Biodegradable-Polymer or Durable-Polymer Stents in Patients at High Bleeding Risk: A Randomized, Open-Label Clinical Trial.

BACKGROUND: Limited information is available on the comparative efficacy and safety of different stent platforms in patients at high bleeding risk undergoing an abbreviated dual antiplatelet therapy duration after percutaneous coronary intervention (PCI). The aim of this study was to compare the safety and effectiveness of the biodegradable-polymer sirolimus-eluting stent with the durable-polymer zotarolimus-eluting stent in patients at high bleeding risk receiving 1 month of dual antiplatelet therapy after PCI. METHODS: The Bioflow-DAPT Study is an international, randomized, open-label trial conducted at 52 interventional cardiology hospitals in 18 countries from February 24, 2020, through September 20, 2021. Patients with a clinical indication to PCI because of acute or chronic coronary syndrome who fulfilled 1 or more criteria for high bleeding risk were eligible for enrollment. Patients were randomized to receive either biodegradable-polymer sirolimus-eluting stents or durable-polymer, slow-release zotarolimus-eluting stents after successful lesion preparation, followed by 1 month of dual antiplatelet therapy and thereafter single antiplatelet therapy. The primary outcome was the composite of death from cardiac causes, myocardial infarction, or stent thrombosis at 1 year, and was powered for noninferiority, with an absolute margin of 4.1% at 1-sided 5% alpha. RESULTS: A total of 1948 patients at high bleeding risk were randomly assigned (1:1) to receive biodegradable-polymer sirolimus-eluting stents (969 patients) or durable-polymer zotarolimus-eluting stents (979 patients). At 1 year, the primary outcome was observed in 33 of 969 patients (3.6%) in the biodegradable-polymer sirolimus-eluting stent group and in 32 of 979 patients (3.4%) in the durable-polymer zotarolimus-eluting stent group (risk difference, 0.2 percentage points; upper boundary of the 1-sided 95% CI, 1.8; upper boundary of the 1-sided 97.5% CI, 2.1; P<0.0001 for noninferiority for both tests). CONCLUSIONS: Among patients at high risk for bleeding who received 1 month of dual antiplatelet therapy after PCI, the use of biodegradable-polymer sirolimus-eluting stents was noninferior to the use of durable-polymer zotarolimus-eluting stents with regard to the composite of death from cardiac causes, myocardial infarction, or stent thrombosis. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT04137510.

TriGuard Embolic Protection Device in percutaneous cardiac interventions with intracavitary cardiac thrombosis: A case series.

Embolic cerebral protection devices are not routinely used in clinical practice during electrophysiological interventions. We report a case series of patients with intracardiac thrombosis undergoing a percutaneous left atrial appendage (LAA) closure and a ventricular tachycardia (VT) catheter ablation supported by TriGuard 3 Cerebral Embolic Protection Device.

A new knee arthrometer demonstrated to be reliable and accurate to assess anterior tibial translation in comparison with stress radiographs.

INTRODUCTION: For several years, many arthrometers have been developed to assess anterior knee laxity. The aim of our study was to evaluate the validity of a new practical and handy testing device with the hypothesis that the new arthrometer had good validity in terms of reliability and accuracy. METHODS: Lachman test was performed on five fresh frozen cadaveric knees by five examiners. Anterior tibial translation (ATT) was measured with a new arthrometer (BLU-DAT) and on lateral stress radiographs. Data on ATT were obtained under 7 kg (69 N), 9 kg (88 N), and maximum manual traction (MMT). Tests were performed on the same specimens before and after arthroscopic ACL excision. Inter-rater reliability of the BLU-DAT measures was assessed with the intraclass correlation coefficient (ICC) for single and average measurements. The Bland-Altman method was used to estimate agreement between the BLU-DAT and stress radiographs. RESULTS: ICC values for single measurements were 0.62, 0.54 and 0.58 for 7-kg, 9-kg and MMT assessment, respectively. Overall reliability was good (ICC = 0.63). ICC values for average measurements were 0.89, 0.85 and 0.88 for 7-kg, 9-kg and MMT assessment, respectively. Overall reliability was very good (ICC = 0.90) SEM ranged from 1.4 mm to 1.6 mm for single measurements and was below 1 mm at each testing condition for average measurements. Analysis of agreement between BLU-DAT and radiographic measurements showed a mean difference equal to 0.83 mm ± 2.1 mm (95% CI: 0.55-1.11). Upper LOA was equal to 4.9 mm (95% CI: 5.39-4.41). Lower LOA was equal to - 3.2 mm (95% CI: - 2.71 to - 3.69). CONCLUSION: Measurement of anterior knee laxity with the BLU-DAT testing device has a good to very good inter-rater reliability and good agreement with a gold standard such as stress radiographs. Cadaveric Diagnostic Study, Level of Evidence IV.

