Ultrathin-strut Sirolimus-eluting Stent Research Articles

TCT-168 Clinical Outcomes of Biodegradable Polymer-Coated Ultrathin Strut Sirolimus-Eluting Stents in a Real-World Patient Population With High-Risk Subgroups: Three-Year Results

TCT-168 Clinical Outcomes of Biodegradable Polymer-Coated Ultrathin Strut Sirolimus-Eluting Stents in a Real-World Patient Population With High-Risk Subgroups: Three-Year Results

E-24 | Clinical Outcomes of Biodegradable Polymer-coated Ultrathin Strut Sirolimus-eluting Stents in a Real-world Patient Population with High-risk Subgroups: Three-year Results

New-generation drug-eluting stents (DES) are superior to earlier-generation DES in terms of efficacy and safety — this may be attributable to the ultrathin metallic backbone. T-Flex registry sought to assess clinical outcomes of ultrathin (60 μm) biodegradable polymer-coated sirolimus-eluting stents (SES) designed with a unique long dual Z (LDZ) link on a cobalt-chromium platform (Sahajanand Medical Technologies Ltd., Surat, India) in a real-world population with high-risk subgroups at 3-year follow-up.

Can an ultrathin strut stent design and a polymer free, proendothelializing probucol matrix coating improve early strut healing? The FRIENDLY-OCT trial. An intra-patient randomized study with OCT, evaluating early strut coverage of a novel probucol coated polymer-free and ultra-thin strut sirolimus-eluting stent compared to a biodegradable polymer sirolimus-eluting stent

Backgroundincomplete strut coverage determines the risk of stent thrombosis in the first months after stent implantation. AimsTo evaluate the potential better early healing of a novel probucol coated polymer free ultra-thin strut sirolimus eluting stent (PF-SES). [Clinical trial unique identifier: NCT02785237]. MethodsPatients with two (angiographically similar) lesions with clinical indication for PCI were enrolled. The investigated stent was compared to a thin strut, bioresorbable polymer, sirolimus eluting stent (BP-SES). Every patient received both stents, one in each lesion, assigned in a randomized sequence. OCT was systematically performed at 3 months.Primary end point was the difference in the proportion of covered struts at 3 months (defined as ≥20 μm of tissue coverage). Secondary end points included differences in percentage of uncovered struts (0 μm coverage), mean strut coverage thickness, and malapposed struts' coverage proportion. Major adverse cardiac events (cardiac death, myocardial infarction, target lesion revascularization, and definite or probable stent thrombosis) at 12 months were also evaluated. Results70 patients were included. At 3 months, a consistent and significantly higher strut coverage rate (≥20 μm) was observed in PF-SES as compared to BP-SES, both for well apposed (87.3% versus 79.1%, p < 0.001) and malapposed struts (50.4% vs 37.8%, p 0.00). Uncoverage rate (0 μm) was also significantly lower for the PF-SES (3.1% vs 5.3%, p < 0.001). There were no differences in clinical endpoints. ConclusionThe probucol coated non-polymeric ultra-thin strut sirolimus eluting stent showed a significantly better early strut coverage at 3 months.

Clinical outcomes of an ultrathin-strut sirolimus-eluting stent in all-comers population: Thailand Orsiro registry

