Concordance between vessel-specific and vascular territory coronary functional assessment: A comparison of quantitative flow ratio and myocardial perfusion scintigraphy.

BACKGROUND: Quantitative flow ratio (QFR) and myocardial perfusion scintigraphy (MPS) are utilized for assessing coronary artery disease (CAD) significance. We aimed to analyze their concordance and prognostic impact. AIMS: We aimed to analyze the concordance between QFR and MPS and their risk stratification. METHODS: Patients with invasive coronary angiography and MPS were categorized as concordant if QFR ≤ 0.80 and summed difference score (SDS) ≥ 4 or if QFR > 0.80 and SDS < 4; otherwise, they were discordant. Concordance was classified by coronary territory involvement: total (three territories), partial (two territories), poor (one territory), and total discordance (zero territories). Leaman score assessed coronary atherosclerotic burden. RESULTS: 2010 coronary territories (670 patients) underwent joint QFR and MPS analysis. MPS area under the curve for QFR ≤ 0.80 was 0.637. Concordance rates were total (52.5%), partial (29.1%), poor (15.8%), and total discordance (2.6%). Most concordance occurred in patients without significant CAD or with single-vessel disease (89.5%), particularly without MPS perfusion defects (91.5%). Leaman score (odds ratio [OR]: 0.839, 95% confidence interval [CI]: 0.805-0.875, p < 0.001) and MPS perfusion defect (summed stress score [SSS] ≥ 4) (OR: 0.355, 95% CI: 0.211-0.596, p < 0.001) were independent predictors for discordance. After 1400 days, no significant difference in death/myocardial infarction was observed based on MPS assessment, but Leaman score, functional Leaman score, and average QFR identified higher risk patients. CONCLUSIONS: MPS showed good overall accuracy in assessing QFR significance but substantial discordance existed. Predictors for discordance included higher atherosclerotic burden and MPS perfusion defects (SSS ≥ 4). Leaman score, QFR-based functional Leaman score, and average QFR provided better risk stratification for all-cause death and myocardial infarction than MPS.

Polymer-based or Polymer-free Stents in Patients at High Bleeding Risk.

BACKGROUND: Polymer-free drug-coated stents provide superior clinical outcomes to bare-metal stents in patients at high bleeding risk who undergo percutaneous coronary intervention (PCI) and are treated with 1 month of dual antiplatelet therapy. Data on the use of polymer-based drug-eluting stents, as compared with polymer-free drug-coated stents, in such patients are limited. 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.).

Diabetes mellitus in transfemoral transcatheter aortic valve implantation: a propensity matched analysis.

BACKGROUND: Diabetes Mellitus (DM) affects a third of patients with symptomatic severe aortic valve stenosis undergoing transcatheter aortic valve implantation (TAVI). DM is a well-known risk factor for cardiac surgery, but its prognostic impact in TAVI patients remains controversial. This study aimed to evaluate outcomes in diabetic patients undergoing TAVI. METHODS: This multicentre registry includes data of > 12,000 patients undergoing transfemoral TAVI. We assessed baseline patient characteristics and clinical outcomes in patients with DM and without DM. Clinical outcomes were defined by the second valve academic research consortium. Propensity score matching was applied to minimize potential confounding. RESULTS: Of the 11,440 patients included, 31% (n = 3550) had DM and 69% (n = 7890) did not have DM. Diabetic patients were younger but had an overall worse cardiovascular risk profile than non-diabetic patients. All-cause mortality rates were comparable at 30 days (4.5% vs. 4.9%, RR 0.9, 95%CI 0.8-1.1, p = 0.43) and at one year (17.5% vs. 17.4%, RR 1.0, 95%CI 0.9-1.1, p = 0.86) in the unmatched population. Propensity score matching obtained 3281 patient-pairs. Also in the matched population, mortality rates were comparable at 30 days (4.7% vs. 4.3%, RR 1.1, 95%CI 0.9-1.4, p = 0.38) and one year (17.3% vs. 16.2%, RR 1.1, 95%CI 0.9-1.2, p = 0.37). Other clinical outcomes including stroke, major bleeding, myocardial infarction and permanent pacemaker implantation, were comparable between patients with DM and without DM. Insulin treated diabetics (n = 314) showed a trend to higher mortality compared with non-insulin treated diabetics (n = 701, Hazard Ratio 1.5, 95%CI 0.9-2.3, p = 0.08). EuroSCORE II was the most accurate risk score and underestimated 30-day mortality with an observed-expected ratio of 1.15 in DM patients, STS-PROM overestimated actual mortality with a ratio of 0.77 and Logistic EuroSCORE with 0.35. CONCLUSION: DM was not associated with mortality during the first year after TAVI. DM patients undergoing TAVI had low rates of mortality and other adverse clinical outcomes, comparable to non-DM TAVI patients. Our results underscore the safety of TAVI treatment in DM patients. TRIAL REGISTRATION: The study is registered at clinicaltrials.gov (NCT03588247).

