Compared with bare metal stents, first-generation drug-eluting stents (DES) are associated with an increased risk of late restenosis and stent thrombosis (ST). Whether this risk continues or ...attenuates during long-term follow-up remains unknown.
We extended the follow-up of 1012 patients sirolimus-eluting stent (SES): N = 503 and paclitaxel-eluting stent (PES): N = 509 included in the all-comers, randomized Sirolimus-Eluting vs. Paclitaxel-Eluting Stents for Coronary Revascularization (SIRTAX) trial to 10 years. Follow-up was complete in 895 patients (88.4%) at 10 years. At 1, 5, and 10 years of follow-up, rates of ischaemia-driven target lesion revascularization (ID-TLR) were 8.1%, 14.6% and 17.7%, respectively, and rates of ST were 1.9%, 4.5% and 5.6%, respectively. The annual risks of ID-TLR and definite ST were significantly higher between 1 and 5 years as compared with the 5- to 10-year period ID-TLR: 1.8% vs. 0.7%/year, hazard ratio (HR) 0.36, 95% confidence intervals (95% CI) 0.21-0.62, P < 0.001; definite ST: 0.67% vs. 0.23%/year, HR 0.31, 95% CI 0.13-0.75, P = 0.01. The attenuation of the risk of ID-TLR and ST beyond 5 years was independent of age. Major adverse events (cardiac death, myocardial infarction, and ID-TLR) occurred in 33.7% of SES- and 33.8% of PES-treated patients (P = 0.72).
During long-term follow-up through 10 years, the annual risks of ID-TLR and definite ST significantly decreased beyond 5 years after first-generation DES implantation. These findings may have important implications for secondary prevention after percutaneous coronary intervention with first-generation DES including long-term antiplatelet therapy.
http://www.clinicaltrials.gov. Unique identifier: NCT00297661.
To analyse reasons, timing and predictors of hospital readmissions after transcatheter aortic valve implantation (TAVI).
Patients included in the Bern TAVI Registry between August 2007 and June 2014 ...were analysed. Fine and Gray competing risk regression was used to identify factors predictive of hospital readmission within 1 year after TAVI with bootstrap analysis for internal validation. Of 868 patients alive at discharge, 221 (25.4%) were readmitted within 1 year. Compared with patients not requiring readmission, those with at least one readmission more frequently were male and more often had atrial fibrillation and higher creatinine values (P < 0.05 for all cases). For overall 308 readmissions, cardiovascular causes accounted for 46.1% with heart failure as the most frequent indication; non-cardiovascular readmissions occurred for surgery (11.7%), gastrointestinal disorders (9.7%), malignancy (4.9%), respiratory diseases (4.6%) and chronic kidney failure (2.6%). Male gender (subhazard ratio, SHR, 1.33, 95% confidence intervals, CI, 1.02-1.73, P = 0.035) and stage 3 kidney injury (SHR 2.04, 95% CI 1.12-3.71, P = 0.021) were found independent risk factors for any hospital readmission, whereas previous myocardial infarction (SHR 1.88, 95% CI 1.22-2.90, P = 0.004) and in-hospital life-threatening bleeding (SHR 2.18, 95%CI 1.24-3.85, P = 0.007) were associated with cardiovascular readmissions. The event rate for mortality was significantly increased after readmissions for any cause (RR 4.29, 95% CI 2.86-6.42, P < 0.001).
Hospital readmission was observed in one out of four patients during the first year after TAVI and was associated with a significant increase in mortality.
This study sought to determine the impact of left ventricular diastolic dysfunction (LVDD) on clinical outcomes in patients undergoing transcatheter aortic valve replacement (TAVR).
Left ventricular ...(LV) hypertrophy in response to afterload increase promotes the development of LVDD and represents an early stage in the progression to valvular heart failure.
In a consecutive cohort of 777 aortic stenosis patients undergoing TAVR, LVDD was categorized according to the latest guidelines. The primary endpoint was 1-year all-cause mortality.
