Composite Endpoint Of Cardiac Death Research Articles

Everolimus-eluting bioresorbable scaffolds in patients with coronary artery disease: results from the German-Austrian ABSORB RegIstRy (GABI-R).

The aim of this study was to analyse the procedural results and midterm safety of everolimus-eluting bioresorbable vascular scaffolds (BVS) used for percutaneous coronary intervention in a large all-comers cohort from the German-Austrian ABSORB RegIstRy (GABI-R). A total of 3,231 patients were included in this prospective, observational, multicentre study (ClinicalTrials.gov NCT02066623) of consecutive patients undergoing BVS implantation between November 2013 and January 2016. Endpoints were major adverse cardiac events (MACE; a composite endpoint of death, target vessel revascularisation, and myocardial infarction), and target lesion failure (TLF; a composite endpoint of cardiac death, target vessel myocardial infarction, and target lesion revascularisation). Scaffold thrombosis was a further endpoint. Of all patients, 51.5% presented with acute coronary syndrome. Predilatation and post-dilatation were performed in 91.5% and 71.9% of patients, respectively. Procedural success was 98.9%. After six months, the incidence of MACE was 4.1% and of TLF 2.4%. The rate of target vessel MI was 1.5%, and target lesion revascularisation was performed in 1.8%. Definite/ probable scaffold thrombosis was documented in 1.4% of patients. GABI-R, the largest registry to provide data regarding safety after BVS implantation in a real-world setting, reveals high procedural success and low six-month event rates.

Impact of a regimented aminophylline administration protocol on the burden of regadenoson-induced ischemia detected by SPECT myocardial perfusion imaging

BackgroundIn patients undergoing regadenoson SPECT myocardial perfusion imaging (MPI), it is unknown how soon and at which dose intravenous aminophylline can be administered to reverse regadenoson-related adverse effects without blunting stress-induced myocardial ischemia. Methods and ResultsWe analyzed the pooled database of the ASSUAGE and ASSUAGE-CKD trials (n = 548). These were double-blinded, placebo-controlled, randomized clinical trials in which 75 mg of aminophylline or placebo was administered intravenously 90 seconds following 99mTc-tetrofosmin injection. There were no statistically significant differences in summed difference score (SDS) burden (P = .87) and in the rates of myocardial ischemia (SDS ≥ 2) (P = .93) between the aminophylline (n = 274) and placebo (n = 274) groups. There was no interaction between aminophylline use and SDS as a determinant of the composite endpoint of cardiac death or MI (P = .32) or the composite endpoint of cardiac death, MI, or coronary revascularization (P = .92). ConclusionIn patients undergoing regadenoson-stress SPECT-MPI, the intravenous administration of 75 mg of aminophylline as early as 90 seconds after radioisotope injection does not seem to attenuate the burden of myocardial ischemia.

A Prospective Evaluation of a Pre-Specified Absorb BVS Implantation Strategy in ST-Segment Elevation Myocardial Infarction: The BVS STEMI STRATEGY-IT Study

ObjectivesThe aim of this study was to assess the feasibility and clinical results following a pre-specified bioresorbable scaffold (Absorb BVS) implantation strategy in patients with ST-segment elevation myocardial infarction (STEMI). BackgroundConcerns were raised about the safety of Absorb because a non-negligible rate of thrombosis was reported within 30 days and at midterm follow-up after primary percutaneous coronary intervention. MethodsThis was a prospective, multicenter study of patients with STEMI (<75 years of age with symptom onset <12 h) undergoing primary percutaneous coronary intervention with Absorb following a dedicated implantation protocol. The primary endpoint was a device-oriented composite endpoint of cardiac death, target vessel myocardial infarction, and ischemia-driven target lesion revascularization within 30 days. ResultsDuring the study period, 505 patients with STEMI (16.9% of the overall STEMI population) were treated with the Absorb BVS. The mean age was 56.6 ± 9.4 years, and 487 patients (96.4%) were in Killip class I or II at admission. According to the study protocol, direct Absorb implantation was feasible in 47 patients (9.3%), whereas post-dilatation was performed in 468 cases (92.7%). Procedural success was attained in 94.8% of the cases. Dual antiplatelet therapy with ticagrelor or prasugrel was administered at discharge in 481 patients (95.1%). At 30-day follow-up, the hierarchical device-oriented composite endpoint rate was 0.6% (0.4% cardiac death, 0.2% target vessel myocardial infarction and ischemia-driven target lesion revascularization). One episode (0.2%) of probable scaffold thrombosis was reported. ConclusionsA pre-specified Absorb implantation strategy in real-world patients with STEMI undergoing primary percutaneous coronary intervention was feasible and associated with a low 30-day device-oriented composite endpoint rate. Mid- and long-term follow-up is strongly needed to eventually confirm these early results. (Use of BVS in ST-Segment Elevation Myocardial Infarction [STEMI]: The BVS STEMI STRATEGY-IT Prospective Registry [STRATEGY-IT]; NCT02601781)

