Summary Background We report the 5-year results of the SYNTAX trial, which compared coronary artery bypass graft surgery (CABG) with percutaneous coronary intervention (PCI) for the treatment of ...patients with left main coronary disease or three-vessel disease, to confirm findings at 1 and 3 years. Methods The randomised, clinical SYNTAX trial with nested registries took place in 85 centres in the USA and Europe. A cardiac surgeon and interventional cardiologist at each centre assessed consecutive patients with de-novo three-vessel disease or left main coronary disease to determine suitability for study treatments. Eligible patients suitable for either treatment were randomly assigned (1:1) by an interactive voice response system to either PCI with a first-generation paclitaxel-eluting stent or to CABG. Patients suitable for only one treatment option were entered into either the PCI-only or CABG-only registries. We analysed a composite rate of major adverse cardiac and cerebrovascular events (MACCE) at 5-year follow-up by Kaplan-Meier analysis on an intention-to-treat basis. This study is registered with ClinicalTrials.gov , number NCT00114972. Findings 1800 patients were randomly assigned to CABG (n=897) or PCI (n=903). More patients who were assigned to CABG withdrew consent than did those assigned to PCI (50 vs 11). After 5 years’ follow-up, Kaplan-Meier estimates of MACCE were 26·9% in the CABG group and 37·3% in the PCI group (p<0·0001). Estimates of myocardial infarction (3·8% in the CABG group vs 9·7% in the PCI group; p<0·0001) and repeat revascularisation (13·7% vs 25·9%; p<0·0001) were significantly increased with PCI versus CABG. All-cause death (11·4% in the CABG group vs 13·9% in the PCI group; p=0·10) and stroke (3·7% vs 2·4%; p=0·09) were not significantly different between groups. 28·6% of patients in the CABG group with low SYNTAX scores had MACCE versus 32·1% of patients in the PCI group (p=0·43) and 31·0% in the CABG group with left main coronary disease had MACCE versus 36·9% in the PCI group (p=0·12); however, in patients with intermediate or high SYNTAX scores, MACCE was significantly increased with PCI (intermediate score, 25·8% of the CABG group vs 36·0% of the PCI group; p=0·008; high score, 26·8% vs 44·0%; p<0·0001). Interpretation CABG should remain the standard of care for patients with complex lesions (high or intermediate SYNTAX scores). For patients with less complex disease (low SYNTAX scores) or left main coronary disease (low or intermediate SYNTAX scores), PCI is an acceptable alternative. All patients with complex multivessel coronary artery disease should be reviewed and discussed by both a cardiac surgeon and interventional cardiologist to reach consensus on optimum treatment. Funding Boston Scientific.
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.
Abstract Objectives The aim of this study was to compare outcomes among transfemoral (TF), transaortic (TAo), and transapical (TA) transcatheter aortic valve replacement (TAVR). Background Very few ...studies have investigated the differences among TF, TAo, and TA TAVR in terms of safety and feasibility. Methods Between January 2011 and December 2014, 467 consecutive cases of TF TAVR, 289 cases of TAo TAVR, and 42 cases of TA TAVR were analyzed. Baseline characteristics, procedural characteristics, and outcomes were compared between TF and TAo and between TAo and TA approaches. Results Balloon-expandable prostheses were used in 320 cases of TF TAVR (69%), 209 cases of TAo TAVR (72%), and all cases of TA TAVR. The remaining cases were performed using self-expandable prostheses. Patient age and Society of Thoracic Surgeons score were similar (83.8 years vs. 83.7 years vs. 81.3 years and 6.2% vs. 5.8% vs. 7.1%) among all groups. Although nonsignificant, a trend toward lower 30-day mortality (5% vs. 9%; p = 0.057) was observed with TF TAVR compared with TAo TAVR. Kaplan-Meier analysis revealed a trend toward a higher 1-year survival rate (log-rank p = 0.067) with TF TAVR compared with TAo TAVR. There was no significant difference in 30-day mortality between TAo and TA TAVR (9% vs. 14%; p = 0.283). Kaplan-Meier analysis revealed a trend toward a higher 1-year survival rate (log-rank p = 0.154) with TAo TAVR compared with TA TAVR. Conclusions Although the 30-day mortality and 1-year survival rates were similar between TF and TAo TAVR patients, a trend in favor of the TF approach was observed. In addition, the TAo approach can be considered as an alternative to the TA approach when the TF approach seems unsuitable.
