Three-year clinical outcomes of the novel sirolimus-eluting bioresorbable scaffold for the treatment of de novo coronary artery disease: A prospective patient-level pooled analysis of NeoVas trials.

OBJECTIVES: We aimed to evaluate the long-term outcomes of the novel NeoVas sirolimus-eluting bioresorbable scaffold (BRS) for the treatment of de novo coronary artery disease. BACKGROUND: The long-term safety and efficacy of the novel NeoVas BRS are still needed to be elucidated. METHODS: A total of 1103 patients with de novo native coronary lesions for coronary stenting were enrolled. The primary endpoint of target lesion failure (TLF) was defined as a composite of cardiac death (CD), target vessel myocardial infarction (TV-MI), or ischemia-driven-target lesion revascularization (ID-TLR). RESULTS: A three-year clinical follow-up period was available for 1,091 (98.9%) patients. The cumulative TLF rate was 7.2% with 0.8% for CD, 2.6% for TV-MI, and 5.1% for ID-TLR. Additionally, 128 (11.8%) patient-oriented composite endpoint and 11 definite/probable stent thromboses (1.0%) were recorded. CONCLUSIONS: The extended outcomes of the NeoVas objective performance criterion trial demonstrated a promising 3-year efficacy and safety of the NeoVas BRS in low-risk patients with low complexity in terms of lesions and comorbidities.

Safety and efficacy of the novel sirolimus-eluting bioresorbable scaffold for the treatment of de novo coronary artery disease: One-year results from a prospective patient-level pooled analysis of NeoVas trials.

OBJECTIVES: This prospective, patient-level analysis assessed the safety and efficacy of NeoVas sirolimus-eluting bioresorbable scaffold (BRS) in patients with coronary lesions. Furthermore, to meet China Food and Drug Administration requirements, we conducted an objective performance criterion study by pooling all patients implanted with the NeoVas BRS in a previous randomized controlled trial (RCT) and registry trial. BACKGROUND: Drug-eluting stent-related permanent vessel caging by metallic struts may lead to several complications associated with percutaneous coronary intervention. BRSs reportedly result in more stent thromboses (ST) in comparison to everolimus-eluting stents. The NeoVas (Lepu Medical, Beijing, China) is a novel sirolimus-eluting poly-l-lactic acid (PLLA)-based BRS whose safety and efficacy remains to be fully elucidated. METHODS: Patient-level data derived from 1,103 patients with de novo native coronary lesions in the NeoVas RCT (n = 278) and NeoVas registry (n = 825) were prospectively collected, pooled, and analyzed. The primary outcome was 12-month target lesion failure (TLF), a composite of cardiac death, target vessel myocardial infarction, or ischemia-driven-target lesion revascularization. The patient-oriented composite endpoint (PoCE) of all-cause death, all MI, or any revascularization was also analyzed. RESULTS: The 12-month rate of TLF in 1,103 patients (follow-up rate, 99.8%) was 3.0%, significantly lower than the performance goal of 8.5% (P < 0.0001). Furthermore, 50 (5.4%) PoCEs and five definite/probable ST (0.5%) were recorded. CONCLUSIONS: This pooled, patient-level analysis indicates that the NeoVas BRS has promising 1-year efficacy and safety profiles.

Nine-month clinical outcomes in patients with diabetes treated with polymer-free sirolimus-eluting stents and 6­month vs. 12­month dual-antiplatelet therapy (DAPT).