Current use of guideline-based medical therapy in elderly patients admitted with acute heart failure with reduced ejection fraction and its impact on event-free survival

BackgroundAcute heart failure (HF) is a frequently encountered cardiac condition. Its prevalence increases exponentially with age. In spite of this, elderly patients are underrepresented in clinical trials and the implementation of guideline-based medical therapy (GBMT) in them is not well established. We investigated the current use of GBMT and its effects on mortality and HF rehospitalization among elderly patients with acute HF with reduced ejection fraction (HFrEF) using data obtained from a contemporary multi-center registry. Methods and resultsWe analyzed data from 1,441 consecutive acute HF patients registered in the West Tokyo Heart Failure (WET-HF) registry (mean age 73.2 ± 13.6 years). Reduced ejection fraction (<45%) was noted in 803 patients (55.7%), of which 237 were aged ≥80 years (elderly group). The prescription rate of GBMT (use of renin-angiotensin system inhibitors and β-blockers at discharge) was significantly lower in the elderly than in the younger (aged < 80 years) group (46.8% vs. 66.9%, p<0.001). Although GBMT at discharge was associated with reductions in HF readmission or the composite endpoint of cardiac death and HF readmission (HR 0.49, 95% CI 0.30–0.80; and HR 0.53, 95% CI 0.32–0.89, respectively) in the younger group, this association was not observed in the elderly group (HR 1.41, 95% CI 0.68–2.92; and HR 1.54, 95% CI 0.76–3.13, respectively) ConclusionsGBMT implementation in elderly patients with HFrEF was found to be suboptimal. However, the underuse of GBMT did not appear to be responsible for poorer outcomes in elderly HFrEF patients. Further research is required to establish an ideal therapeutic approach for this population. Clinical trial registrationURL: http://www.umin.ac.jp/icdr/index-j.html. Unique identifier: UMIN000001171.

Midterm and one-year outcome of amphilimus polymer free drug eluting stent in patients needing short dual antiplatelet therapy. Insight from the ASTUTE registry (AmphilimuS iTalian mUlticenTer rEgistry)

BackgroundTo assess clinical outcomes of patients needing short dual antiplatelet therapy (S-DAPT) after PCI with Cre8 polymer-free amphilimus eluting-stent (AES). The Cre8-AES with pure i-Carbofilm coating was supposed to induce faster stent endothelialization and reduce device thrombogenicity. MethodsWe performed a sub-analysis of unrestricted consecutive patients treated with Cre8-AES between August 2011 and January 2015. Two groups were formed: 1) patients discharged with S-DAPT (≤3-month), because of high bleeding risk or attending urgent non-cardiac surgery; and 2) patients discharged with Recommended DAPT duration (R-DAPT; ≥6-month). The primary ischemic- and bleeding-safety endpoints were Target Vessel Failure (TVF, composite endpoint of cardiac-death, target vessel-myocardial infarction and target vessel-revascularization), and major-bleeding (BARC ≥type-3a) at 6-month and 1-year. Results106 patients (8.7%) were discharged with ≤3-month DAPT (83±19days; S-DAPT group) and 1102 patients (90.6%) with ≥6-month DAPT (342±62days; R-DAPT group). Between S-DAPT and R-DAPT groups no significant differences were observed in TVF at 1-year (5.7% vs 5.1%); 1-year BARC major bleeding rate was higher in S-DAPT group (3.4% vs 0.2%, p=0.007) with all bleeding events occurred within 3months. The landmark analysis (started at 90days, ended at 1year) showed no differences in BARC major bleedings between groups (0% vs. 0.3%). ConclusionsThe results of this multicenter registry show that the use of Cre8 AES in patients needing short DAPT (≤3-month) was safe regarding ischemic events and could favor a reduction of bleeding events related to the recommended DAPT. A large randomized trial is necessary to support these preliminary findings.

Prognostic incremental role of right ventricular function in acute decompensation of advanced chronic heart failure.

