Comparison of zotarolimus- and everolimus-eluting coronary stents: final 5-year report of the RESOLUTE all-comers trial

BACKGROUND Newer-generation drug-eluting stents that release zotarolimus or everolimus have been shown to be superior to the first-generation drug-eluting stents. However, data comparing long-term safety and efficacy of zotarolimus- (ZES) and everolimus-eluting stents (EES) are limited. RESOLUTE all-comers (Randomized Comparison of a Zotarolimus-Eluting Stent With an Everolimus-Eluting Stent for Percutaneous Coronary Intervention) trial compared these 2 stents and has shown that ZES was noninferior to EES at 12-month for the primary end point of target lesion failure. We report the secondary clinical outcomes at the final 5-year follow-up of this trial. METHODS AND RESULTS RESOLUTE all-comer clinical study is a prospective, multicentre, randomized, 2-arm, open-label, noninferiority trial with minimal exclusion criteria. Patients (n=2292) were randomly assigned to treatment with either ZES (n=1140) or EES (n=1152). Patient-oriented composite end point (combination of all-cause mortality, myocardial infarction, and any revascularizations), device-oriented composite end point (combination of cardiac death, target vessel myocardial infarction, and clinically indicated target lesion revascularization), and major adverse cardiac events (combination of all-cause death, all myocardial infarction, emergent coronary bypass surgery, or clinically indicated target lesion revascularization) were analyzed at 5-year follow-up. The 2 groups were well-matched at baseline. Five-year follow-up data were available for 98% patients. There were no differences in patient-oriented composite end point (ZES 35.3% versus EES 32.0%, P=0.11), device-oriented composite end point (ZES 17.0% versus EES 16.2%, P=0.61), major adverse cardiac events (ZES 21.9% versus EES 21.6%, P=0.88), and definite/probable stent thrombosis (ZES 2.8% versus EES 1.8%, P=0.12). CONCLUSIONS At 5-year follow-up, ZES and EES had similar efficacy and safety in a population of patients who had minimal exclusion criteria. CLINICAL TRIAL REGISTRATION URL: http://www.clinicaltrials.gov. Unique identifier: NCT00617084

Study of β-delayed charged particle emission of 11Li: Evidence of new decay channels

5 pags., 3 figs. -- 9th International Conference on Clustering Aspects of Nuclear Structure and Dynamics (CLUSTERS'07) 3–7 September 2007, Stratford upon Avon, UKThe break-up of the 18.2 MeV state in 11Be was studied in a 11Li β-decay experiment. We report here on the study of the dominating breakup channels involving na6He or 3n2α in the final state, with special emphasis dedicated in this contribution to the three-particle channel. The two emitted charged particles were detected in coincidence using a highly segmented experimental set-up. The observed experimental energy-vs-energy scatter plot indicates a sequential breakup where nuclei of mass 4, alpha particles, and mass 7, 7He, are involved. A Monte-Carlo simulation of the sequential channel, 11Be* → α + 7He → nα6He was performed and compared to the experimental data and to a simulation of the direct break-up of the 18.2 MeV state nα6He by phase space energy distribution. The energy-versus-energy plot are explained by the sequential simulation but not by the phase space simulation. © 2008 IOP Publishing Ltd

Impact of body mass index on outcomes after primary angioplasty in acute myocardial infarction.

BACKGROUND: The prognostic importance of obesity after primary percutaneous coronary intervention (PCI) in patients with acute myocardial infarction (AMI) is unknown. We therefore sought to investigate the impact of body mass index (BMI) in patients with AMI undergoing primary PCI. METHODS: In the CADILLAC trial, 2082 patients of any age with AMI within 12 hours onset undergoing primary PCI were randomized to balloon angioplasty versus stenting, each +/-abciximab. Outcomes were stratified by baseline BMI. RESULTS: Baseline BMI was measured in 2035 (98%) randomized patients; 552 (27%) patients have normal weight (BMI \u3c 25 kg/m2), 915 (45%) were overweight (\u3e or = 25 to \u3c 30 kg/m2), and 568 (28%) were obese (\u3e or = 30 kg/m2). Compared with normal-weight patients, obese patients were younger and more frequently had diabetes, hyperlipidemia, hypertension, non-anterior myocardial infarction, and higher creatinine clearance. Obese patients were less likely to develop thrombocytopenia (1.8% vs 4.2%), moderate hemorrhagic complications (1.4% vs 3.3%), or required blood product transfusions (3.2% vs 6.3%) (all P \u3c or = .04). Obese compared with normal-weight patients had lower inhospital mortality (0.9% vs 2.7%, P = .03) at 30 days (1.1% vs 3.8%, P = .02) and 1 year (1.8% vs 7.5%, P \u3c .0001). Independent predictors of 30-day and 1-year mortality included lower ejection fraction, advanced age, 3-vessel disease, anterior AMI, and lower creatinine clearance, but not BMI. CONCLUSIONS: Obese patients with AMI have an improved prognosis after primary PCI compared with normal-weight patients, a finding attributable to AMI onset at younger age, with better renal function and less anterior infarction

First report of the Global SYMPLICITY Registry on the effect of renal artery denervation in patients with uncontrolled hypertension.

