Randomized comparison of TAVI valves: The Compare-TAVI trial.

INTRODUCTION: Based on technical advancements and clinical evidence, transcatheter aortic valve implantation (TAVI) has been widely adopted. New generation TAVI valve platforms are continually being developed. Ideally, new valves should be superior or at least non-inferior regarding efficacy and safety, when compared to best-in-practice contemporary TAVI valves. METHODS AND ANALYSIS: The Compare-TAVI trial (ClinicalTrials.gov NCT04443023) was launched in 2020, to perform a 1:1 randomized comparison of new vs contemporary TAVI valves, preferably in all comers. Consecutive cohorts will be launched with sample sizes depending on the choice of interim analyses, expected event rates, and chosen superiority or non-inferiority margins. Enrollment has just been finalized in cohort B, comparing the Sapien 3/Sapien 3 Ultra Transcatheter Heart Valve (THV) series (Edwards Lifesciences, Irvine, California, USA) and the Myval/Myval Octacor THV series (Meril Life Sciences Pvt. Ltd., Vapi, Gujarat, India) balloon expandable valves. This non-inferiority study was aimed to include 1062 patients. The 1-year composite safety and efficacy endpoint comprises death, stroke, moderate-severe aortic regurgitation, and moderate-severe valve deterioration. Patients will be followed until withdrawal of consent, death, or completion of 10-year follow-up, whichever comes first. Secondary endpoints will be monitored at 30 days, 1, 3, 5, and 10 years. SUMMARY: The Compare-TAVI organization will launch consecutive cohorts wherein patients scheduled for TAVI are randomized to one of two valves. The aim is to ensure that the short- and long-term performance and safety of new valves being introduced is benchmarked against what achieved by best-in-practice contemporary valves.

Randomized Comparison of the Polymer-Free Biolimus-Coated BioFreedom Stent With the Ultrathin Strut Biodegradable Polymer Sirolimus-Eluting Orsiro Stent in an All-Comers Population Treated With Percutaneous Coronary Intervention: The SORT OUT IX Trial.

BACKGROUND: In patients with increased bleeding risk, the biolimus A9-coated BioFreedom stent, a stainless steel drug-coated stent free from polymer, has shown superiority compared with a bare-metal stent. The aim of this study was to investigate whether the BioFreedom stent is noninferior to a modern ultrathin strut biodegradable polymer cobalt-chromium sirolimus-eluting Orsiro stent in an all-comers patient population treated with percutaneous coronary intervention. METHODS: The SORT OUT IX trial (Scandinavian Organization for Randomized Trials With Clinical Outcome IX), was a large-scale, registry-based, randomized, multicenter, single-blind, 2-arm, noninferiority trial. The primary end point, major adverse cardiovascular events, was defined as the composite of cardiac death, myocardial infarction not related to any segment other than the target lesion, or target lesion revascularization within 1 year, analyzed by intention-to-treat. The trial was powered to assess noninferiority for major adverse cardiovascular events of the BioFreedom stent compared with the Orsiro stent with a predetermined noninferiority margin of 0.021. RESULTS: Between December 14, 2015 and April 21, 2017, 3151 patients were assigned to treatment with the BioFreedom stent (1572 patients, 1966 lesions) or to the Orsiro stent (1579 patients, 1985 lesions). Five patients were lost to follow-up because of emigration (99.9% follow-up rate). Mean age was 66.3±10.9, diabetes mellitus was seen in 19.3% of patients, and 53% of the patients had acute coronary syndromes. At 1 year, intention-to-treat analysis showed that 79 (5.0%) patients, who were assigned the BioFreedom stent, and 59 (3.7%), who were assigned the Orsiro stent, met the primary end point (absolute risk difference 1.29% [upper limit of one-sided 95% CI 2.50%]; Pnoninferiority=0.14). Significantly more patients in the BioFreedom stent group had target lesion revascularization than those in the Orsiro stent group (55 [3.5%] vs 20 [1.3%], rate ratio 2.77 [95% CI, 1.66-4.62]; P<0.0001). CONCLUSIONS: The biolimus A9-coated BioFreedom polymer-free stent did not meet criteria for noninferiority for major adverse cardiovascular events at 12 months when compared with the ultrathin strut biodegradable polymer sirolimus-eluting Orsiro stent in an all-comers population Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02623140.

Acute myocardial infarction treatments and outcomes in 6.5 million patients with a current or historical diagnosis of cancer in the USA.

