Five-year clinical follow-up of a randomized comparison of a polymer-free sirolimus-eluting stent versus a polymer-based paclitaxel-eluting stent in patients with diabetes mellitus (LIPSIA Yukon trial).

OBJECTIVES: The long-term performance of polymer-free stent systems in patients with diabetes mellitus has not been investigated extensively. This study reports long-term results of the LIPSIA Yukon trial which compared the polymer-free sirolimus-eluting Yukon Choice stent with the polymer-based paclitaxel-eluting Taxus Liberté stent in this subpopulation. At 9 months, the Yukon Choice stent failed to show non-inferiority in terms of the primary end point late lumen loss, while no significant difference in clinical outcome was detected. METHODS AND RESULTS: The LIPSIA Yukon trial randomized 240 patients with diabetes mellitus to a polymer-free sirolimus eluting stent (Yukon Choice, Translumina) versus a polymer-based paclitaxel-eluting stent (Taxus Liberté, Boston Scientific). Clinical follow-up was conducted with a standardized telephone follow-up and all events were centrally adjudicated. Follow-up was available for 98.3% of patients after a median of 5.0 years. The incidence of all-cause death (16.9% versus 14.0%, P = 0.67), respectively definite or presumed cardiovascular death (7.6% versus 8.8%, P = 0.94) were similar in the Yukon Choice and the Taxus Liberté group. There were no significant differences in the rates of myocardial infarction (9.3% versus 7.9%, P = 0.88), definite stent thrombosis (0.8% versus 0.9%, P = 1.0), target lesion revascularization (15.3% versus 15.8%, P = 1.0), target vessel revascularization (18.6% versus 23.7%, P = 0.44), non-target vessel revascularization (18.6% versus 26.3%, P = 0.21), and stroke (3.4% versus 4.4%, P = 0.96) between patients assigned to the Yukon Choice and the Taxus Liberté stent. CONCLUSION: At 5 years of follow-up, clinical outcome was similar between the polymer-free sirolimus-eluting Yukon Choice stent and the polymer-based paclitaxel-eluting Taxus Liberté stent.

Determinants of lipid goal achievement in patients on extended-release nicotinic acid/laropiprant in primary care clinical practice.

OBJECTIVES: To establish determinants of lipid goal attainment in primary care patients, with particular focus on participation in a disease management programme (DMP) on diabetes mellitus (DM) and/or coronary heart disease (CHD), with real-world practical relevance. METHODS: The present analysis was based on an observational study in 2359 patients with dyslipidaemia or hypercholesterolaemia that were treated with nicotinic acid 1000 mg/laropiprant 20 mg (Tredaptive) one or two tablets daily. Subgroups were formed by DMP participation (DMP vs. no DMP). A stepwise logistic regression model with backward selection of variables was applied to investigate factors influencing the probability of reaching lipid goals. Follow-up was 23 ± 7 weeks. RESULTS: Low density lipoprotein cholesterol (LDL-C) <100 mg/dl was achieved by 30.8% in DMP versus 26.8% (no DMP), high density lipoprotein (HDL-C) >40/50 mg/dl in 61.3% versus 66.1%, and triglycerides (TG) <150 mg/dl in 28.9% versus 31.7%. On multivariate analysis, age, sex, concomitant high-risk cardiovascular disease, or participation in a DMP appeared to have inconsistent effects on reaching LDL-C, HDL-C and TG goals. Likelihood to reach the LDL-C goal tended to be higher in males, in patients outside DMP, and in patients with DM or CHD, and those treated with 1 tablet (versus 2 tablets) extended release nicotinic acid 1000 mg/laropiprant 20 mg. The likelihood of reaching the HDL-C goal was higher in males and in patients without DM or DM+CHD (no effect of DMP). The likelihood of reaching the TG goals was higher in females, in patients outside DMP, and in patients with DM and/or CHD. Limitations include potential bias due to study design, physician and patient selection, and missing values at follow-up. CONCLUSION: DMP participation was not associated with overall improved lipid goal attainment. Physicians cannot predict the magnitude of effects of newly initiated lipid modifying therapy based on baseline characteristics of their patients.

First prospective, multi-centre clinical experience with a novel left ventricular quadripolar lead.

