Scaffold Thrombosis Research Articles

Second generation, sirolimus-eluting, bioresorbable Tyrocore scaffold implantation in patients with ST-segment elevation myocardial infarction: Baseline OCT and 30-day clinical outcomes - A FANTOM STEMI pilot study.

There is paucity of data on acute performance of Fantom (REVA Medical, CA), a second generation sirolimus-eluting bioresorbable scaffold (BRS), in ST-segment elevation myocardial infarction (STEMI) patients undergoing primary percutaneous coronary intervention. The aim of this study was to evaluate safety and efficacy of the Fantom BRS in the acute setting of STEMI characterized by thrombogenic milieu. Ten STEMI patients treated with a sirolimus-eluting Fantom BRS were enrolled into prospective, observational study. The scaffold sizing, positioning, and optimization were optical coherence tomography (OCT) guided. The primary end-point was the device-oriented composite endpoint (DOCE), additionally angiographic and OCT analysis were performed. The primary-end point, defined as DOCE, did not occur in any patient within the 30-day follow-up. The procedural and angiographic success rates were both 100%, there was no case of scaffold thrombosis, target lesion revascularization nor death. In QCA, an in-device minimum lumen diameter was 2.89 ± 0.24 mm and the residual diameter stenosis was 3.56 ± 3.17%. OCT revealed an incomplete scaffold apposition in five patients with an average of seven malapposed struts per scaffold and mean distance of 120 ± 30 μm. There was no proximal edge dissection, the distal edge dissection was recorded in one patient. This is the first pilot study evaluating safety and efficacy of the Fantom BRS, a second generation fully bioresorbable coronary scaffold, in STEMI patients undergoing primary PCI with OCT guidance. Fantom BRS showed adequate safety and efficacy in the acute 30-day angiographic, OCT, and clinical follow-up.

Everolimus- vs. novolimus-eluting bioresorbable scaffolds in patients with acute coronary syndrome.

Limited data exist on bioresorbable scaffolds (BRS) in patients with acute coronary syndrome (ACS). The aim of the present study was to evaluate novolimus-eluting BRS (DESolve) as interventional treatment for patients with ACS, and to compare its 12-month outcomes with the everolimus-eluting bioresorbable scaffolds (Absorb). In this retrospective study, patients with ACS (including unstable angina pectoris, ST-segment elevation myocardial infarction, or non-ST-segment elevation myocardial infarction) treated with either the Absorb or the DESolve BRS were evaluated in a1:1 matched-pair analysis. Major adverse cardiac events (MACE), including death, myocardial infarction, and target lesion revascularization, were evaluated as amajor endpoint. The occurrence of scaffold thrombosis was also assessed. Atotal of 102 patients were eligible for this analysis. The rate of MACE at 12months was comparable between the Absorb and the DESolve group (8.3% vs. 6.8%, p = 0.738). The occurrence of target lesion revascularization (6.2% vs. 4.7%; p = 0.700) and scaffold thrombosis (4.1% vs. 2.1%; p = 0.580) was comparable as well. All instances of scaffold thrombosis occurred within 30days of the index procedure. In this study, similar 12-month event rates were observed for both BRS types after implantation for the treatment of ACS.

The 1‑year safety and efficacy outcomes of Absorb bioresorbable vascular scaffolds for coronary artery disease treatment in diabetes mellitus patients: the ABSORB DM Benelux study.

