Real-world Single-center Experience Research Articles

Cardiovascular Toxicity in Cancer Patients Treated with Tyrosine Kinase Inhibitors: A Real-World Single-Center Experience

Background: Target therapy can cause various cardiovascular complications. The aim of this study was to evaluate the burden of cardiovascular complications related to treatment with anti-BCR-ABL tyrosine kinase inhibitors (TKIs) and to determine if there are differences between the latest- and first-generation TKIs. Methods: A retrospective observational study was carried out on 55 patients (39 men, 16 women; mean age ± SD: 58 ± 11 years) treated with TKIs targeting Bcr-Abl for a median period of 3.5 years. Patients were divided in two groups according to the type of treatment. Group A included patients treated with latest-generation TKI (nilotinib, dasatinib, and ponatinib), while group B included patients treated with first-generation TKI (imatinib). Cardiological evaluation included electrocardiogram, echocardiogram with global longitudinal strain of left ventricle (GLS), and carotid ultrasound scan with arterial stiffness measurement (pulse wave velocity, PWV). Adverse cardiovascular events were recorded in both groups. Results: Statistical analysis showed that cardiovascular adverse events (myocardial ischemia, peripheral artery disease, deep vein thrombosis, and pleural effusion) were significantly more frequent in group A than group B (p value = 0.044). Moreover, there was a significant reduction in GLS and PWV in group A when compared to group B (respectively, p = 0.03 and p = 0.004). Conclusions: Our study confirms that imatinib is a relatively safe drug, while it reveals that the latest-generation TKIs may cause a burden of cardiovascular complications. GLS and PWV allow detection of early signs of cardiac and vascular toxicity in oncohematologic patients treated with TKI, and their use is advisable.

Clinical outcomes of aortic arch hybrid repair in a real-world single-center experience

ObjectiveAortic arch aneurysmal disease remains a therapeutic challenge. For patients unsuitable for standard open surgery, hybrid repair with debranching of the supra-aortic arteries followed by thoracic endovascular grafting has been shown to be an effective solution. The aim of this study was to report the clinical outcomes of a single-institution experience using hybrid aortic arch repair. MethodsThe cases of all consecutive patients submitted to hybrid aortic arch repair between January 2010 and June 2018 were prospectively collected and retrospectively analyzed. The outcomes of the study were 30-day mortality, perioperative complications, 2-year survival, endoleak, and reintervention rates. ResultsA total of 35 patients with a median age of 71 years (interquartile range, 62-77 years) were submitted to hybrid aortic arch repair, with a median follow-up of 26.9 months (interquartile range, 2.4-63.6 months). Ten procedures (28.6%) were performed urgently for contained rupture. The most common etiology was degenerative (n = 14 [40.0%]). The proximal landing zones according to the Ishimaru classification were zone 2 in 20 patients (57.1%), zone 1 in 12 patients (34.3%), and zone 0 in 3 patients (8.6%). Early endoleaks were observed in six patients (17.1%), equally distributed between type I and type II. Late endoleaks were identified in 4 of 24 patients (16.7%; type I, n = 2 [8.3%]; type II, n = 1 [4.2%]; and type III, n = 1 [4.2%]).Thirty-day mortality rate was 14.3% (n = 5) with an early death rate of 8.7% (2/23) in elective cases and 30.0% (3/10) in urgent cases (odds ratio [OR], 4.93; confidence interval [CI], 0.68-35.67; P = .128). Except in one patient, 30-day mortality was associated with landing zone 0 or zone 1 (26.7% vs 5.0%; OR, 6.91; CI, 0.68-69.86; P = .141). Three patients (8.6%) suffered a postoperative stroke, and no episodes of spinal cord ischemia were observed. Two-year survival rate was 67.8% (CI, 49.4%-80.8%). Survival rates were significantly lower with increasing age (hazard ratio [HR], 1.10; CI, 1.03-1.18; P = .004), urgent procedure (HR, 4.80; CI, 1.56-14.80; P = .003), zone 0 or zone 1 (HR, 6.34; CI, 1.73-23.18; P = .001), presence of arrhythmia (HR, 3.76; CI, 1.22-11.62; P = .013), and cerebrovascular disease (HR, 4.12; CI, 1.38-12.35; P = .006). A multivariate analysis identified age (HR, 1.11; P = .047) and zone 0 or zone 1 (HR, 4.93; P = .033) as the only predictors for overall mortality. ConclusionsHybrid aortic arch repair seems to be an alternative for higher risk patients not suitable for open repair, but selection of patients is crucial and may benefit from further refinement. In this study, worse outcomes were seen in older patients and those who required more proximal landing zones.

