Summary Background No medium-term data are available on the random comparison between everolimus-eluting bioresorbable vascular scaffolds and everolimus-eluting metallic stents. The study aims to ...demonstrate two mechanistic properties of the bioresorbable scaffold: increase in luminal dimensions as a result of recovered vasomotion of the scaffolded vessel. Methods The ABSORB II trial is a prospective, randomised, active-controlled, single-blind, parallel two-group, multicentre clinical trial. We enrolled eligible patients aged 18–85 years with evidence of myocardial ischaemia and one or two de-novo native lesions in different epicardial vessels. We randomly assigned patients (2:1) to receive treatment with an everolimus-eluting bioresorbable scaffold (Absorb; Abbott Vascular, Santa Clara, CA, USA) or treatment with an everolimus-eluting metallic stent (Xience; Abbott Vascular, Santa Clara, CA, USA). Randomisation was stratified by diabetes status and number of planned target lesions. At 3 year follow-up, the primary endpoint was superiority of the Absorb bioresorbable scaffold versus the Xience metallic stent in angiographic vasomotor reactivity after administration of intracoronary nitrate. The co-primary endpoint is the non-inferiority of angiographic late luminal loss. For the endpoint of vasomotion, the comparison was tested using a two-sided t test. For the endpoint of late luminal loss, non-inferiority was tested using a one-sided asymptotic test, against a non-inferiority margin of 0·14 mm. The trial is registered at ClinicalTrials.gov , number NCT01425281. Findings Between Nov 28, 2011, and June 4, 2013, we enrolled 501 patients and randomly assigned them to the Absorb group (335 patients, 364 lesions) or the Xience group (166 patients, 182 lesions). The vasomotor reactivity at 3 years was not statistically different (Absorb group 0·047 mm SD 0·109 vs Xience group 0·056 mm 0·117; psuperiority =0·49), whereas the late luminal loss was larger in the Absorb group than in the Xience group (0·37 mm 0·45 vs 0·25 mm 0·25; pnon-inferiority =0·78). This difference in luminal dimension was confirmed by intravascular ultrasound assessment of the minimum lumen area (4·32 mm2 SD 1·48 vs 5·38 mm2 1·51; p<0·0001). The secondary endpoints of patient-oriented composite endpoint, Seattle Angina Questionnaire score, and exercise testing were not statistically different in both groups. However, a device-oriented composite endpoint was significantly different between the Absorb group and the Xience group (10% vs 5%, hazard ratio 2·17 95% CI 1·01–4·70; log-rank test p=0·0425), mainly driven by target vessel myocardial infarction (6% vs 1%; p=0·0108), including peri-procedural myocardial infarction (4% vs 1%; p=0·16). Interpretation The trial did not meet its co-primary endpoints of superior vasomotor reactivity and non-inferior late luminal loss for the Absorb bioresorbable scaffold with respect to the metallic stent, which was found to have significantly lower late luminal loss than the Absorb scaffold. A higher rate of device-oriented composite endpoint due to target vessel myocardial infarction, including peri-procedural myocardial infarction, was observed in the Absorb group. The patient-oriented composite endpoint, anginal status, and exercise testing, were not statistically different between both devices at 3 years. Future studies should investigate the clinical impact of accurate intravascular imaging in sizing the device and in optimising the scaffold implantation. The benefit and need for prolonged dual antiplatelet therapy after bioresorbable scaffold implantation could also become a topic for future clinical research. Funding Abbott Vascular.
