Sirolimus-eluting Stents Group Research Articles

Biodegradable-Polymer or Durable-Polymer Stents in Patients at High Bleeding Risk: A Randomized, Open-Label Clinical Trial.

Limited information is available on the comparative efficacy and safety of different stent platforms in patients at high bleeding risk undergoing an abbreviated dual antiplatelet therapy duration after percutaneous coronary intervention (PCI). The aim of this study was to compare the safety and effectiveness of the biodegradable-polymer sirolimus-eluting stent with the durable-polymer zotarolimus-eluting stent in patients at high bleeding risk receiving 1 month of dual antiplatelet therapy after PCI. The Bioflow-DAPT Study is an international, randomized, open-label trial conducted at 52 interventional cardiology hospitals in 18 countries from February 24, 2020, through September 20, 2021. Patients with a clinical indication to PCI because of acute or chronic coronary syndrome who fulfilled 1 or more criteria for high bleeding risk were eligible for enrollment. Patients were randomized to receive either biodegradable-polymer sirolimus-eluting stents or durable-polymer, slow-release zotarolimus-eluting stents after successful lesion preparation, followed by 1 month of dual antiplatelet therapy and thereafter single antiplatelet therapy. The primary outcome was the composite of death from cardiac causes, myocardial infarction, or stent thrombosis at 1 year, and was powered for noninferiority, with an absolute margin of 4.1% at 1-sided 5% alpha. A total of 1948 patients at high bleeding risk were randomly assigned (1:1) to receive biodegradable-polymer sirolimus-eluting stents (969 patients) or durable-polymer zotarolimus-eluting stents (979 patients). At 1 year, the primary outcome was observed in 33 of 969 patients (3.6%) in the biodegradable-polymer sirolimus-eluting stent group and in 32 of 979 patients (3.4%) in the durable-polymer zotarolimus-eluting stent group (risk difference, 0.2 percentage points; upper boundary of the 1-sided 95% CI, 1.8; upper boundary of the 1-sided 97.5% CI, 2.1; P<0.0001 for noninferiority for both tests). Among patients at high risk for bleeding who received 1 month of dual antiplatelet therapy after PCI, the use of biodegradable-polymer sirolimus-eluting stents was noninferior to the use of durable-polymer zotarolimus-eluting stents with regard to the composite of death from cardiac causes, myocardial infarction, or stent thrombosis. URL: https://www. gov; Unique identifier: NCT04137510.

Comparative Clinical Performance of Two Types of Drug-Eluting Stents with Abluminal Biodegradable Polymer Coating: Five-Year Results of the DESTINY Randomized Trial

Introduction and Objectives: The Stents Coated with the Biodegradable Polymer on Their Abluminal Faces and Elution of Sirolimus versus Biolimus Elution for the Treatment of de Novo Coronary Lesions - DESTINY Trial is a non-inferiority randomized study that compared the InspironTM sirolimus-eluting stent (SES) with the control BiomatrixTM Flex biolimus-eluting stent (BES). Previous reports in the first year showed similar outcomes for both stents, in clinical, angiographic, optical coherence tomography, and intravascular ultrasound assessments. The present analysis aims to compare the clinical performance of these two biodegradable polymer drug-eluting stents five years after the index procedure. Methods: A total of 170 patients (194 lesions) were randomized in a 2:1 ratio for treatment with SES or BES, respectively. The primary endpoint for the present study was the five-year rate of combined major adverse cardiac events, defined as cardiac death, myocardial infarction, or target lesion revascularization. Results: At five years, the primary endpoint occurred in 12.5% and 17.9% of the SES and BES groups, respectively (p=0.4). There was no definite or probable stent thrombosis among patients treated with the novel SES stent during the five years of follow-up, and no stent thrombosis after the first year in the BES group. Conclusions: The novel InspironTM stent had similar good clinical performance in long-term follow-up when compared head-to-head with the control latest-generation BiomatrixTM Flex biolimus-eluting stent.

