Comparison of Supraflex Cruz 60 µm Versus Ultimaster Tansei 80 µm Stent Struts in High Bleeding Risk PCI Patients: Study design and Rational of Compare 60/80 HBR trial.

Up to 45% of patients who underwent percutaneous coronary intervention (PCI) may have a high bleeding risk (HBR), depending on the bleeding risk definition.1 This condition is often associated with an enhanced risk of thrombotic events with a negative impact on short- and long-term outcomes,2-8 making the choice of an appropriate antithrombotic regimen after PCI particularly challenging. Advances in stent technologies, in which the introduction of newer generations of thinner strut drug-eluting stents (DES), have significantly reduced the rate of thrombotic complications and may justify a shorter dual antiplatelet therapy (DAPT) duration. Both in vitro and in vivo studies have shown that local hemodynamic factors may critically affect the natural history of atherosclerosis. Strut thickness correlates with flow disturbances and endothelial shear stress. Flow separation within struts determines areas of recirculation with low endothelial shear stress which promotes local concentration of activated platelets.9 By mitigating inflammation, vessel injury, and neointimal proliferation, thin and streamlined struts have been associated with faster vascular healing and re-endothelization and have resulted in lower rates of thrombotic events after PCI.10,11 The use of thin strut and ultra-thin strut stents may lead to a favorable trade-off in bleeding and ischemic events in patients with HBR. However, dedicated studies evaluating the performance of thin strut versus ultrathin strut stents in patients with HBR are lacking.

Less bleeding by omitting aspirin in non-ST-segment elevation acute coronary syndrome patients: Rationale and design of the LEGACY study.

BACKGROUND: Early aspirin withdrawal, also known as P2Y12-inhibitor monotherapy, following percutaneous coronary intervention (PCI) for non-ST-segment elevation acute coronary syndrome (NSTE-ACS) can reduce bleeding without a trade-off in efficacy. Still the average daily bleeding risk is highest during the first months and it remains unclear if aspirin can be omitted immediately following PCI. METHODS: The LEGACY study is an open-label, multicenter randomized controlled trial evaluating the safety and efficacy of immediate P2Y12-inhibitor monotherapy versus dual antiplatelet therapy (DAPT) for 12 months in 3,090 patients. Patients are randomized immediately following successful PCI for NSTE-ACS to 75-100 mg aspirin once daily versus no aspirin. The primary hypothesis is that immediately omitting aspirin is superior to DAPT with respect to major or minor bleeding defined as Bleeding Academic Research Consortium type 2, 3, or 5 bleeding, while maintaining noninferiority for the composite of all-cause mortality, myocardial infarction and stroke compared to DAPT. CONCLUSIONS: The LEGACY study is the first randomized study that is specifically designed to evaluate the impact of immediately omitting aspirin, and thus treating patients with P2Y12-inhibitor monotherapy, as compared to DAPT for 12 months on bleeding and ischemic events within 12 months following PCI for NSTE-ACS.

Impact of multisite artery disease on clinical outcomes after percutaneous coronary intervention: an analysis from the e-Ultimaster registry.

BACKGROUND: Multisite artery disease is considered a 'malignant' type of atherosclerotic disease associated with an increased cardiovascular risk, but the impact of multisite artery disease on clinical outcomes after percutaneous coronary intervention (PCI) is unknown. METHODS: Patients enrolled in the large, prospective e-Ultimaster study were grouped into (1) those without known prior vascular disease, (2) those with known single-territory vascular disease, and (3) those with known two to three territories (i.e coronary, cerebrovascular, or peripheral) vascular disease (multisite artery disease). The primary outcome was coronary target lesion failure (TLF), defined as the composite of cardiac death, target vessel-related myocardial infarction, and clinically driven target lesion revascularization at 1-year. Inverse propensity score weighted (IPSW) analysis was performed to address differences in baseline patient and lesion characteristics. RESULTS: Of the 37 198 patients included in the study, 62.3% had no prior known vascular disease, 32.6% had single-territory vascular disease, and 5.1% had multisite artery disease. Patients with known vascular disease were older and were more likely to be men and to have more co-morbidities. After IPSW, the TLF rate incrementally increased with the number of diseased vascular beds (3.16%, 4.44%, and 6.42% for no, single, and multisite artery disease, respectively, P < 0.01 for all comparisons). This was also true for all-cause death (2.22%, 3.28%, and 5.29%, P < 0.01 for all comparisons) and cardiac mortality (1.26%, 1.91%, and 3.62%, P ≤ 0.01 for all comparisons). CONCLUSIONS: Patients with previously known vascular disease experienced an increased risk of adverse cardiovascular events and mortality post-PCI. This risk is highest among patients with multisite artery disease.Trial Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT02188355.

