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

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

Bleeding and thrombotic risk of different antiplatelet regimens posttranscatheter edge-to-edge mitral valve repair in patients with an indication for oral anticoagulation: Results from an all-comers national registry.

BACKGROUND: Evidence-based recommendations for antithrombotic treatment in patients who have an indication for oral anticoagulation (OAC) after transcatheter edge-to-edge mitral valve repair (TEER) are lacking. AIMS: To compare bleeding and thrombotic risk for different antithrombotic regimens post-TEER with MitraClip in an unselected population with the need for OACs. METHODS: Bleeding and thrombotic complications (stroke and myocardial infarction) up to 3 months after TEER with mitraclip were evaluated in 322 consecutive pts with an indication for OACs. These endpoints were defined by the Mitral Valve Academic Research Consortium criteria and were compared between two antithrombotic regimens: single antithrombotic therapy with OAC (single ATT) and double/triple ATT with a combination of OAC and aspirin and/or clopidogrel (combined ATT). RESULTS: Collectively, 108 (34%) patients received single ATT, 203 (63%) received double ATT and 11 (3%) received triple ATT. Bleeding events occurred in 67 patients (20.9%), with access site related events being the most frequent cause (37%). Bleeding complications were observed more frequently in the combined ATT group than in the single ATT group: 24% versus 14% [p = 0.03, adjusted RR: 0.55 (0.3-0.98)]. Within the combined group, the bleeding risk was 23% in the double ATT and 45% in the triple ATT group. Thrombotic complications occurred in only three patients (0.9%), and all belonged to the combined ATT group. CONCLUSIONS: In patients with an indication for OACs, withholding of antiplatelet therapy post-TEER with Mitraclip was associated with a 45% reduction in bleeding and without a signal of increased thrombotic risk.

Aspirin with or without Clopidogrel after Transcatheter Aortic-Valve Implantation.

BACKGROUND: The effect of single as compared with dual antiplatelet treatment on bleeding and thromboembolic events after transcatheter aortic-valve implantation (TAVI) in patients who do not have an indication for long-term anticoagulation has not been well studied. METHODS: In a randomized, controlled trial, we assigned a subgroup of patients who were undergoing TAVI and did not have an indication for long-term anticoagulation, in a 1:1 ratio, to receive aspirin alone or aspirin plus clopidogrel for 3 months. The two primary outcomes were all bleeding (including minor, major, and life-threatening or disabling bleeding) and non-procedure-related bleeding over a period of 12 months. Most bleeding at the TAVI puncture site was counted as non-procedure-related. The two secondary outcomes were a composite of death from cardiovascular causes, non-procedure-related bleeding, stroke, or myocardial infarction (secondary composite 1) and a composite of death from cardiovascular causes, ischemic stroke, or myocardial infarction (secondary composite 2) at 1 year, with both outcomes tested sequentially for noninferiority (noninferiority margin, 7.5 percentage points) and superiority. RESULTS: A total of 331 patients were assigned to receive aspirin alone and 334 were assigned to receive aspirin plus clopidogrel. A bleeding event occurred in 50 patients (15.1%) receiving aspirin alone and in 89 (26.6%) receiving aspirin plus clopidogrel (risk ratio, 0.57; 95% confidence interval [CI], 0.42 to 0.77; P = 0.001). Non-procedure-related bleeding occurred in 50 patients (15.1%) and 83 patients (24.9%), respectively (risk ratio, 0.61; 95% CI, 0.44 to 0.83; P = 0.005). A secondary composite 1 event occurred in 76 patients (23.0%) receiving aspirin alone and in 104 (31.1%) receiving aspirin plus clopidogrel (difference, -8.2 percentage points; 95% CI for noninferiority, -14.9 to -1.5; P<0.001; risk ratio, 0.74; 95% CI for superiority, 0.57 to 0.95; P = 0.04). A secondary composite 2 event occurred in 32 patients (9.7%) and 33 patients (9.9%), respectively (difference, -0.2 percentage points; 95% CI for noninferiority, -4.7 to 4.3; P = 0.004; risk ratio, 0.98; 95% CI for superiority, 0.62 to 1.55; P = 0.93). A total of 44 patients (13.3%) and 32 (9.6%), respectively, received oral anticoagulation during the trial. CONCLUSIONS: Among patients undergoing TAVI who did not have an indication for oral anticoagulation, the incidence of bleeding and the composite of bleeding or thromboembolic events at 1 year were significantly less frequent with aspirin than with aspirin plus clopidogrel administered for 3 months. (Funded by the Netherlands Organization for Health Research and Development; POPular TAVI EU Clinical Trials Register number, 2013-003125-28; ClinicalTrials.gov number, NCT02247128.).

