or the need for hemodialysis during index hospitalization. RESULTS: The mean age of the patients was 72 ± 11 years (28.3% women). Median estimated glomerular filtration rate (eGFR) was 43.7 ml/min/1.73 m2 (interquartile range: 30.9 to 60.1 ml/min/1.73 m2), and was <60 ml/min/1.73 m2 in 74.9% of the patients. AKI after MitraClip occurred in 106 patients (14.7%). Baseline hemoglobin (<11 g/dl) (odds ratio [OR]: 1.97; p = 0.003), urgent procedure (OR: 3.44; p = 0.003), and absence of device success (OR: 3.37; p < 0.001) were independent predictors of AKI. Patients with AKI had worse outcomes compared to those without AKI, including a higher proportion of in-hospital bleeding events (3.8% vs. 0.8%; p = 0.011), 2-year all-cause mortality (40.5% vs. 18.7%; p <0.001), and major adverse cardiac events (63.6% vs. 23.5%; p <0.001). Combination of AKI with significant residual MR after the procedure conferred even worst outcomes (2-year all-cause mortality 50.0% vs. 19.6%; p = 0.001, and major adverse cardiac events 70.0% vs. 18.9%; p < 0.001). CONCLUSIONS: Despite being a "zero-contrast" procedure, one-sixth of patients undergoing transcatheter mitral valve repair had AKI, linked to device failure or other severe conditions. The occurrence of AKI was associated with worse outcomes, highlighting the importance to detect and reduce this complication in high-risk population.

Bioresorbable scaffolds versus permanent sirolimus-eluting stents in patients with ST-segment elevation myocardial infarction: vascular healing outcomes from the MAGSTEMI trial.

AIMS: 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). METHODS AND RESULTS: 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. CONCLUSIONS: 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. CLINICAL TRIAL REGISTRATION: NCT03234348

Right ventricle assessment in patients with severe aortic stenosis undergoing transcatheter aortic valve implantation.

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.

Impact of chronic obstructive pulmonary disease and dyspnoea on clinical outcomes in ticagrelor treated patients undergoing percutaneous coronary intervention in the randomized GLOBAL LEADERS trial.

AIMS: To evaluate long-term safety and efficacy of ticagrelor monotherapy in patients undergoing percutaneous coronary interventions (PCIs) in relation to chronic obstructive pulmonary disease (COPD) at baseline and the occurrence of dyspnoea reported as adverse event (AE) that may lead to treatment non-adherence. METHODS AND RESULTS: This is a non-prespecified, post hoc analysis of the randomized GLOBAL LEADERS trial (n = 15 991), comparing the experimental strategy of 23-month ticagrelor monotherapy following 1-month dual antiplatelet therapy (DAPT) after PCI with the reference strategy of 12-month DAPT followed by 12-month aspirin monotherapy. Impact of COPD and dyspnoea AE (as a time-dependent covariate) on clinical outcomes was evaluated up to 2 years. The primary endpoint was a 2-year all-cause mortality or non-fatal, centrally adjudicated, new Q-wave myocardial infarction. The presence of COPD (n = 832) was the strongest clinical predictor of 2-year all-cause mortality after PCI [hazard ratio (HR) 2.84; 95% confidence interval (CI) 2.21-3.66; P adjusted = 0.001] in this cohort (n = 15 991). No differential treatment effects on 2-year clinical outcomes were found in patients with and without COPD (primary endpoint: HR 0.88; 95% CI 0.58-1.35; P = 0.562; P int = 0.952). Overall, at 2 years dyspnoea was reported as an AE in 2101 patients, more frequently among COPD patients, irrespective of treatment allocation (27.2% in experimental arm vs. 14.5% in reference arm, P = 0.001). Its occurrence was not associated with a higher rate of the primary endpoint (P adjusted = 0.640) in the experimental vs. the reference arm. CONCLUSION: In this exploratory analysis, COPD negatively impacted long-term prognosis after PCI. Despite higher incidence of dyspnoea in the experimental arm, in particular among COPD patients, the safety of the experimental treatment strategy appeared not to be affected. CLINICAL TRIAL REGISTRATION UNIQUE IDENTIFIER: NCT01813435.

Magnesium-Based Resorbable Scaffold Versus Permanent Metallic Sirolimus-Eluting Stent in Patients With ST-Segment Elevation Myocardial Infarction: The MAGSTEMI Randomized Clinical Trial.

BACKGROUND: The use of poly-l-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. METHODS: 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). RESULTS: 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%; P=0.010). Conversely, late lumen loss was significantly lower in the SES group (in-segment: 0.39±0.49mm versus 0.02±0.27mm, P<0.001; in-device: 0.61±0.55mm versus 0.06±0.21mm; P<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 (12[16.2%] versus 4[5.2%], P=0.030). Definite thrombosis rate was similar between groups (1[1.4%] in the MgBRS arm versus 2[2.6%] in the SES group; P=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, P=0.003). CONCLUSIONS: 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. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT03234348.

