Stopping or continuing clopidogrel 12 months after drug-eluting stent placement: the OPTIDUAL randomized trial.

AIM: This open-label, randomized, and multicentre trial tested the hypothesis that, on a background of aspirin, continuing clopidogrel would be superior to stopping clopidogrel at 12 months following drug-eluting stent (DES) implantation. METHODS AND RESULTS: Patients (N = 1799) who had undergone placement of ≥1 DES for stable coronary artery disease or acute coronary syndrome were included in 58 French sites (January 2009-January 2013). Patients (N = 1385) free of major cardiovascular/cerebrovascular events or major bleeding and on aspirin and clopidogrel 12 months after stenting were eligible for randomization (1:1) between continuing clopidogrel 75 mg daily (extended-dual antiplatelet therapy, DAPT, group) or discontinuing clopidogrel (aspirin group). The primary outcome was net adverse clinical events defined as the composite of death, myocardial infarction, stroke, or major bleeding. Follow-up was planned from a minimum of 6 to a maximum of 36 months after randomization. Owing to slow recruitment, the study was stopped after enrolment of 1385 of a planned 1966 patients. Median follow-up after stenting was 33.4 months. The primary outcome occurred in 40 patients (5.8%) in the extended-DAPT group and 52 in the aspirin group (7.5%; hazard ratio 0.75, 95% confidence interval 0.50-1.28; P = 0.17). Rates of death were 2.3% in the extended-DAPT group and 3.5% in the aspirin group (HR 0.65, 95% CI 0.34-1.22; P = 0.18). Rates of major bleeding were identical (2.0%, P = 0.95). CONCLUSIONS: Extended DAPT did not achieve superiority in reducing net adverse clinical events compared to 12 months of DAPT after DES placement. The power of the OPTIDUAL trial was however low and reduced by premature termination of enrolment. CLINICALTRIALSGOV NUMBER: NCT00822536.

Low level exercise echocardiography helps diagnose early stage heart failure with preserved ejection fraction: a study of echocardiography versus catheterization.

BACKGROUND: Increased left ventricular end-diastolic pressure (LVEDP) with exercise is an early sign of heart failure with preserved left ventricular ejection fraction (LVEF). The abnormal exercise increase in LVEDP is nonlinear, with most change occurring at low-level exercise. Data on non-invasive approach of this condition are scarce. Our objective was assessing E/e' to estimate low level exercise LVEDP using a direct invasive measurement as the reference method. METHODS AND RESULTS: Sixty patients with LVEF >50 % prospectively underwent both exercise cardiac catheterization and echocardiography. E/e' was measured at rest and during low-level exercise. Abnormal LVEDP was defined as >16 mmHg. Patients with a history of coronary artery disease and/or abnormal LV morphology were classified as having apparent cardiac disease (CD). Thirty-four (57 %) patients had elevated LVEDP only during exercise. Most of the change in LVEDP occurred since the first exercise level (25 W). There was a correlation between LVEDP and septal E/e' at rest and during exercise. Lateral E/e' and E/average e' ratio had worse correlations with LVEDP. In the whole population, exercise septal E/e' at 25 W had the best accuracy for abnormal exercise LVEDP, area under curve (AUC) = 0.79. However, while low-level exercise septal E/e' had a high accuracy in CD patients (n = 26, AUC = 0.96), E/e' was not linked to LVEDP in patients without CD (n = 34). CONCLUSION: Low-level exercise septal E/e' is valuable for predicting abnormal exercise LVEDP in patients with preserved LVEF and apparent CD. However, this new diagnosis approach appears not reliable in patients with normal LV morphology and without coronary artery disease. CLINICAL TRIAL REGISTRATION: https://clinicaltrials.gov . Unique identifier: NCT01714752.

Primary percutaneous coronary intervention for ST elevation myocardial infarction in nonagenarians.