Comparative clinical performance of two types of drug-eluting stents with abluminal biodegradable polymer coating: Five-year results of the DESTINY randomized trial

Introduction and ObjectivesThe Stents Coated With the Biodegradable Polymer on Their Abluminal Faces and Elution of Sirolimus Versus Biolimus Elution for the Treatment of de Novo Coronary Lesions – DESTINY Trial is a non-inferiority randomized study that compared the Inspiron™ sirolimus-eluting stent (SES) with the control Biomatrix™ Flex biolimus-eluting stent (BES). Previous reports in the first year showed similar outcomes for both stents, in clinical, angiographic, optical coherence tomography, and intravascular ultrasound assessments. The present analysis aims to compare the clinical performance of these two biodegradable polymer drug-eluting stents five years after the index procedure. MethodsA total of 170 patients (194 lesions) were randomized in a 2:1 ratio for treatment with SES or BES, respectively. The primary endpoint for the present study was the five-year rate of combined major adverse cardiac events, defined as cardiac death, myocardial infarction, or target lesion revascularization. ResultsAt five years, the primary endpoint occurred in 12.5% and 17.9% of the SES and BES groups, respectively (p=0.4). There was no definite or probable stent thrombosis among patients treated with the novel SES stent during the five years of follow-up, and no stent thrombosis after the first year in the BES group. ConclusionsThe novel Inspiron™ stent had similar good clinical performance in long-term follow-up when compared head-to-head with the control latest-generation Biomatrix™ Flex biolimus-eluting stent.

Everolimus-eluting stents versus sirolimus-eluting stents in patients with cardiac allograft vasculopathy.

IntroductionCardiac allograft vasculopathy remains one of the most important factors leading to chronic cardiac allograft rejection. When revascularization is needed percutaneous coronary interventions are the method of choice.AimTo compare the short- and long-term outcomes of cardiac allograft vasculopathy patients treated with everolimus- (EES) or sirolimus-eluting stents (SES).Material and methodsBetween December 2012 and December 2020, 319 patients after heart transplantation undergoing coronary angiography at our institution were analysed. Subsequently 39 patients underwent de novo angioplasty with second-generation EES. The primary study endpoint was angiographic restenosis as evaluated by quantitative coronary angiography. Secondary outcomes included binary restenosis, target lesion revascularization and cardiac death during the follow-up period (6 months).ResultsTwenty-four patients were treated with EES and 15 treated with SES. No significant differences were observed regarding the rate of risk factors of cardiovascular diseases and comorbidities. The patients treated with EES were younger (55.8 ±11.8 vs. 60.1 ±12.2) and less frequently male (79% vs. 93%). The majority of patients were diagnosed with single vessel disease with LAD involvement (62% and 86% in the EES group, and 47% and 56% in the SES group). In 6 months follow-up, late lumen loss was comparable in both groups, 0.19 ±0.15 vs. 0.14 ±0.15, and binary restenosis was 4% and 0% for EES and SES groups, respectively.ConclusionsSecond generation drug-eluting stents eluting rapamycin analogues are associated with high direct efficacy of procedures and low incidence of restenosis in a 6-month follow-up.

Ten-year survival of patients undergoing coronary angioplasty with first-generation sirolimus-eluting stents and bare-metal stents

IntroductionCompared to bare-metal stents (BMS), drug-eluting stents reduce stent restenosis and improve subsequent revascularization rates. The impact on patients’ survival has been the subject of debate. ObjectiveTo assess the long-term (10-year) survival of patients undergoing percutaneous coronary intervention (PCI) with first-generation sirolimus-eluting stents (SES) in comparison with BMS. MethodsIn a single-center registry, 600 consecutive patients who underwent successful PCI with SES between April 2002 and February 2003 were compared to 594 patients who underwent PCI with BMS between January 2002 and April 2002, just before the introduction of SES. Clinical and procedural data were collected at the time of intervention and 10-year survival status was assessed via the national life status database. ResultsAll baseline characteristics were similar between groups except for smaller stent diameter (2.84±0.38 vs. 3.19±0.49 mm; p<0.001), greater stent length (18.50±8.2 vs. 15.96±6.10 mm; p<0.001) and higher number of stents per patient (1.95 vs. 1.46, p<0.001) in the SES group. Overall five- and 10-year all-cause mortality was 9.6% (n=110) and 22.7% (n=272), respectively. The adjusted HR for 10-year mortality in patients undergoing PCI with SES was 0.74 (95% CI 0.58-0.94; p=0.013), corresponding to a relative risk reduction of 19.8%. Other than PCI with BMS, older age, chronic kidney disease, chronic obstructive pulmonary disease and lower ejection fraction were independent predictors of 10-year mortality. ConclusionTo date, this is the longest follow-up study ever showing a potential survival benefit of first-generation sirolimus-eluting stents versus bare-metal stents, supporting prior observations on their sustained efficacy and safety relative to contemporary BMS.