BackgroundDespite numerous studies supporting the outperformance of ultrathin-strut bioresorbable polymer sirolimus-eluting stent (Orsiro SES, Biotronik AG), the generalizability of the study results remains unclear in the Asian population. We sought to evaluate the clinical outcomes of the Orsiro SES in unselected Thai population.MethodsThe Thailand Orsiro registry was a prospective, open-label clinical study evaluating all patients with obstructive coronary artery disease implanted with Orsiro SES. The primary endpoint was target lesion failure (TLF) at 12 months. TLF is defined as a composite of cardiac death, target vessel myocardial infarction (TVMI), emergent coronary artery bypass graft (CABG), and clinically driven target lesion revascularization (CD-TLR). Patients with diabetes, small vessels (≤ 2.75 mm), chronic total occlusions (CTOs), and acute myocardial infarction (AMI) were pre-specified subgroups for statistical analysis.ResultA total of 150 patients with 235 lesions were included in the analysis. Half of the patients (53.3%) presented with AMI, and 24% had diabetes. Among 235 lesions, 93(39.4%) were small vessels, and 24(10.2%) were chronic total occlusions. The primary endpoint, TLF at 12 months, occurred in eight patients (5.3%), predominately caused by cardiac death. By contrast, the incidences of TVMI and CD-TLR were null. The outcomes in pre-specified subgroup were not different from the overall population (all p > 0.05). One definite late stent thrombosis(0.7%) was incidentally observed during primary percutaneous coronary intervention to the non-target vessel.ConclusionThe safety and efficacy of the ultrathin strut sirolimus-eluting stent in unselected cases are confirmed in the Thailand Orsiro registry. Despite the high proportion of pre-specified high-risk subgroups, the excellent stent performance was consistent with the overall population.Trial Registration TCTR20190325001.

Abstract 12894: Suppressed Local Coagulative Response After Newer-generation Ultrathin Strut SES Implantation Compared to Older-generation SES Implantation

Background: We have previously demonstrated local persistent hypercoagulation after durable polymer (DP)-sirolimus-eluting stent (SES) implantation by measuring plasma prothrombin fragment 1+2 (F1+2) levels. The aim of this study is to evaluate local coagulative response after newer-generation ultrathin strut SES implantation. Method: Forty-five patients who were treated about 6-12 months earlier with coronary stenting, with no evidence of restenosis, were studied [DP-SES (Cypher): 26pts, biodegradable polymer (BP)-SES (older BP-SES, Ultimaster): 12pts and ultrathin strut BP-SES (newer BP-SES, Orsiro): 7pts]. We measured plasma levels of F1+2 sampled in coronary sinus (CS) and sinus of Valsalva (V). The transcardiac gradient (Δ) was defined as CS level minus V level. Results: No significant difference was observed in the percent diameter stenosis among DP-SES, older BP-SES, and newer BP-SES groups (10.1 ± 16.5 vs 13.1 ± 12.9 vs 12.1 ± 11.9 %). The ΔF1+2 was significantly lower in the BP-SES groups than in the DP-SES group (8.9 ± 10.1 vs 23.4 ± 21.1 pmol/l, p&lt;0.05). The ΔF1+2 was lower in the newer BP-SES group than in the older BP-SES group, however, significant difference was not observed (7.0 ± 7.0 vs 9.7 ± 12.3 pmol/l). Conclusion: Suppressed local coagulative response after newer-generation ultrathin strut SES implantation was observed. These findings might indicate that lower strut thickness is more important factor than faster polymer resorption in the newer-generation DES era.

Diabetic patients treated with novel thin composite-wire strut zotarolimus-eluting stents versus ultrathin strut sirolimus-eluting stents in the BIONYX trial: 2-year results of a prespecified analysis

