Coronary arterial repair in patients with stable angina pectoris or acute coronary syndrome after ultrathin biodegradable polymer sirolimus-eluting stent implantation at 1-year follow-up by coronary angioscopy

Background

Imaging modality-based evidence is limited that compares the extent of coronary arterial repair after percutaneous coronary intervention between patients with stable angina pectoris (SAP) and those with acute coronary syndrome (ACS).

Methods

Between December 2018 and November 2021, a single-center, nonrandomized, observational study was conducted in 92 patients with SAP (n = 42) or ACS (n = 50), who were implanted with Orsiro sirolimus-eluting stent (O-SES) providing a hybrid (active and passive) coating and underwent 1-year follow-up by coronary angioscopy (CAS) after implantation. CAS assessed neointimal coverage (NIC), maximum yellow plaque (YP), and mural thrombus (MT).

Results

Baseline clinical characteristics were comparable between the SAP and ACS groups. The follow-up periods were comparable between the two groups (390.1 ± 69.9 vs. 390.6 ± 65.7 days, p = 0.99). The incidences of MT at 1 year after implantation were comparable between the two groups (11.4% vs. 11.1%, p = 0.92). The proportions of “Grade 1” in dominant NIC grades were highest in both groups, and the proportions of maximum YP grades and MT were comparable between the two groups.

Conclusion

O-SES-induced coronary arterial repair at the site of stent implantation, irrespective of the types of coronary artery disease.     

Three-Year Outcomes After Revascularization With Everolimus- and Sirolimus-Eluting Stents From the SORT OUT IV Trial

ObjectivesThe study sought to compare the risk of late outcome with a focus on very late definite stent thrombosis of the everolimus-eluting stent (EES) with that of the sirolimus-eluting stent (SES) at 3-year follow-up.BackgroundIn the SORT OUT IV (SORT OUT IV Trial), comparing the EES with the SES in patients with coronary artery disease, the EES was noninferior to the SES at 9 months. The SORT OUT IV trial provides long-term head-to-head randomized comparison of the EES with the SES.MethodsWe prospectively randomized 2,774 patients in the SORT OUT IV trial. Follow-up through 3 years was complete in 2,771 patients (99.9%). The 3-year pre-specified endpoints were composites of safety and efficacy (major adverse cardiac events [MACE]: cardiac death, myocardial infarction, target vessel revascularization, and definite stent thrombosis).ResultsAt 3 years, the composite endpoint MACE occurred in 9.8% of the EES group and in 11.1% of the SES group (hazard ratio [HR]: 0.89, 95% confidence interval [CI]: 0.70 to 1.12). Overall rate of definite stent thrombosis was lower in the EES group (0.2% vs. 1.4%; HR: 0.15, 95% CI: 0.04 to 0.50), which was largely attributable to a lower risk of very late definite stent thrombosis: 0.1% versus 0.8% (HR: 0.09, 95% CI: 0.01 to 0.70).ConclusionsAt 3-year follow-up, the MACE rate did not differ significantly between EES- and SES-treated patients. A significant reduction of overall and very late definite stent thrombosis was found in the EES group. (The SORT OUT IV TRIAL [SORT OUT IV]; NCT00552877).     

Comparison of a Novel Biodegradable Polymer Sirolimus-Eluting Stent With a Durable Polymer Everolimus-Eluting Stent: 5-Year Outcomes of the Randomized BIOFLOW-II Trial

Objectives

The authors aimed to compare long-term data of an ultrathin cobalt-chromium stent with passive silicon carbide coating and an active biodegradable polymer that releases sirolimus (O-SES) (Orsiro, BIOTRONIK, Bülach, Switzerland) with the durable polymer-based Xience Prime everolimus-eluting stent (X-EES) (Abbott Vascular, Santa Clara, California).

