Emile Ferrari

Atherosclerosis of the thoracic aorta and aortic debris as a marker of poor prognosis: benefit of oral anticoagulants

OBJECTIVESnOur aim was to confirm the poor prognosis related to thoracic aortic plaques, in particular aortic debris, diagnosed by transesophageal echocardiography (TEE) and to evaluate patients prognosis as a function of the antithrombotic treatment.nnnBACKGROUNDnAortic atheroma (AA) has been widely studied. However, it is still not known which antithrombotic treatment should be adopted in this disease.nnnMETHODSnPatients referred for TEE and diagnosed with AA were followed. All thromboembolic events and deaths were recorded during a follow-up of 22+/-10 months. The antithrombotic treatment to be adopted was left to the discretion of the practitioner in charge of the patient.nnnRESULTSnAortic atheroma was found in 12% of all TEE performed and in 27.5% of TEE performed for stroke. This prevalence was higher when no other etiology existed to explain the stroke (p < 0.001). During follow-up, an end point occurred in 22.5% of patients. The more severe the AA the greater the incidence of events (p = 0.007). A higher mortality rate is shown in patients with aortic debris (p = 0.049). Compared with those treated with oral anticoagulants, patients with aortic plaques >4 mm thick treated with antiplatelets had more embolic events and combined events (p = 0.01 and p = 0.007, relative risk [RR] = 5.9, 95% confidence interval [CI] = 1.4 to 15, respectively); patients with aortic debris had more combined events and a higher mortality rate (p = 0.001, RR = 7.1, 95% CI = 1.2 to 19 and p = 0.019, RR = 9.1, 95% CI = 1.2 to 25, respectively).nnnCONCLUSIONSnWe confirm the high incidence of vascular events and deaths in patients with AA. We have demonstrated, for the first time in this condition, a better outcome among patients treated with oral anticoagulants versus antiplatelets.

Effect of Radial Versus Femoral Access on Radiation Dose and the Importance of Procedural Volume: A Substudy of the Multicenter Randomized RIVAL Trial

OBJECTIVESnThe authors sought to compare the radiation dose between radial and femoral access.nnnBACKGROUNDnSmall trials have shown an increase in the radiation dose with radial compared with femoral access, but many were performed during the operators learning curve of radial access.nnnMETHODSnPatients were randomized to radial or femoral access, as a part of the RIVAL (RadIal Vs. femorAL) trial (N = 7,021). Fluoroscopy time was prospectively collected in 5740 patients and radiation dose quantified as air kerma in 1,445 patients and dose-area product (DAP) in 2,255 patients.nnnRESULTSnMedian fluoroscopy time was higher with radial versus femoral access (9.3 vs. 8.0 min, p < 0.001). Median air kerma was nominally higher with radial versus femoral access (1,046 vs. 930 mGy, respectively, p = 0.051). Median DAP was not different between radial and femoral access (52.8 Gy-cm(2) vs. 51.2 Gy·cm(2), p = 0.83). When results are stratified according to procedural volume, air kerma was increased only in the lowest tertile of radial volume centers (low 1,425 vs. 1,045 mGy, p = 0.002; middle 987 vs. 958 mGy, p = 0.597; high 652 vs. 621 mGy, p = 0.403, interaction p = 0.026). Multivariable regression showed procedural volume was the greatest independent predictor of lower air kerma dose (ratio of geometric means 0.55; 95% confidence interval 0.49 to 0.61 for highest-volume radial centers).nnnCONCLUSIONSnRadiation dose as measured by air kerma was nominally higher with radial versus femoral access, but differences were present only in lower-volume centers and operators. High-volume centers have the lowest radiation dose irrespective of which access site approach that they use. (A Trial of Trans-radial Versus Trans-femoral Percutaneous Coronary Intervention (PCI) Access Site Approach in Patients With Unstable Angina or Myocardial Infarction Managed With an Invasive Strategy [RIVAL]; NCT01014273).