Abstract Background/Introduction The novel thin composite-wire strut zotarolimus-eluting stent (ZES) is a drug-eluting stent that is frequently used for treating patients with obstructive coronary artery disease, but so far no clinical outcome data have been published in patients with diabetes. In all-comer patients, the BIONYX trial (NCT02508714) has established non-inferiority of the ZES versus the ultrathin strut biodegradable-polymer sirolimus-eluting stent (SES) regarding the primary composite endpoint of target vessel failure at 1 year follow-up. Purpose To assess in patients with diabetes, the 2-year safety and efficacy of the current generation thin composite-wire strut ZES, compared to the ultrathin strut SES. Methods In the international, multicentre BIONYX trial, randomisation was stratified for sex and the presence of diabetes mellitus. We performed a prespecified subgroup analysis of patients with diabetes. The main endpoint target vessel failure was a composite of safety and efficacy, consisting of cardiac death, target vessel-related myocardial infarction or clinically indicated target vessel revascularisation. Secondary endpoints, such as target lesion revascularisation and stent thrombosis were also assessed. Results A total of 510/2488 (20.5%) BIONYX trial participants had diabetes, and were therefore included in this analysis. Patients were on average 66.4±10.3 years old, and 28.6% were female. Most participants presented with acute coronary syndromes (65.1%), and 182/510 (35.7%) patients were insulin dependent. Two-year follow up was available in 500 of 510 (98.0%) patients. Target vessel failure occurred in 31/260 (12.2%) patients assigned to ZES versus 26/250 (10.7%) patients assigned to SES (HR 1.14, 95%-CI 0.68–1.92; P-logrank=0.63). Kaplan Meier curves of target vessel failure are displayed in Figure 1. There were no significant between-stent differences in the individual components of this endpoint. Target lesion revascularisation occurred in 15/260 (6.0%) patients treated with ZES versus 9/250 (3.7%) patients treated with SES (HR 1.61, 95%-CI 0.71–3.68; P-logrank=0.25). Definite stent thrombosis was an infrequent event and did not differ significantly between stent-arms (0.4% vs. 1.2%; HR 0.32, 95%-CI 0.03–3.06; P-logrank=0.30). Conclusion In patients with diabetes, the novel thin composite-wire strut durable polymer ZES was similarly safe and efficacious as compared to the ultrathin cobalt-chromium strut biodegradable-polymer SES at 2-year follow-up. Figure1. Target vessel failure at 2 years Funding Acknowledgement Type of funding source: Private company. Main funding source(s): The BIONYX trial was equally funded by Biotronik and Medtronic.

Clinical outcomes with unselected use of an ultrathin-strut sirolimus-eluting stent: a report from the Swedish Coronary Angiography and Angioplasty Registry (SCAAR).

The aim of this study was to assess the real-world clinical performance of a sirolimus-eluting ultrathin-strut drug-eluting stent (DES) (Orsiro) in a large nationwide cohort of patients undergoing percutaneous coronary intervention (PCI). From the Swedish Coronary Angiography and Angioplasty Registry, the two-year outcomes of 4,561 patients implanted with Orsiro (Orsiro group) and 69,570 receiving other newer-generation DES (n-DES group) were analysed. The rate of definite stent thrombosis was low in both groups (0.67% and 0.83% for Orsiro and n-DES, respectively; adjusted hazard ratio [HR] 0.90, 95% confidence interval [CI]: 0.55-1.46, p-value 0.66). Restenosis was also infrequent (1.5% vs 2.0% with Orsiro and n-DES, adjusted HR 0.81, 95% CI: 0.63-1.03, p-value=0.09). The risk of target lesion revascularisation by PCI was lower in the Orsiro group (1.6% vs 2.3%, adjusted HR 0.75, 95% CI: 0.60-0.94, p-value=0.013). All-cause mortality and myocardial infarction did not show a statistically significant difference between the two groups (mortality of 7.5% in both groups, adjusted HR 0.99, 95% CI: 0.72-1.35, p-value=0.94; 6.0% vs 5.2% for myocardial infarction, adjusted HR 1.19, 95% CI: 1.00-1.43, p-value=0.06). In a nationwide scenario, the use of a sirolimus-eluting ultrathin-strut DES portended favourable clinical outcomes.

Clinical outcomes following polymer-free sirolimus-eluting stent implantations in unselected patients: A descriptive subgroup analysis in patients with renal impairment.