OBJECTIVE: To assess outcomes following primary percutaneous coronary intervention (PCI) for ST-segment elevation acute myocardial infarction (STEMI) in nonagenarian patients. METHODS: We conducted a multicentre retrospective study between 2006 and 2013 in five international high-volume centres and included consecutive all-comer nonagenarians treated with primary PCI for STEMI. There were no exclusion criteria. We enrolled 145 patients and collected demographic, clinical and procedural data. Severe clinical events and mortality at 6 months and 1 year were assessed. RESULTS: Cardiogenic shock was present at admission in 21%. Median (IQR) delay between symptom onset and balloon was 3.7 (2.4-5.6) hours and 60% of procedures were performed through the transradial approach. Successful revascularisation of the culprit vessel was obtained in 86% of the cases (thrombolysis in myocardial infarction flow of 2 or 3). Major or clinically relevant bleeding was observed in 4% of patients. Median left ventricular ejection fraction post PCI was 41.5% (32.0-50.0). The in-hospital mortality was 24%, with 6 months and 1-year survival rates of 61% and 53%, respectively. CONCLUSIONS: In our study, primary PCI in nonagenarians with STEMI was achieved and feasible through a transradial approach. It is associated with a high rate of reperfusion of the infarct-related artery and 53% survival at 1 year. These results suggest that primary PCI may be offered in selected nonagenarians with acute myocardial infarction.

Impact of renal failure on all-cause mortality and other outcomes in patients treated by percutaneous coronary intervention.

BACKGROUND: Patients with renal failure (RF) have been systematically excluded from clinical trials; consequently their outcomes have not been well studied in the setting of percutaneous coronary intervention (PCI). AIMS: To compare cardiovascular outcomes after contemporary PCI in patients with versus without RF, according to clinical presentation (ST-segment elevation myocardial infarction [STEMI], acute coronary syndrome [ACS] or stable coronary artery disease [sCAD]). METHODS: Consecutive patients undergoing PCI with stent were prospectively included from 2007 to 2012. RF was defined as creatinine clearance<60mL/min. The primary endpoint was all-cause mortality; secondary endpoints were major adverse cardiovascular and cerebrovascular events (MACCE: composite of cardiovascular death, myocardial infarction, stroke and target lesion revascularization [TLR]), TLR and Academic Research Consortium definite/probable stent thrombosis (ST) at 1 year. RESULTS: Among 5337 patients, 23% had PCI for STEMI, 34% for ACS and 43% for sCAD, while 27% had RF. RF patients had a higher unadjusted death rate than those with preserved renal function (nRF) in all PCI indication groups (STEMI, 41% vs. 7.5%; ACS, 19% vs. 6%; sCAD, 10% vs. 3%; P<0.0001 for all). The rate of MACCE was also higher in RF patients whatever the PCI indication (STEMI, 45% vs. 15%; ACS, 23% vs. 14%; sCAD, 14% vs. 9%; P<0.05 for all). Rates of TLR (5.5-7.4%) and ST (<2.5%) were similar (P>0.05 for both). sCAD-RF and STEMI-nRF patients had similar rates of mortality (P=0.209) and MACCE (P=0.658). RF was independently associated with mortality, with a doubled relative risk in STEMI versus ACS and sCAD groups (odds ratio 5.3, 95% confidence interval 3.627-7.821 vs. 2.1, 1.465-3.140 and 2.3, 1.507-3.469, respectively; P<0.0001). CONCLUSION: RF is a stronger independent predictor of death after PCI in STEMI than in ACS or sCAD patients. sCAD-RF and STEMI-nRF patients had similar prognoses.

Sex-related differences after contemporary primary percutaneous coronary intervention for ST-segment elevation myocardial infarction.

BACKGROUND: Whether outcomes differ for women and men after percutaneous coronary intervention (PCI) for ST-segment elevation myocardial infarction (STEMI) remains controversial. AIM: To compare 1-year outcomes after primary PCI in women and men with STEMI, matched for age and diabetes. METHODS: Consecutive women with STEMI of<24 hours' duration referred (August 2007 to January 2011) for primary PCI were compared with men matched for age and diabetes. Rates of all-cause mortality, target vessel revascularization (TVR) and major cardiovascular and cerebrovascular events (MACCE) (death/myocardial infarction/stroke) were assessed at 1 year. RESULTS: Among 775 consecutive patients, 182 (23.5%) women were compared with 182 matched men. Mean age was 69±15 years, 18% had diabetes. Patient characteristics were similar, except for lower creatinine clearance (73±41 vs 82±38 µmol/L; P=0.041), more cardiogenic shock (14.8% vs 6.6%; P=0.017) and less radial PCI (81.3% vs 90.1%; P=0.024) in women. Rates of 1-year death (22.7% vs 18.1%), TVR (8.3% vs 6.0%) and MACCE (24.3% vs 20.9%) were not statistically different in women (P>0.05 for all). After exclusion of patients with shock (10.7%) and out-of-hospital cardiac arrest (6.6%), death rates were even more similar (11.3% vs 11.8%; P=0.10). Female sex was not independently associated with death (odds ratio 1.01, 95% confidence interval 0.55-1.87; P=0.97). CONCLUSION: In our consecutive unselected patient population, women had similar 1-year outcomes to men matched for age and diabetes, after contemporary primary PCI for STEMI, despite having a higher risk profile at baseline.