There were 545 (70.1%) patients with LVDD. Ninety-eight (18.0%), 198 (36.3%), and 104 (19.1%) patients were classified as LVDD grades I, II, and III, respectively. In 145 (26.6%) patients, LVDD grade could not be determined because of only 1 or 2 discrepant variables. One-year all-cause mortality was higher in patients with LVDD grades I (16.3%; adjusted hazard ratio HRadj: 2.32; 95% confidence interval CI: 1.15 to 4.66), II (17.9%; HRadj: 2.58; 95% CI: 1.43 to 4.67), and III (27.6%; HRadj: 4.21; 95% CI: 2.25 to 7.86) than in those with normal diastolic function (6.9%). The difference in clinical outcome emerged within 30 days, was driven by cardiovascular death, and maintained in a sensitivity analysis of patients with normal systolic LV function. Furthermore, LVDD grades I (HRadj: 2.36; 95% CI: 1.17 to 4.74), II (HRadj: 2.58; 95% CI: 1.42 to 4.66), and III (HRadj: 4.41; 95% CI: 2.37 to 8.20) were independent predictors of 1-year mortality.
Advancing stages of LVDD are associated with an incremental risk of all-cause mortality after TAVR, driven by cardiovascular death and taking effect as early as 30 days after the intervention.
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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.
B-type natriuretic peptide (BNP) levels are elevated in patients with aortic stenosis (AS) and decrease acutely after replacement of the stenotic valve. The long-term prognostic value of BNP after ...transcatheter aortic valve implantation (TAVI) and the relative prognostic utility of single versus serial peri-interventional measurements of BNP and N -terminal prohormone BNP (NT-pro-BNP) are unknown. This study sought to determine the impact of BNP levels on long-term outcomes after TAVI and to compare the utility of BNP versus NT-pro-BNP measured before and after intervention. We analyzed 340 patients with severe AS and baseline pre-TAVI assessment of BNP. In 219 patients, BNP and NT-pro-BNP were measured serially before and after intervention. Clinical outcomes over 2 years were recorded. Patients with high baseline BNP (higher tertile ≥591 pg/ml) had increased risk of all-cause mortality (adjusted hazard ratio 3.16, 95% confidence interval 1.84 to 5.42; p <0.001) and cardiovascular death at 2 years (adjusted hazard ratio 3.37, 95% confidence interval 1.78 to 6.39; p <0.001). Outcomes were most unfavorable in patients with persistently high BNP before and after intervention. Comparing the 2 biomarkers, NT-pro-BNP levels measured after TAVI showed the highest prognostic discrimination for 2-year mortality (area under the curve 0.75; p <0.01). Baseline-to-discharge reduction, but not baseline levels of BNP, was related to New York Heart Association functional improvement. In conclusion, high preintervention BNP independently predicts 2-year outcomes after TAVI, particularly when elevated levels persist after the intervention. BNP and NT-pro-BNP and their serial periprocedural changes provide complementary prognostic information for symptomatic improvement and survival.
The study aims to assess characteristics and outcomes of patients suffering a mechanical complication (MC) after ST-segment elevation myocardial infarction (STEMI) in a contemporary cohort of ...patients in the percutaneous coronary intervention era.
This retrospective single-center cohort study encompasses 2508 patients admitted with STEMI between March 9, 2009 and June 30, 2014. A total of 26 patients (1.1%) suffered a mechanical complication: ventricular septal rupture (VSR) in 17, ventricular free wall rupture (VFWR) in 2, a combination of VSD and VFWR in 2, and papillary muscle rupture (PMR) in 5 patients. Older age (74.5 ± 10.4 years versus 63.9 ± 13.1 years, p < 0.001), female sex (42.3% versus 23.3%, p = 0.034), and a longer latency period between symptom onset and angiography (> 24h: 42.3% versus 16.2%, p = 0.002) were more frequent among patients with MC as compared to patients without MC. The majority of MC patients had multivessel disease (77%) and presented in cardiogenic shock (Killip class IV: 73.1%). Nine patients (7 VSR, 2 VFWR & VSR) were treated conservatively and died. Out of the remaining 10 VSR patients, four underwent surgery, three underwent implantation of an occluder device, and another three patients had surgical repair following occluder device implantation. All patients with isolated VFWR and PMR underwent emergency surgery. At 30 days, mortality for VSR, VFWR, VFWR & VSR and PMR amounted to 71%, 50%, 100% and 0%, respectively.
