Amparo Benedicto

A Prospective Randomized Trial of Drug-Eluting Balloons Versus Everolimus-Eluting Stents in Patients With In-Stent Restenosis of Drug-Eluting Stents: The RIBS IV Randomized Clinical Trial.

BACKGROUND Treatment of patients with drug-eluting stent (DES) in-stent restenosis (ISR) remains a major challenge. OBJECTIVES This study evaluated the comparative efficacy of drug-eluting balloons (DEB) and everolimus-eluting stents (EES) in patients presenting with DES-ISR. METHODS The study design of this multicenter randomized clinical trial assumed superiority of EES for the primary endpoint, in-segment minimal lumen diameter at the 6- to 9-month angiographic follow-up. RESULTS A total of 309 patients with DES-ISR from 23 Spanish university hospitals were randomly allocated to DEB (n = 154) or EES (n = 155). At late angiography (median 247 days; 90% of eligible patients), patients in the EES arm had a significantly larger minimal lumen diameter (2.03 ± 0.7 mm vs. 1.80 ± 0.6 mm; p < 0.01) (absolute mean difference: 0.23 mm; 95% CI: 0.07 to 0.38) [corrected], net lumen gain (1.28 ± 0.7 mm vs. 1.01 ± 0.7 mm; p < 0.01), and lower percent diameter stenosis (23 ± 22% vs. 30 ± 22%; p < 0.01) and binary restenosis rate (11% vs. 19%; p = 0.06), compared with patients in the DEB arm. Consistent results were observed in the in-lesion analysis. At the 1-year clinical follow-up (100% of patients), the main clinical outcome measure (composite of cardiac death, myocardial infarction, and target vessel revascularization) was significantly reduced in the EES arm (10% vs. 18%; p = 0.04; hazard ratio: 0.58; 95% CI: 0.35 to 0.98), mainly driven by a lower need for target vessel revascularization (8% vs. 16%; p = 0.035). CONCLUSIONS In patients with DES-ISR, EES provided superior long-term clinical and angiographic results compared with DEB. (Restenosis Intra-Stent of Drug-Eluting Stents: Drug-Eluting Balloon vs Everolimus-Eluting Stent [RIBS IV]; NCT01239940).

Spontaneous coronary artery dissection: new insights into diagnosis and treatment.

Spontaneous coronary artery dissection (SCAD) remains an infrequent, elusive, and challenging clinical entity of unknown etiology eight decades after its initial description. Our understanding of the pathophysiology of SCAD, initially limited to information from early pathological studies, case reports, and very short series, has been enriched recently by relatively large contemporary series of patients studied prospectively. The typical presentation involves a young woman without coronary risk factors suffering an acute coronary syndrome but, actually, most patients are middle-aged and have coronary risk factors. A high number of conditions have been related to SCAD, but fibromuscular dysplasia has shown a major intriguing association with potential pathophysiological implications. SCAD may present (a) with an intimal tear and the classic angiographic ‘flap’ leading to the appearance of two lumens (true and false), or (b) without an intimal rupture, as an intramural hematoma. An increased clinical awareness together with new diagnostic tools have led to a major surge in the diagnosis of SCAD. High-resolution intracoronary techniques provide unique diagnostic insights into the underlying pathophysiology and facilitate identification of the disease in patients misdiagnosed previously. After the initial acute ischemic insult, most patients stabilize and have a benign clinical course and eventually experience spontaneous healing of the vessel wall during follow-up. However, recurrences may still occur in up to 10–20% of cases. Accordingly, a conservative medical management (watchful waiting strategy) has been recommended as the initial approach. Revascularization remains particularly challenging and may be associated with suboptimal results, acute complications, and poor long-term outcome. Nevertheless, in patients with ongoing or refractory ischemia and adequate anatomy, revascularization should be attempted. Some novel and attractive coronary interventions have been proposed in this uniquely challenging anatomic scenario. This review aims to present a comprehensive and contemporary update on this elusive and intriguing clinical entity.

Dilated cardiomyopathy as a presenting feature of Cushing’s syndrome

Patients with Cushings syndrome can rarely present with systolic heart failure as the mainstay feature. In these patients, heart failure is usually secondary to left ventricular hypertrophy (LVH) and not to dilated cardiopathy. We herewith report a patient with Cushings syndrome, who presented with systolic ventricular failure secondary to dilated myocardiopathy and signs of proximal myopathy as predominant features. All symptoms regressed after successful treatment.