Five-year outcomes after first- and second-generation drug-eluting stent implantation in all patients undergoing percutaneous coronary intervention

BackgroundUse of the everolimus-eluting stent (EES) instead of the sirolimus-eluting stent (SES) has been shown to improve clinical outcomes in patients undergoing percutaneous coronary intervention (PCI) out to 3 years. However, it is not known whether the differences in efficacy and safety outcomes remain constant throughout 5 years. MethodsThis was a retrospective, non-randomized, observational study. We followed 1460 consecutive patients undergoing PCI in our institutions from April 2005 to March 2012. There were 718 cases in patients with SES (SES group) and 742 with EES (EES group). Ten-month angiographic follow-up results and 5-year clinical follow-up outcomes were compared between the EES and SES groups. The primary outcome of this study was major adverse cardiac events (MACE), defined as the composite of cardiac death, recurrent myocardial infarction (MI), target vessel revascularization (TVR), and stent thrombosis (ST). ResultsAt 5 years, the rates of target lesion revascularization (TLR), TVR, recurrent MI and ST were significantly lower in the EES group compared to the SES group (TLR: 4.6% vs. 8.2%, p<0.05; TVR: 5.0% vs. 9.0%, p<0.05; recurrent MI: 1.5% vs. 4.4%, p<0.05; ST: 1.2% vs. 3.9%, p<0.05). Thus, MACE were significantly lesser in the EES group compared to the SES group (8.8% vs. 12.8%, p=0.006). ConclusionsEES improved clinical outcomes compared to SES, and specifically, was associated with reductions in TVR, ST, and recurrent MI out to 5 years.

Interim Results of the Basket of Real-World Randomised Clinical PRISM Trials for M’Sure-S, a Next-Generation Sirolimus-Eluting Stent, Versus Eliminator, an Everolimus-Eluting Stent

Objective: This study compared sirolimus-eluting stents (SES) with everolimus-eluting stents (EES) in coronary artery disease patients. Methods: A total of 1,174 patients were enrolled in the study; 290 patients (25.28%) were treated with EES and 884 patients (74.72%) were treated with SES. The trial (PRISM) was a randomised (in a 3:1 ratio), multicentre, single-blind, all-comers, single-arm, non-inferiority trial comparing SES and EES-implanted patients with coronary artery disease. The primary endpoint was a composite of safety parameters (including major adverse cardiac events [MACE], cardiac death, and myocardial infarction) and efficacy (parameters concerned to quantitative coronary angiogram). An intention-to-treat analysis was performed at 9 and 18-month follow-ups. Results: The baseline characteristics were similar for both EES and SES groups. At the 9-month follow-up, MACE occurred in 5.86% and 2.43% of patients in the EES and SES groups, respectively. At the 18-month follow-up, this differential remained almost the same (i.e., 5.17 % of patients treated with the EES versus 2.14% treated with the SES). The rate of definite stent thrombosis at 9-month follow-up was lower in the SES group (11 patients [1.24%]) compared to the EES group (9 patients [3.10%]). At 18-month follow-up, the rate was 2.14% (19 patients) in the SES group and 4.13% (12 patients) in the EES group. When censoring the patients at the time of stent thrombosis, no significant differences between the two stent groups were found. Conclusion: In this real-world trial, at 9 and 18-month follow-ups, SES (M’Sure-S) exhibited a better safety and efficacy profile when compared to EES in terms of MACE rates and definite stent thrombosis. However, the difference was not statistically significant and SES was found to be non-inferior to EES.

First-in-man randomised comparison of the BuMA Supreme biodegradable polymer sirolimus-eluting stent versus a durable polymer zotarolimus-eluting coronary stent: the PIONEER trial.

A second iteration of a sirolimus-eluting stent (SES) that has a biodegradable PLGA polymer coating with an electrografting base layer on a thin-strut (80 µm) cobalt-chromium platform (BuMA Supreme; SINOMED, Tianjin, China) has been developed. This first-in-man trial aimed to assess the efficacy and safety of the novel device. This randomised, multicentre, single-blinded, non-inferiority trial compared the BuMA Supreme SES versus a contemporary durable polymer zotarolimus-eluting stent (ZES) in terms of angiographic in-stent late lumen loss (LLL) at nine-month follow-up as the primary endpoint. A total of 170 patients were randomly allocated to treatment with either SES (n=83) or ZES (n=87). At nine-month angiographic follow-up, in-stent LLL was 0.29±0.33 mm in the SES group and 0.14±0.37 mm in the ZES group (pnon-inferiority=0.45). The in-stent percent diameter stenosis and the binary restenosis rate of the two treatment arms were similar (19.2±12.0% vs. 16.1±12.6%, p=0.09, and 3.3% vs. 4.4%, p=1.00, respectively). At 12-month clinical follow-up, there was no difference between treatment arms with regard to the device-oriented composite clinical endpoint (4.9% vs. 5.7%; p=0.72). The PIONEER trial did not meet its primary endpoint in terms of in-stent LLL at nine-month follow-up. However, this result did not translate into any increase in restenosis rate or impairment in 12-month clinical outcomes.