The purpose of this study was to evaluate the additional prognostic value of echocardiography in acute decompensation of advanced chronic heart failure (CHF), focusing on right ventricular (RV) dysfunction and its interaction with loading conditions. Few data are available on the prognostic role of echocardiography in acute HF and on the significance of pulmonary hypertension in patients with severe RV failure. A total of 265 NYHA IV patients admitted for acute decompensation of advanced CHF (EF 22 ± 7%, systolic blood pressure 107 ± 20 mmHg) were prospectively enrolled. Fifty-nine patients met the primary composite endpoint of cardiac death, urgent heart transplantation, and urgent mechanical circulatory support implantation at 90 days. Pulmonary hypertension failed to predict events, while patients with a low transtricuspid systolic gradient (TR gradient <20 mmHg) showed a worse outcome [hazard ratio (HR) 2.37, 95% confidence interval (CI) 1.12-5.00, P = 0.02]. RV dysfunction [tricuspid annular plane systolic excursion (TAPSE) ≤14 mm] in the presence of a low TR gradient identified patients at higher risk of events (HR 2.97, 95% CI 1.19-7.41, P = 0.02). Multivariate analysis showed as best predictors of outcome low RV contraction pressure index (RVCPI), defined as TAPSE × TR gradient, and high estimated right atrial pressure (eRAP). Adding RVCPI (<400 mm*mmHg) and eRAP (≥20 mmHg) to conventional clinical (ADHERE risk tree and NT-proBNP) and echocardiographic risk evaluation resulted in an increase in net reclassification improvement of +19.1% and +20.1%, respectively (P = 0.01) and in c-statistic from 0.59 to 0.73 (P < 0.01). In acute decompensation of advanced CHF, pulmonary hypertension failed to predict events. The in-hospital and short-term prognosis can be better predicted by eRAP and RVCPI.

The prognostic value of regadenoson SPECT myocardial perfusion imaging in patients with end-stage renal disease

BackgroundThe prognostic value of regadenoson SPECT myocardial perfusion imaging (MPI) has not been specifically studied in patients with end-stage renal disease (ESRD). Methods and ResultsWe prospectively followed ESRD patients enrolled in the ASSUAGE and ASSUAGE-CKD trials in which they received regadenoson-stress 99mTc-tetrofosmin SPECT-MPI. Images were semiquantitatively analyzed by an investigator blinded to clinical and outcome data. Patients were followed for cardiac death, myocardial infarction (MI), and coronary revascularization (CR). Revascularizations occurring >90 days post-MPI were considered “late” events. Survival analysis was performed using Cox regression models, adjusting for age, gender, diabetes, dyslipidemia, smoking, and known coronary artery disease. We analyzed 303 patients (mean age 54 years; 64% men), who were followed for 35 ± 10 months. Adjusting for clinical covariates, abnormal regadenoson-stress MPI (SSS ≥ 4) was associated with increased risk of the composite of cardiac death or MI (23.9% vs 14.4%; HR 1.88; CI 1.04-3.41; P = .037) and the composite of cardiac death, MI, or late CR (27.3% vs 16.7%; HR 1.80; CI 1.03-3.14; P = .039). Adjusting for clinical covariates, regadenoson-induced myocardial ischemia (SDS ≥ 2) was associated with increased rate of the composite endpoint of cardiac death, MI, or CR (33.3% vs 16.9%; HR 1.97; CI 1.19-3.27; P = .008). ConclusionRegadenoson-stress SPECT-MPI provides a significant prognostic value in patients with ESRD. ESRD patients with normal SPECT-MPI have relatively high adverse event rates.

Prognostic value of heart rate response during regadenoson stress myocardial perfusion imaging in patients with end stage renal disease