Patency and functionality of radiocephalic arteriovenous fistulas with an external support device (VasQ™): Real-world single-center experience.

Background:The VasQTM device was designed to improve the outcome of arteriovenous fistulae by optimizing the hemodynamics of the flow in the juxta-anastomotic region of the arteriovenous fistulae through tailored external support. The aim of the study was to evaluate the impact of the VasQ on outcome of radiocephalic arteriovenous fistulae in a real-world setting.Methods:This was a single-center, retrospective analysis of patients with either fistula creation before or after dialysis initiation with implantation of the VasQ device during creation of end-to-side radiocephalic arteriovenous fistulae between June 2018 and May 2019. The flow rate and vein diameter were evaluated intraoperatively, at discharge within 48 h postprocedure and at a follow-up of 1, 3, 6, 9, and 12 months.Results:Thirty-three VasQ devices were implanted during 33 radiocephalic arteriovenous fistula procedures. The study population comprised mostly of men, with an average age of 66 years. Mean intraoperative flow was 428 mL/min (range: 130–945). All patients were discharged with patent arteriovenous fistulae and mean fistula flow of 740 mL/min (range: 230–1300 mL/min). The primary patency was 100% and 79% at 3 and 6 months, respectively. Cumulative/secondary patency was 100% and 90% at 3 and 6 months, respectively.Conclusion:Data presented here suggest that the VasQ device has the potential to provide benefit to the functionality of radiocephalic arteriovenous fistulae.

Real-world single-center experience with direct-acting antivirals for improvement of the liver fibrosis after chronic hepatitis C treatment.

BackgroundRecently, new direct-acting antivirals (DAAs) are known to eradicate chronic hepatitis C (CHC) virus infection and prevent the progression of liver fibrosis. Liver fibrosis may predispose to liver cirrhosis or hepatocellular carcinoma. We investigated the effect of DAAs on liver fibrosis using non-invasive methods, and evaluated the correlations of these methods.MethodsWe retrospectively analyzed 68 patients with CHC who were treated with DAAs and reached sustained virologic response at 12 weeks post-treatment from January 2016 to October 2018. The degree of liver fibrosis was assessed using serum biomarkers, such as AST-to-platelet ratio index (APRI) and fibrosis-4 (FIB-4) index. Liver stiffness was assessed using two-dimensional shear-wave elastography (2 D-SWE). The pre- and post-treatment serum biomarker levels and SWE findings were evaluated and compared.ResultsA total of 68 patients with CHC were enrolled. The median age was 58 years (52.3–73 years) and 37 patients (54.4%) were female. After treatment, the median APRI was decreased from 0.701 to 0.328 (P < 0.0001), and the median FIB-4 was decreased from 2.355 to 1.860 (P < 0.0001). The median kPa in 2 D-SWE significantly reduced from 6.85 to 5.66 (P = 0.013). APRI and FIB-4 were significantly correlated pre- and post-treatment; however, the correlation between the serum biomarkers and 2 D-SWE was partially significant.ConclusionThe serum fibrosis biomarkers and liver stiffness on 2 D-SWE were shown to be improved after the treatment with DAAs. Further research including larger number of patients is needed to compare the efficacy of each evaluating method.

