Sirolimus Stents Research Articles

Incidence and Management of In-Stent Restenosis in Patients with Drug-Eluting Stents

Introduction: The most prevalent complication of cardiac intervention is restenosis. After the BMS period, drug-eluting stents (DES) are the most suitable choice for stenosis treatment, particularly for patients with a high risk of bleeding. The rate of restenosis was much lower with current DES technology. The introduction of drug-eluting balloons (DEBs) is a potential breakthrough for coronary revascularisation treatments, particularly in-stent restenosis. Objective: This retrospective study was carried out to find the incidence and management of in-stent restenosis in patients with drug-eluting strains. Methods: After the hospital ethics committee's permission, patients' medical data was evaluated. Clinical and personal data were acquired from medical records. Risk variables for atherosclerosis were collected, along with baseline labs and echocardiography, to assess the ejection fraction of each patient. Classified interventional cardiologists analysed angiographic pictures to confirm the existence of ISR. Details about prior angioplasty and the kind of stent were noted. All patients with considerable drug-eluting in-stent restenosis (DES-ISR) and eligible for therapy with DEB were included in the analysis. Results: Two hundred ninety-eight patients received at least one DES throughout the research period. ISR was identified in 50 individuals (16.77%). Thus, 50 patients who fulfilled the inclusion criteria were included in the study. 2% of the study population presented with STEMI, 22% with NSTEMI, 24% with UA, and 52% presented with non-ACS. Among all the patients that had ISR, diabetes and hypertension were the most common comorbidities found in the study population. Following coronary angiography, it was discovered that the frequency of ISR was 11(22%) in patients with Xlimus sirolimus stent, 10(20%) with Xience (everolimus-eluting stent), 13(26%) with Ultimate (sirolimus-eluting stent), and 16(32%) with Biomatrix stent. Twenty-eight patients with DES ISR who met the inclusion criteria received revascularisation with DEB. After a median of 18 months of follow-up, eight patients remained symptomatic, with 4 developing MACE, one resulting in cardiac death, and 3 requiring revascularisation. Thus, the overall MACE rate was 21%. There were two fatalities from non-cardiac causes. Conclusions: In all new-generation DES, ISR often manifests as angina. There was no statistically significant difference in terms of ISR between second- and third-generation DES.DEB technology, particularly for DES, holds potential for ISR. Our experience highlights the need for more data, including randomised studies in various patient groups.

A more-Comers populAtion trEated with an ultrathin struts polimer-free Sirolimus stent: an Italian post-maRketing study (the CAESAR registry).

The use of contemporary drug-eluting stents (DES) has significantly improved outcomes of patients with coronary artery disease (CAD) undergoing percutaneous coronary intervention (PCI). However, concerns exist regarding the long-term proinflammatory effects of durable polymer coatings used in most DES, potentially leading to long-term adverse events. First-generation polymer-free stent technologies, such as sirolimus- and probucol-eluting stents (PF-SES), have shown an excellent safety and efficacy profile. The aim of this study was to evaluate the safety and efficacy of the new ultrathin Coroflex ISAR NEO PF-SES, in a more-comers PCI population. The CAESAR (a more-Comers populAtion trEated with an ultrathin struts polimer-free Sirolimus stent: An Italian post-maRketing study) registry is a multicenter, prospective study conducted in Italy, enrolling more-comers CAD patients undergoing PCI with the Coroflex ISAR NEO stent. Patients with left main (LM) disease, cardiogenic shock (CS), or severely reduced left-ventricular ejection fraction (LVEF) were excluded. The primary endpoint was target-lesion revascularization (TLR) at 1 year. A total of 425 patients were enrolled at 13 centers (mean age 66.9 ± 11.6 years, Diabetes mellitus 29%, acute coronary syndrome 67%, chronic total occlusion 9%). Of these, 40.9% had multivessel disease (MVD) and in 3.3% cases, the target lesion was in-stent restenosis (ISR). Clinical device success was reached in 422 (99.6%) cases. At 1 year, only two (0.5%) subjects presented ischemia-driven TLR. The 1-year rates of target vessel revascularization and MACE were 0.5% and 5.1%, respectively. Major bleeding was observed in four (1.0%) patients. In this multicenter, prospective registry, the use of a new ultrathin Coroflex ISAR NEO PF-SES in a more-comers PCI population showed good safety and efficacy at 1 year.