BackgroundBlunted heart rate response (HRR) to vasodilator stress agents is associated with worse outcomes. There are limited data assessing the effect of impaired HRR to regadenoson among patients with end-stage renal disease (ESRD) undergoing stress myocardial perfusion imaging (MPI). MethodsWe prospectively followed patients with ESRD enrolled in the ASSUAGE and ASSUAGE-CKD trials. HRR was defined as 100*(peak stress heart rate-resting heart rate)/resting heart rate. Study cohort was dichotomized to blunted and normal HRR groups according to an established median HRR value <28% or ≥28%, which were propensity-score matched based on 22 clinical and imaging covariates. The Primary endpoint was all-cause death. The secondary cardiac-specific endpoints included: (1) the composite endpoint of cardiac death or myocardial infarction; (2) the composite endpoint of cardiac death, myocardial infarction, or late (>90 days) coronary revascularization. ResultsThere were 303 patients followed for 35 ± 10 months. In the entire cohort, there was a stepwise increase in the rates of death and all secondary endpoints with worsening HRR (P values ≤.001). Blunted HRR (<28%) was associated with increased risk of death (unadjusted hazard ratio 4.10 [1.98-8.46], P < .001) and all secondary endpoints (P ≤ .001). After multivariate adjustment, HRR remained an independent predictor of mortality and secondary endpoints whether used as continuous or dichotomous variable, and added incremental prognostic value for all-cause death (P = .046). Blunted HRR was associated with increased event rate among patients with normal myocardial perfusion (P = .001) and abnormal perfusion (P = .053). In the propensity-matched cohort of 132 patients (66 in each group), blunted HRR was associated with significant increase in all-cause death (21% vs. 5%, HR 5.09 [1.46-17.7], P=.011), and similarly for the secondary endpoints. ConclusionBlunted HRR (<28%) to regadenoson is a strong and independent predictor of death and cardiovascular events in patients with ESRD and adds incremental prognostic value.

Resultados Angiográficos e do Seguimento Clínico de 5 Anos Após Implante de Stents Farmacológicos com Revestimento Biodegradável em Pacientes com Alto Risco de Reestenose. Análise de Subgrupo do Estudo Randomizado PAINT

Introdução: Polímeros biodegradáveis foram desenvolvidos para reduzir a reação de hipersensibilidade associada aos polímeros duráveis dos stents farmacológicos de primeira geração, mantendo sua eficácia antiproliferativa e aumentado sua segurança. Avaliamos os resultados angiográficos de 9 meses e os resultados clínicos de longo prazo dos stents farmacológicos com polímeros biodegradáveis em pacientes com alto risco de reestenose. Métodos: Pacientes com diâmetro de referência ≤ 2,5 mm, extensão da lesão ≥ 15 mm, diabetes, ou uma combinação dessas características foram selecionados da população do estudo PAINT. Esses pacientes foram previamente randomizados e alocados para intervenção coronária percutânea recebendo os stents farmacológicos com polímeros biodegradáveis com sirolimus ou com paclitaxel ou stents metálicos, na razão 2:2:1. Resultados: Cento e setenta e oito pacientes foram tratados com stents farmacológicos com polímeros biodegradáveis (n = 142) ou stents metálicos (n = 36). No acompanhamento angiográfico de 9 meses, os primeiros mostraram menor perda tardia (0,40 ± 0,42 mm vs. 0,90 ± 0,47 mm; p < 0,01) e reestenose binária (7,4% vs. 25%; p < 0,01). No acompanhamento clínico de 5 anos, o grupo com stents farmacológicos com polímeros biodegradáveis mostrou menores taxas do desfecho combinado de morte cardíaca, infarto do miocárdio e revascularização do vaso-alvo (16,2% vs. 38,0%; p = 0,03), principalmente devido à redução da revascularização do vaso-alvo (9,9% vs. 36,1%; p < 0,01). Morte total, morte cardíaca e infarto do miocárdio não foram diferentes entre os grupos. A trombose do stent, provável ou definitiva, ocorreu em 2,8% vs. 0% (p = 0,30). Conclusões: Os stents farmacológicos com polímeros biodegradáveis eluidores de paclitaxel ou sirolimus foram eficazes na redução de reestenose angiográfica aos 9 meses e na necessidade de reintervenção por reestenose clínica em 5 anos, sem aumentar o risco de trombose do stent.

Abstract 20350: Discordant Left Bundle Branch Block is Associated With Left Ventricular Dyssyncrhony at Cardiac Magnetic Resonance Imaging in Patients With Nonischemic Cardiomyopathy

