The effect of a Prasugrel- vs. a Ticagrelor-based strategy on total ischaemic and bleeding events in patients with acute coronary syndromes.

AIMS: The effect of a prasugrel vs. a ticagrelor based strategy on total (including both first and recurrent) ischaemic and bleeding events in patients with acute coronary syndromes (ACS) has not been evaluated. The aim of this analysis was to investigate the treatment effect of a prasugrel vs. a ticagrelor based strategy in patients with ACS undergoing an invasive management strategy when both first and recurrent non-fatal ischaemic and bleeding events are taken into account. METHODS AND RESULTS: This is a post-hoc analysis of the ISAR-REACT 5 randomized control trial, including all 4018 patients in the trial. The main clinical endpoints of interest included ischaemic events [myocardial infarction (MI) and stroke] and bleeding events [Bleeding Academic Research Consortium (BARC) type 3 to 5 bleeding]. An additional endpoint of interest was definite/probable stent thrombosis. The effect of the prasugrel vs. ticagrelor based strategies on these endpoints was evaluated on both time-to-first event and total events analyses. Patients in the prasugrel group had a lower risk of MI in comparison to the ticagrelor group on both time-to-first event [hazard ratio (HR) = 0.61; 95% confidence interval 0.44-0.85] and total events [HR = 0.62 (0.45-0.86)] analysis. The risk of BARC type 3 to 5 bleeding was comparable between the prasugrel and ticagrelor groups on both time-to-first event [HR = 0.96 (0.75-1.25)] and total events [HR = 0.99 (0.76-1.31)] analysis. CONCLUSION: A prasugrel based strategy was associated with a reduction in total MI events in comparison to a ticagrelor based strategy in patients with ACS undergoing invasive assessment. Total BARC type 3 to 5 bleeding events were comparable between the two groups. Given the importance of this topic, future studies to confirm these findings would be welcome. ClinicalTrials.gov identifier: NCT01944800.

Six-month clinical and angiographic results of a dedicated drug-eluting stent for the treatment of coronary bifurcation narrowings.

Percutaneous intervention for coronary bifurcation lesions has been associated with increased clinical complication rates compared with nonbifurcation lesions, primarily as a result of restenosis. Therefore, there is a need for new techniques. The purpose of this study was to evaluate a new drug-eluting stent and implantation technique for the treatment of de novo coronary bifurcation lesions. The Axxess Plus trial was a prospective multicenter single-arm study that enrolled 139 patients. Each patient received a self-expanding, conically shaped nickel-titanium Axxess Plus biolimus A9-eluting stent at the level of the carina. Depending on the lesion anatomy, additional nonstudy stents were placed distally if necessary. Clinical and angiographic follow-up were scheduled at 6 months after the procedure. The overall rate of target lesion revascularization was 7.5% at 6 months. A mean of 2.4 stents were implanted per patient; 51.2% of patients received a stent to the side branch, 29.4% received balloon angioplasty only, and 20.6% of side branches were not treated. In-stent late loss in the Axxess stents was 0.09 mm. Incidences of angiographic in-stent restenosis were 7.1% in the parent vessel stents and 9.2% in the group receiving stents in the side branch (7.9% excluding bare metal stents placed distal to the Axxess stent), compared with 25% for balloon angioplasty treatment and 12% for no treatment. Late stent thrombosis was observed in 3 cases, 2 of which were associated with confirmed premature cessation of antiplatelet therapy. In conclusion, the Axxess Plus conical stent effectively treats bifurcation lesions alone or in conjunction with other drug-eluting stents.

Percutaneous Coronary Intervention of Chronic Total Occlusions in Patients With Low Left Ventricular Ejection Fraction.

OBJECTIVES: The study sought to assess the outcome of percutaneous coronary intervention (PCI) of chronic total occlusions (CTOs) in patients with low left ventricular ejection fraction (LVEF) (≤35%). BACKGROUND: Data regarding the outcome of PCI in patients with low LVEF affected by CTO are scarcely reported. METHODS: The authors performed a prospective longitudinal multicenter study including consecutive patients undergoing elective PCI of CTOs. Patients were subdivided into 3 groups: group 1 (LVEF ≥50%), group 2 (LVEF 35% to 50%), and group 3 (LVEF ≤35%). RESULTS: A total of 839 patients (mean 64.6 ± 10.5 years of age, 87.7% men) underwent CTO PCI attempts. Baseline LVEF ≤35% was present in 72 (8.6%) patients. The angiographic success was high (overall 93.6%) and similar among the 3 groups (93.5% vs. 94.4% vs. 91.7%, respectively; all p = NS). In group 3, no periprocedural complications of CTO PCI were observed. Mean clinical follow-up of 16.3 ± 8.2 months duration was available in 781 (93.1%) patients including those with LVEF ≤35%. At 2 years, major cardiac and cerebrovascular events (MACCE) free survival was similar in the 3 groups (86% vs. 82.8% vs. 75.2%; all p = NS). In patients with LVEF ≤35%, LVEF improved significantly in the presence of a successful CTO PCI from 29.1 ± 3.4% to 41.6 ± 7.9% (p < 0.001). CONCLUSIONS: In CTO patients with low LVEF, PCI could represent a safe and effective revascularization strategy achieving good midterm outcome and LVEF improvement.

Complex interventional procedures for the management of early postoperative left main coronary artery embolism after bioprosthetic aortic valve insertion.

The incidence of calcified debris coronary embolism after aortic valve replacement (AVR) with a bioprosthesis is a rare but potentially life-threatening condition. We sought to describe a case of immediate postoperative left main coronary artery embolism, resulting to severe acute coronary syndrome and cardiogenic shock, after aortic valve surgery due to severe aortic valve stenosis, with the use of bioprosthesis. Complex interventional procedures and possible diagnostic challenges are being described.

Analysis of bifurcation lesions treated with novel drug-eluting dedicated bifurcation stent system: intravascular ultrasound results of the AXXESS PLUS trial.

OBJECTIVE: The aim of this intravascular ultrasound (IVUS) study was to assess the efficacy of the AXXESS Plus stent system for the treatment of bifurcation coronary lesions. BACKGROUND: The AXXESS Plus is a novel bifurcation drug-eluting stent, comprised of a self-expanding flare-shaped stent platform and bioabsorbable polymer coating that releases Biolimus A9. METHODS: Data were obtained from the AXXESS PLUS trial, a prospective, multicenter, nonrandomized, single-arm study to evaluate safety and efficacy. Six-month follow-up IVUS analysis was available in 49 cases. Volumetric analysis using Simpson's method within the AXXESS stent, and cross-sectional analysis at the ostium of main branch and/or side branch was performed. Impact of bifurcation angle on stent expansion at the carina was also evaluated. RESULTS: Within the AXXESS stent, neointimal volume obstruction percentage was 2.3% +/- 2.2%, with a minimum lumen area of 7.9 +/- 2.6 mm(2). Lumen area was 5.2 +/- 1.7 mm(2) at main branch ostium, and 4.0 +/- 1.5 mm(2) at side branch ostium. In two cases, incomplete stent apposition was observed at the proximal edge of the AXXESS stent. In one case, a gap between the AXXESS stent and an additional stent was observed. Greater bifurcation angle inversely correlated with smaller stent area at side branch ostium (r = -0.54, P = 0.03) but not at main branch ostium (r = -0.2, P = 0.29). CONCLUSIONS: This novel self-expanding, drug-eluting bifurcation stent demonstrated effective lesion coverage along with significant neointimal suppression equivalent to current generation balloon-expandable drug-eluting stent technology.