Ignacio Plaza

Randomized Comparison of Sirolimus-Eluting and Everolimus-Eluting Coronary Stents in the Treatment of Total Coronary Occlusions Results From the Chronic Coronary Occlusion Treated by Everolimus-Eluting Stent Randomized Trial

Background—Patients with coronary total occlusions are at especially high risk for restenosis and new revascularizations. Sirolimus-eluting stents dramatically improved the clinical outcome of this subset of patients in randomized trials, but other drug-eluting stents, mainly the everolimus-eluting stent (currently the most frequently used stent), have not yet been evaluated in patients with coronary total occlusions. The objective was to compare the second-generation everolimus-eluting stent with the first-generation sirolimus-eluting stent in patients with coronary total occlusions. Methods and Results—A total of 207 patients with coronary total occlusions and estimated time since occlusion >2 weeks were randomized to everolimus- or sirolimus-eluting stent. The primary end point was in-stent late loss at 9-month angiographic follow-up (noninferiority trial). Clinical follow-up was performed at 1 and 12 months. In-stent late loss at 9 months was 0.29±0.60 versus 0.13±0.69 mm in patients allocated to sirolimus- and everolimus-eluting stent, respectively. The observed difference in in-stent late loss between both groups was –0.16 mm (95% confidence interval, 0.04 to –0.36 mm; P for noninferiority <0.01). The rate of binary angiographic restenosis was 10.8% and 9.1% in patients allocated to sirolimus- and everolimus-eluting stent, respectively (P=0.709), whereas the rate of vessel reocclusion was 3.2% and 1.1%, respectively (P=0.339). At 12 months, the rate of major adverse events was 15.9% versus 11.1% with sirolimus- and everolimus-eluting stent, respectively (P=0.335), and probable or definitive stent thrombosis occurred in 3.0% and 0.0% of patients, respectively (P=0.075). Conclusions—In patients with coronary total occlusions, everolimus-eluting stent is as effective as sirolimus-eluting stent. Clinical Trial Registration—URL: http://www.clinicaltrials.gov. Unique identifier: NCT00793221.

Clinical and prognostic implications of atrial fibrillation in patients undergoing transcatheter aortic valve implantation

AIM To study a cohort of consecutive patients undergoing transcatheter aortic valve implantation (TAVI) and compare the outcomes of atrial fibrillation (AF) patients vs patients in sinus rhythm (SR). METHODS All consecutive patients undergoing TAVI in our hospital were included. The AF group comprised patients in AF at the time of TAVI or with history of AF, and were compared with the SR group. Procedural, echocardiographic and follow-up variables were compared. Likewise, the CHA(2)DS(2)-VASC stroke risk score and HAS-BLED bleeding risk score and antithrombotic treatment at discharge in AF patients were compared with that in SR patients. RESULTS From a total of 34 patients undergoing TAVI, 17 (50%) were allocated to the AF group, of whom 15 (88%) were under chronic oral anticoagulation. Patients in the AF group were similar to those in the SR group except for a trend (P = 0.07) for a higher logistic EuroSCORE (28% vs 19%), and a higher prevalence of hypertension (82% vs 53%) and chronic renal failure (17% vs 0%). Risk of both stroke and bleeding was high in the AF group (mean CHA(2)DS(2)-VASC 4.3, mean HAS-BLED 2.9). In the AF group, treatment at discharge included chronic oral anticoagulation in all except one case, and in association with an antiplatelet drug in 57% of patients. During a mean follow-up of 11 mo (maximum 32), there were only two strokes, none of them during the peri-procedural period: one in the AF group at 30 mo and one in the SR group at 3 mo. There were no statistical differences in procedural success, and clinical outcome (survival at 1 year 81% vs 74% in AF and SR groups, respectively, P = NS). CONCLUSION Patients in AF undergoing TAVI show a trend to a higher surgical risk. However, in our cohort, patients in AF did not have a higher stroke rate compared to the SR group, and the prognosis was similar in both groups.

