Seif El-Jack

Primary endpoint results of the EVOLVE trial: a randomized evaluation of a novel bioabsorbable polymer-coated, everolimus-eluting coronary stent.

OBJECTIVES This study sought to compare the safety and efficacy of 2 dose formulations of SYNERGY, a novel bioabsorbable polymer everolimus-eluting stent (EES) (Boston Scientific Corp., Natick, Massachusetts) compared with the durable polymer PROMUS Element EES (Boston Scientific Corp.). BACKGROUND Durable polymer coatings on drug-eluting stents have been associated with chronic inflammation and impaired healing. Bioabsorbable polymer-coated drug-delivery systems may reduce the risk of late adverse events, including stent thrombosis, and thus the need for prolonged dual-antiplatelet therapy. METHODS A total of 291 patients with a de novo lesion ≤28 mm in length, in a coronary artery of ≥2.25 to ≤3.5 mm diameter, were enrolled in the EVOLVE study, a prospective, randomized, single-blind, noninferiority trial. Patients were randomly assigned in a 1:1:1 ratio to PROMUS Element, SYNERGY, or SYNERGY half dose. The primary clinical endpoint was the 30-day rate of target lesion failure, defined as cardiac death or myocardial infarction related to the target vessel, or target lesion revascularization. The primary angiographic endpoint was 6-month in-stent late loss measured by quantitative coronary angiography. RESULTS The 30-day primary clinical endpoint of target lesion failure occurred in 0%, 1.1%, and 3.1% of patients in the PROMUS Element, SYNERGY, and SYNERGY half dose groups, respectively. The 6-month in-stent late loss was 0.15 ± 0.34 mm for PROMUS Element, 0.10 ± 0.25 mm for SYNERGY, and 0.13 ± 0.26 mm for SYNERGY half dose (SYNERGY, difference -0.06, upper 95.2% confidence limit: 0.02, p for noninferiority <0.001; SYNERGY half dose, difference -0.03, upper 95.2% confidence limit: 0.05, p for noninferiority <0.001). Clinical event rates remained low and comparable between groups, with no stent thromboses in any group at 6 months. CONCLUSIONS The EVOLVE trial confirms the effective delivery of everolimus by a unique directional bioabsorbable polymer system utilizing the SYNERGY stent. (A Prospective Randomized Multicenter Single-Blind Noninferiority Trial to Assess the Safety and Performance of the Evolution Everolimus-Eluting Monorail Coronary Stent System [Evolution Stent System] for the Treatment of a De Novo Atherosclerotic Lesion [EVOLVE]; NCT01135225).

PLATINUM QCA: a prospective, multicentre study assessing clinical, angiographic, and intravascular ultrasound outcomes with the novel platinum chromium thin-strut PROMUS Element everolimus-eluting stent in de novo coronary stenoses

AIMS Assess clinical, angiographic, and intravascular ultrasound results in lesions treated with the PROMUS Element platinum chromium everolimus-eluting stent (EES). METHODS AND RESULTS Patients (N=100) with one de novo target lesion ≤ 34 mm long and reference vessel diameter (RVD) ≥ 2.25-≤ 4.25 mm were enrolled at 14 sites. The primary endpoint was the 30-day composite of cardiac death, myocardial infarction, target lesion revascularisation (TLR), or definite/probable stent thrombosis (ST). The efficacy endpoint of 9 month in-stent late loss in workhorse lesions (defined as RVD ≥ 2.5-≤ 4.25 mm, lesion ≤ 24 mm) was compared to a performance goal based on historical results with TAXUS Express paclitaxel-eluting stents. Post-procedure incomplete stent apposition (ISA) was compared to a performance goal based on results with the PROMUS/XIENCE V EES in SPIRIT III. Mean age was 61.8 ± 9.9 years; 77.0% were male; 19% had medically treated diabetes. Baseline RVD was 2.72 ± 0.53 mm; lesion length was 15.4 ± 7.0 mm. The primary endpoint occurred in one patient (periprocedural ST with TLR) with no additional major clinical events through one year. Nine-month in-stent late loss in workhorse lesions (0.17 ± 0.25 mm, N=73) and post-procedure ISA (5.7%, 5/88) were below performance goals (p<0.001). CONCLUSIONS Through one year, PROMUS Element EES had an acceptable safety and efficacy profile with low in-stent late loss and post-procedure ISA.

