Predictors and Trends of New Permanent Pacemaker Implantation: A Subanalysis of the International Navitor IDE Study.

Background: The Navitor Investigational Device Exemption (IDE) study is a prospective, multicenter, global study assessing the safety and effectiveness of the Navitor valve in a population with severe, symptomatic aortic stenosis who are at high and extreme surgical risk. The impact of pre-existing conduction abnormalities and implantation technique on new permanent pacemaker implantation (PPI) for the Navitor platform is not fully understood. Therefore, the goal of this analysis was to investigate the associations between patient and procedural factors and the 30-day new PPI rate. Methods: A total of 260 patients who underwent implantation of a Navitor valve in the Navitor IDE study were reviewed. Patients with preprocedural permanent pacemakers (n = 28) were excluded. Baseline risk factors were assessed for statistical significance. Multivariable logistic regression analyses were performed to identify independent predictors of new PPI. Results: Mean age of the pacemaker-naïve population was 83.3 ± 5.2 years, 58.6% were female, average Society of Thoracic Surgeons score was 3.8% ± 1.9%, median frailty score was 1 (interquartile range 1, 2), and 17.7% were deemed at extreme surgical risk. Pre-existing first-degree atrioventricular block and right bundle branch block significantly increased the risk of new PPI postimplantation, whereas left bundle branch block did not. Membranous septum length in relation to noncoronary cusp implant depth was a significant predictor of new PPI, with higher rates of new PPI observed when noncoronary cusp implant depth exceeded membranous septum length. Analysis of implant depth alone revealed deeper implants were associated with a higher rate of new PPI, regardless of patient baseline conduction abnormality. Conclusions: The 30-day rate of new PPI in the Navitor IDE study is associated with patient pre-existing baseline conduction disturbances and implantation depth.

30-Day Clinical Outcomes of a Self-Expanding Transcatheter Aortic Valve: The International PORTICO NG Study.

BACKGROUND: The self-expanding, intra-annular Navitor (Abbott Structural Heart) valve includes an outer cuff to reduce paravalvular leak (PVL) and large stent cells for future coronary access. OBJECTIVES: The purpose of the PORTICO NG (Evaluation of the Portico NG [Next Generation] Transcatheter Aortic Valve in High and Extreme Risk Patients With Symptomatic Severe Aortic Stenosis) study is to evaluate the safety and effectiveness of the Navitor valve in patients with symptomatic, severe aortic stenosis who are at high or extreme surgical risk. METHODS: PORTICO NG is a prospective, multicenter, global study with follow-up at 30 days, 1 year, and annually through 5 years. The primary endpoints are all-cause mortality and moderate or greater PVL at 30 days. Valve Academic Research Consortium-2 events and valve performance are assessed by an independent clinical events committee and echocardiographic core laboratory. RESULTS: A total of 260 subjects were treated at 26 clinical sites across Europe, Australia, and the United States between September 2019 and August 2022. The mean age was 83.4 ± 5.4 years, 57.3% were female, and the average Society of Thoracic Surgeons score was 3.9% ± 2.1%. At 30 days, the rate of all-cause mortality was 1.9%, and no subjects had moderate or greater PVL. The rate of disabling stroke was 1.9%, life-threatening bleeding was 3.8%, stage 3 acute kidney injury was 0.8%, major vascular complications were 4.2%, and new permanent pacemaker implantation was 19.0%. Hemodynamic performance included a mean gradient of 7.4 ± 3.5 mm Hg and an effective orifice area of 2.00 ± 0.47 cm2. CONCLUSIONS: The Navitor valve is safe and effective for the treatment of subjects with severe aortic stenosis who are at high or greater risk for surgery, which is supported by low rates of adverse events and PVL. (Evaluation of the Portico NG [Next Generation] Transcatheter Aortic Valve in High and Extreme Risk Patients With Symptomatic Severe Aortic Stenosis [PORTICO NG]; NCT04011722).

Thirty-day and one-year outcomes of the Navitor transcatheter heart valve in patients with aortic stenosis: the prospective, multicentre, global PORTICO NG Study.