A sirolimus-eluting bioabsorbable polymer-coated stent (MiStent) versus an everolimus-eluting durable polymer stent (Xience) after percutaneous coronary intervention (DESSOLVE III): a randomised, single-blind, multicentre, non-inferiority, phase 3 trial

MiStent is a drug-eluting stent with a fully absorbable polymer coating containing and embedding a microcrystalline form of sirolimus into the vessel wall. It was developed to overcome the limitation of current durable polymer drug-eluting stents eluting amorphous sirolimus. The clinical effect of MiStent sirolimus-eluting stent compared with a durable polymer drug-eluting stents has not been investigated in a large randomised trial in an all-comer population. We did a randomised, single-blind, multicentre, phase 3 study (DESSOLVE III) at 20 hospitals in Germany, France, Netherlands, and Poland. Eligible participants were any patients aged at least 18 years who underwent percutaneous coronary intervention in a lesion and had a reference vessel diameter of 2·50-3·75 mm. We randomly assigned patients (1:1) to implantation of either a sirolimus-eluting bioresorbable polymer stent (MiStent) or an everolimus-eluting durable polymer stent (Xience). Randomisation was done by local investigators via web-based software with random blocks according to centre. The primary endpoint was a non-inferiority comparison of a device-oriented composite endpoint (DOCE)-cardiac death, target-vessel myocardial infarction, or clinically indicated target lesion revascularisation-between the groups at 12 months after the procedure assessed by intention-to-treat. A margin of 4·0% was defined for non-inferiority of the MiStent group compared with the Xience group. All participants were included in the safety analyses. This trial is registered with ClinicalTrials.gov, number NCT02385279. Between March 20, and Dec 3, 2015, we randomly assigned 1398 patients with 2030 lesions; 703 patients with 1037 lesions were assigned to MiStent, of whom 697 received the index procedure, and 695 patients with 993 lesions were asssigned to Xience, of whom 690 received the index procedure. At 12 months, the primary endpoint had occurred in 40 patients (5·8%) in the sirolimus-eluting stent group and in 45 patients (6·5%) in the everolimus-eluting stent group (absolute difference -0·8% [95% CI -3·3 to 1·8], pnon-inferiority=0·0001). Procedural complications occurred in 12 patients (1·7%) in the sirolimus-eluting stent group and ten patients (1·4%) in the everolimus-eluting stent group; no clinical adverse events could be attributed to these dislodgements through a minimum of 12 months of follow-up. The rate of stent thrombosis, a safety indicator, did not differ between groups and was low in both treatment groups. The sirolimus-eluting bioabsorbable polymer stent was non-inferior to the everolimus-eluting durable polymer stent for a device-oriented composite clinical endpoint at 12 months in an all-comer population. MiStent seems a reasonable alternative to other stents in clinical practice. The European Cardiovascular Research Institute, Micell Technologies (Durham, NC, USA), and Stentys (Paris, France).

Ultrathin, bioresorbable polymer sirolimus-eluting stents versus thin, durable polymer everolimus-eluting stents in patients undergoing coronary revascularisation (BIOFLOW V): a randomised trial