Implantación de prótesis valvulares aórticas por vía transfemoral. Evaluación de pacientes candidatos al procedimiento

BACKGROUND AND OBJECTIVE In recent years, techniques for implantation of aortic prosthesis via catheter have been developed as a therapeutic alternative in patients with severe aortic stenosis rejected for surgery. The correct selection of candidates is one of the more complex aspects of this treatment. We analyzed the acceptance rate in our environment for transcatheter aortic valve implantation in patients referred to our hospital for evaluation as possible candidates, describing the exclusion reasons. PATIENTS AND METHOD 30 patients with severe aortic stenosis and rejected for surgical aortic valve replacement were referred to our hospital to evaluate transcatheter aortic valve implantation. The patients first underwent clinical evaluation and were studied with echocardiography, angiography and computed tomography. RESULTS Of the 30 patients, 18 were rejected for the procedure (60%): 4 patients with non-severe aortic stenosis, 2 asymptomatic patients, 2 patients who finally underwent surgery because of a low-surgical-risk, 5 patients with contraindications for the procedure, 2 patients who finally did not want to undergo the procedure and 3 patients were further rejected because the vascular access was inappropriate. Of the remaining 12 patients initially accepted, 3 died before the procedure was performed. Finally, only 9 patients (30%) underwent transcatheter aortic valve implantation. CONCLUSIONS Of the patients referred for transcatheter aortic valve implantation, only 40% were accepted. The mortality rate during the evaluation process of this procedure is high, showing that these patients are terminally ill.

Long-term Follow-up After Transcatheter Aortic Valve Implantation for Severe Aortic Stenosis

INTRODUCTION AND OBJECTIVES Transcatheter aortic valve implantation is used as an alternative to surgical valve replacement in patients with severe aortic stenosis who are considered high-surgical-risk or inoperable. Two of the main areas of uncertainty in this field are valve durability and long-term survival. METHODS This prospective single-center registry study from a tertiary hospital included all consecutive patients who underwent percutaneous aortic valve implantation between 2008 and 2012. Clinical follow-up lasted a minimum of 2.5 years and a maximum of 6.5 years. Valve Academic Research Consortium-2 definitions were used. RESULTS Seventy-nine patients were included, with an immediate success rate of 94.9%. The median survival was 47.6 months (95% confidence intervals, 37.4-57.9 months), ie, 4 years. One quarter of deaths occurred in the first month, and most were of cardiovascular cause. After the first month, most deaths were due to noncardiovascular causes. The mean values of valve gradients did not increase during follow-up. The cumulative rate of prosthetic valve dysfunction was 15.3%, with no cases of repeat valve replacement. CONCLUSIONS Half of the patients with aortic stenosis who underwent transcatheter aortic valve implantation were alive 4 years after the procedure. There was a 15.3% prosthetic valve dysfunction rate in cumulative follow-up, with no cases of repeat valve replacement.

Periprocedural (30-day) risk of myocardial infarction after drug-eluting coronary stent implantation: a meta-analysis comparing cobalt-chromium and stainless steel drug-eluting coronary stents

AIMS Because of the reduction in the rate events related with in-stent restenosis, most events after drug-eluting stent implantation occur shortly after coronary stenting. Cobalt-chromium alloys allow to reduce strut thickness and improve flexibility and deliverability of coronary stent platforms, and thus could be associated with lower short-term events after stenting. The aim of this study was to test the hypothesis that drug-eluting coronary stents with a cobalt-chromium platform reduce the incidence of periprocedural (30-day) myocardial infarction in comparison with stainless steel drug-eluting coronary stents. METHODS AND RESULTS A meta-analysis from nine randomised trials comparing cobalt-chromium and stainless steel drug-eluting coronary stents that overall included 11,313 patients was performed. The incidence of myocardial infarction, stent thrombosis, and cardiac death at 30 days was compared between both types of stents. At 30 days, the incidence of acute myocardial infarction was significantly lower in patients allocated to cobalt-chromium drug-eluting stents (2.3% vs. 3.9%, respectively; p=0.006; odds ratio 0.72, 95% confidence interval 0.58-0.91), due to a significant reduction in the rate of non-Q-wave myocardial infarction (odds ratio 0.67, 95% confidence interval 0.51-0.88). The incidence of stent thrombosis was similar between both groups of patients, (0.5% vs. 0.5%, p=0.76; odds ratio 1.09, 95% confidence interval 0.63-1.89). CONCLUSIONS Drug-eluting coronary stents that use cobalt-chromium stent platforms have a better safety profile at 30 days in comparison with stainless steel drug-eluting stents, due to a significant reduction in the rate of myocardial infarction.

