Drug Eluting Research Articles

Abstract WMP82: National Trends In Endovascular Therapy For Intracranial Atherosclerotic Disease 2008-2019

Introduction: Endovascular therapy is a treatment option for patients with severe symptomatic intracranial atherosclerotic disease (ICAD). The utilization of angioplasty and stenting has varied since the development of stents for this disease in 2005. This study assesses the longitudinal trends for endovascular treatment of ICAD in the U.S. Methods: We performed a data search from the National Inpatient Sample (NIS) database using ICD9 and ICD10 procedure codes from 2008 through 2019. Data was collected for patients with stroke from ICAD who underwent stenting or angioplasty alone. We also assessed the utilization of stenting or angioplasty in thrombectomy cases for large vessel occlusion (LVO), the use of drug eluting stents, patient demographics, regional trends, length of stay, and mortality statistics. Results: Between 2008 and 2019, the nadir of ICAD stenting cases in the U.S. was in 2011 (n=242). There was over a 207% increase in stenting cases in 2015 (n=730), and another increase of 47% in ICAD stenting in 2018 and 2019 (2018=965, 2019=1,175). There was a significant increase in stenting for ICAD over the entire study period (p=0.003). The data also shows a significant increase in the use of stenting as adjunctive therapy to thrombectomy for LVO. In 2011, stenting with thrombectomy in LVO represented 17.8% (43/242) of patients stented with stroke from ICAD. In 2019, these cases represented 48.1% (565/1,175) of the patients stented. Over the study period, this increase in stent use during LVO treatment was significant (p<0.001). Angioplasty alone for ICAD in non-occluded vessels has not significantly changed (p=0.289). Angioplasty as an adjunct to thrombectomy for LVO has steadily increased over the past 10 years, with 94 cases in 2008 and 210 cases in 2019, representing a 123% increase. Conclusion: There has been a progressive increase in stenting for ICAD since the nadir of this procedure in 2011 which is statistically significant. This increase was seen in patients with severe symptomatic ICAD, but also in patients undergoing thrombectomy for acute LVO with ICAD. Positive clinical stenting trials such as WEAVE and the post-hoc analysis from SAMMPRIS, and the increase in endovascular therapy for LVO appear temporally related to these changes.

Abstract TP149: Balloon Mounted Drug Eluting Stents For Treatment Of Intracranial Atherosclerosis In Emergent Large Vessel Ichemic Stroke

Introduction: Intracranial atherosclerotic disease (ICAD) is an important etiology of ischemic stroke, and often poses a challenge to successful endovascular reperfusion in the setting of emergent large vessel stroke (ELVS). We aimed to evaluate the safety and efficacy of balloon-mounted drug eluting stents (DES) in the treatment of ELVS. Methods: Retrospective review of endovascular database from our comprehensive stroke center from Jan 2021 - Aug 2022. Patients undergoing endovascular therapy for anterior circulation ELVS with ≥70% stenosis in the target vessel treated with DES were included. Patients with tandem cervical carotid lesions requiring stenting were excluded. Primary outcomes were symptomatic intracranial hemorrhage (sICH) within 72 hrs and mortality at 30 days. Secondary outcomes were feasibility of treatment with DES and recurrent stroke within 30 days. Results: Of 359 endovascular stroke interventions performed, 11 patients met the inclusion criteria. Mean age was 60 [51-78], and 7 (64%) were female. Target lesions included 8 M1 (73%), 1 M2 (9%), 1 cavernous ICA (9%), and 1 ICA/M1 junction (9%). Average time from last known well to arterial puncture was 14 hrs, 15 mins [1 hr, 9 mins to 25 hrs, 23 mins]. 2 patients (18%) received IV alteplase. Average ASPECT score 8.3 [5-10], average core infarct 10 mL [0-48] and average mismatch 68 mL [12-179]. 5 procedures (45%) performed via radial access and 6 via femoral (55%), all under general anesthesia. 5 patients (45%) underwent mechanical thrombectomy and 6 (55%) underwent angioplasty prior to DES. 3 (27%) underwent primary DES treatment. Average pre-treatment stenosis was 83% [70-95%], average post-treatment stenosis was 14% [0-45%]. All DES were delivered successfully with no procedural complications. All patients achieved successful reperfusion (8 TICI 3 [73%], 2 TICI 2C [18%], and 1 TICI 2B [9%]). Average NIHSS score was 12.4 [5-28] at presentation and 7.5 [0-20] at 7-10 days. There were no sICH at 72 hrs, and no deaths at 30 days. 1 patient returned with stroke secondary to stent occlusion at 29 days, with successful TICI 3 recanalization following angioplasty. Conclusions: Endovascular treatment of ICAD-related ELVS with DES is safe and effective, and warrants further investigation.

