Gerard Roura

Comparison of Paclitaxel-Eluting Stents (Taxus) and Everolimus-Eluting Stents (Xience) in Left Main Coronary Artery Disease With 3 Years Follow-Up (from the ESTROFA-LM Registry)

Evidence regarding therapy with drug-eluting stents in the left main coronary artery (LM) is based mostly on trials performed with first-generation drug-eluting stents. The aim of this study was to evaluate long-term clinical outcomes after treatment for unprotected LM disease with paclitaxel-eluting stents (PES) and everolimus-eluting stents (EES). The ESTROFA-LM is a multicenter retrospective registry including consecutive patients with unprotected LM disease treated with PES or EES. A total of 770 patients have been included at 21 centers, 415 with treated PES and 355 with EES. Treatment with 2 stents was more frequent with PES (17% vs 10.4%, p = 0.007), whereas intravascular ultrasound was more frequently used with EES (35.2% vs 26%, p = 0.006). The 3-year death and infarction survival rates were 86.1% for PES and 87.3% for EES (p = 0.50) and for death, infarction, and target lesion revascularization were 83.6% versus 82% (p = 0.60), respectively. Definite or probable thrombosis was 1.6% for PES and 1.4% for EES (p = 0.80). The use of 2 stents, age, diabetes, and acute coronary syndromes were independent predictors of mortality. In the subgroup of distal lesions, the use of intravascular ultrasound was an independent predictor of better outcome. Comparison of propensity score-matched groups did not yield differences between the 2 stents. In conclusion, the results of this multicenter registry show comparable safety and efficacy at 3 years for PES and EES in the treatment of LM disease. The use of bifurcation stenting techniques in distal lesions was a relevant independent predictor for events. The use of intravascular ultrasound appears to have a positive impact on patients treated for LM distal disease.

A Randomized Comparison of Reservoir-Based Polymer-Free Amphilimus-Eluting Stents Versus Everolimus-Eluting Stents With Durable Polymer in Patients With Diabetes Mellitus : The RESERVOIR Clinical Trial

OBJECTIVES The aim of this study was to compare the efficacy of amphilimus-eluting stents (AES) with that of everolimus-eluting stents (EES) in patients with diabetes mellitus (DM). BACKGROUND The AES is a polymer-free drug-eluting stent that elutes sirolimus formulated with an amphiphilic carrier from laser-dug wells. This technology could be associated with a high efficacy in patients with DM. METHODS This was a multicenter, randomized, noninferiority trial. Patients with DM medically treated with oral glucose-lowering agents or insulin and de novo coronary lesions were randomized in a 1:1 fashion to AES or EES. The primary endpoint was the neointimal (NI) volume obstruction assessed by optical coherence tomography at 9-month follow-up. RESULTS A total of 116 lesions in 112 patients were randomized. Overall, 40% were insulin-treated patients, with a median HbA1c of 7.3% (interquartile range: 6.7% to 8.0%). The primary endpoint, NI volume obstruction, was 11.97 ± 5.94% for AES versus 16.11 ± 18.18% for EES, meeting the noninferiority criteria (p = 0.0003). Pre-specified subgroup analyses showed a significant interaction between stent type and glycemic control (p = 0.02), with a significant reduction in NI hyperplasia in the AES group in patients with the higher HbA1c (p = 0.03). By quantitative coronary angiography, in-stent late loss was 0.14 ± 0.24 for AES versus 0.24 ± 0.57 mm for EES (p = 0.27), with a larger minimal lumen diameter at follow-up for AES (p = 0.02), mainly driven by 2 cases of occlusive restenosis in the EES group. CONCLUSIONS AES are noninferior to EES for the coronary revascularization of patients with DM. These results suggest a high efficacy of the AES and may support the potential benefit of this stent in patients with DM. (A Randomized Comparison of Reservoir-Based Polymer-Free Amphilimus-Eluting Stents Versus Everolimus-Eluting Stents With Durable Polymer in Patients With Diabetes Mellitus [RESERVOIR]; NCT01710748).

Lumen enlargement of the coronary segments located distal to chronic total occlusions successfully treated with drug-eluting stents at follow-up.

