P2804Initial experience with the novel BioMime Morph 40–60 mm long sirolimus-eluting tapered stent in long coronary lesions

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
A Premawardhana ◽  
A Choudhury ◽  
B Sekar ◽  
H Hussain
Keyword(s):  
Primary Endpoint ◽  
Biodegradable Polymer ◽  
Cardiac Death ◽  
Positive Family History ◽  
Composite Endpoint ◽  
The Novel ◽  
Cobalt Chromium ◽  
Coronary Lesions ◽  
Procedural Success

Abstract Aims Aims: Long lesions treated with overlapping stents has been reported to be associated with healing problems and/or adverse events. The novel BioMime Morph is a 40, 50 and 60 mm long sirolimus-eluting cobalt chromium stent (65 μm strut thickness, biodegradable polymer) with a tapered design (0.5 mm taper from proximal to distal end) and is available in the following proximal and distal diameters (2.75–2.2 5mm, 3–2.5 mm and 3.5–3 mm). It can be a novel alternative for treatment of long coronary lesions, overcoming the limitations of overlapping stents. Methods and results Methods: Data was evaluated from our centre's prospective BioMime Morph database from August 2016 - January 2019. Primary endpoint was device oriented composite endpoint (DOCE: cardiac death, TV-MI, TLR and TVR). Secondary endpoints were technical (successful Morph implantation) and procedural success (successful procedure with Morph without in-hospital MACE). Results 103 patients had BioMime Morph stents implanted, with mean follow up of 411 (±214) days and a mean age of 66 (±11) years. Co-morbidities included hypertension (58%), hypercholesterolemia (38%), diabetes mellitus (28%), PVD (2%), CVD (5%), CKD (12%), previous MI (17%), smoking (40%) and positive family history (20%). There was history of previous PCI in 18% and CABG in 4%. Indication for PCI was predominantly ACS (78% including 13% STEMI), 15% were CTOs. 80% of the procedures were performed via radial access using 5–6F sheath in 73%. Vessels treated included LAD (43%), Cx (12%) and RCA (45%). Pre-dilatation was performed in 96% including use of non-complaint balloons in 51%, scoring balloons in 12% and rotablation in 4%. Post-dilatation was performed in 99%. Buddy wire was used in 41% while a guideliner used in 13%. Technical success (secondary endpoint) was achieved in 100 whilst procedural success was achieved in 96% (4 cases of contrast induced nephropathy). Cumulative DOCE (primary endpoint) was % (cardiac death 1%, TV-MI 1%, definitive ST 0%, possible ST 1%, TLR 2% and TVR 2%). OCT follow up at 1 month, 3 month and 6 months in 2 patients showed endothelialisation even at 1 month. Conclusions Our initial experience of the use of the novel BioMime Morph tapered DES for treatment of long coronary lesions exhibit promising results in short to medium follow-up. Elution of the drug in 1 month along with biodegradable polymer and ultra thin struts potentially helps early healing and raises the possibility of short DAPT even in these complex long lesions. BioMime Morph stents can potentially be an alternative to overlapping conventional stents for treating long coronary lesions.

scholarly journals One-Year Follow-Up Results From the Observational, Multicenter, Prospective, and Controlled Registry: The WALTZ All-Comers Study

2019 ◽  
Vol 13 ◽  
pp. 117954681985405 ◽  
Author(s):  
Alfredo E Rodriguez ◽  
Miguel Larribau ◽  
Carlos Fernandez-Pereira ◽  
Jorge Iravedra ◽  
Omar Santaera ◽  
...  
Keyword(s):  
Primary Endpoint ◽  
Cardiac Death ◽  
Risk Scores ◽  
Exclusion Criterion ◽  
Cobalt Chromium ◽  
Left Main ◽  
Cardiac Events ◽  
Vessel Disease ◽  
Coronary Stent Implantation

