Long-Term Effectiveness of a Stent-Less Strategy With Drug Coated Balloon in Coronary Artery Disease: 3-Year Follow-Up of a Prospective All-Comers Observational Study.

Introduction: Drug-eluting stent (DES) angioplasty is the gold standard treatment for coronary lesions. Drug-coated balloon (DCB) is an option for in-stent restenosis, and has also shown promise for small-calibre coronary artery disease. We evaluated the 3-year effectiveness of a decision algorithm for percutaneous coronary intervention (PCI) that favoured a stent-less strategy (SLS) in primary angioplasty.

Successful Endovascular Microembolization for Post-Traumatic High-Flow Priapism: A Case Report.

BACKGROUND High-flow (non-ischemic) priapism is a rare urological condition usually related to blind trauma to the penis or perineum causing an arterial-lacunar fistula. It can be treated conservatively, but in some cases when conservative treatment fails, the interventional approach is indicated. In the past, only surgical treatment was available, which was associated with a significant risk of complications.

The effect of gender on clinical outcomes following routine revascularizations with polymer-free sirolimus-eluting stents.

Background: Gender-specific outcomes after percutaneous coronary interventions were studied by a number of research groups with different endpoints and cohorts of different ethnic extractions. The purpose of this report is to use propensity score matching to determine gender-specific differences in clinical outcomes after percutaneous coronary interventions with polymer-free sirolimus-coated stents.

Materials And Methods: The basis for this post hoc analysis was two large all-comers studies with prospectively enrolled patients from Europe and Asia.

Crystalline sirolimus-coated balloon (cSCB) angioplasty in an all-comers, patient population with stable and unstable coronary artery disease including chronic total occlusions: rationale, methodology and design of the SCORE trial.

Background: A decade ago, the iopromide-paclitaxel coated balloon (iPCB) was added to the cardiologist's toolbox to initially treat in-stent restenosis followed by the treatment of de novo coronary lesions. In the meantime, DES technologies have been substantially improved to address in-stent restenosis and thrombosis, and shortened anti-platelet therapy. Recently, sirolimus-coated balloon catheters (SCB) have emerged to provide an alternative drug to combat restenosis.

Prospective, single-centre evaluation of the safety and efficacy of percutaneous coronary interventions following a decision tree proposing a no-stent strategy in stable patients with coronary artery disease (SCRAP study).

Aim: We evaluated a decision algorithm for percutaneous coronary interventions (PCI) based on a no-stent strategy, corresponding to a combination of scoring balloon angioplasty (SCBA) and drug-coated balloon (DCB), as a first line approach. Stents were used only in unstable patients, or in case of mandatory bailout stenting (BO-stent).

Methods: From April 2019 to March 2020, 984 consecutive patients, including 1922 lesions, underwent PCI.

Results from the "Me & My Heart" (eMocial) Study: a Randomized Evaluation of a New Smartphone-Based Support Tool to Increase Therapy Adherence of Patients with Acute Coronary Syndrome.

Purpose: This study evaluated whether patient support, administered via an electronic device-based app, increased adherence to treatment and lifestyle changes in patients with acute coronary syndrome (ACS) treated with ticagrelor in routine clinical practice.

Methods: Patients (aged ≥ 18 years) with diagnosed ACS treated with ticagrelor co-administered with low-dose acetylsalicylic acid were randomized into an active group (with support tool app for medication intake reminders and motivational messages) and a control group (without support tool app), and observed for 48 weeks (ClinicalTrials.gov Identifier: NCT02615704).

The Real-World CONSEQUENT ALL COMERS Study: Predictors for Target Lesion Revascularization and Mortality in an Unselected Patient Population.

We evaluated the safety and efficacy of a resveratrol-paclitaxel-coated peripheral balloon catheter in an all-comer patient cohort undergoing endovascular treatment of above-the-knee and below-the-knee peripheral artery disease. CONSEQUENT ALL COMERS (Clinical Post-Market Clinical Follow-up [PMCF] on Peripheral Arteries treated with SeQuent Please OTW [Over-the Wire]) is a prospective, single-arm, multicenter observational study (ClinicalTrials Identifier: NCT02460042). The primary end point was the 12-month target lesion revascularization (TLR) rate.

Impact of Coronary Stent Architecture on Clinical Outcomes: Do Minor Changes in Stent Architecture Really Matter?

Introduction: The objective of this study was to compare the accumulated clinical outcomes of two Malaysian all-comers populations, each treated with different polymer-free sirolimus-eluting stents (PF-SES) of similar stent design.

Methods: The Malaysian subpopulation of two all-comers observational studies based on the same protocol (ClinicalTrials.gov Identifiers: NCT02629575 and NCT02905214) were combined and compared to a Malaysian-only cohort which was treated with a later-generation PF-SES.

Provisional focal stenting of complex femoropopliteal lesions using the Multi-LOC multiple stent delivery system - 12-month results from the LOCOMOTIVE EXTENDED study.

: This study aimed to evaluate a Multiple Stent Delivery System for provisional focal stenting of the femoropopliteal artery. : The LOCOMOTIVE EXTENDED study (Multi- for flw liiting utcomes after plain old balloon angioplasty and/or drug-coated balloon reatment in the infrainguinal position with the object to implant multiple stent segments) is a prospective, single-arm, multicentre observational study. The Multi-LOC Multiple Stent Delivery System (B.

Prognostic Role of High Sensitivity Troponin T (hsTnT) After Recanalization of Chronic Total Occlusions (CTO).

Background: The prognostic role of periprocedural hsTnT after percutaneous coronary intervention (PCI) of CTOs is unknown. We evaluated the incidence and impact of hsTnT elevations on clinical and angiographic outcomes after CTO-PCI.

