Sirolimus Stents Research Articles

Resultados clínicos de um ano do registro POLAR (Promus eluting stent registry in Latin America)

INTRODUÇÃO: Desde 2002, os stents farmacológicos são utilizados em diversas populações de pacientes objetivando alcançar elevados índices de sucesso, com baixas taxas de reestenose angiográfica e clínica. Com os resultados adversos em relação à trombose tardia associados aos stents farmacológicos de primeira geração eluidores de sirolimus e paclitaxel, surgiram recentemente os stents farmacológicos de segunda geração eluidores de zotarolimus e everolimus. MÉTODOS: O registro POLAR é um registro prospectivo, não-randomizado, multicêntrico, que incluiu 988 pacientes totalizando 1.362 lesões tratadas com o stent Promus®. Objetivando representar a prática clínica, praticamente todos os subtipos de pacientes e lesões foram incluídos neste registro. O seguimento clínico foi planejado para ser realizado 1 mês, 6 meses, 12 meses e 24 meses após o procedimento. RESULTADOS: A maioria dos pacientes era do sexo masculino (69,8%), com média de idade de 64,9 ± 9,4 anos, 35,2% eram diabéticos e 55% tinham sido tratados na vigência de síndrome coronária aguda. O diâmetro do vaso foi de 2,95 ± 0,43 mm e a extensão da lesão, de 20,5 ± 5,6 mm. Foi implantado 1,14 ± 0,38 stent/paciente e o sucesso do procedimento foi alcançado em 96,6% dos casos. Eventos cardíacos adversos maiores ocorreram em 4,1% dos pacientes, e trombose de stent esteve presente em 5 pacientes (0,5%) após o seguimento clínico de 12 meses. CONCLUSÕES: O presente registro sugere que os stents farmacológicos eluidores de everolimus são seguros e eficazes em pacientes da prática clínica diária, com baixas taxas de eventos cardíacos adversos maiores ao término do primeiro ano de seguimento.

DRUG-ELUTING STENTS FOR THE TREATMENT OF SMALL CORONARY ARTERY WITH DIABETES MELLITUS: A COMPARISON WITH SIROLIMUS, PACLITAXEL, ZOTAROLIMUS (ENDEAVOR RESOLUTE), BIOLIMUSA9, EPC CAPTURE AND EVEROLIMUS-ELUTING STENT: MULTICENTER REGISTRY IN ASIA

Aim: The aim of this study is to compare the safety and efficacy of Sirolimus (SES), Paclitaxel (PES), Zotarolimus (ZES-R/ Endeavor Resolute), BiolimusA9 (BES), EPC capture (ECS) and Everolimus-eluting stent (EES) on the outcome of stenting in patients with diabetic very long coronary lesion (VLL) (lesion length ≥40 mm). Methods: A prospective analysis of 1317 patients with diabetic VLL (328 SES, 280 PES, 189 ZES-R, 190 BES, 143 ECS, 187 EES) was performed. The study endpoints were major adverse cardiac events (MACE) at 12 months, restenosis rate and target lesion revascularization (TLR) at 12 months. Results: See table for clinical results. Conclusion: (1) The use of drug-eluting stents in patients with diabetic VLL seems to be favorable in terms of in-hospital clinical outcome and long-term results. (2) Patients treated with BES and EES showed lesser restenosis rate and TLR compared with PES and ECS.

Acute and Long-Term Angiographic Outcomes of Side Branch Stenosis after Randomized Treatment of Zotarolimus-, Sirolimus-, and Paclitaxel-Eluting Stent for Coronary Artery Stenosis