Objectives We investigated the 6-month clinical outcomes after implantation of second-generation 3.0-mm bioresorbable everolimus-eluting vascular scaffolds (BVS) in small coronary vessels (<2.5 mm). ...Background BVS are a novel approach to treating coronary lesions and are untested in small vessels. Methods The ABSORB Cohort B Trial is a multicenter, single-arm, prospective, open-label trial assessing the performance of the second-generation BVS, in which 101 patients were enrolled. The pre-procedural reference vessel diameter (RVD) was assessed by quantitative coronary angiography during post hoc analysis. The vessel size was overestimated, by visual assessment, in 41 patients before implantation of 3.0-mm BVS in vessels with a pre-procedural RVD <2.5 mm. The study population was divided into 2 groups, group I (n = 41) with RVD <2.5 mm and group II (n = 60) with RVD ≥2.5 mm. The composite endpoint of ischemia-driven major adverse cardiac events, defined as ischemia-driven target lesion revascularization, myocardial infarction, or cardiac death, was assessed. Of the 45 patients scheduled for 6-month coronary angiography, 42 patients had the procedure performed, with intravascular ultrasound undertaken in 40 of these patients. Results At 6 months, no significant differences in ischemia-driven major adverse cardiac events (3 of 41 7.3% cases vs. 2 of 60 3.3% cases; p = 0.3933) were observed in the small- and large-vessel groups, respectively. No cardiac deaths or episodes of in-scaffold thromboses were seen. Angiographic and intravascular ultrasound follow-up demonstrated no differences in late lumen loss (0.16 ± 0.18 mm vs. 0.21 ± 0.17 mm; p = 0.3525) or percentage lumen area stenosis (17.6 ± 6.0% vs. 19.8 ± 8.5%; p = 0.3643). Conclusions The second-generation 3.0-mm BVS appears to be safe in small vessels, with similar clinical and angiographic outcomes compared with those of large vessels.
Summary Background Despite rapid dissemination of an everolimus-eluting bioresorbable scaffold for treatment for coronary artery disease, no data from comparisons with its metallic stent counterpart ...are available. In a randomised controlled trial we aimed to compare an everolimus-eluting bioresorbable scaffold with an everolimus-eluting metallic stent. Here we report secondary clinical and procedural outcomes after 1 year of follow-up. Methods In a single-blind, multicentre, randomised trial, we enrolled eligible patients aged 18–85 years with evidence of myocardial ischaemia and one or two de-novo native lesions in different epicardial vessels. We randomly assigned patients in a 2:1 ratio to receive treatment with an everolimus-eluting bioresorbable scaffold (Absorb, Abbott Vascular, Santa Clara, CA, USA) or treatment with an everolimus-eluting metallic stent (Xience, Abbott Vascular, Santa Clara, CA, USA). Randomisation was stratified by diabetes status and number of planned target lesions. The co-primary endpoints of this study are vasomotion (change in mean lumen diameter before and after nitrate administration at 3 years) and difference between minimum lumen diameter (after nitrate administration) after the index procedure and at 3 years. Secondary endpoints were procedural performance assessed by quantitative angiography and intravascular ultrasound; composite clinical endpoints based on death, myocardial infarction, and coronary revascularisation; device and procedural success; and angina status assessed by the Seattle Angina Questionnaire and exercise testing at 6 and 12 months. Cumulative angina rate based on adverse event reporting was analysed post hoc. This trial is registered at ClinicalTrials.gov , number NCT01425281. Findings Between Nov 28, 2011, and June 4, 2013, we enrolled 501 patients and randomly assigned them to the bioresorbable scaffold group (335 patients, 364 lesions) or the metallic stent group (166 patients, 182 lesions). Dilatation pressure and balloon diameter at the highest pressure during implantation or postdilatation were higher and larger in the metallic stent group, whereas the acute recoil post implantation was similar (0·19 mm for both, p=0·85). Acute lumen gain was lower for the bioresorbable scaffold by quantitative coronary angiography (1·15 mm vs 1·46 mm, p<0·0001) and quantitative intravascular ultrasound (2·85 mm2 vs 3·60 mm2 , p<0·0001), resulting in a smaller lumen diameter or area post procedure. At 1 year, however, cumulative rates of first new or worsening angina from adverse event reporting were lower (72 patients 22% in the bioresorbable scaffold group vs 50 30% in the metallic stent group, p=0·04), whereas performance during maximum exercise and angina status by SAQ were similar. The 1-year composite device orientated endpoint was similar between the bioresorbable scaffold and metallic stent groups (16 patients 5% vs five patients 3%, p=0·35). Three patients in the bioresorbable scaffold group had definite or probable scaffold thromboses (one definite acute, one definite sub-acute, and one probable late), compared with no patients in the metallic stent group. There were 17 (5%) major cardiac adverse events in the bioresorbable scaffold group compared with five (3%) events in the metallic stent group, with the most common adverse events being myocardial infarction (15 cases 4% vs two cases 1%, respectively) and clinically indicated target-lesion revascularisation (four cases 1% vs three cases 2%, respectively). Interpretation The everolimus-eluting bioresorbable scaffold showed similar 1-year composite secondary clinical outcomes to the everolimus-eluting metallic stent. Funding Abbott Vascular.