The aim of this study was to evaluate 1-year follow-up results in an all “comers” population treated with a new cobalt chromium bare-metal stent (BMS) design. Since August 2016 to March 2017, 201 (9.7% of screening population) consecutive patients undergoing coronary stent implantation in 11 centers in Argentina were prospectively included in our registry. The inclusion criteria were multiple-vessel disease and/or unprotected left main disease, acute coronary syndromes (ACS) with at least one severe (⩾70%) stenosis in any of major epicardial vessel. In-stent restenosis, protected left main stenosis, or impossibility to receive dual-antiplatelet therapy was an exclusion criterion. Major adverse cardiac events (MACE) were the primary endpoint and included cardiac death, myocardial infarction (MI), and target lesion revascularization (TLR); also, all components of the primary endpoint were separately analyzed. Completeness of revascularization was analyzed as post hoc data using residual SYNTAX or ERACI risk scores. Demographic characteristics showed that 6.5% of patients were very elderly, 22.5% have diabetes, 47% have multiple-vessel disease, 67% have ACS, and 32% have ST elevation MI. At a mean of 376 ± 18.1 days of follow-up, MACE was observed in 10.4% of patients: death + MI + cardiovascular accident (CVA) in 3% (6 of 201) and cardiac death + MI + CVA in 1.5% (3 of 201). Residual ERACI score ⩽5 was associated with 98% of event-free survival ( P < .04). In conclusion, this prospective, multicenter, and observational all-comers registry with this novel BMS design showed a low incidence of adverse events at 1 year mainly due to coronary restenosis.

scholarly journals Clinical Outcomes from Unselected “Real-World” Patients with Long Coronary Lesion Receiving 40 mm Biodegradable Polymer Coated Sirolimus-Eluting Stent

Scientifica ◽  
2015 ◽  
Vol 2015 ◽  
pp. 1-6 ◽  
Author(s):  
Anurag Polavarapu ◽  
Raghava Sarma Polavarapu ◽  
Jayesh Prajapati ◽  
Kamlesh Thakkar ◽  
Asif Raheem ◽  
...  
Keyword(s):  
Real World ◽  
Biodegradable Polymer ◽  
Cardiac Death ◽  
Target Lesion ◽  
Cardiac Events ◽  
Target Vessel Revascularization ◽  
Primary Endpoints ◽  
Coronary Lesions ◽  
Sirolimus Eluting Stent

Background. Long lesions being implanted with drug-eluting stents (DES) are associated with relatively high restenosis rates and higher incidences of adverse events.Objectives. We aimed to examine the safety and efficacy of the long (40 mm) biodegradable polymer coated Indolimus sirolimus-eluting stent (SES) in real-world patients with long coronary lesions.Methods. This study was observational, nonrandomized, retrospective, and carried out in real-world patients. A total of 258 patients were enrolled for the treatment of long coronary lesions, with 40 mm Indolimus. The primary endpoints in the study were incidence of major adverse cardiac events (MACE), a miscellany of cardiac death, myocardial infarction (MI), target lesion revascularization (TLR) or target vessel revascularization (TVR), and stent thrombosis (ST) up to 6-month follow-up.Results. The study population included higher proportion of males (74.4%) and average age was 53.2 ± 11.0 years. A total of 278 lesions were intervened successfully with 280 stents. The observed MACE at 6-month follow-up was 2.0%, which included 0.8% cardiac death and 1.2% MI. There were no TLR or TVR and ST observed during 6-month follow-up.Conclusions. The long (40 mm) Indolimus stent demonstrated low MACE rate and was proven to be safe and effective treatment for long lesions in “real-world” patients.