Endovascular therapeutic hypothermia adjunctive to percutaneous coronary intervention in acute myocardial infarction: realistic simulation as a game changer.

BACKGROUND: Endovascular therapeutic hypothermia (ETH) reduces the damage by ischemia/reperfusion cell syndrome in cardiac arrest and has been studied as an adjuvant therapy to percutaneous coronary intervention (PCI) in ST-elevation myocardial infarction (STEMI). New available advanced technology allows cooling much faster, but there is paucity of resources for training to avoid delays in door-to-balloon time (DTB) due to ETH and subsequently coronary reperfusion, which would derail the procedure. The aim of the study was to describe the process for the development of a simulation, training & educational protocol for the multidisciplinary team to perform optimized ETH as an adjunctive therapy for STEMI. METHODS AND RESULTS: We developed an optimized simulation protocol using modern mannequins in different realistic scenarios for the treatment of patients undergoing ETH adjunctive to PCI for STEMIs starting from the emergency room, through the CathLab, and to the intensive care unit (ICU) using the Proteus® Endovascular System (Zoll Circulation Inc™, San Jose, CA, USA). The primary endpoint was door-to-balloon (DTB) time. We successfully trained 361 multidisciplinary professionals in realistic simulation using modern mannequins and sham situations in divisions of the hospital where real patients would be treated. The focus of simulation and training was logistical optimization and educational debriefing with strategies to reduce waste of time in patient's transportation from different departments, and avoiding excessive rewarming during transfer. Afterwards, the EHT protocol was successfully validated in a trial randomizing 50 patients for 18 minutes cooling before coronary recanalization at the target temperature of 32 ± 1.0 ∘C or PCI-only. A total of 35 patients underwent ETH (85.7% [30/35] in 90 ± 15 minutes), without delays in the mean door-to-balloon time for primary PCI when compared to 15 control group patients (92.1 minutes versus 87 minutes, respectively; p = 0.509). CONCLUSIONS: Realistic simulation, intensive training and educational debriefing for the multidisciplinary team propitiated feasible endovascular therapeutic hypothermia as an adjuvant therapy to primary PCI in STEMI. CLINICALTRIALS: gov: NCT02664194.

Sirolimus-coated balloon versus everolimus-eluting stent in de novo coronary artery disease: Rationale and design of the TRANSFORM II randomized clinical trial.

BACKGROUND: Percutaneous coronary intervention (PCI) with drug-eluting stent (DES) implantation is a widely adopted strategy for the treatment of de novo coronary artery disease. DES implantation conveys an inherent risk for short- and long-term complications, including in-stent restenosis and stent thrombosis. Drug-coated balloons are emerging as an alternative approach to fulfill the "leaving nothing behind" principle and avoid long-term DES-related complications. DESIGN: TRANSFORM II is an investigator-initiated, multicenter, noninferiority, randomized clinical trial, testing a sirolimus-coated balloon (SCB) versus the standard of care for native coronary vessels with a 2-3 mm diameter, in terms of 12-month target lesion failure (TLF; primary endpoint) and net adverse cardiovascular events (coprimary endpoint). Patients undergoing PCI will be randomized to be treated with either SCB or new-generation everolimus-eluting stent and will be followed up clinically for up to 60 months. Assuming a TLF rate of 8% at 12 months with DES, a sample size of 1325 patients was chosen to ensure an 80% power to detect a 1.5% lower incidence in the SCB group with a type I error rate of 0.05. The TRANSFORM II trial is registered on clinicaltrials.gov (identification number NCT04893291). Several substudies, including an optical coherence tomography assessment at 9 months (intracoronary imaging substudy), will investigate the study device in different clinical and lesion settings. CONCLUSIONS: The randomized TRANSFORM II trial will determine whether a novel SCB is noninferior to a current everolimus-eluting stent when adopted for the treatment of de novo lesions in coronary vessels with a diameter between 2 and 3 mm.

Clinical outcomes according to lesion complexity in high bleeding risk patients treated with 1-month dual antiplatelet therapy following PCI: Analysis from the Onyx ONE clear study.

