Rationale and design of a prospective substudy of clinical endpoint adjudication processes within an investigator-reported randomised controlled trial in patients with coronary artery disease: the GLOBAL LEADERS Adjudication Sub-StudY (GLASSY)

pragmatic and superiority randomised controlled trial designed to challenge the current treatment paradigm of dual antiplatelet therapy (DAPT) for 12 months followed by aspirin monotherapy among patients undergoing percutaneous coronary intervention. By design, all study endpoints are investigator reported (IR) and not subject to formal adjudication by an independent Clinical Event Committee (CEC), which may introduce detection, reporting or ascertainment bias. Methods and analysis We designed the GLOBAL LEADERS Adjudication Sub-StudY (GLASSY) to prospectively implement, in a large sample of patients enrolled within the GLOBAL LEADERS trial (7585 of 15 991, 47.5%), an independent adjudication process of reported and unreported potential endpoints, using standardised CEC procedures, in order to assess whether 23-month ticagrelor monotherapy (90mg twice daily) after 1-month DAPT is non-inferior to a standard regimen of DAPT for 12 months followed by aspirin monotherapy for the primary efficacy endpoint of death, nonfatal myocardial infarction, non-fatal stroke or urgent target vessel revascularisation and superior for the primary safety endpoint of type 3 or 5 bleeding according to the Bleeding Academic Research Consortium criteria. This study will comprehensively assess the comparative safety and efficacy of the two tested antithrombotic strategies on CEC-adjudicated ischaemic and bleeding endpoints and will provide insights into the role of a standardised CEC adjudication process on the interpretation of study findings by quantifying the level of concordance between IR-reported and CEC-adjudicated events. Ethics and dissemination GLASSY has been approved by local ethics committee of all study sites and/or by the central ethics committee for the country depending on country-specific regulations. In all cases, they deemed that it was not neces

Age and Outcomes in TAVR Patients: Are We Barking Up the Wrong Tree?

We read with great interest the recent analysis from the prospective Swiss-TAVI Registry by Attinger-Toller et al.(1) The authors described a linear relationship between increasing age and prevalence of all-cause mortality, stroke and pacemaker implantation after transcatheter aortic valve implantation (TAVI). For their purpose, they divided patients into four groups based on age (< 70, 71-79, 80-89, > 90) and investigated the occurrence of all-cause mortality at 1 year as well as of a series of secondary endpoints (1). However, the clinical application of this important finding is controversial. Age is a gross estimate of patients’ both clinical condition and risk. In addition, it is not actionable. Therefore, it is unlikely to be utilized per se as gatekeeper for TAVI eligibility, especially for older patients with no feasible alternative. On the contrary, frailty, whose occurrence is linearly correlated with age, has been demonstrated as a major driver of prognosis after TAVI (2) and most of its substrates, such as malnutrition and inactivity, are actionable. To this end, it has been recently showed that frail patients undergoing radial balloon aortic valvuloplasty and a subsequent prehabilitation program aimed at frailty reduction, were able to improve both their frailty level at the time of TAVI and their prognosis afterwards (3). Therefore, improving frailty status before TAVI could be the right way to ameliorate the clinical outcome, especially in older patients. Further randomized trials are needed to confirm this hypothesis

Angio-based index of microcirculatory resistance for the assessment of the coronary resistance: A proof of concept study

Background. The study of coronary microcirculation has gained increasing consideration and importance in cath lab. Despite the increase of evidence, its use still remains very limited. QFR is a novel angio-based approach for the evaluation of coronary stenosis. The aim of our study was to use the QFR assessment in stable patients to recreate the IMR formula and to correlate the result of the two techniques. Methods. From June 1, 2019, to February 29, 2019, 200 patients with CCS and indication of coronary artery angiography and referred to the cath lab of the University Hospital of Ferrara (Italy) were enrolled. After baseline coronary angiogram, quantitative flow ratio, fractional flow reserve, and index of microcirculatory resistance evaluation were performed. Results. Pearson correlation (r) between angio-based index of microcirculatory resistance (A-IMR) and IMR 0.32 with R2 = 0.098, P = 0.03: McNemar test showed a difference between the two tests of 6.82% with 95% CI from -12.05% to 22.89%, which is not significant (P = 0.60). Bland and Altman plot showed a mean difference of 23.3 (from −26.5 to 73.1). Sensitivity, specificity, NPV, and PPV were 70%, 83.3%, 75%, and 70% for A-IMR value >44.2. The area under the ROC curve for A-IMR was 0.76 (95% CI 0.61-0.88, P = 0.0003). Conclusion. We have validated for the first time the formula of the A-IMR, a tool for the calculation of microvascular resistance which does not require the use of pressure guides and the induction of hyperemia