BACKGROUND: Diabetes mellitus is known to be associated with worse clinical outcomes in patients with coronary artery disease (CAD) undergoing percutaneous coronary interventions (PCI) with drug-eluting stents (DES). Defining the optimal duration of dual antiplatelet therapy (DAPT) after DES implantation is still under debate. The objective of this subgroup analysis of the all-comers ISAR 2000 registry was to assess the safety and efficacy of a short DAPT (<6 month) versus a longer DAPT (>6 month) in patients with diabetes electively treated with the polymer-free sirolimus-coated ultrathin strut drug-eluting stent (PF-SES). METHODS: Patients who received the PF-SES were investigated in a multicenter all-comers observational study. The primary endpoint was the 9­month target lesion revascularization (TLR) rate, whereas secondary endpoints included the 9­month major adverse cardiac event (MACE) and procedural success rates. RESULTS: In all, 167 patients were treated with DAPT for ≤6 months (S-DAPT group) and 350 patients underwent DAPT treatment for 12 months (L-DAPT group). There was no significant difference in the overall MACE rate (4.6% vs. 3.1%, p = 0.441), the 9­month accumulated stent thrombosis rates (0.8% vs. 0.3%, p = 0.51), or the accumulated rate of bleeding complications (5.3% vs. 3.4%, p = 0.341). CONCLUSION: PF-SES are safe and effective in daily clinical routine with low rates of TLR and MACE in patients with diabetes and stable disease. Our data suggest that extending the duration of DAPT beyond 6 months does not improve MACE or TLR at 9 months in patients with stable CAD (ClinicalTrials.gov Identifier NCT02629575).

Efficacy and safety of a biodegradable polymer Cobalt-Chromium sirolimus-eluting stent (EXCROSSAL) in treating de novo coronary artery disease: A pooled analysis of the CREDIT II and CREDIT III trials.

BACKGROUND: The safety and efficacy of the second-generation biodegradable polymer Cobalt-Chromium sirolimus-eluting stent (EXCEL2) in daily clinical practice remains unknown. Additionally, to meet the China Food and Drug Administration requirements, we conducted an objective performance criterion study from the CREDIT II and CREDIT III trials. METHODS: CREDIT II was a randomized trial comparing the EXCEL2 versus EXCEL stent in patients with up to 2 de novo coronary lesions. CREDIT III was a prospective, single-arm study evaluating the efficacy and safety of EXCEL2 in broad types of de novo coronary artery lesions. This pooled analysis included patients in the CREDIT III and EXCEL2 arm of the CREDIT II trial. The primary outcome was 12-month target lesion failure (TLF), a composite of cardiac death, target vessel myocardial infarction (TV-MI), and clinical indicated target lesion revascularization (CI-TLR). The patient-oriented composite endpoint (PoCE) of all-cause death, all MI, or any revascularization was also analyzed. RESULTS: A total of 833 patients were included, consisting of 625 in the CREDIT III trial and 208 in the EXCEL2 arm of the CREDIT II trial. Twelve-month TLF occurred in 6.1% patients, cardiac death in 0.4%, TV-MI in 5%, and CI-TLR in 1.1%. Additionally, 64 (7.7%) PoCE and 3 probable late stent thromboses (0.4%) were recorded. CONCLUSION: EXCEL2 stent met the objective performance criterion on efficacy and safety with a low level of 12-month TLF as well as stent thrombosis when treating patients with de novo coronary lesions. © 2017 Wiley Periodicals, Inc.

Clinical results of everolimus-eluting stents and sirolimus-eluting stents in patients undergoing percutaneous coronary intervention.

Background: It has been pronounced that everolimus-eluting stent (EES) had lower charge of goal-lesion revascularization and stent thrombosis as compared with sirolimus-eluting stents (SES).The goal of this observation was to compare the efficacy and protection of EES with SES in primary percutaneous coronary intervention (PCI) for acute myocardial infarction (AMI). Methods: In this retrospective study, a total of 404 patients with coronary artery stenosis who underwent angioplasty of one or more coronary arteries were included in the study. Of these, 202 were treated with SES and the others with EES. The data were collected by a questionnaire through which the annual incidence of coronary stent complications including the occurrence of stent thrombosis (confirmed by re-angiography), the occurrence of acute coronary syndrome leading to hospitalization, the occurrence of vascular myocardial infarction related to the stenting vessel, the need for re-angiography and angioplasty and finally the incidence of cardiac mortality were evaluated. Results: This study showed that the odds ratio of EES thrombosis to SES stent in the unadjusted model is 1.01 (0.06-16.34) and in the adjusted model for confounding variables was equal to 0.80 (0.04-13.35) which in both models, these values were not statistically significant. Conclusion: The findings of the present study indicate that there is no statistically significant difference between the outcomes in the two groups treated with SES and EES release stents.