Frequency of In-Stent Restenosis among Different 2nd/3rd Drug Eluting Stents in Patients Presenting with ACS/Angina at Trtiary Cradiac Care Centre

Objective: Primary objective was to determine the frequency of in-stent restenosis (ISR) among second/third generation drug eluting stents (DES), diagnosed angiographically in cardiac catheterization laboratory either in emergency settings or elective stage procedure and to determine the risk factors precipitating ISR.
 Study Design: Analytical Cross-sectional study.
 Place and Duration of the study: Tertiary Cardiac Care Center of Rawalpindi Pakistan, from Nov 2021 to Apr 2022.
 Methodology: After hospital ethical committee approval, medical data of consecutive patients were analyzed. Clinical and bio data were obtained followed by admission. Risk factors for atherosclerosis obtained along with baseline investigations and echocardiogram obtained to calculate ejection fraction. Classified interventional cardiologists analyzed angiographic images and confirmed the presence of ISR. Details of previous angioplasty and type of stent were documented.
 Results: Out of total 137 patients, 98(72%) were males and 39(28%) females. 94(68%) patients were diabetic, 102(72%) were hypertensive, 72(52%) had dyslipidemia, 56(40%) were smokers, and 32(23.35%) strong family history of CHD. After coronary angiography we found that frequency of ISR was 32(23%) in patients who had Xlimus sirolimus stent, 34(24.8%) patients had Xience (everolimus eluting stent), 33(24%) had Ultimaster (sirolimus eluting stent), 38(27%) had Biomatrix stent with p-value=0.25.
 Conclusion: The clinical presentation of ISR is usually with angina in all new generation DES. There was no statistically significant difference in terms of ISR among second/3rd generation DES. DES ISR not only depends upon the type of DES used but also depends upon multiple patient ...

Assessment of the safety and effectiveness of the first sirolimus stent manufactured in Viet Nam

Objectives: To evaluate the effectiveness and safety of the first sirolimus-eluting stent made in Vietnam (Xplosion stent) on Vietnamese patients via the following outcomes: restenosis rate in the stent and at the two heads of stent, stent occlusion rate, and mortality rate due to myocardial infarction at 6 months and 12 months following stent placement. Methods and Results: The prospective, open-label, non-randomized, longitudinal study enrolled 43 patients diagnosed with stable angina and de novo lesions with a 2.5 – 3.5 mm reference diameter and 24 mm in length. The patients received one stent per branch, and some received stents in multiple branches. All patients were scheduled for angiographic follow-up at 6 months, and if subjects consented, at 12 months. The subjects' mean age was 60.05 +/- 11.07 years, and many had cardiovascular risk factors, such as hypertension (83.72%), dyslipidemia (53.49%), and diabetes mellitus (25.58%). Stenting was performed on 50 lesions with a sirolimus drug-eluting stent (1.16 stent/patient on average). Of the patients, 92% had single-vessel coronary artery disease, and type B lesions (AHA) accounted for the majority (56%), with distribution on the LAD (42%), LCx (24%), and RCA (34%). The technical and procedural success rate of stent placement was 97.67%, with a very low complication rate (0%). The restenosis rate at 6 months was 0%. All patients were followed up to 12 months. Only two patients had recurrent chest pain and underwent coronary angiography; however, there was no in-stent restenosis and no need for revascularization. Therefore, the rate of chest pain recurrence after 12 months was 4.65% (2/43), and the rate of target vessel revascularization at 12 months was 0%. At 6- and 12-month follow-up, we observed no death due to unknown causes, no target-vessel myocardial infarction, and two clinically-driven re-angiographies with no need for revascularization. No additional events were reported beyond the 6-month follow-up. During the entire 12-month follow-up period, none of the patients experienced a definite or probable stent thrombosis. Conclusion: The new sirolimus-eluting stents manufactured in Vietnam use a new technology transferred from the United States. They were placed successfully and showed a sustained favorable safety profile for up to 12 months. These findings suggest that these new stents could be used in many catheterization laboratories in Viet Nam.

Ticagrelor monotherapy versus dual anti-platelet therapy in patients undergoing percutaneous coronary intervention: a subgroup analysis of safety in multiple comorbidities

Abstract Background The TICO trial evaluated the effectiveness of ticagrelor monotherapy after 3 months of dual antiplatelet therapy (DAPT) versus continued DAPT and measured the risk of major bleeding and adverse cardiac/cerebrovascular events at 12 months, however there are certain subgroups such as the elderly that have higher bleeding risks than the average population. Objective To determine if specific comorbidities or patient demographics increase the risks of major bleeding or major cardiac/cerebrovascular events in patients receiving ticagrelor monotherapy versus aspirin plus ticagrelor in patients post percutaneous coronary intervention with acute coronary syndrome. Methods This was a post-hoc subgroup analysis of multiple cohorts (Age, diabetes, hypertension, chronic kidney disease, and obesity) from the TICO (The ticagrelor monotherapy after 3 months in the patients treated with new generation sirolimus stent for acute coronary syndrome) study. The co-primary outcomes that were measured were major bleeding events and major adverse cardiac and cerebrovascular events. Results Compared to DAPT, ticagrelor monotherapy significantly decreases risk of major bleeding events in patients >65 (HR 0.48; 95% CI 0.24–0.95), without diabetes (HR 0.48; 95% CI 0.25–0.94), without CKD (HR 0.48; 95% CI 0.25–0.95), and non-obese (HR 0.49; 95% CI 0.25–0.95). Ticagrelor monotherapy also decreases risk of major cardiac and cerebrovascular events in patients >65 (HR 0.52; 95% CI 0.29–0.95) compared to DAPT. Conclusion This post-hoc subgroup analysis reveals that, in certain populations, ticagrelor monotherapy after a three month DAPT course significantly decreases risk of major bleeding events and major cardiac and cerebrovascular outcomes in patients with acute coronary syndrome. This is especially seen in the elderly population where risks of adverse events are higher. Nonetheless, larger studies need to be performed for further analysis. Funding Acknowledgement Type of funding sources: None.