AIMS: Cardiac resynchronization therapy (CRT) is sometimes complicated by elevated pacing thresholds and phrenic nerve stimulation (PNS), both of which may require that the coronary sinus lead be repositioned. The purpose of this study was to evaluate the performance of a novel quadripolar electrode lead and cardiac resynchronization therapy-defibrillator (CRT-D) device that enables electrical repositioning, potentially obviating a lead reposition procedure. METHODS AND RESULTS: Patients indicated for CRT were enrolled and received a quadripolar electrode lead and CRT-D device (Quartetmodel 1458Q and Promote Q; St Jude Medical, Sylmar, CA, USA). Electrical data, and the presence of PNS during pacing from each left ventricular (LV) configuration, were documented at pre-hospital discharge and at 1 month. Seventy-five patients were enrolled and 71 were successfully implanted with a Quartetlead. Electrical measurements were stable over the follow-up period. Ninety-seven per cent (64 of 66) of patients had one or more programmable configurations with a threshold < 2.5 V and no PNS vs. 86% (57 of 66) if only conventional bipolar configurations were considered. Physicians were able to use the increased programming options to manage threshold changes and PNS. CONCLUSION: The new quadripolar electrode LV lead provides more programming options to address common problems faced when managing CRT patients. Electrical measurements from new vectors are comparable with conventional configurations. Furthermore, 11% of patients in the study suffered PNS on all conventional bipolar vectors.

Randomized comparison of a polymer-free sirolimus-eluting stent versus a polymer-based paclitaxel-eluting stent in patients with diabetes mellitus: the LIPSIA Yukon trial.

OBJECTIVES: The objective of the study was to assess noninferiority of the polymer-free sirolimus-eluting Yukon Choice stent (Translumina GmbH, Hechingen, Germany) compared with the polymer-based Taxus Liberté stent (Boston Scientific, Natick, Massachusetts) with regard to the primary endpoint, in-stent late lumen loss, at 9 months in patients with diabetes mellitus. BACKGROUND: The Yukon Choice stent has been evaluated in several randomized controlled trials before, albeit to date, there has been no trial that exclusively enrolled patients with diabetes mellitus. METHODS: Patients with diabetes mellitus undergoing percutaneous coronary intervention for clinically significant de novo coronary artery stenosis were randomized 1:1 to receive either the polymer-free sirolimus-eluting Yukon Choice stent or the polymer-based paclitaxel-eluting Taxus Liberté stent. RESULTS: A total of 240 patients were randomized. Quantitative coronary angiography was available for 79% of patients. Mean in-stent late lumen loss was 0.63 ± 0.62 mm for the Yukon Choice stent and 0.45 ± 0.60 mm for the Taxus Liberté stent. Based on the pre-specified margin, the Yukon Choice stent failed to show noninferiority for the primary endpoint. During follow-up, there were no significant differences between groups regarding death, myocardial infarction, stent thrombosis, target lesion revascularization, target vessel revascularization, or nontarget vessel revascularization. CONCLUSIONS: Compared with the Taxus Liberté stent, the polymer-free sirolimus-eluting Yukon Choice stent failed to show noninferiority with regard to the primary endpoint, in-stent late lumen loss, in patients with diabetes mellitus after 9-month follow-up. Both stents showed comparable clinical efficacy and safety. (Yukon Choice Versus Taxus Liberté in Diabetes Mellitus; NCT00368953).

A prospective randomized evaluation of VV delay optimization in CRT-D recipients: echocardiographic observations from the RHYTHM II ICD study.

BACKGROUND: All current cardiac resynchronization therapy (CRT) devices allow the programming of the atrioventricular (AV/PV) delays and the sequential stimulation of the ventricles via the inter ventricular (VV) delay. AIM: This post hoc analysis of the RHYTHM II study was conducted to compare the reverse remodeling associated with VV delay optimization in patients randomly assigned to simultaneous (SIM) biventricular stimulation versus patients assigned to optimized VV delay programming (OPT) (1:3 randomization scheme). METHODS: The analysis included 14 patients assigned to the SIM group and 34 patients to the OPT group who completed the 6-month follow-up period with paired echocardiographic recordings. RESULTS: In both study groups, changes consistent with left ventricular (LV) remodeling were observed between baseline and 6 months, with significant improvements in LV function and decrease in LV dimensions. In the OPT group, there was also a decrease in left atrial diameter and mitral valve closure to opening time. At 6 months, the overall proportion of echocardiographic responders (> or =10% decrease in LV end-systolic volume or > or =5% absolute increase in LV ejection fraction) was similar in both groups. The optimal AV/VV delays, evaluated by maximization of LV outflow tract velocity time integral, changed over time. CONCLUSIONS: Ventriculo-ventricular delay optimization was associated with better immediate hemodynamic function than simultaneous biventricular stimulation, though did not promote additional reverse remodeling at 6 months and did not increase the proportion of echocardiographic responders to CRT. Optimization of both the AV and VV intervals was patient-specific and optimal values changed over time.