AIMS Chronic total occlusions (CTO) are the final stage of atherosclerosis. Occluded coronary arteries have large plaque burden and negative remodelling. The aim of this study was to assess lumen and vessel changes of segments located distal to successfully recanalised CTO. METHODS AND RESULTS Ninety-one CTO treated with drug-eluting stents underwent quantitative coronary angiography (QCA) at baseline and at 12-18 months; 31 underwent serial intravascular ultrasound (IVUS) imaging. Angiographic changes were assessed with QCA as differences in minimal, mean and maximal lumen diameter (MinLD, MeanLD and MaxLD, respectively). Vessel changes were assessed with IVUS as changes in plaque and vessel volume. At follow-up, angiographic MinLD increased 23.9% (from 0.88±0.32 to 1.09±0.35 mm; p<0.01), MeanLD 16.4% (from 1.59±0.44 to 1.85±0.45 mm; p<0.01) and MaxLD 11.7% (from 2.39±0.67 to 2.67±0.70 mm; p<0.01). Lumen enlargement was greater in non-restenotic lesions, small lumen area at the end of the index procedure and low LDL-cholesterol levels during the study. By IVUS, lumen volume increased 26.9% (from 108.1±89.2 to 137.3±115.3 mm3; p<0.01), vessel volume increased 12.1% (from 207.1±170.2 to 232.2±196.0 mm3; p<0.01) and plaque volume tended to decrease 3.9% (from 98.9±88.7 to 94.9±89.3 mm3; p=0.07). Small lumen at baseline was related to greater lumen enlargement. CONCLUSIONS Segments distal to recanalised CTO showed a notable lumen and vessel enlargement with a trend toward mild plaque regression. Low LDL-cholesterol levels increase lumen enlargement.

Use of Impella Recover LP 2.5 in elective high risk percutaneous coronary intervention

We describe a single-center experience in using the Impella Recover LP 2.5 in the setting of high-risk elective percutaneous coronary interventions. This device is placed percutaneously to support cardiac output and has a better profile than other left ventricular assist devices. Our study shows that the use of the Impella Recover LP 2.5 device is feasible, has an overall favorable safety profile, and may help prevent periprocedural and short-term complications derived from high-risk procedures.

Efficacy of Bleeding Risk Scores in Elderly Patients with Acute Coronary Syndromes

INTRODUCTION AND OBJECTIVES The incidence of acute coronary syndromes is high in the elderly population. Bleeding is associated with a poorer prognosis in this clinical setting. The available bleeding risk scores have not been validated specifically in the elderly. Our aim was to assess predictive ability of the most important bleeding risk scores in patients with acute coronary syndrome aged ≥ 75 years. METHODS We prospectively included consecutive acute coronary syndromes patients. Baseline characteristics, laboratory findings, and hemodynamic data were collected. In-hospital bleeding was defined according to CRUSADE, Mehran, ACTION, and BARC definitions. CRUSADE, Mehran, and ACTION bleeding risk scores were calculated for each patient. The ability of these scores to predict major bleeding was assessed by binary logistic regression, receiver operating characteristic curves, and area under the curves. RESULTS We included 2036 patients, with mean age of 62.1 years; 369 patients (18.1%) were ≥ 75 years. Older patients had higher bleeding risk (CRUSADE, 42 vs 22; Mehran, 25 vs 15; ACTION, 36 vs 28; P<.001) and a slightly higher incidence of major bleeding events (CRUSADE bleeding, 5.1% vs 3.8%; P=.250). The predictive ability of these 3 scores was lower in the elderly (area under the curve, CRUSADE: 0.63 in older patients, 0.81 in young patients; P=.027; Mehran: 0.67 in older patients, 0.73 in younger patients; P=.340; ACTION 0.58 in older patients, 0.75 in younger patients; P=.041). CONCLUSIONS Current bleeding risk scores showed poorer predictive performance in elderly patients with acute coronary syndromes than in younger patients.

