Impact of balloon post-dilation on valve durability and long-term clinical outcomes after self-expanding transcatheter aortic valve implantation.

BACKGROUND: Balloon post-dilation (BPD) is a widely adopted strategy to optimize acute results of TAVI, with a positive impact on both paravalvular leak and mean gradients. On the other hand, the inflation of the balloon inside prosthetic leaflets may damage them increasing the risk of structural valve deterioration (SVD). Furthermore, the impact of BPD on long-term clinical outcomes and valve hemodynamics is yet unknown. AIMS: To evaluate the impact of BPD on valve durability and long-term clinical outcomes in patients undergoing self-expanding transcatheter valve implantation (TAVI). METHODS: Echocardiographic and clinical data from the ClinicalService (a nation-based data repository and medical care project) were analyzed. Patients were divided into two groups, those who underwent BPD after TAVI and those who did not. Coprimary endpoints were all-cause death and SVD. Cumulative incidence functions for SVD were estimated. RESULTS: Among 1835 patients included in the study, 417 (22.7%) underwent BPD and 1418 (77.3%) did not undergo BPD. No statistically significant differences at 6-year follow-up were found between groups in terms of all-cause mortality (HR: 1.05, 95% CI: 0.9-1.22; p = 0.557) and SVD (2.1% vs. 1.4%, p = 0.381). In addition, BPD did not predispose to higher risk of cardiovascular death, myocardial infarction, valve thrombosis, and endocarditis at 6-year follow-up. CONCLUSIONS: BPD following TAVI with a self-expanding prosthesis does not seem to be associated with an increased risk of adverse clinical outcomes or SVD at 6-year follow-up.

Safety of metformin continuation in diabetic patients undergoing invasive coronary angiography: the NO-STOP single arm trial.

BACKGROUND: Despite paucity of data, it is common practice to discontinue metformin before invasive coronary angiography due to an alleged risk of Metformin-Associated Lactic Acidosis (M-ALA). We aimed at assessing the safety of metformin continuation in diabetic patients undergoing coronary angiography in terms of significant increase in lactate levels. METHODS: In this open-label, prospective, multicentre, single-arm trial, all diabetic patients undergoing coronary angiography with or without percutaneous coronary intervention at 3 European centers were screened for enrolment. The primary endpoint was the increase in lactate levels from preprocedural levels at 72-h after the procedure. Secondary endpoints included contrast associated-acute kidney injury (CA-AKI), M-ALA, and all-cause mortality. RESULTS: 142 diabetic patients on metformin therapy were included. Median preprocedural lactate level was 1.8 mmol/l [interquartile range (IQR) 1.3-2.3]. Lactate levels at 72 h after coronary angiography were 1.7 mmol/l (IQR 1.3-2.3), with no significant differences as compared to preprocedural levels (p = 0.91; median difference = 0; IQR - 0.5 to 0.4 mmol/l). One patient had 72-h levels ≥ 5 mmol/l (5.3 mmol/l), but no cases of M-ALA were reported. CA-AKI occurred in 9 patients (6.1%) and median serum creatinine and estimated glomerular filtration rate remained similar throughout the periprocedural period. At a median follow-up of 90 days (43-150), no patients required hemodialysis and 2 patients died due to non-cardiac causes. CONCLUSIONS: In diabetic patients undergoing invasive coronary angiography, metformin continuation throughout the periprocedural period does not increase lactate levels and was not associated with any decline in renal function. TRIAL REGISTRATION: The study was registered at Clinicaltrials.gov (NCT04766008).

Safety and efficacy of an ultra low dose fluoroscopic protocol for chronic total occlusion recanalization.

