BACKGROUND: The current generation of bioresorbable scaffolds has several limitations, such as thick square struts with large footprints that preclude their deep embedment into the vessel wall, resulting in protrusion into the lumen with microdisturbance of flow. The Mirage sirolimus-eluting bioresorbable microfiber scaffold is designed to address these concerns.
METHODS: In this prospective, single-blind trial, 60 patients were randomly allocated in a 1:1 ratio to treatment with a Mirage sirolimus-eluting bioresorbable microfiber scaffold or an Absorb bioresorbable vascular scaffold. The clinical endpoints were assessed at 30 days and at 6 and 12 months. In-device angiographic late loss at 12 months was quantified. Secondary optical coherence tomographic endpoints were assessed post-scaffold implantation at 6 and 12 months.
RESULTS: Median angiographic post-procedural in-scaffold minimal luminal diameters of the Mirage and Absorb devices were 2.38 mm (interquartile range [IQR]: 2.06 to 2.62 mm) and 2.55 mm (IQR: 2.26 to 2.71 mm), respectively; the effect size (d) was -0.29. At 12 months, median angiographic in-scaffold minimal luminal diameters of the Mirage and Absorb devices were not statistically different (1.90 mm [IQR: 1.57 to 2.31 mm] vs. 2.29 mm [IQR: 1.74 to 2.51 mm], d = -0.36). At 12-month follow-up, median in-scaffold late luminal loss with the Mirage and Absorb devices was 0.37 mm (IQR: 0.08 to 0.72 mm) and 0.23 mm (IQR: 0.15 to 0.37 mm), respectively (d = 0.20). On optical coherence tomography, post-procedural diameter stenosis with the Mirage was 11.2 ± 7.1%, which increased to 27.4 ± 12.4% at 6 months and remained stable (31.8 ± 12.9%) at 1 year, whereas the post-procedural optical coherence tomographic diameter stenosis with the Absorb was 8.4 ± 6.6%, which increased to 16.6 ± 8.9% and remained stable (21.2 ± 9.9%) at 1-year follow-up (Mirage vs. Absorb: dpost-procedure = 0.41, d6 months = 1.00, d12 months = 0.92). Angiographic median in-scaffold diameter stenosis was significantly different between study groups at 12 months (28.6% [IQR: 21.0% to 40.7%] for the Mirage, 18.2% [IQR: 13.1% to 31.6%] for the Absorb, d = 0.39). Device- and patient-oriented composite endpoints were comparable between the 2 study groups.
CONCLUSIONS: At 12 months, angiographic in-scaffold late loss was not statistically different between the Mirage and Absorb devices, although diameter stenosis on angiography and on optical coherence tomography was significantly higher with the Mirage than with the Absorb. The technique of implantation was suboptimal for both devices, and future trials should incorporate optical coherence tomographic guidance to allow optimal implantation and appropriate assessment of the new technology, considering the novel mechanical properties of the Mirage.
BACKGROUND: Treatment of coronary in-stent restenosis (ISR) remains challenging. PCBs are an established treatment option outside the United States with a Class I, Level of Evidence: A recommendation in the European guidelines. However, their efficacy is better in bare-metal stent (BMS) ISR compared with drug-eluting stent (DES) ISR.
METHODS: Fifty patients with DES ISR were enrolled in a randomized, multicenter trial to compare a novel SCB (SeQuent SCB, 4 μg/mm2) with a clinically proven PCB (SeQuent Please Neo, 3 μg/mm2) in coronary DES ISR. The primary endpoint was angiographic late lumen loss at 6 months. Secondary endpoints included procedural success, major adverse cardiovascular events, and individual clinical endpoints such as stent thrombosis, cardiac death, target lesion myocardial infarction, clinically driven target lesion revascularization, and binary restenosis.
RESULTS: Quantitative coronary angiography revealed no differences in baseline parameters. After 6 months, in-segment late lumen loss was 0.21 ± 0.54 mm in the PCB group versus 0.17 ± 0.55 mm in the SCB group (p = NS; per-protocol analysis). Clinical events up to 12 months also did not differ between the groups.
CONCLUSIONS: This first-in-man comparison of a novel SCB with a crystalline coating shows similar angiographic outcomes in the treatment of coronary DES ISR compared with a clinically proven PCB. (Treatment of Coronary In-Stent Restenosis by a Sirolimus [Rapamycin] Coated Balloon or a Paclitaxel Coated Balloon [FIM LIMUS DCB]; NCT02996318).
AREAS COVERED: Literature was searched in different resources for eligible studies. The pooled risk ratio was measured using RevMan software, with p<0.05 (two-sided) set as statistically significant.