Determining clinical benefits of drug-eluting coronary stents according to the population risk profile: A meta-regression from 31 randomized trials

BACKGROUND The use of drug-eluting stents (DES) in unfavourable patients has been associated with higher rates of clinical complications and stent thrombosis, and because of that concerns about the use of DES in high-risk settings have been raised. OBJECTIVE This study sought to demonstrate that the clinical benefit of DES increases as the risk profile of the patients increases. METHODS A meta-regression analysis from 31 randomized trials that compared DES and bare-metal stents, including overall 12,035 patients, was performed. The relationship between the clinical benefit of using DES (number of patients to treat [NNT] to prevent one episode of target lesion revascularization [TLR]), and the risk profile of the population (rate of TLR in patients allocated to bare-metal stents) in each trial was evaluated. RESULTS The clinical benefit of DES increased as the risk profile of each study population increased: NNT for TLR=31.1-1.2 (TLR for bare-metal stents); p<0.001. The use of DES was safe regardless of the risk profile of each study population, since the effect of DES in mortality, myocardial infarction, and stent thrombosis, was not adversely affected by the risk profile of each study population (95% confidence interval for β value 0.09 to 0.11, -0.12 to 0.19, and -0.03 to-0.15 for mortality, myocardial infarction, and stent thrombosis, respectively). CONCLUSIONS The clinical benefit of DES increases as the risk profile of the patients increases, without affecting safety.

Does new onset atrial fibrillation have a true impact on the incidence of stroke after transcatheter aortic valve implantation

We read with interest the paper by Amat-Santos et al. ([1][1]) describing the importance of new-onset atrial fibrillation (NOAF) after transcatheter aortic valve implantation (TAVI). They describe an association between NOAF and embolic events (EE), suggesting that NOAF may be a mechanism for late

Stent thrombosis did biodegradable polymers fail or are we too impatient

We read with interest the report by Holmes et al. ([1][1]), in which the current knowledge about stent thrombosis is revisited, and the possibility that biodegradable polymers improve the long-term safety of drug-eluting stents is mentioned. Durable polymers are associated with persistent arterial

Echogenic mobile images in intraprocedural three-dimensional transesophageal echocardiographic monitoring during percutaneous aortic valve implantation: Incidence, characteristics and clinical implications

INTRODUCTION AND OBJECTIVES To investigate the incidence and clinical relevance of the presence of mobile echogenic images (MEI) during transesophageal echocardiography (TEE) for monitoring of transcatheter aortic valve implantation (TAVI). METHODS Consecutive patients referred to our center for transfemoral or transapical TAVI were included. The procedure was monitored by three-dimensional (3D) TEE and images were analyzed by two independent experts. In-hospital follow-up was carried out and correlated with imaging findings. RESULTS A total of 104 patients were included. MEI were visualized in 11 patients during the procedure (11%) and in over 50% of cases were identified as thrombi, however no differences in periprocedural stroke were found in follow-up. CONCLUSIONS Visualization of MEI during 3D TEE monitoring of TAVI is relatively common (11%) and in over 50% of cases they are identified as thrombi. The clinical implications of this finding are uncertain, as despite their frequency, the incidence of clinical stroke in this patient population was no higher. 3D TEE is a useful tool for diagnosis of MEI and can alert the operator to their presence.

Prognostic impact of decisions taken by the heart team in patients evaluated for transcatheter aortic valve implantation

OBJECTIVE To analyze long-term survival and predictors of mortality in patients evaluated for transcatheter aortic valve implantation (TAVI) depending on the decision taken by the heart team. METHODS All patients with severe aortic stenosis and high surgical risk evaluated for TAVI between June 2008 and June 2012 were included. Patients were grouped according to the therapeutic strategy decided by the heart team. Mean follow-up was 16.6 months (maximum 55.3). RESULTS A total of 149 patients were evaluated: 79 were accepted for TAVI, 12 had no current indication for valve replacement and were deferred, 13 were redirected to conventional surgery and 45 received medical treatment. The evaluated patients had a mean age of 83.7 years and a mean EuroSCORE of 19.8±12.3. Median survival free from all-cause death was 34.7 months (95% CI 27.1-42.3) in the TAVI group, 47.4 months (95% CI 0-97.4) in the deferred intervention group, not available in the surgery group and 8.2 months (95% CI 5.6-10.9) in the medical treatment group (log-rank p<0.001). After multivariable adjustment, only treatment group remained as an independent predictor of mortality. Considering the TAVI group as the reference category, the adjusted hazard ratio for all-cause death was 0.70 (95% CI 0.24-2.04) for the deferred intervention group, 0.16 (95% CI 0.02-1.19) for the surgery group and 2.47 (95% CI 1.46-4.18) for the medical treatment group. CONCLUSION The decision taken by the heart team on potential candidates for TAVI has a decisive prognostic significance, as those who are unsuitable for any kind of valve replacement have a significantly higher mortality.