Jason Nogic

Novel bioabsorbable polymer and polymer-free metallic drug-eluting stents.

The introduction of drug-eluting stents (DES) significantly reduced angiographic restenosis and the clinical need for revascularization following percutaneous coronary intervention. However, concerns remain regarding the long-term safety and efficacy of DES. The use of durable polymers for drug elution that have limited biocompatibility is thought to contribute toward DES failure, by promoting an adverse local inflammatory response and vascular toxicity. Biodegradable polymer and polymer-free metallic stents represent two novel technological solutions to this challenging clinical problem. This review summarizes the available clinical evidence supporting the use of either biodegradable polymer or polymer-free DES platforms.

The utility of personal activity trackers (Fitbit Charge 2) on exercise capacity in patients post acute coronary syndrome [UP-STEP ACS Trial]: a randomised controlled trial protocol

BackgroundThe benefits of physical activity and cardiovascular rehabilitation on the reduction of cardiovascular risk are well documented. Despite this, significant barriers and challenges remain in optimizing patient risk factors post acute coronary syndromes (ACS) and ensuring patient compliance. Consumer wearable personal activity trackers represent a cost effective and readily available technology that may aid in this endeavour.MethodsUP-STEP ACS is a prospective single-blinded, two-arm, parallel, randomized control trial with an aim to enrol 200 patients all undertaking cardiac rehabilitation. It will assess the affect that personal activity monitors have on change in exercise capacity in patients post acute coronary syndromes primarily measured by a six-minute walk test (6MWT). Secondary end points will be the improvement in other cardiovascular risk factors, namely; blood lipid and glucose levels, weight, waist circumference, along with mood, quality of life and cardiac rehabilitation adherence. Patients will be randomized to either receive a personal activity tracker or standard post hospital care during their index event. After the 8- week intervention period, patients will return for a clinical review and repeat of baseline assessments including the 6MWT.DiscussionThe utility and impact on exercise capacity of personal activity trackers in patient’s post-acute coronary syndrome has not been assessed. This study aims to add to the scientific evidence emerging regarding the clinical utility and validity of these devices in different patient population groups. If proven to be of benefit, these devices represent a cost effective, easily accessible technology that could aid in the reduction of cardiovascular events.Trial registrationThe trial has been registered with the Australian New Zealand Clinical Trials Registry (ANZCTR). The registration number is ACTRN12617000312347 (28/02/2017).

Polymer-free versus permanent polymer-coated drug eluting stents for the treatment of coronary artery disease: A meta-analysis of randomized trials

BACKGROUND Polymer-free drug eluting stents (PF-DES) were developed, in part, to overcome risk of late ischemic events observed with permanent polymer-coated DES (PP-DES). However, trial results are inconsistent with longer-term safety and efficacy of PF-DES remaining unknown. We performed a meta-analysis of randomized trials assessing outcomes of patients receiving PF-DES versus PP-DES for treatment of coronary artery disease (CAD). METHODS Electronic searches were performed for randomized trials comparing outcomes between PF-DES and PP-DES. Trials reporting major adverse cardiovascular events (MACE), myocardial infarction (MI), stent thrombosis (ST), all-cause death, target lesion/vessel revascularization (TLR/TVR), and late lumen loss (LLL) were included. Analyses were performed at longest follow-up and landmarked beyond 1-year. RESULTS Twelve trials (6,943 patients) were included. There was no significant difference in MACE between PF-DES and PP-DES at longest follow-up (Odds Ratio [OR] 0.96, 95%CI 0.85-1.10, P = 0.59) or landmark analysis beyond 1-year (OR 0.96, 95%CI 0.76-1.20, P = 0.70). Although PF-DES were associated with a significant reduction in all-cause death (OR 0.85, 95%CI 0.72-1.00, P < 0.05), this effect was not present on landmark analysis beyond 1-year (OR 0.89, 95%CI 0.73-1.10, P = 0.30). There were no differences observed for MI (OR 1.00, 95%CI 0.77-1.28, P = 0.99) or ST (OR 0.95, 95%CI 0.54-1.68, P = 0.86), with similar efficacy outcomes including TVR (OR 1.07, 95%CI 0.91-1.26, P = 0.42), TLR (OR 1.03, 95%CI 0.88-1.21, P = 0.68) and angiographic LLL (pooled mean difference 0.01 mm, 95%CI -0.08 to 0.11, P = 0.76). CONCLUSIONS PF-DES are as safe and efficacious as PP-DES for the treatment of patients with CAD, but do not significantly reduce late ischemic complications.

Drug eluting versus bare metal stents for percutaneous coronary intervention of saphenous vein graft lesions: An updated meta-analysis of randomized controlled trials

BACKGROUND/PURPOSE Percutaneous coronary intervention (PCI) is the preferred strategy for treatment of saphenous vein graft (SVG) disease. However, there remains ongoing debate on whether drug-eluting stents (DES) or bare-metal stents (BMS) should be used during SVG-PCI. METHODS/MATERIALS We performed a meta-analysis of randomized controlled trials (RCTs) comparing DES and BMS for SVG-PCI. The primary end point was major adverse cardiac events (MACE), defined as composite of all-cause death, myocardial infarction (MI) or repeat revascularization. Secondary end points included individual MACE components, cardiac death and stent thrombosis (ST). RESULTS Six RCTs including 1582 patients (50% receiving DES) met inclusion criteria. MACE occurred in 31% (244/797) patients receiving DES and 36% (281/785) patients receiving BMS (median follow-up, 12-35 months). There was no significant difference in MACE between DES and BMS (Odds Ratio (OR) 0.62, 95%CI 0.36-1.09, p = 0.10, I2 = 77%). However, for individual components of MACE, DES was associated with a significant reduction in repeat revascularization (OR 0.53, 95%CI 0.29-0.97, p = 0.04, I2 = 73%). There was no difference in all-cause death (OR 1.30, 95%CI 0.77-2.20, p = 0.33, I2 = 40%), MI (OR 0.68, 95%CI 0.38-1.25, p = 0.22, I2 = 56%), cardiac death (OR 1.08, 95%CI 0.45-2.64, p = 0.86, I2 = 42%) or ST (OR 0.89, 95%CI 0.37-2.17, p = 0.80, I2 = 35%) between stents. CONCLUSIONS Although there was no significant difference in MACE, DES is associated with a reduction in repeat revascularization compared with BMS in pooled randomized trials for SVG-PCI. The high occurrence of MACE in both stent platforms highlights the need for novel therapeutic approaches to improve clinical outcomes following SVG intervention. SUMMARY We performed a meta-analysis of randomized controlled trials comparing DES and BMS for SVG-PCI. There was no significant difference in MACE between DES and BMS. However, for individual components of MACE, DES was associated with a significant reduction in repeat revascularization. The high occurrence of MACE in both stent platforms highlights the need for novel therapeutic approaches to improve clinical outcomes following SVG intervention.

TCT-812 Long Term Clinical and Echocardiographic Outcomes following Percutaneous Transluminal Septal Myocardial Ablation for Hypertrophic Obstructive Cardiomyopathy: a 16 Year Single-Centre Australian Experience

Percutaneous Transluminal Septal Myocardial Ablation (PTSMA) is a recognized option for the relief of symptoms in patients with HOCM. However, data are limited regarding long-term procedural safety & efficacy. We report long-term clinical & echocardiographic outcomes in patients undergoing PTSMA in