Montserrat Gracida

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).

The Benefit of a Second Burst Antitachycardia Sequence for Fast Ventricular Tachycardia in Patients with Implantable Cardioverter Defibrillators

In patients with implantable cardioverter defibrillators (ICDs), an empirical burst of antitachycardia pacing (ATP) is moderately effective in terminating fast ventricular tachycardias (FVTs). It is unknown whether, in the case of failure of a first burst, a second burst attempt increases the efficacy of the intervention, without increasing morbidity. Our aim was to evaluate the safety and efficacy of a strategy of programming successive ATP sequences for FVT episodes.

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.

MGuard Mesh-Covered Stent for Treatment of ST-Segment Elevation Myocardial Infarction with High Thrombus Burden Despite Manual Aspiration

OBJECTIVES To assess the usefulness of the MGuard stent in patients with ST-segment elevation myocardial infarction (STEMI) in whom a high thrombus burden persists after manual aspiration. BACKGROUND In some patients with STEMI, a high thrombus burden may persist after manual aspiration. These patients may be at high risk of distal embolization and therefore impaired myocardial reperfusion. The MGuard is a novel mesh-covered stent designed to minimize thrombus embolization. METHODS Single-arm, prospective registry of patients with STEMI and high thrombus burden after aggressive thrombus aspiration treated with the MGuard stent. High thrombus burden was defined as thrombus burden grade 4 or 5 according to the TIMI score. Lesions with a side branch ≥2 mm and patients with cardiogenic shock were not included. The study end-points were proportion of final TIMI 3 flow, normal myocardial blush, and complete ST-segment resolution. RESULTS Fifty-six patients were included. After MGuard stent implantation >85% of cases had thrombus score = 0. Final TIMI 3 flow was achieved in 82% of cases, normal myocardial blush in 55%, and complete ST-segment resolution in 59%. Occlusion of a side branch (<2 mm) occurred in 2 cases (3.5%), embolization to a distal branch in 5 cases (8.9%), and transient no-reflow in 4 cases (7.1%). Major adverse cardiac events rate at 9 months was 3.6%, including 1 definite acute stent thrombosis and 1 target-vessel revascularization. CONCLUSIONS The MGuard stent may be useful to prevent distal embolization in patients with STEMI and high thrombus burden despite mechanical aspiration.

The MGuard coronary stent: safety, efficacy, and clinical utility

Atheromatous and thrombotic embolization during percutaneous coronary revascularization is a feared complication that may cause impaired myocardial reperfusion even with a patent epicardial vessel. The MGuard stent is a cobalt chromium bare metal stent with a porous net attached to its outer surface that has been designed to prevent thrombus fragmentation and distal embolization during stent implantation. This review summarizes the available evidence supporting the use of the MGuard stent in different scenarios such as lesions with high thrombus burden, saphenous vein graft interventions, coronary perforations, or carotid lesions.

Rationale and study design of the RESERVOIR trial: A randomized trial comparing reservoir‐based polymer‐free amphilimus‐eluting stents versus everolimus‐eluting stents with durable polymer in patients with diabetes mellitus

Patients with diabetes mellitus (DM) remain at high risk for stent restenosis and adverse cardiovascular events in the drug‐eluting stent era. The amphilimus‐eluting stent (AES) is a third generation reservoir‐based polymer‐free drug‐eluting stent that has shown promising preliminary results in patients with DM. It has been suggested that the formulation of the drug with fatty acids could not only modulate the drug release in a timely manner but also achieve convenient levels of drug concentration in diabetic cardiac cells. The aim of this trial is to assess the efficacy of the AES in patients with DM compared with the cobalt chromium everolimus‐eluting stent with non‐erodible polymer (EES).

In Vivo Evaluation of the Synergic Effect of Metformin and mTOR Inhibitors on the Endothelial Healing of Drug-eluting Stents in Diabetic Patients

INTRODUCTION AND OBJECTIVES Recent animal studies have shown metformin (MF) to impair endothelialization of drug-eluting stents (DES). The aim of this study was to evaluate the effect of MF on the healing of DES in human coronary arteries of patients with diabetes mellitus by optical coherence tomography (OCT). METHODS The RESERVOIR trial randomized 116 lesions in 112 patients with diabetes mellitus to amphilimus- or everolimus-eluting stents and included mandatory OCT at 9 months of follow-up. Patients were divided in 3 groups according to the glucose-lowering agents received: a) no MF; b) MF in noninsulin treated patients, and c) MF in insulin-treated patients. The primary safety endpoint was the rate of uncovered stents. RESULTS Seventeen patients with 19 lesions did not receive MF, whereas MF was administered to 53 noninsulin treated patients (54 lesions) and 28 insulin-treated patients (28 lesions). Baseline characteristics were comparable, although noninsulin treated patients who received MF had better glycemic control (P < .01). By OCT, rates of uncovered struts were comparable between groups (3.07±4.80% vs 2.23±4.73% vs 3.43±6.69%, respectively; P = .48). Multivariate models confirmed that MF had no effect on the healing of DES (OR, 1.49, 95%CI, 0.71-3.08; P = .29). Similarly, quantitative angiography showed no effect of MF on late lumen loss, whereas patients treated with exogenous insulin had greater late lumen loss (P = .02). CONCLUSIONS Metformin use does not impair endothelial healing of DES in patients with both insulin- and noninsulin-treated diabetes mellitus. According to these results, MF should not be discouraged in these patients.

Thrombocytopenia after transcatheter aortic valve implantation. A comparison between balloon-expandable and self-expanding valves

Thrombocytopenia after transcatheter aortic valve implantation (TAVI) is common and has been related to higher mortality and major complications. No comparison between balloon‐expandable (BEV) and self‐expanding valves (SEV) regarding drop platelet count (DPC) has been reported to date. The objectives of this study were to analyze the differences in DPC between BEVs or SEVs and their prognostic implications in clinical outcomes.

RED BLOOD CELL TRANSFUSION INCREASES PLATELET REACTIVITY IRRESPECTIVE OF ANTIPLATELET THERAPY

background: Red blood cell (RBC) transfusion is an independent risk factor of ischemic events, including mortality, in patients with an acute coronary syndrome. It has been reported that RBC transfusion enhances platelet activation and aggregation in vitro in healthy volunteers. The aim of the present investigation was to evaluate ex vivo if RBC transfusion increases platelet activation in patients with and without antiplatelet therapy.