LBBB is frequently linked to left ventricular (LV) dyssynchrony and adverse prognosis in HF. LBBB has been defined as concordant (cLBBB) or discordant (dLBBB), when associated in lead I and V5, V6 with a positive or negative T wave respectively. dLBBB has been associated with a worse clinical and prognostic profile in HF patients. We sought to evaluate association between different patterns of LV dV/dT curves at CMR, LBBB morphology, clinical correlates and prognostic role in patients with nonischemic systolic HF. Methods and Results: One hundred and fifteen consecutive patients with LBBB were submitted between 2004 and 2014 to a complete cardiological evaluation, including CMR with analysis of dV/dT curves of LV contraction, and follow-up for cardiac events. We distinguished two different patterns of global and segmental LV systole: a “narrow” pattern (NP) generated by synchronous contraction of wall segments; a “wide” pattern (WP), when delay in contraction between wall segments resulted in a prolungation of systolic peak with a flat or notched morphology. Fourteen patients presenting with normal LV dimensions and function all had cLBBB and NP, while out of 101 patients with HF, those with dLBBB (65%) presented with shorter QRS duration (p &lt; .01) and higher level of NT-proBNP (p &lt; .001). WP was observed more frequent in dLBBB patients (p &lt; .003) as a mark of greater intraventricular dyssynchrony. According to systolic pattern, those with WP had higher levels of NT-proBNP, lower EF and higher LV volumes than those with NP, whereas no significant difference was found in QRS duration. At multivariate analysis only dLBBB (p=.006) and EF (p=.001) were independent predictors of WP. At Kaplan-Meier analysis, the presence of WP was associated with a worse prognosis considering a composite end-point of cardiac death, hospitalization for HF and ICD shock (p&lt;.005). At Cox analysis only presence of WP (p = .029) and level of NT-proBNP (p= .004) were independent predictors. Conclusions: In nonischemic systolic HF patients with LBBB, presence of a WP at CMR dV/dT curves is associated with dLBBB, identifies greater LV dyssynchrony with possible major benefits from resynchronization therapy and is an independent prognosticator.

Three-year data from the XIENCE V INDIA study: safety and efficacy of XIENCE V in 1000 real world Indian patients.

Cardiovascular disease in Asia has reached epidemic proportions in recent years. Use of drug eluting stents in Asians has rapidly expanded with varying penetration rates across different countries. The XIENCE V INDIA Study included 'real world' patients who underwent XIENCE V stent implantation to assess short and intermediate term outcomes in Indian patients with diverse risk factors. To evaluate 3-year clinical outcomes in a cohort of 'real world' Indian patients with CAD being treated with XIENCE V Everolimus Eluting Coronary Stent System. 1000 patients were enrolled from 18 sites in India between June 2008 and March 2009. Patients were included if their index procedures were completed using only XIENCE V. There were no clinical or angiographic exclusions. An independent Clinical Events Committee adjudicated all endpoint-related events. The primary endpoint was stent thrombosis rate annually through to 3 years as defined by the Academic Research Consortium criteria. The co-primary endpoint was the composite rate of cardiac death and myocardial infarction at 1 year. At 1-year the primary endpoint of definite/probable stent thrombosis rate was 0.51%. No additional very late stent thrombosis was reported through a 3-year follow up. The composite endpoint of cardiac death and any myocardial infarction was 1.9%, 2.7% and 3.1% at 1, 2 and 3 years respectively. Despite the high risk population of coronary artery disease, the use of XIENCE V in 'real world' Indian patients was associated with very low clinical event rates upto three years of follow up.

Comparison of Newer-Generation Drug-Eluting With Bare-Metal Stents in Patients With Acute ST-Segment Elevation Myocardial Infarction: A Pooled Analysis of the EXAMINATION (clinical Evaluation of the Xience-V stent in Acute Myocardial INfArcTION) and COMFORTABLE-AMI (Comparison of Biolimus Eluted From an Erodible Stent Coating With Bare Metal Stents in Acute ST-Elevation Myocardial Infarction) Trials

This study sought to study the efficacy and safety of newer-generation drug-eluting stents (DES) compared with bare-metal stents (BMS) in an appropriately powered population of patients with ST-segment elevation myocardial infarction (STEMI). Among patients with STEMI, early generation DES improved efficacy but not safety compared with BMS. Newer-generation DES, everolimus-eluting stents, and biolimus A9-eluting stents, have been shown to improve clinical outcomes compared with early generation DES. Individual patient data for 2,665 STEMI patients enrolled in 2 large-scale randomized clinical trials comparing newer-generation DES with BMS were pooled: 1,326 patients received a newer-generation DES (everolimus-eluting stent or biolimus A9-eluting stent), whereas the remaining 1,329 patients received a BMS. Random-effects models were used to assess differences between the 2 groups for the device-oriented composite endpoint of cardiac death, target-vessel reinfarction, and target-lesion revascularization and the patient-oriented composite endpoint of all-cause death, any infarction, and any revascularization at 1 year. Newer-generation DES substantially reduce the risk of the device-oriented composite endpoint compared with BMS at 1 year (relative risk [RR]: 0.58; 95% confidence interval [CI]: 0.43 to 0.79; p = 0.0004). Similarly, the risk of the patient-oriented composite endpoint was lower with newer-generation DES than BMS (RR: 0.78; 95% CI: 0.63 to 0.96; p = 0.02). Differences in favor of newer-generation DES were driven by both a lower risk of repeat revascularization of the target lesion (RR: 0.33; 95% CI: 0.20 to 0.52; p < 0.0001) and a lower risk of target-vessel infarction (RR: 0.36; 95% CI: 0.14 to 0.92; p = 0.03). Newer-generation DES also reduced the risk of definite stent thrombosis (RR: 0.35; 95% CI: 0.16 to 0.75; p = 0.006) compared with BMS. Among patients with STEMI, newer-generation DES improve safety and efficacy compared with BMS throughout 1 year. It remains to be determined whether the differences in favor of newer-generation DES are sustained during long-term follow-up.

