Fractional flow reserve measurements and long-term mortality-results from the FLORIDA study.

Background: Randomized evidence suggested improved outcomes in fractional flow reserve (FFR) guidance of coronary revascularization compared to medical therapy in well-defined patient cohorts. However, the impact of FFR-guided revascularization on long-term outcomes of unselected patients with chronic or acute coronary syndromes (ACS) is unknown. Aims: The FLORIDA (Fractional FLOw Reserve In cardiovascular DiseAses) study sought to investigate outcomes of FFR-guided vs. angiography-guided treatment strategies in a large, real-world cohort. Methods: This study included patients enrolled into the German InGef Research Database. Patients undergoing coronary angiography between January 2014 and December 2015 were included in the analysis. Eligible patients had at least one inpatient coronary angiogram for suspected coronary artery disease between January 2014 and December 2015. Patients were stratified into FFR arm if a coronary angiography with adjunctive FFR measurement was performed, otherwise into the angiography-only arm. Matching was applied to ensure a balanced distribution of baseline characteristics in the study cohort. Patients were followed for 3 years after index date and primary endpoint was all-cause mortality. Results: In the matched population, mortality at 3 years was 9.6% in the FFR-assessed group and 12.6% in the angiography-only group (p = 0.002), corresponding to a 24% relative risk reduction with use of FFR. This effect was most pronounced in patients in whom revascularization was deferred based on FFR (8.7% vs. 12.3%, p = 0.04) and in high-risk subgroups including patients aged ≥75 years (14.9% vs. 20.1%, p < 0.01) and those presenting with ACS (10.2% vs. 14.0%, p = 0.04). Conclusions: FFR-based revascularization strategy was associated with reduced mortality at 3 years. These findings further support the use of FFR in everyday clinical practice.

Prognostic impact of fractional flow reserve measurements in patients with acute coronary syndromes: a subanalysis of the FLORIDA study.

Randomized trials suggest benefits for fractional flow reserve (FFR)-guided vs. angiography-guided treatment strategies in well-defined and selected patient cohorts with acute coronary syndromes (ACS). The long-term prognostic value of FFR measurement in unselected all-comer ACS patients, however, remains unknown. This subanalysis of the Fractional FLOw Reserve In cardiovascular DiseAses (FLORIDA) study sought to investigate the long-term effects of FFR in the management of lesions in patients with acute coronary syndrome (ACS). FLORIDA was an observational all-comer cohort study performed in Germany, that was population-based and unselected. Patients enrolled into the anonymized InGef Research Database presenting with ACS and undergoing coronary angiography between January 2014 and December 2015 were included in the analysis. Patients were stratified into either the FFR-guided or the angiography-guided treatment arm, based on the treatment received. A matched cohort study design was used. The primary endpoint was all-cause mortality. The secondary endpoint was major adverse cardiovascular events (MACE), a composite of death, non-fatal myocardial infarction (MI), and repeat revascularization. Follow-up time was 3 years. Rates of 3-year mortality were 10.2 and 14.0% in the FFR-guided and the angiography-guided treatment arms (p = 0.04), corresponding to a 27% relative risk reduction for FFR in ACS patients. Rates of MACE were similar in both arms (47.7 vs. 51.5%, p = 0.14), including similar rates of non-fatal MI (27.7 vs. 25.4%, p = 0.47) and revascularization (9.9 vs. 12.1%, p = 0.17). In this large, all-comer observational study of ACS patients, FFR-guided revascularization was associated with a lower mortality at 3 years. This finding encourages the routine use of FFR to guide lesion revascularization in patients presenting with ACS.

The future of personalized care for vascular patients: an industry perspective.