Twelve months clinical outcomes of ultrathin strut sirolimus-eluting stent in real-world Indian patients with coronary artery disease.

PURPOSE: Although the field of interventional cardiology has witnessed extraordinary progression, the search of an ideal coronary drug-eluting stent is still going on. Tetriflex (Sahajanand Medical Technologies Limited, Surat, India) is a latest generation biodegradable polymer-coated ultrathin (60 µm) sirolimus-eluting stent (SES) with unique Long Dual Z-link (LDZ) design. The present registry reports the 12 months clinical follow-up results of Tetriflex SES in unselected, real-world patients with coronary artery disease (CAD). METHODS: This was an investigator-initiated, retrospective, multi-center, single-arm, observational registry conducted in India between March-2017 and March-2018. The registry included 1269 consecutive patients with CAD who underwent implantation of at least one Tetriflex SES. The primary outcome was considered as target lesion failure (TLF), which was a composite of cardiac death, target-vessel myocardial infarction (TV-MI) and clinically-driven target lesion revascularisation (CD-TLR) at 12 months follow-up. The safety outcome, at 12 months follow-up, was stent thrombosis. RESULTS: Mean age of patients was 54.99±10.80 years. Among all, 36.6% patients had diabetes and 51.7% patients had multi-vessel disease. A total of 1515 lesions were treated with 1682 Tetriflex SES of which 73.2% lesions were complex B2/C type and 14.7% were totally occluded. At 12 months, the cumulative incidence of TLF was 5.75% comprising 0.8% cardiac death, 3.20% TV-MI and 1.72% CD-TLR. All the incidences of definite/probable stent thrombosis (n = 4, 0.32%) were reported within 30 days of the index procedure. Twelve-month cumulative incidence of TLF in diabetic subgroup was 7.10%. CONCLUSION: Twelve months clinical follow-up results of an ultrathin (60 µm), biodegradable polymer-coated Tetriflex SES, with unique LDZ-link, further clarify its safety and effectiveness in real-world, unselected Indian patients.

A serial optical frequency-domain imaging study of early and late vascular responses to bioresorbable-polymer sirolimus-eluting stents for the treatment of acute myocardial infarction and stable coronary artery disease patients: results of the MECHANISM-ULTIMASTER study.

The purpose of this study was to assess early and late vascular healing in response to bioresorbable-polymer sirolimus-eluting stents (BP-SESs) for the treatment of patients with ST-elevation myocardial infarction (STEMI) and stable coronary artery disease (CAD). A total of 106 patients with STEMI and 101 patients with stable-CAD were enrolled. Optical frequency-domain images were acquired at baseline, at 1- or 3-month follow-up, and at 12-month follow-up. In the STEMI and CAD cohorts, the percentage of uncovered struts (%US) was significantly and remarkably decreased during early two points and at 12-month (the STEMI cohort: 1-month: 18.75 ± 0.78%, 3-month: 10.19 ± 0.77%, 12-month: 1.80 ± 0.72%; p < 0.001, the CAD cohort: 1-month: 9.44 ± 0.78%, 3-month: 7.78 ± 0.78%, 12-month: 1.07 ± 0.73%; p < 0.001 respectively). The average peri-strut low-intensity area (PLIA) score in the STEMI cohort was significantly decreased during follow-up period (1.90 ± 1.14, 1.18 ± 1.25, and 1.01 ± 0.72; p ≤ 0.001), whereas the one in the CAD cohort was not significantly changed (0.89 ± 1.24, 0.67 ± 1.07, and 0.64 ± 0.72; p = 0.59). In comparison with both groups, differences of %US and PLIA score at early two points were almost disappeared or close at 12 months. The strut-coverage and healing processes in the early phase after BP-SES implantation were significantly improved in both cohorts, especially markedly in STEMI patients. At 1 year, qualitatively and quantitatively consistent neointimal coverage was achieved in both pathogenetic groups.