Knotless PEEK and double-loaded biodegradable suture anchors ensure comparable clinical outcomes in the arthroscopic treatment of traumatic anterior shoulder instability: a prospective randomized study.

PURPOSE: To compare the clinical outcome of arthroscopic capsulolabral repair for traumatic anterior shoulder instability with PEEK knotless and knotted biodegradable suture anchors. METHODS: Arthroscopic stabilization was performed in 78 patients with recurrent traumatic anterior shoulder instability. They were divided into 2 groups of 39 patients each, according to suture anchors used: knotless PEEK anchors in group 1, and biodegradable anchors in group 2. Exclusion criteria were: instability without dislocation, posterior or multidirectional instability, glenoid bone loss > 20%, off-track lesions, concomitant rotator cuff tears and previous surgery. The primary outcome was the Disabilities of the Arm, Shoulder and Hand (DASH) self-administered questionnaire. Secondary outcomes were: Work-DASH, Sport-DASH, Rowe score, recurrent instability and subsequent surgery. The following independent variables were considered: age, gender, dominance, generalized ligamentous hyperlaxity, duration of symptoms, age at first dislocation, number of dislocations, type of work, type of sport, sports activity level, capsule-labral injury pattern, SLAP lesion and number of anchors. Differences between groups for numerical variables were analyzed by use of the Student's t-test or Mann-Whitney U-test. Fisher's exact test was used for analysis of categorical variables. Significance was set at p < 0.05. RESULTS: Seven patients (9%) were lost at follow-up, 5 from group 1 and 2 from group 2. Follow-up ranged from 36 to 60 months (median: 44; IQR: 13). Comparison between groups did not show significant differences for each independent variable considered. No differences could be found either for DASH (n.s.) or Rowe (p = n.s.) scores between the two groups. Overall recurrence rate was 7%. Three re-dislocations were reported in group 1 and two in group 2 (n.s.). Only one patient in each group underwent re-operation. CONCLUSIONS: The study showed no significant differences in clinical outcomes after arthroscopic treatment of traumatic anterior shoulder instability using PEEK knotless or biodegradable knotted anchors at mid-term follow-up. LEVEL OF EVIDENCE: I.

Biologic and synthetic ligament reconstructions achieve better functional scores compared to osteosynthesis in the treatment of acute acromioclavicular joint dislocation.

PURPOSE: To systematically review the outcomes of surgical treatments of acute acromioclavicular joint dislocation. METHODS: Studies were identified by electronic databases (Ovid, PubMed). All studies reporting functional and radiological outcomes of surgical treatments of acute acromioclavicular joint dislocations were included. Following data were extracted: authors and year, study design, level of evidence, number of patients, age, classification of acromioclavicular joint dislocation, time to surgery, surgical technique, follow-up, clinical and imaging outcomes, complications, and failures. Descriptive statistics was used, when a data pooling was not possible. Comparable outcomes were pooled to generate summary outcomes reported as frequency-weighted values. Quality appraisal was assessed through the MINORS checklist. RESULTS: One hundred and thirty-three studies were included for a total of 4473 shoulders. Mean age of participants was 36.9 years. Mean follow-up was 42.06 months. Arthroscopy showed better ASES (p < 0.0001) and lower VAS pain score (p = 0.0249) compared to an open approach. Biologic and synthetic reconstructions demonstrated better results over osteosynthesis techniques. Biologic techniques showed overall better Constant (p = 0.0001) and DASH (p = 0.0215) scores, while synthetic reconstruction showed better UCLA score (p = 0.0001). Among suture buttons, triple button showed overall better results in Constant (p = 0.0001) and VAS (p = 0.0001) scores, while better results in DASH score (p = 0.0003) were achieved by 2 double button techniques. Overall, the level of evidence was low. CONCLUSION: Biological and synthetic reconstructions achieved better functional scores compared to osteosynthesis. Among suture buttons, the triple button showed better functional performance. LEVEL OF EVIDENCE: IV.

