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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]

Even in the era of primary percutaneous coronary intervention (PCI) in patients with ST-segment elevation myocardial infarction (STEMI) complicated by cardiogenic shock (CS), mortality remains high. Whether admission hemoglobin (Hb) concentration is a predictor of mortality in patients with CS treated with primary PCI is unexplored. We assessed the relation between admission Hb concentration and 1-year mortality in patients with STEMI and CS who were treated with PCI at admission. We investigated a cohort of 265 patients with STEMI with CS on admission. Patients were categorized in 3 groups according to plasma Hb levels at admission: 9.6 g/dl (group I, n = 22), 9.6 to 12 g/dl (group II, n = 59), and >12 g/dl (group III, n = 184). All-cause mortality at 1 year was 64%, 46%, and 35% for groups I, II, and III, respectively (p = 0.007). Multivariate logistic regression analysis showed that the odds for mortality increased 17% for every 1.0 g/dl decrease in plasma Hb (odds ratio 1.17, 95% confidence interval 1.01 to 1.35, p = 0.042). In conclusion, admission Hb concentration is an independent predictor for 1-year mortality in patients with STEMI undergoing primary PCI. [Copyright &y& Elsevier]

Despite early revascularization, mortality remains high in patients with ST-segment elevation myocardial infarction (STEMI) complicated by cardiogenic shock. It has been shown that the effect of multivessel disease (MVD) on mortality in patients with STEMI treated with primary percutaneous coronary intervention is mainly caused by the presence of chronic total occlusion (CTO) in a noninfarct-related coronary artery. Whether this association also exists in patients with STEMI with cardiogenic shock is unknown. In our institution, 292 consecutive patients with STEMI complicated by cardiogenic shock were admitted from 1997 to 2005 and treated with primary percutaneous coronary intervention. Patients were classified as having single vessel disease, MVD without CTO, and CTO. Cox regression analysis was used for multivariate analysis. The 1-year mortality rate of patients with single-vessel disease, MVD, and CTO was 31%, 47%, and 63%, respectively. After adjustment for possible confounders, MVD alone was not an independent predictor of 1-year mortality (hazard ratio 1.5, 95% confidence interval 0.98 to 2.3, p = 0.07). In contrast, CTO in a noninfarct-related artery was an independent predictor of 1-year mortality (hazard ratio 2.1, 95% confidence interval 1.5 to 3.1, p <0.01). In conclusion, the presence of CTO in a non–infarct-related artery was an independent predictor of 1-year mortality. In contrast, MVD alone lost its predictive significance after multivariate analysis. [Copyright &y& Elsevier]

Background: Despite advances in treatment, mortality in acute myocardial infarction (AMI) complicated by cardiogenic shock (CS) remains high. Short-term mechanical circulatory support devices acutely improve hemodynamic conditions.Objectives: The aim of this study was to determine whether a new percutaneous mechanical circulatory support (pMCS) device (Impella CP, Abiomed, Danvers, Massachusetts) decreases 30-day mortality when compared with an intra-aortic balloon pump (IABP) in patients with severe shock complicating AMI.Methods: In a randomized, prospective, open-label, multicenter trial, 48 patients with severe CS complicating AMI were assigned to pMCS (n = 24) or IABP (n = 24). Severe CS was defined as systolic blood pressure <90 mm Hg or the need for inotropic or vasoactive medication and the requirement for mechanical ventilation. The primary endpoint was 30-day all-cause mortality.Results: At 30 days, mortality in patients treated with either IABP or pMCS was similar (50% and 46%, respectively; hazard ratio with pMCS: 0.96; 95% confidence interval: 0.42 to 2.18; p = 0.92). At 6 months, mortality rates for both pMCS and IABP were 50% (hazard ratio: 1.04; 95% confidence interval: 0.47 to 2.32; p = 0.923).Conclusions: In this explorative randomized controlled trial involving mechanically ventilated patients with CS after AMI, routine treatment with pMCS was not associated with reduced 30-day mortality compared with IABP. (IMPRESS in Severe Shock; NTR3450). [ABSTRACT FROM AUTHOR]

Background Current data about the impact of concomitant mitral regurgitation (MR) on outcome in patients who undergo transcatheter aortic valve implantation (TAVI) are conflicting. Our purpose was to analyze the clinical course of MR and to assess the influence of MR on survival and clinical status after TAVI. Methods We included 375 consecutive patients who underwent TAVI. MR grade and NYHA class were determined before TAVI and at follow-up. Results In total 171 patients (46%) had MR grade ≥ 2 at baseline and of these 29% improved to MR grade ≤ 1 after TAVI. MR grade ≤ 1 at baseline was present in 204 patients (54%) and of these 17% worsened to grade ≥ 2 after TAVI. Improvement of MR was associated with absence of atrial fibrillation (OR: 2.35, 95%CI: 1.17–4.71, p = 0.02). Worsening of MR was associated with moderate or more aortic valve regurgitation after TAVI (OR: 4.2, CI: 1.83–9.49, p = 0.001). NYHA class improved at follow-up. Baseline MR grade did not determine the degree of clinical improvement (MR grade ≤ 1: NYHA ≥ 3 from 67% to 17%; MR grade ≥ 2: NYHA ≥ 3 from 69% to 14%). Although patients with MR grade ≥ 2 at baseline improved symptomatically, this degree of MR was associated with reduced two year survival compared with patients with MR grade ≤ 1(mortality 37% vs 26%; HR 1.99; 95% CI 1.27–3.13; p = 0.003). Conclusion In patients who undergo TAVI almost half have MR grade ≥ 2 prior to the procedure. TAVI had no influence on MR grade at follow-up. Although patients with MR grade ≥ 2 at baseline improved symptomatically after TAVI, concomitant MR at baseline significantly reduced two year survival. [ABSTRACT FROM AUTHOR]