P2797Clinical outcomes of an ultra-thin strut sirolimus-eluting stent with biodegradable polymer in all-comers patients undergoing coronary intervention

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
I B A Menown ◽  
R De Silva ◽  
R Mitra ◽  
K Balachandran ◽  
R More ◽  
...  
Keyword(s):  
Stent Thrombosis ◽  
Primary Endpoint ◽  
Biodegradable Polymer ◽  
Cardiac Death ◽  
Bypass Graft ◽  
Coronary Intervention ◽  
Efficacy And Safety ◽  
Complex Anatomy ◽  
Sirolimus Eluting Stent

Abstract Background Thin stent struts may be associated with reduced vessel injury and use of biodegradable polymers may further improve long term outcomes. However, data with earlier stents has been inconsistent; thus further studies with newer devices are needed. Purpose To evaluate the efficacy and safety of a new ultra-thin (65um) strut cobalt chromium sirolimus-eluting stent with a hybrid design (closed cell at ends and open cells in middle to reduce edge injury and optimise conformability) in all-comers patients undergoing percutaneous coronary intervention (PCI). Methods We enrolled 752 patients from 14 sites undergoing PCI into a prospective, non-randomised, multi-centre, open-label, observational registry. Inclusion of patients with complex anatomy (long stent lengths, bifurcations and chronic total occlusions) was encouraged. Clinical follow-up was scheduled at 1, 9, 12 and 24 months. The primary endpoint was incidence of major adverse cardiac events (MACE) - cardiac death, non-fatal myocardial infarction (MI), or target vessel revascularization (TVR) - at 9 months. Results Mean patient age was 64.7±12.2 years, 20.7% had diabetes, 58.8% had dyslipidaemia, 40.4% had multi-vessel disease, 22% had previous PCI, 4.7% had previous coronary-artery bypass graft, and 19.6% had a clinical history of previous MI. Mean lesion length was 25.7±17.3 mm. The primary endpoint of cumulative MACE up to 9 months (from 624 patients reaching 9 months follow-up) occurred in 12 patients (1.92%), including 6 (0.96%) cardiac death, 5 (0.80%) MI and 6 (0.96%) clinically indicated TVR. Definite stent thrombosis was reported in 3 patients (0.48%) and probable stent thrombosis in 2 patients (0.32%). Conclusions Use of an ultra-thin strut biodegradable polymer sirolimus-eluting stent in all-comers patients undergoing PCI was associated with good clinical efficacy and safety. Acknowledgement/Funding Meril Life

Photoablative atherectomy followed by a paclitaxel-coated balloon to inhibit restenosis in instent femoro-popliteal obstructions (PHOTOPAC)

VASA ◽  
2021 ◽  
pp. 1-7
Author(s):  
Tanja Böhme ◽  
Elias Noory ◽  
Ulrich Beschorner ◽  
Frederik Lerke ◽  
Andrej Schmidt ◽  
...  
Keyword(s):  
Primary Endpoint ◽  
Ankle Brachial Index ◽  
Target Lesion ◽  
Primary Patency ◽  
Small Sample ◽  
Adverse Event Rate ◽  
Control Cohort ◽  
Procedural Success ◽  
Laser Atherectomy

Summary: Background: To evaluate the safety and effectiveness of preparing instent femoropopliteal lesion with photoablative laser atherectomy or plain balloon angioplasty (POBA) prior to drug-coated balloon (DCB) angioplasty. Patients and methods: The prospective, multicenter, randomized study enrolled patients with Rutherford-Becker-class (RBC) 1 to 5 and instent lesions located in superficial femoral artery and/or popliteal artery above the knee joint. Primary endpoint was target lesion percent stenosis at 1 year as determined by the angiographic core-laboratory. Secondary endpoints included procedural success, major adverse event rate, clinical improvement and improvement in ankle-brachial index (ABI), clinically-driven target lesion revascularization (CD-TLR), and primary patency rate at until 2-year follow-up. Results: The study was terminated prior to the enrollment goal due to slow enrollment. Thirty patients were included in the laser plus DCB cohort and 31 patients in the control cohort. Primary endpoint was not significantly different (p=0.331). Procedural success was 83.3% and 87.1% for the laser plus DCB and the control cohort, respectively. Serious adverse events at 30 days and 1-year were not statistically different between the two cohorts. For the ABI, significant improvements were present at discharge as well as at the follow-up visits. This was also evident for the RBC at the follow-up visits. One- and two-year freedom from CD-TLR was 86.7% vs. 87.1%, and 63.6% vs. 72%, respectively. Duplex derived primary patency was 90% at 6-months, 65.5% at one year and 56.5% at two year for the laser cohort and 90.3%, 75.9% and 53.8% for the control cohort. Conclusions: Safety of instent photoablative laser atherectomy followed by DCB angioplasty is confirmed by this study. Due to the small sample size, no benefit over POBA as vessel preparation could be shown.