Prognosis of PCI in AMI setting in the elderly population: Outcomes from the multicenter prospective e-ULTIMASTER registry.

BACKGROUND: Elderly patients with ST-elevation myocardial infarction (STEMI) who undergo percutaneous coronary intervention (PCI) are usually excluded from major trials. HYOPTHESIS: This study sought to assess 1-year clinical outcomes following PCI with a drug-eluting stent in patients older than 80 years old with STEMI. METHODS: The large all-comer, multicontinental e-ULTIMASTER registry included 7507 patients with STEMI who underwent PCI using the Ultimaster stent. The primary clinical endpoint was 1-year target lesion failure, a composite of cardiac death (CD), target vessel-related myocardial infarction (TV-MI), or clinically driven target lesion revascularization (CD-TLR). RESULTS: There were 457 (6.1%) patients in the elderly group (≥80 years old) that were compared to 7050 (93.9%) patients <80 years. The elderly patients included more female patients and had significantly more comorbidities and had more complex coronary anatomy. The primary endpoint occurred in 7.2% of the elderly, compared to 3.1% of the younger group (p < .001). All-cause mortality was significantly higher among the elderly group compared to the younger group (10.1% vs. 2.3%, p < .0001), as well as CD (6.1% vs. 1.6%, p < .0001), but not TV-MI (1.1% vs. 0.7%, p = .34) or CD-TLR (1.1% vs. 1.4%, p = .63). CONCLUSION: Elderly patients with STEMI presentation had a higher incidence of the composite endpoint than younger patients. All-cause and CD were higher for elderly patients compared to patients younger than 80 years old. However, there was no difference in the incidence of TV-MI or target lesion revascularizations. These findings suggest that PCI for STEMI in elderly patients is relatively safe.

Clinical Performance of a Paclitaxel Drug-Coated Balloon in Real-World Percutaneous Coronary Intervention Practice: The PEARL Registry.

BACKGROUND: Randomized controlled trials for in-stent restenosis (ISR) and de novo lesions in small-diameter vessels have shown promising results, but data on DCB use in real-world practice are still scarce. The aim of the PEARL (Paclitaxel-Eluting Angioplasty Balloon in the Real-World) registry was to evaluate the safety and efficacy of a paclitaxel DCB in real-world percutaneous coronary intervention (PCI) practice. METHODS: Between 2014 and 2019, a total of 513 patients treated with the Protégé paclitaxel DCB (Wellinq) were prospectively included at 4 hospitals in the Netherlands. The primary endpoint was 2-year major adverse cardiac event (MACE), defined as cardiac death, target-vessel myocardial infarction, or target-lesion revascularization (TLR). RESULTS: DCB was used for ISR in 382 patients and for de novo lesions in 131 patients. Acute coronary syndrome was the reason for presentation in 58.9% of patients. At lesion level, 34.1% of lesions were classified as type B2 and 36.1% as type C. Predilation was performed in 62.2% and noncompliant DCB was used in 40.7% of lesions. DCB-related procedural complications were infrequent (3.3%, mostly coronary dissection [2.3%]). Bailout stenting was required in 3.1%. MACE during 2-year follow-up occurred in 17.1% of patients treated for ISR and 9.7% of patients treated for de novo lesions. The incidence of TLR was 11.7% of ISR patients and 2.9% of de novo patients. History of coronary artery bypass grafting and lesion length were predictors of MACE in patients treated for ISR. CONCLUSION: The use of Protégé paclitaxel DCB for PCI of ISR and de novo lesions is safe and effective during 2-year follow-up.