UNLABELLED This study aimed to assess the safety and effectiveness of renal denervation using the Symplicity system in real-world patients with uncontrolled hypertension (NCT01534299). The Global SYMPLICITY Registry is a prospective, open-label, multicenter registry. Office and 24-hour ambulatory blood pressures (BPs) were measured. Change from baseline to 6 months was analyzed for all patients and for subgroups based on baseline office systolic BP, diabetic status, and renal function; a cohort with severe hypertension (office systolic pressure, ≥160 mm Hg; 24-hour systolic pressure, ≥135 mm Hg; and ≥3 antihypertensive medication classes) was also included. The analysis included protocol-defined safety events. Six-month outcomes for 998 patients, including 323 in the severe hypertension cohort, are reported. Mean baseline office systolic BP was 163.5±24.0 mm Hg for all patients and 179.3±16.5 mm Hg for the severe cohort; the corresponding baseline 24-hour mean systolic BPs were 151.5±17.0 and 159.0±15.6 mm Hg. At 6 months, the changes in office and 24-hour systolic BPs were -11.6±25.3 and -6.6±18.0 mm Hg for all patients (P70% and 5 cases of hospitalization for a hypertensive emergency. In clinical practice, renal denervation resulted in significant reductions in office and 24-hour BPs with a favorable safety profile. Greater BP-lowering effects occurred in patients with higher baseline pressures. CLINICAL TRIAL REGISTRATION URL: www.clinicaltrials.gov. Unique identifier: NCT01534299

Impact of anemia on outcomes of patients undergoing percutaneous coronary interventions.

Of 6,929 consecutive patients who were treated with percutaneous coronary intervention, 1,708 (24.6%) had anemia according to criteria of the World Health Organization. Compared with patients who did not have anemia, those who did have anemia were older, more frequently women and African-American, had a smaller body mass index, and higher frequencies of cardiovascular risk factors and co-morbid conditions. Patients who had anemia compared with those who did not have anemia had significantly (p <0.0001) higher mortality rates during hospitalization (1.9% vs 0.4%) and at 1 year (12.8% vs 3.5%). After adjustment for potential confounders, baseline hematocrit remained a significant predictor of a 1-year mortality rate (hazard ratio 0.93 per 1% increase in hematocrit, 95% confidence interval 0.91 to 0.95)

Impact of overlapping newer generation drug-eluting stents on clinical and angiographic outcomes: pooled analysis of five trials from the international Global RESOLUTE Program

BACKGROUND Overlapping first generation sirolimus- and paclitaxel-eluting stents are associated with persistent inflammation, fibrin deposition and delayed endothelialisation in preclinical models, and adverse angiographic and clinical outcomes--including death and myocardial infarction (MI)--in clinical studies. OBJECTIVES To establish as to whether there are any safety concerns with newer generation drug-eluting stents (DES). DESIGN Propensity score adjustment of baseline anatomical and clinical characteristics were used to compare clinical outcomes (Kaplan-Meier estimates) between patients implanted with overlapping DES (Resolute zotarolimus-eluting stent (R-ZES) or R-ZES/other DES) against no overlapping DES. Additionally, angiographic outcomes for overlapping R-ZES and everolimus-eluting stents were evaluated in the randomised RESOLUTE All-Comers Trial. SETTING Patient level data from five controlled studies of the RESOLUTE Global Clinical Program evaluating the R-ZES were pooled. Enrollment criteria were generally unrestrictive. PATIENTS 5130 patients. MAIN OUTCOME MEASURES 2-year clinical outcomes and 13-month angiographic outcomes. RESULTS 644 of 5130 patients (12.6%) in the RESOLUTE Global Clinical Program underwent overlapping DES implantation. Implantation of overlapping DES was associated with an increased frequency of MI and more complex/calcified lesion types at baseline. Adjusted in-hospital, 30-day and 2-year clinical outcomes indicated comparable cardiac death (2-year overlap vs non-overlap: 3.0% vs 2.1%, p=0.36), major adverse cardiac events (13.3% vs 10.7%, p=0.19), target-vessel MI (3.9% vs 3.4%, p=0.40), clinically driven target vessel revascularisation (7.7% vs 6.5%, p=0.32), and definite/probable stent thrombosis (1.4% vs 0.9%, p=0.28). 13-month adjusted angiographic outcomes were comparable between overlapping and non-overlapping DES. CONCLUSIONS Overlapping newer generation DES are safe and effective, with comparable angiographic and clinical outcomes--including repeat revascularisation--to non-overlapping DES