This was designed to assess the outcomes of side branch (SB) stenosis after implantation of three drug-eluting stents (DES). From 2,645 patients in the ZEST (Comparison of the Efficacy and Safety of Zotarolimus-Eluting Stent with Sirolimus-Eluting and PacliTaxel-Eluting Stent for Coronary Lesions) Trial, 788 patients had 923 bifurcation lesions with SB ≥ 1.5 mm were included. SB was treated in 150 lesions, including 35 (3.8%) receiving SB stenting. Of untreated SB with baseline stenosis < 50%, the incidences of periprocedural SB compromise was similar in the zotarolimus (15.8%), sirolimus (17.2%), and paclitaxel (16.6%) stent groups (P = 0.92). At follow-up angiography, delayed SB compromise occurred in 13.9%, 3.2%, and 9.4% (P = 0.010) of these groups. When classified into four groups (< 50%, 50%-70%, 70%-99%, and 100%), 9.0% of untreated SB were worsened, whereas improvement and stationary were observed in 9.6% and 81.4%. In a multivariable logistic regression model, main branch (MB) stenosis at follow-up (%) was the only independent predictor of SB stenosis worsening (odds ratio, 1.03; 95% confidence interval, 1.01-1.04; P < 0.001). After MB stenting in bifurcation lesions, a minority of SB appears to worsen. DES with strong anti-restenotic efficacy may help maintain SB patency.

A late coronary aneurysm after sirolimus stent implantation which was treated with coronary graft stent

A late coronary aneurysm after sirolimus stent implantation which was treated with coronary graft stent

Coronary pseudoaneurysm in a non-polymer drug-eluting stent: a rare entity

Coronary pseudoaneurysms following implantation of drug-eluting stents, although rare, are not unknown. Nearly all such cases have been reported in patients with sirolimus or paclitaxel polymer-based stents. We describe a case of coronary pseudoaneurysm developing with a non-polymer-based drug-eluting stent in a 50-year-old man who was successfully managed by coronary artery bypass grafting.

Clinical outcome of percutaneous treatment of in-stent restenosis with drug-eluting stents: results from the first phase of the prospective multicentre German DES.DE registry

Treatment of in-stent restenosis (ISR) was historically considered the Achilles heel of percutaneous coronary intervention (PCI) and has been associated with worse clinical outcome than PCI of de novo lesions. However, comparative data on ISR and de novo lesions using drug-eluting stents (DES) are scarce. Therefore, we aimed to assess the impact of ISR on procedural and long-term outcome in patients treated with DES. We analysed data from 5,144 patients enrolled in the prospective multicentre German Drug-Eluting Stent Registry (DES.DE). The registry included 872 patients (17%) treated for ISR with follow-up data (median 12.4 months) available for 817 patients (94%). Of the ISR patients, 37.1% (n=323) presented with acute coronary syndromes. In total, 1,027 DES were used (528 sirolimus-eluting stents and 499 paclitaxel-eluting stents), with successful implantation in 97.7% of patients. In the ISR cohort, myocardial infarction (MI) during hospitalisation was observed in 1.6% of patients (n=14) and in-hospital mortality was only 0.3% (n=3). Major adverse cardiac and cerebrovascular events (MACCE) rate at follow-up (defined as a composite of death, MI and stroke) was 8.7% (n=71) versus 8.2% (n=325) in patients treated for de novo lesions (p=0.63). Target vessel revascularisation (TVR) rate was 12.7% (n=100), numerically higher than in patients with de novo lesions (10.5%, p=0.07). Ten patients (1.3%) suffered from ARC definite stent thrombosis versus 0.7% observed in patients with de novo lesions (p=0.13). After adjustment for differences in baseline characteristics, TVR rates were statistically higher in the ISR cohort (OR 1.27, 95%CI 1.01-1.61, p=0.04), while MACCE rates remained comparable (OR 1.10, 95%CI 0.83-1.44, p=0.51). The type of stent used (sirolimus vs. paclitaxel-eluting stent) did not impact the rate of MACCE, TVR or definite stent thrombosis at one year. Results from this large prospective multicentre registry confirm that treatment of ISR with DES is effective and safe, with similar procedural outcome but slightly higher revascularisation rates at one year compared to patients treated for de novo lesions, with no differences in outcome between sirolimus- and paclitaxel-eluting stents.