Evaluation of procedural and clinical outcomes of transcatheter aortic valve implantation: A single-center experience.

Objective:Transcatheter aortic valve implantation (TAVI) is an established alternative to surgical aortic valve replacement. Our study aimed to evaluate the implementation of TAVI at our large-volume center, having an all-comer patient population with short and long-term follow-ups.Methods:This retrospective, single-center analysis included 556 consecutive patients with symptomatic severe aortic stenosis (AS) who underwent TAVI between July 2011 and December 2019.Results:The mean age of the entire population was 77.6±7.9 years, and 54.9% were women. The Society of Thoracic Surgeons (STS) mean score of the cohort was 6.0%±3.5%. The balloon-expandable valve (Sapien XT, Sapien 3; Edwards Lifesciences, Irvine, California) was the most frequently used valves in this cohort (94.6%). Transfemoral access was used in 96.3% of patients. Implantation success was achieved in 96.6% of cases. During the TAVI procedure, 7.2% of patients required permanent pacemaker implantation, with 37.5% in the Lotus valve group needing the most permanent pacemakers. The mean length of hospital stay for the entire cohort was 4.5±2.3 days. Overall, 22 (3.9%) in-hospital deaths occurred before hospital discharge. The mean follow-up period was 15.1±14.9 months for all patients, and a significant improvement was noted in all echocardiographic parameters and functional capacity. Paravalvular leak (PVL) was documented in 18.9% patients, mild in 17.9%, and moderate in 1% at discharge. No cases with severe PVL, necessitating additional procedures. The multiple logistic regression analysis revealed that sex, STS score, baseline SYNTAX score, bicuspid valve morphology, common femoral artery diameter, and post-TAVI PVL were independent predictors of overall mortality.Conclusion:To our knowledge, this study, which is the largest single-center real-world experience of TAVI in Turkey, demonstrated low complication rates with favorable short- and mid-term THV performance in patients undergoing TAVI.

Early Salvage Treatment with Second-Generation Novel Agents at Biochemical Relapse Prolongs Overall Survival: A Real-World Single Center Experience

In Multiple Myeloma (MM) relapse can be defined according to disease aggressiveness and the presence of clinical symptoms. Aggressive relapse can occur even at biochemical level, characterized by a rapid and relevant increase of monoclonal component or LDH, or at clinical level, defined by the presence of extramedullary disease, acute renal injury or progression to secondary plasma cell leukemia. To identify the clinical outcome upon treatment with second generation novel agents (pomalidomide, carfilzomib) and monoclonal antibodies (elotuzumab, daratumumab), we collected evidence of the best timing in providing early salvage treatment to RRMM. We reviewed files of 128 R/R MM (58% males, median age 64 years, range 43-83), treated at biochemical (N=54, 42%) or clinical relapse (N=74, 58%) between January 2017 and December 2019 in our single Institution. Median number of previous lines was 2 (1-9), including autologous stem cell transplantation (ASCT) in half of cases. FISH was repeated before to start the second-generation drugs, and it was available in 53 cases: 11 carried on high-risk (del 17p, t4;14 or t14;16) and 42 standard-risk cytogenetics, without any additional marker compared to the matched sample at diagnosis. Our series included patients who received IMiD-s based treatments, alone (pomalidomide, N= 76, 59%) or in combination with proteasome inhibitors (carfilzomib, lenalidomide and dexamethasone, KRd, N= 43, 33%) or monoclonal antibodies (daratumumab-lenalidomide, N= 3 elotuzumab-lenalidomide, N 12); 16 patients (%) received Daratumumab in monotherapy, and N=16 associated to bortezomib. After a median follow-up of 19.2 months, 66 (52%) patients were alive and 33 (25%) received a further line of therapy due to progression. In multivariable analysis only the type of relapse (biochemical versus clinical) and refractory status were independent predictors of overall survival (p&lt;0.0001). Longer overall survival (OS) was associated to treatment at biochemical relapse (27.8 vs 15.2 months, p=0.0005), in relapsed patients instead of relapsed and refractory (34.1 vs 19.3 months, p=0.0004). Patients who received less than 3 lines of therapy or carrying standard-risk cytogenetics had longer OS (respectively, 33.6 vs 19.1 months, p=0.002 and 20.4 vs 11.2 months, p=0.04) without any significant difference due to previous ASCT or the type of second-generation treatment chosen. In 20/33 individuals who further progressed under novel agents treatment we found second biochemical relapse was anticipated by doubling sFLC ratio one month before. In 5 patients who developed extramedullary lesions (EMD) an increase of sFLC always preceded the diagnosis ofEMD relapse irrespective of M-spike measurement. Taken together, our findings suggest that using second generation novel agents can improve outcome even in heavily pretreated patients. Earlier treatment at biochemical asymptomatic relapse is associated with longer OS. Longitudinal monitoring of sFLC assay ratio can anticipateearly detection of aggressive and/or EMD relapse in the RRMM setting in real life. Disclosures Del Fabro: Janssen: Consultancy. Di Raimondo:Takeda: Consultancy; Celgene: Consultancy, Honoraria, Research Funding; Amgen: Consultancy, Honoraria, Research Funding. Conticello:Celgene: Consultancy, Honoraria, Research Funding; Amgen: Consultancy, Honoraria, Research Funding.