Five-Year Optical Coherence Tomography in Patients With ST-Segment–Elevation Myocardial Infarction Treated With Bare-Metal Versus Everolimus-Eluting Stents

Background—The main causes of late (>1 month) stent thrombosis (ST) are stent uncoverage, malapposition, and neoatherosclerosis. First-generation drug-eluting stents were associated with higher rate of late ST compared with bare-metal stents (BMS), especially in patients with ST-segment–elevation myocardial infarction. Second-generation everolimus-eluting stents (EES) have shown similar rate of late ST than BMS. The aims of the study are to compare the ratio of uncovered to total struts per cross-section ≥30% and other optical coherence tomographic findings associated with ST between EES and BMS in patients with ST-segment–elevation myocardial infarction at 5 years. Methods and Results—One hundred and sixty-nine consecutive event-free patients of the randomized EXAMINATION study (A Clinical Evaluation of Everolimus Eluting Coronary Stents in the Treatment of Patients With ST-Segment Elevation Myocardial Infarction) were screened for optical coherence tomographic imaging at 5 years. Patients with target vessel–related events or life-threatening comorbidities were excluded. Finally, 64 patients (32 EES and 32 BMS) underwent optical coherence tomographic imaging. At 5 years, uncovered struts (4.1% versus 1.0%; P<0.01), length of uncoverage (3.4 versus 1.4 mm; P=0.02), and ratio of uncovered to total struts per cross-section ≥30% (35.5% versus 9.7%; P=0.02) were larger with EES than that with BMS. Malapposed struts (1.2% versus 0.3%; P=0.02) and malapposition length (1.3 versus 0.4 mm; P=0.06) were also larger with EES. Neoatherosclerotic plaques (16.1% versus 25.8%; P=0.35) and macrophage accumulations (19.4% versus 48.4%; P=0.02) were numerically more frequent with BMS. Conclusions—Despite substantial dropout of patients, the healing pattern in event-free ST-segment–elevation myocardial infarction patients differs between EES and BMS at 5 years. EES presented with larger amount of uncovered and malapposed struts and similar rate of neoatherosclerosis as compared with BMS. The clinical relevance of these findings warrants longer follow-up. Clinical Trial Registration—URL: http://www.clinicaltrials.gov. Unique identifier: NCT00828087.

Clopidogrel pretreatment in primary percutaneous coronary intervention: Prevalence of high on-treatment platelet reactivity and impact on preprocedural patency of the infarct-related artery

To date, there is limited data on levels of platelet inhibition achieved in patients with ST-elevation myocardial infarction (STEMI) who are loaded with clopidogrel and aspirin (ASA) prior to undergoing primary percutaneous coronary intervention (P-PCI). The aim of this investigation was to evaluate the percentage of STEMI patients with high on-treatment platelet reactivity (HPR) to clopidogrel at the time of initiating P-PCI and its association with the initial patency of the infarct-related artery (IRA). This prospective pharmacodynamic study included 50 STEMI patients, previously naïve to oral antiplatelet agents, who received 500-mg ASA and 600-mg clopidogrel loading doses prior to P-PCI. Platelet function assessment was performed at the beginning of the procedure using various assays, including VerifyNow™ system (primary endpoint), light transmission aggregometry and multiple electrode aggregometry. The percentage of patients with suboptimal response to clopidogrel and ASA assessed with the VerifyNow™ system was 88.0% and 28.6%, respectively. Similar results were obtained with the other assays used. A higher percentage of patients with initial patency of the IRA was observed among those patients without HPR compared with those with HPR to clopidogrel (66.7% vs 15.9%; p=0.013), while no differences were observed regarding postprocedural angiographic or electrocardiographic outcomes. In conclusion, this study shows that a high percentage of STEMI patients have inadequate levels of clopidogrel-induced and, to a lesser extent, aspirin-mediated platelet inhibition when starting a P-PCI procedure, and suggests that a poor response to clopidogrel might be associated with impaired initial TIMI flow in the IRA.