OBJECTIVES: To compare clinical outcomes in high bleeding risk (HBR) patients with and without complex percutaneous coronary intervention (PCI) treated with Resolute Onyx zotarolimus-eluting stents (ZES) after 1-month dual antiplatelet therapy (DAPT). BACKGROUND: PCI with 1-month DAPT has been demonstrated to be safe in HBR patients treated with Resolute Onyx ZES. Whether these outcomes are consistent in patients with complex lesions is uncertain. METHODS: Among HBR patients who were event-free 1 month after PCI with ZES and treated thereafter with single antiplatelet therapy (SAPT), the clinical outcomes between 1 month and 1 year were compared after complex PCI (3 vessels treated, ≥ 3 lesions treated, total stent length > 60 mm, bifurcation with ≥ 2 stents implanted, atherectomy, or left main, surgical bypass graft or chronic total occlusion PCI) versus noncomplex PCI. Propensity score adjustment was performed to adjust for baseline differences among complex and noncomplex patients. RESULTS: Complex patients (N = 401, 26.6% of total) had a higher prevalence of hyperlipidemia, diabetes mellitus and previous myocardial infarction (MI). Between 1 month and 1 year, rates of MI (7.1% vs. 4.0%, p = 0.02) and cardiac death/MI (9.3% vs. 6.1%, p = 0.04) were higher among complex versus noncomplex patients, although stent thrombosis rates were similar. After adjustment for baseline characteristics, differences in outcomes were no longer significant between groups. CONCLUSIONS: Higher rates of ischemic outcomes in complex PCI patients were largely explained by baseline clinical differences, rather than lesion complexity, among HBR patients treated with 1-month DAPT following PCI with Resolute Onyx ZES.

Healing and early stent coverage after ultrathin strut biodegradable polymer-coated sirolimus-eluting stent implantation: SiBi optical coherence tomography study.

AIMS: The aim of SiBi study was to evaluate the early vascular healing and neointimal coverage after implantation of ultrathin (60 µm) biodegradable polymer-coated Tetriflex (Sahajanand Medical Technologies Pvt. Ltd., Surat, India) sirolimus-eluting stent (SES) using optical coherence tomography (OCT) at 4 to 6 weeks after implantation. METHODS: SiBi was a single-center, observational, investigator-initiated study. From January 15, 2018 to April 15, 2018, total 29 consecutive patients who had consented and underwent OCT examination at 4-6 weeks after Tetriflex SES implantation were enrolled. All OCT images were analyzed at an independent core laboratory by analysts who were blinded to patient and procedural information. RESULTS: Of 29 patients, four patients were excluded, as those OCT images were technically inadequate for analysis. Therefore, 25 patients were included in final OCT analysis. Average OCT analysis was performed after 35.3 ± 5 days of Tetriflex implantation. Total 14,024 stent struts in 1,520 cross sections were analyzed. Strut tissue coverage was observed in 91.26 ± 5.53% of struts and malapposed struts were seen in 0.89 ± 1.67%. The mean neointimal hyperplasia (NIH) thickness on the covered struts was 50 ± 30 µm. CONCLUSION: A large percentage of struts were found to be covered with thin layer of NIH evenly distributed along the stent length at around 1 month from stent implantation. The results of this pilot study serve as ethical and scientific backbone to conduct an adequately powered clinical trial to evaluate outcomes of short dual-antiplatelet therapy in context of ultrathin strut stent.

Comparison of neointimal coverage between ultrathin biodegradable polymer-coated sirolimus-eluting stents and durable polymer-coated everolimus-eluting stents: 6 months optical coherence tomography follow-up from the TAXCO study.