P098 - Treatment outcomes and survival of metastatic non-clear cell renal cell carcinoma: A single center real-world experience

P098 - Treatment outcomes and survival of metastatic non-clear cell renal cell carcinoma: A single center real-world experience

Treatment Patterns and Clinical Outcomes Across Consecutive Treatment Lines in Multiple Myeloma Patients: Single-Center Real World Experience.

Multiple myeloma follows a relapsing-remitting course; therefore multiple lines of therapy are usually required. Treatment options are now more numerous and effective than ever before. We aimed to explore patterns of treatment, in particular the characteristics of patients reaching advanced treatment lines, in a real world setting.

A 2-step fast-track elastometry service for advanced workup of nonalcoholic fatty liver disease (NAFLD) patients - single-center real-world experience of outpatient clinical practice.

Nonalcoholic fatty liver disease (NAFLD) is increasing globally with an estimated prevalence of approximately 25 %. Nonalcoholic steatohepatitis as the progressive disease entity often leads to fibrosis and end-stage disease. The magnitude of NAFLD patients are not diagnosed and have no access to further clinical assessment. Diagnostic pathways for individual risk evaluation fitting with available resources are of utmost importance in real-world clinical practice. Retrospective analysis of 1346 anonymized outpatient datasets at Würzburg University Hospital, Germany. Transient elastography (TE) with controlled attenuation parameter and laboratory-based risk scores (NFS, FIB-4) were the main diagnostic workup tools for risk stratification. After preselection based on questionnaire information NAFLD still accounts for one-fifth of patients in the liver outpatient service. More than 80 % of NAFLD patients receive their first-time diagnosis in our unit. Laboratory-based risk scores and TE are valuable tools for second-step risk assessment as shown in our clinical data analysis. Moreover, 65 % of NAFLD patients use inpatient services for at least 1 day. The policy to perform liver biopsy in high-risk patients above the recommended threshold of 9.6 kPa if any clinical doubt exists regarding the diagnosis of cirrhosis leads to a histological down staging in almost 80 %. Questionnaire-based referral from primary care followed by broadly available fast-track TE and eventually liver biopsy for selected patients is the standard practice in our unit. This approach represents a feasible model to handle the large gap between availability and clinical need for TE facilities.

Real-world single-center experience with 10 cases of generalized pustular psoriasis successfully treated with ixekizumab

Generalized pustular psoriasis, a severe systemic inflammatory disease accompanied by erythema and pustules on the entire body, is so rare that data on the treatment for it is quite limited. Our ten cases revealed that ixekizumab was highly effective for GPP regardless of mutations in IL36RN and CARD14.