Abstract Objectives This study sought to develop a scoring model predicting percutaneous coronary intervention (PCI) success in chronic total occlusions. Background Coronary chronic total occlusion ...is the lesion subtype in which angioplasty is most likely to fail. Chronic total occlusion for PCI (CTO-PCI) failure is associated with higher 1-year mortality and major adverse cardiac events compared with successful CTO-PCI. Although several independent predictors of final procedural success have been identified, no study has yet produced a model predicting final procedural outcome. Methods Data from 1,657 consecutive patients who underwent a first-attempt CTO-PCI were prospectively collected. The scoring model was developed in a derivation cohort of 1,143 patients (70%) using a multivariable stepwise analysis to identify independent predictors of CTO-PCI failure. The model was then validated in the remaining 514 (30%). Results The overall procedural success rate was 72.5%. Independent predictors of CTO-PCI failure were identified and included in the clinical and lesion-related score (CL-score) as follows: previous coronary artery bypass graft surgery +1.5 (odds ratio OR: 2.49, 95% confidence interval CI: 1.56 to 3.96), previous myocardial infarction +1 (OR: 1.6, 95% CI: 1.17 to 2.2), severe lesion calcification +2 (OR: 2.72, 95% CI :1.78 to 4.16), longer CTOs +1.5 (≥20 mm OR: 2.04, 95% CI: 1.54 to 2.7), non–left anterior descending coronary artery location +1 (OR: 1.56, 95% CI: 1.14 to 2.15), and blunt stump morphology +1 (OR: 1.39, 95% CI: 1.05 to 1.81). Score values of 0 to 1, >1 and <3, ≥3 and <5, and ≥5 identified subgroups at high, intermediate, low, and very low probability, respectively, of CTO-PCI success (derivation cohort: 84.9%, 74.9%, 58%, and 31.9%; p < 0,0001; validation cohort: 88.3%, 73.1%, 59.4%, and 46.2%; p < 0.0001). Conclusions This clinical and angiographic score predicted the final CTO-PCI procedural outcome of our study population.
Objectives The goal of the study was to clarify the impact of post-procedural aortic regurgitation (post-AR) grade 2/4 on clinical outcomes. Background Post-AR >2/4 is known to be associated with ...poor short- to midterm outcome after transcatheter aortic valve implantation (TAVI). Methods We compared clinical outcomes in 400 consecutive TAVI recipients according to post-AR grade: grade 0 or 1 (group 1 = 74.8%), grade 2 (group 2 = 22.2%), or grade 3 or 4 (group 3 = 3.0%). Results The mean age was similar in the 3 groups (83.4 ± 6.1 years) as was the logistic EuroSCORE (22.5 ± 11.4%, 24.5 ± 11.6%, and 21.5 ± 9.4%, p = 0.28) and annulus size (22.0 ± 1.8, 22.2 ± 2.1, and 22.5 ± 2.1 mm, p = 0.53). The Edwards valve was most frequently used in group 1 compared with groups 2 and 3 (89.3%, 78.7%, and 83.3%, p = 0.03), and the implanted valve size was similar in all groups (25.6 ± 2.0, 25.4 ± 2.2, and 25.5 ± 2.2 mm, respectively, p = 0.69). Post-dilation was required more frequently in group 3 (4.7%, 24.1%, and 50.0%, respectively, p < 0.01). Post-procedural increase in mitral regurgitation was in line with the post-AR grade (0.78 ± 0.73, 1.22 ± 0.80, and 1.89 ± 0.78, respectively, p < 0.01). Despite the absence of difference in 30-day mortality, longer-term outcome was significantly poorer in patients with AR grade 2 than in those with AR grade 0 or 1 (log-rank p < 0.01), albeit better than in patients with AR grade 3 or 4 (p = 0.04), regardless of TAVI type and left ventricular function. Post-AR ≥2/4 was also identified as an independent predictor of mid- to long-term mortality (hazard ratio: 1.68, 95% confidence interval: 1.21 to 1.44, p < 0.01). Conclusions Post-AR grade 2/4 after TAVI is associated with worse outcome compared with grade 0 or 1. Careful valve selection and post-dilation when required to avoid post-AR grade 2 may contribute to improved clinical outcome after TAVI.
Summary Background A novel stent platform eluting biolimus, a sirolimus analogue, from a biodegradable polymer showed promising results in preliminary studies. We compared the safety and efficacy of ...a biolimus-eluting stent (with biodegradable polymer) with a sirolimus-eluting stent (with durable polymer). Methods We undertook a multicentre, assessor-blind, non-inferiority study in ten European centres. 1707 patients aged 18 years or older with chronic stable coronary artery disease or acute coronary syndromes were centrally randomised by a computer-generated allocation sequence to treatment with either biolimus-eluting (n=857) or sirolimus-eluting (n=850) stents. The primary endpoint was a composite of cardiac death, myocardial infarction, or clinically-indicated target vessel revascularisation within 9 months. Analysis was by intention to treat. 427 patients were randomly allocated to angiographic follow-up, with in-stent percentage diameter stenosis as principal outcome measure at 9 months. The trial is registered with ClinicalTrials.gov , number NCT00389220. Findings We analysed all randomised patients. Biolimus-eluting stents were non-inferior to sirolimus-eluting stents for the primary endpoint at 9 months (79 9% patients vs 89 11%, rate ratio 0·88 95% CI 0·64–1·19, p for non-inferiority=0·003, p for superiority=0·39). Frequency of cardiac death (14 1·6% vs 21 2·5%, p for superiority=0·22), myocardial infarction (49 5·7% vs 39 4·6%, p=0·30), and clinically-indicated target vessel revascularisation (38 4·4% vs 47 5·5%, p=0·29) were similar for both stent types. 168 (79%) patients in the biolimus-eluting group and 167 (78%) in the sirolimus-eluting group had data for angiographic follow-up available. Biolimus-eluting stents were non-inferior to sirolimus-eluting stents in in-stent percentage diameter stenosis (20·9% vs 23·3%, difference −2·2% 95% CI −6·0 to 1·6, p for non-inferiority=0·001, p for superiority=0·26). Interpretation Our results suggest that a stent eluting biolimus from a biodegradable polymer represents a safe and effective alternative to a stent eluting sirolimus from a durable polymer in patients with chronic stable coronary artery disease or acute coronary syndromes. Funding Biosensors Europe SA, Switzerland.