A global registry of fractional flow reserve (FFR)-guided management during routine care: Study design, baseline characteristics and outcomes of invasive management.

BACKGROUND: The use and clinical outcomes of fractional flow reserve (FFR)-guided revascularization in patients presenting with either stable coronary artery disease (CAD) or an acute coronary syndrome (ACS) in daily clinical practice are uncertain. OBJECTIVE: To prospectively characterize the frequency of the change in treatment plan when FFR is performed compared to the initial decision based on angiography alone and procedure-related outcomes. METHODS: We undertook a prospective, multicenter, multinational, open-label, observational study of coronary physiologic measurements during clinically indicated coronary angiography. The treatment plan, including medical therapy, PCI or CABG, was prospectively recorded before and after performing FFR. Adverse events were pre-defined and prospectively recorded per local investigators (PRESSUREwire; ClinicalTrials.gov identifier: NCT02935088). RESULTS: Two thousand two hundred and seventeen subjects were enrolled in 70 hospitals across 15 countries between October 2016-February 2018. The mean FFR (all measurements) was 0.84. The treatment plan based on angiography-alone changed in 763/2196 subjects (34.7%) and 872/2931 lesions (29.8%) post-FFR. In the per-patient analysis, the initial treatment plan based on angiography versus the final treatment plan post-FFR were medical management 1,350 (61.5%) versus 1,470 (66.9%) (p = .0017); PCI 717 (32.7%) versus 604 (27.5%) (p = .0004); CABG 119 (5.4%) versus 121 (5.5%) (p = .8951). The frequency of intended revascularization changed from 38.1 to 33.0% per patient (p = .0005) and from 35.5 to 29.6% per lesion (p < .0001) following FFR. CONCLUSIONS: On an individual patient basis, use of FFR in everyday practice changes the treatment plan compared to angiography in more than one third of all-comers selected for physiology-guided managements. FFR measurement is safe, providing incremental information to guide revascularization decisions.

Carotid Artery Stenting With Proximal Embolic Protection via a Transradial or Transbrachial Approach: Pushing the Boundaries of the Technique While Maintaining Safety and Efficacy.

PURPOSE: To compare the feasibility and safety of proximal cerebral protection to a distal filter during carotid artery stenting (CAS) via a transbrachial (TB) or transradial (TR) approach. METHODS: Among 856 patients who underwent CAS between January 2007 and July 2015, 214 (25%) patients (mean age 72±8 years; 154 men) had the procedure via a TR (n=154) or TB (n=60) approach with either Mo.MA proximal protection (n=61) or distal filter protection (n=153). The Mo.MA group (mean age 73±7 years; 54 men) had significantly more men and more severe stenosis than the filter group (mean age 71±8 years; 100 men). Stent type and CAS technique were left to operator discretion. Heparin and a dedicated closure device or bivalirudin and manual compression were used in TR and TB accesses, respectively. Technical and procedure success, crossover to femoral artery, 30-day major adverse cardiovascular/cerebrovascular events (MACCE; death, all strokes, and myocardial infarction), vascular complications, and radiation exposure were compared between groups. RESULTS: Crossover to a femoral approach was required in 1/61 (1.6%) Mo.MA patient vs 11/153 (7.1%) filter patients mainly due to technical difficulty in engaging the target vessel. Five Mo.MA patients developed acute intolerance to proximal occlusion; 4 were successfully shifted to filter protection. A TR patient was shifted to filter because the Mo.MA system was too short. CAS was technically successful in the remaining 55 (90%) Mo.MA patients and 142 (93%) filter patients. The MACCE rate was 0% in the Mo.MA patients and 2.8% in the filter group (p=0.18). Radiation exposure was similar between groups. Major vascular complications occurred in 1/61 (1.6%) and in 3/153 (1.96%) patients in the Mo.MA and filter groups (p=0.18), respectively, and were confined to the TB approach in the early part of the learning curve. Chronic radial artery occlusion was detected by Doppler ultrasound in 2/30 (6.6%) Mo.MA patients and in 4/124 (3.2%) filter patients by clinical assessment (p=0.25) at 8.1±7.5-month follow-up. CONCLUSION: CAS with proximal protection via a TR or TB approach is a feasible, safe, and effective technique with a low rate of vascular complications.

Serial intravascular ultrasound analysis of complex bifurcation coronary lesions treated with the Tryton Bifurcation Stent in conjunction with an everolimus-eluting stent: IUVANT (Intravascular Ultrasound Evaluation of Tryton Stent) study.