Evaluating cost-effectiveness using an economic model: analysis from the TAXUS ATLAS long lesion trial

Objective: Drug-eluting stents (DES) are known to impact vascular functions. The impact of the polymers and the drugs used in DES on the pathways regulating vascular reactivity is not well understood. The objective of the present study was to investigate the effect of rapamycin class of DES on vascular reactivity and the genes involved in the vasoregulating nitric oxide pathway. Methods: A porcine model of stent implantation was used. Bare-metal stents (BMS), DES, sirolimus, zotarolimus or other limus stents were placed in two epicardial vessels of each animal with S/A ratio of 1.1:1 and overlapping segment of 1/3 to 1/2 of single stent length. After 28 days, vascular function was determined by acetylcholine (Ach) challenge. Tissue samples from the stented segment of four arteries from each group were collected. RNA and proteins were isolated. Selected genes and proteins regulating the nitric oxide pathway were further analyzed by real-time polymerase chain reaction (PCR) and western blotting. Results and conclusions: As compared to the BMS, the vascular reactivity to Ach challenge was significantly impaired and super oxide generation was significantly increased in vessels implanted with DES. Quantitative reverse transcriptase PCR analysis of genes involved in vascular reactivity and nitric oxide pathway indicated changes in the expression of VEGF, DDAH and Arginase genes. Western blotting showed that the total or phosphorylated forms of eNOS were similar in BMSand DES-implanted vessels. However, the phosphorylated form of the eNOS regulating protein kinase AKT was significantly increased in zotarolimus stent but not in sirolimus stent. The latter results suggest that nitric oxide pathway sites in addition to eNOS gene expression or protein level may play a role in modulating vascular reactivity in response to DES. Our studies suggest that an interplay between multiple vascular genes including AKT may play an important role in the impairment of vascular response by DES. Further studies will delineate the role of various genes in the pathophysiology of DES leading to vascular dysfunction.

Understanding the impact of drug-eluting stent on vascular function and the nitric oxide pathway genes using a pig coronary artery stent implantation model

Objective: Drug-eluting stents (DES) are known to impact vascular functions. The impact of the polymers and the drugs used in DES on the pathways regulating vascular reactivity is not well understood. The objective of the present study was to investigate the effect of rapamycin class of DES on vascular reactivity and the genes involved in the vasoregulating nitric oxide pathway. Methods: A porcine model of stent implantation was used. Bare-metal stents (BMS), DES, sirolimus, zotarolimus or other limus stents were placed in two epicardial vessels of each animal with S/A ratio of 1.1:1 and overlapping segment of 1/3 to 1/2 of single stent length. After 28 days, vascular function was determined by acetylcholine (Ach) challenge. Tissue samples from the stented segment of four arteries from each group were collected. RNA and proteins were isolated. Selected genes and proteins regulating the nitric oxide pathway were further analyzed by real-time polymerase chain reaction (PCR) and western blotting. Results and conclusions: As compared to the BMS, the vascular reactivity to Ach challenge was significantly impaired and super oxide generation was significantly increased in vessels implanted with DES. Quantitative reverse transcriptase PCR analysis of genes involved in vascular reactivity and nitric oxide pathway indicated changes in the expression of VEGF, DDAH and Arginase genes. Western blotting showed that the total or phosphorylated forms of eNOS were similar in BMSand DES-implanted vessels. However, the phosphorylated form of the eNOS regulating protein kinase AKT was significantly increased in zotarolimus stent but not in sirolimus stent. The latter results suggest that nitric oxide pathway sites in addition to eNOS gene expression or protein level may play a role in modulating vascular reactivity in response to DES. Our studies suggest that an interplay between multiple vascular genes including AKT may play an important role in the impairment of vascular response by DES. Further studies will delineate the role of various genes in the pathophysiology of DES leading to vascular dysfunction.