BACKGROUND: The Navitor transcatheter heart valve (THV) is a self-expanding valve, with an intra-annular leaflet position and an outer cuff intended to reduce paravalvular leak (PVL). AIMS: The aim of the PORTICO NG Study is to assess the safety and performance of the Navitor THV in patients with symptomatic, severe aortic stenosis who are at high or extreme surgical risk. METHODS: PORTICO NG is a prospective, multicentre, global, single-arm, investigational study with follow-up at 30 days, 1 year, and annually up to 5 years. The primary endpoints are all-cause mortality and moderate or greater PVL at 30 days. Valve Academic Research Consortium-2 events and valve performance are assessed by an independent clinical events committee and echocardiographic core laboratory. RESULTS: A total of 120 high- or extreme-risk subjects (age 83.5±5.4 years; 58.3% female; Society of Thoracic Surgeons score 4.0±2.0%) were enrolled in the European conformity (CE) mark cohort. Procedural success was high at 97.5%. At 30 days, the rate of all-cause mortality was 0%, and no subjects had moderate or greater PVL. The rate of disabling stroke was 0.8%, life-threatening bleeding was 2.5%, stage 3 acute kidney injury 0%, major vascular complications 0.8%, and new pacemaker implantation 15.0%. At 1 year, the rates of all-cause mortality and disabling stroke were 4.2% and 0.8%, respectively. The rate of moderate PVL was 1.0% at 1 year. Haemodynamic performance with a mean gradient of 7.5±3.2 mmHg and effective orifice area of 1.9±0.4 cm2 was sustained up to 1 year. CONCLUSIONS: The PORTICO NG Study demonstrates low rates of adverse events and PVL up to 1 year in patients at high or extreme surgical risk, confirming the safety and efficacy of the Navitor THV system.

Early vs. Late Readmission following Percutaneous Coronary Intervention: Predictors and Impact on Long-Term Outcomes.

BACKGROUND: Readmissions within 1 year after percutaneous coronary intervention (PCI) are common (18.6-50.4% in international series) and a burden to patients and health services, however their long-term implications are not well characterised. We compared predictors of 30-day (early) and 31-day to 1-year (late) unplanned readmission and the impact of unplanned readmission on long-term clinical outcomes post-PCI. METHODS: Patients enrolled in the GenesisCare Cardiovascular Outcomes Registry (GCOR-PCI) from 2008 to 2020 were included in the study. Multivariate logistic regression analysis was performed to identify predictors of early and late unplanned readmission. A Cox proportion hazards regression model was used to explore the impact of any unplanned readmission during the first year post-PCI on the clinical outcomes at 3 years. Finally, patients with early and late unplanned readmission were compared to determine which group was at the highest risk of adverse long-term outcomes. RESULTS: The study comprised 16,911 consecutively enrolled patients who underwent PCI between 2009-2020. Of these, 1422 patients (8.5%) experienced unplanned readmission within 1-year post-PCI. Overall, the mean age was 68.9 ± 10.5 years, 76.4% were male and 45.9% presented with acute coronary syndromes. Predictors of unplanned readmission included increasing age, female gender, previous CABG, renal impairment and PCI for acute coronary syndromes. Unplanned readmission within 1 year of PCI was associated with an increased risk of MACE (adjusted HR 1.84 (1.42-2.37), p < 0.001) and death over a 3-year follow-up (adjusted HR 1.864 (1.34-2.59), p < 0.001) compared with those without readmission within 1-year post-PCI. Late compared with early unplanned readmission within the first year of PCI was more frequently associated with subsequent unplanned readmission, MACE and death between 1 and 3 years post-PCI. CONCLUSIONS: Unplanned readmissions in the first year following PCI, particularly those occurring more than 30 days after discharge, were associated with a significantly higher risk of adverse outcomes, such as MACE and death at 3 years. Strategies to identify patients at high risk of readmission and interventions to reduce their greater risk of adverse events should be implemented post-PCI.

30-Day Outcomes With the Portico Transcatheter Heart Valve: Insights From a Multi-Centre Australian Observational Study.