Anticoagulation with or without Clopidogrel after Transcatheter Aortic-Valve Implantation.

BACKGROUND: The roles of anticoagulation alone or with an antiplatelet agent after transcatheter aortic-valve implantation (TAVI) have not been well studied. METHODS: We performed a randomized trial of clopidogrel in patients undergoing TAVI who were receiving oral anticoagulation for appropriate indications. Patients were assigned before TAVI in a 1:1 ratio not to receive clopidogrel or to receive clopidogrel for 3 months. The two primary outcomes were all bleeding and non-procedure-related bleeding over a period of 12 months. Procedure-related bleeding was defined as Bleeding Academic Research Consortium type 4 severe bleeding, and therefore most bleeding at the puncture site was counted as non-procedure-related. The two secondary outcomes were a composite of death from cardiovascular causes, non-procedure-related bleeding, stroke, or myocardial infarction at 12 months (secondary composite 1) and a composite of death from cardiovascular causes, ischemic stroke, or myocardial infarction (secondary composite 2), both tested for noninferiority (noninferiority margin, 7.5 percentage points) and superiority. RESULTS: Bleeding occurred in 34 of the 157 patients (21.7%) receiving oral anticoagulation alone and in 54 of the 156 (34.6%) receiving oral anticoagulation plus clopidogrel (risk ratio, 0.63; 95% confidence interval [CI], 0.43 to 0.90; P = 0.01); most bleeding events were at the TAVI access site. Non-procedure-related bleeding occurred in 34 patients (21.7%) and in 53 (34.0%), respectively (risk ratio, 0.64; 95% CI, 0.44 to 0.92; P = 0.02). Most bleeding occurred in the first month and was minor. A secondary composite 1 event occurred in 49 patients (31.2%) receiving oral anticoagulation alone and in 71 (45.5%) receiving oral anticoagulation plus clopidogrel (difference, -14.3 percentage points; 95% CI for noninferiority, -25.0 to -3.6; risk ratio, 0.69; 95% CI for superiority, 0.51 to 0.92). A secondary composite 2 event occurred in 21 patients (13.4%) and in 27 (17.3%), respectively (difference, -3.9 percentage points; 95% CI for noninferiority, -11.9 to 4.0; risk ratio, 0.77; 95% CI for superiority, 0.46 to 1.31). CONCLUSIONS: In patients undergoing TAVI who were receiving oral anticoagulation, the incidence of serious bleeding over a period of 1 month or 1 year was lower with oral anticoagulation alone than with oral anticoagulation plus clopidogrel. (Funded by the Netherlands Organization for Health Research and Development; POPular TAVI EU Clinical Trials Register number, 2013-003125-28; ClinicalTrials.gov number, NCT02247128.).

Comparison of Radifocus versus Silverway Guidewires for Percutaneous Radial Angiography Following Failed Use of a J-Tip Guidewire.

BACKGROUND During transradial coronary angiography, when conventional J-tip wires fail to deliver catheters to the aortic root due to anatomical obstacles, additional hydrophilic wires, such as Radifocus (Terumo) or Silverway (Asahi), are used. We recently showed that the Silverway guidewire was effective at delivering the catheter to the aortic root. In this study, we aimed to compare the efficacy and safety of Radifocus and Silverway guidewires in 100 patients after failed use of the J-tip guidewire. MATERIAL AND METHODS After patients had a failure of a conventional J-tip wire to reach the aortic root, 100 patients were 1:1 randomized to either the Silverway or Radifocus wire. All patients with failure of the J-tip wire were eligible. The primary endpoint was the time between wire entry in the catheter and successful delivery of the catheter to the aortic root. Secondary endpoints included change of access site, number of complications, and questionnaires on subjective wire assessments by the performing interventional cardiologist. RESULTS The primary endpoint was significantly shorter in patients randomized to the Silverway arm (median 30 s [21-39] vs 48 s [36-66]; P<0.001)). The percentage of patients with change of access site was not different between the groups (2 vs 2, not significant). Only 1 minor complication (2%) occurred, in the Radifocus group. Questionnaires revealed that torque control, crossing, and support were all significantly better with the Silverway wire (P<0.001). CONCLUSIONS Silverway showed superior torque control, resulting in faster catheter delivery to the aortic root when compared with the Radifocus guidewire.