Predictors, Incidence, and Outcomes of Patients Undergoing Transfemoral Transcatheter Aortic Valve Implantation Complicated by Stroke.

BACKGROUND: Stroke remains one of the most devastating complications of transcatheter aortic valve implantation (TAVI). The aim of this study was to identify the incidence, timing, temporal trends, and predictors of stroke after TAVI and evaluate the outcomes of patients with stroke. METHODS AND RESULTS: The CENTER-Collaboration is an international collaboration consisting of 3 national registries and 7 local registries or prospective clinical trials, selected through a systematic review. Accordingly, a total of 10 982 patients undergoing transfemoral TAVI between 2007 and 2018 were included in the current patient-level pooled analyses. A total of 261 patients (2.4%) experienced stroke during the first month after TAVI. The median time between TAVI and stroke was 1 day (interquartile range, 0-6 days). The stroke rate was comparable in procedures performed in the early years of TAVI (2007-2012) to those in the more recent years of TAVI (2013-2018; both 2.4%; P=1.0). Independent predictors of stroke at 30 days were a history of cerebrovascular events (odds ratio, 2.2; 95% CI, 1.4-3.6; P=0.0012) and a glomerular filtration rate of <30 mL/min per 1.73 m2 (odds ratio, 1.7; 95% CI, 1.0-2.8; P=0.05). Stroke occurring within the first 30 days after TAVI was associated with a 6-fold increase of 30-day mortality (odds ratio, 6.0; 95% CI, 4.4-8.1; P<0.001). Moreover, patients with stroke more frequently had documented new-onset atrial fibrillation (16% versus 3%; P<0.001) and major or life-threatening bleedings (12% versus 7%; P=0.002) at 30-day follow-up. CONCLUSIONS: In this large, global, patient-level analysis, the incidence of stroke after transfemoral TAVI was 2.4%. Prior cerebrovascular events and a low glomerular filtration rate independently predicted the occurrence of stroke after TAVI. The occurrence of stroke after TAVI was associated with a strikingly 6-fold increase of 30-day mortality; additionally, there was a 5-fold higher rate of new-onset atrial fibrillation in patients with stroke. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov . Unique identifier: NCT03588247.

Invasive Versus Conservative Strategy in Frail Patients With NSTEMI: The MOSCA-FRAIL Clinical Trial Study Design.

INTRODUCTION AND OBJECTIVES: Although clinical guidelines recommend invasive management in non-ST-segment elevation myocardial infarction (NSTEMI), this strategy is underused in frail elderly patients in the real world. Furthermore, these patients are underrepresented in clinical trials and therefore the evidence is scarce. Our hypothesis is that an invasive strategy will improve prognosis in elderly frail patients with NSTEMI. METHODS: This will be a prospective, multicenter, randomized trial, in which the conservative and invasive strategies will be compared in patients meeting all of the following inclusion criteria: NSTEMI diagnosis, age ≥ 70 years, and frailty defined by a category ≥ 4 in the Clinical Frailty Scale. Participants will be randomized to an invasive (coronary angiogram and revascularization if anatomically amenable) or conservative (medical treatment and coronary angiogram only if persistent clinical instability) strategy. The primary endpoint will be the number of days alive out of hospital during the first year. The coprimary endpoint will be the time until the first cardiac event (cardiac death, reinfarction or postdischarge revascularization). We estimate a sample size of 178 patients (89 per arm), considering an increase of 20% in the proportion of days alive out of hospital with the invasive management. RESULTS: The results of this study will add important knowledge to inform the management of frail elderly patients hospitalized with NSTEMI. CONCLUSIONS: We hypothesize that the invasive strategy will improve outcomes in frail elderly patients with NSTEMI. If this is confirmed, frailty status should not dissuade physicians from implementing an invasive management strategy. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov.Identifier: NCT03208153.

MAGnesium-based bioresorbable scaffold and vasomotor function in patients with acute ST segment elevation myocardial infarction: The MAGSTEMI trial: Rationale and design.

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.

Identification of candidates for coronary artery bypass grafting admitted with STEMI and Multivessel Disease.