FFR pressure wire comparative study for drift: piezo resistive versus optical sensor.

BACKGROUND: This study aimed to assess the stability of pressure derived fractional flow reserve (FFR) measurement and the handling performance of the OptoWire Deux with an optical pressure sensor relative to the PressureWire X with piezo resistive pressure sensors. METHODS: This multicenter centre observational study included 50 patients between June 2017 and November 2018 undergoing a diagnostic coronary angiography with FFR measurement of moderate to severe lesions. The reliability of FFR measurement measured with the OptoWire Deux relative to the PressureWire X in each lesion was assessed by the presence of drift. Handling characteristics for both pressure wires were assessed by a 5-point scale and by comparing the time between equalization and crossing the distal target lesion. RESULTS: Hundred and sixteen measurements in 50 patients were performed. Very stable and reliable FFR measurements with the optical sensors were registered, relative to the piezo resistive pressure sensors. There is statistically significant difference in favor of the OptoWire Deux over the PressureWire X (P=0.001). However, the differences are small, when drift values were compared as continuous variables, no statistically significant difference was found for both directional (P=0.435) as for absolute drift (P=0.058). CONCLUSIONS: In patients undergoing FFR measurement, both optical sensor pressure wires (Optowire Deux) as piezo resistive sensor pressure wires (PressureWire X) generate stable and reliable pressure and thus FFR measurement. The optical pressure sensor is less susceptible for drift relative to the piezo resistive pressure sensor, but the difference is within an acceptable range.

Outcomes and regional differences in practice in a worldwide coronary stent registry.

OBJECTIVE: The primary objective was to assess the performance of a new generation thin-strut sirolimus-eluting coronary stent with abluminal biodegradable polymer in an all comer population. The secondary objective was to detail differences in contemporary percutaneous coronary intervention (PCI) practice worldwide. METHODS: e-Ultimaster was an all-comer, prospective, global registry (NCT02188355) with independent event adjudication enrolling patients undergoing PCI with the study stent. The primary outcome measure was target lesion failure (TLF) at 1 year, defined as the composite of cardiac death, target vessel myocardial infarction and clinically driven target lesion revascularisation. Data were stratified according to 4 geographical regions. RESULTS: A total of 37 198 patients were enrolled (Europe 69.2%, Asia 17.8%, Africa/Middle East 6.6% and South America/Mexico 6.5%) and 1-year follow-up was available for 35 389 patients (95.1%). One-year TLF occurred in 3.2% of the patients, ranging from 2% (Africa/Middle East) to 4.1% (South America/Mexico). In patients with acute coronary syndrome, potent P2Y12 inhibitors were prescribed in 48% of patients at discharge, while at 1 year 72% were on any dual antiplatelet therapy. Lipid-lowering treatment was administered in 80.9% and 75.5% of patients at discharge and 1 year, respectively. Regional differences in the profile of the treated patients as well as in PCI practice were reported. CONCLUSIONS: In this investigation with worldwide representation, contemporary PCI using a new generation thin-strut sirolimus-eluting coronary stent with abluminal biodegradable polymer was associated with low 1-year TLF across clinical presentations and continents. Suboptimal adherence to current recommendations around antiplatelet and lipid lowering treatments was detected.

Impact of age on the comparison between short-term vs 12-month dual antiplatelet therapy in patients with acute coronary syndrome treated with the COMBO dual therapy stent: 2-Year follow-up results of the REDUCE trial.