BACKGROUND: Chronic total occlusion (CTO) revascularization is a major source of radiation for both patients and physicians. Therefore, efforts to minimize radiation during CTO percutaneous coronary intervention (PCI) are highly encouraged. AIMS: To evaluate the impact of an Ultra Low fluoroscopic Dose Protocol (ULDP), based on 3.75 frames per second for the fluoroscopy and 7.5 frames per second for the cine acquisition, during CTO PCI. METHODS: One hundred fifty consecutive patients who underwent CTO PCI were retrospectively enrolled. Eighty-five underwent standard dose protocol (SDP) and 65 ULDP. Radiation exposure and acute clinical outcomes were compared between groups. Results were stratified according to lesion complexity. RESULTS: Patients undergoing ULDP, as compared to those undergoing SDP, showed a significant reduction of kerma area product, both for simple lesions (6861.0 vs. 13236.0 mGy × cm2 ; p = 0.014) and complex lesions (CL) (8865.0 vs. 16618.0 mGy × cm2 ; p < 0.001). Similarly, Air Kerma (AK) was lower when ULDP was used (1222.5 vs. 2015.0 cGy in SL, p = 0.134; 1499.0 vs. 2794.0 cGy in CL, p < 0.001). No significant differences were reported regarding procedural success and in-hospital major adverse cardiovascular events between groups. Notably, there was not any crossover from ULDO to SDP due to poor quality images. Interestingly, fluoroscopy time, procedural time and contrast volume was significantly lower in patients undergoing ULDP only for CLs. CONCLUSIONS: ULDP significantly reduces radiation exposure in the setting of high complexity procedures such as CTO PCI. This reduction seemed to be greater with increased procedural complexity and did not impact acute success or adverse clinical events.

SUOH 03 Guidewire for the Management of Coronary Artery Dissection: Insights from a Multicenter Registry.

Background: In the setting of coronary artery dissection, both spontaneous and iatrogenic, fixing the intimal tear, usually with stent implantation, can be extremely challenging if the distal wire position has been lost. Common complications are mainly related to the inadvertent subintimal tracking of the guidewire while attempting to gain the distal true lumen. Aims: To report the registry results of using the SUOH 0.3 guidewire for managing coronary artery dissection in a real-world multicenter setting. Methods: The study population in this retrospective, multicenter, international registry included 75 consecutive patients who underwent PCI and required an antegrade wiring of a dissected coronary artery. Results: Successful use of SUOH 0.3 was achieved in 69 (92%) patients. The use of a microcatheter was associated with a significantly higher rate of TIMI 3 flow at the end of the procedure (no microcatheter: n = 17, 81%; microcatheter: n = 52, 96.3%; p = 0.017). The first recanalization attempt was made with the SUOH 03 guidewire in 48 (64%) cases, and it was successful in 42 (87%). The overall PCI success rate was reported in 72 (96%) patients, with no significant differences among patients with different origins, mechanisms, and locations of dissection. Conclusions: In this setting, the SUOH 0.3 guidewire provides high procedural success without additional complex techniques.

Early arrhythmia recurrence after cryoballoon ablation in atrial fibrillation: A systematic review and meta-analysis.

INTRODUCTION: Early arrhythmia recurrence within the 3-month blanking period is a common event that historically has been attributed to reversible phenomena. While its mechanistic links remain obscure, accumulating evidence support the argument of shortening the blanking period. We aimed to elucidate the association between early and late arrhythmia recurrence after atrial fibrillation cryoablation. METHODS: The MEDLINE database, ClinicalTrials. gov, medRxiv, and Cochrane Library were searched for studies evaluating early and late arrhythmia recurrence rates in patients undergoing cryoablation for atrial fibrillation. Data were pooled by meta-analysis using a random-effects model. The primary endpoint was late arrhythmia recurrence. RESULTS: Early arrhythmia recurrence was found predictive of decreased arrhythmia-free survival after evaluating 3975 patients with paroxysmal or persistent atrial fibrillation who underwent cryoablation (odds ratio [OR]: 5.31; 95% confidence interval [CI]: 3.75-7.51). This pattern remained unchanged after subanalyzing atrial fibrillation type (paroxysmal; OR: 7.16; 95% CI: 4.40-11.65 and persistent; OR: 7.63; 95% CI: 3.62-16.07) as well as cryoablation catheter generation (first generation; OR: 5.15, 95% CI: 2.39-11.11 and advanced generation; OR: 5.83, 95% CI: 3.68-9.23). Studies permitting antiarrhythmic drug utilization during the blanking period or examining early recurrence as a secondary outcome were found to be a significant source of statistical heterogeneity. CONCLUSION: Our findings suggest that early arrhythmia recurrence is predictive of late outcomes after cryoablation for atrial fibrillation. Identifying which patients deserve earlier reintervention is an open research avenue.