BACKGROUND: Transcatheter aortic valve implantation (TAVI) is an established therapy for the treatment of aortic valve disease in appropriately selected patients. Previous studies using the self-expanding Portico transcatheter heart valve (THV), (Abbott Structural Heart, St Paul, MN, USA) have demonstrated the technical feasibility of this system albeit in the hands of relatively inexperienced Portico users. The objective of this study was to assess the real-world safety and efficacy of the Portico THV (with and without the FlexNav delivery system, Abbott Structural Heart) at the 30-day timepoint in an Australian cohort. METHODS AND RESULTS: This study was a retrospective real-world cohort analysis of 269 consecutive patients with severe aortic valve disease who underwent TAVI at multiple centres within Australia between February 2015 and April 2021. Of the 269 patients, 51.7% were female, mean Society of Thoracic Surgeons (STS) score was 5.2 (±6.8) and 98.5% had successful implantations. Thirty (30)-day post-implantation all-cause mortality was observed in one (0.4%) patient, major vascular complications in two (0.7%) patients, more-than-mild paravalvular leak in six (2.2%) patients and requirement for new permanent pacemaker implantation in 27 (10.2%) patients. Haemodynamic parameters at 30 days included mean effective orifice area (EOA) of 2.3 (±0.9) cm2 and mean aortic valve gradient (AVG) of 9.6 (±6.2) mmHg. CONCLUSION: This analysis of the Portico THV in a real-world setting suggested that the system is associated with satisfactory safety and efficacy parameters. Previously published datasets may not have found similar findings owing to lower operator experience with the Portico THV system.

Polymer-Based Versus Polymer-Free Stents in High Bleeding Risk Patients: Final 2-Year Results From Onyx ONE.

BACKGROUND: Resolute Onyx polymer-based zotarolimus-eluting stents (ZES) were noninferior in safety and effectiveness to BioFreedom polymer-free biolimus A9-coated stents (DCS) in high-bleeding-risk (HBR) patients treated with 1-month dual antiplatelet therapy (DAPT) followed by single antiplatelet therapy (SAPT) at 1 year. OBJECTIVES: This study reports the final 2-year results of the randomized Onyx ONE trial. METHODS: The Onyx ONE (A Randomized Controlled Trial With Resolute Onyx in One Month Dual Antiplatelet Therapy (DAPT) for High-Bleeding Risk Patients) trial randomly assigned HBR patients to treatment with ZES or DCS. Following 1-month DAPT, event-free patients received SAPT (either aspirin or a P2Y12 inhibitor at physician discretion). The primary safety endpoint, a composite of cardiac death, myocardial infarction, or stent thrombosis at 1 year, was determined at 1 year. Rates of primary and secondary endpoints were calculated after final follow-up at 2 years. RESULTS: A total of 1,003 patients were randomly allocated to ZES and 993 patients to DCS. Follow-up was complete in 980 (97.7%) ZES patients and 962 (96.9%) DCS patients at 2 years. The primary safety endpoint occurred in 208 (21.2%) patients in the ZES group and 199 (20.7%) patients in the DCS group (risk difference: 0.5%; 95% CI: -3.1% to 4.2%; P = 0.78) at 2 years without significant differences in individual components of the composite endpoint. The secondary effectiveness endpoint occurred in 217 (22.1%) patients in the ZES group and 202 (21.0%) patients in the DCS group (risk difference: 1.1%; 95% CI: -2.5% to 4.8%; P = 0.54). CONCLUSIONS: Among patients at HBR treated with 1-month DAPT followed by SAPT, the Resolute Onyx polymer-based ZES had similar 2-year outcomes for the primary safety and secondary effectiveness endpoint compared with the BioFreedom polymer-free DCS. (A Randomized Controlled Trial With Resolute Onyx in One Month Dual Antiplatelet Therapy [DAPT] for High-Bleeding Risk Patients [Onyx ONE]; NCT03344653).

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.

Long-Term Outcomes of Contemporary Percutaneous Coronary Intervention with the Xience Drug-Eluting Stent: Results from a Multicentre Australian Registry.

