TCT-37 Prospective, Multi-Center Evaluation of the DESolve Nx Novolimus-Eluting Bioresorbable Coronary Scaffold: First Report of One Year Clinical and Imaging Outcomes (original) (raw)
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Journal of the American College of Cardiology, 2014
Background: The new InspironÔ (Scitech, Brazil) is a thin-strut (75 mm) cobaltchromium stent, abluminally coated with a thin (4.4 mg) PLA-PLGA polymeric layer, eluted with low-dose sirolimus. The present study aims to evaluate the safety and efficacy profile of the novel drug-eluting-stent in a very high-risk population treated in a tertiary university hospital. Methods: Up to May 2014, a total of 276 all-comers, without any specific anatomical or clinical restriction, have been treated with the novel sirolimus-eluing stent implantation and comprise this study population. Patients were maintained in dual antiplatelet therapy for a minimum of 6 months and aspirin was prescribed indefinitely thereafter. Patients have been clinically followed-up at 1, 6 and 12 months postprocedure. Results: For the entire cohort, a total of 342 lesions were treated with 429 InspironÔ stents. The included population had a very high risk profile. Overall 53.6% were diabetics, 70.7% had multivessel disease, 39.5% were admitted with acute coronary syndromes, heart failure was present in 16.7%, and 19.2% had previous coronary surgery. Most lesions were type B2/C (79.8%), 31.7% were bifurcations, and 17.6% were restenosis of a previously implanted stent. After a mean follow-up of 136 AE 101 days, the rate of target lesion-related death was 0.5%, myocardial infarction 4.9%, and target lesion revascularization 2.3%. There was only one episode of (probable) stent thrombosis (total any thrombosis rate at 140 days was 0.4%). Conclusions: The interim results of this real life registry demonstrate promising midterm safety and efficacy results for the novel InspironÔ sirolimus-eluing stent in the treatment of highly complex patients. TCT-609 Comparison of one year outcomes in real world patients treated with a polymer free amphilimus eluting coronary stent versus second generation everolimus eluting stents
Journal of the American College of Cardiology, 2013
Background: Bioresorbable scaffold is a novel approach that provides transient vessel support with drug delivery capability without the long-term limitations of metallic drug-eluting stents. The everolimus-eluting bioresorbable scaffold (ABSORB; Abbott vascular, CA, USA) has been shown to be effective in the context of first-in-man trials including simple lesion(s). However, the effect of ABSORB implantation in more complex patients cannot be directly extrapolated from these findings. We sought to evaluate the impact of this novel technology on the short-and intermediate-term clinical outcomes in a real-life population with complex lesions. Methods: Since September 1st 2013, our institution commenced the use of ABSORB scaffold in patients with complex lesions including a long lesion (>32mm in length), a calcified lesion, a bifurcation lesion and a large vessel with up to 4mm in diameter. Patients presenting with stable angina, unstable angina and non-ST elevation myocardial infarction were included. In total 300 patients presenting with de novo complex lesions will be treated exclusively with ABSORB scaffolds. Results: Up to May 1, 2013, 137 patients were included in the study. In total 248 scaffolds were implanted, with a procedural success rate of 95%, in the lesions including 40 bifurcations and 11 chronic total occlusions. In 52 patients (53 lesions), more than one scaffold was implanted with overlap. An interim analysis of the population at one month revealed no MACE event except for one myocardial infarction. The enrolment is ongoing while the updated one-month and 6-month data on the occurrence of death, MI, repeat revascularization and scaffold thrombosis are currently being collected and will be presented at the time of the meeting. Survival information will be obtained from municipal civil registries. Conclusions: The short-term and intermediate-term clinical safety and efficacy of the ABSORB scaffold in complex lesions will be presented at the meeting.
Journal of the American College of Cardiology, 2017
RESULTS One hundred seventeen men and 67 women with a mean age of 65.5 AE 10.8 were enrolled at 18 clinical sites in Europe, Brazil and Singapore. Hypertension was present in 79.3% of the subjects and 62% of patient had hyperlipidemia. 189 lesions have been treated with the study device. 41.3% of lesions were located in the left anterior descending, 33.9% the right coronary artery, 23.3% in the left circumflex and 1.6% in the ramus intermedius. The mean lesion length is 12.5AE5.1 mm with a mean reference vessel diameter of 2.7AE0.4mm. At 6-month, the target lesion failure (TLF) rate of the combined population was 3.3%, including two cardiac deaths (1.1%), one target vessel myocardial infarction (0.6%), and three clinically driven target lesion revascularizations (1.7%). The clinical and angiographic 12-month results of BIOSOLVE-II study are available with an in-segment late lumen loss of 0.25þ0.22 mm (for 42 subjects) and a TLF rate of 3.4%. It consists of one death of unknown cause, one target-vessel myocardial infarction, and two clinically driven target lesion revascularizations. The 12-months clinical and angiographic data of the combined cohort will be available upon presentation. CONCLUSION The 12-month encouraging safety and angiographic results of this novel absorbable metal scaffold will be presented for a larger population of subjects enrolled in BIOSOLVE-II and BIOSOLVE-III studies.