Early goal-directed haemodynamic optimization of cerebral oxygenation in comatose survivors after cardiac arrest: the Neuroprotect post-cardiac arrest trial.

AIMS: During the first 6-12 h of intensive care unit (ICU) stay, post-cardiac arrest (CA) patients treated with a mean arterial pressure (MAP) 65 mmHg target experience a drop of the cerebral oxygenation that may cause additional cerebral damage. Therefore, we investigated whether an early goal directed haemodynamic optimization strategy (EGDHO) (MAP 85-100 mmHg, SVO2 65-75%) is safe and could improve cerebral oxygenation, reduce anoxic brain damage, and improve outcome when compared with a MAP 65 mmHg strategy. METHODS AND RESULTS: A total of 112 out-of-hospital CA patients were randomly assigned to EGDHO or MAP 65 mmHg strategies during the first 36 h of ICU stay. The primary outcome was the extent of anoxic brain damage as quantified by the percentage of voxels below an apparent diffusion coefficient (ADC) score of 650.10-6 mm2/s on diffusion weighted magnetic resonance imaging (at day 5 ± 2 post-CA). Main secondary outcome was favourable neurological outcome (CPC score 1-2) at 180 days. In patients assigned to EGDHO, MAP (P < 0.001), and cerebral oxygenation during the first 12 h of ICU stay (P = 0.04) were higher. However, the percentage of voxels below an ADC score of 650.10-6 mm2/s did not differ between both groups [16% vs. 12%, odds ratio 1.37, 95% confidence interval (CI) 0.95-0.98; P = 0.09]. Also, the number of patients with favourable neurological outcome at 180 days was similar (40% vs. 38%, odds ratio 0.98, 95% CI 0.41-2.33; P = 0.96). The number of serious adverse events was lower in patients assigned to EGDHO (P = 0.02). CONCLUSION: Targeting a higher MAP in post-CA patients was safe and improved cerebral oxygenation but did not improve the extent of anoxic brain damage or neurological outcome.

Mean arterial pressure of 65 mm Hg versus 85-100 mm Hg in comatose survivors after cardiac arrest: Rationale and study design of the Neuroprotect post-cardiac arrest trial.

BACKGROUND: Post-cardiac arrest (CA) patients admitted to the intensive care unit (ICU) have a poor prognosis, with estimated survival rates of around 30%-50%. On admission, these patients have a large cerebral penumbra at risk for additional damage in case of suboptimal brain oxygenation during their stay in the ICU. The aim of the Neuroprotect post-CA trial is to investigate whether forcing mean arterial blood pressure (MAP) and mixed venous oxygen saturation (SVO2) in a specific range (MAP 85-100 mm Hg, SVO2 65%-75%) with additional pharmacological support (goal-directed hemodynamic optimization) may better salvage the penumbra, reduce cerebral ischemia, and improve functional outcome when compared with current standard of care (MAP 65 mm Hg). DESIGN: The Neuroprotect post-CA trial (NCT02541591) is a multicenter, randomized, parallel-group, open-label, assessor-blinded, monitored, and investigator-driven clinical trial. The trial will be conducted in 2 tertiary care hospitals in Belgium (UZ Leuven and ZOL-Genk). A total of 112 eligible patients will be randomly assigned in a 1:1 ratio to goal-directed hemodynamic optimization or standard care strategy by an interactive voice response system. Patients will be stratified according to the presence of an initial shockable rhythm. Adult patients (≥18 years) resuscitated from out-of-hospital CA of a presumed cardiac cause who are unconscious upon hospital admission are eligible for inclusion. Patients can be included irrespective of their presenting heart rhythm but need to have a sustained return of spontaneous circulation. Trial interventions will take 36 hours starting from ICU admission. The primary outcome is the extent of cerebral ischemia as quantified by the apparent diffusion coefficient on diffusion-weighted magnetic resonance imaging to be performed at day 4-5 post-CA. Secondary outcomes include surrogate biomarkers of brain injury (neuron specific enolase) at day 1-5, neuropsychological and functional testing at hospital discharge, a Short Form-36 health questionnaire at 180 days, and outcome as assessed with cerebral performance category scores at ICU discharge and at 180 days. CONCLUSIONS: The Neuroprotect post-CA trial will investigate whether a more aggressive hemodynamic strategy to obtain a MAP 85-100 mm Hg and SVO2 65%-75% reduces brain ischemia and improves outcome when compared with standard treatment (MAP 65 mm Hg) in comatose post-CA survivors.