EXPERT OPINION: The ABCB1 C3435T homozygous mutant (TT) was associated with significantly increased risk of MACE compared to either wild type genotype (CC) or the combination of wild type and heterozygous genotypes (TT vs. CC: RR 1.33; 95% CI 1.06-1.68; p=0.02; TT vs. CC+CT: RR 1.32; 95% CI 1.10-1.60; p=0.004). Safety outcomes, i.e. bleeding events were not significantly different between the genetic models investigated (TT vs. CC: RR 1.93; 95% CI 0.86-4.35; p=0.11; TT vs. CC+CT: RR 1.36; 95% CI 0.89-2.09; p=0.16; CT+TT vs. CC: RR 1.20; 95% CI 0.59-2.44; p=0.61). It is suggested that ABCB1 C3435T genotype should be tested for ACS/CAD patients undergoing PCI to ensure optimum therapy of clopidogrel.
METHODS: In an international, randomized, single-blind trial, we compared polymer-based zotarolimus-eluting stents with polymer-free umirolimus-coated stents in patients at high bleeding risk. After PCI, patients were treated with 1 month of dual antiplatelet therapy, followed by single antiplatelet therapy. The primary outcome was a safety composite of death from cardiac causes, myocardial infarction, or stent thrombosis at 1 year. The principal secondary outcome was target-lesion failure, an effectiveness composite of death from cardiac causes, target-vessel myocardial infarction, or clinically indicated target-lesion revascularization. Both outcomes were powered for noninferiority.
RESULTS: A total of 1996 patients at high bleeding risk were randomly assigned in a 1:1 ratio to receive zotarolimus-eluting stents (1003 patients) or polymer-free drug-coated stents (993 patients). At 1 year, the primary outcome was observed in 169 of 988 patients (17.1%) in the zotarolimus-eluting stent group and in 164 of 969 (16.9%) in the polymer-free drug-coated stent group (risk difference, 0.2 percentage points; upper boundary of the one-sided 97.5% confidence interval [CI], 3.5; noninferiority margin, 4.1; P = 0.01 for noninferiority). The principal secondary outcome was observed in 174 patients (17.6%) in the zotarolimus-eluting stent group and in 169 (17.4%) in the polymer-free drug-coated stent group (risk difference, 0.2 percentage points; upper boundary of the one-sided 97.5% CI, 3.5; noninferiority margin, 4.4; P = 0.007 for noninferiority).
CONCLUSIONS: Among patients at high bleeding risk who received 1 month of dual antiplatelet therapy after PCI, use of polymer-based zotarolimus-eluting stents was noninferior to use of polymer-free drug-coated stents with regard to safety and effectiveness composite outcomes. (Funded by Medtronic; ONYX ONE ClinicalTrials.gov number, NCT03344653.).
METHODS: The Multinational Abluminal Sirolimus Coated BiO-Engineered StenT (MASCOT) registry was a prospective post-marketing study conducted from June 2014-May 2017 across 60 centers globally. Patients were eligible if COMBO stent implantation was attempted, and they received dual antiplatelet therapy (DAPT) per local guidelines. Follow-up was conducted by trained research staff at 1, 6 and 12 months by phone or clinic visit to capture clinical events and DAPT cessation events. The primary endpoint was 1-year target lesion failure (TLF), composite of cardiac death, non-fatal myocardial infarction not clearly attributable to a non-target vessel, or ischemia-driven target lesion revascularization.
RESULTS: A total of 2614 patients were enrolled over the study period with 96.7% completion of 1-year follow-up. The mean age of enrolled patients was 62.9 ± 11.2 years and 23.0% were female. Diabetes mellitus was present at baseline in 33.5%. A total of 56.1% patients underwent PCI for acute coronary syndrome (ACS). The 1-year primary endpoint of TLF occurred in 3.4% patients (n = 88). Definite stent thrombosis occurred in 0.5% patients (n = 12).
CONCLUSION: The MASCOT post marketing registry provides comprehensive safety and efficacy outcomes following contemporary PCI using the novel COMBO stent in an all-comer population. This platform is associated with low rates of 1-year TLF and ST. CLINICALTRIALS.
GOV IDENTIFIER: NCT02183454.
DESIGN AND SETTINGS: This is a retrospective study of all patients who had undergone coronary angioplasty from 2007 to 2009 in 11 hospitals across Malaysia.
METHODS: Data were obtained from the NCVD-PCI Registry, 2007 to 2009. Patients were categorized into 2 groups-young and old, where young was defined as less than 45 years for men and less than 55 years for women and old was defined as more than or equals to 45 years for men and more than or equals to 55 years for women. Patients' baseline characteristics, risk factor profile, extent of coronary disease and outcome on dis.charge, and 30-day and 1-year follow-up were compared between the 2 groups.