THE EFFECT OF DRUG-ELUTING STENTS ON CLINICAL AND ANGIOGRAPHIC OUTCOMES IN DIABETIC, PATIENTS, 2 YEARS RESULT: MULTICENTER REGISTRY IN ASIA

The aim of this study is to compare the safety and efficacy of Sirolimus (SES), Paclitaxel (PES), EPC capture (ECS), Zotarolimus (ZES-R/ Endeavor Resolute), BiolimusA9 (BES) and Everolimus-eluting stent (EES) on the outcome of percutaneous coronary intervention in patients with diabetes mellitus (DM

The 5352 A allele of the pro-inflammatory caspase-1 gene predicts late-acquired stent malapposition in STEMI patients treated with sirolimus stents

Late-acquired stent malapposition (LASM) is a common finding after sirolimus-eluting stent (SES) implantation and may be the cause for late stent thrombosis. Inflammation may play a pivotal role in LASM just as it plays in stent restenosis. We have therefore investigated seven polymorphisms involved in inflammatory processes, related in previous reports to restenosis, on the risk of LASM in SES patients. Patients with ST-elevation myocardial infarction who underwent SES implantation and had intravascular ultrasonography (IVUS) data available for both immediate post-intervention and 9-month follow-up were included in the present study. In total, 104 patients from the MISSION! Intervention Study were genotyped for the caspase-1 5352 G/A, eotaxin 1382 A/G, CD14 260 A/G, colony stimulating factor 2 1943 C/T, IL10 -1117 C/T, IL10 4251 C/T, and the tumor necrosis factor alpha 1211 C/T polymorphisms. LASM occurred in 26/104 (25%) of patients. We found a significantly higher risk for LASM in patients carrying the caspase-1 (CASP1) 5352 A allele (RR = 2.32; 95% CI 1.22-4.42). In addition, mean neointimal growth was significantly lower in patients carrying this LASM risk allele (1.6 vs. 4.1%, p = 0.014). The other six polymorphisms related to inflammation were not significantly related to the risk of LASM. In conclusion, carriers of the 5352 A allele in the caspase-1 gene are at increased risk of developing LASM after SES implantation. If this is confirmed in larger studies, then screening for this polymorphism in patients undergoing percutaneous coronary interventions could eventually help cardiologists to better select between commercially available stents.

E0231 Polymer-free sirolimus and probucol-eluting stent for renal artery: an initial experience in swine

ObjectiveBare metal stent (BMS) implantation can resolve renal artery stenosis successfully, but in-stent restenosis does occur, especially in small diameter renal arteries (<5.0 mm). The aim of this study is...

TCT-360: Difference of Heterogeneity of Neointima Thickness in Daibetic Patients between Sirolimus and Paclitaxel-Eluting Stents by Optical Coherence Tomography Analysis

TCT-360: Difference of Heterogeneity of Neointima Thickness in Daibetic Patients between Sirolimus and Paclitaxel-Eluting Stents by Optical Coherence Tomography Analysis

Long-term clinical outcome and prognosis after treatment of the first generation drug-eluting stent thrombosis

There are many reports concerning about the incidence, predictor, and the in-hospital outcomes of stent thrombosis (ST) of drug-eluting stent (DES) [ 1 Jeremias A. Sylvia B. Bridges J. et al. Stent thrombosis after successful sirolimus-eluting stent implantation. Circulation. 2004; 109: 1930-1932 Crossref PubMed Scopus (326) Google Scholar , 2 Airoldi F. Colombo A. Morici N. et al. Incidence and predictors of drug-eluting stent thrombosis during and after discontinuation of thienopyridine treatment. Circulation. 2007; 116: 745-754 Crossref PubMed Scopus (422) Google Scholar , 3 Kuchulakanti P.K. Chu W.W. Torguson R. et al. Correlates and long-term outcomes of angiographically proven stent thrombosis with sirolimus- and paclitaxel-eluting stents. Circulation. 2006; 113: 1108-1113 Crossref PubMed Scopus (621) Google Scholar , 4 Win H.K. Caldera A.E. Maresh K. et al. Clinical outcomes and stent thrombosis following off-label use of drug-eluting stents. JAMA. 2007; 297: 2001-2009 Crossref PubMed Scopus (315) Google Scholar , 5 Ong A.T. Hoye A. Aoki J. et al. Thirty-day incidence and six-month clinical outcome of thrombotic stent occlusion after bare-metal, sirolimus, or paclitaxel stent implantation. J Am Coll Cardiol. 2005; 45: 947-953 Abstract Full Text Full Text PDF PubMed Scopus (456) Google Scholar , 6 Iakovou I. Schmidt T. Bonizzoni E. et al. Incidence, predictors, and outcome of thrombosis after successful implantation of drug-eluting stents. JAMA. 2005; 293: 2126-2130 Crossref PubMed Scopus (2930) Google Scholar ]. However, there are limited data for the long-term outcomes of patients who have been treated for ST after DES implantation and recurrence rate of ST in real world. The purpose of the present study was to investigate the recurrence rate and the long-term outcomes of patients who successfully treated for first generation DES thrombosis.