Influence of continuously evolving transcatheter aortic valve implantation technology on cerebral oxygenation.

This study assessed the influence of the evolution in Transcatheter Aortic Valve Implantation technology on cerebral oxygenation. Cerebral oxygenation was measured continuously with Near-Infrared Spectroscopy and compared retrospectively between balloon-expandable, self-expandable and differential deployment valves which were implanted in 12 (34%), 17 (49%) and 6 patients (17%), respectively. Left and right SctO2 values were averaged at four time points and used for analysis (i.e. at baseline, balloon-aortic valvuloplasty, valve deployment, and at the end of the procedure). During balloon-aortic valvuloplasty and valve deployment, cerebral oxygenation decreased in patients treated with balloon or self-expandable valves (balloon-expandable: p = 0.003 and p = 0.002; self-expandable: p < 0.001 and p = 0.003, respectively). The incidence of cerebral desaturations below 80% of baseline was significantly larger in patients treated with balloon-expandable valves (p = 0.001). In contrast, patients who received differential deployment valves never experienced a cerebral desaturation below 80% of baseline. Furthermore, both the incidence and duration below a cerebral oxygenation of 55% was significantly different between balloon and self-expandable valves (p = 0.038 and p = 0.018, respectively). This study demonstrated that Transcatheter Aortic Valve Implantation procedures are associated with significant cerebral desaturations, especially during balloon-aortic valvuloplasty and valve deployment. Moreover, our results showed that latest innovations in Transcatheter Aortic Valve Implantation technology beneficially influenced the adequacy of cerebral perfusion.

Is venous congestion associated with reduced cerebral oxygenation and worse neurological outcome after cardiac arrest?

BACKGROUND: Post-cardiac arrest (CA) patients are at risk of secondary ischemic damage in the case of suboptimal brain oxygenation during an ICU stay. We hypothesized that elevated central venous pressures (CVP) would impair cerebral perfusion and oxygenation (venous cerebral congestion). The aim of the present study was to investigate the relationship between CVP, cerebral tissue oxygen saturation (SctO2) as assessed with near-infrared spectroscopy (NIRS) and outcome in post-CA patients. METHODS: This was an observational study in 48 post-CA patients with continuous CVP and SctO2 monitoring during therapeutic hypothermia. RESULTS: The relationship between CVP and mean SctO2 was best described by an S-shaped, third-degree polynomial regression curve (SctO2 = -0.002 × CVP(3) + 0.08 × CVP(2) - 1.07 × CVP + 69.78 %, R (2) 0.89, n = 1,949,108 data points) with high CVP (>20 mmHg) being associated with cerebral desaturation. Multivariate linear regression revealed CVP to be a more important determinant of SctO2 than mean arterial pressure (MAP) without important interaction between both (SctO2 = 0.01 × MAP - 0.20 × CVP + 0.001 × MAP × CVP + 65.55 %). CVP and cardiac output were independent determinants of SctO2 with some interaction between both (SctO2 = 1.86 × CO - 0.09 × CVP - 0.05 × CO × CVP + 60.04 %). Logistic regression revealed that a higher percentage of time with CVP above 5 mmHg was associated with lower chance of survival with a good neurological outcome (cerebral performance category (CPC) 1-2) at 180 days (OR 0.96, 95 % CI 0.92-1.00, p = 0.04). In a multivariate model, the negative association between CVP and outcome persisted after correction for hemodynamic variables, including ejection fraction and MAP. CONCLUSIONS: Elevated CVP results in lower brain saturation and is associated with worse outcome in post-CA patients. This pilot study provides support that venous cerebral congestion as indicated by high CVP may be detrimental for post-CA patients.