Healthcare has entered a brave new world in the early part of the 21st century: the landscape has changed and continues to change rapidly, evolving at a rate as never seen before. Fuelled by technological advancement, big data analytics, and the explosion of apps and sensors, as well as by telemedicine and remote monitoring needs driven by the COVID-19 pandemic, the healthcare ecosystem is metamorphosing literally before our eyes. So, what is the role for the Medtech industry as healthcare systems reshape themselves to address emerging patients' needs and desires, and how can the use of data and novel technologies be leveraged to bring about the kind of change needed to deliver truly holistic patient care?

Impact of the COVID-19 pandemic: a perspective from industry.

The global COVID-19 pandemic has led to unprecedented change throughout society.1 As the articles in this supplement outline, all segments of the broader cardiovascular community have been forced to adapt, to change models of care delivery, and to evolve and innovate in order to deliver optimal management for cardiovascular patients. The medtech/device industry has not been exempt from such change and has been forced to navigate direct and indirect COVID-associated disruption, with effects felt from supply chain logistics to the entire product lifecycle, from the running of clinical trials to new device approvals and managing training, proctoring and congresses in an increasingly-online world. This sea-change in circumstances itself has enforced the industry, in effect, to disrupt its own processes, models and activities. Whilst some of these changes may be temporary, many will endure for some time and some will doubtless become permanent; one thing is for sure: the healthcare ecosystem, including the medical device industry, will never look quite the same again. Although the pandemic has brought a short- to medium-term medical crisis to many countries, its role as a powerful disruptor cannot be underestimated, and may indeed prove to be a force for long-term good, given the accelerated innovation and rapid adaptation that it has cultivated.

Contemporary practice and technical aspects in coronary intervention with bioresorbable scaffolds: a European perspective.

AIMS: Next to patient characteristics, the lack of a standardised approach for bioresorbable vascular scaffold (BVS) implantation is perceived as a potential explanation for the heterogeneous results reported so far. To provide some guidance, we sought to find a consensus on the best practices for BVS implantation and management across a broad array of patient and lesion scenarios. METHODS AND RESULTS: Fourteen European centres with a high volume of BVS procedures combined their efforts in an informal collaboration. To get the most objective snapshot of different practices among the participating centres, a survey with 45 multiple choice questions was prepared and conducted. The results of the survey represented a basis for the technical advice provided in the document, whereas areas of controversy are highlighted. CONCLUSIONS: Consensus criteria for patient and lesion selection, BVS implantation and optimisation, use of intravascular imaging guidance, approach to multiple patient and lesion scenarios, and management of complications, were identified.

First clinical trial of nitinol self-expanding everolimus-eluting stent implantation for peripheral arterial occlusive disease.

BACKGROUND: A novel self-expanding drug-eluting stent was designed to slowly release everolimus to prevent restenosis following peripheral arterial intervention. The purpose of the first-in-human Superficial Femoral Artery Treatment with Drug-Eluting Stents (STRIDES) trial was to evaluate the safety and efficacy of this device for the treatment of symptomatic superficial femoral and proximal popliteal arterial occlusive disease. METHODS AND RESULTS: One hundred four patients were enrolled at 11 European investigative centers in a prospective, nonrandomized, single-arm trial. The patients had severe symptomatic vascular disease, including a significant proportion of patients with critical limb ischemia (17%), diabetes (39%), and single-vessel outflow (26%). The mean lesion length was 9.0 ± 4.3 cm. Ninety-nine percent of patients were available for 12-month follow-up, including duplex imaging in 90% and arteriography in 83%. Clinical improvement, defined as a sustained decrease in Rutherford-Becker clinical category, was achieved in 80% of patients. Primary patency (freedom from ≥50% in-stent restenosis) was 94 ± 2.3% and 68 ± 4.6% at 6 and 12 months, respectively. Plain radiographic examination of 122 implanted devices at 12 months revealed no evidence for stent fracture. CONCLUSIONS: The everolimus-eluting self-expanding nitinol stent can be successfully implanted in patients with severe peripheral arterial disease with favorable outcomes and clinical improvements observed in the majority of patients.