OBJECTIVES: To characterize the treatment of complex bifurcation lesions (BL) with the Tryton Bifurcation Stent (TBS) paired with an everolimus-eluting stent (EES). BACKGROUND: Complex BL are associated with higher procedural complications and poorer long-term outcomes. The TBS is a dedicated side-branch (SB) stent designed to be used in conjunction with a standard drug-eluting stent. METHODS: Prospectively identified, consecutive patients underwent TBS+EES stenting of BL using a protocol which included TBS postdilation and simultaneous final kissing balloon inflations (FKBI). All lesions were systematically evaluated with coronary angiography and IVUS, obtained at procedure completion and at 9 months, and were assessed by independent core laboratories. RESULTS: Thirty-three BL were treated in 32 patients presenting primarily (87.5%) with stable angina and complex BL with angiographic apparent disease in the main vessel (MV) and SB in 87.9% and 75% by site and core evaluation, respectively. Procedural success was 100% and high postprocedure percent stent expansion (MV 96 [93, 109]%, SB 88 [77, 100]%, carina MV 135 [99, 166]%, carina SB 116 [91, 130]%) was demonstrated by IVUS. At 9-month angiographic follow-up (n = 28 patients), one MV in-segment restenosis and one SB in-stent restenosis were observed. SB in-stent late lumen loss was 0.41 ± 0.27 mm. IVUS assessment revealed the absence of stent recoil; percent carinal neointimal hyperplasia (NIH) was 1.8 [0.0,11.2]% in MV and 15.0 [6.7,23.5]% in SB, with NIH volume obstruction of 2.0 [0.7,4.3]% in MV and 14.2 [7.5,29.6]% in SB. CONCLUSIONS: Stenting of complex BL with the TBS+EES provides high acute success with sustained clinical, angiographic, and IVUS results at 9 months. These excellent results are likely due to the extent of stent expansion at the carina.

Carotid artery stenting in patients with left ICA stenosis and bovine aortic arch: a single-center experience in 60 consecutive patients treated via the right radial or brachial approach.

PURPOSE: To assess the safety and efficacy of carotid artery stenting (CAS) of the left internal carotid artery (LICA) from a right radial/brachial approach in patients with bovine aortic arch. METHODS: Among 505 consecutive CAS patients treated at our facility between June 2007 and December 2012, 60 (11.9%) patients (44 men; mean age 73±9 years) with LICA stenosis and bovine arch were treated from a right radial (n=32) or brachial (n=28) approach. Three quarters of the patients had characteristics qualifying them at high surgical risk; 52 were asymptomatic. The types of cerebral protection (a distal filter or proximal MO.MA system), stent, and technique were at the operation's discretion. RESULTS: The radial/brachial approach was successful in 59 (98.3%) of 60 procedures; 1 case was converted to a femoral approach. Proximal protection was used in 15 cases (11 brachial, 4 radial) with severe, soft plaques, although the MO.MA system proved too short in a tall patient having a radial approach and a filter was used. Clinical success with no adverse events was 96.7% owing to 1 retinal embolism and 1 minor stroke. Vascular complications occurred in 2 (3.3%) brachial group patients. No major bleeding was encountered. Over a mean follow-up of 18.7±17.5 months, midterm event-free survival was 93%. No target vessel revascularization was necessary. CONCLUSION: CAS via a right radial or brachial approach is safe and effective in patients with LICA stenosis and types 1 or 2 bovine arch.

Reliability of Magnetic Resonance Imaging Criteria for the Preoperative Assessment of Rotator Cuff Tears: A Systematic Review.