Smooth Muscle Cells Orchestrate the Endothelial Cell Response to Flow and Injury

Local modulation of vascular mammalian target of rapamycin (mTOR) signaling reduces smooth muscle cell (SMC) proliferation after endovascular interventions but may be associated with endothelial cell (EC) toxicity. The trilaminate vascular architecture juxtaposes ECs and SMCs to enable complex paracrine coregulation but shields SMCs from flow. We hypothesized that flow differentially affects mTOR signaling in ECs and SMCs and that SMCs regulate mTOR in ECs. SMCs and/or ECs were exposed to coronary artery flow in a perfusion bioreactor. We demonstrated by flow cytometry, immunofluorescence, and immunoblotting that EC expression of phospho-S6 ribosomal protein (p-S6RP), a downstream target of mTOR, was doubled by flow. Conversely, S6RP in SMCs was growth factor but not flow responsive, and SMCs eliminated the flow sensitivity of ECs. Temsirolimus, a sirolimus analog, eliminated the effect of growth factor on SMCs and of flow on ECs, reducing p-S6RP below basal levels and inhibiting endothelial recovery. EC p-S6RP expression in stented porcine arteries confirmed our in vitro findings: Phosphorylation was greatest in ECs farthest from intact SMCs in metal stented arteries and altogether absent after sirolimus stent elution. The mTOR pathway is activated in ECs in response to luminal flow. SMCs inhibit this flow-induced stimulation of endothelial mTOR pathway. Thus, we now define a novel external stimulus regulating phosphorylation of S6RP and another level of EC-SMC crosstalk. These interactions may explain the impact of local antiproliferative delivery that targets SMC proliferation and suggest that future stents integrate design influences on flow and drug effects on their molecular targets.

Sirolimus versus paclitaxel-eluting stents in small coronary vessels: long-term outcomes from a single-center registry

Several studies showed that small vessel diameter is a determinant of increased risk of adverse events after stenting. The efficacy of different drug-eluting stent types implanted in small vessels has still not been established. The aim of the present observational study was to compare long-term clinical outcomes after sirolimus-eluting stent (SES) or paclitaxel-eluting stent (PES) implantation in lesions located in small coronary vessels. For the purpose of this analysis patients undergoing SES or PES implantation in vessels with diameter 2.5 mm or less, from May 2002 to December 2006, were included. Long-term rates of major adverse cardiac events were evaluated and compared between the two groups. Independent predictors of major adverse cardiac events were also investigated. A total of 336 patients were included, 225 were treated only with SES and 111 only with PES. During a mean follow-up of 23.3 +/- 12.1 months the major adverse cardiac events rates were 12.8 versus 13.6%, P = 0.98 in SES versus PES groups, respectively. The rates of target lesion revascularization (8.0 versus 6.3%, P = 0.75), mortality (3.5 versus 4.5%, P = 0.88) and myocardial infarction (2.6 versus 4.5%, P = 0.41) were similar between SES and PES, respectively. The overall thrombosis rate was also not significantly different in SES and PES groups (1.3% SES versus 4.5% PES, P = 0.12). In this study SES and PES provided similar long-term results after treatment of lesions in small vessels. Nevertheless, larger randomized studies are needed to confirm these findings.

