Effectiveness of polypill for primary and secondary prevention of cardiovascular disease: a pragmatic cluster-randomised controlled trial (PolyPars).

BACKGROUND: We aimed to investigate the effectiveness of fixed-dose combination therapy (polypill) for primary and secondary prevention of major cardiovascular diseases in a typical rural setting. METHODS: The PolyPars Study is a two-arm pragmatic cluster-randomised trial nested within the PARS cohort study, including all residents aged over 50 years in the entire district in southern Iran. The 91 villages underwent random allocation into two arms: the control arm, encompassing 45 clusters, was subjected to non-pharmacological intervention (educational training on healthy lifestyle), whereas the intervention arm, comprising 46 clusters, received the non-pharmacological interventions in conjunction with a once-daily polypill tablet. This tablet comprised two antihypertensive agents, a statin and aspirin. The primary outcome was the first occurrence of major cardiovascular events defined as a composite of hospitalisation for acute coronary syndrome (non-fatal myocardial infarction and unstable angina), fatal myocardial infarction, non-fatal and fatal stroke, sudden death and heart failure. The Cox regression model, with shared frailty, was used to account for clustering effect. RESULTS: During December 2015-December 2016, a total of 4415 participants aged 50-75 years were recruited (2200 participants in the intervention arm and 2215 participants in the control arm). The overall median of follow-up duration was 4.6 years (interquartile interval 4.4-4.9). The achieved adherence rate to polypill in intervention arm was 86%. In the control group, 176 (8.0%) of 2215 participants developed primary outcome, compared with 88 (4.0%) of 2200 participants in the polypill group. We found substantial reduction in risk of primary outcome both in relative and absolute scales (HR 0.50, 95% CI 0.38 to 0.65; absolute risk reduction 4.0%, 95% CI 2.5% to 5.3%). No difference in serious adverse events was observed between the two groups. CONCLUSIONS: The fixed-dose combination therapy using polypill can safely halve the risk of major cardiovascular diseases at the population level. TRIAL REGISTRATION NUMBER: NCT03459560.

Effect of Tricuspid Valve Repair in Patients with Moderate Tricuspid Regurgitation undergoing Left-Sided Valve Surgery.

BACKGROUND: The benefits of tricuspid valve (TV) repair in patients with moderate tricuspid regurgitation (TR) during left-sided valve surgery are under debate. We investigated independent predictors for reduction in TR severity following left-sided valve surgery in patients with moderate TR. METHODS: In this study, we included 106 patients (male: 33%) with a mean age of 4.23 ± 12.61 years who had moderate TR and underwent mitral or aortic valve surgery between March 2012 and November 2016. Concomitant tricuspid annuloplasty was done for one group of patients based on surgeon's decision. Transthoracic echocardiography was done before and at a median followup of 4.71 months for all patients. The patients were divided into improved and unimproved TR groups, with the term "improved" signifying a reduction of at least one grade in TR severity. RESULTS: Tricuspid annuloplasty was performed on 65 (61.3%) patients. TR improvement was observed in 87.7% of patients in the TV repair group and 56.1% of patients in the no-TV repair group, indicating a significant difference (P < 0.001). Tricuspid annulus diameter was not significantly different between the two groups (32.41 ± 4.68 mm in no-TV repair group and 33.87 ± 4.34 mm in TV repair group, P = 0.128). At follow-up with echocardiography, 80 (75.5%) patients were placed in the improved group and the majority of patients (71.3% vs. 30.8%; P < 0.001) underwent tricuspid repair in the improved group. TV annuloplasty was correlated with reduced TR severity following left-sided valve surgery (odds ratio [OR]: 5.19, 95% CI: 1.70-15.85, P < 0.001). TR changed from moderate to severe in 17 (17.1%) patients with no concomitant tricuspid repair, while only one patient (1.5%) with tricuspid repair showed an increased TR severity. CONCLUSION: Tricuspid annuloplasty may be useful in patients who have moderate TR undergoing left-sided valve surgery regardless of the tricuspid annulus diameter, and it can play an effective role in the improvement of TR at mid-term follow-up.