Safety and efficacy of sirolimus-eluting stent implantation in patients with acute coronary syndrome in the real world

The use of drug-eluting stents in patients with acute coronary syndrome (ACS), particularly those with acute myocardial infarction (AMI), is controversial owing to concerns about late adverse events. We evaluated the long-term safety of sirolimus-eluting stent implantation in patients with ACS. Of 10,778 patients treated exclusively with a sirolimus-eluting stent in the j-Cypher registry, the 3-year outcomes of 2,308 patients with ACS (953 patients with AMI) were compared to those of 8,470 patients without ACS. Compared to patients without ACS, the patients with ACS had a significantly greater adjusted risk of death or myocardial infarction (hazard ratio [HR] 1.24, 95% confidence interval [CI] 1.12 to 1.37, p <0.0001) and definite or probable stent thrombosis (HR 1.43, 95% CI 1.11 to 1.82, p = 0.006) within the first year after sirolimus-eluting stent implantation. However, after 1 year, patients with ACS no longer had a greater risk of death or myocardial infarction (HR 1.01, 95% CI 0.90 to 1.13, p = 0.87) and stent thrombosis (HR 1.32, 95% CI 0.92 to 1.86, p = 0.13). Of the patients with ACS, those with AMI had a greater risk of death or myocardial infarction (HR 1.33, 95% CI 1.12 to 1.6, p = 0.001) and stent thrombosis (HR 1.57, 95% CI 1.05 to 2.39, p = 0.03) than those with unstable angina pectoris within the first year. However, they had a similar risk of death or myocardial infarction (HR 1.00, 95% CI 0.78 to 1.22, p = 0.83) and stent thrombosis (HR 0.83, 95% CI 0.38 to 1.6, p = 0.59) after 1 year. The risk of late adverse events >1 year after sirolimus-eluting stent implantation was similar between those with and without ACS and between those with AMI and those with unstable angina pectoris.     

Safety and efficacy of the Yukon Choice Flex sirolimus-eluting coronary stent in an all-comers population cohort

Aims

The use of biodegradable-polymer drug-eluting stents has been shown to provide favorable results when compared with durable polymer drug-eluting stents and long-term follow up data have recently shown significant reductions in terms of very late stent thrombosis.Aim of the present study was to assess the safety and efficacy profile of a novel biodegradable polymer DES, the Yukon Choice Flex sirolimus-eluting stent.

Methods

We report here the one-year clinical outcomes associated with the use of the Yukon Choice Flex sirolimus-eluting stent in an all-comers patient population. The present stent represents a further refinement of the stent platform tested in the ISAR TEST 3 and 4 randomized clinical trials. A total of 778 consecutive patients undergoing implantation of this stent were enrolled in the present observational study and prospectively followed for one year.

Results

The use of the Yukon Choice Flex stent in a patient population with complex coronary lesion morphology was associated with optimal immediate angiographic results. At one year follow up the rates of death, myocardial infarction, definite stent thrombosis and ischemia-driven target lesion revascularization were respectively 2.4%, 1.9%, 0.3% and 11.3%.

Conclusions

The use of the sirolimus-eluting biodegradable polymer Yukon Choice Flex stent in an all-comers population of patients with complex coronary artery disease is associated with a favorable safety and efficacy profile up to one year follow up.     

Complex primary percutaneous coronary intervention with ultrathin-strut biodegradable versus thin-strut durable polymer drug-eluting stents in patients with ST-segment elevation myocardial infarction: A subgroup analysis from the BIOSTEMI randomized trial

Background

Ultrathin-strut biodegradable polymer sirolimus-eluting stents (BP-SES) are superior to thin-strut durable polymer everolimus-eluting stents (DP-EES) with respect to target lesion failure (TLF) at 2 years among patients with ST-segment elevation myocardial infarction (STEMI). We sought to determine the impact of primary percutaneous coronary intervention (pPCI) complexity on long-term clinical outcomes with BP-SES versus DP-EES in STEMI patients.

Methods

We performed a post hoc subgroup analysis from the BIOSTEMI (NCT02579031) randomized trial, which included individual data from 407 STEMI patients enrolled in the BIOSCIENCE trial (NCT01443104). STEMI patients were randomly assigned to treatment with ultrathin-strut BP-SES or thin-strut DP-EES, and further categorized into those undergoing complex versus noncomplex pPCI. Complex pPCI was defined by the presence of ≥1 of the following criteria: 3 vessel treatment, ≥3 stents implanted, ≥3 lesions treated, bifurcation lesion with ≥2 stents implanted, total stent length ≥60 mm, and/or chronic total occlusion treatment. The primary endpoint was TLF, a composite of cardiac death, target-vessel myocardial reinfarction, or clinically indicated target lesion revascularization, within 2 years.