One-year clinical outcome of percutaneous coronary intervention with very long (≥ 40 mm) drug-eluting stent

ObjectivesThe aim of this study was to assess the clinical outcome of patients with diffuse coronary lesions treated with very long drug-eluting coronary stents (DES) (≥ 40mm) over a period of one year. MethodsThis single-center prospective study enrolled a total of 343 consecutive patients (376 long stents) who underwent percutaneous coronary stent implantation with very long DES. One year clinical outcomes were analyzed. A subgroup analysis of diabetic patients was also performed. ResultsOne year follow up data was available for 314 patients (91.5%). All-cause mortality was 5 (1.6%). Eleven (3.5%) patients had non-ST-elevation myocardial infarction. Definite / probable stent thrombosis was reported in 7 (2.2%) patients. Over one year, 3 (1%) patients underwent target lesion revascularization (TLR). The total number of target lesion failure was 9 (2.9%). The rate of target lesion failure at one year was 2.6% using one vessel per patient analysis. Two patients had ischemic stroke. Any major adverse cardiac event (MACE) was observed in 19 (6%) patients. The event rates between sirolimus and everolimus stent groups were compared - cardiac death (1.7% vs 1.5%; p=0.911), stent thrombosis (2.5% vs 1.7%; p=0.612), TLR (1% vs 0.8%; p=0.878), any MACE (7% vs 4.1%; p=0.284). Exertional dyspnea was reported by 47 (15%) patients at the end of one year. Dual antiplatelet adherence rate was 96% (n=301 of 314). ConclusionUse of very long stents (≥40mm) for diffuse coronary lesions is safe and effective with acceptably low event rates. No significant differences in event rates were observed between the types of DES used in this study (Sirolimus Vs. everolimus).

12-month intravascular ultrasound observations from BiOSS® first-in-man studies.

The aim of this study was to analyze the difference in neointima pattern assessed by intravascular ultrasound (IVUS) between two dedicated bifurcation stents, BiOSS® Expert and BiOSS® LIM at 12-month follow-up. This manuscript reports IVUS findings obtained from the analysis of patients enrolled into first-in-man registries initially assessing the BiOSS Expert® (paclitaxel) and BiOSS LIM® (sirolimus) stents. Quantitative angiographic analysis was performed pre, post-stenting, and at follow-up. IVUS examination was performed at 12 months. There were analyzed 34 cases (BiOSS Expert® 11 patients, BiOSS LIM® 23 patients). Procedural characteristics in the two groups were similar, except for rates of main vessel predilatation and FKB/POT, which were higher in BiOSS® LIM group, 54.5 % vs 73.9 % (P < 0.05) and 0 % vs 39.1 % (P < 0.05), respectively. When comparing late lumen loss (LLL) for both stents there were significantly bigger values for main vessel and main branch in the BiOSS® Expert group, but not in side branch. Intravascular ultrasound examination showed that in the BiOSS LIM® group comparing with the BiOSS Expert® group there was lower neointima burden in the whole stent (24.7 ± 7.5 % vs 19.4 ± 8.6 %, P < 0.05) as well as in main vessel (22.8 ± 5.6 % vs 16.9 ± 6.1 %, P < 0.05) and main branch (36.1 ± 6.5 % vs 27.6 ± 8.7 %, P < 0.05), but not at the level of bifurcation (15.1 ± 3.8 % vs 13.6 ± 5.4 %, P = NS). In addition, we found that final kissing balloon/proximal optimization technique (FKB/POT) was associated with significantly smaller value of LLL in main vessel (0.24 ± 0.09 mm vs 0.32 ± 0.14 mm, P < 0.05), which in IVUS analysis resulted in smaller neointima burden in main vessel (13.7 ± 3.9 % vs 18.9 ± 4.45 %, P < 0.05) as well as at the bifurcation site (12.6 ± 4.1 % vs 14.1 ± 2.4 %, P < 0.05). The obtained results suggest that neointima proliferation was the largest in main branches of both stents assessed in quantitative angiography (LLL) as well as in IVUS (neointima burden) and the neointima increase was smaller in BiOSS LIM® stents than in BiOSS Expert® stents. Moreover, the middle part of the stent seems to not to be associated with excessive neointima proliferation and more aggressive protocol of implantation with the use FKB/POT seems to decrease this process.Electronic supplementary materialThe online version of this article (doi:10.1007/s10554-016-0926-9) contains supplementary material, which is available to authorized users.