Frequency of in-Stent Restenosis in patients having DES, with Stent Length Greater than 30mm Presenting to Tertiary Care Center

Objective: The purpose of this study was to calculate the incidence of in-stent restenosis in patients with DES and stent lengths higher than 30mm who presented to a tertiary care hospital. Study Design: A Cross-sectional study Place and Duration: This cross-sectional study was conducted at Department of Cardiology, Rashid Latif Medical College, Lahore in the duration from February, 2022 to July, 2022. Methods: There were 83 patients of coronary artery disease (CAD)were included. After obtaining written consent from participants, researchers collected information about their participants' ages, sexes, body mass indexes, and co-morbidities. Atherosclerosis risk variables were collected with baseline investigations and an echocardiography for ejection fraction determination. Imaging studies were reviewed by board-certified interventional cardiologists, who found evidence of ISR. Past angioplasty information and stent details were recorded. Results: In our study mean age of the presented cases was 54.13±7.44 years and mean BMI 25.2±13.87 kg/m2. Most common comorbidity was diabetes found in 25 (30.1%) followed by hypertension in 23 (27.7%) and dyslipidemia in 20 (24.1%) cases. We found that 40 (48.2%) patients were smokers. Mean LDL cholesterol of the patients was 68.6±1.97 mg/dl and mean uric acid was 6.2±2.35 mg/dl. Majority of the cases 45 (54.2%) had poor socio-economic status. We found that frequency of ISR was higher among cases of biomatrix stent 24 (28.9%), followed by Xience stent in 22 (26.5%) cases, Ultimaster stent in 19 (22.9%) and Xlimus stent in 18 (21.7%) cases after coronary angiograpghy. Our results showed that the stents longer than 30mm were associated with a higher incidence of In-Stent Restenosis (p=0.03). Conclusion: Based on the findings of this study, we came to the conclusion that a previous diagnosis of diabetes mellitus and a longer stent length are both significant risk factors for developing in-stent restenosis. In our research, we found that instances with biomatrix stents had a greater incidence of ISR. Keywords: CAD, Drug eluting stents (DES), Coronary angiography, In-Stent Restenosis