Utility of a novel risk score for prediction of ventricular tachycardia and cardiac death in chronic Chagas disease - the SEARCH-RIO study

The SEARCH-RIO study prospectively investigated electrocardiogram (ECG)-derived variables in chronic Chagas disease (CCD) as predictors of cardiac death and new onset ventricular tachycardia (VT). Cardiac arrhythmia is a major cause of death in CCD, and electrical markers may play a significant role in risk stratification. One hundred clinically stable outpatients with CCD were enrolled in this study. They initially underwent a 12-lead resting ECG, signal-averaged ECG, and 24-h ambulatory ECG. Abnormal Q-waves, filtered QRS duration, intraventricular electrical transients (IVET), 24-h standard deviation of normal RR intervals (SDNN), and VT were assessed. Echocardiograms assessed left ventricular ejection fraction. Predictors of cardiac death and new onset VT were identified in a Cox proportional hazard model. During a mean follow-up of 95.3 months, 36 patients had adverse events: 22 new onset VT (mean±SD, 18.4±4‰/year) and 20 deaths (26.4±1.8‰/year). In multivariate analysis, only Q-wave (hazard ratio, HR=6.7; P<0.001), VT (HR=5.3; P<0.001), SDNN<100 ms (HR=4.0; P=0.006), and IVET+ (HR=3.0; P=0.04) were independent predictors of the composite endpoint of cardiac death and new onset VT. A prognostic score was developed by weighting points proportional to beta coefficients and summing-up: Q-wave=2; VT=2; SDNN<100 ms=1; IVET+=1. Receiver operating characteristic curve analysis optimized the cutoff value at >1. In 10,000 bootstraps, the C-statistic of this novel score was non-inferior to a previously validated (Rassi) score (0.89±0.03 and 0.80±0.05, respectively; test for non-inferiority: P<0.001). In CCD, surface ECG-derived variables are predictors of cardiac death and new onset VT.

Prospective, multi-center evaluation of the desolve NX novolimus-eluting bioresorbable coronary scaffold: principal clinical and imaging endpoints

Background and aims: Bioresorbable vascular scaffolds represent an exciting advance in percutaneous coronary intervention (PCI), providing an initial coronary scaffold which are eventually resorbed by the body. The DESolve Nx BCSS is a novel drug eluting bioresorbable vascular scaffold that combines a PLLA-based scaffold coated with a biodegradable polylactide-based polymer and the drug Novolimus, a macrocyclic lactone mTOR inhibitor which has demonstrated potent anti-proliferative properties in previous clinical trials using Elixir's metallic Novolimus-eluting coronary stents. The drug dose is 5 mcg per mm of scaffold length and is available in three diameters (3.0, 3.25 and 3.5) and two lengths (14 and 18 mm). The DESolve NX study is a prospective, multicenter evaluation of the safety and efficacy of the DESolve™ Nx Novolimus-Eluting Bioresorbable Coronary Scaffold (BCSS) in patients with single de novo native coronary artery lesions through clinical endpoints and multiple imaging modalities. Methods and results: 126 patients with single, de novo coronary artery lesions were enrolled in this prospective, multi-center, single-arm study. Those patients receiving the study device are being analysed for multiple clinical endpoints including: Device and Procedure Success; Major Adverse Cardiac Events (MACE), a composite endpoint of cardiac death, target vessel MI, or clinically-indicated target lesion revascularization (CI-TLR); Clinically-indicated Target Lesion and Target Vessel Revascularization, (CI-TVR) and Stent Thrombosis assessed at 1, 6 and 12 months and annually to 5 years. All patients underwent angiographic assessment at 6 months and a subset of patients underwent IVUS and OCT assessment at 6 months. Additional imaging analyses will be conducted in the subset of patients at 12 months using MSCT and at 24 months using Angiography, IVUS and OCT to assess the long-term scaffold, lesion and vessel characteristics. Device Success and Procedure Success were 95.2% and 100% respectively demonstrating the feasibility and initial safety of this novel device. Conclusion: The DESolve™ Nx Novolimus-Eluting BCSS demonstrated initial safety and efficacy in this study. A first report of the principal clinical and imaging outcomes through 6 months will be presented.