Angiography-derived versus invasively-determined index of microcirculatory resistance in the assessment of coronary microcirculation: A systematic review and meta-analysis.

BACKGROUND: The index of microvascular resistance (IMR) is an established tool to assess the status of coronary microcirculation. However, the need for a pressure wire and hyperemic agents have limited its routine use and have led to the development of angiography-derived pressure-wire-free methods (angiography-derived IMR [IMRAngio]). In this review and meta-analysis, we aim to assess the global diagnosis accuracy of IMRAngio versus IMR. METHODS: A systematic review of the literature was performed. Studies directly evaluating IMRAngio versus IMR were considered eligible. Pooled values of diagnostic test and summary receiver operator curve were calculated. RESULTS: Seven studies directly comparing IMRAngio versus IMR were included (687 patients; 807 vessels). Pooled sensitivity, specificity, +likelihood ratio (LR), and -LR were 82%, 83%, 4.5, and 0.26 respectively. Pooled accuracy was 83% while pooled positive predictive value and negative predictive value were 76% and 85%, respectively. Comparable results were obtained when analyzing by clinical scenario (acute and nonacute coronary syndromes). CONCLUSION: IMRAngio shows a good diagnostic performance for the prediction of abnormal IMR.

Device entrapment during percutaneous coronary intervention.

INTRODUCTION: Device entrapment is a life-threatening complication during percutaneous coronary intervention (PCI). However, the success for its management is predominantly based on operator experience with limited available guidance in the published literature. METHODS: A systematic review was performed on December 2021; we searched PubMed for articles on device entrapment during PCI. In addition, backward snowballing (i.e., review of references from identified articles and pertinent reviews) was employed. RESULTS: A total of 4209 articles were retrieved, of which 150 studies were included in the synthesis of the data. A methodical algorithmic approach to prevention and management of device entrapment can help to optimize outcomes. The recommended sequence of steps are as follows: (a) pulling, (b) trapping, (c) snaring, (d) plaque modification, (e) telescoping, and (f) surgery. CONCLUSIONS: In-depth knowledge of the techniques and necessary tools can help optimize the likelihood of successful equipment retrieval and minimization of complications.

Long term follow-up after balloon expandable covered stents implantation for management of transcatheter aortic valve replacement related vascular access complications.

OBJECTIVES: To report the experience of a high-volume center with balloon-expandable (BE) stents implantation to manage vascular complications after transcatheter aortic valve replacement (TAVR). BACKGROUND: Despite increased operator experience and better devices, vascular complications after TAVR are still a major issue and covered stent implantation is often required. METHODS: We retrospectively collected baseline and procedural data about 78 consecutive patients who underwent BE stent implantation to manage a vascular complication after transfemoral TAVR. Primary endpoints were technical success, incidence of new-onset claudication and need for vascular interventions during long-term follow-up. Secondary endpoints included length of hospitalization, in-hospital and 30-day mortality, and major postoperative complications. RESULTS: BE stents implantation to manage vascular complications after TAVR was successfully performed in 96.2% of the cases, with bailout surgery required in two cases. One patient suffered in-hospital death. Predischarge Doppler Ultrasound revealed no cases of in-stent occlusion or fracture. At a median follow-up of 429 days (interquartile range, 89-994 days), no cases of symptomatic leg ischemia were reported and only one patient experienced new-onset claudication. CONCLUSIONS: Our experience showed good periprocedural and long-term results of BE covered stent implantation to manage vascular complication after TAVR. Their great radial outward force may guarantee effective hemostasis without necessarily being associated with stent deformation/fracture resulting in restenosis or further interventions. More research is needed to define the role of BE covered stents in this setting.

Left atrial appendage closure with the II generation Ultraseal device: An international registry. The LIGATE study.