Introduction: Several large registries have evaluated outcomes after percutaneous coronary intervention (PCI) in the USA, however there are no contemporary data regarding long-term outcomes after PCI, particularly comparing new generation drug-eluting stents (DES) with other stents in Australia. Additionally, approval of new-generation drug-eluting stents (DES) is almost exclusively based on non-inferiority trials comparing outcomes with early generation DES, and there are limited data comparing safety and efficacy outcomes of new-generation DES with bare metal stents (BMS). This study reports in-hospital and long-term outcomes after PCI with the Xience DES from a large national registry, the GenesisCare Outcomes Registry (GCOR). Methods: The first 1500 patients consecutively enrolled from January 2015 to January 2019 and treated exclusively with either Xience DES or BMS and eligible for 1-year follow-up were included. Baseline patient and procedural data, major adverse cardiovascular events (MACE) in-hospital, at 30 days and 1-year, and medications were reported and analysed with respect to Xience DES (n = 1000) or BMS (n = 500) use. Results: In this cohort the mean age was 68.4 ± 10.7 years, 76.9% were male, 24.6% had diabetes mellitus and 45.9% presented with acute coronary syndromes. Of the overall cohort of 4765 patients from this period including all DES types, and patients who received multiple DES or a combination of DES and BMS, DES were exclusively used in 3621 (76.0%) patients, and BMS were exclusively used in 596 (12.5%). In comparison to international cohorts, adverse clinical event rates were low at 30 days in terms of mortality (0.20%), target lesion revascularisation (TLR, 0.27%) and MACE (0.47%), and at 12 months for mortality (1.26%) TLR (1.16%) and MACE (1.78%). Conclusions: Clinical practice and long-term outcomes of PCI with the Xience DES in Australia are consistent with international series. Recent trends indicate DES use has increased in parallel with good outcomes despite an increasingly complex patient and lesion cohort.

Coronary Stenting in High Bleeding Risk Patients With Small Coronary Arteries Followed by One-Month Dual Antiplatelet Therapy: Onyx ONE Clear.

Background: Small reference vessel diameters (RVDs) are a predictor of ischemic events after coronary stenting. Among patients at high bleeding risk (HBR) precluding long-term dual antiplatelet therapy (DAPT), those with small vessel disease (SVD) constitute an especially high-risk subgroup. Here, we evaluated the results of a durable-polymer, coronary zotarolimus-eluting stent (ZES) for the treatment of patients with SVD at HBR with 1-month DAPT. Methods: In the prospective, multicenter Onyx ONE (One-Month DAPT) Clear study, 1506 patients at HBR treated with a ZES that discontinued DAPT at 30 days were included. The clinical outcomes of patients undergoing treatment of lesions with an RVD of ≤2.5 mm (SVD group, as determined by the angiographic core laboratory) were compared with patients without SVD. The primary end point was the composite of cardiac death or myocardial infarction between 1 and 12 months. Results: Small vessel diameter treatment was performed in 489 (32.5%) patients. Patients with SVD were more likely to be women, have undergone a previous percutaneous intervention, and have multivessel coronary artery disease than patients without SVD. There were no significant differences in lesion, device, or procedural success between the groups. The Kaplan-Meier rate estimate of the primary end point was 8.5% and 6.8% in patients with SVD and those without SVD, respectively (P = .425). No significant differences were found in any secondary end point. The Kaplan-Meier rate of stent thrombosis was 0.6% and 0.8% in patients with SVD and those without SVD, respectively (P = .50). Conclusions: Among patients at HBR treated with a ZES and 1-month DAPT, those with SVD had favorable 12-month ischemic and bleeding outcomes, which were comparable with those of patients with larger caliber vessels.