Accuracy in precise DAPT score compared with CRUSADE score in Thai population

Abstract Funding Acknowledgements Type of funding sources: Public hospital(s). Main funding source(s): Rajavithi hospital Introduction Myocardial infarction is one of the most common cardiovascular disease in the world including Thai population. The current treatment strategy is percutaneous coronary intervention (PCI) with drug eluting stent (DES) which need to receive aspirin and P2Y12 inhibitor called Dual antiplatelets (DAPT) The previous studies showed unwanted bleeding in patients who received DAPT. Many scores are developed and valid to use as indicator of bleeding risk. However, the study of accuracy, performance and validity of Precise DAPT and CRUSADE score in Thailand are still limited. Method and Materials This is retrospective study of Thai patients aged 20 – 85 years old diagnose with acute coronary syndrome (ACS) and chronic coronary syndrome (CCS) who underwent PCI with DES and took DAPT for 6 months in CCS and 1 year in ACS at Rajavithi hospital from 2017 to 2019. Exclusion criteria are patients who take anticoagulant, previous major bleeding, currently received DAPT. We calculated the Precise DAPT score and CRUSADE score of the enrolled patients and follow up the bleeding events for 1 year. Objectives The primary outcome is the accuracy of the Precise DAPT score and the secondary outcome is to compare the performance of the Precise DAPT and Crusade score. Results Total of 90 patients were enrolled in this study with mean age of 63 ± 11.8 years old. Mainly are males (73.3%). The diagnosis of patients with STEMI 31.1%, NSTEMI/UA 38.8% and CCS 30.0%. The bleeding events defined by TIMI major and minor bleeding were 6 patients comprised of 1 TIMI major and 5 TIMI minor events. The bleeding events in Precise DAPT score < 25 were 3 of 47 patients (6.4%) compared with Precise DAPT score ³25 were 3 of 43 patients (7.0%) The events of bleeding in CRUSADE score <31 were 2 of 39 patients (5.1%), CRUSADE score 31-40 were 2 of the 17 patients (11.8%) and CRUSADE score > 40 were 2 of 34 patients (5.9%). The accuracy of Precise DAPT and CRUSADE score to predict TIMI major bleeding by ROC curve were excellence with AUC of Precise DAPT score = 0.955 (95%CI 0.912-0.998) and AUC of CRUSADE score =0.966 (95%CI 0.927-1.000). However, the Accuracy of Precise DAPT score and CRUSADE score to predict TIMI major and minor bleeding by ROC curve were poor with AUC = 0.529 (95%CI 0.250-0.799) and AUC = 0.531 (95%CI 0.254-0.807) respectively. The sensitivity and specificity of the cut-off ³ 25 point in Precise DAPT is 50.0 % and 57.1%%, respectively. While the sensitivity and specificity of the cut-off > 40 in CRUSADE score is 33.0% and 63.1% respectively. Conclusions This study showed that Precise DAPT score with cut-off ³ 25 and CRUSADE score with cut-off >40 have excellent accuracy to predict TIMI major bleeding but poor accuracy on TIMI minor bleeding in patients who take DAPT after PCI with DES.

Ciprofloxacin Release and Corrosion Behaviour of a Hybrid PEO/PCL Coating on Mg3Zn0.4Ca Alloy

In the present work, a hybrid hierarchical coating (HHC) system comprising a plasma electrolytic oxidation (PEO) coating and a homogeneously porous structured polycaprolactone (PCL) top-coat layer, loaded with ciprofloxacin (CIP), was developed on Mg3Zn0.4Ca alloy. According to the findings, the HHC system avoided burst release and ensured gradual drug elution (64% over 240 h). The multi-level protection of the magnesium alloy is achieved through sealing of the PEO coating pores by the polymer layer and the inhibiting effect of CIP (up to 74%). The corrosion inhibition effect of HHC and the eluted drug is associated with the formation of insoluble CIP-Me (Mg/Ca) chelates that repair the defects in the HHC and impede the access of corrosive species as corroborated by FTIR spectra, EIS and SEM images after 24 h of immersion. Therefore, CIP participates in an active protection mechanism by interacting with cations coming through the damaged coating.

Efficacy of intravascular ultrasound versus coronary angiographic guided drug-eluting stent implantation in the treatment of left main coronary artery disease: a meta-analysis

Objective: To compare the efficacy of intravascular ultrasound (IVUS) and coronary angiography guided drug eluting stent (DES) implantation for the treatment of left main coronary artery (LMCA) lesions. Methods: Randomized controlled trials (RCT) and observational studies, which compared IVUS with coronary angiography guided DES implantation for the treatment of LMCA lesions published before August 2021 were searched in PubMed, Embase and Cochrane Library databases. Baseline data, interventional procedures and endpoint events of each study were collected. The primary endpoint was major cardiovascular adverse events (MACE), and the secondary endpoints were all-cause death, cardiac death, myocardial infarction (MI), target lesion revascularization (TLR) and target vessel revascularization (TVR). The Newcastle-Ottawa Scale (NOS) and the Cochrane Collaboration Risk of Bias tool were used to evaluate the quality of the included studies. Results: Nine studies were included, including 3 RCT and 6 observational studies, with a total of 5 527 cases of LMCA. All the 6 observational studies had NOS scores≥6, and the 3 RCT had a low risk of overall bias. The results of meta-analysis showed that compared with coronary angiography guided group, MACE rate (OR=0.55, 95%CI 0.47-0.66, P<0.001), all-cause death (OR=0.56, 95%CI 0.43-0.74, P<0.001), cardiac death (OR=0.43, 95%CI 0.30-0.61, P<0.001), MI (OR=0.64, 95%CI 0.52-0.79, P<0.001), TLR (OR=0.49, 95%CI 0.28-0.86, P=0.013) and TVR (OR=0.77, 95%CI 0.60-0.98, P=0.037) were all significantly lower in the IVUS guided group. Conclusions: Compared with angiography guided, IVUS guided PCI with DES implantation in LMCA lesions could significantly reduce the risk of MACE, death, MI, TLR and TVR. IVUS is thus superior to coronary angiography for guiding PCI treatment among patients with LMCA.