Acute myocardial infarction and large coronary thrombosis in a patient with COVID-19

This is a case report of a 60-year-old male, without any cardiovascular risk factor and no cardiac history admitted to hospital with a diagnosis of interstitial pneumonia caused by coronavirus disease 2019 (COVID-19). After 7 days, the blood tests showed a significant rise of inflammatory and procoagulant markers, along with a relevant elevation of high-sensitivity Troponin I. Electrocardiogram and transthoracic echocardiogram (TTE) were consistent with a diagnosis of infero-posterolateral acute myocardial infarction and the patient was transferred to the isolated Cath Lab for primary percutaneous coronary intervention (PCI). The angiography showed an acute massive thrombosis of a dominant right coronary artery without clear evidence of atherosclerosis. Despite the optimal pharmacological therapies and different PCI techniques, the final TIMI flow was 0/1 and after 3 hr the clinical condition evolved in cardiac arrest for pulseless electric activity. Acute coronary syndrome–ST-elevation myocardial infarction is a relevant complication of COVID-19. Due to high levels of proinflammatory mediators, diffuse coronary thrombosis could occur even in patients without cardiac history or comorbidities. This clinical case suggests that coronary thrombosis in COVID-19 patients may be unresponsive to optimal pharmacological (GP IIb–IIIa infusion) and mechanical treatment (PCI)

Snuffbox approach for balloon aortic valvuloplasty: A case series

In the era of transcatheter aortic valve replacement (TAVR), the spectrum of indications for balloon aortic valvuloplasty is growing, especially in old and frail patients. Mini-invasive approaches via radial access reduce vascular complications and length of hospital stay. The snuffbox approach has never been described for Balloon aortic valvuloplasty (BAV). We performed a review of patients who underwent BAV using distal radial access between January 2019 and December 2019 in a single Italian Centre. All patients received a 30-day follow-up. The procedure was successfully conducted by anatomical snuffbox in all reported cases. All patients were mobilized within 10 h from the procedure without vascular access-related complications. Thirty-day color Doppler ultrasound showed distal radial artery patency in 89% of cases. In our case series, the snuffbox approach for balloon aortic valvuloplasty appeared to be safe and feasible. This approach could be a valid alternative especially in old and frail adults waiting for TAVR

Optical coherence tomography evaluation of overlapping everolimus-eluting bioresorbable vascular scaffold implantation guided by enhanced stent visualization system

Bioresorbable vascular scaffold; Enhanced stent visualization systems; Overlap; PC

Short- Versus Long-Term Duration of Dual Antiplatelet Therapy in Patients Treated for In-Stent Restenosis: A PRODIGY Trial Substudy (Prolonging Dual Antiplatelet Treatment After Grading Stent-Induced Intimal Hyperplasia)

This study sought to investigate the clinical outcome of patients treated with percutaneous coronary intervention (PCI) for in-stent restenosis (ISR) randomized to short (6 months) versus long (24 months) dual antiplatelet therapy (DAPT) regimen. BACKGROUND: It is still unclear if patients treated for ISR may benefit from a long DAPT regimen. METHODS: For the present purpose, we selected 224 patients undergoing the PCI procedure for ISR enrolled in the PRODIGY (Prolonging Dual Antiplatelet Treatment After Grading Stent-Induced Intimal Hyperplasia) trial and randomized to short (6 months) versus long (24 months) DAPT regimen. The primary objective was the cumulative incidence of death, nonfatal myocardial infarction (MI), or cerebrovascular accident at 24 months. Safety endpoints were moderate and major bleeding complications. RESULTS: Overall, 114 patients were allocated to short DAPT regimen, whereas 110 patients were allocated to long DAPT regimen. Twenty-seven patients reached the primary endpoint (19 in short DAPT regimen vs. 8 in long DAPT regimen; p = 0.02). The cumulative incidence of the primary endpoint at 24 months was 16.7% in the short DAPT regimen group compared with 7.3% in the long DAPT regimen group (p = 0.034). This is principally due to a lower occurrence of death and MI in the long DAPT regimen group as compared to the short DAPT regimen group (6.5% vs. 15.5%; p = 0.03). There was no difference in the occurrence of bleeding complications between long and short DAPT regimen. CONCLUSIONS: Our study offers preliminary evidence that patients receiving a new PCI procedure for ISR may benefit from long-term administration of aspirin plus clopidogrel