RESULTS: We analyzed 10268 patients, and the prevalence of young CAD was 16% (1595 patients). There was a significantly low prevalence of Chinese patients compared to other major ethnic groups. Active smoking (30.2% vs 17.7%) and obesity (20.9% vs 17.3%) were the 2 risk factors more associated with young CAD. There is a preponderance toward single vessel disease in the young CAD group, and they had a favorable clinical outcome in terms of all-cause mortality at discharge (RR 0.49 [CI 0.26-0.94]) and 1-year follow-up (RR 0.47 [CI 0.19-1.15]).
CONCLUSION: We observed distinctive features of young CAD that would serve as a framework in the primary and secondary prevention of the early onset CAD.
OBJECTIVES: To identify the risk factors associated with mortality for each gender and compare differences, if any, among ST-elevation myocardial infarction (STEMI) patients.
DESIGN: Retrospective analysis.
SETTINGS: Hospitals across Malaysia.
PATIENTS AND METHODS: We analyzed data on all STEMI patients in the National Cardiovascular Database-Acute coronary syndrome (NCVD-ACS) registry for the years 2006 to 2013 (8 years). We collected demographic and risk factor data (diabetes mellitus, hypertension, smoking status, dyslipidaemia and family history of CAD). Significant variables from the univariate analysis were further analysed by a multivariate logistic analysis to identify risk factors and compare by gender.
MAIN OUTCOME MEASURES: Differential risk factors for each gender.
RESULTS: For the 19484 patients included in the analysis, the mortality rate over the 8 years was significantly higher in females (15.4%) than males (7.5%) (P < .001). The univariate analysis showed that the majority of male patients < 65 years while females were >=65 years. The most prevalent risk factors for male patients were smoking (79.3%), followed by hypertension (54.9%) and diabetes mellitus (40.4%), while the most prevalent risk factors for female patients were hypertension (76.8%), followed by diabetes mellitus (60%) and dyslipidaemia (38.1%). The final model for male STEMI patients had seven significant variables: Killip class, age group, hypertension, renal disease, percutaneous coronary intervention and family history of CVD. For female STEMI patients, the significant variables were renal disease, smoking status, Killip class and age group.
CONCLUSION: Gender differences existed in the baseline characteristics, associated risk factors, clinical presentation and outcomes among STEMI patients. For STEMI females, the rate of mortality was twice that of males. Once they reach menopausal age, when there is less protection from the estrogen hormone and there are other risk factors, menopausal females are at increased risk for STEMI.
LIMITATION: Retrospective registry data with inter-hospital variation.
Objectives: This study aimed to determine post-treatment oral cancer patients' concerns and its relationship with patients' clinical characteristics, health-related quality of life (HRQoL), psychological distress and patient satisfaction with the follow-up consultation.
Methods: A total of 85 oral cancer patients were recruited from a three-armed pragmatic RCT study on the patient concerns inventory for head and neck cancer (PCI-H&N), which was conducted at six hospital-based oral maxillofacial specialist clinics throughout Malaysia. Malaysians aged 18 years and above and on follow-ups from 1 month to 5 years or more were eligible. Patients completed the PCI-H&N, functional assessment of cancer therapy -H&N v4.0 and Distress Thermometer at pre-consultation and satisfaction questionnaire at post-consultation. The data were analysed descriptively; multiple linear regression and multivariate logistic regression analyses were used to determine possible predictors of patients' HRQoL and psychological distress.
Results: 'Recurrence or fear of cancer coming back' (31.8%) was most frequently selected. 43.5% of patients selected ≥4 concerns. A significantly high number of concerns were associated with patients of '1-month to 1-year post-treatment' (n = 84%; p = 0.001). A significant association existed between 'time after treatment completed' and patients' concerns of 'chewing/eating', 'mouth opening', 'swelling', 'weight', 'ability to perform', 'cancer treatment' and 'supplement/diet-related'. 'Chewing/eating' was predicted for low HRQoL (p < 0.0001) followed by 'appearance' and 'ability to perform recreation activities' (personal functions domain). Patients with high psychological distress levels were 14 times more likely to select 'ability to perform recreation activities' and seven times more likely to select 'feeling depressed'. No significant association was identified between patients' concerns and patients' satisfaction with the consultation.
Conclusion: Routine follow-up consultations should incorporate the PCI-H&N prompt list to enhance patient-centred care approach as the type and number of patients' concerns are shown to reflect their HRQoL and psychological distress.TRIAL REGISTRATION: NMRR-18-3624-45010 (IIR).