BACKGROUND: The optimal management of patients with multivessel coronary artery disease (MVD) admitted with STEMI is under debate. CABG is rarely performed, even on ideal candidates. A provisional PCI without stent implantation may allow complete surgical revascularization (CSR) in a subset of patient that we sought to identify in this study. METHODS: Patients with STEMI from April 2014 to October 2016 were evaluated and those with a TIMI flow <3 in the culprit vessel, and an additional stenosis of >70% in an epicardial vessel or sidebranch >2.5 mm were selected. Epidemiological variables, surgical risk scores and SYNTAX and SYNTAX II scores were analyzed. All the selected patients were discussed in a post hoc heart-team, and predictors of 12-month events were also analyzed. RESULTS: Seventy-two (19.0%) accomplished MVD criteria. Mean SYNTAX was 19 ±â€¯13 points and SYNTAX II score recommended CABG in 12 patients (16.7%) and heart-team discussion in 60 (83.3%). All patients were discussed in a post hoc heart-team, which concluded that 21 (29.2%) patients could have been good candidates for CSR. After one year follow-up, SYNTAX II PCI > 40 was found to be the sole independent predictor for 12-month events (OR 12.9 [2.7-62.1], p = 0.001). CONCLUSIONS: MVD and STEMI with a SYNTAX II PCI > 40 should be discussed in an ad-hoc heart team, after a provisional revascularization of the culprit vessel, and should be considered for CSR, especially when the RCA is the culprit artery and there is a complex disease in the left coronary artery.

First-in-man randomised comparison of the BuMA Supreme biodegradable polymer sirolimus-eluting stent versus a durable polymer zotarolimus-eluting coronary stent: the PIONEER trial.

AIMS: A second iteration of a sirolimus-eluting stent (SES) that has a biodegradable PLGA polymer coating with an electrografting base layer on a thin-strut (80 µm) cobalt-chromium platform (BuMA Supreme; SINOMED, Tianjin, China) has been developed. This first-in-man trial aimed to assess the efficacy and safety of the novel device. METHODS AND RESULTS: This randomised, multicentre, single-blinded, non-inferiority trial compared the BuMA Supreme SES versus a contemporary durable polymer zotarolimus-eluting stent (ZES) in terms of angiographic in-stent late lumen loss (LLL) at nine-month follow-up as the primary endpoint. A total of 170 patients were randomly allocated to treatment with either SES (n=83) or ZES (n=87). At nine-month angiographic follow-up, in-stent LLL was 0.29±0.33 mm in the SES group and 0.14±0.37 mm in the ZES group (pnon-inferiority=0.45). The in-stent percent diameter stenosis and the binary restenosis rate of the two treatment arms were similar (19.2±12.0% vs. 16.1±12.6%, p=0.09, and 3.3% vs. 4.4%, p=1.00, respectively). At 12-month clinical follow-up, there was no difference between treatment arms with regard to the device-oriented composite clinical endpoint (4.9% vs. 5.7%; p=0.72). CONCLUSIONS: The PIONEER trial did not meet its primary endpoint in terms of in-stent LLL at nine-month follow-up. However, this result did not translate into any increase in restenosis rate or impairment in 12-month clinical outcomes.

Functional comparison between the BuMA Supreme biodegradable polymer sirolimus-eluting stent and a durable polymer zotarolimus-eluting coronary stent using quantitative flow ratio: PIONEER QFR substudy.

AIMS: 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). METHODS AND RESULTS: 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). CONCLUSIONS: 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.

Puncture Versus Surgical Cutdown Complications of Transfemoral Aortic Valve Implantation (from the Spanish TAVI Registry).

Vascular complications in transcatheter aortic valve implantation using transfemoral approach are related to higher mortality. Complete percutaneous approach is currently the preferred technique for vascular access. However, some centers still perform surgical cutdown. Our purpose was to determine complications related to vascular access technique in the population of the Spanish TAVI National Registry. From January 2010 to July 2015, 3,046 patients were included in this Registry. Of them, 2,465 underwent transfemoral approach and were treated with either surgical cutdown and closure (cutdown group, n = 632) or percutaneous approach (puncture group, n = 1,833). Valve Academic Research Consortium-2 definitions were used to assess vascular and bleeding complications. Propensity matching resulted in 615 matched pairs. Overall, 30-day vascular complications were significantly higher in the puncture group (109 [18%] vs 42 [6.9%]; relative risk [RR] 2.60; 95% confidence interval [CI] 1.85 to 3.64, p <0.001) due mostly by minor vascular events (89 [15%] vs 25 [4.1%], RR 3.56, 95% CI 2.32 to 5.47, p <0.001). Bleeding rates were lower in the puncture group (18 [3%] vs 40 [6.6%], RR 0.45, 95% CI 0.26 to 0.78, p = 0.003) mainly driven by major bleeding (9 [1.5%] vs 21 [3.4%], RR 0.43, 95% CI 0.20 to 0.93, p = 0.03). At a mean follow-up of 323 days, complication rates remained significantly different between groups (minor vascular complications 90 [15%] vs 31 [5.1%], hazard ratio 2.99, 95% CI 1.99 to 4.50, p <0.001 and major bleeding 10 [1.6%] vs 21 [3.4%], hazard ratio 0.47, 95% CI 0.22 to 1.0, p = 0.04, puncture versus cutdown group, respectively). In conclusion, percutaneous approach yielded higher rates of minor vascular complications but lower rates of major bleeding compared with the surgical cutdown, both at 30-day and at mid-term follow-up in our population.