Clinical trials and regulatory science in cardiology最新文献

Background

Albeit DES might be considered as a breakthrough against neointimal hyperplasia, concerns on stent thrombosis and increase incidence of in-stent restenosis after multiple DES implantations in complex, long lesions still exist. Hereby, we tried to test efficacy and safety of using PEB in long lesions followed by focal BMS implantation in a pilot multicenter study.

Methods

This study enrolled 16 patients with long lesions (> 30 mm) that were treated with PEB angioplasty followed by focal stenting with BMS. IVUS was performed before, after PEB and post stenting. Clinical and angiographic follow-up was done at 6 months. The primary end-point was angiographic late lumen loss.

Results

Patient age was 64.6 ± 8.1 years, 15 (93.7%) were males, and 7 (43.7%) diabetics. Target vessels were most commonly the left anterior descending (6 [31.6%]) and the right coronary artery (6 [31.6%]). PEB diameter was 2.8 ± 0.4 mm with a 31.3 ± 8.9 mm length. Stents per patient were 2.1 ± 0.8. No overlapping stents were deployed. Angiographic success was achieved in 100% of patients. Peri-procedural myocardial infarction occurred in 4 patients (25%). At 6 months follow-up angiography, MLD was 1.55 ± 0.53 mm with a late loss of 0.48 ± 0.52 mm, a binary re-stenosis rate of 2 (12.5%).

Conclusion

Using PEB with focal stenting by BMS proved to be a feasible, safe, and promising strategy in long coronary lesions. However larger study are needed to confirm these data.

Background

Vaccinia based immunizations have caused myo/pericarditis and vaccine study volunteers are monitored by ECG. We report ECG outcome obtained during the screening period for an HIV vaccine trial.

Methods

ECG was performed in healthy Tanzanian volunteers. ECG abnormalities and findings interfering with the interpretation of myo/pericarditis were subject to study ineligibility. We determined the prevalence of left ventricular hypertrophy (LVH) defined by the Sokolow-Lyon (SL) or the Cornell index, ST-elevations and early repolarization (ERP) in association with gender, age, BMI and body height by regression analysis adjusted for gender and age.

Results

In 257 volunteers (median age 23 years, 63% males) overall positivity for LVH defined by SL or Cornell criteria was seen in 20.6% and 3.5%, ST-elevations ≥ 0.1 mV or ≥ 0.2 mV in 77.8% and 38.1%, and ERP in 23.4%. Positive SL criteria were associated with male gender (PR 7.84, p < 0.001) and lower age (PR 0.70, p = 0.002), and associated with increased body height and lower BMI in univariate analysis. Positive Cornell criteria were only associated with lower age (PR 0.44, p = 0.010). ST-elevations ≥ 0.2 mV were associated with male gender (PR 8.05, p < 0.001) and lower age (PR 0.81, p = 0.003), and ERP with male gender (PR 2.86, p < 0.001). Vaccine study ineligibility due to ECG findings was concluded in 22.1% of the screening population.

Conclusions

High prevalence of LVH according to SL in association with ST-elevation and ERP is especially found in young and male Africans. ECG variations need to be considered for eligibility criteria in studies investigating potential cardiotoxic agents in Africa.

Background

Vitamin K-antagonists such as warfarin treatment remain the mainstay to prevent thromboembolic events in various conditions. The quality of the treatment is reflected through time in therapeutic (INR) range (TTR) with a threshold at ≥ 70% indicating ‘good quality’; achieving this quality is not trivial. We conducted a randomised controlled trial to assess the impact of decision aiding model on treatment quality in a high quality vitamin K-antagonist treatment setting.

Methods

We investigated if algorithm-suggested warfarin dosing was superior to standard dosing in a high-quality setting involving self-managing warfarin patients. Patients were initially allocated to either algorithm-suggested warfarin dosing or to standard care treatment, and were crossed over after three months. The trial period was a total of six months, and the primary endpoint was TTR; we also investigated a secondary endpoint of log-transformed INR variability.

Results

A total of 191 patients contributed to the main analysis with a mean follow-up time of 140 days; 75% were males and the mean age was 65 years old. The intervention arm achieved a TTR of 81.6, while the placebo arm attained a TTR of 80.9 (difference [intervention arm minus placebo arm]: 0.67 (95% confidence interval − 2.93 to 4.27). The difference in INR variability was 0.30 (0.14 to 0.47), favouring the placebo arm in terms of lower log transformed variability.