The development of coronary drug-eluting stents has included use of new metal alloys, changes in stent architecture, and use of bioresorbable polymers. Whether these advancements improve clinical safety and efficacy has not been shown in previous randomised trials. We aimed to examine the clinical outcomes of a bioresorbable polymer sirolimus-eluting stent compared with a durable polymer everolimus-eluting stent in a broad patient population undergoing percutaneous coronary intervention. BIOFLOW V was an international, randomised trial done in patients undergoing elective and urgent percutaneous coronary intervention in 90 hospitals in 13 countries (Australia, Belgium, Canada, Denmark, Germany, Hungary, Israel, the Netherlands, New Zealand, South Korea, Spain, Switzerland, and the USA). Eligible patients were those aged 18 years or older with ischaemic heart disease undergoing planned stent implantation in de-novo, native coronary lesions. Patients were randomly assigned (2:1) to either an ultrathin strut (60 μm) bioresorbable polymer sirolimus-eluting stent or to a durable polymer everolimus-eluting stent. Randomisation was via a central web-based data capture system (mixed blocks of 3 and 6), and stratified by study site. The primary endpoint was 12-month target lesion failure. The primary non-inferiority comparison combined these data from two additional randomised trials of bioresorbable polymer sirolimus-eluting stent and durable polymer everolimus-eluting stent with Bayesian methods. Analysis was by intention to treat. The trial is registered with ClinicalTrials.gov, number NCT02389946. Between May 8, 2015, and March 31, 2016, 4772 patients were recruited into the study. 1334 patients met inclusion criteria and were randomly assigned to treatment with bioresorbable polymer sirolimus-eluting stents (n=884) or durable polymer everolimus-eluting stents (n=450). 52 (6%) of 883 patients in the bioresorbable polymer sirolimus-eluting stent group and 41 (10%) of 427 patients in the durable polymer everolimus-eluting stent group met the 12-month primary endpoint of target lesion failure (95% CI -6·84 to -0·29, p=0·0399), with differences in target vessel myocardial infarction (39 [5%] of 831 patients vs 35 [8%] of 424 patients, p=0·0155). The posterior probability that the bioresorbable polymer sirolimus-eluting stent is non-inferior to the durable polymer everolimus-eluting stent was 100% (Bayesian analysis, difference in target lesion failure frequency -2·6% [95% credible interval -5·5 to 0·1], non-inferiority margin 3·85%, n=2208). The outperformance of the ultrathin, bioresorbable polymer sirolimus-eluting stent over the durable polymer everolimus-eluting stent in a complex patient population undergoing percutaneous coronary intervention suggests a new direction in improving next generation drug-eluting stent technology. BIOTRONIK.

Polymer-free dual drug-eluting stents evaluated in a porcine model

BackgroundAlthough drug-eluting stents have dramatically reduced the rates of restenosis and target lesion revascularization, they are associated with stent thrombosis (ST), a catastrophic event likely due to delayed endothelialization and chronic inflammation caused by the polymer and the metal scaffolds. To increase the safety and efficacy of stents, polymer-free dual drug-eluting stents (DDES) have been developed.MethodsA total 160 stents (Bare-metal stents (BMS), polymer-free probucol stents (PrES), sirolimus-eluting stents (SES) and DDES) were randomly implanted in the coronary arteries of 80 pigs. 14, 28, 90 and 191 days after implantation, QCA and OCT evaluations were performed in 20 pigs respectively, and the arteries were harvested for scanning electron microscope (SEM), histomorphology, histopathology analyses and for the relative expression of CD31, CD34 and CD133 on mRNA and protein levels.ResultsAt the 14-day time point, there were significant differences in the strut rate coverage (p = 0.011), with greater coverage in the PrES than in the SES group (53.2%vs. 20.3%, p = 0.002). As well, there were no significant differences in the expression of CD31, CD34 and CD133 between groups in mRNA and protein level.ConclusionsDDES were as safe as BMS and SES, but they did not further improve the endothelialization of the stented coronary arteries in the porcine model.

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.

Efficacy of everolimus-eluting stent implantation in patients with small coronary arteries (≤2.5 mm): outcomes of 3-year clinical follow-up

Previous studies have demonstrated that patients with small coronary artery lesions are at increased risk for late cardiac events after percutaneous coronary intervention. It remains uncertain whether second-generation drug-eluting stents have an advantage over first-generation drug-eluting stents in patients with small vessel lesions. Our aim was to compare in the 3-year clinical impact between second-generation everolimus-eluting stents (EES) and first-generation sirolimus-eluting stents (SES) in small vessel lesions. Four-hundred forty-four patients with small vessel lesions defined as reference diameter <2.5mm were treated with EES (237 patients, 265 lesions) or SES (207 patients, 220 lesions) and completed 3-year follow-up. We compared the major adverse clinical events (MACE) between the two groups. EES had no significant impact on the MACE rate compared with SES (4.6 vs. 7.2%, p=0.14). No significant differences were observed in the individual components of cardiac death (1.7 vs. 1.9%, p=0.78), myocardial infarction (1.3 vs. 3.4%, p=0.12), and ischemia-driven target lesion revascularization (2.3 vs. 4.6%, p=0.13) in EES and SES, respectively. Stent thrombosis, however, was significantly less in the EES group than in the SES group (0.7 vs. 3.4%, HR: 0.53, 95% CI 0.38-0.88, p<0.05). EES implantation did not significantly impact 3-year MACE rates compared to SES implantation in small vessel lesions. A significant reduction in the overall rate of stent thrombosis was observed in recipients of EES. While the SES group showed increasing rates of late and very late thrombosis, the EES group did not. EES offers a safe and effective treatment for small vessel lesions.