Preclinical evaluation of a third-generation absorbable antibacterial envelope

The TYRX (Medtronic) absorbable antibacterial envelope has been shown to stabilize implantable cardiac devices and reduce infection. A third-generation envelope was developed to reduce surface roughness with a redesigned multifilament mesh and enhanced form factor but identical polymer coating and antibiotic concentrations as the currently available second-generation envelope. The purpose of this study was to compare drug elution, bacterial challenge efficacy, stabilization, and absorption of second- vs third-generation envelopes. Antibiotic elution was assessed invitro and invivo. For efficacy against gram-positive/gram-negative bacteria, 40 rabbits underwent device insertions with or without third-generation envelopes. For stabilization (migration, rotation), 5 sheep were implanted with 6 devices each in second- or third-generation envelopes. Prespecified acceptance criteria were <83-mm migration and <90° rotation. Absorption was assessed via gross pathology. Elution curves were equivalent (similarity factors ≥50 per Food and Drug Administration guidance). Third-generation envelopes eluted antibiotics above minimal inhibitory concentration (MIC) invivo at 2 hours postimplant through 7 days, consistent with second-generation envelopes. Bacterial challenge showed reductions (P <.05) in infection with second- and third-generation envelopes. Device migration was 5.5 ± 3.5 mm (third-generation) vs 9. 9 ±7.9 mm (second-generation) (P <.05). Device rotation was 18.9° ± 11.4° (third-generation) vs 17.6° ± 15.1° (second-generation) and did not differ (P = .79). Gross pathology confirmed the absence of luminal mesh remainders and no differences in peridevice fibrosis at 9 or 12 weeks. The third-generation TYRX absorbable antibacterial envelope demonstrated equivalent preclinical performance to the second-generation envelope. Antibiotic elution curves were similar, elution was above MIC for 7 days, infections were reduced compared to no envelope, and acceptance criteria for migration, rotation, and absorption were met.

Fabrication and application of drug eluting stent for peripheral artery disease

Fabrication and application of drug eluting stent for peripheral artery disease

A Novel Chitosan Composite Biomaterial with Drug Eluting Capacity for Maxillary Bone Regeneration.

Bone grafting is one of the most commonly performed treatments for bone healing or repair. Autografts, grafts from the same patient, are the most frequently used bone grafts because they can provide osteogenic cells and growth factors at the site of the implant with reduced risk of rejection or transfer of diseases. Nevertheless, this type of graft presents some drawbacks, such as pain, risk of infection, and limited availability. For this reason, synthetic bone grafts are among the main proposals in regenerative medicine. This branch of medicine is based on the development of new biomaterials with the goal of increasing bone healing capacity and, more specifically in dentistry, they aim at simultaneously preventing or eliminating bacterial infections. The use of fibers made of chitosan (CS) and hydroxyapatite (HA) loaded with an antibiotic (doxycycline, DX) and fabricated with the help of an injection pump is presented as a new strategy for improving maxillary bone regeneration. In vitro characterization of the DX controlled released from the fibers was quantified after mixing different amounts of HA (10-75%). The 1% CS concentration was stable, easy to manipulate and exhibited adequate cuttability and pH parameters. The hydroxyapatite concentration dictated the combined fast and controlled release profile of CSHA50DX. Our findings demonstrate that the CS-HA-DX complex may be a promising candidate graft material for enhancing bone tissue regeneration in dental clinical practice.

Three years performance of Biodegradable Polymer Sirolimus Eluting Stent in all comer patients undergoing Percutaneous Coronary Intervention.