Conclusions

We found no difference between the two trial-arms in a high-quality warfarin treatment setup. However in general, the model performed similarly as to routine patient self-management care. (ClinicalTrials.gov number: NCT02705976)

Background

Habitual cocoa consumption has been shown to improve cardiometabolic risk. This study compared the effects of two doses of cocoa on blood pressure and other cardiometabolic risk factors in adults with stage 1 hypertension.

Methods

Randomized, controlled, modified Latin square parallel design to compare effects of two daily doses (i.e., 5 vs. 10 g) of cocoa powder in cocoa-containing products for 8 weeks on cardio-metabolic risk factors in 122 adults (average age 53.6 years; 63 women and 59 men) with stage 1 hypertension on no more than one medication.

Results

Daily cocoa consumption did not improve (p > 0.05) blood pressure, endothelial function, lipid profile, or insulin resistance in analyses of our entire sample. Daily consumption of cocoa, compared to placebo, reduced blood pressure in participants on ACE inhibitors (24-hour SBP: − 3.2 ± 9.3 vs. 3.6 ± 8.5; p = 0.038, 24-hour DBP: − 2.0 ± 5.0 vs. 2.3 ± 5.6 mm Hg; p = 0.023), beta blockers (− 4.6 ± 3.2 vs. 1.8 ± 2.8 mm Hg; p = 0.009) or diuretics (24-hour SBP 5.5 ± 7.4 vs. − 0.6 ± 4.7; p = 0.022); and improved endothelial function (3.1 ± 2.3 vs. − 3.4 ± 7.4%; p = 0.031) in participants on beta blockers. Dose-response on blood pressure was evident in participants on ACE inhibitors, with more benefit from the high dose compared to the low dose.

Conclusions

Including cocoa in the diet of patients with stage 1 hypertension seems to exert differential beneficial effects on cardiometabolic risk factors in certain sub-groups of patients.

Background

Cardiac surgery is one of the most frequently performed surgeries worldwide and its postoperative period is associated with complications. Studies show that massage therapy alone or accompanied by other complementary treatments is beneficial in reducing pain and psychological symptoms.

Objective

The aim of this study was to review the effects of treatment with massage therapy on the symptoms of pain and anxiety reported by patients who underwent heart surgery.

Methods

The electronic databases searched were (from inception to March 2016): MEDLINE, PEDro, Cochrane CENTRAL and EMBASE. In addition, a manual search of the references on the published papers used in the study was performed. These included randomized clinical trials with patients who underwent heart surgery, comparing the postoperative treatment with massage and the usual treatment. Studies that did not provide necessary information were excluded from the meta-analysis. The primary outcome extracted was pain measured by the visual analog scale. The other outcome was anxiety.

Results

A number of 962 records was identified in the database search; 10 randomized clinical trials were included in the systematic review, providing data on 888 individuals. Massage therapy was associated with decreased pain (− 1.52 [95% CI, − 2.2, − 0.84; I2 91%], p < 0.0001) and with lower anxiety in the postoperative period when compared to the control group (− 1.48 [95% CI, − 1.93, − 1.04; I2 0%], p < 0.0001).

Conclusion

Massage therapy might be a useful method to reduce pain and anxiety in patients undergoing cardiac surgery.

Background

Provisional stenting (PS) is effective for great majority of patients with coronary bifurcation lesions. Double kissing (DK) crush approach demonstrated significant reduction of target lesion revascularization (TLR) for patients with more complex bifurcation lesion when compared with PS. Furthermore, DK crush technique was associated with lower rate of composite major adverse cardiac event (MACE), revascularization and stent thrombosis (ST) for patients with unprotected distal left main coronary artery bifurcation lesions (ULMb), compared to culotte stenting approach. The DKCRUSH V trial is designed to elucidate the benefits of DK crush over PS in patients with ULMb.

Study design

DKCRUSH V is a randomized, prospective, multinational clinical trial designed to evaluate the efficacy and safety of DK crush over PS for patients with ULMb. Subjects with Medina 1,1,1 or 0,1,1 ULMb will be randomized in a 1:1 fashion to PS or DK crush. The primary endpoint is target lesion failure (TLF) including target vessel myocardial infarction, cardiac death and TLR. Other endpoints address individual event of primary endpoint, and target vessel revascularization. The safety objective is the ST. Recruitment began in January 2012 and was completed in December 2015; 484 patients were randomized. The trial will continue until at least 56 adjudicated primary endpoints occur.

