Different vascular healing process between bioabsorbable polymer-coated everolimus-eluting stents versus bioresorbable vascular scaffolds via optical coherence tomography and coronary angioscopy (the ENHANCE study: ENdothelial Healing Assessment with Novel Coronary tEchnology).

Recent clinical trials have raised concerns about the safety and efficacy of ABSORB™ bioresorbable vascular scaffolds (BVS). The difference in the vascular healing process between SYNERGY™ bioabsorbable polymer-coated everolimus-eluting stents (BP-EES) and BVS remains unclear. The aim of the ENHANCE study was to compare vascular healing on BP-EES versus BVS by optical coherence tomography (OCT) and coronary angioscopy (CAS) at 4- and 12-month follow-ups. This is a prospective, non-randomized, single center clinical trial. Thirteen eligible patients with multivessel disease were enrolled. BP-EES and BVS were simultaneously implanted in the same patients, but in different coronary vessels. Imaging follow-up with both OCT and CAS was completed in 11 patients at 12 months. Neointimal coverage rates were similar between the two groups based on OCT measurements. The neointimal thickness of BP-EES was significantly thicker at the 12th month than at the 4th month, whereas the neointimal thickness of BVS did not change between the measurements taken at the 4th and 12th month. Existence of intra-stent thrombus was significantly higher in the BVS group, compared to the BP-EES group. On the other hand, CAS revealed that red-thrombi and yellow-plaque were more frequently observed in BVS at 4 months and up to 12-month follow-ups than in BP-EES. These findings suggested that the evidence of instability remained up to 12 months in the vascular healing with BVS, compared to that with BP-EES. Vascular healing of the stented wall was recognized at the very early phase after BP-EES implantation. However, vascular healing with BVS was still incomplete after 12 months.

Individually-tailored multifactorial intervention to reduce falls in the Malaysian Falls Assessment and Intervention Trial (MyFAIT): A randomized controlled trial.

OBJECTIVE: To determine the effectiveness of an individually-tailored multifactorial intervention in reducing falls among at risk older adult fallers in a multi-ethnic, middle-income nation in South-East Asia. DESIGN: Pragmatic, randomized-controlled trial. SETTING: Emergency room, medical outpatient and primary care clinic in a teaching hospital in Kuala Lumpur, Malaysia. PARTICIPANTS: Individuals aged 65 years and above with two or more falls or one injurious fall in the past 12 months. INTERVENTION: Individually-tailored interventions, included a modified Otago exercise programme, HOMEFAST home hazards modification, visual intervention, cardiovascular intervention, medication review and falls education, was compared against a control group involving conventional treatment. PRIMARY AND SECONDARY OUTCOME MEASURES: The primary outcome was any fall recurrence at 12-month follow-up. Secondary outcomes were rate of fall and time to first fall. RESULTS: Two hundred and sixty-eight participants (mean age 75.3 ±7.2 SD years, 67% women) were randomized to multifactorial intervention (n = 134) or convention treatment (n = 134). All participants in the intervention group received medication review and falls education, 92 (68%) were prescribed Otago exercises, 86 (64%) visual intervention, 64 (47%) home hazards modification and 51 (38%) cardiovascular intervention. Fall recurrence did not differ between intervention and control groups at 12-months [Risk Ratio, RR = 1.037 (95% CI 0.613-1.753)]. Rate of fall [RR = 1.155 (95% CI 0.846-1.576], time to first fall [Hazard Ratio, HR = 0.948 (95% CI 0.782-1.522)] and mortality rate [RR = 0.896 (95% CI 0.335-2.400)] did not differ between groups. CONCLUSION: Individually-tailored multifactorial intervention was ineffective as a strategy to reduce falls. Future research efforts are now required to develop culturally-appropriate and affordable methods of addressing this increasingly prominent public health issue in middle-income nations. TRIAL REGISTRATION: ISRCTN Registry no. ISRCTN11674947.