Clinical outcome of drug-coated balloon angioplasty in patients with femoropopliteal disease: A real-world single-center experience

BackgroundSeveral multicenter industry-sponsored clinical trials reported satisfactory results in the use of drug-coated balloons (DCBs) for treatment of femoropopliteal occlusive disease. However, few single-center studies have been published to verify the outcome from real-world experience. MethodsIn this study, 228 patients treated with DCB angioplasty (Lutonix 0.35; Bard, Tempe, Arizona) were analyzed. Perioperative major adverse events (death, amputation, target lesion thrombosis or reintervention) were calculated. Kaplan-Meier analysis was used to estimate primary patency rates (based on duplex ultrasound with or without ankle-brachial index) and limb salvage rates. ResultsLesions treated were primarily TransAtlantic Inter-Society Consensus (TASC) type C and D lesions. Indications included claudication (Rutherford classes 2 and 3) in 40% and critical limb ischemia (CLI; Rutherford classes 4 and 5) in 60%. Lesions treated included 61% in the superficial femoral artery, 15% in the popliteal artery, and 24% in both superficial femoral artery and popliteal artery. Mean follow-up was 12.2 months (range, 1-42 months). Overall perioperative morbidity and mortality rates were 13% and 1%. The perioperative major adverse event rate was 3%. Symptom relief (improvement of one Rutherford category or more) was obtained in 64%. Primary patency rates were 56% and 39% at 1 year and 2 years, respectively. Limb salvage rates were 92% and 83% at 1 year and 2 years. Patients with claudication had a lower rate of early perioperative complications (4% vs 19%; P = .001). Symptom improvement was 76% for claudication vs 49% for CLI (P < .001). Overall, major amputation rate was 0% for claudication vs 13% for CLI (P < .001). The primary patency rates at 1 year and 2 years were 59% and 41% for claudication vs 54% and 37% for CLI (P = .307). The assisted primary patency rates at 1 year and 2 years were 72% and 52% for claudication vs 64% and 46% for CLI (P = .223). Primary patency rates at 1 year and 2 years were 82% and 71% for TASC A to C lesions vs 29% and 14% for TASC D lesions (P < .001). Limb salvage rates at 1 year and 2 years were 100% and 100% for claudication vs 85% and 74% for CLI (P < .001). ConclusionsClinical outcomes after DCB angioplasty in femoropopliteal lesions were inferior to what has been reported in previous studies, particularly for TASC D lesions. Further investigation from real-world experience with long-term follow-up is needed to confirm these results.

Single-centre real world experience of the Mynx Femoral closure device in patients undergoing percutaneous coronary intervention

Single-centre real world experience of the Mynx Femoral closure device in patients undergoing percutaneous coronary intervention

Mo1912 – Vedolizumab in Elderly Patients with Inflammatory Bowel Disease is Associated with Improved Disease Outcomes and Low Rates of Serious Infection: A Single Center Real World Experience

Mo1912 – Vedolizumab in Elderly Patients with Inflammatory Bowel Disease is Associated with Improved Disease Outcomes and Low Rates of Serious Infection: A Single Center Real World Experience

Clinicopathological Profile of Myelomatous Pleural Effusion: Single-center Real-world Experience and Review of Literature