Comparison of Different Types of Drug-Eluting Stents for De Novo Long Coronary Artery Lesions.

Background: Outcomes of percutaneous coronary intervention for diffuse long lesions remain relatively unfavorable. Prior clinical trials investigated the relative efficacy and safety of different types of drug-eluting stents (DES) in long lesions. Objectives: This study sought to compare the relative performance of different types of DES for de novo long (≥25 mm) coronary artery lesions. Methods: Using a pooled analysis of individual data of 1,450 patients from 3 randomized clinical trials, we compared angiographic and clinical outcomes of 5 different types of DES: 224 patients with cobalt-chromium everolimus-eluting stents (EES), 255 with platinum-chromium EES, 250 with Resolute zotarolimus-eluting stents, 245 with biodegradable polymer biolimus-eluting stents, and 476 with first-generation sirolimus-eluting stents (SES). The primary endpoint was in-segment late lumen loss at 9 months. Results: The primary endpoint was not significantly different between 4 second-generation DES and 1 first-generation SES (0.17 ± 0.41 mm in cobalt-chromium EES; 0.11 ± 0.37 in platinum-chromium EES: 0.14 ± 0.38 in Resolute zotarolimus-eluting stents; 0.14 ± 0.38 in biodegradable polymer biolimus-eluting stents; or 0.10 ± 0.37 in SES, respectively, overall P = 0.38). Also, there were no significant between-group differences with respect to death, myocardial infarction, target-vessel revascularization, or stent thrombosis at 12 months. In the multiple treatment propensity-score analysis, the risk of angiographic and clinical outcomes was also similar among several types of DES. Conclusions: In this patient-level pooled analysis, several second-generation DES showed similar angiographic and clinical outcomes in patients with de novo long coronary lesions. (Percutaneous Treatment of LONG Native Coronary Lesions With Drug-Eluting Stent-III [LONG-DES-III]; NCT01078038; Percutaneous Treatment of LONG Native Coronary Lesions With Drug-Eluting Stent-IV [LONG-DES-IV]; NCT01186094; and Everolimus-eluting [PROMUS-ELEMENT] vs. Biolimus A9-Eluting [NOBORI] Stents for Long-Coronary Lesions [LONG-DES-V]; NCT01186120).

A meta-analysis of everolimus-eluting stents versus sirolimus-eluting stents and paclitaxel-eluting stents in diabetic patients.

OBJECTIVE: We performed this meta-analysis to determine which stent among everolimus eluting stents (EES), sirolimus eluting stents (SES) and paclitaxel eluting stents (PES) should be preferred for the treatment of DM patients. METHODS: A systematic search of publications about randomized controlled trials (RCTs) focused on diabetic patients received EES, SES or PES was conducted. We evaluated the following indicators: target vessel revascularization (TVR), target lesion revascularization (TLR), late luminal loss (LLL), stent thrombosis (ST), myocardial infarction (MI), all-cause mortality and cardiac mortality. RESULTS: EES showed obvious advantages over SES for DM patients, as it induced the lowest rate of target vessel revascularization and target lesion revascularization (TLR) (p = 0.04). In addition, EES induced lower in-segment LLL than PSE and SES and lower in-stent LLL than PES in DM patients (all p < 0.05). Moreover, EES effectively reduced all-cause mortality compared to SES (RR = 0.71, 95% CI: 0.52-0.99, p = 0.04) and MI rates compared to PES (RR = 0.44, 95% CI: 0.26-0.73, p = 0.0002). Furthermore, EES could reduce the ST rate compared with both SES (RR = 0.53, 95% CI: 0.28-0.98, p = 0.04) and PES (RR = 0.18, 95% CI: 0.07-0.51, p = 0.001). CONCLUSION: Among those three types of stents, EES should be the first recommended stent for DM patients.