Procedural Volume and Outcomes With Radial or Femoral Access for Coronary Angiography and Intervention

OBJECTIVESnThe study sought to evaluate the relationship between procedural volume and outcomes with radial and femoral approach.nnnBACKGROUNDnRIVAL (RadIal Vs. femorAL) was a randomized trial of radial versus femoral access for coronary angiography/intervention (N = 7,021), which overall did not show a difference in primary outcome of death, myocardial infarction, stroke, or non-coronary artery bypass graft major bleeding.nnnMETHODSnIn pre-specified subgroup analyses, the hazard ratios for the primary outcome were compared among centers divided by tertiles and among individual operators. A multivariable Cox proportional hazards model was used to determine the independent effect of center and operator volumes after adjusting for other variables.nnnRESULTSnIn high-volume radial centers, the primary outcome was reduced with radial versus femoral access (hazard ratio [HR]: 0.49; 95% confidence interval [CI]: 0.28 to 0.87) but not in intermediate- (HR: 1.23; 95% CI: 0.88 to 1.72) or low-volume centers (HR: 0.83; 95% CI: 0.52 to 1.31; interaction p = 0.021). High-volume centers enrolled a higher proportion of ST-segment elevation myocardial infarction (STEMI). After adjustment for STEMI, the benefit of radial access persisted at high-volume radial centers. There was no difference in the primary outcome between radial and femoral access by operator volume: high-volume operators (HR: 0.79; 95% CI: 0.48 to 1.28), intermediate (HR: 0.87; 95% CI: 0.60 to 1.27), and low (HR: 1.10; 95% CI: 0.74 to 1.65; interaction p = 0.536). However, in a multivariable model, overall center volume and radial center volume were independently associated with the primary outcome but not femoral center volume (overall percutaneous coronary intervention volume HR: 0.92, 95% CI: 0.88 to 0.96; radial volume HR: 0.88, 95% CI: 0.80 to 0.97; and femoral volume HR: 1.00, 95% CI: 0.94 to 1.07; p = 0.98).nnnCONCLUSIONSnProcedural volume and expertise are important, particularly for radial percutaneous coronary intervention. (A Trial of Trans-radial Versus Trans-femoral Percutaneous Coronary Intervention [PCI] Access Site Approach in Patients With Unstable Angina or Myocardial Infarction Managed With an Invasive Strategy [RIVAL]; NCT01014273).

Impact of Thrombolytic Therapy on the Long-Term Outcome of Intermediate-Risk Pulmonary Embolism.

BACKGROUNDnThe long-term effect of thrombolytic treatment of pulmonary embolism (PE) is unknown.nnnOBJECTIVESnThis study investigated the long-term prognosis of patients with intermediate-risk PE and the effect of thrombolytic treatment on the persistence of symptoms or the development of late complications.nnnMETHODSnThe PEITHO (Pulmonary Embolism Thrombolysis) trial was a randomized (1:1) comparison of thrombolysis with tenecteplase versus placebo in normotensive patients with acute PE, right ventricular (RV) dysfunction on imaging, and a positive cardiac troponin test result. Both treatment arms received standard anticoagulation. Long-term follow-up was included in the third protocol amendment; 28 sites randomizing 709 of the 1,006 patients participated.nnnRESULTSnLong-term (median 37.8 months) survival was assessed in 353 of 359 (98.3%) patients in the thrombolysis arm and in 343 of 350 (98.0%) in the placebo arm. Overall mortality rates were 20.3% and 18.0%, respectively (pxa0=xa00.43). Between day 30 and long-term follow-up, 65 deaths occurred in the thrombolysis arm and 53 occurred in thexa0placebo arm. At follow-up examination of survivors, persistent dyspnea (mostly mild) or functional limitation was reported by 36.0% versus 30.1% of the patients (pxa0= 0.23). Echocardiography (performed in 144 and 146 patients randomized to thrombolysis and placebo, respectively) did not reveal significant differences in residual pulmonary hypertension or RV dysfunction. Chronicxa0thromboembolic pulmonary hypertension (CTEPH) was confirmed in 4 (2.1%) versus 6 (3.2%) cases (pxa0= 0.79).nnnCONCLUSIONSnApproximately 33% of patients report some degree of persistent functional limitation after intermediate-risk PE, but CTEPH is infrequent. Thrombolytic treatment did not affect long-term mortality rates, and it did not appear to reduce residual dyspnea or RV dysfunction in these patients. (Pulmonary Embolism Thrombolysis study [PEITHO]; NCT00639743).