BACKGROUND: Magnetic resonance (MR) imaging is the most common modality for assessment of the rotator cuff before and after surgery. Several classifications have been described aiming to define main tear characteristics. However, there is still confusion when it comes to the reliability of those classifications. PURPOSE: (1) To identify all MR classifications available in the literature for preoperative assessment of rotator cuff tears, (2) to summarize available data on the reliability of identified classifications, and (3) to assess the methodological quality of reliability studies. STUDY DESIGN: Systematic review; Level of evidence, 4. METHODS: This systematic review was conducted following the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines. All studies reporting MR assessment in patients with a superior or posterosuperior rotator cuff tear were included. After identification of the available MR criteria, reliability studies were analyzed. Descriptive statistics were used to summarize findings. Methodological quality was assessed using the Quality Appraisal of Reliability Studies checklist. RESULTS: A total of 75 studies were included in this review. Eight categories of outcomes could be identified. Of the total, 62 studies reported interobserver reliability whereas 32 reported intraobserver reliability of some of the identified criteria. Each category reflected a variety of reliability, ranging from poor to excellent agreement. MR proved to be a reliable imaging modality to detect the structural integrity of the posterosuperior cuff, especially in cases of full-thickness tear; it was also reliable in terms of tear width and length and muscle atrophy based on a tangent sign or Thomazeau classification. All other classifications did not prove acceptable reliability. Methodological quality was high for 23 articles and moderate for 14. CONCLUSION: Preoperative MR is a reliable imaging modality to identify full-thickness tears, measure tear size and morphology, and identify muscle atrophy with tangent sign or Thomazeau classification. All other outcomes and classifications did not show acceptable reliability; therefore, caution is needed when using them for preoperative evaluation of a rotator cuff tear.

A prospective, randomized trial of intravascular-ultrasound guided compared to angiography guided stent implantation in complex coronary lesions: the AVIO trial.

BACKGROUND: No randomized studies have thus far evaluated intravascular ultrasound (IVUS) guidance in the drug-eluting stent (DES) era. The aim was to evaluate if IVUS optimized DES implantation was superior to angiographic guidance alone in complex lesions. METHODS: Randomized, multicentre, international, open label, investigator-driven study evaluating IVUS vs angiographically guided DES implantation in patients with complex lesions (defined as bifurcations, long lesions, chronic total occlusions or small vessels). Primary study endpoint was post-procedure in lesion minimal lumen diameter. Secondary end points were combined major adverse cardiac events (MACE), target lesion revascularization, target vessel revascularization, myocardial infarction (MI), and stent thrombosis at 1, 6, 9, 12, and 24 months. RESULTS: The study included 284 patients. No significant differences were observed in baseline characteristics. The primary study end point showed a statistically significant difference in favor of the IVUS group (2.70 mm ± 0.46 mm vs. 2.51 ± 0.46 mm; P = .0002). During hospitalization, no patient died, had repeated revascularization, or a Q-wave MI. No difference was observed in the occurrence of non-Q wave MI (6.3% in IVUS vs. 7.0% in angio-guided group). At 24-months clinical follow-up, no differences were still observed in cumulative MACE (16.9%vs. 23.2 %), cardiac death (0%vs. 1.4%), MI (7.0%vs. 8.5%), target lesion revascularization (9.2% vs. 11.9%) or target vessel revascularization (9.8% vs. 15.5%), respectively in the IVUS vs. angio-guided groups. In total, only one definite subacute stent thrombosis occurred in the IVUS group. CONCLUSIONS: A benefit of IVUS optimized DES implantation was observed in complex lesions in the post-procedure minimal lumen diameter. No statistically significant difference was found in MACE up to 24 months.

The 'Trawl Fishing' Technique: A Quick Engagement of the Left Common Carotid Artery With the Simmons Catheter During Carotid Artery Stenting From the Right Radial Approach.

BACKGROUND: Transradial approach for carotid artery stenting (TRCAS) is an established technique in specific anatomies potentially associated with high periprocedural event rate from femoral catheterization. The engagement of left common carotid artery originating from the aortic arch is the most challenging scenario requiring specific catheters and techniques. METHODS: Among 542 consecutive TRCAS 66 had left, non-bovine carotid stenosis as the target vessel. We retrospectively compared the feasibility, safety, efficacy, fluoroscopy time and radiation exposure of two different techniques, the standard (ST) and the 'trawl-fishing' (TFT), to engage the LCCA with the 5F, 125 cm-long Simmons-2 catheter. RESULTS: The ST was initially used in 20 patients with a technical success of 85 % (17/20). In the following 46 patients, the TFT was successfully tested first as bailout after ST failure in 12 cases and as first option in the remaining 34 patients. Full technical success was obtained in all patients at the first attempt. No MACCEs or vascular complications occurred in all patients. Fluoroscopy time and radiation exposure were significantly lower with the TFT vs. ST (p < 0.001). CONCLUSIONS: TFT represents a definite improvement in the technique of LCCA engagement during TRCAS.

Preclinical evaluation of the degradation kinetics of third-generation resorbable magnesium scaffolds.