OBJECTIVES: To assess feasibility and safety of second-generation left atrial appendage closure (LAAC) Ultraseal device in patients with nonvalvular atrial fibrillation (NVAF). BACKGROUND: LAAC with first-generation Ultraseal device (Cardia, Eagan, Minnesota) has been shown to be a feasible therapeutic option in patients with NVAF. However, there is a paucity of data regarding the novel second-generation Ultraseal device. METHODS: All patients with NVAF undergoing second-generation Ultraseal device implantation between February 2018 and September 2020 were included in a multicenter international registry. Periprocedural and post-discharge events were collected through 6-month follow-up. Co-primary efficacy endpoints were device success and technical success while primary safety endpoint was in-hospital major adverse event (MAE) occurrence. RESULTS: A total of 52 patients were included: mean age 75 ± 8, 30.8% women, mean HAS-BLED 3 ± 1. The device was successfully implanted in all patients. Technical success was achieved in 50 patients (96.1%). In-hospital MAEs occurred in three patients (5.8%). The incidence of 6-month all-cause death and major bleeding was 11.6% and 2.1%, respectively. No strokes, transient ischemic attacks, systemic embolisms, or device embolization were reported after discharge. CONCLUSIONS: Second-generation Ultraseal device implantation was associated with high success rates and a low incidence of peri-procedural complications. Larger studies with longer follow-up are warranted to further evaluate the safety and the efficacy of this device, especially at long-term follow-up.

Radial artery occlusion after conventional and distal radial access: Impact of preserved flow and time-to-hemostasis in a propensity-score matching analysis of 1163 patients.

OBJECTIVES: To compare incidence of forearm radial artery occlusion (RAO) and hemostasis characteristics between distal and conventional transradial approach (DRA and TRA, respectively). BACKGROUND: DRA has the potential advantage of reducing RAO. DRA effectively reduces time-to-hemostasis, however its role on preserving flow in the radial artery (PF) during hemostasis and consequent impact on RAO remains speculative. METHODS: Eight hundred thirty-seven patients with TRA were previously enrolled in a prospective registry investigating the relationship of residual anticoagulation and RAO. Three hundred twenty-six additional patients with DRA were added to the cohort and matched to the original cohort by propensity score. The composite end-point of RAO at forearm and distal site of puncture (dRAO) was evaluated as secondary end-point. RESULTS: RAO occurred in 4.8% (41 of 837) of patients undergoing TRA and in 0% (0 of 326) of those undergoing DRA (p < 0.0001). DRA was associated with higher percentage of PF (97.2% vs. 78.5% in TRA group, p < 0.0001) and reduced time-to-hemostasis (147 ± 99 min vs. 285 ± 138 min, p < 0.0001). After matching, hemostasis characteristics were still significant different (PF 95.7% vs. 90.1%, p = 0.023, and 190 ± 92 vs. 323 ± 162 min, p < 0.0001) with reduction in the incidence of RAO (0 of 213, 0% vs. 7 of 213, 3.3%, p = 0.0015). dRAO occurred in one case (0.3% and 0.5% after matching, p < 0.0001 and p = 0.032 compared to TRA). CONCLUSIONS: DRA was associated with lower rates of RAO compared to TRA. This effect is potentially explained by reduced time-to-hemostasis and maintained flow at the wrist during hemostasis.

Monotherapy with a P2Y12 inhibitor or aspirin for secondary prevention in patients with established atherosclerosis: a systematic review and meta-analysis.