Patients with chronic kidney disease (CKD are frequently excluded from coronary artery disease trials. The aim of this assessment was to study the clinical outcomes of polymer-free sirolimus-eluting stent implantations in patients with impaired renal function.Large-scale, international, single-armed, multicenter, ‘all comers’ observational studies (ClinicalTrials.gov Identifier: NCT02629575 and NCT02905214) were used for this post-hoc subgroup analysis to compare the clinical outcomes in patients with normal renal function (NRF) to those with renal insufficiency (CKD, dialysis dependence). The accumulated target lesion revascularization rate was the primary endpoint at 9 to 12 months whereas the accumulated major adverse cardiac event, stent thrombosis (ST) and procedural success rates were part of the secondary endpoints.There were 6791 patients with NRF, whereas 369 patients had CKD and 83 patients were dialysis dependent. The target lesion revascularization rate at 9 to 12 months was significantly higher in dialysis patients (2.1% vs 3.3% vs 6.7%, P = .011). The accumulated major adverse cardiac events rates in the dialysis and in the CKD group were significantly higher as compared to patients with NRF (13.3% vs 4.0%, P < .001; 6.5% vs 4.0%, P = .024). Finally, ST rates (NRF: 0.7%, CKD: 0.6%, dialysis: 1.3%) were not statistically different between subgroups (P = .768). All-cause cumulative mortality rates were 3.3% (CKD) and 4.0% (dialysis) respectively.Percutaneous coronary interventions with polymer-free, ultra-thin strut sirolimus-eluting stents have comparable revascularization rates in CKD and dialysis dependent patients as compared to percutaneous coronary interventions with other 2nd generation drug-eluting stents. ST and all-cause mortality rates were low as compared to available literature references.

Clinical outcomes three-year after revascularization with biodegradable polymer stents: ultrathin-strut sirolimus-eluting stent versus biolimus-eluting stent: from the Scandinavian organization for randomized trials with clinical outcome VII trial.

Drug-eluting stents with biodegradable polymers have been designed to improve safety and efficacy. However, drug-eluting stents with biodegradable polymers may not be a class effect, as stent strut thickness, polymer coating, and drug resorption differ between these groups of stents. Twelve months results of Scandinavian Organization for Randomized Trials With Clinical Outcome VII showed that ultrathin-strut sirolimus-eluting Orsiro stent was noninferior to the biolimus-eluting Nobori stent. The sirolimus-eluting Orsiro stent was associated with a reduced risk of definite stent thrombosis. The Scandinavian Organization for Randomized Trials With Clinical Outcome VII trial is a prospective multicenter randomized clinical trial comparing sirolimus-eluting Orsiro stent and biolimus-eluting Nobori stent in all-comers patients. The endpoint target lesion failure was a composite of cardiac death, myocardial infarction (not related to other than index lesion) and target lesion revascularization. A total of 1261 patients were randomized to treatment with sirolimus-eluting Orsiro stent and 1264 patients to biolimus-eluting Nobori stent and followed for 3 years. At 3-year the target lesion failure was comparable for sirolimus-eluting Orsiro stent (9.0%) and the biolimus-eluting Nobori stent (9.1%), (rate ratio, 0.99; 95% confidence interval, 0.77-1.29). Cardiac death (sirolimus-eluting Orsiro stent 3.0% vs. biolimus-eluting Nobori stent 2.6% [rate ratio, 1.16; 95% confidence interval, 0.73-1.86]), target lesion revascularization (sirolimus-eluting Orsiro stent 5.2% vs. biolimus-eluting Nobori stent 5.9% [rate ratio, 0.90; 95% confidence interval, 0.64-1.25]), myocardial infarction (sirolimus-eluting Orsiro stent 4.7% vs. biolimus-eluting Nobori stent 4.5% [rate ratio, 1.04; 95% confidence interval, 0.72-1.50]), and definite stent thrombosis (sirolimus-eluting Orsiro stent 1.0% vs. biolimus-eluting Nobori stent 1.7% [rate ratio, 0.59; 95% confidence interval, 0.30-1.18]) did not differ significantly between the two groups. At 3-year follow-up, target lesion failure did not differ among ultrathin-strut sirolimus-eluting Orsiro stent and biolimus-eluting Nobori stent with biodegradable polymers.