Optical Coherence Tomography Findings in Patients With Stent Thrombosis

INTRODUCTION AND OBJECTIVES Stent thrombosis (ST) is a rare but potentially serious complication. Optical coherence tomography (OCT) provides high-resolution images and additional information to angiography in the study of this event. METHODS Prospective study of patients with ST undergoing reintervention with OCT imaging. RESULTS The study included a total of 40 consecutive patients with ST. Mean age was 69 ± 13 years and 83% were male. Early ST (≤ 30 days) was observed in 16 patients and late ST (> 30 days) in 24 patients. Stent thrombosis occurred in 17 bare-metal stents and 23 drug-eluting stents. In 34 patients (85%), adequate OCT images were obtained at the time of the ST. The predominant mechanism in early ST was stent malapposition (39%). In late ST, high frequencies of uncovered (46%) and malapposed struts (17%) were observed, especially in patients with drug-eluting stents. Furthermore, the presence of neoatherosclerosis was very high (67%) in patients with late ST. After intervention, improvements were observed in malapposition length and the amount of residual thrombus. CONCLUSIONS OCT allows identification of the underlying mechanisms potentially involved in ST. This imaging modality is helpful in guiding reintervention in these patients, which improves the area and length of malapposition, as well as the maximal residual thrombus area.

Factors Associated With Delays in Seeking Medical Attention in Patients With ST-segment Elevation Acute Coronary Syndrome

INTRODUCTION AND OBJECTIVES Prompt coronary reperfusion is crucial in patients with ST-segment elevation acute coronary syndrome. The aim of this study was to determine factors associated with a delay in seeking medical attention after the onset of symptoms in patients with this condition. METHODS Prospective cohort study in consecutive patients with ST segment elevation infarction. Multiple logistic regression analysis was used to identify factors independently associated with a longer delay in requesting medical help. RESULTS In total, 444 consecutive patients were included (mean age, 63 years; 76% men, 20% with diabetes). Median total ischemia time was 225 (160-317) minutes; median delay in seeking medical attention was 110 (51-190) minutes. Older patients (age > 75 years; odds ratio = 11.6), women (odds ratio = 3.4), individuals with diabetes (odds ratio = 2.3), and those requesting medical care from home (odds ratio = 2.2) showed the longest delays in seeking medical attention. Lengthy delay was associated with higher in-hospital mortality (9.8% vs 2.7%; P<.005) and 1-year mortality (7.3% vs 2.9%; P<.05) than when attention was promptly solicited. CONCLUSIONS Elderly patients, women, and diabetic individuals with ST-segment elevation myocardial infarction show longer delays in seeking medical attention for their condition. Delays in seeking medical attention are associated with greater in-hospital and 1-year mortality.

Nonatherosclerotic Causes of Acute Coronary Syndrome: Recognition and Management

Acute coronary syndromes (ACS) frequently result from the rupture or erosion of a vulnerable coronary plaque, with associated intracoronary thrombosis. ACS also may occur in patients with angiographically normal coronary arteries. Some of these patients, however, still have angiographically silent underlying coronary artery disease. In this setting, subtle atherosclerotic changes frequently associated with unstable morphologic features or residual intracoronary thrombus may be detected with intracoronary imaging techniques. Nevertheless, other patients develop ACS as a result of nonatherosclerotic coronary artery disease (NA-CAD). ACS in patients with NA-CAD may be the consequence of coronary spasm or transient coronary embolic phenomena. In these patients, after the initial ischemic insult, late coronary angiography usually reveals normal epicardial coronary vessels. Kounis syndrome is a type of ACS generated by allergic reactions. Takotsubo cardiomyopathy is characterized by normal coronary arteries with a distinct pattern of transient left ventricular wall motion abnormalities. ACS also may occur in young patients following illicit drug use. Finally, spontaneous coronary artery dissection and intramural hematoma represent other etiologies of NA-CAD. In this review, we discuss current evidence regarding diagnostic and treatment strategies in patients presenting with ACS as a result of NA-CAD.

New Insights on Plaque Erosion and Calcified Nodules: “Seeing Is Believing”

Plaque erosion (PE) and calcified nodules (CN) have been classically described in pathological studies as causes of acute coronary syndromes (ACS) [(1)][1]. However, until very recently, the diagnosis of these entities in the clinical setting has remained largely elusive [(1)][1]. In this regard,

Outcomes of Aortic Valve Replacement According to Surgical Approach in Intermediate and Low Risk Patients: A Propensity Score Analysis