Introduction: Contemporary evidence suggest the comparable performance of biodegradable polymer sirolimus eluting stents (BPSES) with that of second generation durable polymer drug eluting stents. This study was done to evaluate the performance of BPSES in all comer patients undergoing percutaneous intervention (PCI) in real world setting over a period of three years. Materials &amp; Methods: This was a prospective observational study, wherein all comer consecutive patients undergoing PCI with BPSES (Yukon Choice Elite stent by Translumina Therapeutics, India) were enrolled and followed up for 3 years. The study's primary endpoint was the Device Oriented Composite Endpoint (DOCE), which included cardiac death, target vessel myocardial infarction (MI), and clinically driven target lesion revascularization (TLR); the co-primary endpoint was the Patient-Oriented Composite Endpoint (POCE), which included all-cause mortality, any MI , and any repeat revascularization and the secondary endpoint was definite or probable stent thrombosis (DST &amp; PST). Results: 301 patients with 502 lesions were treated with 485 BP-SES. Mean age of the study cohort was 61.6± 9.3 yrs and males were 79.1%. 18.6% patients were diabetic, 29.6% had ejection fraction less than 40% and 73.1% patients presented with acute coronary syndrome (ACS). Majority of the patient had triple vessel disease (TVD) (51.8%), multivessel PCI was done in 15.6% and complex PCI in 26.2% patients. A mean of 1.6 ±0.8 stents per patient with mean diameter 3.0 ± 0.3 mm and mean length of 27.2 ± 0.8 mm were placed. DOCE &amp; POCE occurred in 7.9% (cardiac death-4.8%, TLR-2.6% &amp; target vessel MI-0.4%) and 12.8% (All deaths-9.7%, any MI- 0.4% and any revascularisation-2.6%) patients respectively at three years follow-up. DST &amp; PST rate was 0.9% and 0.4% respectively in the study cohort. All the cases of stent thrombosis occurred within 30 days. Kaplan Meier analysis revealed that diabetes mellitus, low ejection fraction (EF), acute coronary syndrome (ACS), long stents and complex intervention had no impact on occurrence of DOCE &amp; POCE while using BP-SES in all-comer patient population. Conclusion: Present study showed favourable long term safety and efficacy profile of BP-SES for all-comer patients undergoing PCI.

Evaluation of protein/polysaccharide blend biopolymeric material for fabrication of drug eluting wound dressing

Evaluation of protein/polysaccharide blend biopolymeric material for fabrication of drug eluting wound dressing

Evaluation of protein/polysaccharide blend biopolymeric material for fabrication of drug eluting wound dressing

Silk fibroin protein and polysaccharide xanthan was mixed in three ratios, i.e., 80:20 (SFX82), 60:40 (SFX64) and 50:50 (SFX55) to fabricate blended dressing and functionalised with antibiotic amoxicillin. The dressings exhibited sustained release of incorporated antibiotics for prolonged period which helped in maintaining therapeutic concentrations of drug for quick wound recovery. The dressings showed biphasic release profile, i.e., burst followed by sustained release. SFX64 showed highest cumulative drug release among all three dressing. Further, SFX64 exhibited smoother surface leading to less bacterial adhesion. Changes in wound size and histological assessments of wound tissues over time confirmed that amoxicillin loaded dressings showed faster healing, higher wound closure rate, regular and thicker formation of epidermis. SFX64 dressing was the best performer with pronounced sustained delivery of antibiotic at therapeutic concentration, smoother surface, and maximum wound recovery of 99.12 ± 0.33%.

Comparative study between Nano-surface Polyzene F and drug eluting stents in acute coronary syndrome patients with one-month dual antiplatelet therapy: Immediate and one-year clinical outcome.

The current clinical practice advocates dual antiplatelet therapy (DAPT) for a year after ST segment elevation myocardial infarction (STEMI), primarily owing to persistent thrombotic risk. The novel COBRA PzF coronary stent was developed to reduce stent thrombosis risk. The primary goal of the current research was to compare the efficacy and safety of the novel nanocoated PzF stenting with one-month DAPT (dual anti-platelet therapy) against 12-month DAPT after the current drug- eluting stent (DES) in STEMI patients and single-vessel coronary artery disease (CAD).