Effectiveness and Safety of Contemporary Drug-Eluting Stents in Patients With Diabetes Mellitus.

Background: Diabetes mellitus (DM) is a well-known risk factor for adverse cardiovascular events in patients receiving percutaneous coronary intervention (PCI). Limited data are available on the relative performance of different types of contemporary drug-eluting stents (DES) for diabetic patients. Objectives: The authors investigated the effectiveness and safety profiles of several contemporary DES in patients with DM in a "real-world" clinical setting. Methods: Among 24,516 patients enrolled in a multicenter, prospective registry, 7,823 patients with DM were treated with 4 contemporary DES: 2,877 with a cobalt chromium everolimus-eluting stent (EES), 789 with a biodegradable polymer biolimus-eluting stent, 2,286 with a platinum chromium-EES, and 1,871 with a Resolute zotarolimus-eluting stent. The primary outcome was target vessel failure (TVF) (a composite of cardiac death, target vessel myocardial infarction, and target vessel revascularization). Results: The median follow-up duration was 2.9 years. Observed 3-year rates of TVF were not significantly different according to different DES types. On multigroup propensity-score analysis, the adjusted HRs for TVF were similar in between-group comparisons: biodegradable polymer biolimus-eluting stent (HR: 0.94; 95% CI: 0.76-1.16; P = 0.57), platinum chromium-EES (HR: 0.94; 95% CI: 0.81-1.09; P = 0.41), and Resolute zotarolimus-eluting stent (HR: 1.01; 95% CI: 0.86-1.18; P = 0.93) compared with the cobalt chromium-EES (reference). This trend was maintained in patients with non-insulin- and insulin-treated DM. Conclusions: In this multicenter clinical-practice PCI registry, no significant between-group differences were found for a 3-year risk of TVF in patients with DM undergoing PCI with various types of contemporary DES. (Evaluation of the First, Second, and New Drug-Eluting Stents in Routine Clinical Practice [IRIS-DES]; NCT01186133).

Stent-Related Adverse Events as Related to Dual Antiplatelet Therapy in First- vs Second-Generation Drug-Eluting Stents.

Background: There are limited data on the long-term stent-related adverse events as related to the duration of dual antiplatelet therapy (DAPT) in second-generation (G2) drug-eluting stents (DES) compared with first-generation (G1) DES. Objectives: This study sought to compare the long-term stent-related outcomes of G2-DES with those of G1-DES. Methods: The study group consisted of 15,009 patients who underwent their first coronary revascularization with DES from the CREDO-Kyoto PCI/CABG (Coronary Revascularization Demonstrating Outcome Study in Kyoto Percutaneous Coronary Intervention/Coronary Artery Bypass Grafting) Registry Cohort-2 (first-generation drug-eluting stent [G1-DES] period; n = 5,382) and Cohort-3 (second-generation drug eluting stent [G2-DES] period; n = 9,627). The primary outcome measures were definite stent thrombosis (ST) and target vessel revascularization (TVR). Results: The cumulative 5-year incidences of definite ST and TVR were significantly lower in the G2-DES group than in the G1-DES group (0.7% vs 1.4%; P < 0.001; and 16.2% vs 22.1%; P < 0.001, respectively). The lower adjusted risk of G2-DES relative to G1-DES for definite ST and TVR remained significant (HR: 0.53; 95% CI: 0.37-0.76; P < 0.001; and HR: 0.74; 95% CI: 0.68-0.81; P < 0.001, respectively). In the landmark analysis that was based on the DAPT status at 1 year, the lower adjusted risk of on-DAPT status relative to off-DAPT was significant for definite ST beyond 1 year in the G1-DES stratum (HR: 0.42; 95% CI: 0.24-0.76; P = 0.004) but not in the G2-DES stratum (HR: 0.66; 95% CI: 0.26-1.68; P = 0.38) (P interaction = 0.14). Conclusions: G2-DES compared with G1-DES were associated with a significantly lower risk for stent-related adverse events, including definite ST and TVR. DAPT beyond 1 year was associated with a significantly lower risk for very late ST of G1-DES but not for that of G2-DES.

