Effect of collaterals on deaths and re-infarctions in patients with coronary artery disease: a meta-analysis

BACKGROUND: It is generally believed that there is a beneficial effect of collaterals on death and re-infarction statistics in patients with coronary artery disease (CAD) but studies to date are small and inconsistent. OBJECTIVE: To meta-analyse the studies published in this field in order to obtain more powerful information. METHODS: We searched Medline and major journals (2000 to 2011) for studies evaluating the effect of coronary collaterals on mortality. Publication bias, lack of heterogeneity, and lack of robustness were assessed using the standard procedures for such purposes. RESULTS: A total of 10 studies describing mortality, enrolling 6791 participants, were included in this analysis. In patients with collateralisation a significant relation with reduced mortality was seen compared with those without collateralisation, at an odds ratio of 0.47, p < 0.0001, and a reduction in deaths and re-infarctions at 0.54, p < 0.0001. Some publication bias, some heterogeneity and some lack of robustness were demonstrated. A meta-regression with the odds ratios of the presence of traditional atherosclerotic risk factors as predictors and the odds ratios of mortality and the composite deaths and re-infarctions as outcome showed no relationships. CONCLUSIONS: In CAD patients from the post-percutaneous coronary intervention era the presence of collaterals reduced mortality by 0.47 (p < 0.0001) and deaths and re-infarctions by 0.54 (p < 0.0001). Furthermore, in the present meta-data, the atherosclerotic risk factors were no more present in patients with collaterals than they were in those without

Paclitaxel-eluting balloon versus everolimus-eluting stent in patients with diabetes mellitus and in-stent restenosis: Insights from the randomized DARE trial

Objectives: To investigate the relative performance of treatment with a paclitaxel-eluting balloon (PEB) compared with an everolimus-eluting stent (EES) for in-stent restenosis (ISR) in patients with diabetes mellitus (DM). Background: ISR remains a challenge in contemporary clinical practice, particularly in patients with DM. Methods: In the multicenter randomized DARE trial, patients with BMS or DES ISR were randomized in a 1:1 fashion to treatment with a PEB or an EES. Patients underwent angiographic follow-up after 6 months. For the purpose of this analysis, the relative performance of PEB versus EES in diabetic patients was investigated. Results: Of 278 patients enrolled in DARE, 88 (32%) had DM, of whom 46 were randomized to EES and 42 to PEB treatment. Of patients with DM, 48 (55%) had DES-ISR. Angiographic follow-up was available in 30 patients (72%) in the PEB group and 36 patients (78%) in the DES group. There were no differences in terms of 6-months minimal lumen diameter in diabetic patients treated with EES (1.46 ± 0.66 mm) versus PEB (1.78 ± 0.58 mm, P = 0.15). Adverse events at one year follow-up were similar in both groups, with Major Adverse Events (MAE, death, target vessel MI, or TVR) occurring in 17.4% in the EES group versus 11.9% in the PEB group, P = 0.44. Conclusions: In patients with ISR and DM, use of a PEB resulted in similar 6-months in-segment minimal lumen diameter and comparable rates of MAE. In-segment late loss at 6 months was significantly lower in the PEB arm. Although larger trials in DM patients with ISR are necessary, PEB is a promising treatment option obviating the need for additional stent implantation

A Randomized Comparison of Paclitaxel-Eluting Balloon Versus Everolimus-Eluting Stent for the Treatment of Any In-Stent Restenosis The DARE Trial

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. (c) 2018 by the American College of Cardiology Foundatio

Ezetimibe added to statin therapy after acute coronary syndromes

BACKGROUND: Statin therapy reduces low-density lipoprotein (LDL) cholesterol levels and the risk of cardiovascular events, but whether the addition of ezetimibe, a nonstatin drug that reduces intestinal cholesterol absorption, can reduce the rate of cardiovascular events further is not known. METHODS: We conducted a double-blind, randomized trial involving 18,144 patients who had been hospitalized for an acute coronary syndrome within the preceding 10 days and had LDL cholesterol levels of 50 to 100 mg per deciliter (1.3 to 2.6 mmol per liter) if they were receiving lipid-lowering therapy or 50 to 125 mg per deciliter (1.3 to 3.2 mmol per liter) if they were not receiving lipid-lowering therapy. The combination of simvastatin (40 mg) and ezetimibe (10 mg) (simvastatin-ezetimibe) was compared with simvastatin (40 mg) and placebo (simvastatin monotherapy). The primary end point was a composite of cardiovascular death, nonfatal myocardial infarction, unstable angina requiring rehospitalization, coronary revascularization ( 6530 days after randomization), or nonfatal stroke. The median follow-up was 6 years. RESULTS: The median time-weighted average LDL cholesterol level during the study was 53.7 mg per deciliter (1.4 mmol per liter) in the simvastatin-ezetimibe group, as compared with 69.5 mg per deciliter (1.8 mmol per liter) in the simvastatin-monotherapy group (P<0.001). The Kaplan-Meier event rate for the primary end point at 7 years was 32.7% in the simvastatin-ezetimibe group, as compared with 34.7% in the simvastatin-monotherapy group (absolute risk difference, 2.0 percentage points; hazard ratio, 0.936; 95% confidence interval, 0.89 to 0.99; P = 0.016). Rates of pre-specified muscle, gallbladder, and hepatic adverse effects and cancer were similar in the two groups. CONCLUSIONS: When added to statin therapy, ezetimibe resulted in incremental lowering of LDL cholesterol levels and improved cardiovascular outcomes. Moreover, lowering LDL cholesterol to levels below previous targets provided additional benefit