BackgroundMultiple myeloma (MM) is a hematologic malignancy of plasma cell origin. MM primarily affects bone marrow, but extramedullary sites can also be involved. Myelomatous pleural effusion (MPE) is an atypical and rare complication of MM. We aimed to systematically study the incidence and clinicopathologic profile of patients with MPE in a real-world setting. Patients and MethodsIn this retrospective study, 415 consecutive patients with MM managed at a tertiary care center in North India during a study period of January 1, 2010 to December 31, 2015 were evaluated for MPE. The patients with MPE were analyzed for their clinical profile, diagnosis, treatment, and outcomes. ResultsOf these 415 patients, 11 (2.65%) patients had MPE. The median age of the study population was 50 years with male preponderance. The majority of these patients had immunoglobin (Ig)G Kappa disease. All patients had higher than International Staging System stage I disease. MPE was a presenting feature at MM diagnosis in 45.45% (n = 5) of the patients, whereas the rest developed MPE during follow-up. MPE presented predominantly (81.8%) as a unilateral effusion. Concurrent extramedullary involvement at other site was seen in 45.45% (n = 5), with 3 (27%) patients having concurrent myelomatous ascites. Six of these were managed aggressively, whereas 5 patients opted for palliation. The outcomes were dismal (90.9% mortality), with a median survival of 2.47 months. ConclusionMPE is a rare entity, and positive outcomes of therapy remain low with dismal prognosis.

Clinical outcomes of patients with injuries of adjacent organs by expanded polytetrafluoroethylene grafts used for middle hepatic vein reconstruction in right lobe living donor liver transplantation: a single-center real-world experience

Clinical outcomes of patients with injuries of adjacent organs by expanded polytetrafluoroethylene grafts used for middle hepatic vein reconstruction in right lobe living donor liver transplantation: a single-center real-world experience

Mid-term outcomes (up to 5 years) of percutaneous edge-to-edge mitral repair in the real-world according to regurgitation mechanism: A single-center experience.

To report mid-term results after MitraClip repair, according to mitral regurgitation (MR) mechanism, in a real-world single-center experience. Mid-term outcomes of percutaneous edge-to-edge mitral repair in the real world are still limited. We assessed the follow-up results of patients treated with MitraClip at a single high-volume mitral center from 2008 to 2016. All patients underwent Heart-Team discussion, prospective data collection and enrolment in a dedicated outpatient clinic. Functional (FMR, n = 242, 68.6%) and degenerative (DMR, n = 97, 27.5%) MR patients were separately analyzed. 5-Year survival was 53.5 ± 4.5% in FMR vs 57.1 ± 7.5% in DMR (P = 0.087). Reduced survival was strongly associated with worse left ventricle remodeling (ESV HR 1.01, CI 1.01-1.02, P < 0.001) in FMR, and with worse symptoms (New York Heart Association IV HR 6.72, CI 1.78-25.45, P = 0.005) in DMR. 5-Year cumulative incidence function for MR ≥ 3 was 23.7 ± 3.4% in FMR vs 27.9 ± 5.9% in DMR (P = 0.39), being associated with residual MR = 2 both in FMR (HR 4.67, CI 2.49-8.74, P < 0.001) and DMR (HR 7.15, CI 2.72-18.75, P < 0.001). At 5-year, patients in NYHA class I-II increased from 17.9% to 45.3% in FMR (P < 0.001) and from 33.3% to 51.3% in DMR (P < 0.001). In this single-center real-world experience, 5-year after MitraClip, half of the patients were alive and 3/4 were free from MR, both in FMR and DMR. Symptoms benefit was sustained in both groups. Advanced ventricular remodeling, advanced symptoms, and suboptimal MR reduction were associated with worse results. Refined patient selection, improved efficacy and more data will be all required to improve long-term outcomes.

Clinical Outcome of Drug-Eluting Balloon Angioplasty in Patients With Femoropopliteal Disease: Real-World Single Center Experience

Clinical Outcome of Drug-Eluting Balloon Angioplasty in Patients With Femoropopliteal Disease: Real-World Single Center Experience