JACC: Cardiovascular Interventions, 2016
OBJECTIVES This study sought to report the late multimodality imaging and clinical outcomes of the novel poly-L-lactic-acid-based DESolve novolimus-eluting bioresorbable coronary scaffold for the treatment of de novo coronary lesions. BACKGROUND Bioresorbable scaffolds are an alternative to drug-eluting metallic stents and provide temporary vascular scaffolding, which potentially may allow vessel restoration and reduce the risk of future adverse events. METHODS Overall, 126 patients were enrolled at 13 international sites between November 2011 and June 2012. The primary endpoint was in-scaffold late lumen loss at 6 months. Major adverse cardiac events, the main safety endpoint, were defined as the composite of cardiac death, target vessel myocardial infarction, or clinically indicated target lesion revascularization. All patients underwent angiography at 6 months. Serial intravascular ultrasound and optical coherence tomography were performed in a subset of patients. RESULTS The scaffold device success rate was 97% (n ¼ 122 of 126), and procedural success was 100% (n ¼ 122 of 122). The major adverse cardiac event rate was 3.3% (n ¼ 4 of 122) at 6 months and 7.4% (n ¼ 9 of 122) at 24 months, including 1 probable stent thrombosis within the first month. At 6-month angiographic follow-up, in-scaffold late lumen loss was 0.20 AE 0.32 mm. Paired intravascular ultrasound analysis demonstrated a significant increase in vessel, lumen and scaffold dimensions between post-procedure and 6-month follow-up, and strut-level optical coherence tomography analysis showed full strut coverage in 99 AE 1.7%. CONCLUSIONS Our results showed favorable performance of the DESolve scaffold, effective inhibition of neointimal hyperplasia, and for the first time, early luminal and scaffold growth at 6 months with sustained efficacy and safety through 2 years.
Journal of the American College of Cardiology, 2015
is a novel device that combines a PLLA-based scaffold coated with a potent antiproliferative sirolimus metabolite-Novolimus (5 mcg per mm of scaffold length). methods: 126 pts w/ single de novo coronary lesions ≤14 mm in length located in a native coronary vessel 2.75 to 3.5 mm in diameter by online quantitative coronary angiography (QCA) were prospectively enrolled at 13 international sites between Nov/2011 and Jun/2012. Key exclusion criteria were left main or ostial location, bifurcation, total occlusion and heavy calcification. All pts were assigned for 6 months angiographic follow-up (FU). In addition, a subset of 19 pts included in a single site was scheduled for a second angiographic FU at 18 months. Angiographic analyses were performed at an independent core laboratory. The primary efficacy endpoint was in-scaffold late lumen loss at 6 months. results: Overall, mean age was 62 yrs, 21% had diabetes, and 75% presented with stable angina. Baseline QCA demonstrated mean lesion length, reference diameter, and % diameter stenosis (DS) of 11.23 ± 3.75 mm, 3.00 ± 0.30 mm and 69.6±12.1%, respectively. Overall, the study scaffold was successfully implanted in 122 of 126 lesions. At postprocedure, % DS was 13.2 ± 7.5% and % acute recoil was 6.4%. At 6 angiographic follow-up (113 lesions or 93% of eligible patients), mean in-scaffold late lumen loss was 0.20 ± 0.32 mm. Considering only those with paired angiographic follow-up evaluation (n=19), mean in-scaffold late lumen loss at 6 and 18 months were 0.25 ± 0.33 mm and 0.32 ± 0.36 mm, respectively (p=0.31), with a mean difference of 0.07 mm (95% confidence interval of-0.02 to 0.14). Conclusion: Overall, the DESolve BCSS demonstrated efficacy on the treatment of single de novo lesions, as demonstrated by the relatively low late lumen loss-a surrogate of neointimal hyperplasia, at 6 months follow-up. Serial angiographic evaluation at 6 and 18 months demonstrated minimal change in late lumen loss, thus, suggests sustained efficacy overtime.