Methods: In a retrospective database analysis we identified 309 successfully treated CTO-PCI patients that had a re-angiography 6 months after the initial procedure.

Clinical outcomes following polymer-free sirolimus-eluting stent implantations in unselected patients: A descriptive subgroup analysis in patients with renal impairment.

Patients with chronic kidney disease (CKD are frequently excluded from coronary artery disease trials. The aim of this assessment was to study the clinical outcomes of polymer-free sirolimus-eluting stent implantations in patients with impaired renal function.Large-scale, international, single-armed, multicenter, 'all comers' observational studies (ClinicalTrials.

Impact of Different Geriatric Conditions on Choice of Therapy and In-Hospital Outcomes in Elderly Patients with Acute Coronary Syndrome.

Introduction: The clinical benefit of invasive therapy in elderly patients with acute coronary syndrome (ACS) remains unclear. Furthermore, the decision-making process to treat this growing patient group is also debatable. The purpose of this study was to assess the association between elderly ACS patients, the treatment choice and their in-hospital outcomes after non-ST-elevation (NSTE)-ACS in a consecutive series of patients >75 years of age.

Real-World Dual Antiplatelet Therapy Following Polymer-Free Sirolimus-Eluting Stent Implantations to Treat Coronary Artery Disease.

Objectives: The objective of this post hoc analysis was to analyze real-world dual antiplatelet therapy (DAPT) regimens following polymer-free sirolimus-eluting stent (PF-SES) implantations in an unselected patient population.

Methods: Patient-level data from two all-comers observational studies (ClinicalTrials.gov Identifiers: NCT02629575 and NCT02905214) were pooled and analyzed in terms of their primary endpoint.

Endpoint selection for noninferiority percutaneous coronary intervention trials: a methodological description.

Background: The objective of this review is to provide a practical update on endpoint selection for noninferiority (NI) studies in percutaneous coronary intervention studies.

Methods: A PubMed search was conducted for predefined terms to explore the use of NI designs and intrapatient comparisons to determine their current importance. Sample size calculations for the most frequently used endpoints with NI hypotheses were done to increase statistical awareness.

Lesion Revascularisation Subsequent to Femoropopliteal Spot Stenting Using the Multi-LOC Stent Delivery System.

Background/aim: Restenosis and stent fractures are well-characterised treatment failures following femoropopliteal (FP) stent-based interventions. We aimed to determine patterns of restenosis and fracture rates following focal stenting of FP arteries.

Patients And Methods: This retrospective study investigated angiographic patterns of restenosis and the occurrence of stent fractures following focal FP stenting with the multiple stent delivery system VascuFlex® Multi-LOC.

Drug Coated Balloon-Only Strategy in De Novo Lesions of Large Coronary Vessels.

Objectives: We analyzed the efficacy of drug coated balloons (DCB) as a stand-alone-therapy in de novo lesions of large coronary arteries. DCBs seem to be an attractive alternative for the stent-free interventional treatment of de novo coronary artery disease (CAD). However, data regarding a DCB-only approach in de novo CAD are currently limited to vessels of small caliber.

Design and rationale for the "Me & My Heart" (eMocial) study: A randomized evaluation of a new smartphone-based support tool to increase therapy adherence of patients with acute coronary syndrome.

A novel smartphone-based patient support tool was developed to increase the adherence to antiplatelet therapy and lifestyle changes in patients after coronary angioplasty for acute coronary syndrome (ACS). The eMocial study (ClinicalTrials.gov Identifier: NCT02615704) investigates whether an electronic support tool will improve adherence to comedication and lifestyle changes in ACS patients.

Correction to: Impact of Patient and Lesion Characteristics on Drug-Coated Balloon Angioplasty in the Femoropopliteal Artery: A Pooled Analysis of Four Randomized Controlled Multicenter Trials.

In their recently published pooled analysis of four drug-coated balloon (DCB) studies, which focused on the impact of patient and lesion characteristics on LLL at 6 months (Albrecht T et al. Cardiovasc Intervent Radiol. 2018 Dec 11.

Two-Year Mortality After Angioplasty of the Femoro-Popliteal Artery with Uncoated Balloons and Paclitaxel-Coated Balloons-A Pooled Analysis of Four Randomized Controlled Multicenter Trials.

Purpose: In view of a recent meta-analysis reporting increased mortality following angioplasty with paclitaxel-coated devices in peripheral arteries, we performed a patient-level 2-year mortality analysis based on pooled original data of four randomized controlled trials (THUNDER, FEMPAC, PACIFIER and CONSEQUENT).

Methods And Results: Clinical data of four randomized controlled trial were pooled to assess 2-year mortality following paclitaxel-coated balloon (PCB) angioplasty compared to angioplasty without paclitaxel (control group). A logistic regression model was applied to identify potential predictors of mortality.

Comparative preclinical evaluation of a polymer-free sirolimus-eluting stent in porcine coronary arteries.

Background:: Polymer-free drug-eluting stents (DES) without permanent-polymer coating may be associated with rapid vessel healing, providing a rationale to reduce dual-antiplatelet therapy (DAPT). The aim of the current study was to compare vessel healing of a polymer-free sirolimus-eluting stent (PF-SES), its bare metal stent (BMS) analogue to a permanent polymer-based sirolimus-eluting stent (SES) with proven effectiveness in porcine coronary arteries.

Material And Methods:: An ultrathin-strut cobalt-chromium PF-SES, its BMS analogue and an SES with a permanent polymer were used to study vessel healing and their antistenotic potential.