Final 3-Year Outcomes of MiStent Biodegradable Polymer Crystalline Sirolimus-Eluting Stent Versus Xience Permanent Polymer Everolimus-Eluting Stent: Insights From the DESSOLVE III All-Comers Randomized Trial.

BACKGROUND: Numerous randomized clinical trials have demonstrated the superiority of thin-strut biodegradable polymer second-generation drug-eluting stent to the first-generation drug-eluting stent and the noninferiority to the thin-strut second-generation permanent polymer drug-eluting stent. Data on long-term clinical outcomes with a novel ultrathin drug-eluting stent, to date, are limited. METHODS: The DESSOLVE III trial (Multicenter Randomized Study of the MiStent Sirolimus Eluting Absorbable Polymer Stent System for Revascularization of Coronary Arteries; n=1398) is a prospective, multicenter, single-blinded, all-comers, randomized controlled trial (NCT02385279), allocating in a 1:1 ratio to either ultrathin-strut biodegradable polymer MiStent sirolimus-eluting stent or to thin-strut permanent polymer Xience everolimus-eluting stent. The primary end point was device-oriented composite end point, defined as the composite of cardiac death, target vessel myocardial infarction, or clinically indicated target lesion revascularization. The secondary end point was patient-oriented composite end point, defined as the composite of all-cause mortality, any myocardial infarction, or any revascularization. RESULTS: At 3 years, follow-up data were available in 1381 patients (98.8%). The primary end point of device-oriented composite end point occurred in 10.5% for MiStent sirolimus-eluting stent and in 11.5% for Xience everolimus-eluting stent (P=0.55). Rates of cardiac death (3.9% versus 3.8%; P=0.88), target vessel myocardial infarction (3.2% versus 2.5%; P=0.43), and clinically indicated target lesion revascularization (5.2% versus 6.5%; P=0.30) did not differ significantly between the 2 devices. The rate of definite or probable stent thrombosis was infrequent and similar between the 2 arms (1.2% versus 1.5%; P=0.64). The 90-day landmark analysis showed no significant difference in device-oriented composite end point between the 2 groups after polymer degradation of MiStent. The risk of patient-oriented composite end point was comparable between the 2 groups (22.7% versus 22.9%; P=0.34). CONCLUSIONS: In the DESSOLVE III trial, early safety and efficacy with MiStent sirolimus-eluting bioabsorbable polymer-coated stent are confirmed at a longer term follow-up when compared with Xience everolimus-eluting permanent polymer-coated stent in a large all-comers population. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02385279.

7-Year Outcomes of a Randomized Trial Comparing the First-Generation Sirolimus-Eluting Stent Versus the New-Generation Everolimus-Eluting Stent: The RESET Trial.

OBJECTIVES: The aim of this study was to compare 7-year outcomes between the first-generation sirolimus-eluting stent (SES) and the new-generation everolimus-eluting stent (EES) in a randomized clinical trial. BACKGROUND: There is a scarcity of very long-term (beyond 5 years) data from clinical trials investigating whether new-generation drug-eluting stents have clear clinical advantages over first-generation drug-eluting stents. METHODS: RESET (Randomized Evaluation of Sirolimus-Eluting Versus Everolimus-Eluting Stent Trial) is the largest randomized trial comparing EES with SES (NCT01035450). Among a total of 3,197 patients in the original RESET population from 100 centers, the present extended 7-year follow-up study was conducted in 2,667 patients from 75 centers after excluding those patients enrolled from centers that denied participation. Complete 7-year follow-up was achieved in 91.5% of patients. RESULTS: The cumulative 7-year incidence of the primary efficacy endpoint of target lesion revascularization was not significantly different between EES and SES (10.2% vs. 11.7%; hazard ratio: 0.87; 95% confidence interval: 0.68 to 1.10; p = 0.24). The risk for the primary safety endpoint of death or myocardial infarction trended lower with EES than with SES (20.6% vs. 23.6%; hazard ratio: 0.85; 95% confidence interval: 0.72 to 1.005; p = 0.06). The cumulative 7-year incidence of definite stent thrombosis was very low and similar between EES and SES (0.9% vs. 1.0%; p = 0.82). The lower risk of EES relative to SES was significant for the composite secondary endpoint of target lesion failure (13.3% vs. 18.1%; hazard ratio: 0.72; 95% confidence interval: 0.59 to 0.88; p = 0.001). CONCLUSIONS: During 7 years of follow-up, the risk for target lesion revascularization was not significantly different between the new-generation EES and the first-generation SES.