Sirolimus-eluting stent is superior to paclitaxel-eluting stent for coronary intervention in patients with renal insufficiency: Long-term clinical outcomes.

Renal insufficiency (RI) is an independent risk factor for the adverse cardiovascular events. Long-term clinical outcome of percutaneous coronary intervention (PCI) in patients with RI is unknown especially in the era of first generation drug-eluting stents (DES). This study aims at comparing clinical outcomes between sirolimus-eluting stents (SES) and paclitaxel-eluting stents (PES) based on large scaled registry. Patients who underwent PCI with DES from January 2004 to December 2009 in the Catholic University of Korea-PCI (COACT) registry were prospectively enrolled. A group of 1,033 patients with RI, defined as estimated glomerular filtration rate under 60 mL/min, were analyzed. Major adverse cardiac events (MACE), including all-cause death, non-fatal myocardial infarction (MI), target lesion revascularization (TLR), and target vessel revascularization (TVR) according to the type of stents were compared. Median follow-up period was 810 days (interquartile range: from 361 to 1,354 days). A group of 612 (59.2%) patients were treated with SES and 421 (40.8%) patients were treated with PES. The PES vs. SES group had significantly higher rate of MACE (35.9% vs. 28.3%, p = 0.01). In multivariate Cox hazard regression analysis, PES vs. SES group had significantly higher rate of MACE (adjusted hazard ratio [AHR] 1.29, 95% confidence interval [CI] 1.02-1.64, p = 0.033), particularly pronounced by all-cause death (AHR 1.34, 95% CI 1.008-1.770; p = 0.044). In further analysis with propensity score matching, overall findings were consistent. In patients with RI, PCI using PES provides poorer clinical outcomes than SES in terms of MACE and all-cause death.

Abstract 652: Coronary Angioscopic Observation of Extremely Late Arterial Repair Catch-up after Sirolimus-eluting Stent Implantation

Sirolimus, a bio-suppressive drug, delays coronary arterial repair after implantation of Cypher sirolimus-eluting stents (SES), a representative first generation drug-eluting stent. It remains unclear, however, whether this delayed repair would catch up with bare metal stents (BMS) along extremely long observation. The aim of this study was angioscopic comparison of coronary arterial repair through a decade after implantation of SES and BMS. Enrolled were 31 patients with previous implantation of SES (n = 22) or BMS (n = 9). Duration after stent implantation (DSI) ranged from 3 to 10.5 years in both groups. Thirty-seven SES were implanted into the SES group and 17 BMS into the BMS group. The 54 stented segments were analyzed by quantitative coronary angiography (QCA) and non-obstructive coronary angioscopy (CAS). Under continuous flush of low-molecular-weight dextran, CAS visualized in-stent appearance, i.e. endothelial stent coverage (ESC), presence of yellow plaque (YP), and in-stent mural thrombi (ISMT). ESC was semi-quantified into 4 grades (grade 0, no coverage; grade 1, thin coverage; grade 2, decent coverage; grade 3, full coverage). QCA showed in-stent restenosis neither in SES- nor BMS-implanted segments (% diameter stenosis 14.8 ± 7.9 vs. 16.2 ± 8.2, respectively). Incidence of YP was 27% in SES and 6% in BMS (P &lt; 0.03). Incidence of ISMT was 24% in SES, whereas never in BMS. ESC grade of BMS was either grade 1 (24%) or grade 3 (76%). SES-implanted segments were divided into two groups, i.e. DSI &gt; 8 years (n = 5) and DSI &lt; 8 years (n = 32). In the former (10.5 &gt; DSI &gt; 8 years), ESC grade of SES was either grade 1 (40%) or grade 3 (60%), being similar to ESC after BMS implantation. In the latter (8 &gt; DSI &gt; 3 years), however, ESC grade varied from grade 0 (6%), grade 1 (63%), grade 2 (25%), and grade 3 (6%). Incidence of YP or ISMT was 60% in the former, suggesting progression of neoatherosclerosis at extremely late phase. In conclusion, from the viewpoint of ESC, coronary arterial repair at SES implantation appeared to catch up with BMS at around 8 years later, although incidence of YP or ISMT remained still greater in SES than BMS at extremely late phase.