Association between UCP2A55V polymorphism and risk of cardiovascular events in patients with multi-vessel coronary arterial disease

BackgroundUCP2 (uncoupling protein 2) plays an important role in cardiovascular diseases and recent studies have suggested that the A55V polymorphism can cause UCP2 dysfunction. The main aim was to investigate the association of A55V polymorphism with cardiovascular events in a group of 611 patients enrolled in the Medical, Angioplasty or Surgery Study II (MASS II), a randomized trial comparing treatments for patients with coronary artery disease and preserved left ventricular function.MethodsThe participants of the MASS II were genotyped for the A55V polymorphism using allele-specific PCR assay. Survival curves were calculated with the Kaplan–Meier method and evaluated with the log-rank statistic. The relationship between baseline variables and the composite end-point of cardiac death, acute myocardial infarction (AMI), refractory angina requiring revascularization and cerebrovascular accident were assessed using a Cox proportional hazards survival model.ResultsThere were no significant differences for baseline variables according genotypes. After 2 years of follow-up, dysglycemic patients harboring the VV genotype had higher occurrence of AMI (p=0.026), Death+AMI (p=0.033), new revascularization intervention (p=0.009) and combined events (p=0.037) as compared with patients carrying other genotypes. This association was not evident in normoglycemic patients.ConclusionsThese findings support the hypothesis that A55V polymorphism is associated with UCP2 functional alterations that increase the risk of cardiovascular events in patients with previous coronary artery disease and dysglycemia.

CRT-62 Age Differences in Long-Term Outcomes of Coronary Patients Treated with Drug Eluting Stents at a Tertiary Medical Center

≥65 years) patients for target lesion failure (TLF) at 2-year follow-up in an unselected consecutive series of patients treated with the everolimus- (EES) and paclitaxel-eluting (PES) stents at a tertiary medical center. 348 consecutive patients (younger 150; older 198) stented with the EES and PES were retrospectively analyzed. The primary endpoint was TLF (composite endpoint of cardiac death, non fatal myocardial infarction due to index vessel and target lesion revascularization (TLR)). At 2 years follow up, younger versus older patients had the following outcomes respectively: TLF 27.7% versus 25.5% (�� = 0.71 ), TLR 24.8% versus 21.4% (�� = 0.52 ), cardiac death 3.4% versus 2.5% ( �� = 0.75 ) and definite and probable stent thrombosis (2.0% versus 1.0%). Multivariate analysis showed that renal failure (odds ratio: 2.55, �� = 0.045 ), number of stents per patient (odds ratio: 1.60,�� = 0.001 ) and younger age (odds ratio: 0.97;�� = 0.010 ), but not gender, diabetes or type of DES stent (EES versus PES) predicted TLF. We conclude that older age was not a predictor of TLF at 2-year follow-up after adjusting for renal insufficiency, number of stents used per patient, gender, diabetes and type of DES used.

Long-term outcome of second-generation everolimus-eluting stents and Endeavor zotarolimus-eluting stents in a prospective registry of ST-elevation myocardial infarction patients