BackgroundDiabetes mellitus (DM) patients show higher rates of repeat revascularisation even in the era of modern drug-eluting stents (DES). The concept of bioresorbable scaffolds is becoming captivating, as it might allow for repeat interventions, prolonging the time span during which patients can be treated by percutaneous coronary intervention (PCI).AimsWe intend to evaluate the short- and long-term safety and efficacy of Absorb bioresorbable vascular scaffolds (Absorb BVS) in the treatment of coronary artery disease (CAD) in DM patients for any indication.MethodsThe ABSORB DM Benelux is an international prospective study in DM patients who have undergone PCI with ≥1 Absorb BVS. Major adverse cardiac events (MACE) at 1 year was the primary endpoint, defined as a composite of all-cause death, any myocardial infarction (MI) and ischaemia-driven target vessel revascularisation (TVR). Secondary endpoints were target lesion failure (TLF) and definite or probable scaffold thrombosis (ScT).ResultsBetween April 2015 and March 2017, 150 DM patients and 188 non-complex lesions were treated. Device implantation was successful in 100%. MACE occurred in 14 (9.5%) patients, with all-cause death occurring in 4 (2.7%), any MI in 6 (4.1%) and ischaemia-driven TVR in 7 (4.8%) respectively. TLF was reported in 11 (7.5%). Definite and probable ScT was observed in 2 (1.4%).ConclusionAbsorb BVS for treatment of anatomically low-risk patients with DM show acceptable safety and efficacy outcomes at 1 year. If these promising results are confirmed after a longer follow-up period, new-generation bioresorbable scaffolds combined with refinement of implantation techniques might open new horizons for CAD treatment in DM patients.Electronic supplementary materialThe online version of this article (10.1007/s12471-019-1293-7) contains supplementary material, which is available to authorised users.

Routine use of optical coherence tomography in bioresorbable vascular scaffold implantation: insights on technique optimization and long-term outcomes.

Data from prior studies have shown increased risk of adverse outcomes with bioresorbable vascular scaffolds (BVS) compared with drug-eluting stents. The objective of this study was to study the long-term outcomes with routine use of optical coherence tomography (OCT) for optimization of BVS implantation. Clinical, procedural, and outcome data were collected for all patients who received ABSORB BVS between February 2014 and March 2016 in our tertiary center (n=86). Preimplantation and postimplantation OCT was performed in all cases. Outcomes of interest included acute device success and long-term clinical outcomes including cardiac mortality, target vessel myocardial infarction, ischemia-driven target lesion revascularization, and scaffold thrombosis. A total of 86 patients were included (106 lesions, 115 BVS implanted). Mean age was 59.5±10.9 years, with 66% men. Mean lesion length was 25.2±15.6 mm and mean reference vessel diameter was 3.42±0.45 mm. Type B2/C accounted for 40% of the lesions. All scaffold implantations followed the predilation, proper sizing, and postdilation strategy. Of the 115 scaffolds analyzed, 11 (9.5%) required further intervention based on prespecified OCT endpoints. On multivariate regression analysis, complex coronary lesion (type B2/C) was the single independent predictor of OCT use in scaffold optimization (odds ratio=6.3, 95% confidence interval: 1.3-7.8, P=0.02). At a mean follow-up duration of 31±7.1 months, no cases of cardiac mortality, target vessel myocardial infarction, ischemia-driven target lesion revascularization, or scaffold thrombosis were reported. Operators may consider OCT use for optimization of BVS implantation particularly in patients with complex coronary lesions.

Clinical and Angiographic Outcomes With a Novel Radiopaque Sirolimus-Eluting Bioresorbable Vascular Scaffold.

Background A novel bioresorbable scaffold, the sirolimus-eluting Fantom, incorporates a radiopaque polymer, struts with a thickness of 125 µm, and a crossing profile of 1.35 mm. The purpose of this study was to evaluate the 9-month angiographic and 12-month clinical outcomes of the FANTOM scaffold in a larger patient population. Methods and Results The FANTOM II study (Safety & Performance Study of the Fantom Sirolimus-Eluting Bioresorbable Coronary Scaffold - First Report on Initial 24 Month Outcomes) was a prospective, multicenter trial which enrolled 240 patients with single de novo coronary stenosis with reference vessel diameter 2.5 to 3.5 mm diameter and lesion length ≤20 mm. Major adverse cardiac events through 12-month follow-up were assessed. Angiographic follow-up was performed in consecutive patient cohorts at 6 months (n=117) and 9 months (n=123). Acute delivery success, acute technical success, acute procedural success, and clinical procedural success rates as defined in the clinical protocol were 97.9% (235/240), 95.8% (230/240), 99.1% (228/230), and 99.6% (227/228), respectively. The mean in-stent late lumen loss at 6 months and 9 months were 0.25±0.40 mm and 0.33±0.36 mm, respectively, and in-segment binary restenosis occurred in 2.0% and 7.6% of patients, respectively. Major adverse cardiac events and target lesion failure through 12 months occurred in 4.2% of 240 patients; scaffold thrombosis developed in only one patient (0.4%). Conclusions The Fantom sirolimus-eluting bioresorbable coronary scaffold demonstrated favorable safety and effectiveness performance at 12-month follow-up. Longer-term follow-up is ongoing to examine the late outcomes with this novel device. Clinical Trial Registration URL: https://www.clinicaltrials.gov . Unique identifier: NCT02539966.