Results

Among a total of 1707 STEMI patients, 421 (24.7%) underwent complex pPCI. Baseline characteristics were similar between groups. At 2 years, TLF occurred in 14 patients (7.1%) treated with BP-SES and 25 patients (11.6%) treated with DP-EES (hazard ratio [HR]: 0.62; 95% confidence interval [CI]: 0.32–1.19; p = 0.15) in the complex pPCI group, and in 28 patients (4.4%) treated with BP-SES and 49 patients (8.2%) treated with DP-EES (HR: 0.54; 95% CI: 0.34–0.86; p = 0.008; p for interaction = 0.74) in the noncomplex pPCI group. Individual TLF components and stent thrombosis rates did not significantly differ between groups.

Conclusion

In a post hoc subgroup analysis from the BIOSTEMI randomized trial, ultrathin-strut BP-SES were superior to thin-strut DP-EES with respect to TLF at 2 years among STEMI patients undergoing both complex and noncomplex pPCI.     

Impact of highly asymmetric stent expansion after sirolimus-eluting stent implantation on twelve-month clinical outcomes

OBJECTIVES: This study investigated the impact of highly asymmetric stent expansion after sirolimus-eluting stent(SES)implantation on clinical outcomes from post procedure to 12 months later. METHODS: Subjects were 118 patients with 171 lesions who underwent SES implantation for angina pectoris and were studied by intravascular ultrasound (IVUS) following the procedure. The stent symmetry index (minimal stent diameter/maximal stent diameter) at the minimal stent area was calculated by IVUS analysis. The patients were divided into two groups for comparative study: those with stent symmetry index > or = 0.7 were classified into the optimal (O) group (93 patients; 145 lesions, mean age 66 +/- 12 years) and those with stent symmetry index < 0.7 were the sub-optimal (S) group (25 patients; 26 lesions, mean age 67 +/- 10 years). RESULTS: Angiographic follow up after 8 months showed no differences in target lesion revascularization (TLR) (O group: 3.1% vs S group: 3.8%, p = 0.833). Multivariate analysis identified the post minimal stent diameter as the independent predictor of TLR (p = 0.038). The stent symmetry index < 0.7 was not a predictor of TLR (p = 0.887). Clinical outcomes after 12 months showed both groups had 0% stent thrombosis and there were no differences in deaths (O group: 2.1% vs S group: 4.0%, p = 0.602). CONCLUSIONS: Highly asymmetric stent expansion after SES implantation may not have a negative impact on clinical outcomes at 12 months.     

Three-year clinical follow-up of an unselected patient population treated with the genous endothelial progenitor cell capturing stent

Background: We assessed the 3‐year clinical outcome in our single‐center cohort of mainly unselected patients treated with the endothelial progenitor cell capturing stent (ECS). The ECS is coated with CD34+ antibodies specifically targeting the circulating endothelial progenitor cells population to accelerate endothelialization that in turn may prevent the occurrence of in‐stent restenosis and stent thrombosis (ST). Methods: All patients in our study had coronary artery lesions that were treated with an ECS. The majority of patients had complex lesions with an estimated high risk of restenosis. Results: A total of 405 patients were enrolled. The primary end‐point of target lesion failure (TLF) was defined as the composite of cardiac death, myocardial infarction, and target lesion revascularization (TLR). At 3 years, TLF was 18.3% and TLR was 14.2%. Early ST occurred in 2 patients. No cases of late and very late definite ST were reported. Conclusions: This single‐center study demonstrates the safety at 3 years of the ECS in an unselected patient population, including a fair number of patients with complex lesions, reflecting daily practice. Our data compare well with drug‐eluting stent and bare metal stent registries enrolling unselected patient populations. Importantly, in our analysis, no cases of late or very late definite ST were reported. (J Interven Cardiol 2011;24:442–449)     

Short and long-term benefits of sirolimus-eluting stent in ST-segment elevation myocardial infarction: a meta-analysis of randomized trials