Does “late catch-up” exist in drug-eluting stents: Insights from a serial quantitative coronary angiography analysis of sirolimus versus paclitaxel-eluting stents

Recent studies have suggested the possibility of late catch-up after drug-eluting stent implantation. There are limited data on whether late catch-up exists in sirolimus-eluting stents (SESs) and paclitaxel-eluting stents (PESs). Consecutive patients were routinely recommended 2 serial angiographic follow-ups (at 6-9 and 18-24 months post-percutaneous coronary intervention). A serial quantitative coronary angiographic analysis was performed in lesions not receiving target lesion revascularization at first follow-up. Early luminal loss (LL) was defined as the difference in minimal luminal diameter between the first angiographic follow-up and immediate post-percutaneous coronary intervention, and delayed LL was defined as the difference in minimal luminal diameter between the second and first angiographic follow-up. Four hundred twelve lesions in the main cohort (PES 128, SES 284) and 47 lesions in the secondary hybrid cohort (PES 23, SES 24), which received serial angiographic follow-ups without target lesion revascularization, were included. In the main cohort, early LL was higher in PES compared with SES (0.56 vs 0.20 mm, P < .01), whereas delayed LL occurring after the first angiographic follow-up was higher in SES (0.10 vs 0.28 mm, P < .01), suggesting more prominent late catch-up in SES. Early LL showed better correlation with total LL (correlation coefficient 0.82 vs 0.30) in PES, whereas delayed LL showed better correlation with total LL (correlation coefficient 0.42 vs 0.91) in SES. Such observations were reproducible in the hybrid cohort, where both SES and PES were implanted at index procedure. Late catch-up occurs in both PES and SES with greater delayed late loss in SES. Our data suggest that the process of neointima formation after SES and PES implantation may follow a slightly different timeline.

Long-Term Effectiveness and Safety of Sirolimus Stent Implantation for Coronary In-Stent Restenosis: Results of the TRUE (Tuscany Registry of Sirolimus for Unselected In-Stent Restenosis) Registry at 4 Years

The aim of this study was to evaluate the long-term clinical outcome of the efficacy and safety of sirolimus-eluting stents (SES) for in-stent restenosis (ISR) in the TRUE (Tuscany Registry of Unselected In-Stent Restenosis) database. The TRUE registry demonstrated that SES in the treatment of bare-metal stent ISR is efficacious (5% of target lesion revascularization [TLR]) and safe (stent thrombosis <1%) at 9 months. Clinical outcome at 4 years is reported. A total of 244 patients with ISR who were treated with SES implantation represent the study population. The incidence of major adverse cardiac events was collected at 4 years. At 4-year follow-up, overall mortality was 9.8% (24 patients). Cardiac death occurred in 11 (4.5%), nonfatal myocardial infarction in 8 (3.2%), and TLR in 27 (11.1%) patients for a cumulative event-free survival rate of 80.3%. Definite stent thrombosis occurred in 5 (2%) patients and possible stent thrombosis in 2 (0.8%). Diabetes remained an independent negative predictor of freedom from TLR (odds ratio [OR]: 0.38; 95% confidence interval [CI]: 0.20 to 0.71, p = 0.002) and major adverse cardiac events (OR: 0.38; 95% CI: 0.20 to 0.71, p = 0.002). The clinical benefit of SES implantation for bare-metal stent ISR is maintained at 4 years with a low TLR rate and an overall incidence of stent thrombosis of 0.7% per year.