Conclusions

The DKCRUSH V study is investigating if DK crush approach versus PS will reduce the incidence of TLF in patients with symptomatic ULMb.

Objectives

Trials of remote ischemic pre-conditioning (RIPC) have suggested this intervention reduces complications of percutaneous coronary intervention and coronary by-pass surgery. The aims of this work were to (i) conduct a systematic review and meta-analysis of the effects of RIPC on cardiac and renal damage in patients undertaking elective percutaneous coronary intervention (PCI); (ii) summarize the results in an evidence-based clinical context.

Methods

We conducted a systematic search of published randomized controlled trials of RIPC for elective PCI up until May 1st, 2015. Studies of peri- or post-ischemic conditioning or emergency PCI were excluded.

Results

Nine studies, totalling 1253 patients were included. Compared to control, RIPC groups exhibited reduced peri-procedural myocardial infarction (MI) Odds Ratio (OR) 0.72 (95% CI 0.54 to 0.97, p = 0.03); ST-segment deviation OR 0.42 (95% CI 0.28 to 0.63, p < 0.0001); major adverse cardiac events (MACE) OR 0.41 (95% CI 0.21 to 0.84, p = 0.01); and acute kidney injury (AKI) OR 0.47 (95% CI 0.26 to 0.86, p = 0.01), but not mortality OR 1.00 (95% CI 0.27 to 3.73, p = 1.00).

Conclusions

RIPC is likely to prevent major adverse cardiac and renal events in patients undertaking elective PCI.

Background

Hospital readmissions are costly and potentially avoidable. This study aimed to develop and validate a clinical score to predict early readmission.

Methods and results

Retrospective analysis of prospectively gathered data over a 10-year period of all patients undergoing cardiac surgery at the Buenos Aires Cardiovascular Institute (n = 5148). Thirty-day readmission was defined as all cause readmission. The scoring model was developed in a randomly selected test set (n = 2529) and was validated on other 2567 patients. Its predictive accuracy was compared by their area under the receiver operating characteristic curve (ROC). P = 0.05 was used for all test. The observed overall frequency of 30-day readmission in the entire sample was 11.7%. The final predictive score ranges between 0 and 6 points. The 30-day readmission rate at each score level in the validation set fell within the 95% confidence intervals of the corresponding frequency in the test set. This demonstrates the validity of the predictive model at all levels of the early readmission score. The frequency of early readmission across all levels in the test set ranged between 4.7 and 24.9%. The area under the ROC curve for the score in the test was 0.663 (95% CI 0.631 to 0.695) and was similar to that in the validation set 0.639.

Conclusions

The present study provides a clinical score to predict early readmission after open-heart surgery and validates that score in a comparable population, which can help in planning future interventions to avoid unnecessary readmissions.

Background and objectives

Coronary artery disease is a common health problem. The aim of this study was to evaluate the prognosis impact on mortality of the variation of hemoglobin (Hb) levels during hospitalization time.

Methods

The retrospective observational study included 2640 patients admitted for acute coronary syndrome in a single coronary care unit from May 2004 until June 2013.

The primary endpoint was all cause of death at 1 year of follow up time, and secondary endpoint was all cause of death at 2 years of the follow up time.

Results

Four groups were created according to the quartiles of Hb variation (admission Hb minus lowest Hb value) during the hospitalization time: group 1: ≥ 2.1 g/dL with 627 patients; group 2: > 1.1 and < 2.1 g/dL with 666 patients; group 3: > 0.3 and ≤ 1.1 g/dL with 686 patients and group 4: ≤ 0.3 g/dL with 661 patients.

A total of 84 patients (3.2%) died during the first year of the follow up. More patients died in group 1 and 4 (6.4% vs 3.7% vs 3.7% vs 6.8%, Log-Rank = 0.023). At 2 years of follow-up, the results were similar, with higher mortality in group 4 (7.3% vs 4.3% vs 4.6% vs 9.2%, Log-Rank = 0.003).

Multivariate analysis showed that Hb variation > 1.1 was an independent predictor of mortality (hazard ration = 0309 95% confidence interval, 0.136–0.702; P = 0.005).

Conclusion

The patients with the lower baseline hemoglobin and the variability of Hb highest than 1.1 mg/dL had the worse prognosis with high mortality rate during the follow up time.