AIM: The TAXCO study was designed to compare the degree of neointimal coverage and the prevalence of malapposition at 6 months subsequent to implantation of ultrathin biodegradable polymer-coated sirolimus-eluting stents (SES) and durable polymer-coated everolimus-eluting stents (EES) of thin strut thickness using optical coherence tomography (OCT). METHODS: The TAXCO study included a total of 42 patients who gave consent and underwent OCT examination between August 2017 and September 2017. Of 42, five patients' OCT examinations were of insufficient quality for quantitative analysis. Thus, the OCT analysis group consisted of 37 patients. Among them, 16 patients were treated with Xience (Abbott Vascular) and 21 with Tetriflex (Sahajanand Medical Technologies Pvt. Ltd., Surat, India), 6 (±1) months earlier at our institution. The OCT was performed using a C7 Dragonfly™ imaging catheter (St. Jude Medical Inc.). All OCT images were analyzed at an independent core laboratory (Cardiovascular Research Center, São Paulo, Brazil) by analysts who were blinded to patient and procedural information. RESULTS: A total of 763 crosssections (6,882 struts) were analyzed in Xience group, and 1,127 crosssections (9,968 struts) in Tetriflex group. At 6 months, on per-lesion basis, no significant differences were observed between Xience group and Tetriflex group in mean percentage of uncovered struts (1.87 ± 3.86 vs. 2.42 ± 3.46, p = .137) and malapposed struts (0.05 ± 0.2 vs. 0.21 ± 0.69, p = .302). Strut-level neointimal thickness also did not differ between Xience group and Tetriflex group (0.18 ± 0.12 vs. 0.14 ± 0.08 mm, p = .286). CONCLUSION: This OCT study found no significant difference in strut coverage and neointimal thickness at 6 months after implantation of biodegradable polymer-coated Tetriflex, when compared with durable polymer-coated Xience.

Long-term serial functional evaluation after implantation of the Fantom sirolimus-eluting bioresorbable coronary scaffold.

BACKGROUND: Quantitative flow ratio (QFR) has been validated as an accurate surrogate of standard wire-based fractional flow reserve. The clinical and angiographic outcomes of the Fantom sirolimus-eluting bioresorbable coronary scaffold (BRS) have been previously studied and reported. We investigate the functional performance of the Fantom BRS. METHODS: The FANTOM II trial prospectively enrolled 240 patients with stable coronary artery disease or unstable angina, of which 235 patients received the Fantom BRS and were included in the present analysis. We performed an independent serial QFR analysis of the target vessel at baseline, post-percutaneous coronary intervention (PCI), and at 6- or 9-month and 24-month follow-up, using a QFR threshold ≤0.80 to define functional ischemia. RESULTS: QFR was analyzable in 178 patients at baseline, 185 post-PCI, 178 at 6- or 9-month follow-up, and 30 at 24-month follow-up. At baseline, 119 patients (66.9%) had a QFR ≤0.80, whereas 12 (6.5%) post-PCI, 13 (7.3%) at 6- or 9-month follow-up, and 3 (10.0%) at 24-month follow-up had a QFR ≤0.80. QFR improved from baseline to post-PCI, and decreased from post-PCI up to 24-month follow-up. During follow-up period, 28 patients (11.9%) had target vessel revascularization, of which 21 had analyzable QFR and 16 patients (76.1%) had QFR ≤0.80 at the time of revascularization. CONCLUSIONS: Off-line serial QFR assessment demonstrated that around 30% patients did not have functionally significant lesions at baseline and the time with target vessel revascularization. PCI with the Fantom BRS improved functional ischemia with a slight decrease in QFR values over 24 months.

Mid- to long-term clinical and echocardiographic outcomes after transcatheter aortic valve replacement with a new-generation, self-expandable system.

OBJECTIVES: The aim of the study was to evaluate mid- to late clinical and echocardiographic outcomes after transcatheter aortic valve replacement (TAVR) with Acurate neo™ (Boston Scientific, Boston, MA). BACKGROUND: TAVR is an established treatment for aortic stenosis (AS). Few data exist on mid- to long-term outcomes and durability after new-generation valves. METHODS: All consecutive patients (n = 104) who underwent Acurate neo™ implantation from 2012 to 2018 were included. Follow-up was systematically performed at 1, 6, 12, and 24 months and yearly thereafter. Outcomes were reported according to VARC-2, and structural valve deterioration (SVD) or bioprosthetic valve failure defined accordingly to new definitions. RESULTS: Mean age was 82 ± 5.4 years, 56.7% were female and the Society of Thoracic Surgeons score for mortality was 5.9 ± 4%. Patients were followed for a median of 3 years (1,092 days; IQR 1.5-4 years), and the maximum follow-up was 7 years. All-cause mortality values at 1 and 5 years were 8.5% and 40.5%, respectively. No relevant changes in mean gradient and orifice area occurred (7.9 ± 3.8 mmHg and 1.9 ± 0.3 cm2 at 1 year; 6.6 ± 2.1 mmHg and 1.8 ± 0.3 cm2 at 5 years), and there was a significant rate of paravalvular leaks resolution at 1, 2, and 3 years (p = .004; p < .001; p < .001, respectively). None of the patients had leaflet thrombosis or endocarditis. One patient developed SVD at 84 months. CONCLUSIONS: Acurate neo™ was associated with sustained echocardiographic results. Reassuring mid- to long-term outcomes was observed in this cohort of elderly patients with severe AS.