The impact of chronic kidney disease severity on clinical outcomes after current generation drug-eluting stent implantation for left main distal bifurcation lesions: the Milan and New-Tokyo registry

Objectives. The impact of chronic kidney disease (CKD) on clinical outcomes after percutaneous coronary intervention (PCI) for unprotected left main distal bifurcation lesions (ULMD) is not fully understood in current generation drug eluting stent (cDES) era. We assessed clinical outcomes after PCI using cDES for ULMD according to CKD severity based on estimated glomerular filtration rate (eGFR). Design. We identified 720 consecutive patients who underwent PCI using cDES for ULMD at three high volume centers between January 2005 and December 2015. We divided those patients to the following five groups according to eGFR. Each group was defined as follows: no CKD (60 mL/min/1.73 m2 ≤ eGFR), mild CKD (45 ≤ eGFR < 60 mL/min/1.73 m2), moderate CKD (30 ≤ eGFR < 45 mL/min/1.73 m2), severe CKD (15 ≤ eGFR < 30 mL/min/1.73 m2) and hemodialysis (HD). The primary endpoint was target lesion failure (TLF) at 3 years. TLF was defined as a composite of cardiac death, target lesion revascularization (TLR) and myocardial infarction (MI). Results. TLF occurred more frequently in severe CKD and HD group compared with other three groups. Conclusions. The patients who have severe CKD or are on HD, were extremely associated with worse clinical outcomes after PCI for ULMD even with cDES.

Polymer Free Amphilimus Drug Eluting Stent for Infrapopliteal Arterial Disease in Patients with Critical Limb Ischemia: A New Device in the Armamentarium.

Background and Objectives: Endovascular technologies have significantly improved the outcome of patients with critical limb ischemia (CLI). Drug eluting stents (DES) have documented their efficacy against percutaneous transluminal angioplasty (PTA) and bare metal stents (BMS) in infrapopliteal arterial occlusive disease. However, late in-stent neoatherosclerosis may lead to vascular lumen loss and eventually thrombosis. Polymer free DES constitute a new technology aiming to improve long term patency which their action is still under investigation. The purpose of this study is to report the mechanism of action and to provide a literature review of a novel polymer free amphilimus eluting stent (Cre8, Alvimedica, Instabul, Turkey) in infrapopliteal arterial disease. Methods: Publications listed in electronic databases, European Union Drug Regulating Authorities Clinical Trials Database, as well as scientific programmes of recent interventional vascular conferences were searched. Three studies were included. We analyzed primary and secondary patency, major amputation rate, freedom from CD-TLR, and mortality. Results: Cre8 was implanted in 79 patients with CLI. Most of the patients (n = 65) were Rutherford class 5-6 (82.3%), and diabetes mellitus (DM) was present in 66 patients (83.5%). Mean primary patency was 82.5% at 12 months. Mean lesion stented length was 20 mm and 35 mm in two studies. Mean limb salvage was 91.3% at 12 months. Freedom from CD-TLR was reported in two out of the three studies and was 96% and 83.8%. Mortality was 15% and 23.8% in the same studies, whilst it was not reported in one study. Conclusion: Stenting of infrapopliteal arteries with Cre8 is safe and feasible in patients with CLI and diabetes. All studies have shown very good primary patency and freedom from CD-TLR at 12 and 24 months. Larger observational prospective studies and randomized trials are necessary to establish long term effectiveness and clinical outcomes using the non-polymer Cre8 DES.

Sex Differences in Clinical Profile and Outcome After Percutaneous Coronary Intervention for Chronic Total Occlusion

BackgroundThere are limited data around sex differences in the risk profile, treatments and outcomes of percutaneous coronary intervention (PCI) in chronic total occlusion (CTO) lesions in contemporary interventional practice. We investigated the impact of sex on clinical and procedural characteristics, complications and clinical outcomes in a national cohort. Methods & resultsWe created a longitudinal cohort (2006–2018, n = 30,605) of patients with stable angina who underwent CTO PCI in the British Cardiovascular Intervention Society (BCIS) database. Clinical, demographic, procedural and outcome data were analysed in two groups stratified by sex: male (n = 24,651), female (n = 5954). Female patients were older (68 vs 64 years, P < 0.001), had higher prevalence of diabetes mellitus (DM), hypertension (HTN) and prior stroke. Utilization of intravascular ultrasound (IVUS), drug eluting stents (DES), radial or dual access and enabling strategies during CTO PCI were higher in male compared to female patients. Following multivariable analysis, there was no significant difference in in-patient mortality (adjusted odds ratio (OR):1.40, 95 % CI: 0.75–2.61, P = 0.29) and major cardiovascular and cerebrovascular events (MACCE) (adjusted OR: 1.01, 95 % CI: 0.78–1.29, P = 0.96). The crude and adjusted rates of procedural complications (adjusted OR: 1.37, 95 % CI: 1.23–1.52, P < 0.001), coronary artery perforation (adjusted OR: 1.60, 95 % CI: 1.26–2.04, P < 0.001) and major bleeding (adjusted OR: 2.06, 95 % CI: 1.62–2.61, P < 0.001) were higher in women compared with men. ConclusionFemale patients treated by CTO PCI were older, underwent lesser complex procedures, but had higher adjusted risk of procedural complications with a similar adjusted risk of mortality and MACCE compared with male patients.

