Bioresorbable Vascular Scaffold (ABSORB BVS); first report in Egyptian patients with 6month angiographic/IVUS follow up (original) (raw)
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The Egyptian Heart Journal, 2016
Background: The newer generation of Bioresorbable Vascular Scaffold ABSORB (BVS 1.1) showed better outcome in regard to scaffold area reduction as a result of improved scaffold design and enhanced polymer processing. Objective: To assess the safety and efficacy of treating significant native coronary artery stenosis using ABSORB BVS. Methods: Ninety-nine patients with de novo native significant coronary artery stenosis were selected between September 2012 and September 2014 and were treated using ABSORB BVS. For each patient, the target and the peri-scaffold segments (5 mm proximal and distal to the scaffold edge) were analyzed by Quantitative Coronary Angiography (QCA) and Intravascular Ultrasound (IVUS) immediately after the procedure and at one year of follow-up. The major clinical endpoint was ischemia-driven major adverse cardiac events (ID-MACE) defined as a composite of cardiac death, myocardial infarction or ischemia-driven target lesion revascularization (ID-TLR). Results: At one year, the overall scaffold area did not demonstrate any significant change. The angiographic insegment late lumen loss was estimated to be 0.11 ± 0.19 mm, while the IVUS assessment revealed a non-significant decrease in the minimal lumen area by 0.5% (p = 0.79), without significant change in the mean lumen area. There were no reported cardiac deaths. However, two cases of ID-TLR were recorded, one case with STEMI after two weeks due to thrombosis at the distal edge of the BVS and another case with restenosis after one year. Both were treated with metallic drug
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).
2016
Bioresorbable vascular scaffolds (BVS) represent a promising novel approach for the treatment of coronary artery disease. BVS promise to address some of the well-known limitations of current drug-eluting stents, while providing a transient scaffolding of the vessel to prevent acute vessel closure/recoil. Drug elution by BVS prevents neointimal proliferation in a similar fashion to drug-eluting stents, and complete bioresorption is associated with late vessel lumen enlargement, plaque regression, and restoration of vasomotion. Based on the pathophysiological reasons and on the results derived from clinical studies, BVS are increasingly being used in clinical practice. The aim of this review is to provide an overview of the current evidence supporting the use of BVS in clinical practice. In particular, we will discuss the randomized controlled trials and registries evaluating the clinical outcome of these devices, with a special focus on their application in patients with acute corona...
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.
JACC: Cardiovascular Interventions, 2017
The aim of this study was to assess the feasibility and clinical results following a pre-specified bioresorbable scaffold (Absorb BVS) implantation strategy in patients with ST-segment elevation myocardial infarction (STEMI). BACKGROUND Concerns were raised about the safety of Absorb because a non-negligible rate of thrombosis was reported within 30 days and at midterm follow-up after primary percutaneous coronary intervention. METHODS This was a prospective, multicenter study of patients with STEMI (<75 years of age with symptom onset <12 h) undergoing primary percutaneous coronary intervention with Absorb following a dedicated implantation protocol. The primary endpoint was a device-oriented composite endpoint of cardiac death, target vessel myocardial infarction, and ischemia-driven target lesion revascularization within 30 days. RESULTS During the study period, 505 patients with STEMI (16.9% of the overall STEMI population) were treated with the Absorb BVS. The mean age was 56.6 AE 9.4 years, and 487 patients (96.4%) were in Killip class I or II at admission. According to the study protocol, direct Absorb implantation was feasible in 47 patients (9.3%), whereas post-dilatation was performed in 468 cases (92.7%). Procedural success was attained in 94.8% of the cases. Dual antiplatelet therapy with ticagrelor or prasugrel was administered at discharge in 481 patients (95.1%). At 30-day follow-up, the hierarchical device-oriented composite endpoint rate was 0.6% (0.4% cardiac death, 0.2% target vessel myocardial infarction and ischemia-driven target lesion revascularization). One episode (0.2%) of probable scaffold thrombosis was reported. CONCLUSIONS A pre-specified Absorb implantation strategy in real-world patients with STEMI undergoing primary percutaneous coronary intervention was feasible and associated with a low 30-day device-oriented composite endpoint rate. Mid-and long-term follow-up is strongly needed to eventually confirm these early results.