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.

OBJECTIVES: 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. BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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).

Evaluation of prolonged safety and efficacy of biodegradable polymer coated sirolimus-eluting coronary stent system: 1-year outcomes of the INDOLIMUS Registry.

BACKGROUND: The main aim is to evaluate prolonged safety and efficacy of the Indolimus (Sahajanand Medical Technologies Pvt. Ltd.) sirolimus-eluting coronary stent system. METHODS: It was a single center, non randomized, retrospective registry. Out of total 530 patients involved in the INDOLIMUS Registry, follow-up of 523 patients were obtained at 1-year The primary end-point of this was major adverse cardiac events, which is a composite of cardiac death, target lesion revascularization, target vessel revascularization, myocardial infarction and stent thrombosis, at 1-year follow-up. RESULTS: Cardiac death, target lesion revascularization and myocardial infarction at 1-year were reported in 19 (3.6%), 2 (0.4%), and 2 (0.4%) patients respectively, while stent thrombosis was reported in 1 (0.2%) patient. The resultant major adverse cardiac events at 1-year were reported to be 24 (4.5%). CONCLUSIONS: The lower incidence of MACE in uncontrolled and more complex cohorts at 1-year follow-up clearly depicts the prolonged safety and efficacy of the Indolimus sirolimus-eluting stent (SES) system.

Clinical outcomes according to diabetic status in patients treated with biodegradable polymer sirolimus-eluting stents versus durable polymer everolimus-eluting stents: prespecified subgroup analysis of the BIOSCIENCE trial.

BACKGROUND: Ultrathin strut biodegradable polymer sirolimus-eluting stents (BP-SES) proved noninferior to durable polymer everolimus-eluting stents (DP-EES) for a composite clinical end point in a population with minimal exclusion criteria. We performed a prespecified subgroup analysis of the Ultrathin Strut Biodegradable Polymer Sirolimus-Eluting Stent Versus Durable Polymer Everolimus-Eluting Stent for Percutaneous Coronary Revascularisation (BIOSCIENCE) trial to compare the performance of BP-SES and DP-EES in patients with diabetes mellitus. METHODS AND RESULTS: BIOSCIENCE trial was an investigator-initiated, single-blind, multicentre, randomized, noninferiority trial comparing BP-SES versus DP-EES. The primary end point, target lesion failure, was a composite of cardiac death, target-vessel myocardial infarction, and clinically indicated target lesion revascularization within 12 months. Among a total of 2119 patients enrolled between February 2012 and May 2013, 486 (22.9%) had diabetes mellitus. Overall diabetic patients experienced a significantly higher risk of target lesion failure compared with patients without diabetes mellitus (10.1% versus 5.7%; hazard ratio [HR], 1.80; 95% confidence interval [CI], 1.27-2.56; P=0.001). At 1 year, there were no differences between BP-SES versus DP-EES in terms of the primary end point in both diabetic (10.9% versus 9.3%; HR, 1.19; 95% CI, 0.67-2.10; P=0.56) and nondiabetic patients (5.3% versus 6.0%; HR, 0.88; 95% CI, 0.58-1.33; P=0.55). Similarly, no significant differences in the risk of definite or probable stent thrombosis were recorded according to treatment arm in both study groups (4.0% versus 3.1%; HR, 1.30; 95% CI, 0.49-3.41; P=0.60 for diabetic patients and 2.4% versus 3.4%; HR, 0.70; 95% CI, 0.39-1.25; P=0.23, in nondiabetics). CONCLUSIONS: In the prespecified subgroup analysis of the BIOSCIENCE trial, clinical outcomes among diabetic patients treated with BP-SES or DP-EES were comparable at 1 year. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01443104.