Increase in cerebral oxygenation during advanced life support in out-of-hospital patients is associated with return of spontaneous circulation.

INTRODUCTION: By maintaining sufficient cerebral blood flow and oxygenation, the goal of cardiopulmonary resuscitation (CPR) is to preserve the pre-arrest neurological state. To date, cerebral monitoring abilities during CPR have been limited. Therefore, we investigated the time-course of cerebral oxygen saturation values (rSO2) during advanced life support in out-of-hospital cardiac arrest. Our primary aim was to compare rSO2 values during advanced life support from patients with return of spontaneous circulation (ROSC) to patients who did not achieve ROSC. METHODS: We performed an observational study to measure rSO2 using Equanox (Nonin, Plymouth, MI) from the start of advanced life support in the pre-hospital setting. RESULTS: rSO2 of 49 consecutive out-of-hospital cardiac arrest patients were analyzed. The total increase from initial rSO2 value until two minutes before ROSC or end of advanced life support efforts was significantly larger in the group with ROSC 16% (9 to 36) compared to the patients without ROSC 10% (4 to 15) (P = 0.02). Mean rSO2 from the start of measurement until two minutes before ROSC or until termination of advanced life support was higher in patients with ROSC than in those without, namely 39% ± 7 and 31% ± 4 (P = 0.05) respectively. CONCLUSIONS: During pre-hospital advanced life support, higher increases in rSO2 are observed in patients attaining ROSC, even before ROSC was clinically determined. Our findings suggest that rSO2 could be used in the future to guide patient tailored treatment during cardiac arrest and could therefore be a surrogate marker of the systemic oxygenation state of the patient.

Drug-eluting versus bare metal stents after rotational atherectomy: clinical outcome in a single centre.

PURPOSE: Heavily calcified atherosclerotic plaques can be prepared for stenting by rotational atherectomy (RA). Clinical outcomes with drug-eluting stents (DES) versus bare-metal stents (BMS) after RA have not been investigated sufficiently. We present a single-centre study comparing the efficacy and long-term outcome of DES versus BMS after RA. METHODS AND RESULTS: We performed a retrospective cohort study of all patients who were treated with RA at our institution between January 2004 and March 2012. Clinical follow-up was obtained at 1 year. Procedural success (defined as a residual stenosis < 30%) was recorded, as was the 1-year incidence of myocardial infarction (MI), stent thrombosis (ST) and major adverse cardiac events (MACE), a composite end point of cardiac death, MI or target lesion revascularization (TLR). Eighty-five patients underwent RA followed by stenting, 30 receiving a BMS and 55 a DES, and completed 1-year clinical follow-up. Baseline clinical and angiographic characteristics were similar, and procedural success was achieved in 99% of the patients. At 1 year the overall incidence of MACE was 19%, and no significant differences in clinical outcome between DES and BMS were seen (MACE: 9 (16%) vs 7 (23%), P = 0.44; cardiac death: 3 (5%) vs 0 (0%); MI: 4 (7%) vs 5 (17%), P = 0.2; TLR: 2 (4%) vs 3 (10%), P = 0.25; ST: 2 (4%) vs 2 (7%), P = 0.52, respectively). CONCLUSIONS: In this study, no significant differences in medium-term clinical outcomes between DES and BMS after RA were observed, although there was a definite trend to improved outcomes with DES.

Left ventricular function and clinical outcome in transient left ventricular ballooning syndrome.