AIMS: The aim of this study is to evaluate temporal trends, treatment, and clinical outcomes of patients who present with an acute myocardial infarction (AMI) and have a current or historical diagnosis of cancer, according to cancer type and presence of metastases. METHODS AND RESULTS: Data from 6 563 255 patients presenting with an AMI between 2004 and 2014 from the US National Inpatient Sample (NIS) database were analysed. A total of 5 966 955 had no cancer, 186 604 had current cancer, and 409 697 had a historical diagnosis of cancer. Prostate, breast, colon, and lung cancer were the four most common types of cancer. Patients with cancer were older with more comorbidities. Differences in invasive treatment were noted, 43.9% received percutaneous coronary intervention (PCI) in patients without cancer, whilst only 21.0% of patients with lung cancer received PCI. Lung cancer was associated with the highest in-hospital mortality [odds ratio (OR) 2.71, 95% confidence interval (CI) 2.62-2.80], major adverse cardiovascular and cerebrovascular complications (OR 2.38, 95% CI 2.31-2.45), and stroke (OR 1.91, 95% CI 1.80-2.02), while colon cancer was associated with highest risk of bleeding (OR 2.82, 95% CI 2.68-2.98). Irrespective of the type of cancer, presence of metastasis was associated with worse in-hospital outcomes, and historical cancer did not adversely impact on survival (OR 0.90, 95% CI 0.89-0.91). CONCLUSION: A concomitant cancer diagnosis is associated with a conservative medical management strategy for AMI, and worse clinical outcomes, compared to patients without cancer. Survival and clinical outcomes in the context of AMI vary significantly according to the type of cancer and metastasis status. The management of this high-risk group is challenging and requires a multidisciplinary and patient-centred approach to improve their outcomes.

Antiplatelet drug selection in PCI to vein grafts in patients with acute coronary syndrome and adverse clinical outcomes: Insights from the British Cardiovascular Intervention Society database.

OBJECTIVE: This study aims to evaluate outcomes associated with different P2Y12 agents in Saphenous Vein graft (SVG) percutaneous coronary intervention (PCI). BACKGROUND: SVG PCI is associated with greater risks of ischemic complications, compared with native coronary PCI. Outcomes associated with the use of potent P2Y12 blocking drugs, Prasugrel and Ticagrelor, in SVG PCI are unknown. METHODS: Patients included in the study underwent SVG PCI in the United Kingdom between 2007 and 2014 for acute coronary syndrome and were grouped by P2Y12 antiplatelet use. In-hospital major adverse cardiac events, major bleeding and 30-day and 1-year mortality were examined. Multiple imputations with chained equations to impute missing data were used. Adjustment for baseline imbalances was performed using (1) multiple logistic regression (MLR) and (separately) (2) propensity score matching (PSM). RESULTS: Data weres analyzed from 8,119 patients and most cases were treated with Clopidogrel (n = 7,401), followed by Ticagrelor (n = 497) and Prasugrel (n = 221). In both MLR and PSM models, there was no significant evidence to suggest that either Prasugrel or Ticagrelor was associated with significantly lower 30-day mortality compared with Clopidogrel. The odds ratios reported from the multivariable analysis were 1.22 (95% CI: 0.60-2.51) for Prasugrel vs. Clopidogrel and 0.48 (95% CI: 0.20-1.16) for Ticagrelor vs. Clopidogrel. No significant differences were seen for in-hospital ischemic or bleeding events. CONCLUSIONS: Our real world national study provides no clear evidence to indicate that use of potent P2Y12 blockers in SVG PCI is associated with improved clinical outcomes.

Influence of the Danish Co-morbidity Index Score on the Treatment and Outcomes of 2.5 Million Patients Admitted With Acute Myocardial Infarction in the United States.

This study aimed to determine the association between the Danish Co-morbidity Index for Acute Myocardial Infarction (DANCAMI) and restricted DANCAMI (rDANCAMI) scores and clinical outcomes in patients hospitalized with AMI. Using the National Inpatient Sample, all AMI hospitalizations were stratified into four groups based on their DANCAMI and rDANCAMI score (0; 1 to 3; 4 to 5; ≥6). The primary outcome was all-cause mortality, whereas secondary outcomes were major adverse cardiovascular/cerebrovascular events, major bleeding, ischemic stroke, and receipt of coronary angiography or percutaneous coronary intervention. Multivariate logistic regression was used to determine adjusted odds ratios (aOR) with 95% confidence intervals (95% CIs). Patients with DANCAMI risk score ≥6 were more likely to suffer mortality (aOR 2.30, 95% CI 2.24 to 2.37) and bleeding (aOR 5.85, 95% CI 5.52 to 6.21) and were less likely to receive coronary angiography (aOR 0.34, 95% CI 0.33 to 0.34) and percutaneous coronary intervention (aOR 0.29, 95% CI 0.28 to 0.29) compared with patients with DANCAMI score of 0. Similar results were observed for the rDANCAMI score. In conclusion, increased DANCAMI and rDANCAMI scores were associated with worse in-hospital outcomes in patients with AMI and lower odds of invasive management. The use of co-morbidity scores identifies patients at high risk of adverse outcomes and highlights disparities in care.