One-year clinical outcomes of everolimus- versus sirolimus-eluting stents in patients with acute myocardial infarction.

BACKGROUND: In contrast to many studies comparing everolimus-eluting stent (EES) with paclitaxel-eluting stent (PES), data directly comparing EES with sirolimus-eluting stent (SES) are limited, especially in patients with acute myocardial infarction (AMI). METHODS: This study includes 2911 AMI patients treated with SES (n=1264) or EES (n=1701) in Korea Acute Myocardial Infarction Registry (KAMIR). Propensity score matching was applied to adjust for baseline imbalance in clinical and angiographic characteristics, yielding a total of 2400 well-matched patients (1200 receiving SES and 1200 receiving EES). One-year clinical outcomes were compared between the two propensity score matched groups. RESULTS: Baseline clinical and angiographic characteristics were similar between the two propensity score matched groups. One-year clinical outcomes of the propensity score matched cohort were comparable between the EES versus the SES groups including the rates of cardiac death (4.8% vs. 4.8%, P=1.000), recurrent myocardial infarction (1.4% vs. 1.7%, P=0.619), target lesion revascularization (1.4% vs. 1.6%, P=0.737), target lesion failure (7.0% vs. 7.3%, P=0.752), and probable or definite stent thrombosis (0.5% vs. 0.9%, P=0.224) except for a trend toward lower incidence of target vessel revascularization (1.9% vs. 3.0%, P=0.087) and a lower rate of total major adverse cardiac events (9.3% vs. 11.9%, P=0.034) in the EES group. CONCLUSIONS: The present propensity score matched analysis performed in a large-scale, prospective, multicenter registry suggests that the second-generation drug-eluting stent EES has at least comparable or even better safety and efficacy profiles as compared with SES in the setting of AMI.

Comparison of sirolimus- and paclitaxel-eluting stents in patients with moderate renal insufficiency: results from the J-DESsERT trial.

BACKGROUND: It is unclear whether there are differences in clinical outcomes between sirolimus-eluting stents (SES) and paclitaxel-eluting stents (PES) in patients with moderate renal insufficiency (RI). METHODS: The Japan-Drug Eluting Stents Evaluation; a Randomized Trial (J-DESsERT) was a prospective, randomized multicenter trial which compared 1:1 coronary stenting between SES and PES patients. Patient with serious RI (serum creatinine value 2mg/dL or higher) were excluded. Patients were classified into 2 arms according to renal function: a non-RI arm of 2220 patients (SES 1094 and PES 1126 patients with estimated glomerular filtration rate (eGFR) ≥60 mL min(-1) 1.73 m(-2)) and an RI arm of 1206 patients (SES 613, PES 593 with 30≤eGFR <60 mL min(-1) 1.73 m(-2)). RESULTS: At 12 months, the primary endpoint of target vessel failure in the non-RI arm occurred in 6.0% in the SES group and 8.7% in the PES group (p=0.02). In the RI arm, this occurred in 5.7% and 8.1% (p=0.10). Mortality rates were 0.8% vs 0.7% (p=0.78) in the non-RI arm, and 2.2% vs 2.1% (p=0.90) in the RI arm. Cardiac death was 0.4% vs 0.1% (p=0.17) in the non-RI arm, and 1.0% vs 1.0% (p=0.96) in the RI arm. Mortality was higher in patients with RI than those without RI (2.1% vs 0.8%; p<0.01). Cardiac death rates increased in the RI arm compared with those in the non-RI arm (1.0% vs 0.2%; p<0.01). CONCLUSIONS: Regardless of the presence or absence of moderate RI, differences in outcomes between SES and PES change little except mortality and cardiac death.