Randomized comparison of simultaneous biventricular stimulation versus optimized interventricular delay in cardiac resynchronization therapy. The Resynchronization for the HemodYnamic Treatment for Heart Failure Management II implantable cardioverter defibrillator (RHYTHM II ICD) study.

BACKGROUND: The clinical value of interventricular (V-V) delay optimization in patients with chronic congestive heart failure (CHF) undergoing implantation of a device for cardiac resynchronization therapy (CRT) has not been clearly demonstrated. METHODS: RHYTHM II was a single-blind randomized trial including 121 recipients of a device for CRT with cardioverter/defibrillator capabilities (CRT-D) randomly assigned in a 1:3 ratio to simultaneous (n = 30) versus optimized (OPT) (n = 91) biventricular pacing. V-V delay was optimized by echocardiography. The study end points were (1) freedom from CRT-D system-related complications and (2) changes between preimplant and 6 months of follow-up in (a) New York Heart Association CHF functional class, (b) distance covered during a 6-minute hall walk, and (c) quality of life (QOL). RESULTS: In the OPT group, the V-V delay ranged from 0 to 80 milliseconds, with 28.4% of patients stimulated at an OPT V-V delay of 0 milliseconds. The overall 6-month survival free of adverse events requiring invasive interventions was 81.8%. In the whole cohort, 6 months of CRT-D was associated with a significant decrease in New York Heart Association class, increase in the distance covered during the 6-minute hall walk, and improvement in QOL (each P < .0001). The effects of CRT-D on these end points were similar in both study groups. CONCLUSIONS: Cardioverter-defibrillator capabilities was associated with a significant alleviation of CHF symptoms, increase in functional capacity, and improvement in QOL. The optimization of the V-V delay conferred no additional benefit compared with simultaneous biventricular stimulation.

Two-year performance of a preshaped lead for left ventricular stimulation.

Important goals, when implanting a cardiac resynchronization therapy (CRT) system, are to reach a stable LV lead position in a suitable coronary sinus (CS) tributary associated with a low capture threshold and no extracardiac stimulation. The aim of this study was to assess the 2-year performance of a new preshaped lead designed for LV stimulation. The study enrolled 102 patients with heart failure and bundle branch block who underwent implantation of a CRT system, including a sheath-guided, unipolar, S-shaped LV lead placed in a CS tributary. At each follow-up the electrical parameters and CRT system related adverse events were recorded. Eight patients who underwent LV stimulation alone, versus 88 patients who received biventricular CRT systems, were analyzed separately. Access to the CS was reached in 98 patients, and the lead was permanently implanted in 96 (94%) patients. The overall procedural time was 98 +/- 28 minutes. During follow-up, three patients underwent reinterventions for phrenic nerve stimulation (n = 2) and hematoma (n = 1). The capture threshold at implantation was 1.4 +/- 0.9 V with LV versus 1.7 +/- 0.5 V with biventricular stimulation, and after a transient increase, remained between 1.6 and 1.9 V in both configurations. The device measured impedance was significantly higher with LV than with biventricular stimulation at the time of CRT system implantation (698 +/- 296 Omega vs 380 +/- 67 Omega, P < 0.05) and during follow-up. The initial R wave amplitude was 14.3 +/- 5.9 mV in LV versus 8.9 +/- 3.2 V in the biventricular configuration (NS) and 13.8 +/- 7 mV in LV versus 12.8 +/- 4.8 mV in the biventricular configuration at 24 months (NS). Implantation of the S-shaped LV lead for CRT was safe, expeditious, and associated with a high success rate and reliable long-term performance.