scholarly journals Ultrathin-strut biodegradable polymer versus durable polymer drug-eluting stents: a meta-analysis

Open Heart ◽  
2020 ◽  
Vol 7 (2) ◽  
pp. e001394 ◽  
Author(s):  
Mohammad Riashad Monjur ◽  
Christian F Said ◽  
Paul Bamford ◽  
Michael Parkinson ◽  
Richard Szirt ◽  
...  
Keyword(s):  
Biodegradable Polymer ◽  
Cardiac Death ◽  
Primary Outcome ◽  
Second Generation ◽  
Meta Analysis ◽  
Target Lesion ◽  
Drug Eluting Stents ◽  
Durable Polymer ◽  
Drug Eluting

ObjectivesDetermine whether an ultrathin biodegradable polymer sirolimus-eluting stent (‘Orsiro’—BP-SES) has clinical benefits over second-generation durable polymer drug-eluting stents (DP-DES).MethodsWe conducted a prospective systematic review and meta-analysis of randomised clinical trials comparing Orsiro BP-SES against DP-DES (PROSPERO Registration: CRD42019147136). The primary outcome was target lesion failure (TLF): composite of cardiac death, target vessel myocardial infarction (TVMI) and clinically indicated target lesion revascularisation (TLR)) evaluated at the longest available follow-up.ResultsNine trials randomised 11 302 patients to either Orsiro BP-SES or DP-DES. At mean weighted follow-up of 2.8 years, the primary outcome (TLF) occurred in 501 of 6089 (8.2%) participants with BP-SES compared with 495 of 5213 (9.5%) participants with DP-DES. This equates to an absolute risk reduction of 1.3% in TLF in favour of Orsiro BP-SES (OR 0.82; 95% CI 0.69 to 0.98; p=0.03). This was driven by a reduction in TVMI (OR 0.80; 95% CI 0.65 to 0.98; p=0.03). There were no significant differences in other clinical endpoints: cardiac death, TLR and stent thrombosis.ConclusionThe Orsiro BP-SES shows promising clinical outcomes in patients undergoing percutaneous coronary intervention compared with contemporary second-generation DES at a short to medium term follow-up. More research is warranted to evaluate performance over a longer follow-up period and in different clinical and lesion subsets.

scholarly journals 575 Heart failure as the cancer for the heart: the prognostic role of the new TNM-like classification

2021 ◽  
Vol 23 (Supplement_G) ◽  
Author(s):  
Paolo Severino ◽  
Andrea D’ Amato ◽  
Marco Valerio Mariani ◽  
Silvia Prosperi ◽  
Danilo Alunni Fegatelli ◽  
...  
Keyword(s):  
Heart Failure ◽  
Cardiac Death ◽  
Tnm Classification ◽  
Composite Endpoint ◽  
Staging System ◽  
Left Ventricular ◽  
Left Ventricular Ejection ◽  
Ventricular Ejection Fraction ◽  
Peripheral Organs