Accuracy of multislice computed tomography in the preoperative assessment of coronary disease in patients scheduled for heart valve surgery.

BACKGROUND: Coronary angiography (CA), an invasive and expensive procedure, is still recommended in most patients referred for elective valve surgery. Multislice computed tomography (MSCT) is a promising alternative technique to rule out significant coronary artery lesions. AIM: To evaluate MSCT in detecting significant coronary artery lesions in patients referred for elective valve surgery. METHODS: Between August 2007 and December 2010, patients referred for elective valve surgery were identified prospectively and underwent 64-slice MSCT and CA. We compared significant coronary stenoses, defined as a reduction of luminal diameter ≥ 50%, to establish the diagnostic accuracy of MSCT. All coronary segments were analysed and uninterpretable lesions were scored positive. RESULTS: Forty-eight patients were included (62.5% male; mean age 65 ± 12 years), the majority had aortic insufficiency (37.7%) or aortic stenosis (32.0%). The prevalence of significant coronary artery stenoses was 27.1%. The sensitivity, specificity, positive and negative predictive values of MSCT were 77%, 89%, 71% and 91%, respectively, in a patient-based analysis; 82%, 86%, 64% and 94% in a revascularization-based analysis; 67%, 94%, 52% and 97% in a vessel-based analysis; and 65%, 98%, 52% and 99% in a segment-based analysis. Overall, CA could have been avoided in 65% of patients. CONCLUSION: In patients referred for elective valve surgery, MSCT had a high diagnostic accuracy to rule out significant coronary stenoses. However, larger multicenter studies in an unselected population of patients are needed to determine its place within the range of diagnostic tool in the preoperative assessment of valvular heart disease.

One-year clinical outcomes in patients with chronic renal failure treated by percutaneous coronary intervention with drug-eluting stent.

BACKGROUND: It is unknown whether the efficacy and safety of drug-eluting stents (DES) apply in patients with chronic renal failure (CRF). AIMS: To compare DES with bare metal stents (BMS) for percutaneous coronary intervention (PCI) in CRF patients. PATIENTS AND METHODS: Consecutive patients treated by PCI were allocated to four groups according to type of stent used (DES versus BMS) and creatinine clearance (CrCl). CRF was defined as CrCl less than 60 mL/minute. Cardiovascular death, major adverse cardiac events (MACE, defined as cardiovascular death, myocardial infarction, stroke and target lesion revascularization [TLR]), TLR and definite stent thrombosis (ST) were recorded at 1 year. RESULTS: We note that 1376 consecutive patients underwent PCI with stent within 18 months: 534 (39%) and 492 (36%) patients without CRF and 224 (16%) and 126 (9%) patients with CRF were treated with BMS and DES, respectively. In the entire cohort, patients treated with DES had a higher restenosis risk profile. BMS were predominantly (87%) used for ST-segment elevation myocardial infarction. At 1 year, 6.2% had cardiovascular death, 15.8% MACE, 7.3% TLR and 1.5% ST. Cardiovascular death and MACE occurred less frequently in DES groups. The TLR rate was not significantly different in the CRF groups (BMS 9.8% vs DES 7.1%; P=0.44). No excess of ST was observed in the DES groups and use of DES was independently associated with absence of MACE and TLR. CONCLUSIONS: In patients with CRF, DES appear to be at least as effective as BMS--despite a higher restenosis risk profile--with no excess of ST at 1 year.