Despite advances in the management of STEMI patients, mortality of mechanical complications stays considerable in this contemporary cohort. Older age, female sex, and a prolonged latency period between symptom onset and angiography are associated with the occurrence of these complications.
Phenotypic plasticity is a crucial mechanism for responding to changes in climatic means, yet we know little about its role in responding to extreme climatic events (ECEs). ECEs may lack the reliable ...cues necessary for phenotypic plasticity to evolve; however, this has not been empirically tested. We investigated whether behavioural plasticity in nest-site selection allows a long-lived shorebird (Haematopus ostralegus) to respond to flooding. We collected longitudinal nest elevation data on individuals over two decades, during which time flooding events have become increasingly frequent. We found no evidence that individuals learn from flooding experiences, showing nest elevation change consistent with random nest-site selection. There was also no evidence of phenotypic plasticity in response to potential environmental cues (lunar nodal cycle and water height). A small number of individuals, those nesting near an artificial sea wall, did show an increase in nest elevation over time; however, there is no conclusive evidence this occurred in response to ECEs. Our study population showed no behavioural plasticity in response to changing ECE patterns. More research is needed to determine whether this pattern is consistent across species and types of ECEs. If so, ECEs may pose a major challenge to the resilience of wild populations.
This article is part of the themed issue ‘Behavioural, ecological and evolutionary responses to extreme climatic events’.
In a COVID‐19 sero‐surveillance cohort study with predominantly healthy and vaccinated individuals, the objectives were (i) to investigate longitudinally the factors associated with the quantitative ...dynamics of antispike (anti‐S1) IgG antibody levels, (ii) to evaluate whether the levels were associated with protection from SARS‐CoV‐2 infection, and (iii) to assess whether the association was different in the pre‐Omicron compared with the Omicron period. The QuantiVac Euroimmun ELISA test was used to quantify anti‐S1 IgG levels. The entire study period (16 months), the 11‐month pre‐Omicron period and the cross‐sectional analysis before the Omicron surge included 3219, 2310, and 895 reactive serum samples from 949, 919, and 895 individuals, respectively. Mixed‐effect linear, mixed‐effect time‐to‐event, and logistic regression models were used to achieve the objectives. Age and time since infection or vaccination were the only factors associated with a decline of anti‐S1 IgG levels. Higher antibody levels were significantly associated with protection from SARS‐CoV‐2 infection (0.89, 95% confidence interval CI 0.82–0.97), and the association was higher during the time period when Omicron was predominantly circulating compared with the ones when Alpha and Delta variants were predominant (adjusted hazard ratio for interaction 0.66, 95% CI 0.53–0.84). In a prediction model, it was estimated that >8000 BAU/mL anti‐S1 IgG was required to reduce the risk of infection with Omicron variants by approximately 20%–30% for 90 days. Though, such high levels were only found in 1.9% of the samples before the Omicron surge, and they were not durable for 3 months. Anti‐S1 IgG antibody levels are statistically associated with protection from SARS‐CoV‐2 infection. However, the prediction impact of the antibody level findings on infection protection is limited.
...short-term DAPT regimens varied between the included trials. ...this meta-analysis indicates that short-term DAPT is associated with a reduced risk of bleeding but preserved antithrombotic ...efficacy compared with guideline-recommended 12-month DAPT after DES implantation.
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