Single Center Real-World Experience of Daratumumab and Extra-Medullary Myeloma

Background: Daratumumab (Dara) was recently FDA approved for the treatment of relapsed/refractory multiple myeloma (RRMM). We evaluated a real-world single-center experience of Dara salvage therapy for RRMM.Methods: Patients treated at the University of Florida with Dara for RRMM between January 2016 and February 2018 were included. Data was collected by chart review and analyzed for patient demographics, disease characteristics, treatment, and outcomes.Results: 25 patients (13 as monotherapy and 12 in combination) were included, with a median age of 63 (range, 42-86) years. Median time from MM diagnosis to Dara initiation was 51.3 (range, 8.4 -162.3) months. The median duration of Dara therapy was 72 days (range, 7 - 622). The median number of Dara doses was 7 (range, 2- 49). The best response to DARA was Very Good Partial Response (VGPR) in 1 (4%), Partial Response (PR) in 17 (68%), while 7 (28%) had Progressive Disease (PD). Overall Response Rate (ORR) to Dara was 72%. By the end of the study period, another 11 (44%) patients progressed while on DARA with a total of 18 (72%) patients having PD at the time of analysis. Estimated median progression free survival (PFS) after starting Dara was 155 days (95% CI: 21 - 289) and estimated median overall survival (OS) in the entire cohort was 11.7 months (95% CI: 4.2 - 19.2). Post DARA, 1 (4%) patient with VGPR underwent ASCT, while 9 (36%) went on to have other therapies which included HyperCVAD, Melphalan, and clinical trials, and 8 (32%) were treated with only best supportive care.Of 18 patients who had PD, 10 (40%) patients had a progressive extramedullary disease (EMD), of whom 6 (24%) had EMD prior to starting Dara, while another 4 (16%) patients developed new EMD while on Dara. PFS in the EMD cohort was 63 days (95% CI: 23 - 103), which was shorter than patients with no EMD (333 days; 95% CI: 42 - 624) (P= 0.08). Estimated median OS in patients with EMD was 5.4 months while in patients with no EMD was 16.1 months (p =0.16).Conclusions: DARA therapy does have good ORR (72%) in RRMM, however, there was an unusually high incidence of progressive or newly diagnosed EMD in RRMM patients treated with Dara/Dara-containing regimens, suggesting that Dara may not be effective in treating or preventing EMD. Moreover, we noticed patients who have EMD or develop new EMD tends to have worse outcomes. The underlying escape mechanism for EMD remains unknown and warrants further investigation. DisclosuresNo relevant conflicts of interest to declare.

Contemporary parenteral antiplatelet bridging strategies: a single-centre real-world experience at a tertiary care centre.

Contemporary parenteral antiplatelet bridging strategies: a single-centre real-world experience at a tertiary care centre.

Seven-year clinical outcomes in patients undergoing percutaneous coronary intervention with biodegradable polymer coated sirolimus-eluting stent: Results from a single-center real-world experience

ObjectiveThe aim of the present study was to assess seven-year clinical outcomes of biodegradable polymer coated Supralimus sirolimus-eluting stent (S-SES) [Sahajanand Medical Technologies Pvt. Ltd., Surat, India] in real-world patients with coronary artery disease. MethodsThis observational, retrospective study was carried out in all 346 consecutive enrolled patients who underwent percutaneous coronary intervention (PCI) with the S-SES, between April 2008 and December 2009, at a single center. We analyzed major adverse cardiac events (MACE) [a composite of cardiac death, myocardial infarction (MI), target lesion revascularization (TLR) and target vessel revascularization (TVR)] as primary outcomes at seven-year follow-up. ResultsOut of 346 patients, seven-year follow-up was obtained in 327 (94.5%) patients and hence results were analyzed for 327 patients. At seven-year, MACE occurred in 41 (12.5%) patients, consisting of 23 (7.0%) cardiac deaths, 14 (4.3%) TLR, and 4 (1.2%) TVR. The incidence of late stent thrombosis was observed in 3 (0.9%) patients. At follow-up of seven-year, the cumulative event-free survival was found to be 84.7% by Kaplan-Meier method. ConclusionsThe present study demonstrated satisfactory and sustained seven-year clinical outcomes as evidenced by the low rates of MACE and ST for the biodegradable polymer coated S-SES.