Clinical observation of sacubitril valsartan sodium in the treatment of resistant hypertension: A randomized clinical trial.

To investigate the effectiveness and safety of sacubitril valsartan sodium in the treatment of resistant hypertension (RH). This study is a single-center, prospective, randomized controlled study. According to the inclusion and exclusion criteria, patients with RH who met the criteria were screened, and all patients adjusted their drug treatment (valsartan 80 mg, amlodipine 5 mg, and hydrochlorothiazide 12.5 mg). After 4 weeks of drug elution, the random envelope method was used for random grouping. The treatment group took sacubitril valsartan sodium 200 mg, amlodipine 5 mg, hydrochlorothiazide 12.5 mg, and the control group took valsartan 80 mg, amlodipine 5 mg, and hydrochlorothiazide 12.5 mg for 8 weeks. The 24 h ambulatory blood pressure (BP) and the echocardiography index using the office sphygmomanometer were observed in the patients. A total of 100 patients with RH were included in the two groups, with 50 cases in each group. There were no significant differences in sex, age, or comorbid diseases between the two groups. During the 8-week follow-up, the office BP of the research group were significantly decreased (24.78/17.86 mmHg) compared with those of the control group. In the research group the 24 h average BP, daytime average BP, and nighttime average BP were 144.84/79.82, 147.10/82.06, and 138.67/76.31 mmHg at baseline, and reduced to 128.96/73.32, 131.50/74.94, and 122.11/69.27 mmHg at week 8, which were significantly decreased (P < 0.05 or P < 0.01), and the left ventricular ejection fraction was significantly increased (P < 0.05), compared with the control group. Sacubitril valsartan sodium can effectively reduce BP and improve cardiac function in RH.

504 ACUTE HEART DISFUNCTION IN PATIENT WITH PACEMAKER, ATRIAL FIBRILLATION AND OLD MYOCARDIAL INFARCTION: WHAT IS THE REASON?

Abstract Patient (pt) 78 years old, ex smoker, with hypertension, dyslipidemia, iperuricemia and overweight. Myocardial inferior infarction with mechanical rivascularization and implant of drug eluting stent on right coronary artery in 2012. Residual ejection fraction of 47% with inferior hypocinesia. Pacemaker DDD implant for 2nd degree atrioventricular block in 2013. Atrial fibrillation from July 2021. Acute nocturnal heart failure with hypoxiemia (PO2 76%) and necessity of non invasive ventilation in November 2021 without worsening of coronary tree at coronarography and echocardiografic finding of EF 47% with inferior and posterior hypocinesia. Troponin I hs 53.6 pg/ml BNP 378 ng/ml. None relevant arrhytmias at pacemaker control. After hospital admission pt done polisonnography with finding of severe obstructive nocturnal apneas and need of CPAP (continous positive airways pressure). Conclusions in literature obstructive sleep apnea syndrome (OSAS) can cause heart failure, cardiac ischemic disease and hypertension. In this case a long obstructive apnea could have caused severe desaturation with hypoxiemia and then an acute episode of heart failure.