Safety and Efficacy of Everolimus- Versus Sirolimus-Eluting Stents: 5-Year Results From SORT OUT IV

BackgroundLong-term safety and efficacy for everolimus-eluting stents (EES) versus those of sirolimus-eluting stents (SES) are unknown. ObjectivesThis study compared 5-year outcomes for EES with those for SES from the SORT OUT IV (Scandinavian Organization for Randomized Trials with Clinical Outcome) trial. MethodsFive-year follow-up was completed for 2,771 patients (99.9%). Primary endpoint was a composite of major adverse cardiac events (MACE), including cardiac death, myocardial infarction (MI), target vessel revascularization (TVR), and definite stent thrombosis. ResultsAt 5-years, MACE occurred in 14.0% and 17.4% in the EES and SES groups, respectively (hazard ratio [HR]: 0.80, 95% confidence interval [CI]: 0.66 to 0.97; p = 0.02). The MACE rate did not differ significantly within the first year (HR: 0.96, 95% CI: 0.71 to 1.19; p = 0.79), but from years 1 through 5, the MACE rate was lower with EES (HR: 0.71, 95% CI: 0.55 to 0.90; p = 0.006; p interaction = 0.12). Definite stent thrombosis was lower with EES (0.4%) than with SES (2.0%; HR: 0.18, 95% CI: 0.07 to 0.46), with a lower risk of very late definite stent thrombosis in the EES group (0.2% vs. 1.4%, respectively; HR: 0.16, 95% CI: 0.05 to 0.53). When censoring the patients at the time of stent thrombosis, we found no significant differences between the 2 stent groups for MACE rates (HR: 0.89, 95% CI: 0.73 to 1.08; p = 0.23), target lesion revascularization (HR: 0.90, 95% CI: 0.64 to 1.27; p = 0.55), and MI (HR: 0.93, 95% CI: 0.64 to 1.36; p = 0.72). ConclusionsAt 5-year follow-up, MACE rate was significantly lower with EES- than with SES-treated patients, due largely due to a lower risk of very late definite stent thrombosis. (Randomized Clinical Comparison of the Xience V and the Cypher Coronary Stents in Non-selected Patients With Coronary Heart Disease [SORT OUT IV]; NCT00552877)

Wound Healing Outcomes and Health-Related Quality-of-Life Changes in the ACHILLES Trial: 1-Year Results From a Prospective Randomized Controlled Trial of Infrapopliteal Balloon Angioplasty Versus Sirolimus-Eluting Stenting in Patients With Ischemic Peripheral Arterial Disease.

The authors sought to report the wound healing outcomes, health-related quality-of-life changes and quality-adjusted life-years (QALYs) gain in the 2 treatment arms of the ACHILLES (Comparing Angioplasty and DES in the Treatment of Subjects With Ischemic Infrapopliteal Arterial Disease) multicenter randomized trial. The ACHILLES randomized trial has previously shown that sirolimus-eluting stents (SES) may achieve lower vessel restenosis and higher event-free survival rates compared with plain balloon angioplasty (PTA) for infrapopliteal lesions. A total of 200 patients were randomly assigned between SES and PTA for the treatment of infrapopliteal arterial occlusive lesions. Progression of wound healing was serially assessed by digital photography. Health-related quality-of-life scores were assessed with the self-administered EQ-5D questionnaire up to 1 year from randomization. QALYs gained were calculated with a standard multiplicative model using distribution-free Bayesian modeling. In total, 109 open wounds (n = 54 in SES; n = 55 in PTA) were documented at baseline. At 6 months, wound volume reduction (%) was significantly higher in the SES group (95% healing [95% confidence interval (CI): 80% to 99%] compared with 60% healing [95% CI: 13% to 90%] in the PTA group; p = 0.048). At 1 year, rates of complete wound closure were higher in the case of SES (72.9% vs. 55.6% closed wounds in PTA; p = 0.088). The recorded weighted EQ-5D score improved significantly up to 1 year in case of SES (p < 0.0001), but not in case of PTA. There was a trend of more QALYs gained with SES compared with PTA up to 1 year after randomization. Relative QALY gain was 0.10 (95% CI: -0.01 to 0.21; p = 0.08) in the whole study and 0.17 (95% CI: -0.03 to 0.35; p = 0.09) in the wound subgroups comparison. Infrapopliteal SES accelerates wound healing and may improve quality of life compared with PTA. (Comparing Angioplasty and DES in the Treatment of Subjects With Ischemic Infrapopliteal Arterial Disease [ACHILLES]; NCT00640770).