Objectives This study sought to assess whether the volume of contrast media (CM) influences the occurrence of acute kidney injury (AKI) following transcatheter aortic valve implantation (TAVI). ...Background The volume of CM has been shown to be associated with increasing risk of AKI; however, in a high-risk elderly TAVI population, the predictive value and optimal threshold of CM dose on AKI remain uncertain. Methods Data of 415 consecutive transfemoral TAVI patients (age 83.6 ± 6.8 years, logistic EuroSCORE 23.0 ± 12.2%) were analyzed. AKI was defined by Valve Academic Research Consortium criteria. Based on a previous formula, the ratio of CM to serum creatinine (SCr) and body weight (BW) (CM × SCr/BW) was calculated as defining the degree of CM use. The association between CM dose and incidence of AKI, as well as predictive factors and prognosis of AKI, were investigated. Results AKI occurred in 63 patients (15.2%). Cumulative 1-year mortality showed significant differences between the AKI and non-AKI groups (47.9% vs. 15.7%, p < 0.001). Mean CM × SCr/BW ratio was higher in the AKI group than in the non-AKI group (4.1 ± 2.9 vs. 2.9 ± 1.6, p < 0.001). By multivariate analysis, CM × SCr/BW per 1.0 increase, ejection fraction <40%, and transfusion were associated with the occurrence of AKI (odds ratio OR: 1.16; 95% confidence interval CI: 1.03 to 1.20; p = 0.017, OR: 3.01; 95% CI: 1.49 to 5.00; p = 0.001, OR: 2.73; 95% CI: 1.54 to 6.15; p = 0.001, respectively). A threshold value of CM × SCr/BW for predicting AKI was statistically identified as 2.7. Conclusions Although mechanisms of AKI following TAVI are multifactorial, the present study identified a relationship between CM dose increment and high prevalence of AKI. Therapeutic efforts not to exceed the threshold value may reduce the risk of AKI.
Summary Background The effectiveness of durable polymer drug-eluting stents comes at the expense of delayed arterial healing and subsequent late adverse events such as stent thrombosis (ST). We ...report the 4 year follow-up of an assessment of biodegradable polymer-based drug-eluting stents, which aim to improve safety by avoiding the persistent inflammatory stimulus of durable polymers. Methods We did a multicentre, assessor-masked, non-inferiority trial. Between Nov 27, 2006, and May 18, 2007, patients aged 18 years or older with coronary artery disease were randomly allocated with a computer-generated sequence to receive either biodegradable polymer biolimus-eluting stents (BES) or durable polymer sirolimus-eluting stents (SES; 1:1 ratio). The primary endpoint was a composite of cardiac death, myocardial infarction, or clinically-indicated target vessel revascularisation (TVR); patients were followed-up for 4 years. Analysis was by intention to treat. This trial is registered with ClinicalTrials.gov , number NCT00389220. Findings 1707 patients with 2472 lesions were randomly allocated to receive either biodegradable polymer BES (857 patients, 1257 lesions) or durable polymer SES (850 patients, 1215 lesions). At 4 years, biodegradable polymer BES were non-inferior to durable polymer SES for the primary endpoint: 160 (18·7%) patients versus 192 (22·6%) patients (rate ratios RR 0·81, 95% CI 0·66–1·00, p for non-inferiority <0·0001, p for superiority=0·050). The RR of definite ST was 0·62 (0·35–1·08, p=0·09), which was largely attributable to a lower risk of very late definite ST between years 1 and 4 in the BES group than in the SES group (RR 0·20, 95% CI 0·06–0·67, p=0·004). Conversely, the RR of definite ST during the first year was 0·99 (0·51–1·95; p=0·98) and the test for interaction between RR of definite ST and time was positive ( pinteraction =0·017). We recorded an interaction with time for events associated with ST but not for other events. For primary endpoint events associated with ST, the RR was 0·86 (0·41–1·80) during the first year and 0·17 (0·04–0·78) during subsequent years ( pinteraction =0·049). Interpretation Biodegradable polymer BES are non-inferior to durable polymer SES and, by reducing the risk of cardiac events associated with very late ST, might improve long-term clinical outcomes for up to 4 years compared with durable polymer SES. Funding Biosensors Europe SA, Switzerland.
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