Cardiovascular Revascularization Medicine, 2015
Background/purpose: Coronary in-stent restenosis (ISR) is a clinical problem for which a satisfactory solution has not been found yet. Bioabsorbable drug eluting vascular scaffolds (BVSs) provide transient vessel scaffolding combined with prolonged drug delivery capability. The aim of this study was to investigate the safety of BVS for the treatment of coronary ISR. Methods/materials: Between January 2013 and June 2013, 27 patients (31 lesions), presenting with either stable or unstable angina due to coronary ISR, were enrolled in a single arm, prospective, open label registry. Primary end point was the occurrence of target vessel revascularization (TVR) at 12 months. Secondary end point was the composite of death, myocardial infarction and TVR at 12 months. Results: A diffuse ISR pattern was present in 70% of the lesions; mean lesion length was 34.6 ± 15. BVS was successfully implanted in all patients with no in hospital MACE. At twelve months of follow up, MACE rate was 18.5%. One patient died for non-cardiac reason, one patient died due to a possible stent thrombosis and TVR was necessary in 3 patients (11.1%). Conclusions: Our data suggest that BVS is safe and technically feasible for treatment of long and diffuse coronary ISR. These data could be considered hypothesis generator for a randomized clinical trial.
Indian Heart Journal, 2017
Background and objective: Studies conducted across the world have reported that the rates of major adverse cardiac events (MACE) following the use of bioresorbable vascular scaffolds (BVS) are comparable to that noted with traditional drug eluting stents (DES). However, there is limited data on the immediate and medium-term clinical outcomes following the use of the Absorb BVS (Abbott Vascular, Santa Clara, SA) in the Indian context. This study was conducted to determine real-world evidence on the immediate and medium-term clinical outcomes in all patients undergoing percutaneous coronary intervention (PCI) with the Absorb BVS. Methods: Data of all patients who were treated with Absorb BVS at our center were evaluated. Between December 2012 and October 2016, 142 patients underwent PCI with BVS. The MACE rates during hospitalization, at 30 days, 3 months, 6 months after PCI, and every 6 months thereafter were the primary endpoints evaluated with median follow up of 13 months. Results: Mean age of the study participants was 53.7 AE 11.8 years. Intravascular ultrasound imaging was performed in 15.34% of patients. Predilatation and postdilatation were performed in 81.8% and 84.6% of scaffolds, respectively. There were no episodes of MACE during hospitalization. However, 1 BVS-related MACE was observed at the 1-month (0.7%) as well as at the !12 month (0.8%) follow up visits. At the 6and 12-month follow up visits, 2 (1.5%) and 3 (2.5%) non-BVS-related MACEs, respectively, were recorded. Conclusion: The use of Absorb BVS in this real-world experience was associated with very good immediate and medium-term clinical outcomes.
JACC. Cardiovascular interventions, 2018
The aim of this study was to characterize post-procedural intravascular ultrasound (IVUS) findings in the ABSORB Japan trial, specifically stratified by the size of target coronary arteries. Despite overall noninferiority confirmed in recent randomized trials comparing bioresorbable vascular scaffolds (BVS) (Absorb BVS) and cobalt-chromium everolimus-eluting metallic stents (CoCr-EES), higher event rates of Absorb BVS have been reported with suboptimal deployment, especially in small coronary arteries. In the ABSORB Japan trial, 150 patients (2:1 randomization) were scheduled in the IVUS cohort. Small vessel was defined as mean reference lumen diameter <2.75 mm. Tapered-vessel lesions were defined as tapering index (proximal/distal reference lumen diameter) ≥1.2. Overall, IVUS revealed that the Absorb BVS arm had smaller device expansion than the CoCr-EES arm did, which was particularly prominent in small- and tapered-vessel lesions. Higher tapering index was also associated with...