Summary Background Drug-eluting stents with durable biocompatible or biodegradable polymers have been developed to address the risk of thrombosis associated with first-generation drug-eluting stents. ...We aimed to compare the safety and efficacy of a biodegradable polymer-coated biolimus-eluting stent with a thin-strut everolimus-eluting stent coated with a durable biocompatible polymer. Methods This open-label, prospective, randomised, controlled, non-inferiority trial was undertaken at 12 sites across Europe. We used limited exclusion criteria (age >18 years, life expectancy >5 years, reference vessel diameter 2·0–4·0 mm) to enrol patients eligible for percutaneous coronary intervention. Patients were randomly allocated (2:1) by computer-generated random numbers to receive either a biodegradable polymer biolimus-eluting stent (Nobori, Terumo, Tokyo, Japan) or a durable fluoropolymer-based everolimus-eluting stent (Xience V or Prime, Abbott Vascular, Santa Clara, CA, USA, or Promus, Boston Scientific, Natick, MA, USA). The primary endpoint was a composite of safety (cardiac death and non-fatal myocardial infarction) and efficacy (clinically indicated target vessel revascularisation) at 12 months, analysed by intention to treat. Patients received dual antiplatelet therapy for 12 months after discharge. The trial is registered with ClinicalTrials.gov , number NCT01233453. Findings From Jan 12, 2009, to Feb 7, 2011, we enrolled 2707 patients (4025 lesions), 1795 of whom were assigned to receive the biolimus-eluting stent (2638 lesions) and 912 to an everolimus-eluting stent (1387 lesions). 2688 (99·3%) patients completed 12 months' follow-up. Significantly more patients in the biolimus-eluting stent group received a non-assigned stent than did those in the everolimus-eluting stent group (105 5·9% vs 19 2·1%; p<0·0001). The primary endpoint occurred in 93 (5·2%) patients in the biolimus-eluting stent group and 44 (4·8%) patients in the everolimus-eluting stent group at 12 months (relative risk 1·07 95% CI 0·75–1·52; pnon-inferiority <0·0001). Analysis per protocol did not change the outcome of this trial (pnon-inferiority <0·0001). Interpretation Biodegradable polymer biolimus-eluting stents are as safe and efficacious as the current standard of a thin-strut everolimus-eluting stent with a durable biocompatible polymer. We need to follow-up patients for longer to show whether the biolimus-eluting stent reduces the risk of stent thrombosis after 1 year when compared with the everolimus-eluting stent. Funding Terumo Europe (Leuven, Belgium) and the Research Foundation of the Cardiology Department, Maasstad Hospital (Rotterdam, Netherlands).
Abstract
Aims
The aim of this study was to compare clinical outcomes of patients undergoing transfemoral transcatheter aortic valve implantation (TAVI) with balloon-expandable (BE) valves vs. ...self-expandable (SE) valves. Transcatheter aortic valve implantation is a minimally invasive and lifesaving treatment in patients with aortic valve stenosis. Even though BE-valves and SE-valves are both commonly used on a large scale, adequately sized trials comparing clinical outcomes in patients with severe aortic valve stenosis treated with BE-valves compared with SE-valves are lacking.
Methods and results
In this CENTER-collaboration, data from 10 registries or clinical trials, selected through a systematic search, were pooled and analysed. Propensity score methodology was used to reduce treatment selection bias and potential confounding. The primary endpoints were mortality and stroke at 30 days follow-up in patients treated with BE-valves compared with SE-valves. Secondary endpoints included clinical outcomes, e.g. bleeding during hospital admission. All outcomes were split for early-generation BE-valves compared with early-generation SE-valves and new-generation BE-valves with new-generation SE-valves. The overall patient population (N = 12 381) included 6239 patients undergoing TAVI with BE-valves and 6142 patients with SE-valves. The propensity matched population had a mean age of 81 ± 7 years and a median STS-PROM score or 6.5% interquartile range (IQR) 4.0–13.0%. At 30-day follow-up, the mortality rate was not statistically different in patients undergoing TAVI with BE-valves compared with SE-valves BE: 5.3% vs. SE: 6.2%, relative risk (RR) 0.9; 95% confidence interval (CI) 0.7–1.0, P = 0.10. Stroke occurred less frequently in patients treated with BE-valves (BE: 1.9% vs. SE: 2.6%, RR 0.7; 95% CI 0.5–1.0, P = 0.03). Also, patients treated with BE-valves had a three-fold lower risk of requiring pacemaker implantation (BE: 7.8% vs. SE: 20.3%, RR 0.4; 95% CI 0.3–0.4, P < 0.001). In contrast, patients treated with new-generation BE-valves more frequently experienced major and life-threatening bleedings compared with new-generation SE-valves (BE: 4.8% vs. SE: 2.1%, RR 2.3; 95% CI 1.6–3.3, P < 0.001).