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

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

Outcomes in Patients Treated With Thin-Strut, Very Thin-Strut, or Ultrathin-Strut Drug-Eluting Stents in Small Coronary Vessels

Stenting small-vessel lesions has an increased adverse cardiovascular event risk. Very thin-strut or ultrathin-strut drug-eluting stents might reduce this risk, but data are scarce. To assess the outcome of all-comer patients with small coronary vessel lesions treated with 3 dissimilar types of drug-eluting stents. This is a prespecified substudy of the Comparison of Biodegradable Polymer and Durable Polymer Drug-eluting Stents in an All Comers Population (BIO-RESORT) trial, an investigator-initiated, randomized, patient-blinded comparative clinical drug-eluting stent trial. Patients treated with ultrathin-strut sirolimus-eluting stents, very thin-strut everolimus-eluting stents, or previous-generation thin-strut zotarolimus-eluting stents were enrolled from December 2012 to August 2015. This multicenter trial was conducted in 4 Dutch centers for cardiac intervention. Of all 3514 all-comer BIO-RESORT participants, 1506 patients with treatment in at least 1 small-vessel lesion (reference vessel <2.5 mm) were included. Data were analyzed between September 2018 and February 2019. Target lesion failure at 3-year follow-up, a composite of cardiac death, target vessel-related myocardial infarction, or target lesion revascularization, analyzed by Kaplan-Meier methods. In 1452 of 1506 participants (96.4%) (1057 men [70.2%]; 449 women [29.8%]; mean [SD] age, 64.3 [10.4] years), follow-up was available. Target lesion failure occurred in 36 of 525 patients (7.0%) treated with sirolimus-eluting stents, 46 of 496 (9.5%) with everolimus-eluting stents, and 48 of 485 (10.0%) with zotarolimus-eluting stents (sirolimus-eluting vs zotarolimus-eluting hazard ratio [HR], 0.68; 95% CI, 0.44-1.05; P = .08; everolimus-eluting vs zotarolimus-eluting HR, 0.93; 95% CI, 0.62-1.39; P = .72). There was a difference in target lesion revascularizations between sirolimus-eluting and zotarolimus-eluting stents (2.1% vs 5.3%; HR, 0.40; 95% CI, 0.20-0.81; P = .009) that emerged after the first year of follow-up (1.0% vs 3.7%; P = .006); multivariate analysis showed that sirolimus-eluting stent implantation was independently associated with a lower target lesion revascularization rate at 3-year follow-up (adjusted HR, 0.42; 95% CI, 0.20-0.85; P = .02). In the everolimus-eluting stents, the revascularization rate was 4.0% (vs zotarolimus-eluting, HR, 0.74; 95% CI, 0.41-1.34; P = .31). There was no significant between-stent difference in cardiac death, target vessel myocardial infarction, or stent thrombosis. Patients stented in small coronary vessels experienced fewer repeated revascularizations if treated with ultrathin-strut sirolimus-eluting stents vs previous generation thin strut zotarolimus-eluting stents. Further research is required to evaluate the potential effect of particularly thin stent struts. ClinicalTrials.gov identifier: NCT01674803.

P1667Efficacy and safety of an ultra-thin strut sirolimus-eluting stent with biodegradable polymer in all-comers patients undergoing coronary intervention

P1667Efficacy and safety of an ultra-thin strut sirolimus-eluting stent with biodegradable polymer in all-comers patients undergoing coronary intervention

Optical coherence tomography findings: insights from the “randomised multicentre trial investigating angiographic outcomes of hybrid sirolimus-eluting stents with biodegradable polymer compared with everolimus-eluting stents with durable polymer in chronic total occlusions” (PRISON IV) trial

