Search

Objectives The authors sought to evaluate the relative performance of a drug-eluting balloon (DEB) and a drug-eluting stent (DES) in patients with any (bare-metal or drug-eluting stent) in-stent restenosis (ISR). Background The treatment of ISR remains challenging in contemporary clinical practice. Methods In a multicenter randomized noninferiority trial, patients with any ISR were randomly allocated in a 1:1 fashion to treatment with a DEB (SeQuent Please paclitaxel-eluting balloon, B. Braun Melsungen, Melsungen, Germany), or a DES (XIENCE everolimus-eluting stent, Abbott Vascular, Santa Clara, California). The primary endpoint was noninferiority in terms of in-segment minimal lumen diameter (MLD) at 6-month angiographic follow-up. Secondary endpoints included angiographic parameters at 6 months and clinical follow-up up to 12 months. Results A total of 278 patients, of whom 56% had DES-ISR, were randomized at 8 sites to treatment with DEB (n = 141) or DES (n = 137). As compared with DEB, DES was associated with larger MLD and lower % stenosis immediately post-procedure (1.84 ± 0.46 vs. 1.72 ± 0.35; p = 0.018; and 26 ± 10% vs. 30 ± 10%; p = 0.03). Angiographic follow up was completed at 196 ± 53 days in 79% of patients. With respect to the primary endpoint of in-segment MLD at 6 months, DEB was noninferior to DES (DEB 1.71 ± 0.51 mm vs. DES 1.74 ± 0.61 mm; p for noninferiority <0.0001). Target vessel revascularization at 12-month follow-up was similar in both groups (DES 7.1% vs. DEB 8.8%; p = 0.65). Conclusions In patients with ISR, treatment with DEB was noninferior compared with DES in terms of 6-month MLD. There were no differences in clinical endpoints, including target vessel revascularization up to 12 months. Therefore, use of a DEB is an attractive treatment option for in-stent restenosis, withholding the need for additional stent implantation. [ABSTRACT FROM AUTHOR]

Aims: Mortality in cardiogenic shock patients remains high. Short-term mechanical circulatory support with Impella can be used to support the circulation in these patients, but data from randomised controlled studies and 'real-world' data are sparse. The aim is to describe real-life data on outcomes and complications of our 12 years of clinical experience with Impella in patients with cardiogenic shock after acute myocardial infarction and to identify predictors of 6-month mortality., Methods: We describe a single-centre registry from October 2004 to December 2016 including all patients treated with Impella for cardiogenic shock after acute myocardial infarction. We report outcomes and complications and identify predictors of 6-month mortality., Results: Our overall clinical experience consists of 250 patients treated with Impella 2.5, Impella CP or Impella 5.0. A total of 172 patients received Impella therapy for cardiogenic shock, of which 112 patients had cardiogenic shock after acute myocardial infarction. The mean age was 60.1±10.6 years, mean arterial pressure was 67 (56-77) mmHg, lactate was 6.2 (3.6-9.7) mmol/L, 87.5% were mechanically ventilated and 59.6% had a cardiac arrest before Impella placement. Overall 30-day mortality was 56.2% and 6-month mortality was 60.7%. Complications consisted of device-related vascular complications (17.0%), non-device-related bleeding (12.5%), haemolysis (7.1%) and stroke (3.6%). In a multivariate analysis, pH before Impella placement is a predictor of 6-month mortality., Conclusions: Our registry shows that Impella treatment in cardiogenic shock after acute myocardial infarction is feasible, although mortality rates remain high and complications occur.

Background: To improve clinical outcomes after percutaneous coronary interventions of coronary bifurcation lesions, the Tryton Side Branch Stent™ (Tryton Medical, Durham) was developed. Registry studies evaluating the Tryton stent has shown promisingclinical results and the stent is currently compared with the provisional single stent strategy in a randomized trial. However, clinical results beyond one year are lacking, and therefore, we investigated the one- and two-year outcomes after Tryton stent placement in a single-center registry study., Methods and Results: All patients in our center in whom Tryton placement was attempted between October 2010 and December 2011 were included. Clinical outcomes were defined as cardiac death, any myocardial infarction (MI), target vessel revascularization (TVR), target lesion revascularization (TLR), stent thrombosis (ST), and target vessel failure (TVF; composite of cardiac death, MI, and TVR). Event rates were estimated using the Kaplan-Meier method. We included 91 patients. Almost half (42%) of the patients included had acute coronary syndrome (ACS) as indication for PCI (12% unstable angina, 14% NSTEMI, and 16% STEMI). Median follow-up duration was 713 days (IQR 617-840). TVF rates were 14.5% (one year) and 20.3% (two year). Two-year cardiac death, MI, TVR, TLR and ST rates were 4.4%, 10.2%, 12.7%, 9.2%, and 2.2%, respectively., Conclusions: In this single-center registry, use of the Tryton stent was associated with acceptable clinical outcomes at two-year follow-up.