BACKGROUND AND AIMS: The impact of advanced age on the optimal duration of dual antiplatelet therapy (DAPT) in patients with acute coronary syndrome (ACS) undergoing percutaneous coronary revascularization (PCI) is still greatly debated. Therefore, the aim of the present sub-analysis of the REDUCE trial was to assess the impact of age on the comparison between a short 3 months vs standard 12 months DAPT in ACS patients treated with the COMBO Dual Stent Therapy. METHODS: The REDUCE trial is a prospective, multicenter, investigator-initiated study that randomized ACS patients undergoing PCI with the COMBO drug eluting stent to either 3 or 12 months of DAPT. The study population was divided according to age (

One-year performance of thin-strut cobalt chromium sirolimus-eluting stent versus thicker strut stainless steel biolimus-eluting coronary stent: a propensity-matched analysis of two international all-comers registries.

OBJECTIVES: Recent improvements in coronary stent design have focussed on thinner struts, different alloys and architecture, more biocompatible polymers, and shorter drug absorption times. This study evaluates safety and efficacy of a newer generation thin-strut cobalt chromium sirolimus-eluting coronary stent (SES, Ultimaster) in comparison with a second-generation thicker strut stainless steel biolimus-eluting stent (BES, Nobori) in percutaneous coronary intervention (PCI) practice. METHODS: A propensity score analysis was performed to adjust for differences in baseline characteristics of 8137 SES patients and 2738 BES patients of two PCI registries (e-Ultimaster and NOBORI 2). An independent clinical event committee adjudicated all endpoint-related adverse events. RESULTS: The use of SES, as compared with BES was associated with a significantly lower rate of myocardial infarction (MI) (1.2% vs 2.2%; P = 0.0006) and target vessel-related MI (1.1% vs 1.8%; P = 0.002) at 1 year. One-year composite endpoints of all predefined endpoints were lower in patients undergoing SES implantation (target lesion failure: 3.2% vs 4.1%; P = 0.03, target vessel failure: 3.7% vs 5.0%; P = 0.003, patient-oriented composite endpoint 5.7% vs 6.8%; P = 0.03). No significant differences between SES and BES were observed in all-cause death (2.0% vs 1.6%; P = 0.19), cardiac death (1.2% vs 1.2%; P = 0.76) or stent thrombosis (0.6% vs 0.8%; P = 0.43). CONCLUSIONS: These findings suggest an improved clinical safety and efficacy of a newer generation thin-strut SES as compared with a second-generation thicker strut BES.

Impact of coronary lesion complexity in percutaneous coronary intervention: one-year outcomes from the large, multicentre e-Ultimaster registry.

AIMS: The present study sought to examine the prevalence, clinical characteristics and one-year outcomes of patients undergoing percutaneous coronary intervention (PCI) to complex lesions (multivessel PCI, ≥3 stents, ≥3 lesions, bifurcation with ≥2 stents, total stent length >60 mm or chronic total occlusion [CTO]) in a prospective multicentre registry. METHODS AND RESULTS: Using the e-Ultimaster multicentre registry, a post hoc subgroup analysis was performed on 35,839 patients undergoing PCI, stratified by procedure complexity, and further by number and type of complex features. Overall, complex PCI patients (n=9,793, 27.3%) were older, more comorbid and were associated with an increased hazard ratio (HR) of the composite endpoint at one year (target lesion failure [TLF]: 1.41 [1.25; 1.59]), driven by an increased hazard of cardiac death (1.28 [1.05; 1.55]), target vessel myocardial infarction (1.48 [1.18; 1.86]) and clinically driven target lesion revascularisation. The hazard of complications increased with the rising number of complex features (3-6 vs 1-2 vs none) for all outcomes. All individual complex features were associated with an increased hazard of composite complications (except CTO) and definite/probable stent thrombosis. CONCLUSIONS: Overall, complex PCI is associated with an increased risk of mortality and complications at one year. The number and types of complex features have differing impacts on long-term outcomes.

Proximal Left Anterior Descending Artery Treatment Using a Bioresorbable Polymer Coating Sirolimus-Eluting Stent: Real-World Outcomes From the Multicenter Prospective e-Ultimaster Registry.