Predictive role of Selvester QRS score in patients undergoing transcatheter aortic valve replacement.

INTRODUCTION: Few data exist regarding the late clinical impact of the Selvester score prediction of myocardial fibrosis after transcatheter aortic valve replacement (TAVR). This study evaluated the predictive power of the Selvester score on survival in patients with aortic stenosis (AS) undergoing TAVR. METHODS AND RESULTS: Patients with severe AS who had preoperative electrocardiograms were included. Clinical follow-up was obtained retrospectively. The primary endpoint was all-cause mortality. Secondary endpoints were cardiovascular death and major adverse cardiac events (MACEs). Two-hundred twenty-eight patients were included (mean age, 81.5 ± 7.4 years; women, 58.3%). Deceased patients had a higher mean score (4.6 ± 3.2 vs. 1.4 ± 1.3; p < .001). At a mean follow-up of 36.2 ± 21.2 months, the Selvester score was independently associated with all-cause mortality (hazard ratio [HR], 1.65; 95% confidence interval [CI], 1.48-1.84; p < .001), cardiovascular death (HR, 1.59; 95% CI, 1.38-1.74; p < .001), and MACE (HR, 1.55; 95% CI, 1.30-1.68; p < .001). After 5 years, the mortality risk was incrementally related to the Selvester score. The involvement of the inferior wall of the left ventricle was a lower mortality risk factor (HR, 0.42; 95% CI, 0.18-0.98; p = .046). For a Selvester score of 3, the area under the curve showed 0.92, 0.94, and 0.86 (p < .001), respectively, for 1, 2, and 3 years. CONCLUSIONS: Elevated Selvester scores increase the risk of poor outcomes in patients with AS undergoing TAVR. The involvement of the anterior or lateral wall presents worse prognosis.

Imaging and 2-year clinical outcomes of thin strut sirolimus-eluting bioresorbable vascular scaffold: The MeRes-1 extend trial.

OBJECTIVES: This study explores the safety and efficacy of thin strut MeRes100 sirolimus-eluting bioresorbable vascular scaffold (BRS) in patients with de novo coronary artery lesions. BACKGROUND: In interventional cardiology, the emergence of BRS technology is catalyzing the next paradigm shift. METHODS: The MeRes-1 Extend was a multicenter, prospective, single-arm, open-label study enrolling 64 patients in Spain, Macedonia, Brazil, South Africa, Malaysia, and Indonesia. The safety endpoint was major adverse cardiac events (MACE) which composed of cardiac death, myocardial infarction (MI), and ischemia-driven target lesion revascularization (ID-TLR). The imaging efficacy endpoint was mean in-scaffold late lumen loss (LLL) evaluated by quantitative coronary angiography (QCA). Optical coherence tomography (OCT) imaging was performed at baseline and 6-month follow-up. RESULTS: A total of 69 target lesions were identified in 64 enrolled patients (mean age 58.30 ± 9.02 years). Of the treated lesions, 49 (71.01%) lesions were of type B2/C. Procedural and device success was achieved in 64 and 62 patients, respectively. At 2-year follow-up, MACE was reported in one patient (1.61%) in the form of ID-TLR. There was no case of MI, cardiac death or scaffold thrombosis through 2-year. In a subset of 32 patients, paired QCA showed mean in-scaffold LLL of 0.18 ± 0.31 mm at 6-month follow-up. In a subset of 21 patients, OCT revealed 97.95 ± 3.69% strut coverage with mean scaffold area of 7.56 ± 1.79 mm2 and no evidence of strut malapposition. CONCLUSIONS: The clinical and imaging outcomes of MeRes-1 Extend trial demonstrated favorable safety and efficacy of MeRes100 sirolimus-eluting BRS in patients with de novo coronary artery lesions.

Patients with COVID-19 who experience a myocardial infarction have complex coronary morphology and high in-hospital mortality: Primary results of a nationwide angiographic study.