Abstract Background Few studies have evaluated the clinical outcomes of transcatheter aortic valve replacement (TAVR) in patients with bicuspid aortic valve stenosis (AS). Particularly, limited data ...exist comparing the results of TAVR with new-generation devices versus early-generation devices. Objectives This study sought to evaluate the clinical outcomes of TAVR for bicuspid AS with early- and new-generation devices. Methods The Bicuspid TAVR Registry is an international multicenter study enrolling consecutive patients with bicuspid AS undergoing TAVR between April 2005 and May 2015. Results Of 301 patients, 199 patients (71.1%) were treated with early-generation devices (Sapien XT Edwards Lifesciences Corporation, Irvine, California: n = 87; CoreValve Medtronic, Minneapolis, Minnesota: n = 112) and 102 with new-generation devices (Sapien 3 Edwards Lifesciences Corporation: n = 91; Lotus Boston Scientific Corporation, Marlborough, Massachusetts: n = 11). The mean Society of Thoracic Surgeons score was 4.7 ± 5.2 without significant differences between groups (4.6 ± 5.1 vs. 4.9 ± 5.4; p = 0.57). Overall, all-cause mortality rates were 4.3% at 30 days and 14.4% at 1 year. Moderate or severe paravalvular leak was absent and significantly less frequent with new-generation compared to early-generation devices (0.0% vs. 8.5%; p = 0.002), which resulted in a higher device success rate (92.2% vs. 80.9%; p = 0.01). There were no differences between early- and new-generation devices in stroke (2.5% vs. 2.0%; p > 0.99), life-threatening bleeding (3.5% vs. 2.9%; p > 0.99), major vascular complication (4.5% vs. 2.9%; p = 0.76), stage 2 to 3 acute kidney injury (2.5% vs. 2.9%; p > 0.99), early safety endpoints (15.1% vs. 10.8%; p = 0.30), and 30-day all-cause mortality (4.5% vs. 3.9%; p > 0.99). Conclusions The clinical outcomes of TAVR in patients with bicuspid AS were favorable. New-generation devices were associated with less paravalvular leak and, hence, a higher device success rate than early-generation devices. (The Bicuspid Aortic Stenosis Following Transcatheter Aortic Valve Replacement Registry Bicuspid TAVR; NCT02394184 )
Because the first-generation Absorb (Abbott Vascular, Santa Clara, California) everolimus-eluting bioresorbable vascular scaffold (BVS) demonstrated late lumen loss thought to be caused by rapid ...changes in strut integrity (1), the second generation was designed for improved mechanical endurance and prolonged radial force. The ABSORB (A Clinical Evaluation of the Bioabsorbable Everolimus Eluting Coronary Stent System in the Treatment of Patients With de Novo Native Coronary Artery Lesions) trial (NCT00856856) is a nonrandomized multicenter, single-arm, efficacy-safety study.