The PRISON IV trial investigated the next-generation sirolimus-eluting stent (SES) with ultra-thin struts and biodegradable polymer against the second-generation everolimus-eluting stent (EES) with thin struts and durable polymer in patients with successfully recanalised chronic total occlusions (CTO). In this study, we examined the secondary optical coherence tomography endpoints. The main PRISON IV trial randomised 330 patients to either SES or EES. At nine months, 281 (85%) patients underwent repeat angiography. Of these, 60 consecutive patients received optical coherence tomography divided over both stent groups. The mean number of struts analysed was 750±337 and 633±358 in SES and EES patients, respectively (p=0.07). The minimal lumen area, minimal stent area, maximal neointima area and neointimal thickness were comparable between the groups (4.8±2.1 and 4.4±1.5 mm2; 5.3±1.8 and 5.3±1.4 mm2; 2.5±2.0 and 2.2±1.5 mm2; 0.7±1.7 and 0.4±0.2 mm). The percentage of uncovered struts was higher with EES (6.2±7.5% and 11.9±13.4%, p=0.04), whereas the percentage of malapposed struts and mean number of coronary evaginations were significantly higher with SES (2.9±4.0% and 1.2±2.4%, p=0.02; 18.5±17.7 and 5.3±3.1, p=0.004). The optical coherence tomography findings of this substudy demonstrated improved strut coverage with ultra-thin strut SES with bioresorbable polymer compared to thin-strut EES with durable polymer in CTO. On the other hand, SES showed a higher rate of stent strut malappositon and coronary evaginations. The clinical relevance of these findings remains to be demonstrated.

Randomized Multicenter Trial Investigating Angiographic Outcomes of Hybrid Sirolimus-Eluting Stents With Biodegradable Polymer Compared With Everolimus-Eluting Stents With Durable Polymer in Chronic Total Occlusions: The PRISON IV Trial

ObjectivesThe aim of this study was to investigate the efficacy and safety of the hybrid ultrathin-strut sirolimus-eluting stent (SES) with biodegradable polymer compared with the thin-strut everolimus-eluting stent (EES) with durable polymer in successfully recanalized chronic total occlusions (CTOs). BackgroundThe introduction of drug-eluting stents revolutionized the treatment of CTOs. However, limited data are available on new-generation drug-eluting stents with biodegradable polymer in CTOs. MethodsIn this multicenter trial, patients were randomized, after successful CTO recanalization, to either SES or EES. The primary noninferiority endpoint was in-segment late lumen loss (noninferiority margin 0.2 mm). Secondary endpoints included in-stent late lumen loss and clinical endpoints. ResultsOverall, 330 patients were included. At 9 months, angiography was available in 281 patients (85%). Duration of occlusion ≥3 months was 92.5%, with mean stent length of 52.4 ± 28.1 mm versus 52.3 ± 26.5 mm in the SES and EES groups. The primary noninferiority endpoint, in-segment late lumen loss, was not met for SES versus EES (0.13 ± 0.63 mm vs. 0.02 ± 0.47 mm; p = 0.08, 2-sided; difference 0.11 mm; 95% confidence interval: −0.01 to 0.25 mm; pnoninferiority = 0.11, 1-sided). In-stent late lumen loss was comparable between SES and EES (0.12 ± 0.59 mm vs. 0.07 ± 0.46 mm; p = 0.52). The incidence of in-stent and in-segment binary restenosis was significantly higher with SES compared with EES (8.0% vs. 2.1%; p = 0.028), with comparable rates of reocclusions (2.2% vs. 1.4%; p = 0.68). Clinically indicated target lesion and target vessel revascularization (9.2% vs. 4.0% [p = 0.08] and 9.2% vs. 6.0% [p = 0.33]), target vessel failure (9.9% vs. 6.6%; p = 0.35), and definite or probable stent thrombosis (0.7% vs. 0.7%; p = 1.00) were comparable between the SES and EES groups. ConclusionsThis randomized trial failed to show noninferiority of hybrid SES relative to EES in terms of in-segment late lumen loss in successfully recanalized CTOs. Furthermore, a statistically significantly higher rate of binary restenosis was found with SES.

TCT-451 Two-year outcomes after revascularization with a biodegradable polymer ultra-thin strut sirolimus eluting stent and a biodegradable polymer biolimus-eluting stent. From the SORT OUT VII trial

Polymer materials used for the first and second generation drug-eluting stents (DES) may trigger chronic inflammatory responses that can lead to late adverse outcomes. DES with biodegradable polymers could have the potential to abolish these late events. However, DES with biodegradable polymers may