Conclusion
In this study, which is the largest study to compare valve types in TAVI, we demonstrated that the incidence of stroke and pacemaker implantation was lower in patients undergoing transfemoral TAVI with BE-valves compared with SE-valves. In contrast, patients treated with new-generation BE-valves more often suffered from major or life-threatening bleedings than patients with new-generation SE-valves. Mortality at 30-days was not statistically different in patients treated with BE-valves compared with SE-valves. This study was a propensity-matched analysis generated from observational data, accordingly current outcomes will have to be confirmed in a large scale randomized controlled trial.
Methods This retrospective cohort study included 1499 consecutive patients with STEMI who underwent PPCI between January 2008 and December 2015. Women with FMCP-PCI <= 90 compared to those with ...FMC-PPI > 90 had lower rates of all-cause mortality (8,5% vs 13,5% , P=0,018) and MACE (13,5% vs 28%, p=0,006) during follow-up.
CHAD2DS2VASc Score was designed to estimate thromboembolic events in atrial fibrilation, nevertheless the components of this score include known coronary risk factors.The aim of this is study to ...analyse the the long-term predictive value in all-cause mortality of the CHAD2DS2Vasc score in STEMI patients undergoing primary PCI compared with the GRACE score. No significative accuracity diferences for all-cause mortality were seen between CHADS2DS2Vasc score and GRACE score (Pairwise comparision of ROC curves by DeLong method z test = 0,821, p=0,417) Conclusion CHAD2VASC2 score was an independent predictor of long term all-cause mortality in our population of STEMI patients who underwent to primary PCI and may be a useful predictor of long term all-cause mortality.
Abstract Objectives We aimed to determine whether body mass index (BMI) is a prognostic indicator for long-term, all-cause mortality in patients undergoing transcatheter aortic valve implantation ...(TAVI). Background Obesity in patients with established cardiovascular disease has previously been identified as an indicator of good prognosis, a phenomenon known as the “obesity paradox”. The prognostic significance of BMI in patients with severe aortic stenosis (AoS) undergoing TAVI is a matter of current debate, as published studies are scarce and their results conflicting. Methods This is an observational, retrospective study involving 770 patients who underwent TAVI for AoS. The cohort was divided into three groups based on their BMI: normal weight (≥ 18.5 to < 25 kg/m2 ), overweight (≥ 25 to < 30 kg/m2 ) and obese (≥ 30 kg/m2 ). The predictive effect of BMI on all-cause mortality 3 years following TAVI intervention was analysed using a Cox regression. Results 155 patients died during follow-up. The overweight group ( n = 302, 38.97%), experienced a lower mortality rate compared to the normal weight and obese groups (15.9% vs 25.7% and 21.0%, respectively log-rank p -value = 0.036). After adjustment by logistic EuroSCORE, being overweight was found to be an independent protective factor against mortality (HR: 0.63 95% CI: 0.42 to 0.94, p = 0.024). This was not the case for obesity (HR: 0.92 95% CI: 0.63 to 1.35, p = 0.664). We therefore describe for the first time, a “J-shaped” regression curve describing the relationship between BMI and mortality. Conclusions BMI is a predictive factor of all-cause mortality in AoS patients undergoing TAVI. This relationship takes the form of a “J-shaped” curve in which overweight patients are associated with the lowest mortality rate at follow-up.
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