One-month dual antiplatelet therapy after pci with resolute onyx des: final 2-year results from onyx one clear

BACKGROUND The optimal duration of dual antiplatelet therapy (DAPT) in patients undergoing percutaneous coronary intervention (PCI) varies based on ischemic and high bleeding risk (HBR) factors. METHODS Onyx ONE Clear was a prospective, global, multicenter study to assess the safety and effectiveness of 1-month DAPT in patients with HBR treated with Resolute Onyx zotarolimus-eluting stents (ZES). Patients with coronary artery disease and at least 1 HBR criterion were enrolled and prescribed DAPT for 1 month post-ZES implantation, followed by single antiplatelet therapy (SAPT) thereafter. The primary endpoint was composite of cardiac death or myocardial infarction (MI) from 1 month to 1 year. The current analysis presents final 2-year results from the study. RESULTS A total of 1,507 patients were analyzed at 2 years. Mean age was 74.0 9.5 years, 32.2% female, 38.8% with type 2 diabetes, 36.0% with previous revascularization, and 48.7% presented with an acute coronary syndrome. Patients were enrolled with mean 1.6 HBR criteria and 44.6% met 2 HBR criteria. Lesion characteristics included 50.0% moderate-to-severe calcification and 78.5% B2/C lesions. At 2 years, 81.1% of patients remained on SAPT, 5.6% received DAPT, and 12.5% were prescribed oral anticoagulation only. The composite of cardiac death or MI between 1 month and 2 years was 11.7%, with rates of 5.3% for cardiac death and 7.4% for MI. Most MIs were non-Q wave (6.7%). Rates of other secondary endpoints between 1 month and 2 years included 0.9% definite or probable stent thrombosis, 13.0% targetlesion failure, 4.7% clinically driven target-lesion revascularization, 2.6% stroke, and 6.2% Bleeding Academic Research Consortium (BARC) 3 to 5 bleeding events (Table 1). CONCLUSION Among patients with HBR treated with Resolute Onyx DES and SAPT after 1 month, 2-year ischemic event rates were acceptable despite an ongoing risk of major bleeding.

One-Month Dual Antiplatelet Therapy Following Percutaneous Coronary Intervention With Zotarolimus-Eluting Stents in High-Bleeding-Risk Patients.

BACKGROUND: Despite treatment guidance endorsing shortened dual antiplatelet therapy (DAPT) duration in high bleeding risk (HBR) patients after drug-eluting stents, limited evidence exists to support these recommendations. The present study was designed to examine the safety and effectiveness of 1-month DAPT duration following percutaneous coronary intervention with zotarolimus-eluting stents in HBR patients. METHODS: Onyx ONE Clear was a prospective, multicenter, nonrandomized study evaluating the safety and effectiveness of 1-month DAPT followed by single antiplatelet therapy in HBR patients undergoing percutaneous coronary intervention with Resolute Onyx drug-eluting stents. The primary analysis of cardiac death or myocardial infarction between 1 month and 1 year was performed in the prespecified one-month clear population of patients pooled from the Onyx ONE US/Japan study and Onyx ONE randomized controlled trial. One-month clear was defined as DAPT adherence and without major adverse events during the first month following percutaneous coronary intervention. RESULTS: Among patients enrolled in Onyx ONE US/Japan (n=752) and Onyx ONE randomized controlled trial (n=1018), 1506 patients fulfilled one-month clear criteria. Mean HBR characteristics per patient was 1.6 with 44.7% having multiple risks. By 2 months and 1 year, respectively, 96.9% and 89.3% of patients were taking single antiplatelet therapy. Between 1 month and 1 year, the rate of the primary end point was 7.0%. The 1-sided upper 97.5% CI was 8.4%, less than the performance goal of 9.7% (P<0.001). CONCLUSIONS: Among HBR patients who were event free before DAPT discontinuation at 1 month, favorable safety and effectiveness through 1 year support treatment with Resolute Onyx drug-eluting stents as part of an individualized strategy for shortened DAPT duration following percutaneous coronary intervention. Registration: URL: https://www.clinicaltrials.gov; Unique identifier NCT03647475.