OBJECTIVES: We aimed to explore angiographic patterns and in-hospital outcomes of patients with concomitant coronavirus disease-19 (COVID-19) and myocardial infarction (MI). BACKGROUND: Patients with COVID-19 may experience MI during the course of the viral infection. However, this association is currently poorly understood. METHODS: This is a multicenter prospective study of consecutive patients with concomitant COVID-19 and MI who underwent coronary angiography. Quantitative and qualitative coronary angiography were analyzed by two observers in an independent core lab. RESULTS: A total of 152 patients were included, of whom 142 (93.4%) had COVID-19 diagnosis confirmation. The median time between symptom onset and hospital admission was 5 (1-10) days. A total of 83 (54.6%) patients presented with ST-elevation MI. The median angiographic Syntax score was 16 (9.0-25.3) and 69.0% had multi-vessel disease. At least one complex lesion was found in 73.0% of patients, 51.3% had a thrombus containing lesion, and 57.9% had myocardial blush grades 0/1. The overall in-hospital mortality was 23.7%. ST-segment elevation MI presentation and baseline myocardial blush grades 0 or 1 were independently associated with a higher risk of death (HR 2.75, 95%CI 1.30-5.80 and HR 3.73, 95%CI 1.61-8.61, respectively). CONCLUSIONS: Patients who have a MI in the context of ongoing COVID-19 mostly present complex coronary morphologies, implying a background of prior atherosclerotic disease superimposed on a thrombotic milieu. The in-hospital prognosis is poor with a markedly high mortality, prompting further investigation to better clarify this newly described condition.

Percutaneous endovascular delivery of calcium chloride to the intact porcine carotid artery: A novel animal model of arterial calcification.

OBJECTIVE: The present study evaluated the effect of endovascular administration of calcium chloride to the carotid artery of swines, to create a model of arterial calcification. METHODS: Fifteen Large White pigs were used for the study. Via endovascular treatment, carotid arteries were exposed during 9 min to either calcium chloride (experimental artery) or saline (control artery) with the use of the TAPAS catheter. Intravascular ultrasound (IVUS) imaging was obtained at baseline, postprocedure and at 30 days. Optical coherence tomography (OCT) imaging was obtained in vitro after carotids were harvested. Longitudinally cut parallel arterial segments were placed in a system of delicate clamps and underwent uniaxial strain test. All arteries underwent histopathological examination. RESULTS: Calcium chloride treated segments showed extensive circumferential parietal calcification evident on both IVUS and OCT. Reduction in minimal lumen area on IVUS was evident in experimental arteries both at 24 hr and 30 days postprocedure. Histopathologic assessment (Von Kossa stain) confirmed medial calcification with mild intimal thickening. Biomechanical testing showed treated segments to have smaller breaking strength and less elastic deformation than controls. CONCLUSION: We developed a nonexpensive, reproducible model of early carotid medial calcification in pigs. Our model has the potential to help the development of research to unravel mechanisms underlying arterial calcification, the use of current or new devices to treat calcified lesions as well as to serve as an option for training interventionalists on the use of such devices.

The REMEDEE trial: 5-Year results on a novel combined sirolimus-eluting and endothelial progenitor cells capturing stent.

OBJECTIVES: To evaluate the long-term safety and efficacy of the novel combined sirolimus-eluting endothelial progenitor cell capture Combo stent (OrbusNeich, Fort Lauderdale, FL) at 5 years in the REMEDEE (Randomized study to Evaluate the safety and effectiveness of an abluMinal sirolimus coated bio-Engineered stEnt) trial. BACKGROUND: Drug-eluting stents have limited restenosis and reintervention but are complicated by late and very late thrombosis and accelerated neoatherosclerosis. Alternative or adjunctive technologies are needed to address these limitations. METHODS: A total of 183 patients with de novo lesions in native coronary arteries were randomized 2:1 to Combo (n = 124) or Taxus Liberté (n = 59). Primary endpoint was 9 month angiographic in-stent late lumen loss and the secondary endpoint was the occurrence of major adverse events (MACE) through 5-year follow-up. RESULTS: Compared with Taxus, after 5 years the Combo stent was associated with similar rates of MACE (18.3% vs. 16.9%, p = .89), cardiac death (0.8% vs. 5.1%, p = .07), myocardial infarction (4.1% vs. 3.4%, p = .81), target lesion (9.4% vs. 10.2%, p = .78), and target vessel revascularization (14.4% vs. 11.9%, p = .73). No cases of definite stent thrombosis were reported in the Combo group. The follow-up rate at 5 years was 97.7%. CONCLUSION: At 5-year follow-up, the Combo stent remained clinically safe and effective with an overall low rate of MACE comparable to Taxus.

Comparison of balloon-expandable vs. self-expandable valves in patients undergoing transfemoral transcatheter aortic valve implantation: from the CENTER-collaboration.