Abstract Background Long-term benefits of coronary stenosis treatment with an everolimus-eluting bioresorbable scaffold are unknown. Objectives This study sought to evaluate clinical and imaging ...outcomes 5 years after bioresorbable scaffold implantation. Methods In the ABSORB multicenter, single-arm trial, 45 (B1) and 56 patients (B2) underwent coronary angiography, intravascular ultrasound (IVUS), and optical coherence tomography (OCT) at different times. At 5 years, 53 patients without target lesion revascularization underwent final imaging. Results Between 6 months/1 year and 5 years, angiographic luminal late loss remained unchanged (B1: 0.14 ± 19 mm vs. 0.13 ± 0.33 mm; p = 0.7953; B2: 0.23 ± 0.28 mm vs. 0.18 ± 0.32 mm; p = 0.5685). When patients with a target lesion revascularization were included, luminal late loss was 0.15 ± 0.20 mm versus 0.15 ± 0.24 mm (p = 0.8275) for B1 and 0.30 ± 0.37 mm versus 0.32 ± 0.48 mm (p = 0.8204) for B2. At 5 years, in-scaffold and -segment binary restenosis was 7.8% (5 of 64) and 12.5% (8 of 64). On IVUS, the minimum lumen area of B1 decreased from 5.23 ± 0.97 mm2 at 6 months to 4.89 ± 1.81 mm2 at 5 years (p = 0.04), but remained unchanged in B2 (4.95 ± 0.91 mm2 at 1 year to 4.84 ± 1.28 mm2 at 5 years; p = 0.5). At 5 years, struts were no longer discernable by OCT and IVUS. On OCT, the minimum lumen area in B1 decreased from 4.51 ± 1.28 mm2 at 6 months to 3.65 ± 1.39 mm2 at 5 years (p = 0.01), but remained unchanged in B2, 4.35 ± 1.09 mm2 at 1 year and 4.12 ± 1.38 mm2 at 5 years (p = 0.24). Overall, the 5-year major adverse cardiac event rate was 11.0%, without any scaffold thrombosis. Conclusions At 5 years, bioresorbable scaffold implantation in a simple stenotic lesion resulted in stable lumen dimensions and low restenosis and major adverse cardiac event rates. (ABSORB Clinical Investigation, Cohort B ABSORB B; NCT00856856 )
Objectives The aim of this study was to compare the angiographic changes in coronary geometry of the bioresorbable vascular scaffolds (BVS) and metallic platform stent (MPS) between baseline and ...follow-up. Background Coronary geometry changes after stenting might result in wall shear stress changes and adverse events. The BVS have better conformability, compared with MPS, but still modify artery geometry. It is uncertain whether the BVS resorption can restore the coronary anatomical configuration at midterm follow-up. Methods All patients of the ABSORB (A Clinical Evaluation of the Bioabsorbable Everolimus Eluting Coronary Stent System BVS EECSS in the Treatment of Patients With de Novo Native Coronary Artery Lesions) and SPIRIT (A Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System in the Treatment of Patients With de Novo Native Coronary Artery Lesions) trials treated with a single 3.0 × 18 mm device and imaged at baseline and 6- to 12-month follow-up were eligible. Coronary geometry changes were assessed with quantitative angiography as changes in curvature and angulation. Curvature and angulation changes between systole and diastole were investigated to assess hinging movements of the coronary artery. Results One hundred sixty-one patients (86 BVS, and 75 MPS) were included. Baseline angiographic characteristics were similar. From post-implantation to follow-up, curvature increased 8.4% (p < 0.01) with BVS and decreased 1.9% (p = 0.54) with MPS; p = 0.01. Angulation increased 11.3% with BVS (p < 0.01) and 3.8% with MPS (p = 0.01); p < 0.01. From pre-implantation to follow-up, BVS decreased 3.4% the artery curvature (p = 0.05) and 3.9% the artery angulation (p = 0.16), whereas MPS presented with 26.1% decrease in curvature (p < 0.01) and 26.9% decrease in angulation (p < 0.01), being larger with MPS (p < 0.01, both). Hinging movements in curvature from pre-implantation to follow-up decreased 19.7% with BVS and 39.0% with MPS (p = 0.27) and decreased 3.9% with BVS and 26.9% with MPS in angulation (p < 0.01). Conclusions At midterm follow-up, the BVS tended to restore the coronary configuration and the systo-diastolic movements to those seen before implantation. The coronary geometry remained similar to that seen at after implantation with MPS. (A Clinical Evaluation of the Bioabsorbable Everolimus Eluting Coronary Stent System BVS EECSS in the Treatment of Patients With de Novo Native Coronary Artery Lesions; NCT00856856 )
Abstract Coronary bifurcations are frequent and account for approximately 20% of all percutaneous coronary interventions. Nonetheless, they remain one of the most challenging lesion subsets in ...interventional cardiology in terms of a lower procedural success rate and increased rates of long-term adverse cardiac events. Provisional side branch stenting should be the default approach in the majority of cases and we propose easily applicable and reproducible stepwise techniques associated with low risk of failure and complications.