One-Month Dual Antiplatelet Therapy Following Percutaneous Coronary Intervention With Zotarolimus-Eluting Stents in High-Bleeding-Risk Patients

BACKGROUND: Despite treatment guidance endorsing shortened dual antiplatelet therapy (DAPT) duration in high bleeding risk (HBR) patients after drug-eluting stents, limited evidence exists to support these recommendations. The present study was designed to examine the safety and effectiveness of 1-month DAPT duration following percutaneous coronary intervention with zotarolimus-eluting stents in HBR patients. METHODS: Onyx ONE Clear was a prospective, multicenter, nonrandomized study evaluating the safety and effectiveness of 1-month DAPT followed by single antiplatelet therapy in HBR patients undergoing percutaneous coronary intervention with Resolute Onyx drug-eluting stents. The primary analysis of cardiac death or myocardial infarction between 1 month and 1 year was performed in the prespecified one-month clear population of patients pooled from the Onyx ONE US/Japan study and Onyx ONE randomized controlled trial. One-month clear was defined as DAPT adherence and without major adverse events during the first month following percutaneous coronary intervention. RESULTS: Among patients enrolled in Onyx ONE US/Japan (n=752) and Onyx ONE randomized controlled trial (n=1018), 1506 patients fulfilled one-month clear criteria. Mean HBR characteristics per patient was 1.6 with 44.7% having multiple risks. By 2 months and 1 year, respectively, 96.9% and 89.3% of patients were taking single antiplatelet therapy. Between 1 month and 1 year, the rate of the primary end point was 7.0%. The 1-sided upper 97.5% CI was 8.4%, less than the performance goal of 9.7% (P<0.001). CONCLUSIONS: Among HBR patients who were event free before DAPT discontinuation at 1 month, favorable safety and effectiveness through 1 year support treatment with Resolute Onyx drug-eluting stents as part of an individualized strategy for shortened DAPT duration following percutaneous coronary intervention.

The Cone Flare Crush Modified-T (CFCT) stenting technique for coronary artery bifurcation lesions.

BACKGROUND: The present study is a prospective observational single arm clinical investigation, with parallel bench test interrogation, aimed at investigating the technical feasibility, safety and clinical outcomes with the cone flare crush modified-T (CFCT) bifurcation stenting technique. Bifurcation percutaneous coronary intervention (PCI) remains an area of ongoing procedural evolution. More widely applicable and reproducible techniques are required. METHODS: From April 2018 until March 2019, 20 consecutive patients underwent bifurcation PCI using the CFCT technique with a Pt-Cr everolimus drug-eluting stent with a bioresorbable polymer. Exercise stress echocardiography was performed at 12-month follow-up. The primary outcome was a composite of cardiac related mortality, myocardial infarction, target lesion/vessel revascularization and stroke. Safety secondary endpoints included bleeding, all-cause mortality and stent thrombosis. RESULTS: All patients underwent a successful CFCT bifurcation procedure with no complications to 30-day follow-up. One patient met the primary endpoint requiring target lesion revascularization at 9 months for stable angina. There were no other primary or secondary outcome events in the cohort. There were no strokes, deaths, stent thrombosis or myocardial infarction during the follow-up period. The mean CCS score improved from 2.25 to 0.25 (p < 0.0001). Optical coherence tomography (OCT) and bench test findings indicated optimal side branch ostial coverage and minimal redundant strut material crowding the neo-carina. CONCLUSIONS: The CFCT technique appears to be a safe, efficacious and feasible strategy for managing coronary artery bifurcation disease. Expanded and randomized datasets with longer term follow-up are required to further explore confirm this feasibility data. (ANZCTR ID: ACTRN12618001145291).

Clinical outcomes according to lesion complexity in patients with high bleeding risk treated with 1-month dual antiplatelet therapy following pci: analysis from the onyx one clear study