Aims: The aim of this study was to compare clinical outcomes of patients undergoing transfemoral transcatheter aortic valve implantation (TAVI) with balloon-expandable (BE) valves vs. self-expandable (SE) valves. Transcatheter aortic valve implantation is a minimally invasive and lifesaving treatment in patients with aortic valve stenosis. Even though BE-valves and SE-valves are both commonly used on a large scale, adequately sized trials comparing clinical outcomes in patients with severe aortic valve stenosis treated with BE-valves compared with SE-valves are lacking. Methods and results: In this CENTER-collaboration, data from 10 registries or clinical trials, selected through a systematic search, were pooled and analysed. Propensity score methodology was used to reduce treatment selection bias and potential confounding. The primary endpoints were mortality and stroke at 30 days follow-up in patients treated with BE-valves compared with SE-valves. Secondary endpoints included clinical outcomes, e.g. bleeding during hospital admission. All outcomes were split for early-generation BE-valves compared with early-generation SE-valves and new-generation BE-valves with new-generation SE-valves. The overall patient population (N = 12 381) included 6239 patients undergoing TAVI with BE-valves and 6142 patients with SE-valves. The propensity matched population had a mean age of 81 ± 7 years and a median STS-PROM score or 6.5% [interquartile range (IQR) 4.0-13.0%]. At 30-day follow-up, the mortality rate was not statistically different in patients undergoing TAVI with BE-valves compared with SE-valves [BE: 5.3% vs. SE: 6.2%, relative risk (RR) 0.9; 95% confidence interval (CI) 0.7-1.0, P = 0.10]. Stroke occurred less frequently in patients treated with BE-valves (BE: 1.9% vs. SE: 2.6%, RR 0.7; 95% CI 0.5-1.0, P = 0.03). Also, patients treated with BE-valves had a three-fold lower risk of requiring pacemaker implantation (BE: 7.8% vs. SE: 20.3%, RR 0.4; 95% CI 0.3-0.4, P < 0.001). In contrast, patients treated with new-generation BE-valves more frequently experienced major and life-threatening bleedings compared with new-generation SE-valves (BE: 4.8% vs. SE: 2.1%, RR 2.3; 95% CI 1.6-3.3, P < 0.001). Conclusion: In this study, which is the largest study to compare valve types in TAVI, we demonstrated that the incidence of stroke and pacemaker implantation was lower in patients undergoing transfemoral TAVI with BE-valves compared with SE-valves. In contrast, patients treated with new-generation BE-valves more often suffered from major or life-threatening bleedings than patients with new-generation SE-valves. Mortality at 30-days was not statistically different in patients treated with BE-valves compared with SE-valves. This study was a propensity-matched analysis generated from observational data, accordingly current outcomes will have to be confirmed in a large scale randomized controlled trial.

Standardized Definition of Structural Valve Degeneration for Surgical and Transcatheter Bioprosthetic Aortic Valves.

Bioprostheses are prone to structural valve degeneration, resulting in limited long-term durability. A significant challenge when comparing the durability of different types of bioprostheses is the lack of a standardized terminology for the definition of a degenerated valve. This issue becomes especially important when we try to compare the degeneration rate of surgically inserted and transcatheter bioprosthetic valves. This document, by the VIVID (Valve-in-Valve International Data), proposes practical and standardized definitions of valve degeneration and provides recommendations for the timing of clinical and imaging follow-up assessments accordingly. Its goal is to improve the quality of research and clinical care for patients with deteriorated bioprostheses by providing objective and strict criteria that can be utilized in future clinical trials. We hope that the adoption of these criteria by both the cardiological and surgical communities will lead to improved comparability and interpretation of durability analyses.

Rationale and design of the Onyx ONE global randomized trial: A randomized controlled trial of high-bleeding risk patients after stent placement with 1 month of dual antiplatelet therapy.