Repeat Percutaneous Treatment of a Large Vein Graft Aneurysm with Covered Stents

We present a case of repeat percutaneous intervention on a coronary artery bypass vein graft using polytetrafluoroethylene (PTFE) covered stents. The original intervention was performed using a combination of PTFE covered stents and bare metal stents for a large vein graft aneurysm. Successful exclusion of the aneurysm was demonstrated on follow up angiography. The patient represented six years after the original intervention with a non ST-segment elevation myocardial infarction. Further angiography demonstrated a recurrence of the aneurysm which we presumed to be due to late malapposition and required repeat PTFE covered stent deployment.

Primary Cardiac Angiosarcoma: Morphologically Deceptive Benign Appearance and Potential Pitfalls in Diagnosis

Cardiac angiosarcoma is the most common malignant primary cardiac tumour. We report a case of cardiac angiosarcoma with recurrent complex pericardial effusion. Histological diagnosis was elusive underscoring the potential difficulty in differentiating this tumour from normal vascular endothelium.

Glycoprotein IIb/III inhibition during acute percutaneous coronary intervention: tool or talisman?

Glycoprotein IIb/IIIa receptor inhibitors (GPI) are a class of antiplatelet agents variably used in the treatment of acute coronary syndromes (ACS) and in high‐risk acute percutaneous coronary intervention (PCI). The three generic GPI (abciximab, eptafibatide, and tirofiban) have differing pharmacologic properties but their efficacy has, largely, rightly or wrongly, been considered a class effect. In this issue of JOIC, Song and co‐workers present an open‐label randomized study of the upstream administration of high bolus tirofiban in acute ST segment elevation myocardial infarction (STEMI) patients scheduled for primary percutaneous intervention (PCI) versus a deferred strategy of its use in select patients with a large thrombus burden or slow flow during PCI. They compare individual and composite traditional end‐points of death, MI, stent thrombosis (ST), and target vessel revascularization (TVR) at 7 days, 1 month, and 6 months. The safety end‐points comprised TIMI major and minor bleeding at 7 days. They also report left ventricular ejection fraction (LVEF) at 7 days. There was no significant difference in TIMI flow before or after PCI between the 2 groups and no difference in individual clinical outcome end‐points at the prespecified times though the composite end‐point was less in the upstream tirofiban group at 7 days and 1 month but not at 6 months (1.5% vs 4.2%, P1⁄4 0.037; 3.3% vs 7.0%, P1⁄4 0.034; and 7.0% vs 10.3%, P1⁄4NS, respectively). There was a trend toward more TIMI major and minor bleeding in the upstream group (4.5% vs 2.4%, P1⁄4NS). In 89% of patients with echocardiographic assessment, LVEFwasmarginally higher in the upstream tirofiban group at 7 days, an increase of 3.5% versus 1.9% to baseline. There are several limitations in this study, some of which are acknowledged by the authors. As per their local hospital protocol at the time (2008–2010), patients were loaded with 300mg of clopidogrel rather than 600mg and those on tirofiban received a longer than usual 24–36 hour infusion. All patients received a nonconventional regimen of 86 IU/kg twice daily of lowmolecular weight heparin for 5 days post‐PCI. This will limit extrapolation of their results into more standard practice. Heparin dosing was adjusted for a target ACT of 200–250 seconds for the upstream tirofiban group and 250–350 seconds for the deferred cohort. This, together with the predominant use of the radial access (86% of procedures), may have contributed to the low rate of bleeding in both groups, potentially with more reduction in the upstream tirofiban group. The limited use of thrombus aspiration (25% of cases) may exaggerate the benefit of tirofiban. The lack of a difference in TIMI flow before and after PCI in both groups together with the lack of difference in individual clinical end‐points (despite the positive trends), makes the apparent difference in the composite end‐point somewhat difficult to apply in clinical practice, particularly that this composite end‐point difference was only maintained at 1 month but not 6 months. The 7‐day outcome measure is probably too short for these end‐points. Finally, an absolute 1.6% Address for reprints: Seif El‐Jack, CardioVascular Unit, North Shore Hospital, Auckland, New Zealand. Fax: þ6494868963; e‐mail: seif. eljack@waitematadhb.govt.nz

BIOENGINEERING SILICON QUANTUM DOT THERANOSTICS USING A NETWORK ANALYSIS OF METABOLOMIC AND PROTEOMIC DATA IN CARDIAC ISCHAEMIA

The aim of this study was to discover biomarkers of ischemic preconditioning using metabolomics and translate these into nanotheranostics. 33 patients underwent angioplasty after myocardial infarction. Blood was sampled from the coronary sinus, aorta and femoral vein before and 20 minutes from one