Contemporary balloon aortic valvuloplasty: Changing indications and refined technique

Even if unable to improve long-term prognosis, balloon aortic valvuloplasty (BAV) may be useful in selected patients with symptomatic severe aortic stenosis either as a bridge to surgical or transcatheter valve replacement (aortic valve replacement [AVR] or transcatheter aortic valve implantation [TAVI]) or as a triage strategy for patients with uncertain indications. International guidelines recommend BAV as: a “bridge” to AVR/TAVI, a “trial” in patients with undetermined symptoms, or a “bridge-to-decision” in case of comorbidities. However, in clinical practice, BAV is also used as a palliative measure to improve hemodynamics and quality of life in many patients who are excluded from AVR/TAVI. Finally, BAV is often performed during TAVI to facilitate prosthesis delivery, optimize frame expansion, or for bioprosthetic valve fracture in selected valve-in-valve procedures. Technical innovations, which allow for a mini-invasive approach via transradial access and pacing delivered through the wire, have led to a decrease in complications over time. This review focuses on contemporary BAV with a specific emphasis on new indications, innovative techniques, and specific complex patient subgroups

Enhanced stent visualization systems during PCI: A case series and review of literature

Enhanced stent visualization systems increase the amount and quality of information during percutaneous coronary interventions. When compared to imaging techniques such as intravascular ultrasound and optical coherence tomography, enhanced stent visualization systems are easy-to-use, as well as time and cost saving. They are useful during stent implantation, overlap, assessment of integrity, and expansion. We review the available data regarding enhanced stent visualization systems and we report 5 cases showing their current applications during percutaneous coronary interventions.<. Learning objective: Enhanced stent visualization (ESV) systems are helpful especially during complex percutaneous coronary interventions (PCI). In everyday clinical practice, ESV systems can be used both along with and instead of intracoronary imaging systems. The present case series show the main current applications of ESV systems during complex PCI cases with a brief review of the available data.>

Two-Year Outcomes After First- or Second-Generation Drug-Eluting or Bare-Metal Stent Implantation in All-Comer Patients Undergoing Percutaneous Coronary Intervention

Objectives This study sought to assess device-specific outcomes after implantation of bare-metal stents (BMS), zotarolimus-eluting Endeavor Sprint stents (ZES-S), paclitaxel-eluting stents (PES), or everolimus-eluting stents (EES) (Medtronic Cardiovascular, Santa Rosa, California) in all-comer patients undergoing percutaneous coronary intervention. Background Few studies have directly compared second-generation drug-eluting stents with each other or with BMS. Methods We randomized 2,013 patients to BMS, ZES-S, PES, or EES implantation. At 30 days, each stent group received up to 6 or 24 months of clopidogrel therapy. The key efficacy endpoint was the 2-year major adverse cardiac event (MACE) including any death, myocardial infarction, or target vessel revascularization, whereas the cumulative rate of definite or probable stent thrombosis (ST) was the key safety endpoint. Results Clinical follow-up at 2 years was complete for 99.7% of patients. The MACE rate was lowest in EES (19.2%; 95% confidence interval [CI]: 16.0 to 22.8), highest in BMS (32.1%; 95% CI: 28.1 to 36.3), and intermediate in PES (26.2%; 95% CI: 22.5 to 30.2) and ZES-S (27.8%; 95% CI: 24.1 to 31.9) groups (chi-square test 18.9, p 0.00029). The 2-year incidence of ST in the EES group (1%; 95% CI: 0.4 to 2.2) was similar to that in the ZES-S group (1.4%; 95% CI: 0.7 to 2.8), whereas it was lower compared with the PES (4.6%, 95% CI: 3.1 to 6.8) and BMS (3.6%; 95% CI: 2.4 to 5.6) groups (chi-square 16.9; p = 0.0001). Conclusions Our study shows that cumulative MACE rate, encompassing both safety and efficacy endpoints, was lowest for EES, highest for BMS, and intermediate for PES and ZES-S groups. EES outperformed BMS also with respect to the safety endpoints with regard to definite or probable and definite, probable, or possible ST. (PROlonging Dual antiplatelet treatment after Grading stent-induced Intimal hyperplasia studY [PRODIGY]; NCT00611286) (C) 2014 by the American College of Cardiology Foundatio