BACKGROUND: It is unknown if the severity of left ventricular dysfunction in patients with transient left ventricular ballooning syndrome (TLVBS) adversely affects clinical outcome. Furthermore, it remains unclear if the patterns of ventricular involvement are distinct patterns or if they represent varying stages of ventricular involvement. METHODS AND RESULTS: All patients with TLVBS who presented to our hospital from August 1998 to August 2012 were prospectively identified and entered into a clinical database. Available ventriculograms were reviewed, the ejection fraction (EF) calculated and a new severity score of left ventricular (LV) involvement was developed to determine the degree of LV dysfunction. The incidence of in-hospital mortality, cardiogenic shock and major cardiac events (heart failure/pulmonary oedema or major cardiac arrhythmia) was recorded. In total, 145 TLVBS episodes were identified in 139 patients. Age at presentation was 67 ± 12 years and 89% (n = 123) of patients were female. Patients who developed cardiogenic shock or other acute cardiac events had a worse LVEF compared to those who did not (P < 0.01 and P = 0.05, respectively). In-hospital mortality was not related to worse EF (P = 0.58). In-hospital and 1-year mortality rates were 6.9% and 12.6%, respectively. Median time from symptom onset to clinical diagnosis was similar between the apical ballooning (n = 104; 12 [3-30] hours) and the mid-ventricular ballooning group (n = 25; 11 [4-35] hours, P = 0.97). CONCLUSIONS: In TLVBS patients the severity of LV dysfunction determines the incidence of cardiogenic shock and early cardiac events. Apical and mid-ventricular forms of TLVBS appear to be distinct patterns.

Temporal changes in coronary plaque as assessed by an artificial intelligence-based optical coherence tomography: from the first-in-human trial on DREAMS 3G scaffold.

AIMS: The aim of the study is to assess the impact of the baseline plaque composition on the DREAMS 3G luminal late loss and to compare the serial plaque changes between baseline and 6 and 12 months (M) follow-up. METHODS AND RESULTS: A total of 116 patients were enrolled in the BIOMAG-I trial. Patients were imaged with optical coherence tomography (OCT) pre- and post-DREAMS 3G implantation and at 6 and 12 M. OCTPlus software uses artificial intelligence to assess composition (i.e. lipid, calcium, and fibrous tissue) of the plaque. The differences between the OCT-derived minimum lumen area (MLA) post-percutaneous coronary intervention and 12 M were grouped into three terciles. Patients with larger MLA differences at 12 M (P = 0.0003) had significantly larger content of fibrous tissue at baseline. There was a reduction of 24.8% and 20.9% in lipid area, both P < 0.001, between the pre-DREAMS 3G OCT and the 6 and 12 M follow-up. Conversely, the fibrous tissue increased by 48.4% and 36.0% at 6 and 12 M follow-up, both P < 0.001. CONCLUSION: The larger the fibrous tissue in the lesion at baseline, the larger the luminal loss seen at 6 and 12 M. Following the implantation of DREAMS 3G, favourable healing of the vessel coronary wall occurs as shown by a decrease in the lipid area and an increase in fibrous tissue.

Healing responses after bifurcation stenting with the dedicated TRYTON Side-Branch Stent™ in combination with XIENCE-V™ stents: a clinical, angiography, fractional flow reserve, and optical coherence tomography study: the PYTON (Prospective evaluation of the TRYTON Side-Branch Stent™ with an additional XIENCE-v™ everolimus-eluting stent in coronary bifurcation lesions) study.

OBJECTIVES: We evaluated healing responses with optical coherence tomography (OCT), and clinical and angiographic outcome after bifurcation stenting with the TRYTON Side-Branch Stent™. BACKGROUND: Dedicated bifurcation stents have been proposed as a potential alternative for treatment of true coronary bifurcation lesions. METHODS: We treated 20 consecutive patients with coronary bifurcation lesions and significant involvement of the side-branch (SB) with the TRYTON Stent and an additional XIENCE-V™ everolimus-eluting stent. At 9 months, we assessed the ratio of uncovered to total stent struts (RUTSS) with OCT, angiographic late luminal loss (LLL), and in-stent and in-segment restenosis. Clinical endpoints at 1 year included major adverse cardiac events (MACE) and their components [target lesion revascularization (TLR), myocardial infarction (MI), and cardiac death]. RESULTS: LLL (N = 16) was 0.34 (0.17-0.46), 0.29 (0.24-0.48) and 0.57 (0.29-0.73) mm in the proximal main vessel (MV), distal MV and SB, respectively. In-bifurcation binary in-stent restenosis occurred in four patients (25%), in-segment restenosis in five (31.25%). The RUTSS (N = 13) was 4.0 ± 5.8, 0.7 ± 1.3, 0, and 2.5 ± 3.6% in the proximal MV, distal MV, SB, and polygon of confluence, respectively. At 1 year, MACE occurred in 5 (25%) [4 TLR (20%), 3 MI (15%)]. CONCLUSION: The homogeneous stent strut coverage and the low LLL in the MV reflect proper healing characteristics of the TRYTON Stent in combination with the XIENCE-V™ stent. However, proximal MV edge and ostial SB restenoses together with overall clinical outcomes do not fulfill expectations of a dedicated bifurcation stent. © 2012 Wiley Periodicals, Inc.