Abstract Aims Heart failure (HF) is the pandemic of the third millennium accounting for the highest mortality rate among general population, second only to lung cancer. Beside heart, HF can affect lungs and peripheral organs, such as kidney, liver, brain, erythropoiesis, leading to multiorgan dysfunction. This is similar to spread of cancer. We proposed a new staging system of HF, named HLM, analogous to TNM classification used in oncology, which refers to heart damage (H), instead of T for tumour, lung involvement (L), instead of N for lymphnodes, and malfunction (M) of peripheral organs, instead of M for metastasis. The aim of this study was a comparison of HLM score with NYHA classes, ACC/AHA stages and HF classification by left ventricular ejection fraction (LVEF), to assess the most accurate prognosis tool for HF patients, in terms of a composite endpoint of all-cause death and hospitalization. Methods and results We performed a multicentre observational, prospective study of consecutive patients admitted for HF, or at risk for HF. All parameters for heart, lungs, and peripheral organ function were collected and examined. Each patient was classified according to HLM, NYHA, ACC/AHA scores and LVEF, at hospital admission and at discharge. The composite endpoint was all-cause death and rehospitalization; the secondary endpoints were all-cause death, cardiac death, and rehospitalization. Patients were followed up at 12 months. We enrolled 2152 patients. Among those, 1720 patients completed the 12-months follow-up. Comparing HLM with other nosologies, the area under the ROC curve (AUC) was greater for HLM score than NYHA, ACC/AHA and LVEF scores regarding the composite endpoint (HLM = 0.644; NYHA = 0.580; ACC/AHA = 0.572; EF = 0.572) and all-cause death (HLM = 0.713; NYHA = 0.596; ACC/AHA = 0.594; EF = 0.565). HLM score related AUC showed statistically significant differences compared to LVEF (P &lt; 0.001), ACC-AHA (P &lt; 0.001), and NYHA (P &lt; 0.001) scores’ AUC, in terms of all-cause death and the composite of all-cause death and rehospitalization, at 12 months follow-up. Moreover, the AIC and BIC values to predict the composite of all-cause death and rehospitalization, all-cause death, cardiac death and rehospitalization rate at 12 months follow-up were always lower for HLM model compared with the others. Conclusions According to our results, HLM score has greater prognostic power compared to other nosologies, in terms of composite outcome, rehospitalization, and all-cause death, as well as all-cause death, cardiac death, and rehospitalization, at 12 months follow-up in HF patients. HLM score overcomes the cardiocentric view of HF and it addresses the pathophysiological mechanisms underlining heart abnormalities. Such a multivariable, holistic staging system may be used in HF patients, in order to improve clinical management and to reduce healthcare costs.

scholarly journals Noninvasive programmed ventricular stimulation for prediction of future events in patients with cardioverter-defibrillator implanted for primary prevention of sudden cardiac death

EP Europace ◽  
2021 ◽  
Vol 23 (Supplement_3) ◽  
Author(s):  
P Futyma ◽  
P Santangeli ◽  
L Zarebski ◽  
A Wrzos ◽  
J Sander ◽  
...  
Keyword(s):  
Primary Prevention ◽  
Sudden Cardiac Death ◽  
Predictive Value ◽  
Cardiac Death ◽  
Composite Endpoint ◽  
Cardioverter Defibrillator ◽  
Programmed Ventricular Stimulation ◽  
Ventricular Stimulation