Hybrid Coronary Percutaneous Treatment with Metallic Stents and Everolimus-Eluting Bioresorbable Vascular Scaffolds: 2-years Results from the GABI-R Registry.

The limitations of the first-generation everolimus-eluting coronary bioresorbable vascular scaffolds (BVS) have been demonstrated in several randomized controlled trials. Little data are available regarding the outcomes of patients receiving hybrid stenting with both BVS and drug-eluting stents (DES). Of 3144 patients prospectively enrolled in the GABI-Registry, 435 (age 62 ± 10, 19% females, 970 lesions) received at least one BVS and one metal stent (hybrid group). These patients were compared with the remaining 2709 (3308 lesions) who received BVS-only. Patients who had received hybrid stenting had more frequently a history of cardiovascular disease and revascularization (p < 0.05), had less frequently single-vessel disease (p < 0.0001), and the lesions treated in these patients were longer (p < 0.0001) and more frequently complex. Accordingly, the incidence of periprocedural myocardial infarction (p < 0.05) and that of cardiovascular death, target vessel and lesion failure and any PCI at 24 months was lower in the BVS-only group (all p < 0.05). The 24-months rate of definite and probable scaffold thrombosis was 2.7% in the hybrid group and 2.8% in the BVS-only group, that of stent thrombosis in the hybrid group was 1.86%. In multivariable analysis, only implantation in bifurcation lesions emerged as a predictor of device thrombosis, while the device type was not associated with this outcome (p = 0.21). The higher incidence of events in patients receiving hybrid stenting reflects the higher complexity of the lesions in these patients; in patients treated with a hybrid strategy, the type of device implanted did not influence patients´ outcomes.

Two-year clinical outcomes of the “Italian diffuse/multivessel disease absorb prospective registry” (IT-DISAPPEARS)

BackgroundLarge prospective studies on the use of bioresorbable vascular scaffolds (BVS) for diffuse coronary artery disease are lacking. IT DISAPPEARS is a large multicentre prospective registry investigating the short and long-term outcomes of everolimus-eluting BVS in patients with long coronary lesions and/or multivessel coronary artery disease (ClinicalTrials.gov: NCT02004730). We hereby report the 2-year outcomes of the registry. MethodsWe enrolled 1002 patients with complex lesions undergoing implantation of 2040 BVS with a prespecified technique including predilation, correct sizing, and postdilation with non-compliant balloons. The primary endpoint was the rate of device-oriented composite endpoint (DOCE), consisting of cardiac death, target vessel-related myocardial infarction (MI), and ischaemia-driven target lesion revascularization (TLR). Secondary endpoints included: 1) patient-oriented composite endpoint (POCE), consisting of all-cause mortality, all infarctions and all revascularisations; 2) definite/probable scaffold thrombosis. ResultsClinical presentation was an acute coronary syndrome in 59.8% of patients. Total BVS length implanted was 47 ± 22 mm. Postdilation of all scaffolds per patient was performed in 96.8%, while optimal implantation as per study guidelines was applied in 71.4%. Through 2-year follow-up, DOCE occurred in 9.5% of patients (cardiac death 0.6%, target vessel-related MI 5.3%, TLR 6.6%). The rate of POCE was 16.6% and of scaffold thrombosis 1.1%. Female gender, total length of coronary lesions, treatment of bifurcation lesions and use of 2.5 mm scaffolds were independent predictors of DOCE. ConclusionsThe 2-year results of IT-DISAPPEARS show that BVS may yield acceptable clinical outcomes in patients with complex coronary lesions when the implantation technique is appropriate.