Background Recent concerns have emerged on the potential higher risk of stent thrombosis after DES implantation, that might be even more pronounced among STEMI patients. The aim of the current study was to perform a meta-analysis to evaluate the benefits and safety of Sirolimus-Eluting Stent (SES) as compared to BMS in patients undergoing primary angioplasty for STEMI. Methods The literature was scanned by formal searches of electronic databases (MEDLINE and CENTRAL). We examined all completed randomized trials of DES for STEMI. The following keywords were used for study selection: randomized trial, myocardial infarction, reperfusion, primary angioplasty, stenting, DES, sirolimus-eluting stent (SES), Cypher. Information on study design, type of stent, inclusion and exclusion criteria, primary endpoint, number of patients, angiographic and clinical outcome, were extracted by two investigators. Disagreements were resolved by consensus. Results A total of 9 trials were included in the meta-analysis, involving 2,769 patients (1389 or 50.2% randomized to DES and 1,380 or 49.8% randomized to BMS). At 12 months follow-up, SES was associated with a significant reduction in TVR (4.9% vs. 13.6%, p < 0.0001), with a trend in benefits in mortality (2.9% vs. 4.2%, p = 0.08) and reinfarction (3.0% vs. 4.3%, p = 0.06), without any significant difference in stent thrombosis (1.9% vs. 2.5%, p = 0.36). Safety and efficacy of DES were confirmed at 2–3 years follow-up (data available from 4 trials including 569 patients). Conclusions This meta-analysis shows that among selected STEMI patients undergoing primary angioplasty, SES as compared to BMS is safe and associated with a significant reduction in TVR at 1 and 2–3 years follow-up.     

Evaluation by optical coherence tomography of neointimal coverage of sirolimus-eluting stent three months after implantation

Confirming complete neointimal coverage after implantation of a drug-eluting stent is clinically important because incomplete stent coverage is responsible for late thrombosis and sudden cardiac death. Optical coherence tomography is a high-resolution (approximately 10 microm) imaging technique capable of detecting a thin layer of neointimal hyperplasia (NIH) inside a sirolimus-eluting stent (SES) and stent malapposition. This investigation evaluated stent exposure and malapposition 3 months after SES implantation using optical coherence tomography in a different clinical presentations, such as acute coronary syndrome (ACS) and non-ACS. Motorized optical coherence tomographic pullback (1 mm/s) was performed at 3-month follow-up to examine consecutive implanted 31 SESs in 21 lesions in 21 patients (9 with ACS and 12 with non-ACS). NIH thickness inside each strut and percent NIH area in each cross section were measured. In total, 4,516 struts in 567-mm single-stented segments were analyzed. Overall, NIH thickness and percent NIH area were 29 +/- 41 microm and 10 +/- 4%, respectively. Rates of exposed struts and exposed struts with malapposition were 15% and 6%, respectively. These were more frequent in patients with ACS than in those with non-ACS (18% vs 13%, p <0.0001; 8% vs 5%, p <0.005, respectively). In conclusion, neointimal coverage over a SES at 3-month follow-up is incomplete in ACS and non-ACS. Our study suggests that dual antiplatelet therapy might be continued >3 months after SES implantation.     

Time course of release of inflammatory markers after coronary stenting: comparison between bare metal stent and sirolimus-eluting stent

BACKGROUND: High levels of release of inflammatory markers after coronary angioplasty are predictors of late restenosis. Sirolimus-eluting stent reduces the risk of restenosis. AIM OF THE STUDY: To compare the release of inflammatory markers after coronary angioplasty with sirolimus-eluting stent and bare metal stent. METHODS: Sixteen patients with a proximal left anterior descending coronery artery stenosis were randomly assigned to receive either bare metal stent (n = 8) or sirolimus-eluting stent (n = 8). We measured simultaneously aortic and coronary sinus concentrations of the von Willebrand factor antigen, tumor necrosis factor-alpha and interleukin-6 before, immediately and after 2 h after stenting. High-sensitivity C-reactive protein and troponin-I circulating levels were measured before and 6 and 24 h after coronary angioplasty. RESULTS: Before stenting, all values were similar in both groups. The coronary sinus change of the von Willebrand factor antigen level between baseline and 2 h after stenting was + 20.1 +/- 26.9% in the bare metal stent group and -5.7 +/- 23.02% in the sirolimus-eluting stent group (P < 0.05). We observed a significant increase in the von Willebrand factor antigen (from 132.8+/-58.8 to 169 +/- 40.7%, P < 0.05) systemic concentrations 24 h after stenting in the bare metal stent group but not in the sirolimus-eluting stent group (from 140.6+/-84% to 136 +/- 39.5%), P = NS). CONCLUSION: The present study shows that a difference in the release of inflammatory markers can be detected after coronary stenting with bare metal stent or sirolimus-eluting stent. The lower release of the von Willebrand factor antigen in the coronary sinus 2 h after the procedure and the lower systemic concentrations of the von Willebrand factor antigen 24 h after stenting in the sirolimus-eluting stent group are likely to reflect a reduced production of the von Willebrand factor antigen at the site of the vascular injury.     