Fundamento e desenho do teste randomizado PAINT

We describe the rationale and design for the 'PercutAneous INTervention with biodegradable-polymer based paclitaxel-eluting or sirolimus-eluting versus bare stents for de novo coronary lesions - PAINT trial'.To evaluate two novel formulations of paclitaxel-eluting stent and the sirolimus-eluting stent against a stent with the same metallic structure but without polymer coating or drug elution.The PAINT is a multicenter 3-arm randomized trial, conducted in Brazilian tertiary institutions, which included 275 patients allocated for the InfinniumR paclitaxel-eluting stent, the SupralimusR sirolimus-eluting stent or the Milennium MatrixR bare metal stent in a 2:2:1 ratio. Patients had de novo coronary lesions in native vessels with a diameter between 2.5 and 3.5 mm, amenable for treatment with a single stent of 29 mm or less in length. The primary objective was to compare the in-stent late loss at 9 months of both paclitaxel- and sirolimus-eluting versus the late loss of control bare metal stents. Important secondary objectives included the comparison in outcomes between sirolimus and paclitaxel stents, as well as the analysis of the incidence of major adverse cardiac events.The PAINT trial had a unique design that allowed for the evaluation of the safety and efficacy profiles of two novel drug-eluting stent formulations, with a biodegradable-polymer carrier and releasing paclitaxel or sirolimus, which were compared against a bare metal stent (primary objective). As the drug-eluting stents differed by the drug, but were identical otherwise, the trial also allowed the comparison of the anti-restenosis effects of sirolimus versus paclitaxel (secondary objective).

Rationale and design of the Patient Related OuTcomes with Endeavor versus Cypher stenting Trial (PROTECT): Randomized controlled trial comparing the incidence of stent thrombosis and clinical events after sirolimus or zotarolimus drug-eluting stent implantation

Drug-eluting stents (DES) reduce restenosis rates compared to bare-metal stents. Most trials using DES enrolled selected patient and lesion subtypes, and primary endpoint focused on angiographic metrics or relatively short-term outcomes. When DES are used in broader types of lesions and patients, important differences may emerge in long-term outcomes between stent types, particularly the incidence of late stent thrombosis. PROTECT is a randomized, open-label trial comparing the long-term safety of the zotarolimus-eluting stent and the sirolimus-eluting stent. The trial has enrolled 8,800 patients representative of those seen in routine clinical practice, undergoing elective, unplanned, or emergency procedures in native coronary arteries in 196 centers in 36 countries. Indications for the procedure and selection of target vessel and lesion characteristics were at the operator's discretion. Procedures could be staged, but no more than 4 target lesions could be treated per patient. Duration of dual antiplatelet therapy was prespecified to achieve similar lengths of treatment in both study arms. The shortest predefined duration was 3 months, as per the manufacturer's instructions. The primary outcome measure is the composite rate of definite and probable stent thrombosis at 3 years, centrally adjudicated using Academic Research Consortium definitions. The main secondary end points are 3-year all-cause mortality, cardiac death, large nonfatal myocardial infarction, and all myocardial infarctions. This large, international, randomized, controlled trial will provide important information on comparative rates of stent thrombosis between 2 different DES systems and safety as assessed by patient-relevant long-term clinical outcomes.

Comparison of 2‐year clinical outcomes with sirolimus and paclitaxel‐eluting stents for patients with diabetes: Results of the Registro Regionale AngiopLastiche Emilia‐Romagna Registry

Long-term outcomes of percutaneous coronary interventions (PCI) with sirolimus-eluting stents (SES) compared to paclitaxel-eluting-stents (PES) in unselected diabetics in routine practice is still debated. This study compared the 2-year incidence of MACE (all-cause mortality, nonfatal myocardial infarction and target vessel revascularization) of SES and PES in a real-world setting of patients with diabetes. Observational, multicenter, nonrandomized study. Prospective web-based registry (REAL Registry; study period, 2002-2005) comprising all 13 hospitals performing PCI. Among the 945 eligible patients treated with either SES alone (n = 606) or PES alone (n = 339), 29% were insulin-requiring, 72% had multivessel coronary disease, 26% had prior myocardial infarction and 10% had poor left ventricular function. Unadjusted and propensity score-adjusted 2-year clinical outcome. After propensity score adjustment, 2-year MACE incidence in the SES and PES groups was equivalent (23.3% vs. 23.7%, HR 1.01, 95%CI 0.72-1.42, P = 0.96). Adjusted 2-year angiographic stent thrombosis occurred in 1.1% of the SES patients versus 2.6% of the PES patients (P = 0.15). In this large, real-world, diabetic population treated with DES, there was no difference in outcome between SES and PES. Further studies are needed to demonstrate the long-term safety of different types of DES in patients with diabetes.