Incidence and Characteristics of Late Catch‐Up Phenomenon Between Sirolimus‐Eluting Stent and Everolimus‐Eluting Stent: A Propensity Matched Study

We evaluated and compared the incidence and characteristics of late catch-up phenomenon (LCU) between everolimus-eluting stent (EES) and sirolimus-eluting stent (SES) implantations. Late catch-up phenomenon after everolimus-eluting stent (EES) implantation has not yet been evaluated sufficiently. Between April 2007 and May 2011, 1,234 patients with coronary artery disease were treated with SES and 502 patients with EES. Following propensity score matching, we evaluated 495 SES-treated patients and 495 ESS-treated patients. The incidences of LCU (i.e., late target lesion revascularization [TLR] [1-3 years]) were compared. The cumulative incidence of TLR at 3 years was 11.9% in the SES group and 6.1% in the EES group (P = 0.001). The incidence of late TLR was 7.5% in the SES group and 3.4% in the EES group (P = 0.004). Even though not statistically significant, intravascular ultrasound showed a higher tendency of stent fracture (SF) in late restenosis lesions in the SES group than in the EES group (37.0% vs 7.7%; P = 0.052). Moreover, the SF rate tended to increase in late restenosis compared with early restenosis (within 1 year) in the SES group compared with the EES group (SES: 37.0% vs 22.2%; P = 0.293, EES: 7.7% vs 10.0%; P = 0.846), although the increase was not significantly different. EES was superior to SES in terms of LCU. SF may be associated with LCU after SES implantation.

Differences in Vessel Healing Between Sirolimus- and Everolimus-Eluting Stent Implantation for Bifurcation Lesions: The J-REVERSE Optical Coherence Tomography Substudy

BackgroundWe aimed to clarify the differences in vessel healing after stenting of bifurcation lesions using sirolimus-eluting stents (SESs) or everolimus-eluting stents (EESs). MethodsJapanese Registry Study in Comparison Between Everolimus-Eluting Stent and Sirolimus-Eluting Stent for the Bifurcation Lesion (J-REVERSE) is a prospective multicentre registry of 303 bifurcation lesions that were treated with provisional SES or EES with or without final kissing inflation. The first 115 lesions at selected study sites were predefined for inclusion in the optical coherence tomography (OCT) substudy, and 9-month follow-up OCT was conducted in 64 lesions (SES, n = 18; EES, n = 46). In addition to standard OCT parameters, stent eccentricity index (SEI; minimum divided by the maximum stent diameter), neointimal unevenness score (NUS; maximum neointimal thickness in the cross-section [CS] divided by the average neointimal thickness [NIT] of the same CS; uniformity of the neointima suppression) were averaged for each segment (proximal, bifurcation, and distal segments). ResultsOverall, the average stent and luminal area, NIT, and frequency of uncovered struts were similar. The frequency of malapposed struts and SEI were significantly lower in the EES group than in the SES group. The EES group had a significantly smaller NUS in the proximal and distal segments. ConclusionsEESs offer homogeneous vessel healing with less malapposition in the treatment of bifurcation lesions.

Long-Term Effects of Novel Combination Coating Anti-CD34 Antibody Applied on Sirolimus-Eluting Stents.

We investigated whether the combination coating of a novel "prohealing coating" hyaluronan-chitosan (HC) and anti-CD34 antibody applied on an SES (HCASES) can reduce neointimal formation while promoting endothelialization compared to either agent alone. Drug-eluting stents have considerably reduced the incidence of in-stent restenosis compared with bare metal stents. However, the beneficial effect of drug elution is overshadowed by delayed re-endothelialization as well as later "catch-up" proliferation related to the drug. Three different stents: Sirolimus-eluting stents (SES), Genous anti-CD34 antibody stents (GS), and the combination of HC-anti-CD34 antibody with sirolimus-eluting stents (HCASES) were deployed in 54 normal porcine coronary arteries and harvested for scanning electron microscopy (SEM) and histological analysis at 60, 90, and 120 days. At 60 and 90 days, SEM analysis showed stent surface endothelial coverage was nearly completed in the HCASES (87 ± 3%, 95 ± 3%) compared with that in the SES (68 ± 6%, 77 ± 8%, P = 0.03). Histological examination at 90 days showed that the HCASES group had less percentage of stenosis than the GS group (P < 0.05). At 120 days, SEM showed a significantly higher extent of endothelial coverage above struts in the HCASES (96 ± 2%) and the GS (95 ± 3%) as compared with the SES group (66 ± 3%; P = 0.02). The HCASES group showed less stenosis than that in the GS group (P < 0.05), but it was not significantly different from the SES group (P = 0.063). Histological and SEM analyses demonstrate that the HCASES can reduce neointimal formation and inflammation while promoting endothelialization in the long term.