Coronary spasm is not a benign entity.

We present a case of unrecognized recurrent severe coronary spasm treated by percutaneous coronary interventions leading to catastrophic complications ultimately requiring emergency coronary artery bypass grafting and later, following occlusion of the grafts, recanalization of a totally occluded left coronary artery. Throughout the case history the recognition and management of this challenging coronary phenomenon is discussed.

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

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

Safety and performance of the third-generation drug-eluting resorbable coronary magnesium scaffold system in the treatment of subjects with de novo coronary artery lesions: 6-month results of the prospective, multicenter BIOMAG-I first-in-human study.

Background: A third-generation coronary drug-eluting resorbable magnesium scaffold (DREAMS 3G) was developed to enhance the performance of previous scaffold generations and achieve angiographic outcomes comparable to those of contemporary drug-eluting stents. Methods: This prospective, multicenter, non-randomized, first-in-human study was conducted at 14 centers in Europe. Eligible patients had stable or unstable angina, documented silent ischemia, or non-ST-elevation myocardial infarction, and a maximum of two single de novo lesions in two separate coronary arteries with a reference vessel diameter between 2.5 mm and 4.2 mm. Clinical follow-up was scheduled at one, six and 12 months and annually thereafter until five years. Invasive imaging assessments were scheduled six and 12 months postoperatively. The primary endpoint was angiographic in-scaffold late lumen loss at six months. This trial was registered at ClinicalTrials.gov (NCT04157153). Findings: Between April 2020 and February 2022, 116 patients with 117 coronary artery lesions were enrolled. At six months, in-scaffold late lumen loss was 0.21 mm (SD 0.31). Intravascular ultrasound assessment showed preservation of the scaffold area (mean 7.59 mm2 [SD 2.21] post-procedure vs 6.96 mm2 [SD 2.48]) at six months) with a low mean neointimal area (0.02 mm2 [SD 0.10]). Optical coherence tomography revealed that struts were embedded in the vessel wall and were already hardly discernible at six months. Target lesion failure occurred in one (0.9%) patient; a clinically driven target lesion revascularization was performed on post-procedure day 166. No definite or probable scaffold thrombosis or myocardial infarction was observed. Interpretation: These findings show that the implantation of DREAMS 3G in de novo coronary lesions is associated with favorable safety and performance outcomes, comparable to contemporary drug-eluting stents. Funding: This study was funded by BIOTRONIK AG.

A new resorbable magnesium scaffold for de novo coronary lesions (DREAMS 3): one-year results of the BIOMAG-I first-in-human study.

BACKGROUND: The third-generation coronary sirolimus-eluting magnesium scaffold, DREAMS 3G, is a further development of the DREAMS 2G (commercial name Magmaris), aiming to provide performance outcomes similar to drug-eluting stents (DES). AIMS: The BIOMAG-I study aims to assess the safety and performance of this new-generation scaffold. METHODS: This is a prospective, multicentre, first-in-human study with clinical and imaging follow-up scheduled at 6 and 12 months. The clinical follow-up will continue for 5 years. RESULTS: A total of 116 patients with 117 lesions were enrolled. At 12 months, after completion of resorption, in-scaffold late lumen loss was 0.24±0.36 mm (median 0.19, interquartile range 0.06-0.36). The minimum lumen area was 4.95±2.24 mm² by intravascular ultrasound and 4.68±2.32 mm² by optical coherence tomography. Three target lesion failures were reported (2.6%, 95% confidence interval: 0.9-7.9), all clinically driven target lesion revascularisations. Cardiac death, target vessel myocardial infarction and definite or probable scaffold thrombosis were absent. CONCLUSIONS: Data at the end of the resorption period of DREAMS 3G showed that the third-generation bioresorbable magnesium scaffold is clinically safe and effective, making it a possible alternative to DES. CLINICALTRIALS: gov: NCT04157153.