Efficacy and safety of bioresorbable vascular scaffold Absorb: 6-month outcomes of GABI-R: Russia registry

Aim. The paper demonstrates the interim analysis of efficacy and safety after everolimus-eluting bioresorbable vascular scaffold (BVS) Absorb implantation in “real-world patients” with coronary artery disease.Methods. A cohort of 500 consecutive patients who underwent percutaneous coronary intervention for stable chest pain or acute coronary syndrome with implantation of at least one BVS (Absorb, Abbott Vascular) and followed up by telephone interview and review of medical charts were included in a singlecenter, prospective, all-comers, first in Russia registry. The primary endpoint, target vessel failure, defined as the combination of cardiac death, target vessel myocardial infarction, or clinically driven target vessel revascularization and secondary endpoints, MACCE (composite of cardiovascular death, myocardial infarction, coronary artery bypass surgery, target vessel revascularization, stroke) and stent thrombosis, were assessed during 6-month follow-up.Results. A total of 500 patients with coronary artery disease (CAD) (stable CAD 54.4%, acute coronary syndrome 45.6%) and different amount of affected vessels (1 vessel CAD 40.8%, n = 204; 2-vessel CAD 32.8%, n = 164; 3-vessel CAD 26.4%, n = 132) received 664 scaffolds and 55 stents in 603 stenoses. Procedure success, defined as a residual stenosis less than 30% and TIMI 3 flow in target vessel at the end of procedure, was observed in 98.51% (n = 594). At the moment of 6-month follow-up 4.2% (n = 24) of patients were lost to contact. After 6 months, incidence of target vessel failure and MACCE was 4.2% (n = 21) and 5% (n = 25). The cumulative rate of definite/probable scaffold thrombosis was 1.6% (n = 8).Conclusion. The interim analysis of Gabi-R: Russia registry, the largest trial of BVS Absorb implantation in routine clinical practice, showed high procedural success and low incidence of adverse events during follow-up. However, a tendency to high incidence of scaffold thrombosis compared to drug-eluting stents can be observed. Considering the long-term results of randomized trials retrospective registries, safety in terms of BVS routine use is of big concern. Longterm 24-month data regarding safety endpoints are required to test the afore-mentioned suggestion. Received 5 January 2019. Revised 28 March 2019. Accepted 29 March 2019.Funding: The study did not have sponsorship.Conflict of interest: Authors declare no conflict of interest.

Incidental Finding of Strut Malapposition Is a Predictor of Late and Very Late Thrombosis in Coronary Bioresorbable Scaffolds.

Malapposition is a common finding in stent and scaffold thrombosis (ScT). Evidence from studies with prospective follow-up, however, is scarce. We hypothesized that incidental observations of strut malapposition might be predictive of late ScT during subsequent follow-up. One hundred ninety-seven patients were enrolled in a multicentre registry with prospective follow-up. Optical coherence tomography (OCT), performed in an elective setting, was available in all at 353 (0–376) days after bioresorbable scaffold (BRS) implantation. Forty-four patients showed evidence of malapposition that was deemed not worthy of intervention. Malapposition was not associated with any clinical or procedural parameter except for a higher implantation pressure (p = 0.0008). OCT revealed that malapposition was associated with larger vessel size, less eccentricity (all p < 0.01), and a tendency for more uncovered struts (p = 0.06). Late or very late ScT was recorded in seven of these patients 293 (38–579) days after OCT. OCT-diagnosed malapposition was a predictor of late and very late scaffold thrombosis (p < 0.001) that was independent of the timing of diagnosis. We provide evidence that an incidental finding of malapposition—regardless of the timing of diagnosis of the malapposition—during an elective exam is a predictor of late and very late ScT. Our data provide a rationale to consider prolonged dual antiplatelet therapy if strut malapposition is observed.

Clinical outcomes of bioresorbable vascular scaffolds implanted with routine versus selective optical coherence tomography guidance: results from a single-centre experience.

We aimed to investigate the effects of an initial learning period with mandatory optical coherence tomography (OCT) guidance for the implantation of everolimus-eluting bioresorbable vascular scaffolds (BVS). We analysed procedural and clinical outcomes of all BVS implantations at a single centre where OCT guidance was mandatory in the initial rollout (OCT-mandatory) phase. We compared these data with the later phase where use of OCT was at operator discretion (OCT-selective or angiography). We implanted 406 BVS in 306 vessels (201 OCT, 105 angiography) in 272 patients. Follow-up duration was 38±10 months. Annualised rates of device-oriented cardiac events (DOCE) and scaffold thrombosis (ScT) were 1.4% and 0.4%, respectively. The risks of DOCE (HR 1.06, 95% CI: 0.33-3.34; p=0.71) and ScT (HR 0.48, 95% CI: 0.07-3.85; p=0.49) were not significantly different when comparing the OCT and angiography groups. Routine use of OCT to guide and optimise BVS implants results in very acceptable outcomes. Further, the benefits of such an early OCT-mandatory "learning" period persist after cessation of routine OCT usage when imaging is not routinely used. A period of mandatory OCT usage for BVS implants may therefore be beneficial in improving patient outcomes with these devices.