Background Guidelines recommend heart team discussion and coronary artery bypass graft consideration in patients with proximal left anterior descending (LAD) artery stenosis. Evidence suggests that outcomes of proximal LAD angioplasty might not differ from treatment of nonproximal LAD locations. We aim to determine clinical outcomes of patients undergoing percutaneous coronary intervention in the proximal LAD segment in comparison with nonproximal LAD angioplasty, using a thin-strut drug-eluting stent. Methods and Results In this analysis of the e-Ultimaster registry, patients undergoing angioplasty in the proximal LAD territory were compared with those treated in nonproximal LAD locations. Multivariate analysis and propensity score were used to adjust for differences among the groups. The primary outcome was target lesion failure: a composite of cardiac death, target-lesion-related myocardial infarction, and/or clinically driven target lesion revascularization at 1-year follow-up. Of the 17 805 patients (mean age, 64.2±11; 76% male), 5452 (30.6%) underwent proximal LAD and 12 353 (69.4%) nonproximal LAD percutaneous coronary intervention. Patients in the proximal LAD group had more multivessel disease (48.7% versus 43.5%; P<0.001) and 2-fold more bifurcations lesions (18.8% versus 9.2%; P<0.0001). After propensity-weighted adjustment, target lesion failure did not differ between the groups (3.3% versus 2.9%; P=0.17 for proximal LAD versus nonproximal LAD angioplasty, respectively). In multivariate analysis, proximal LAD treatment was not an independent predictor of target lesion failure (odds ratio, 1.07; 95% CI, 0.88-1.31; P=0.48). Conclusions At 1-year follow-up, patients had similar clinical outcomes independent of stenting location, questioning whether proximal LAD treatment should be regarded differently from stenting in any other coronary artery territory.

Final results of the randomised evaluation of short-term dual antiplatelet therapy in patients with acute coronary syndrome treated with a new-generation stent (REDUCE trial).

AIMS: The optimal duration of DAPT in ACS patients treated with DES is still unclear. Therefore, the aim of the current study was to investigate a short versus a standard 12-month DAPT regimen in ACS patients undergoing new-generation DES implantation. METHODS AND RESULTS: REDUCE was a prospective, open-label, multicentre, investigator-initiated study that randomised 1,496 ACS patients after treatment with the COMBO stent to either three (n=751) or 12 months (n=745) of DAPT. The primary study endpoint was a composite of all-cause mortality, myocardial infarction, stent thrombosis, stroke, target vessel revascularisation and bleeding at 12 months. No difference was observed in the demographic and clinical characteristics between the two groups, except for gender (p=0.01). At one-year follow-up, non-inferiority of three- versus 12-month DAPT in the primary endpoint was met (8.2% vs 8.4%, pnon-inferiority<0.001). The similar outcome between the two groups was confirmed at two-year follow-up (11.6% vs 12.1%, p=0.76), with no significant difference in overall mortality (3.1% vs 2.2%, p=0.27), cardiac mortality (1.8% vs 1.1%, p=0.28), stent thrombosis (1.6% vs 0.8%, p=0.16) and major bleeding (3.3% vs 4.0%, p=0.46). CONCLUSIONS: The results show that, among ACS patients treated with the COMBO stent, three months is non-inferior to 12 months of DAPT. However, given the numerically higher rates of mortality and ST in the three-month DAPT group, one-year DAPT should still be recommended in ACS until more information becomes available. A three-month DAPT strategy should be considered only if clinically mandated.

Transient left ventricular outflow tract obstruction with systolic anterior motion of the mitral valve: A stunning cause.

Left ventricular outflow tract obstruction (LVOTO) and systolic anterior motion (SAM) of the mitral valve may have various etiologies, of which hypertrophic cardiomyopathy is the most common. More rarely, an acute coronary syndrome, myocardial stunning, and takotsubo cardiomyopathy may give rise to LVOTO and SAM. Here, we present a 70-year-old female patient with a non-ST-elevation acute coronary syndrome treated with percutaneous coronary intervention. Echocardiography the day after, because of dyspnea and hypotension, revealed apical akinesia, LVOTO, and SAM, which proved completely reversible after treatment with a ß-blocker and a 2-month follow-up period. It was concluded that postischemic apical stunning had caused LVOTO and SAM.