Objectives This study sought to assess the influence of chronic kidney disease (CKD) classification on clinical outcomes in patients undergoing transcatheter aortic valve implantation (TAVI). ...Background The prognostic value of impaired renal function according to CKD classification has not been thoroughly investigated in very elderly TAVI cohorts. Methods Data from 642 consecutive patients who underwent TAVI were prospectively collected. Clinical outcomes were compared in enrolled patients, divided into CKD stage 1+2, CKD stage 3a, CKD stage 3b, and CKD stage 4 on the basis of estimated glomerular filtration rate ≥60, 45 to 59, 30 to 44, and 15 to 29 ml/min/1.73 m2 , respectively. Results Among the study patients (mean age: 83.5 ± 6.5 years, logistic European System for Cardiac Operative Risk Evaluation score 20.0% range: 13.6% to 28.8%), 34% were categorized as CKD stage 1+2 (n = 218), 28.3% as CKD stage 3a (n = 182), 28.2% as CKD stage 3b (n = 181), and 9.5% as CKD stage 4 (n = 61). Thirty-day and cumulative 1-year mortality rates increased significantly across the 4 groups (6.9% vs. 8.8% vs. 13.3% vs. 26.2%, p = 0.002, and 17.2% vs. 23.4% vs. 29.2% vs. 47.8%, p < 0.001, respectively). After adjustment for considerable influential confounders in a Cox multivariate regression model, CKD stage 4 was associated with increased risk for 30-day mortality (hazard ratio: 3.04; 95% confidence interval CI: 1.43 to 6.49; p = 0.004), and CKD stages 3b and 4 were related to increased cumulative 1-year mortality (hazard ratios: 1.71 and 2.91; 95% CI: 1.09 to 2.68 and 1.73 to 4.90; p = 0.020 and p < 0.001, respectively) compared with CKD stage 1+2 as the referent. Conclusions Classification of CKD stages before TAVI allows risk stratification for early and midterm clinical outcomes. TAVI for patients with CKD stage 4 is still considered challenging because of high mortality rates after the procedure.
Objectives The purpose of this study was to clarify the impact of sex-related differences in transcatheter aortic valve implantation (TAVI) for high-risk patients with severe aortic stenosis. ...Background Although TAVI is becoming a mature technique, the impact of sex differences remains unclear. Methods The TAVI patients were included prospectively in a dedicated database from October 2006. The proportion of women (n = 131) was similar to that of men (n = 129). The Edwards valve (85.4%) and CoreValve (14.6%) were used through the transfemoral (65.0%), subclavian (3.1%), or transapical (31.9%) approach. All events were defined according to Valve Academic Research Consortium criteria. Results Age was similar (83.1 ± 6.3 years), but women had less coronary and peripheral disease, less previous cardiac surgery, higher ejection fraction, and lower EuroSCORE (European System for Cardiac Operative Risk Evaluation 22.3 ± 9.0% vs. 26.2 ± 13.0%, p = 0.005). Minimal femoral size (7.74 ± 1.03 mm vs. 8.55 ± 1.34 mm, p < 0.001), annulus size (20.9 ± 1.4 vs. 22.9 ± 1.7 mm, p < 0.001), and valve size (23.9 ± 1.6 mm vs. 26.3 ± 1.5 mm, p < 0.001) were smaller in women. Device success was similar (90.8% vs. 88.4%, p = 0.516) despite more frequent iliac complications (9.0% vs. 2.5%, p = 0.030). Residual mean aortic pressure gradient (11.6 ± 4.9 vs. 10.9 ± 4.9, p = 0.279) was also similar. The 1-year survival rate was higher for women, 76% (95% confidence interval: 72% to 80%), than for men, 65% (95% confidence interval: 60% to 69%); and male sex (hazard ratio: 1.62, 95% confidence interval: 1.03 to 2.53, p = 0.037) was identified as a predictor of midterm mortality by Cox regression analysis. Conclusions Female sex is associated with better baseline clinical characteristics and improved survival, and is identified as a predictor of midterm survival after TAVI.
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