In-Vivo Vascular Healing Following Bifurcation Interventions with the Absorb Bioresorbable Vascular Scaffold.

Long-term vascular healing, evaluated by optical coherence tomography (OCT) and histology, following complex bifurcation interventions with polymeric Absorb Bioresorbable Vascular Scaffold (BVS, Abbott Vascular, Santa Clara, CA) has not been previously described. Fifteen New-Zealand-White rabbits (4.0 ± 0.3 kg) underwent stenting of non-diseased aorto-iliac bifurcations with BVS using provisional stenting (PS, n = 2), culotte stenting (n = 7) and modified-T (n = 6) stenting techniques. At 18 months angiography, optical coherence tomography (OCT) and histology were performed. The acute angiographic results were excellent. Three rabbits succumbed acutely due to anaesthetic and renal complications, whilst one was euthanized electively at 4 months for a skin infection. At 18 months, 11 rabbits (PS (2), modified-T (4) and culotte (5)) underwent angiography, revealing excellent results, followed by OCT and histological evaluation. No acute scaffold thrombosis occurred. All non-bifurcation segments revealed complete endothelialisation with excellent healing characteristics on OCT and histology. Following one PS and all 2-stent techniques, uncovered, deformed and malapposed struts were present at the neocarina with adherent fibrin and chronic thrombus in 10/11 cases, extending as long fibrin strands (mean length 11.0 ± 8.3 mm) in 3 culotte and 1 modified-T cases. Late intraluminal scaffold discontinuity was present following five 2-stent cases. Pathological vascular healing with uncovered, distorted and malapposed neocarinal struts with adherent strands of chronic thrombus, suggest that exposed polymeric breakdown products may be thrombogenic and caution against the use of polymeric BVS in interventions when there is a chance of suboptimal results with strut malapposition or compromise of scaffold integrity.

The relationship of pre-procedural Dmax based sizing to lesion level outcomes in Absorb BVS and Xience EES treated patients in the AIDA trial

Due to expansion limits of the Absorb bioresorbable scaffold a meticulous implantation with correct sizing is required. We sought to investigate the clinical outcomes based on the sizing of the device related to the maximal lumen diameter measured by quantitative coronary angiography in Absorb BVS and Xience EES treated lesions in the AIDA trial. Sizing of Absorb bioresorbable vascular scaffold (BVS) and Xience everolimus eluting stent (EES) was graded according to the definitions of device non-oversize and device oversize on pre-procedural angiography. Lesion-oriented outcomes (LOCE) (device thrombosis, TLR and TVMI) that occurred during 2 years follow-up were related to device non-oversized or oversized status. In the Absorb BVS group, LOCE occurred in 48 (7.4%) lesions in the oversized group and in 32 (8.2%) lesions in the non-oversized group (HR 0.91; 95% CI 0.58–1.42; p = 0.681), whereas TLR occurred in 34 (5.3%) lesions and in 23 lesions (5.9%), respectively (HR 0.89; 95% CI 0.52–1.51; p = 0.666). Definite scaffold thrombosis occurred in 11 (1.7%) device oversized treated lesions against 16 (4.1%) device non-oversized treated lesions (HR 0.41; 95% CI 0.19–0.89; p = 0.020). There were no differences in event rates between oversized and non-oversized groups in lesions treated with Xience EES. There was no significant difference in LOCE between oversized and non-oversized treated Absorb BVS and Xience EES treated lesions. Non-oversized Absorb BVS implantation was associated with a higher risk of scaffold thrombosis at complete 2 years follow-up. The majority of very late scaffold thrombosis occurred in properly sized devices.