BACKGROUND: The novel sirolimus-eluting resorbable scaffold DREAMS 3G was designed as a third-generation development of its predecessor, the Magmaris scaffold. AIMS: This preclinical study aimed to examine the qualitative and temporal course of the degradation of the DREAMS 3G relative to the Magmaris scaffold. METHODS: Forty-nine DREAMS 3G and 24 Magmaris scaffolds were implanted into 48 mini swine for degradation kinetics analysis. Another DREAMS 3G was implanted into one mini swine for crystallinity analysis of the degradation end product after 730 days. Degradation kinetics were determined at 28, 90, 120, 180, and 365 days. RESULTS: Discontinuity density in DREAMS 3G was significantly lower than that in Magmaris scaffolds for the follow-up timepoints of 90 and 120 days. Planimetric analysis indicated 99.6% backbone degradation for DREAMS 3G at 12 months. Compared to the Magmaris scaffold, individual strut degradation in DREAMS 3G showed less variability and the remaining backbone core was more homogeneous. The degradation end product of DREAMS 3G manifested as calcium phosphate with a minor share of aluminium phosphate. CONCLUSIONS: DREAMS 3G showed almost complete degradation after one year, with amorphous calcium and aluminium phosphate as the end products of degradation. Despite its thinner struts, scaffold discontinuity was significantly lower in the DREAMS 3G than in the Magmaris scaffold, likely providing a longer scaffolding time.

Comparison of acute versus stable coronary syndrome in patients treated with the Magmaris scaffold: Two-year results from the Magmaris Multicenter Italian Registry.

BACKGROUND: The magnesium Magmaris scaffold is the latest resorbable technology with low thrombogenicity, short scaffolding time, and almost complete resorption at 12 months (95 %). As compared with stable coronary artery disease (SCAD), acute coronary syndrome (ACS) is associated with increased risk of adverse clinical outcome after percutaneous coronary intervention. We analyzed the data of the Magmaris Multicenter Italian Registry to compare clinical outcomes in SCAD versus ACS patients. METHODS: We evaluated the 24-month rates of target lesion failure (TLF) and scaffold thrombosis (ST). Device implantation procedures were performed according to the manufacturer's recommendations (proper patient/lesion selection, pre-dilatation, proper scaffold sizing, and post-dilatation). Dual antiplatelet therapy was terminated after 12 months. RESULTS: Data from 207 patients (145 SCAD and 62 ACS) were collected from July 2016 to June 2018. The 2-year follow-up compliance was 92.8 % (192 patients). At 2 years, TLF rates were 7.4 % in the SCAD group and 8.8 % in the ACS group (p = 0.7); ST rates were 0 % in the SCAD group and 1.8 % in the ACS group (p = 0.1). CONCLUSION: The 2-year clinical results from the Magmaris Multicenter Italian Registry are favorable in terms of TLF and ST, indicating the safety and effectiveness of the Magmaris scaffold in both SCAD and ACS patients.

Design and Rationale of the BIOFLOW-DAPT Trial: a Prospective, Randomized, Multicenter Study to Assess the Safety of the Orsiro Mission Stent Compared to the Resolute Onyx Stent in Subjects at High Risk for Bleeding in Combination with 1-Month Dual Antiplatelet Therapy.

The optimal duration of dual antiplatelet therapy (DAPT) in high bleeding risk (HBR) patients undergoing percutaneous coronary intervention (PCI) with implantation of the Orsiro Mission stent remains unclear. The BIOFLOW-DAPT (clinicaltrials.gov, NCT04137510) trial is a prospective, multi-center, randomized controlled study designed to assess the safety of the Orsiro Mission versus the Resolute Onyx stent in HBR patients. Patients are treated with DAPT (aspirin and a P2Y12 inhibitor) for 1 month, followed by a single antiplatelet therapy (SAPT). The primary endpoint is the composite of cardiac death, myocardial infarction, and definite or probable stent thrombosis at 1 year. With a final sample size of 1948 HBR patients, this study is powered to assess the noninferiority of the Orsiro Mission stent with respect to the primary study endpoint. The BIOFLOW-DAPT is the first randomized clinical trial investigating 1-month DAPT duration in HBR patients after implantation of the Orsiro Mission stent.Trial Registration: ClinicalTrials.gov number, NCT04137510 Study design and key features. Patient selection starts before the index PCI, when consented patients will be randomized to the Orsiro Mission or the Resolute Onyx stent with mandated 1-month DAPT. At 1 month, eligibility is reassessed and if met, patients will discontinue DAPT and continue with P2Y12 inhibitor or aspirin monotherapy. PCI, percutaneous coronary intervention; DAPT, dual antiplatelet therapy; DES, drug-eluting stent; HBR, high bleeding risk; P2Y12i, P2Y12 inhibitor; ST, stent thrombosis.