Abstract Funding Acknowledgements Type of funding sources: None. OnBehalf The NIPS-ICD Investigators Background Implantable cardioverter-defibrillator (ICD) offers an opportunity to examine vulnerability to ventricular tachycardia (VT) or ventricular fibrillation (VF) by performing non-invasive programmed ventricular stimulation (NIPS). Whether NIPS can predict mortality in patients with primary prevention ICD, has not yet been examined. Purpose To examine a long-term predictive value of NIPS for identification of patients at increased risk of death during follow up. Methods The study group consisted of consecutive 41 patients with ICD implanted for primary prevention of sudden cardiac death, included in the prospective NIPS-ICD study (ClinicalTrials ID: NCT02373306) (34 males, age 64 ± 11 years). The patients underwent NIPS using the protocol up to three premature extrastimuli at 600, 500 and 400ms drive cycle lengths. The end-point of NIPS was induction of sustained VT or VF or completion of the protocol. Results At baseline NIPS, VT/VF was induced in 8 (20%) patients. After 5 year follow up mortality rate was significantly higher in patients who had VT/VF induced at NIPS vs no VT/VF at NIPS (38% vs 12%, p = 0.04). The difference in mortality was most remarkable at 3 (38% vs 3%, p = 0.001) and 4 years (38% vs 6%, p = 0.007). The NIPS-induced VT/VF had a sensitivity of 37.5%, specificity of 88%, positive predictive value of 43% and negative predictive value of 85% for occurrence of death during follow up. An occurrence of secondary composite endpoint consisting of VT/VF recurrence or death was also most frequent in NIPS-inducible group (75% vs 24%, p = 0.037). In a multivariate Cox-Proportional Hazard model induction of VT/VF at NIPS along with age≥65, and treatment with amiodarone was an independent predictor of the composite endpoint during follow-up Conclusions Inducibility of VF/VF during NIPS in patients with primary prevention ICD is associated with higher mortality and higher incidence of composite endpoint consisting of  death or VT/VF during a long term observation. Abstract Figure. Kaplan-Meier survival curves

scholarly journals Use of sirolimus-coated balloon in de novo small vessel coronary lesions; Long-term follow-up from a single centre registry

2021 ◽  
Vol 42 (Supplement_1) ◽  
Author(s):  
B H Loku Waduge ◽  
H Kalkat ◽  
A Saif ◽  
A M Fawzy ◽  
S Athukorala ◽  
...  
Keyword(s):  
Cardiac Death ◽  
De Novo ◽  
Small Vessel ◽  
Target Vessel ◽  
Long Term Outcome ◽  
Coronary Syndrome ◽  
The Mean ◽  
Coronary Lesions

Abstract Background Drug coated balloons (DCBs) in Europe are mainly used in restenotic lesions as endorsed by the European Society of Cardiology, with a class IA recommendation. However, some of the recent data suggest, it can also be considered in a subset of denovo lesions, especially in small vessels. Most DCBs used, are coated with Paclitaxcel. There is no data on the efficacy of Sirolimus in DCBs, the drug of choice in drug eluting stents. In this study, we report outcomes from the use of a Sirolimus coated balloon (SCB) in de novo small-vessel coronary lesions, from a single high yield centre. Methods A retrospective analysis was conducted on all patients treated with an SCB between March 2018 and October 2020. Follow-up was achieved with clinic visits, telephone calls and admission records. The outcomes measured include cardiac death, target-vessel myocardial-infarction (TVMI), target lesion revascularisation (TLR) and MACE (combination of cardiac death, target-vessel MI and TLR). Results During the study period, 279-patients (with 332-lesions) with de novo lesions were treated with an SCB. The mean age of patients was 65±12 years, 219 (79%) were male, 36% (n=100) had diabetes, 16% (n=45) had chronic kidney disease and 61% were in the setting of acute coronary syndrome (n=169). Predilatation was performed in 96% (320-lesions). Bailout stenting (with DES) was required in 5% of lesions (n=18) of which 16 were due to dissections and 2 were due to recoil &gt;30% following DCB use. The mean diameter and length of DCBs were 2.35 mm and 26 mm respectively. During a median follow-up of 584-days (19-months) cardiac death was reported in 8 patients (3%). Target vessel MI was in 3% (n=9), TLR per lesion was 8% (n=26) and the MACE rate was 11% (n=31). There were no documented cases of acute vessel closure. Conclusion The long-term outcome from the first ever study on sirolimus eluting balloons in de novo small vessel lesions appears promising with low rates of hard endpoints, and acceptable repeat rates of TLR despite a complex group of patients (50% ACS, 36% diabetics and 19% CKD) and lesion subsets (small vessel and diffuse disease). Implanting stents in these subsets renders them vulnerable to restenosis, making treatment challenging and resulting in high rates of recurrence. FUNDunding Acknowledgement Type of funding sources: None.

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