BACKGROUND Safety and effectiveness outcomes were examined at 1 year among high bleeding risk (HBR) patients treated with 1 month of dual antiplatelet therapy (DAPT) following PCI with zotarolimus eluting stents (ZES) (Resolute Onyx, Medtronic, Santa Rosa, Califor nia) according to lesion complexity (Table). METHODS The 1-year clinical outcomes were evaluated in HBR pa tients treated with ZES who were event-free following 1-month DAPT post-procedure with planned single antiplatelet therapy thereafter. Propensity score adjustment was performed to account for baseline differences (Table). RESULTS A total of 1,506 patients were stratified by complex (n » 395) or noncomplex (n » 1,111) PCI criteria (Table). Complex patients were more frequently men (72.2% vs. 66.1%; p » 0.03) and had higher rates of prior myocardial infarction (MI) (34.4% vs. 23.4%), prior CABG (24.1% vs. 8.9%), multivessel disease (78.2% vs. 39.8%), and B2/C lesion classification (84.2% vs. 75.6%), all p < 0.001. Complex patients had more lesions treated (1.7 vs. 1.2), longer stent length per patient (65.1 mm vs. 26.9 mm), and longer procedure time (58.8 min vs. 35.3 min), all p < 0.001. Procedural success was higher among noncomplex patients (90.8% vs. 82.0%; p < 0.001). In unadjusted analysis, the rate of MI was higher in patients with complex lesions (p » 0.04). How ever, no significant differences in any outcomes between patients with and without complex lesions were present after propensity score adjustment (Table). CONCLUSION Despite greater anatomic and procedural complexity, similar safety and effectiveness were observed in complex and noncomplex patients treated with 1-month DAPT following PCI with Resolute Onyx ZES after propensity score adjustment. These findings support 1-month DAPT among selected HBR patients undergoing PCI with Resolute Onyx ZES irrespective of lesion and procedural complexity.

Ischemic and bleeding outcomes in patients with versus without atrial fibrillation: analysis from the onyx one month dapt program

BACKGROUND The Onyx ONE and Onyx ONE CLEAR studies demonstrated favorable safety and effectiveness in patients at high bleeding risk (HBR) who were event-free 1 month following Resolute Onyx zotarolimus-eluting stent (ZES) implantation and were then treated with single antiplatelet therapy (SAPT) through to 1 year. The present analysis assessed outcomes in patients with versus without history of atrial fibrillation (AF) in whom oral anticoagulant (OAC) use is common. METHODS HBR patients who were event-free at 1 month were sepa rated into 2 groups according to history of AF. Clinical outcomes be tween 1 and 12 months were assessed. RESULTS Among 1,506 patients who were event-free at 1 month in whom treatment with SAPT was intended, 536 (35.6%) had a history of AF and 970 (64.4%) did not. The mean number of HBR criteria at enrollment was 1.7 for AF compared with 1.5 for non-AF patients (p < 0.001). AF patients were more likely to be men (73% vs. 65%; p » 0.001), were more likely to have had prior PCI (34% vs. 28%; p » 0.03) or CABG (16% vs. 11%; p » 0.003), and were more likely taking OACs (80.6% vs. 10.6%; p < 0.001). At 1 year, 89% of AF and non-AF patients were taking SAPT (p » 1.00), although 85.8% of AF patients and 12.4% of non-AF patients were taking OAC (p < 0.001). Ischemic event rates were similar between AF and non-AF groups: target lesion failure (8.5% vs. 7.9%), cardiac death (2.8% vs. 2.5%), myocardial infarction (4.7% vs. 4.9%), target lesion revascularization (2.8% vs. 3.6%), and definite/probable stent thrombosis (0.4% vs. 0.8%), all p > 0.05. BARC 2 to 5 (16.0% vs. 9.4%) bleeding events were higher for AF compared with non-AF patients (p < 0.001) driven by BARC 2 bleeding; BARC 3 to 5 events were similar (4.5% vs. 3.7%; p » 0.49). CONCLUSION After Resolute Onyx ZES implantation in HBR patients and intended treatment of SAPT after 1 month, despite differences in baseline characteristics, ischemic events were similar but moderate bleeding events were higher in patients with versus without a history of AF. Further studies are warranted to optimize management of AF patients post-stenting to minimize the bleeding.

The REMEDEE trial: 5­Year results on a novel combined sirolimus­eluting 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.

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.).

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.

Aortic distensibility is associated with both resting and hyperemic coronary blood flow.