The optimal drug-eluting stent (DES) in ST-elevation myocardial infarction (STEMI) patients remains unclear. We sought to compare the long-term performance of everolimus-eluting stents (EES) and Endeavor zotarolimus-eluting stents (E-ZES) in STEMI. The current analysis of a prospective registry included consecutive patients treated with EES or E-ZES for STEMI. Adjustment for measured confounders was done using Cox regression. In total, 931 patients met the inclusion criteria (412 EES and 519 E-ZES). Baseline characteristics were balanced, apart from a lower rate of renal insufficiency in EES. Median follow-up duration was 2.4 years (IQR 1.6-3.1). Mortality outcomes were similar. Up to three-year follow-up, the composite endpoint of cardiac death, target vessel-related myocardial infarction and target lesion revascularisation (TLR) was lower in EES; 9.7% vs. 13.7% in E-ZES (HR 0.64, 95% CI: 0.42-0.99), primarily driven by reduced TLR rates; 3.4% in EES vs. 7.3% in E-ZES (HR 0.46, 95% CI: 0.23-0.92). Definite stent thrombosis rates were low and similar between groups (1.1% in EES vs. 1.9% in E-ZES, p=0.190). Use of EES led to lower rates of the composite endpoint, driven by reduced TLR. This suggests that EES are more efficacious than Endeavor ZES in STEMI. Definite ST rates were low, and the strategy of second-generation DES implantation and the administration of upfront GP IIb/IIIa inhibitors appear to be safe in STEMI.

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Ramipril

Age Differences in Long Term Outcomes of Coronary Patients Treated with Drug Eluting Stents at a Tertiary Medical Center

We evaluate differences in outcomes in younger (<65 years) and older (≥65 years) patients for target lesion failure (TLF) at 2-year follow-up in an unselected consecutive series of patients treated with the everolimus- (EES) and paclitaxel-eluting (PES) stents at a tertiary medical center. 348 consecutive patients (younger 150; older 198) stented with the EES and PES were retrospectively analyzed. The primary endpoint was TLF (composite endpoint of cardiac death, non fatal myocardial infarction due to index vessel and target lesion revascularization (TLR)). At 2 years follow up, younger versus older patients had the following outcomes respectively: TLF 27.7% versus 25.5% (P = 0.71), TLR 24.8% versus 21.4% (P = 0.52), cardiac death 3.4% versus 2.5% (P = 0.75) and definite and probable stent thrombosis (2.0% versus 1.0%). Multivariate analysis showed that renal failure (odds ratio: 2.55, P = 0.045), number of stents per patient (odds ratio: 1.60, P = 0.001) and younger age (odds ratio: 0.97; P = 0.010), but not gender, diabetes or type of DES stent (EES versus PES) predicted TLF. We conclude that older age was not a predictor of TLF at 2-year follow-up after adjusting for renal insufficiency, number of stents used per patient, gender, diabetes and type of DES used.

Abstract 18819: Multi-Center, First-In-Man Evaluation of the Myolimus-Eluting Bioresorbable Coronary Scaffold: 6-Month Clinical and Imaging Results

Aims: To evaluate the clinical safety and effectiveness of the DESolve™ Myolimus-Eluting Bioresorbable Coronary Scaffold (DESolve) in patients with single de novo native coronary artery lesions through clinical endpoints and multiple imaging modalities. Methods and Results: Background: The DESolve Bioresorbable Scaffold is a novel drug eluting device that combines a PLLA-based scaffold coated with a bioresorbable polylactide-based polymer and the drug Myolimus. Myolimus, a macrocyclic lactone mTOR inhibitor has demonstrated potent anti-proliferative properties in two First-in-Man (FIM) trials using Elixir’s metallic Myolimus-eluting coronary stents. The drug dose is 3 mcg per mm of scaffold length; the same dose as used as in the FIM studies. Sixteen patients with single, de novo coronary artery lesions were enrolled in this prospective, multi-center, single-arm FIM study. One patient did not receive a study stent and was deregistered. The 15 remaining patients are being analysed for multiple clinical endpoints: Device and Procedure Success; Major Adverse Cardiac Events (MACE), a composite endpoint of cardiac death, target vessel MI, and clinically-indicated target lesion revascularization (CI-TLR); clinically-indicated Target Lesion and Target Vessel Revascularization, (CI-TVR) and stent thrombosis assessed at 1, 6 and 12 months and annually to 5 years. Multiple assessments by angiographic, IVUS and OCT at 6 months were completed. An additional analysis using multislice computed tomography (MSCT) will be completed at 12 and 24 months. At 6 months, the in-scaffold late lumen loss was 0.19 ± 0.19 by QCA, the % volume obstruction was 7.18 ± 3.37 by IVUS, and by OCT 98.68 ± 2.44% of struts were demonstrated as covered. There was one MACE, event, a TLR, during the follow-up period. Detailed clinical and imaging results through 6 months will be presented. Conclusion: The DESolve™ Myolimus-Eluting Bioresorbable Coronary Scaffold demonstrated both excellent safety and effectiveness in this FIM study, thus warranting further clinical evaluation of the novel technology in larger clinical studies. Detailed clinical and imaging results through 6 months will be presented.