Bioresorbable vascular scaffolds for percutaneous treatment of chronic total coronary occlusions: a meta-analysis

BackgroundBRS represent a new approach to treating coronary artery disease. Beneficial properties of BRS regarding the restoration of vasomotility after resorption make them attractive devices in CTO revascularization. However, experience in this setting is limited.MethodsWe systematically searched Medline, Scholar, and Scopus for reports of at least 9 patients with CTO undergoing BRS implantation. Patients’ and procedural characteristics were summarized. The primary outcome of interest was target lesion revascularization (TLR). Pooled estimates were calculated using a random-effects meta-analysis. The study protocol was registered in PROSPERO (CRD42017069322).ResultsThirteen reports for a total of 843 lesions with a median follow-up of 12 months (IQR 6–12) were included in the analysis. At short-term, the summary estimate rate of TLR was 2.6% (95% CI: 1 to 4%, I2 = 0%, P = 0.887) while at mid to long-term it was 3.8% (95% CI: 2 to 6%, I2 = 0%, P = 0.803). At long-term follow-up (≥12 months), the summary estimate rate of cardiac death was 1.1% (95% CI: 0 to 2%, I2 = 0%, P = 0.887). The summary estimate rates of scaffold thrombosis and clinical restenosis were respectively 0.9% (95% CI: 0 to 2%, I2 = 0%, P = 0.919) and 1.8% (95% CI: 0 to 4%, I2 = 0%, P = 0.448). Finally, the summary estimate rate of target vessel revascularization was 6.6% (95% CI: 0 to 11%, I2 = 0%, P = 0.04).ConclusionsImplantation of BRS in a population with CTO is feasible, although further longer-term outcome studies are necessary.

Everolimus-eluting bioresorbable scaffolds for treatment of coronary artery disease in patients with diabetes mellitus: the midterm follow-up of the prospective ABSORB DM Benelux study

BackgroundPercutaneous coronary intervention (PCI) in patients with diabetes mellitus (DM) remains challenging even with modern drug-eluting stents (DES) due to high rates of repeat revascularization. Everolimus-eluting bioresorbable scaffolds (EE-BRS) might allow for repeat intervention prolonging the time interval of percutaneous treatment options.MethodsThe ABSORB DM Benelux Study is a dedicated prospective, international study to evaluate the midterm safety and efficacy of EE-BRS in DM patients. All DM patients that received ≥ 1 EE-BRS for any indication were enrolled and prospectively followed. Study endpoints were major adverse cardiac events (MACE): a composite of all-cause death, any myocardial infarction (MI) and ischemic-driven target vessel revascularization (TVR); target lesion failure (TLF): a composite of cardiac death (CD), target vessel MI, and ischemic-driven target lesion revascularization (TLR), as well as definite or probable scaffold thrombosis (ScT).ResultsBetween April 2015 till March 2017, 150 DM patients and 188 lesions were treated and followed up to 3 years. Device implantation success was 100%. MACE occurred in 15.2% (event rate of 8.8 per 100 PY). TLF was reported in 11.7% (7.0 events per 100 PY). CD, target vessel MI, ischemic-driven TLR occurred in 3.4%, 3.6% and 5.5% respectively, while ScT was observed in 1.4%. There were no occurrences of late or very late ScT.ConclusionEE-BRS treatment in DM patients shows comparable midterm safety and efficacy outcomes when historically compared with modern DES. New-generation EE-BRS might offer an attractive alternative to metallic DES in treatment of fast progressing atherosclerosis population as in DM patients.Trial registration NTR5447. Registered 05 October 2015, retrospectively registered

LONG-TERM AUSTRALIAN BIORESORBABLE SCAFFOLD OUTCOMES FOLLOWING WITHDRAWAL FROM MARKET: A REPORT FROM THE VICTORIAN CARDIAC OUTCOMES REGISTRY

Bioresorbable scaffolds (BRS) have emerged as a novel technology in interventional cardiology. However, recent trials demonstrate higher rates of scaffold thrombosis and device failure compared to conventional drug eluting stents. Limited Australian data on BRS outcomes are available. BRS

Preclinical Evaluation of a Novel Sirolimus-Eluting Iron Bioresorbable Coronary Scaffold in Porcine Coronary Artery at 6 Months