Deliverability of the Resolute Integrity stent and a post hoc comparison of radial and femoral access: the DELIVER study.

BACKGROUND/PURPOSE: DELIVER (DELiverability of the Resolute Integrity Stent in All-Comer Vessels and Cross-OvER stenting) was a prospective, multicenter, all-comers registry to assess the deliverability of the Resolute Integrity™ zotarolimus-eluting stent (R-ZES). METHODS/MATERIALS: Patients (n=7740 patients, 10449 lesions) undergoing percutaneous coronary intervention and deemed suitable for R-ZES implantation were enrolled and treated according to standard practice of the participating centers in 30 countries. Outcomes included delivery success and in-hospital target lesion failure (TLF), major adverse cardiac event (MACE), and Academic Research Consortium definite/probable stent thrombosis. We performed a post hoc analysis comparing deliverability, in-hospital clinical outcomes and resource utilization with radial vs. femoral access. RESULTS: A high proportion of the population had complex disease (71%): mean lesion length was 26.7±17.5 mm, 35% of lesions were moderately/severely calcified and 17% were bifurcated. Femoral and radial accesses were used in 53% and 46% of patients, respectively. Patients treated using femoral access had more complex coronary artery disease. Primary delivery success was 98.9% and did not differ by approach. Radial access was associated with lower stent and balloon utilization, but higher guide catheter utilization, lower procedure duration, and contrast administered compared with femoral access. In-hospital TLF and MACE occurred in 1.6% of patients; definite or probable stent thrombosis occurred in 0.2%. Clinical outcomes did not differ by vascular access. CONCLUSIONS: R-ZES was found to be highly deliverable in a complex, all-comers, international population, regardless of whether radial or femoral access was used. In-hospital outcomes were excellent with very low risk of complications.

Distal left main coronary disease is a major predictor of outcome in patients undergoing percutaneous intervention in the drug-eluting stent era: an integrated clinical and angiographic analysis based on the Rapamycin-Eluting Stent Evaluated At Rotterdam Cardiology Hospital (RESEARCH) and Taxus-Stent Evaluated At Rotterdam Cardiology Hospital (T-SEARCH) registries.

OBJECTIVES: This study sought to investigate whether the anatomical location of the disease carries prognostic implications in patients undergoing drug-eluting stent (DES) implantation for the left main coronary artery (LMCA) stenosis. BACKGROUND: Liberal use of DES, compared with a bare metal stent (BMS), has resulted in an improved outcome in patients undergoing LMCA intervention. However, the overall event rate in this subset of patients remains high, and alternative tools to risk-stratify this population beyond conventional surgical risk status would be desirable. METHODS: From April 2002 to June 2004, 130 patients received DES as part of the percutaneous intervention for LMCA stenoses in our institution. Distal LMCA disease (DLMD) was present in 94 patients. They were at higher surgical risk and presented with a greater coronary disease extent compared with patients without DLMD. RESULTS: After a median of 587 days (range 368 to 1,179 days), the cumulative incidence of major adverse cardiac events (MACE) was significantly higher in patients with DLMD at 30% versus 11% in those without DLMD (hazard ratio [HR] 3.42, 95% confidence interval [CI] 1.34 to 9.7; p = 0.007), mainly driven by the different rate of target vessel revascularization (13% and 3%; HR 6, 95% CI 1.2 to 29; p = 0.02). After adjustment for confounders, DLMD (HR 2.79,95% CI 1.17 to 8.9; p = 0.032) and surgical risk status (HR 2.18,95% CI 1.06 to 4.5; p = 0.038) remained independent and complementary predictors of MACE. CONCLUSIONS: Distal LMCA disease carries independent prognostic implications, and it may help in selecting the most appropriate patient subset for LMCA intervention beyond the conventional surgical risk status in the DES era.