Periprocedural continuation versus interruption of oral anticoagulant drugs during transcatheter aortic valve implantation: rationale and design of the POPular PAUSE TAVI trial.

About one-third of patients undergoing transcatheter aortic valve implantation (TAVI) use oral anticoagulants (OAC), mainly due to atrial fibrillation. General guidelines advise interrupting OAC in patients with a high risk of bleeding undergoing interventions. However, preliminary observational data suggest that the continuation of OAC during TAVI is safe and may reduce the risk of periprocedural thromboembolic events. The Periprocedural Continuation Versus Interruption of Oral Anticoagulant Drugs During Transcatheter Aortic Valve Implantation (POPular PAUSE TAVI) is a multicentre, randomised clinical trial with open-label treatment and blinded endpoint assessment. Patients are randomised 1:1 to periprocedural continuation versus interruption of OAC and are stratified for vitamin K antagonist or direct oral anticoagulant use. The primary endpoint is a composite of cardiovascular mortality, all stroke, myocardial infarction, major vascular complications and type 2-4 bleeding within 30 days after TAVI, according to the Valve Academic Research Consortium-3 criteria. Secondary endpoints include separate individual and composite outcomes, quality of life and cost-effectiveness. Since continuation of OAC is associated with the ancillary benefit that it simplifies periprocedural management, the primary outcome is first analysed for non-inferiority; if non-inferiority is proven, superiority will be tested. Recruitment started in November 2020, and the trial will continue until a total of 858 patients have been included and followed for 90 days. In summary, POPular PAUSE TAVI is the first randomised clinical trial to assess the safety and efficacy of periprocedural continuation versus interruption of OAC in patients undergoing TAVI.

Risk assessment for percutaneous coronary intervention of the unprotected left main coronary artery in a real-world population.

BACKGROUND: Available clinical and angiographic scoring systems fail to predict clinical outcomes in real-world patients undergoing revascularization of the unprotected left main coronary artery (ULMCA). METHODS: We prospectively assessed major adverse cardiac and cerebrovascular events (MACCE) in a real-world population undergoing percutaneous coronary intervention (PCI) for ULMCA disease. Cumulative risk-adjusted mortality in our patients was compared with expected mortality at 30 days based on logistic EuroSCORE and SYNTAX SCORE. Similarly, we plotted cumulative risk-adjusted MACCE at 1 year based on SYNTAX SCORE. Finally, both scores were combined in 1 year Global Risk Charts, including the use of drug-eluting stents (DES), diabetic status, and several factors precluding coronary surgery. RESULTS: Over a 12-year period, 240 patients underwent elective (76%) or urgent (24%) PCI of the ULMCA. Median logistic EuroSCORE and SYNTAX SCORE were 8.7% (3.5; 21) and 23% (14; 31). During the first year of follow-up, 89 patients presented MACCE (37.1%) (46 deaths [19.2%], 18 acute myocardial infarctions [7.5%], 45 revascularizations [18.8%] and 4 strokes [1.7%]). Cumulative risk-adjusted mortality based on individual logistic EuroSCORE and SYNTAX SCORE pointed towards significant overestimation (+19 deaths) and underestimation (-35 deaths) of risk by these respective scoring systems. Similarly, the anatomic SYNTAX SCORE largely underestimated cumulative risk-adjusted MACCE (-60 MACCE). The Global Risk Charts provided a more balanced view on 1-year clinical outcome. CONCLUSION: An integrated risk evaluation combining EuroSCORE, SYNTAX SCORE, diabetic status, stent type and general condition, may predict outcomes more accurately awaiting validation in a larger and multicentre setting.