Clinical Outcomes of the Dual-Therapy CD34 Antibody-Covered Sirolimus-Eluting Stent Versus Standard Drug-Eluting Coronary Stents: A Meta-Analysis

BackgroundCoronary stent neoatherosclerosis, thrombosis, and restenosis remain significant concerns with new-generation drug-eluting stents (DES). The Dual-Therapy CD34 antibody-covered sirolimus-eluting stent [dual therapy stent (DTS)] is a sirolimus-eluting stent with CD34 antibodies immobilized on its luminal surface to capture circulating endothelial progenitor cells and promote early endothelialization. We conducted a meta-analysis to determine whether the DTS was superior to standard DES.MethodsWe conducted a comprehensive search for controlled randomized and non-randomized studies. We presented data using risk ratios (95% confidence intervals) and measured heterogeneity using Higgins' I².ResultsFive studies with a low risk of bias met the inclusion criteria, with a total of 1884 patients in the DTS and 1819 in standard DES arms. There was no difference between the 2 arms in the following 1-year outcomes: cardiac death [1% vs 0.9% RR 1.13 (95% CI 0.49–2.62) I² = 0%], target lesion failure [6.2% vs 5.3% RR 1.12 (0.80–1.58) I² = 0%], target lesion revascularization (TLR) [4.9% vs 3.4% RR 1.40 (0.93–2.10) I² = 15%], target vessel failure [8.2% vs 6.1% RR 1.24 (0.75–2.04) I² = 0%], target vessel myocardial infarction [1.1% vs 1.8% RR 0.73 (0.19–2.90) I² = 62%] and stent thrombosis [0.4% vs 0.6% HR 0.85 (0.27–2.62) I² = 0%]. However, compared with second-generation DES (EES and ZES), the DTS had significantly higher one-year TLR [5% vs. 3.1% RR 1.58 (1.02–2.46) P = 0.04 I² = 0%].ConclusionOne-year TLR was significantly higher in the DTS arm compared with second-generation DES. There was no difference in the other 1-year clinical outcomes compared with standard DES.     

A Meta‐Analysis of the Impact of EPC Capture Stent on the Clinical Outcomes in Patients with Coronary Artery Disease

Background

Damage to the vascular endothelium may be one of the pathophysiological causes of in‐stent thrombosis and restenosis. Endothelial progenitor cell (EPC) capture stents (ECS) have the ability to accelerate the damage repair process. However, the clinical outcomes of ECS remain unknown thus far.

Objectives

To evaluate the impact of ECS use on the clinical outcomes of patients with coronary artery disease by comparing ECS to drug‐eluting stent (DES) and/or bare metal stent (BMS).

Methods

Studies and abstracts were retrieved from the PubMed, Cochrane Library, and EMBASE online databases and from the conference compilations of the American Heart Association (AHA), the American College of Cardiology (ACC), and Transcatheter Cardiovascular Therapeutics (TCT). These studies were analyzed to investigate whether there was a difference in the clinical therapeutic effects between the ECS group and the DES/BMS group. The primary clinical end‐point events were in‐stent thrombosis and target lesion revascularization (TLR). The secondary clinical end‐point events were target lesion failure (TLF), total mortality, cardiac death, and myocardial infarction (MI).

Results

A total of 2,024 patients were enrolled in the analysis of in‐stent thrombosis. There was no significant difference in the incidence of in‐stent thrombosis between the ECS group and the DES/BMS group. A total of 1,745 patients were enrolled in the analysis of TLR, and there was no significant difference in the TLR incidence between the ECS group and the DES/BMS group. However, compared with DES, the TLR incidence for ECS increased 1.73‐fold (relative risk [RR]: 1.73, 95% confidence interval [95% CI]: 1.01–2.94, P = 0.04). Moreover, the incidence of cardiac death and TLF also increased 3.54‐fold (RR: 3.54, 95% CI: 1.13–11.08, P = 0.03) and 1.90‐fold (RR: 1.90, 95% CI: 1.05–3.45, P = 0.03), respectively. But compared with BMS, there is no significance of the clinical events.