Seguimiento a largo plazo tras el tratamiento percutáneo del tronco coronario izquierdo no protegido en pacientes de alto riesgo no aptos para cirugía de revascularización

INTRODUCTION AND OBJECTIVES Percutaneous coronary intervention is recommended in patients with unprotected left main stenosis non suitable for coronary artery bypass graft. Long-term follow-up of those patients remains uncertain. METHODS All patients with de novo unprotected left main stenosis treated with stent implantation were consecutively enrolled. Percutaneous coronary intervention was indicated according to the standards of care, taking into account clinical and anatomical conditions unfavorable for coronary artery bypass graft. The primary end point was the occurrence of major adverse cardiac events, a composite of death, nonfatal acute myocardial infarction, or target lesion revascularization. RESULTS Of 226 consecutive patients included, 202 (89.4%) were treated with drug-eluting stents. Mean age was 72.1 years, 41.1% had renal dysfunction, and mean Syntax score and EuroSCORE were 28.9 and 7.4, respectively. Angiographic and procedural success was achieved in 99.6% and 92.9% of patients. At 3 years, the rates of major adverse cardiac events, death, nonfatal acute myocardial infarction and target lesion revascularization were 36.2%, 25.2%, 8.4%, 8.0%, respectively. Target lesion revascularization was more frequently observed when ≥ 2 stents were implanted rather than a single stent (18.5% vs 5.8%, P=.03); and with bare metal stents rather than drug-eluting stents (13.0% vs 7.9%, P=.24). Definite stent thrombosis was observed in 2 patients (0.9%) and probable stent thrombosis in 7 (3.1%). Female sex, impaired left ventricular function, and use of bare metal stents were significantly related with all-cause mortality. CONCLUSIONS High-risk patients with unprotected left main stenosis treated with percutaneous coronary intervention presented with a high rate of major adverse cardiac events at long-term follow-up. Female sex, impaired left ventricular function, and use of bare metal stents were predictors of poor prognosis.

Preserved endothelial vasomotor function after everolimus-eluting stent implantation

AIMS To compare the degree of endothelial dysfunction (ED) in patients treated with everolimus-eluting stent (EES) versus bare metal stent (BMS) implantation. METHODS AND RESULTS This is an observational study. A total of 30 elective patients (15 treated with EES and 15 with BMS) were recruited. All patients underwent coronary angiography and intracoronary acetylcholine (Ach) test at different doses at six months after stent implantation. Quantitative coronary angiography analysis was performed to evaluate the changes in mean luminal diameter (MLD) of the segments distal to the distal stent edge after increasing doses of Ach. Both EES and BMS groups had similar baseline characteristics except for stent length (18.6±2.5 vs. 16.5±2.5 mm; p=0.033) and diameter (3.1±0.2 vs. 3.4±0.3 mm; p=0.007). The vasomotion test showed that EES had 3.14% of MLD decrease after Ach infusion and BMS had 2.35% of vasoconstriction (p=0.62). After adjustment for baseline characteristics, no statistical difference was observed between groups. CONCLUSIONS In our study EES implantation was associated with a low degree of ED and had a similar vasomotion response as compared to BMS. Prospective randomised investigations are warranted to confirm these findings.

IVUS-guided treatment strategies for definite late and very late stent thrombosis

AIMS Our aim was to describe the intravascular ultrasound (IVUS) findings of patients with late stent thrombosis (ST) undergoing percutaneous intervention, and to compare the pre- and post-intervention IVUS findings of patients treated with balloon angioplasty (BA) vs. additional stent implantation (ASI). METHODS AND RESULTS A total of 117 patients with late ST imaged with IVUS were included (51.2% had drug-eluting stent ST). Treatment was left to the operators discretion: BA was performed in 53.8% and ASI in 46.2%. Pre-intervention, incomplete stent apposition (ISA) was observed in 69.8% vs. 63.0% (p=0.43), underexpansion in 33.3% vs. 18.5% (p=0.07) and restenosis in 15.9% vs. 27.8% (p=0.12), respectively. Post-intervention, persistent ISA was observed in 37.2% vs. 60.9% (p=0.03) and malapposition volume decreased by 43.6% vs. 2.6% (p=0.03). Persistent underexpansion was observed in 9.3% vs. 17.4% (p=0.26); however, the stent expansion index was largely increased with BA (from 0.75 to 0.88) compared to ASI (from 0.80 to 0.82); p=0.046. At two years, recurrent ST was observed in one (1.7%) vs. four (7.7%) patients, respectively; p=0.09. CONCLUSIONS Non-optimal IVUS criteria of stent implantation are often observed in patients with late ST. Treatment of late ST with BA leads to a larger reduction of malapposition and underexpansion with respect to ASI and is associated with favourable outcomes.