Diagnostic accuracy of subendocardial vs. transmural myocardial perfusion defect for the detection of in-stent restenosis or progression of coronary artery disease after percutaneous coronary intervention.

BACKGROUND: The ADVANTAGE study demonstrated in a cohort of stented patients a diagnostic accuracy of stress myocardial CT perfusion (CTP) significantly higher than that of coronary CT angiography (CCTA) for the detection of in-stent restenosis (ISR) or CAD progression vs. quantitative coronary angiography (QCA). This is a pre-defined subanalysis of the ADVANTAGE aimed at assessing the difference in terms of diagnostic accuracy vs. QCA of a subendocardial vs. a transmural perfusion defect using static stress CTP. METHODS: We enrolled consecutive patients who previously underwent coronary stenting and were referred for QCA. All patients underwent stress CTP and rest CTP â€‹+ â€‹CCTA. The diagnostic accuracy of CCTA and CTP were evaluated in territory-based and patient-based analyses. We compared the diagnostic accuracy of "subendocardial" perfusion defect, defined as hypo-enhancement encompassing >25% but <50% of the transmural myocardial thickness within a specific coronary territory vs. "transmural" perfusion defect, defined as hypo-enhancement encompassing >50% of the transmural thickness. RESULTS: In 150 patients (132 men, mean age 65.1 â€‹± â€‹9.1 years), the diagnostic accuracy of subendocardial vs. transmural perfusion defect in a vessel-based analysis was 93.5% vs. 87.7%, respectively (p â€‹< â€‹0.0001). The sensitivity and specificity of subendocardial vs. transmural defect were 87.9% vs. 46.9% (p â€‹< â€‹0.001) and 94.9% vs. 97.9% (p â€‹= â€‹0.004), respectively. In a patient-based analysis, the diagnostic accuracy of the subendocardial vs. transmural approach was 86.6% vs. 68% (p â€‹< â€‹0.0001). CONCLUSIONS: This study shows that detection of a subendocardial perfusion defect as compared to a transmural defect is significantly more accurate to identify coronary territories with ISR or CAD progression.

Diagnostic performance of exercise stress tests for detection of epicardial and microvascular coronary artery disease: the UZ Clear study.

BACKGROUND: Cardiac stress tests remain the cornerstone for evaluating patients suspected of having obstructive coronary artery disease (CAD). Coronary microvascular dysfunction (CMD) can lead to abnormal non-invasive tests. AIMS: We sought to assess the diagnostic performance of exercise stress tests with indexes of epicardial and microvascular resistance as reference. METHODS: This was a prospective, single-arm, multicentre study of patients with an intermediate pretest probability of CAD and positive exercise stress tests who were referred for invasive angiography. Patients underwent an invasive diagnostic procedure (IDP) with measurement of fractional flow reserve (FFR) and index of microvascular resistance (IMR) in at least one coronary vessel. Obstructive CAD was defined as diameter stenosis (DS) >50% by quantitative coronary angiography (QCA). The objective was to determine the false discovery rate (FDR) of cardiac exercise stress tests with both FFR and IMR as references. RESULTS: One hundred and seven patients (137 vessels) were studied. The mean age was 62.1±8.7, and 27.1% were female. The mean diameter stenosis was 37.2±27.5%, FFR was 0.84±0.10, coronary flow reserve was 2.74±2.07, and IMR 20.3±11.9. Obstructive CAD was present in 39.3%, whereas CMD was detected in 20.6%. The FDR was 60.7% and 62.6% with QCA and FFR as references (p-value=0.803). The combination of FFR and IMR as clinical reference reduced the FDR by 25% compared to QCA (45.8% vs 60.7%; p-value=0.006). CONCLUSIONS: In patients with evidence of ischaemia, an invasive functional assessment accounting for the epicardial and microvascular compartments led to an improvement in the diagnostic performance of exercise tests, driven by a significant FDR reduction.

Coronary in-stent restenosis: assessment with CT coronary angiography.