Conclusion

Compared with DES/BMS use, ECS use may not reduce the incidence of in‐stent thrombosis and TLR. In addition, the incidence of TLR and cardiac death with ECS is possibly relatively higher compared with DES and no difference compared with BMS, but this also needs more large RCTs to guarantee. (J Interven Cardiol 2013;26:228–238)

     

Coronary angioscopic findings 9 months after everolimus-eluting stent implantation compared with sirolimus-eluting stents

ObjectivesWe assessed angioscopic findings after everolimus-eluting stents (EES) implantation, compared with sirolimus-eluting stents (SES).BackgroundCoronary angioscopy (CAS) provides an opportunity to assess neointimal coverage over stent struts, thrombus, and plaque color by direct visualization. CAS is a useful tool for evaluating stent struts after drug-eluting stent implantation. Angioscopic findings after EES implantation have not been reported before.MethodsWe performed CAS in 23 patients who were treated with EES and 41 patients with SES. CAS was performed 8.5 months after stent implantation. We assessed neointimal coverage, thrombus, and plaque color. We classified neointimal coverage in 4 grades: grade 0 = struts were completely exposed; grade 1 = struts were visible with dull light reflexion; grade 2 = there was no light reflexion from slightly visible struts; grade 3 = struts were completely covered.ResultsThere was no significant difference in minimum, maximum, dominant grade of neointimal coverage, and heterogeneity index between EES and SES. Thrombus was less frequently observed in EES than SES (4% vs 29%, p = 0.02). When we divided study patients into acute coronary syndrome (ACS) or stable angina pectoris (SAP), there was a tendency toward less thrombus in EES than SES, in both ACS and SAP. Maximum color grade of the plaques was less advanced in EES than SES (p < 0.01). Yellow plaques of grade 2 or 3 were less frequent in EES than SES (35% vs 76%, p < 0.01).ConclusionsThis study suggested that EES were associated with lower risk of thrombus formation than SES.     

Late restenosis following sirolimus-eluting stent implantation

Despite encouraging results from randomized trials, concerns exist about long-term results of sirolimus-eluting stent implantation. We sought to determine whether in-stent restenosis occurring >1 year ("late") after sirolimus-eluting stent implantation is a real clinical entity. We analyzed data on all sirolimus-eluting stents implanted in our institution before March 2003. During the study period 928 lesions in 433 patients were treated. Angiographic follow-up was performed in 306 patients (70.6%) with 679 lesions (73.2%). Angiography after 1 year was performed only in symptomatic patients. We considered restenosis "early" if it occurred during the first year and late if after 1 year. Late restenosis required demonstration of a widely patent stent at 6 to 9 months, with repeat angiography after 1 year demonstrating restenosis. Restenosis occurred in 160 lesions overall (23.5%). Of the 31 (4.6%) that were documented after 1 year, 13 were excluded from analysis due to absence of 6- to 9-month angiography; the remaining 18 (2.6%, 1.7 to 4.2) fulfilled our criteria for late restenosis (median time of documentation 607 days, interquartile range 511 to 923). In conclusion, late restenosis is an infrequent but real entity; its existence implies we should not discount the possibility of restenosis as the cause of symptoms that develop >1 year after sirolimus-eluting stent implantation.     

1-Year Outcomes with COMBO Stents in Small-Vessel Coronary Disease: Subgroup Analysis From the COMBO Collaboration