ObjectivesThe aim of this study was to investigate the operability, 6-month efficacy, and safety of the novel sirolimus-eluting iron bioresorbable coronary scaffold (IBS) system compared with a cobalt-chromium everolimus-eluting stent (EES) (XIENCE Prime stent) in porcine coronary arteries. BackgroundBioresorbable scaffolds have been considered the fourth revolution in percutaneous coronary intervention. However, the first-generation bioresorbable scaffold showed suboptimal results. MethodsForty-eight IBS and 48 EES were randomly implanted into nonatherosclerotic swine. The operability, efficacy, and safety of the IBS and EES were evaluated using coronary angiography, optical coherence tomography, micro–computed tomography, scanning electron microscopy, and histopathologic evaluation at 7, 14, 28, 90, and 180 days after implantation. ResultsThe operability of the ultrathin IBS (∼70 μm) was comparable with that of the EES, except for its visibility. There was no statistically significant difference in area stenosis between the IBS and EES from 28 to 180 days. The IBS maintained its integrity up to 90 days without corrosion, while corrosion was observed in a few struts in 2 of 10 IBS at 180 days. The percentage of endothelialization of IBS was higher than that of XIENCE Prime stents within 14 days after implantation. The fibrin score was higher in the IBS group at 28 days but comparable with the EES group at 90 and 180 days. No scaffold or stent thrombosis was seen in either group. No abnormal histopathologic changes in scaffolded or stented vessel segments and 5 main remote organs were observed in either group. ConclusionsPreclinical results suggest that the novel IBS has comparable operability, mid-term efficacy, and safety with the EES, and its corrosion profile in porcine coronary arteries is reasonable, which could support initial clinical study of the IBS.

Clinical results of bioresorbable drug-eluting scaffolds in short and long coronary artery lesions using the PSP technique

BackgroundData on bioresorbable vascular scaffolds (BVS) for the treatment of long lesions are limited. We studied the use of BVS-Absorb in routine clinical practice and compared the outcome of long lesions with short lesions. Implantation of drug-eluting scaffolds without PSP-technique (predilation, proper sizing and postdilation) is associated with an increased thrombotic risk. We compared the long-term outcome up to 36 months of patients with short (< 20 mm) and long (≥20 mm) coronary artery lesions after implantation of bioresorbable vascular scaffolds (BVS) via PSP-technique.MethodsThree hundred twenty-six patients with 424 lesions were enrolled in this prospective study and underwent percutaneous coronary intervention with the Absorb BVS. Clinical follow-up was scheduled after 12, 24 and 36 months. In all lesions the PSP-technique was used. The device oriented composite endpoint (DOCE) was defined as cardiac death, myocardial infarction (MI) not clearly related to a non-target vessel and target lesion revascularization (TLR).ResultsKaplan-Meier estimates for DOCE after 12 months were 2.63% for short lesions and 8.09% for long lesions (p = 0.0131), 5.51% vs. 11.35% (p = 0.0503) after 24 months and 8.00% vs. 18.00% (p = 0.0264) after 36 months of clinical follow-up. Kaplan-Meier estimates for TLR after 12 months were 1.46% for short and 7.69% for long lesions (p = 0.0012), 2.06% vs. 8.75% after 24 months (p = 0.0027) and 4.96% vs. 9.59% after 36 months of follow-up (p = 0.0109). Scaffold thrombosis rates were low.ConclusionsIn long lesions compared to short ones the bioresorbable scaffold Absorb implanted with the proper PSP technique Absorb has significant higher rates of DOCE.The Level of EvidenceIs 3 (non-random sample).

Procedural Predictors for Bioresorbable Vascular Scaffold Thrombosis: Analysis of the Individual Components of the "PSP" Technique.