A large body of evidence demonstrates an independent association between arterial stiffness and prospective risk of cardiovascular events. A reduction in coronary perfusion is presumed to underscore this association; however, studies confirming this are lacking. This study compared invasive measures of coronary blood flow (CBF) with cardiac magnetic resonance (CMR)-derived aortic distensibility (AD). Following coronary angiography, a Doppler FloWire and infusion microcatheter were advanced into the study vessel. Average peak velocity (APV) was acquired at baseline and following intracoronary adenosine to derive coronary flow velocity reserve (CFVR = hyperemic APV/resting APV) and CBF [π × (diameter)2 × APV × 0.125]. Following angiography, patients underwent CMR to evaluate distensibility at the ascending aorta (AA), proximal descending aorta (PDA) and distal descending aorta (DDA). Fifteen participants (53 ± 13 yr) with minor epicardial disease (maximum stenosis <30%) were enrolled. Resting CBF was 44.1 ± 11.9 mL/min, hyperemic CBF was 143.8 ± 37.4 mL/min, and CFVR was 3.15 ± 0.48. AD was 3.89 ± 1.72·10-3mmHg-1 at the AA, 4.08 ± 1.80·10-3mmHg-1 at the PDA, and 4.42 ± 1.67·10-3mmHg-1 at the DDA. All levels of distensibility correlated with resting CBF (R2 = 0.350-0.373, P < 0.05), hyperemic CBF (R2 = 0.453-0.464, P < 0.01), and CFVR (R2 = 0.442-0.511, P < 0.01). This study demonstrates that hyperemic and, to a lesser extent resting CBF, are significantly associated with measures of aortic stiffness in patients with only minor angiographic disease. These findings provide further in vivo support for the observed prognostic capacity of large artery function in cardiovascular event prediction.NEW & NOTEWORTHY Cardiac magnetic resonance-derived aortic distensibility is associated with invasive measures of coronary blood flow. Large artery function is more strongly correlated with hyperemic than resting blood flow. Increased stiffness may represent a potential target for novel antianginal medications.

End-stage renal failure is associated with impaired coronary microvascular function.

BACKGROUND: Cardiovascular disease is the leading cause of death in patients with chronic kidney disease. Studies investigating the disproportionate burden of cardiovascular disease have occurred predominantly in the peripheral vasculature, often used noninvasive imaging modalities, and infrequently recruited patients receiving dialysis. This study sought to evaluate invasive coronary dynamic vascular function in patients with end-stage renal failure (ESRF). PATIENTS AND METHODS: Patients referred for invasive coronary angiography prior to renal transplantation were invited to participate. Control patients were recruited in parallel. Baseline characteristics were obtained. Coronary diameter (via quantitative coronary angiography) and coronary blood flow (via Doppler Flowire) were measured; macrovascular endothelial-dependent and independent effects were evaluated in response to intracoronary acetylcholine infusion (10 and 10 mol/l) and intracoronary glyceryl trinitrate, respectively. Microvascular function was evaluated by response to adenosine and expressed as coronary flow velocity reserve. Mean values were compared. RESULTS: Thirty patients were evaluated: 15 patients with ESRF (mean age 52.1 ± 9, male 73%) and 15 control patients (mean age 53.3 ± 13, male 60%). Comorbidity profile, aside from ESRF, was well matched. Baseline coronary blood flow was similar between groups (101.6 ± 10.3 vs. 103.4 ± 9.1 ml/min, P = 0.71), as was endothelial-dependent response to acetylcholine (159.1 ± 16.9 vs. 171.1 ± 16.8 ml/min, P = 0.41). Endothelial-independent response to glyceryl trinitrate was no different between groups (14.3 ± 3.1 vs. 13.1 ± 2.3%, P = 0.73. A significantly reduced coronary flow velocity reserve was observed in the ESRF cohort compared to controls (2.34 ± 0.4 vs. 3.05 ± 0.3, P = 0.003). CONCLUSION: Patients with ESRF had preserved endothelial-dependent function however compared to controls, demonstrated significantly attenuated microvascular reserve. An impaired response to adenosine may not only represent a component of the pathophysiological milieu in patients with ESRF but may also provide a basis for the suboptimal diagnostic performance of vasodilatory stress in this population.