PURPOSE: To compare accuracy and radiation exposure of a new computed tomographic (CT) scanner with improved spatial resolution (scanner A) with those of a CT scanner with standard spatial resolution (scanner B) for evaluation of coronary in-stent restenosis (ISR) by using invasive coronary angiography (ICA) and intravascular ultrasonography (US) as reference methods. MATERIALS AND METHODS: Written informed consent was obtained and study protocol was approved by institutional ethics committee. A total of 180 consecutive patients (154 men [mean age ± standard deviation, 66 years±12; range, 51-79 years] and 36 women [mean age, 70 years±12; range, 55-83 years]) scheduled to undergo ICA for suspected ISR were enrolled. Ninety patients were studied with scanner A (group 1: 72 men [mean age, 65 years±11; range, 52-79], 18 women [mean age, 68 years±12; range, 55-83 years]) and 90 with scanner B (group 2: 74 men [mean age, 64 years±10; range, 51-77 years], 16 women [mean age, 68 years±11; range, 55-82 years). Examination with the two scanners was compared with ICA and intravascular US. Radiation dose exposure was estimated. To compare stent evaluability between the two groups, χ2 test was used. RESULTS: Stent evaluability was higher in group 1 than in group 2 (99% vs 92%, P=.0021). A significantly lower rate of beam-hardening artifact was observed in group 1 (two cases) than group 2 (12 cases, P<.05). For stent-based analysis, sensitivity, specificity, and accuracy of multidetector CT for ISR identification were 96%, 95%, and 96% in group 1 and 90%, 91%, and 91% in group 2, respectively, without statistically significant differences. The correlation between percent ISR evaluated at multidetector CT versus intravascular US was higher in group 1 than in group 2 (r=0.89 vs r=0.58; P=.019). The correlations of diameter and area measurements at reference site and stent maximal lumen narrowing site between multidetector CT and intravascular US were higher in group 1 than in group 2. Radiation dose was low in both multidetector CT groups (1.9 mSv±0.2). CONCLUSION: Scanner A, with improved spatial resolution, allowed reliable detection and quantification of coronary ISR with low radiation exposure.

Drug-eluting balloon for treatment of in-stent restenosis after carotid artery stenting: preliminary report.

PURPOSE: To evaluate the safety and efficacy of drug-eluting balloons (DEB) for the treatment of in-stent restenosis (ISR) after carotid artery stenting (CAS). METHODS: Among 830 consecutive patients undergoing CAS between November 2001 and June 2012, significant ISR (>80% stenosis) occurred in 10 (1.2%) asymptomatic patients. Angioplasty with DEB treatment was performed in 7 patients (6 internal and 1 common carotid arteries) at a mean of 20.9 ± 19.4 months (median 12.1) after CAS. Intravascular ultrasound (IVUS)-guided predilation with distal cerebral protection was carried out with a cutting balloon followed by inflation of a DEB with a 1:1 stent-to-balloon size ratio. RESULTS: Technical/procedural success was achieved in all cases. Angiographic stenosis decreased from 83%± 5% to 18%± 6%. At IVUS evaluation, minimal lumen area increased from 3.19 ± 1.73 to 12.78 ± 1.97 mm(2) (p=0.0001), stent area was unchanged (from 17.36 ± 4.36 to 17.52 ± 4.34 mm(2), p=0.70), and the restenosis area decreased from 13.58 ± 5.27 to 4.71 ± 3.06 mm(2) (p=0.0005). At a mean follow-up of 13.7 ± 1.5 months (median 13.7), 1 patient had a minor stroke ipsilateral to the ISR vessel 2 months after DEB treatment; the stent was widely patent on duplex ultrasound and angiographic images. Overall, the average PSV decreased from 4.0 ± 1.0 to 0.9 ± 0.1 m/s (p=0.0001). At 6 and 12 months, PSVs after DEB treatment were significantly lower compared to those assessed at comparable intervals after CAS. CONCLUSION: The use of DEBs to treat ISR after CAS shows promising acute and midterm results.

Aortic Rupture and Hemorrhagic Shock After Percutaneous Retrieval of an Embolized Left Atrial Appendage Occluder.

Left atrial appendage (LAA) closure may be complicated by occluder embolization. Percutaneous retrieval is preferred for devices embolized to large vessels. In this report, the successful percutaneous retrieval of an LAA occluder embolized to the abdominal aorta was followed by several complications, culminating in iatrogenic aortic rupture requiring endovascular repair. (Level of Difficulty: Advanced.).