Prospective non-randomized multi-centre evaluation of the non-polymer based ACHIEVE Paclitaxel Eluting Coronary Stent System in treatment of lesions with high risk of revascularization due to restenosis: the DELIVER II study.

BACKGROUND: The ACHIEVE Paclitaxel Eluting Coronary Stent System (CSS) is a non-polymeric paclitaxel coated stent loaded with a dose density of 3.0 microg/mm2 stent surface area. DELIVER II set out to evaluate the use of this stent in the treatment of patients with coronary lesions with a higher risk of revascularization including chronic total or sub-total occlusion, small vessel, bifurcated, and long lesions, multivessel disease, and restenotic lesions. METHODS: DELIVER II was a prospective, non-randomized, single-arm, multi-centre study. A total of 1531 patients with 1986 lesions were enrolled at 86 sites worldwide. The primary endpoint was target lesion revascularization (TLR) rate at six months follow-up. The lesion subsets were comprised of 28.5% restenotic lesions, 16.5% chronic total or subtotal occlusions, 29.0% bifurcation lesions, 37.4% small vessels and 16.6% long lesions. RESULTS: The Target Lesion Revascularization (TLR) rate (intent-to-treat) at 180 days was 8.2% (156/1909). The MACE rate for the overall per-protocol population was 3.6% (47/1310) at 30 days, 13.0% (167/1287) at 180 days, and in a sub-set of 500 patients, 20.5% (84/409) at 365 days. Multivariable logistic regression analysis identified that the factors leading to higher risk of revascularization were left anterior descending artery lesions, restenotic lesions, the post-procedural minimum luminal diameter, total stent length and number of diseased vessels. CONCLUSION: DELIVER II demonstrated comparatively low rates of TLR and MACE for the ACHIEVE Paclitaxel Eluting CSS in high risk patients. In addition, this registry helped to identify risk factors leading to an increased risk of revascularization in difficult-to-treat patient groups.

A randomised comparison of an everolimus-eluting coronary stent with a paclitaxel-eluting coronary stent:the SPIRIT II trial.

BACKGROUND: Everolimus has been successfully tested in humans using both an erodable and a durable polymer in small previous studies. METHODS: This single blind multi-centre non-inferiority randomised (3:1) controlled trial evaluated the safety and performance of the XIENCE V Everolimus Eluting Coronary Stent System (XIENCE V EECSS) versus the TAXUS Paclitaxel Eluting Coronary Stent System (TAXUS(R) PECSS) in the treatment of patients with a maximum of two de novo native coronary artery lesions located in two different epicardial vessels. Three hundred patients with evidence of myocardial ischaemia were allocated to stent implantation with an everolimus-eluting stent (n=223) or a paclitaxel-eluting stent (n=77). Suitable lesions had a diameter stenosis of <50-99%, a length of <28 mm, and a reference vessel diameter between 2.5 mm and 4.25 mm. The primary endpoint was in-stent late loss (LL) at 180 days. Percentage in-stent volume obstruction (%VO) was measured by intravascular ultrasound (IVUS) in a subset of 152 patients. Clinical secondary endpoints included ischaemia driven major adverse cardiac events (ID-MACE) at 180 days. RESULTS: At 6 months, the in-stent LL was 0.11+/-0.27 mm in the everolimus-eluting stent arm, as compared to 0.36+/-0.39 mm in the paclitaxel-eluting stent arm (p<0.0001). Percentage VO in the everolimus-eluting stent arm was 2.5+/-4.7% versus 7.4+/-7.0% in the paclitaxel-eluting stent arm (p<0.0001). Hierarchical MACE was 2.7% (6/222) in the everolimus-eluting stent arm vs. 6.5% (5/77) in the paclitaxel-eluting stent arm. CONCLUSION: This non-inferiority randomised trial not only met its primary endpoint, but also demonstrated the superiority of the everolimus-eluting stent over the paclitaxel-eluting stent in terms of in-stent late loss.