673 A CRACK AND A CLOT

Abstract A 74-year-old man with a history of ischaemic heart disease (multiple percutaneous coronary interventions (PCI)), broke his ankle. Therefore, he discontinued dual antiplatelet therapy (DAPT) -acetylsalicylic acid plus clopidogrel- and started enoxaparin sodium 4000 UI/day on medical advice. A few days later, he was admitted to the emergency department for refractory chest pain, vomit and syncope. Twelve-lead electrocardiogram (ECG) showed a sinus rhythm interrupted by frequent premature ventricular contractions in a pattern of trigeminy. The transthoracic echocardiogram revealed a mildly dilated LV with normal wall thickness and marked hypokinesis/ akinesis in apical, infero-lateral and antero-lateral walls, with a 33% ejection fraction. High sensitivity cardiac troponin was increased, and a second ECG showed a diffuse ST segment depression. The patient was loaded with aspirin and emergently taken to the cardiac catheterization lab. Coronary angiography showed a very late stent thrombosis of the left circumflex artery (LCx), with occlusion of the extreme distality of the second obtuse marginal artery and a 50-60% intrastent restenosis of the ostium-proximal tract of the left anterior descending artery (LAD). Given the non-obstructive nature of the thrombus, risk of peripheral embolization, TIMI flow grade 3 and improvement of symptoms, the decision was made to adopt a conservative strategy with loading dose of ticagrelor, heparin and tirofiban infusion. Besides, an optical coherence tomography (OCT) control was scheduled for the next day. OCT of the LCx revealed a well apposed and well expanded stent with a non-obstructive residual thrombus, nevertheless not visible on angiography. Thus, the tirofiban infusion was prolonged up to 48 hours. OCT of the LAD detected a fibro-calcific disease determining a significant restenosis of the distal left main (LM)-LAD ostium. OCT-guided provisional stenting with two drug eluting stents on LM-LAD-LCx was performed successfully. The patient was discharged home on acetylsalicylic acid (lifelong), ticagrelor (for 12 months) and enoxaparin sodium 4000 UI/day (according to specialist indication). DAPT is superior to anticoagulant therapy in preventing stent thrombosis in patients undergoing PCI, and a more informed inter-specialist communication is needed. Intracoronary imaging can help in the management of stent failure and in the guidance of complex PCI, allowing a patient-tailored treatment.

1127 APPLICABILITY OF THE EXCEL TRIAL CRITERIA IN AN ALL-COMERS REAL-WORLD POPULATION OF UNPROTECTED LEFT MAIN PCI

Abstract Background The Evaluation of XIENCE versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization (EXCEL) trial is the largest randomized trial comparing percutaneous coronary intervention (PCI) with 2nd generation drug eluting stents (DES) and bypass surgery in unprotected left main disease (ULMD). Our aim was to assess which proportion of patients from a contemporary all-comers population of ULMD-PCI would be eligible for the EXCEL trial and whether these patients showed different short- and long-term outcomes than the rest of the population. Methods and results A total of 246 consecutive patients that underwent ULMD-PCI between January 2018 and December 2021, were retrospectively analyzed. After application of the EXCEL trial inclusion ed exclusion criteria, 98 patients (38.9%) were allocated in the "Excel-like" cohort and 148 in the "Non-Excel-like". Baseline characteristics of the two groups were substantially comparable. Mean baseline Syntax Score (SS) was significantly lower in the "Excel-like" patients (Excel 20.1 ± 7.1 VS Non-Excel 23.0 ± 11.2; p-value = 0.025) than the "Non-Excel-like" group with the latter showing also a higher degree of incomplete revascularization (rSS &amp;gt;8: Excel 11.2%.VS Non-Excel 25.7%; p-value 0.005). At 1 year the cumulative major adverse cardiovascular and cerebral events (MACCEs) rates were 7.2% and 17.2% for the "Excel-like" and "Non-Excel-like" patients respectively (Log-rank p-value = 0.03). At last follow-up available the significant difference in MACCEs rate persisted (Excel 19.3%, VS Non-Excel 37%, Log-rank p-value 0.02) and a significant difference in any unplanned revascularization was also shown (Excel 1.5% VS Non-Excel 12.6%; p-value 0.04). Conclusions in a contemporary real-world cohort of ULMD-PCI only a minority of the patients could be enrolled in the EXCEL trial. This cohort of patients showed a more extensive revascularization and less clinical events at long-term follow-up despite comparable burden of cardiovascular risk factors and atherosclerotic coronary disease. These findings "challenge" the external applicability of the results of the Excel trial in the routine clinical activity.