Journal of the American College of Cardiology, 2016
administration of acetylcholine or nitroglycerine for 80% (20/25) of the subjects at 6-month demonstrates the uncaging aspect of the absorption process with no further change at the 12-month follow-up. Six-month virtual histology (VH) data showed a significant decrease in the dense calcium by 14% (p<0.0001) remaining stable from 6-to 12-month follow-up. This decrease is interpreted as a surrogate assessment for the bioabsorption process of the scaffold material. CONCLUSION The DREAMS 2G showed stable angiographic, IVUS, and clinical measures between 6-and 12-month, with an excellent safety profile up to 12-month and no definite or probable scaffold thrombosis. No intra-luminal masses were observed by OCT up to 12-month.
Advances in Interventional Cardiology, 2018
Introduction: Randomized trials have proven the feasibility and safety of the bioresorbable vascular scaffold (BVS) in selected populations of patients. Data concerning the results of BVS in "real-world" registries with an appropriate sample size are limited. Aim: Assessment of early-and long-term outcomes of patients undergoing bioresorbable scaffold implantation in an all-comers population of the ZABRZE-BVS registry. Material and methods: The ZABRZE-BVS registry is a prospective registry including consecutive patients treated in the period 2013-2016 with the intention to implant a BVS (ABSORB, Abbott Vascular, Santa Clara, California). The primary endpoint was occurrence of the 12-and 24-month device-oriented composite endpoint (DoCE) defined as cardiac death, target-vessel myocardial infarction (TV-MI) or target lesion revascularization (TLR). The secondary endpoint includes occurrence of patient-oriented composite endpoint (PoCE) at 12 and 24 months, device (lesion basis) and procedural success (patient basis). Results: A total of 456 patients during 467 procedures received 588 scaffolds in 563 lesions. Of note, 25.4% of patients presented with diabetes mellitus and 62.3% had an acute coronary syndrome. In QCA analysis, 78.7% of patients had type B2/C lesions, minimal lumen diameter was 0.78 ±0.54 mm, whereas post-procedural acute lumen gain was 1.61 ±0.61 mm. Median follow-up was 781 days. The cumulative rate of DoCE was 6.7% at 12 months and 12.2% at 24 months. Rates of 12-and 24-month PoCE were 12.4% and 20.1%, respectively. The percentage of device success was 98.7%, while the procedural success rate was 96.9%. Conclusions: The Absorb BVS was successfully and safely implanted in an unselected group of patients. Scaffold thrombosis developed predominantly in patients with acute coronary syndrome (ACS).
JACC: Cardiovascular Interventions, 2015
The purpose of this study was to describe the multimodal outcome 12 months after implantation of coronary bioresorbable scaffolds (BVS) for the treatment of patients with acute coronary syndromes (ACS). BACKGROUND Functional and imaging data on the use of BVS are limited to simple, stable lesions; in the setting of ACS, only short-term clinical follow-up data are available, and no information from intracoronary imaging and vasomotion tests has been reported. METHODS A total of 133 patients (age 62 AE 12 years, 74% males, 15% diabetic) underwent BVS (n ¼ 166) implantation for the treatment of thrombotic lesions in the setting of ACS (43% non-ST-segment elevation myocardial infarction, 38% ST-segment elevation myocardial infarction, 20% unstable angina). Clinical, angiographic, intracoronary imaging, and vasomotor endpoints were evaluated at 12 months. RESULTS During the 374 days (interquartile range: 359 to 411 days) of follow-up, there were 4 deaths; 3 definite and 1 probable in-BVS thromboses (all in the first 6 months). At 12-month angiography (75 patients, 83 BVS), in-segment late lumen loss was 0.19 AE 0.45 mm, and 3 (4%) patients showed binary restenosis. Optical coherence tomography (80 BVS, n ¼ 70) showed a mean lumen area of 6.3 AE 2.3 mm 2. Malapposition was evidenced in 21 (26%) BVS. Endotheliumdependent and-independent vasodilation were observed in 48% and 49% of the BVS. CONCLUSIONS Twelve months after BVS implantation, clinical, intracoronary imaging, and vasomotion data appear to provide a rationale for the use of BVS in the setting of ACS and the basis for a randomized study. (J Am Coll Cardiol Intv 2015;8:770-7) © 2015 by the American College of Cardiology Foundation. E verolimus-eluting bioresorbable vascular scaffolds (BVS) have been recently introduced in more than 60 countries worldwide for the treatment of de novo coronary lesions, independently of patient and lesion characteristics. Analogue to metal stents, BVS initially provide mechanical scaffolding, preventing acute occlusion and early recoil, and release everolimus for the inhibition of neointima proliferation. Thereafter, the resorption of the scaffold struts has been hypothesized to protect vascular geometry/biomechanics and, in the longterm, allow positive remodeling (1). The latter concepts extend beyond the traditional treatment with metal stents, and phenomena such as the restoration From the *