The technique used at the time of implantation has a central role in determining the risk of thrombosis in bioresorbable vascular scaffolds (BRS). Different definitions of the “optimal” implantation technique exist, however. The impact of individual procedural characteristics on the risk of scaffold thrombosis (ScT) was evaluated in a single-center observational study that enrolled 657 patients (79% males, mean age 63 ± 12 years) with 763 lesions who received a total of 925 BRS for de novo lesions. During a median 1076 (762–1206) days’ follow-up there were 28 cases of thrombosis. Independent predictors of ScT included the use of predilatation balloons bigger than the nominal BRS diameter (hazard ratio (HR) = 0.4 (0.16–0.98), p = 0.04), sizing (implantation in vessels with reference vessel diameter >3.5 mm or <2.5 mm: HR = 5.71 (2.32–14.05), p = 0.0002) and the degree of vessel expansion (ratio of minimum lumen to reference vessel diameter, HR: 0.005 (0.0001–0.23), p = 0.007). In addition, a mild BRS oversizing (final BRS diameter to vessel diameter 1.14–1.28) was associated with a lower thrombosis risk, whereas undersizing and more severe oversizing (final BRS diameter to vessel diameter <1.04 and >1.35, respectively) were associated with an increased risk of ScT (HR = 0.13 (0.02–0.59), p = 0.0007). In conclusion, different components of the “optimal” technique have different impacts on the risk of BRS thrombosis. Besides predilatation with a balloon larger than the BRS diameter, correct vessel size selection and a mild to moderate oversizing appear to be protective.

Percutaneous coronary interventions with the Absorb Bioresorbable vascular scaffold in real life: 1-year results from the FRANCE ABSORB registry

Several randomized studies have shown that bioresorbable vascular scaffold (BVS) technology is associated with an increased risk of stent thrombosis. This study aimed to assess the rates of adverse outcomes at 1 year in patients treated with the Absorb BVS (Abbott Vascular, Santa Clara, CA, USA), using data from a large nationwide prospective multicentre registry (FRANCE ABSORB). All patients receiving the Absorb BVS in France were included prospectively in the study. Predilatation, optimal sizing and postdilatation were recommended systematically. The primary endpoint was a composite of cardiovascular death, myocardial infarction and target lesion revascularization at 1 year. Secondary endpoints were scaffold thrombosis and target vessel revascularization at 1 year. A total of 2072 patients at 86 centres were included: mean age 55±11 years; 80% men. The indication was acute coronary syndrome (ACS) in 49% of cases. Predilatation and postdilatation were done in 93% and 83% of lesions, respectively. At 1 year, the primary endpoint occurred in 3.9% of patients, the rate of scaffold thrombosis was 1.5% and the rate of target vessel revascularization was 3.3%. In a multivariable analysis, diabetes and total Absorb BVS length>30mm were independently associated with the occurrence of the primary endpoint, whereas oral anticoagulation and total Absorb BVS length>30mm were independently associated with occurrence of scaffold thrombosis. The Absorb BVS was implanted in a relatively young population, half of whom had ACS. Predilatation and postdilatation rates were high, and 1-year outcomes were acceptable.

Three-year clinical and two-year multimodality imaging outcomes of a thin-strut sirolimus-eluting bioresorbable vascular scaffold: MeRes-1 trial.

Although the proof of concept of the bioresorbable vascular scaffold (BRS) is well documented, device-related adverse outcomes with first-generation BRS indicate longer-term surveillance. The current study provides insights into the safety and performance of the MeRes100, a novel second-generation sirolimus-eluting BRS, beyond one-year up to three-year follow-up (FU). A total of 108 enrolled patients with de novo coronary artery lesions who underwent implantation of MeRes100 as part of the first-in-human MeRes-1 trial were followed up clinically beyond one year at two and three years and with multiple modality imaging at six months and two years. At three-year FU, the cumulative major adverse cardiac events rate was 1.87%, in the form of two ischaemia-driven target lesion revascularisations. No scaffold thrombosis was reported. Between six months and two years at quantitative coronary angiography, in-segment late lumen loss (LLL) (0.15±0.22 mm vs. 0.23±0.32 mm; p=0.18) and in-scaffold LLL (0.13±0.22 mm vs. 0.24±0.34 mm; p=0.10) changed insignificantly. IVUS subset analysis revealed a non-significant reduction in mean lumen area (6.17±1.28 mm2 vs. 5.47±1.50 mm2; p=0.21) and minimum lumen area (5.14±1.19 mm2 vs. 4.05±1.42 mm2; p=0.10) at two years compared to post-procedural measurements. OCT subset analysis demonstrated 99.24±2.27% neointimal strut coverage. The extended outcomes of the MeRes-1 trial demonstrated sustained efficacy and safety of the MeRes100 BRS with maintained lumen patency up to two years by multimodality imaging and no very late scaffold thrombosis up to three-year clinical FU.The MeRes-1 trial is registered at the Clinical Trials Registry-India. CTRI Number: CTRI/2015/04/005706.