BACKGROUND: Antiplatelet therapy is recommended among patients with established atherosclerosis. We compared monotherapy with a P2Y12 inhibitor versus aspirin for secondary prevention. METHODS: In this systematic review and meta-analysis, all randomised trials comparing P2Y12 inhibitor with aspirin monotherapy for secondary prevention in patients with cerebrovascular, coronary, or peripheral artery disease were evaluated for inclusion. On Dec 18, 2019, we searched PubMed, Embase, BioMedCentral, Google Scholar, and the Cochrane Central Register of Controlled Trials. Additionally, we reviewed references from identified articles and searched abstracts from 2017 to 2019 presented at relevant scientific meetings. Data about year of publication, inclusion and exclusion criteria, sample size, baseline patients' features including the baseline condition determining study inclusion (ie, cerebrovascular, coronary, or peripheral artery disease), P2Y12 inhibitor type and dosage, aspirin dosage, endpoint definitions, effect estimates, follow-up duration, and percentage of patients lost to follow-up were collected. Odds ratios (ORs) and 95% CIs were used as metric of choice for treatment effects with random-effects models. Co-primary endpoints were myocardial infarction and stroke. Key secondary endpoints were all-cause death and vascular death. Heterogeneity was assessed with the I2 index. This study is registered with PROSPERO (CRD42018115037). FINDINGS: A total of nine randomised trials were identified and included in this study, and 42 108 patients randomly allocated to a P2Y12 inhibitor (n=21 043) or aspirin (n=21 065) were included in our analyses. Patients who received a P2Y12 inhibitor had a borderline reduction for the risk of myocardial infarction compared with those who received aspirin (OR 0·81 [95% CI 0·66-0·99]; I2=10·9%). Risks of stroke (OR 0·93 [0·82-1·06]; I2=34·5%), all-cause death (OR 0·98 [0·89-1·08]; I2=0%), and vascular death (OR 0·97 [0·86-1·09]; I2=0%) did not differ between patients who received a P2Y12 inhibitor and those who received aspirin. Similarly, the risk of major bleeding (OR 0·90 [0·74-1·10]; I2=3·9%) did not differ between patients who received a P2Y12 inhibitor and those who received aspirin. The number needed to treat to prevent one myocardial infarction with P2Y12 inhibitor monotherapy was 244 patients. Findings were consistent regardless of the type of P2Y12 inhibitor used. INTERPRETATION: Compared with aspirin monotherapy, P2Y12 inhibitor monotherapy is associated with a risk reduction for myocardial infarction and a comparable risk of stroke in the setting of secondary prevention. The benefit of P2Y12 inhibitor monotherapy is of debatable clinical relevance, in view of the high number needed to treat to prevent a myocardial infarction and the absence of any effect on all-cause and vascular mortality. FUNDING: Italian Ministry of Education.

Management and outcomes of coronary artery perforations treated with the block and deliver technique.

OBJECTIVES AND BACKGROUND: Coronary artery perforation (CAP) is a potentially life-threatening complication during percutaneous coronary interventions (PCI) and the best strategy for its management is yet to be proved. We aimed to analyze the safety, efficacy, and long-term clinical outcomes of the block and deliver (BAD) technique, as only anecdotal cases are reported in literature. METHODS: From January 2016 to January 2020, all consecutive patients treated with the BAD technique at five high-volume centers in Italy were retrospectively identified. RESULTS: 25 CAPs treated with the BAD technique were included. The most frequently perforated artery was the left anterior descending artery (32%) and spring-coil wires with a hydrophilic coating were the most common culprit wires (68%). Mean sealing time was 46.9 ± 60.1 min, with no significant differences between CTO-PCIs and non-CTO PCIs (p = .921). Acute successful sealing of the CAP was achieved in 96% of the cases. Immediate cardiac tamponade occurred in 28% of patients, four during CTO PCI and three during non-CTO PCI (p = .55). Two patients required pericardiocentesis during hospitalization, one patient developed acute kidney injury, and one patient underwent cardiac surgery due to severe mitral regurgitation. At 1-year follow-up no significant differences were observed between groups in terms of POCE (25 vs 25%, p = .628) and its individual components. CONCLUSION: The BAD technique proved to be effective for the management of CAP, showing high successful sealing rates. Rates of in-hospital events and at 1-year follow-up did not significantly differ between patients suffering CAP during CTO revascularization or during non-CTO PCI.

Drug-Coated balloons vs drug-eluting stents for the treatment of small coronary artery disease: A meta-analysis of randomized trials.