BACKGROUND AND RATIONALE: Polymer-free drug-eluting stent (DES) implantation in combination with 1-month dual antiplatelet therapy (DAPT) has shown superior safety and efficacy outcomes compared with bare-metal stents among patients with high-bleeding risk (HBR) treated with 1-month DAPT. The safety and efficacy of the newer-generation durable-polymer DES Resolute Onyx compared with polymer-free DES among HBR patients treated with 1-month DAPT is unknown. TRIAL DESIGN: The Onyx ONE global randomized trial is an international, prospective, randomized, blinded, controlled study enrolling HBR patients undergoing percutaneous coronary intervention. The trial will randomize up to 2,000 patients in a 1:1 fashion to receive either the durable-polymer Resolute Onyx DES or the polymer-free Biosensors BioFreedom DES. After index procedure, patients in both arms will be treated with 1 month of DAPT (aspirin and oral P2Y12 inhibitor), followed by single antiplatelet therapy thereafter. The primary end point is the composite end point of cardiac death, myocardial infarction, or stent thrombosis at 1-year follow-up. The powered secondary end point is target lesion failure (defined as the composite of cardiac death, target vessel myocardial infarction, or clinically driven target lesion revascularization) at 1 year. Patient follow-up is planned for 1, 2, and 6 months and 1 and 2 years after the procedure. CONCLUSIONS: The Onyx ONE global randomized trial is the first study to directly compare the safety and efficacy of a durable polymer DES (Resolute Onyx) with a polymer-free DES (BioFreedom) in HBR patients treated with 1 month of DAPT.

Three-year clinical outcomes of patients treated with everolimus-eluting bioresorbable vascular scaffolds: Final results of the ABSORB EXTEND trial.

BACKGROUND: There is still limited data on the very long term clinical outcomes after ABSORB BRS in daily practice. We sought to evaluate the 3 year-performance of the Absorb bioresorbable vascular scaffolds for the treatment of low/moderate complexity patients enrolled in the ABSORB EXTEND trial. METHODS: ABSORB EXTEND is a prospective, single-arm, open-label clinical study in which 812 patients were enrolled at 56 sites. This study allowed the treatment of lesions ≤28 mm in length and reference vessel diameter of 2.0-3.8 mm (as assessed by on-line QCA). To determine the independent predictors of MACE, a multivariable logistic regression model was built using a stepwise (forward/backward) procedure. RESULTS: Average population age was 61 years and 26.5% had diabetes. Most patients had single target lesion (92.4%). Adequate scaffold deployment (PSP) was achieved in 14.2% of the cases. At three years, the composite endpoints of MACE and ischemia-driven target vessel failure were 9.2% and 10.6%, respectively. The cumulative rate of ARC definite/probable thrombosis was 2.2%, with 1.2% of the cases occurring after the 1st year. Independent predictors of MACE were hypertension and the need for "bail out" stent. CONCLUSION: At three-year follow-up, the use of ABSORB in low/moderate complex PCI was associated with low and acceptable rates of major adverse clinical events, despite the infrequent use of the recommended contemporary scaffold deployment technique. However, scaffold thrombosis rate was higher than reported with current generation of metallic DES. The study is registered on clinicaltrials.gov (unique identifier NCT01023789).

E/e` ratio is superior to speckle tracking for detecting elevated left ventricular end-diastolic pressure in patients with coronary artery disease and preserved ejection fraction.

BACKGROUND: A weak correlation has been reported between left ventricular filling pressures and the traditional echocardiographic tools for the evaluation of diastolic function in patients with coronary artery disease (CAD) and preserved left ventricular ejection fraction (LVEF). On the other hand, studies that compared invasive measurements with speckle tracking echocardiography have shown promising results, but they were not exclusively targeted on this specific population. METHODS AND RESULTS: Immediately before the left heart catheterization, a comprehensive two-dimensional Doppler echocardiography and speckle tracking analysis was prospectively performed in outpatients referred for coronary angiography. Left ventricular end-diastolic pressure (LVEDP) was measured before any contrast exposure. Eighty-one patients with coronary artery disease were studied, and the group with high LVEDP (n = 40) showed increased left atrial volume index (22 ± 6 mL/m2 vs 26 ± 8.26 mL/m2 , P = 0.04), E-wave velocity (65 ± 15 cm/s vs 78 ± 20 cm/s, P = 0.02), E/e` (average) ratio (8.14 ± 2.0 vs 11.54 ± 2.7, P = 0.03), and E/global circumferential strain rate E peak ratio (E/GCSRE ) (39 cm vs 46 cm, P < 0.01). There was a positive correlation between LVEDP and E/e` (ρ = 0.56; P = 0.03), and between LVEDP and E/GCSRE ratio (ρ = 0.43; P < 0.01). The area under the receiver operating characteristics (ROC) curve was 0.83 and 0.73, respectively (P < 0.05). E/e` and E/GCSRE were both independent predictors of elevated LVEDP (P < 0.05), with a higher C-statistic for the model including E/e` (0.89 vs 0.85). CONCLUSION: The E/e` ratio was able to identify elevated LVEDP in CAD patients with preserved LVEF with more accuracy than the E/GCSRE ratio.