BACKGROUND Previous trials have shown that, among high-risk patients with aortic stenosis, survival rates are similar for transcatheter aortic-valve implantation (TAVI) and surgical aortic valve replacement. The study aimed to compare the outcomes of aortic valve replacement according to the adopted surgical approach in intermediate and low risk patients. METHODS This is a retrospective, observational, cohort study of prospectively collected data from 421 patients undergoing isolated aortic valve replacement between 2011 and 2015. A multinomial logit propensity score model based on preoperative risk factors was used to match patients 1:1:1 between conventional replacement (CAVR), minimally invasive (MIAVR) and TAVI groups, resulting in 50 matched three cohorts. RESULTS After multinomial logit propensity score, the three groups were comparable in terms of preoperative characteristics. Mean age and Logistic EuroSCORE I of CAVR, MIAVR and TAVI groups were (84.2±5.1 vs. 82.3±4.8 vs. 85.6±4.9 years; p=0.002) and (11.4±3.6% vs. 8.3±3.4% vs. 15.8±5.4%; p<0.001) respectively. Overall mortality rates were similar for the three patient cohorts at one year. There were no significant differences related to stroke to 30 days. In the TAVI cohort, pacemaker implantation for new-onset total atrioventricular block became necessary in 30% of patients (p<0.001) and 16% of patients had some degree of paravalvular aortic regurgitation, which was more than mild (p<0.001). Total length of stay was shorter in the TAVI group when compared with surgical groups (11.5±5.3 vs. 10.1±6.9 vs 8.5±3.7 days; p=0.023). After discharge, the survival rate follow-up (average follow up: 46.7 months) was 70%, 84% and 72% for three cohorts (log Rank x2=2.40, p=0.3). CONCLUSIONS In our experience, the three aortic valve replacement approaches offer very good results. Differences in the rate of complications were found between groups. Depending on patients characteristics the Heart-Team group must offer the best surgical approach for each patient.

Drug-eluting balloons in coronary interventions: the quiet revolution?

ABSTRACT Introduction: Drug-eluting balloons (DEB) may be considered as a ‘quiet revolution’ in percutaneous coronary interventions. Early-generation DEB eluting paclitaxel proved to be very effective in animal models to reduce neointimal hyperplasia. Areas covered: Review of DEB efficacy in patients with coronary de novo lesions and in-stent restenosis (ISR). Expert opinion: Many randomized clinical trials and meta-analyses have demonstrated the value of DEB in patients with ISR. In this setting, DEB are safe and effective with clinical and angiographic results superior to plain balloon angioplasty and at least equivalent to first generation drug-eluting stents (DES). In selected ‘de novo’ lesions (bifurcation lesions, small vessels, diffuse disease, myocardial infarction) DEB represent an attractive alternative although additional evidence in these ‘niche’ indications is still required before a widespread clinical utilization can be recommended. Recently, new generation DEB have become available, offering interesting new possibilities (paclitaxel and also sirolimus) for coronary interventions. Further studies are required to compare the results of novel generation DEB with those of second-generation DES.

Diagnostic accuracy of a hybrid approach of instantaneous wave-free ratio and fractional flow reserve using high-dose intracoronary adenosine to characterize intermediate coronary lesions: Results of the PALS (Practical Assessment of Lesion Severity) prospective study

We sought to investigate the diagnostic accuracy of instantaneous wave‐free ratio (iFR) and high‐dose intracoronary adenosine fractional flow reserve (IC‐FFR) compared with classical intravenous adenosine fractional flow reserve (IV‐FFR) to assess coronary stenosis severity. The usefulness of two hybrid strategies combining iFR and high‐dose IC‐FFR was also evaluated. Background: Physiological assessment of intermediate coronary stenoses to guide revascularization is currently recommended. Methods: Consecutive real‐world patients with angiographically intermediate coronary stenosis (40–80% diameter stenosis) were prospectively included in the PALS (Practical Assessment of Lesion Severity) study. In every target lesion iFR, high‐dose IC‐FFR and IV‐FFR were systematically measured to assess the accuracy of an hybrid sequential approach combining iFR and IC‐FFR. Results: A total of 106 patients with 121 intermediate coronary lesions were analyzed. Both, iFR and IC‐FFR showed a significant correlation with IV‐FFR (iFR: r = 0.60, 95%CI 0.48–0.70; IC‐FFR: r = 0.88; 95%CI: 0.83–0.92). High‐dose IC‐FFR provided lower FFR values than IV‐FFR (0.81 ± 0.08 vs. 0.82 ± 0.09, P = 0.25). Using a receiver‐operating‐characteristic curve an optimal iFR threshold of 0.91 for the screening test was identified. A sequential test strategy (initial iFR followed by IC‐FFR only in lesions with iFR <0.91) yielded an excellent diagnostic accuracy (96.7%, 95%CI 96.7–99.1%) with a sensitivity, specificity, positive and negative predicted values of 100%, 94.7%, 91.8%, and 100%, respectively. A hybrid approach using the previously described iFR gray zone (0.85–0.94) also provided an excellent diagnostic accuracy (95%, 95%CI: 89.5–98.1%). Conclusions: In patients with intermediate coronary lesions a hybrid strategy by using a sequential approach of iFR and high‐dose IC‐FFR, provided a very good diagnostic performance to identify physiologically significant stenoses.