BackgroundSmall vessel diameter is associated with higher risk of target lesion revascularization (TLR) after percutaneous coronary intervention (PCI). The COMBO sirolimus-eluting biodegradable-polymer stent has a proprietary anti-CD34 antibody layer to enhance homogeneous endothelialization, which may be advantageous in treating small vessels.ObjectiveWe examined for differences in 1-year clinical outcomes after PCI by maximum implanted stent diameter from the COMBO collaboration.MethodsThe COMBO collaboration (n = 3614) is a patient-level pooled dataset of patients undergoing PCI with COMBO stents in the MASCOT and REMEDEE multicenter registries. Stent diameter was available in 3590 (99.3%) patients. We compared patients receiving COMBO stents <3 mm versus ≥3 mm. The primary endpoint was 1-year target lesion failure (TLF), composite of cardiac death, target vessel-myocardial infarction (TV-MI) or clinically driven TLR. Secondary outcomes included stent thrombosis (ST). Adjusted outcomes were assessed using Cox regression methods.ResultsThe study included 792 (22%) patients with small stents <3 mm and 2798 (78%) patients with large stents ≥3 mm. Small stent patients included more women with lower body mass index and higher prevalence of diabetes but similar prevalence of acute coronary syndrome. Risk of 1-year TLF was similar in small and large stent groups (4.4% vs. 3.8%, HR 1.12, 95% CI 0.74–1.72, p = 0.58). There were no differences in the rates of cardiac death (1.7% vs. 1.5%, p = 0.74), TV-MI (1.4% vs. 1.2%, p = 0.58) or TLR (2.7% vs. 2.1%, p = 0.31). Definite or probable ST occurred in 1.3% of the small stent and 0.7% of the large stent PCI patients, p = 0.14, HR 2.13, 95% CI 0.93–5.00, p = 0.07.ConclusionsOne-year ischemic outcomes after COMBO PCI were similar irrespective of stent diameter in this all-comers international cohort.     

Five-Year Outcomes With Biodegradable-Polymer Sirolimus-Eluting Stents Versus Durable-Polymer Everolimus-Eluting Stents in Patients With Acute Coronary Syndrome: A Subgroup Analysis of the BIOSCIENCE Trial

BackgroundThin-strut biodegradable polymer sirolimus-eluting stents (BP-SES) have been shown to reduce target lesion failure (TLF) at one-year follow-up compared with durable polymer everolimus-eluting stents (DP-EES) among patients with acute coronary syndrome (ACS). The long-term clinical benefits of thin-strut BP-SES over DP-EES in ACS patients after complete degradation of the polymer coating remain uncertain.MethodsWe performed a post-hoc subgroup analysis of ACS patients included into the BIOSCIENCE randomized trial (NCT01443104). The primary endpoint was target lesion failure (TLF), a composite of cardiac death, target-vessel myocardial infarction or clinically indicated target lesion revascularization, at 5 years.ResultsAmong 2119 patients enrolled between March 2012 and May 2013, 1131 (53%) presented with ACS. The 5-year cumulative incidence of TLF was significantly lower in patients with ACS compared to chronic coronary syndrome [16.5% vs. 22.9%; rate ratio (RR), 0.69; 95% confidence interval (CI), 0.57–0.85; p < 0.001]. At 5 years, TLF occurred similarly in ACS patients treated with BP-SES and DP-EES (16.9% vs. 16.0%; RR, 1.04; 95% CI, 0.78–1.41; p = 0.78). The individual components of the primary endpoint did not differ between ACS patients treated with BP-SES or DP-EES at 5 years. Overall, there was no interaction between clinical presentation and treatment effect.ConclusionsIn a subgroup analysis of the BIOSCIENCE trial, we found no difference in long-term outcomes between ACS patients treated with BP-SES or DP-EES at 5 years.     

Comparison of clinical outcomes of coronary artery stent implantation in patients with end‐stage chronic kidney disease including hemodialysis for three everolimus eluting (EES) stent designs: Bioresorbable polymer‐EES,platinum chromium‐EES,and cobalt chrome‐EES

Backgrounds

New‐generation bioresorbable polymer‐everolimus eluting stents (BP‐EES) are available. This study aimed to compare the clinical outcomes for BP‐EES compared to more established stent designs, namely the platinum chromium‐EES (PtCr‐EES) and cobalt chrome‐EES(CoCr‐EES) in patients with the end‐stage chronic kidney disease (CKD) including hemodialysis (HD).

Methods

One‐hundred‐forty‐one consecutive stents (BP‐EES [n = 44], PtCr‐EES [n = 45], and CoCr‐EES [n = 52]) were implanted in 104 patients with CKD. All patients underwent a follow‐up coronary angiography at 12 months after implantation. End‐stage CKD was defined as an estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m², or the need for HD. The following outcome variables were compared among the three stent groups after implantation and the 12‐month follow‐up: target lesion revascularization (TLR), stent thrombosis (ST), and major adverse cardiac event (MACE). Minimal stent diameter (MSD) and %diameter‐stenosis (%DS) were measured using quantitative coronary angiography.