OBJECTIVES AND BACKGROUND: There is conflicting evidence about the effects of drug-coated balloons (DCB) compared with drug-eluting stents (DES) in patients with native small vessel coronary artery disease (CAD). METHODS: The PubMed, Embase, Cochrane Central Register of Controlled Trials, and ClinicalTrials.gov databases and main international conference proceedings were searched for randomized controlled trials (RCT) comparing DCB versus DES in patients with native small vessel CAD. Data were pooled by meta-analysis using a random-effects model. The primary endpoint was target vessel revascularization (TVR). Secondary clinical endpoints were: myocardial infarction (MI), target lesion revascularization (TLR), all-cause death, cardiac death, and stent thrombosis or target vessel thrombosis. Secondary angiographic outcomes were: in-segment restenosis, in-segment percentage-diameter stenosis, in-segment late lumen loss, in-segment net luminal gain, and in-segment minimal lumen diameter. RESULTS: Five trials enrolling 1,459 patients were included. Mean clinical follow-up was 10.2 months. The use of DCB, compared with DES, was associated with similar risk of TVR (odds ratio [OR]: 0.97; 95% confidence interval [CI] 0.56 to 1.68; p = .92), TLR (OR: 1.74; 95% CI: 0.57 to 5.28; p = .33), all-cause death (OR: 1.03; 95% CI: 0.14 to 7.48; p = .98), with a trend toward a lower risk of MI (OR: 0.49; 95% CI: 0.23 to 1.03; p = .06), and with significant lower risk of vessel thrombosis (OR: 0.12; 95% CI: 0.01 to 0.94; p = .04). DCB use was associated with similar risk of angiographic restenosis (OR: 1.12; 95% CI 0.69 to 1.84; p = .64), comparable late luminal loss (standardized mean difference (SMD): -0.18; 95% CI: -0.39 to 0.03; p = .09), while leading to significant higher percentage diameter stenosis (SMD: 0.27; 95% CI 0.12 to 0.41; p < .01) and smaller minimal luminal diameter (SMD: -0.52; 95% CI: -0.86 to -0.18; p = .003). CONCLUSION: Compared with DES, the use of DCB for the treatment of native small vessel CAD is associated with similar TVR and restenosis and reduces the risk of vessel thrombosis, although DES implantation yields slightly better angiographic surrogate endpoints.

One-stop-shop totally percutaneous approach for severe aortic and mitral regurgitation in cardiogenic shock.

Patients presenting with cardiogenic shock and severe combined aortic and mitral regurgitation represent a major clinical challenge. Therapeutic options are limited in this setting as they are often deemed inoperable due to prohibitive risk for surgery, while mechanical circulatory support is usually contraindicated or technically challenging. Medical therapy, on the other hand, is associated with high-mortality rates. Therefore, percutaneous therapies may represent an appealing alternative. Here, we present a "one-stop-shop" totally percutaneous approach for severe aortic and mitral regurgitation in a patient with cardiogenic shock.

Effectiveness of the "new rope coil" composite core Suoh 0.3 guidewire in the management of coronary artery dissections.

Coronary artery dissection is a well-known complication of percutaneous coronary interventions. In this setting, coronary artery dissection is caused by mechanical injury of the arterial wall. However, dissection may also occur spontaneously. In both situations, an intimal tear or dissection allows blood entering and separating the layers of the coronary arterial wall. Despite percutaneous approach is still the preferred and the quickest way to restore coronary flow, it remains challenging. One of the main reasons for procedural failure is due to the difficult advancement of a guidewire into the true lumen. In such situation, the ideal wire should have a soft tip, high torque control, and excellent flexibility. Assuming that, the "new rope coil" composite core Suoh 0.3 guidewire, with its unique combination of characteristics, could allow better orientation insight into a dissected coronary artery increasing the chance of procedural success. We collected a case series of nine consecutive patients in which the Suoh 0.3 guidewire was able to gain the true lumen distally to a dissected segment.

Paraplegia Due to Spinal Cord Ischemia after Endovascular Treatment of a Type II Endoleak.

Type II endoleaks are a common complication after endovascular abdominal aortic aneurysm repair, with transarterial embolization using synthetic surgical glue being an established treatment option. We report a case of paraplegia due to spinal cord ischemia after lumbar arteries embolization by Glubran-lipiodol glue for a type II endoleak. Special attention must be given by interventional specialists when applying surgical diluted glues for the treatment of type II endoleaks to avoid distal embolization and subsequent spinal cord ischemia.

Pharmacological Considerations during Percutaneous Treatment of Heart Failure.

Heart Failure (HF) remains a global health challenge, marked by its widespread prevalence and substantial resource utilization. Although the prognosis has improved in recent decades due to the treatments implemented, it continues to generate high morbidity and mortality in the medium to long term. Interventional cardiology has emerged as a crucial player in HF management, offering a diverse array of percutaneous treatments for both acute and chronic HF. This article aimed to provide a comprehensive review of the role of percutaneous interventions in HF patients, with a primary focus on key features, clinical effectiveness, and safety outcomes. Despite the growing utilization of these interventions, there remain critical gaps in the existing body of evidence. Consequently, the need for high-quality randomized clinical trials and extensive international registries is emphasized to shed light on the specific patient populations and clinical scenarios that stand to benefit most from these innovative devices.