Results

The overall rate of TLR and MACE was 14.6% and 30.8%, respectively, with no incidence of ST. Immediately after implantation, the MSD (P = 0.22) and %DS (P = 0.42) were equivalent among the three groups. However, at the 12‐month follow‐up, a tendency towards higher TLR was observed for the BP‐EES group (22.7%) compared with the PtCr‐EES (8.8%) and CoCr‐EES (9.6%) groups (P = 0.07). Late loss in lumen diameter was also significantly greater for the BP‐EES (0.51 ± 0.64 mm) group than either the PtCr‐EES (0.20 ± 0.61 mm) and CoCr‐EES (0.25 ± 0.70 mm) groups (P = 0.03).

Conclusions

BP‐EES might increase the risk of in‐stent restenosis in patients with end‐stage of CKD or the need for HD.     

Five-year clinical outcomes of the first Korean-made sirolimus-eluting coronary stent with abluminal biodegradable polymer

This study evaluated the 5-year clinical outcomes of the Genoss DES, the first Korean-made sirolimus-eluting coronary stent with abluminal biodegradable polymer.We previously conducted the first-in-patient prospective, multicenter, randomized trial with a 1:1 ratio of patients using the Genoss DES and Promus Element stents; the angiographic and clinical outcomes of the Genoss DES stent were comparable to those of the Promus Element stent. The primary endpoint was major adverse cardiac events (MACE), which was a composite of death, myocardial infarction (MI), and target lesion revascularization (TLR) at 5 years.We enrolled 38 patients in the Genoss DES group and 39 in the Promus Element group. Thirty-eight patients (100%) from the Genoss DES group and 38 (97.4%) from the Promus Element group were followed up at 5 years. The rates of MACE (5.3% vs 12.8%, P = .431), death (5.3% vs 10.3%, P = .675), TLR (2.6% vs 2.6%, P = 1.000), and target vessel revascularization (TVR) (7.9% vs 2.6%, P = .358) at 5 years did not differ significantly between the groups. No TLR or target vessel revascularization was reported from years 1 to 5 after the index procedure, and no MI or stent thrombosis occurred in either group during 5 years.The biodegradable polymer Genoss DES and durable polymer Promus Element stents showed comparable low rates of MACE at the 5-year clinical follow-up.     

Differential Effects of Newer-Generation Ultrathin-Strut Versus Thicker-Strut Drug-Eluting Stents in Chronic and Acute Coronary Syndromes

ObjectivesThe authors sought to compare the differential effects of ultrathin-strut and thicker-strut drug-eluting stents (DES) in patients with chronic (CCS) versus acute (ACS) coronary syndromes.BackgroundNewest-generation ultrathin-strut DES reduce target lesion failure (TLF) compared with thicker-strut second-generation DES in patients undergoing percutaneous coronary intervention.MethodsPubMed, Embase, and Cochrane Central Register of Controlled Trials were searched for randomized controlled trials comparing newer-generation ultrathin-strut (<70 μm) versus thicker-strut (≥70 μm) DES. Patients were divided based on baseline clinical presentation (CCS versus ACS). The primary endpoint was TLF, a composite of cardiac death, target vessel myocardial infarction, or clinically indicated target lesion revascularization (TLR).ResultsA total of 22,766 patients from 16 randomized controlled trials were included, of which 9 trials reported TLF rates in ACS patients. At a mean follow-up of 12.2 months, the risk of TLF was lower among patients treated with ultrathin-strut compared with thicker-strut DES (risk ratio [RR]: 0.85; 95% CI: 0.75-0.95; P = 0.006). The difference was driven by a lower risk of clinically-indicated TLR (RR: 0.75; 95% CI: 0.63-0.89; P < 0.001) among patients treated with ultrathin-strut DES. The treatment effect was consistent between patients presenting with CCS and ACS (relative RR: 0.97; 95% CI: 0.73-1.31; P for interaction = 0.854). In patients with ST-segment elevation myocardial infarction, TLF risk was lower among those treated with ultrathin- compared with thicker-strut DES (RR: 0.74; 95% CI: 0.54-0.99; P = 0.049).ConclusionsUltrathin-strut DES reduce the risk of TLF compared with thicker-strut second-generation DES in patients undergoing percutaneous coronary intervention, a difference caused by a lower risk of ischemia-driven TLR. The treatment effect was consistent among patients with CCS and ACS.