Procedural and clinical impact of intravascular lithotripsy for the treatment of peri-stent calcification.

BACKGROUND: Use of intravascular lithotripsy (IVL) for treating peri-stent calcification is increasing. However, this indication remains 'off-label'. We aimed to investigate the efficacy and clinical outcomes of in-stent IVL. METHODS: Patients from five European centers who underwent in-stent IVL were included between 2019 and 2023. Demographic, clinical, procedural and follow-up data were collected from electronic hospital records. Angiographic and intracoronary imaging (ICI) data were analyzed in a centralized core-laboratory. RESULTS: Of 101 patients (71.2 ± 9.2 years), 56(55 %) received in-stent IVL for late stent failure (median 109 days post-PCI) due to calcific neoatherosclerosis or extra-stent calcification(late-IVL), while 45(45 %) underwent bail-out IVL due to stent infraexpasion (immediate-IVL). Both late-IVL and immediate-IVL significantly improved angiographic %diameter stenosis (73.7[59.6-89.8]% to 16.4 [10.4-26.9]%;p < 0.0001 and 28.6[22.5-43.3]% to 14.1[10.3-29.4]%;p < 0.0001, and minimum lumen area (MLA) (3.4 ± 1.2 to 8.6 ± 2.5 mm2;p < 0.002 and 5.4 ± 1.9 to 7.3 ± 1.9;p < 0.0001).Device(98 %) and procedural success(80 %) were high. MACE rates in-hospital (2 %), 30-days (3 %),6-months(5 %) and 1-year(7 %) were low and comparable in both groups. Acute diameter gain was lower in immediate-IVL (2.1 ± 0.7 mm vs. 0.5 ± 0.4 mm;p < 0.0001). This, however, was explained by significant differences in pre-IVL angiographic and ICI parameters (%diameter stenosis 73.7[59.6-89.8] vs. 28.6[22.5-43.3]%; p < 0.0001 and MLA (3.4 ± 1.2 vs 5.4 ± 1.9 mm2; p < 0.0001), whereas post-IVL percentage diameter stenosis (16.4(10.4-26.9) vs. 14.1(10.3-29.4);p = 0.914) and MLA (8.6 ± 2.5vs. 7.4 ± 1.9 mm2;p = 0.064) in late- and immediate-IVL were comparable. CONCLUSIONS: IVL in-stent due to peri-stent calcification is an effective strategy, both late and immediately after stent implantation. Overall, MACE rates at short- and mid-term were low and comparable in both groups, although clinical findings should be taken with caution.

Uninterrupted direct-acting oral anticoagulation in patients undergoing transradial percutaneous coronary procedures: The DOAC-NOSTOP study rationale and design.

BACKGROUND: patients with atrial fibrillation (AF) under treatment with chronic oral anticoagulation (OAC) often require coronary angiography with or without percutaneous coronary intervention (PCI). Deciding the management of OAC during this periprocedural period requires balancing the risks of hemorrhage and thrombotic complications. Guidelines recommend an uninterrupted strategy in patients receiving Vitamin-K Antagonists (VKA). However, for patients undergoing coronary angiography or PCI while on direct oral anticoagulants (DOACs), withdrawal 12-24 h prior to the procedure is still recommended. This is based on expert opinions given the lack of evidence. Therefore, whether DOAC discontinuation prior to trans-radial coronary procedures should be the strategy of choice is a matter of debate and solid evidence is needed to guide clinical decision making. METHODS: The DOAC-NOSTOP study is a prospective, single-arm, open-label study evaluating the safety of DOACs continuation in 200 patients undergoing transradial percutaneous coronary procedures. DOAC treatment will not be interrupted throughout the periprocedural period. Primary outcome will be Bleeding Academic Research Consortium (BARC) type 2, 3, or 5 events, assessed at a 30-day follow-up. CONCLUSIONS: The DOAC-NOSTOP is the first study prospectively assessing the risk of bleeding with uninterrupted DOAC in patients undergoing trans-radial percutaneous coronary procedures.