Drug diffusion and biological responses of arteries using a drug-eluting stent with nonuniform coating

The purpose of this study was to determine the effect of a nonuniform coating, abluminal-gradient coating (AGC), which leaves the abluminal surface of the curves and links parts of the stent free from the drug coating, on the diffusion direction of the drug and the biological responses of the artery to drug-eluting stent (DES) by comparing the AGC-sirolimus stent and the conventional full-surface coating (CFC) sirolimus stent. The study aimed to verify whether the AGC approach was appropriate for the development of a safer DES, minimizing the risks of stent thrombosis due to delayed endothelialization by the drug and distal embolization due to cracking of the coating layer on the hinge parts of the DES on stent expansion. In the in vitro local drug diffusion study, we used rhodamine B as a model drug, and rhodamine B released from the AGC stent diffused predominantly into the abluminal side of the alginate artery model. Conversely, rhodamine B released from the CFC stent quickly spread to the luminal side of the artery model, where endothelial cell regeneration is required. In the biological responses study, the luminal surface of the iliac artery implanted with the AGC-sirolimus stent in a rabbit iliac artery for 2 weeks was completely covered with endothelial-like cells. On the other hand, the luminal surface of the iliac artery implanted with the CFC-sirolimus stent for 2 weeks only showed partial coverage with endothelial-like cells. While thrombosis was observed in two of the three CFC-sirolimus stents, it was observed in only one of the three AGC-sirolimus stents. Taken together, these findings indicate that the designed nonuniform coating (AGC) is an appropriate approach to ensure a safer DES. However, the number of studies is limited and a larger study should be conducted to reach a statistically significant conclusion.

Optimal interventional strategy for the treatment of coronary in-stent restenosis.

In-stent restenosis (ISR) has been an important issue in the era of percutaneous coronary intervention (PCI) since the first bare metal stent (BMS) was applied to clinical settings. BMS substantially reduces acute vessel closure and restenosis after PCI by attenuating early arterial recoil and contraction, two major limitations of plain old balloon angioplasty (POBA). Thereby, it has been considered as a major advancement over POBA. However, ISR caused by neointimal hyperplasia after stent implantation hampers the benefit of BMS by increasing the rate of target lesion revascularization (TLR) or target vessel revascularization (TVR). With the innovation of stent technology, drug-eluting stents (DES) designed to inhibit excessive neointimal growth was produced and anticipated to reduce the incidence of ISR. Indeed, the RAVEL trial (1), a double-blind randomized study comparing sirolimus-eluting stent with its non-coated counterpart, reported no restenosis in the sirolimus stent group, and 23.4% of the patient in the BMS group developed binary restenosis (P<0.001) at 6-month follow-up. Despite of these promising results, there’s still a certain proportion of ISR occurring after DES implantation due to the expansion of indications for PCI to complex coronary lesions in high-risk patients. Meanwhile, the advent of DES brought new challenges for the interventional cardiologists, such as the higher rate of late stent thrombosis and more bleeding events due to prolonged duration of dual anti-platelet therapy (DAPT). According to the type of stents previously implanted, ISR is classified as BMS ISR and DES ISR. As the literature (2,3) mentioned, 20% to 53% BMS ISR present as unstable angina and 3.5% to 20% as myocardial infarction (MI); The proportion of DES ISR manifesting as unstable angina and MI is 16% to 66% and 1% to 20% respectively. Given the clinical and prognostic importance of ISR, the debate on the optimal strategy to prevent and treat ISR is far from over.

Comparative characteristics of coated stents used in endovascular treatment of patients with coronary heart disease

A comparison of characteristics of drug-eluting stents used in endovascular treatment of patients with chronic ischemic heart disease was carried out. The efficacy of sirolimus stents coated with paclitaxel and their influence on the process of restenosis was evaluated.

Balancing Long-Term Risks of Ischemic and Bleeding Complications After Percutaneous Coronary Intervention With Drug-Eluting Stents

Although trials comparing antiplatelet strategies after percutaneous coronary intervention report average risks of bleeding and ischemia in a population, there is limited information to guide choices based on individual patient risks, particularly beyond 1 year after treatment. Patient-level data from Patient Related Outcomes With Endeavor vs Cypher Stenting Trial (PROTECT), a broadly inclusive trial enrolling 8,709 subjects treated with drug-eluting stents (sirolimus vs zotarolimus-eluting stent), and PROTECT US, a single-arm study including 1,018 subjects treated with a zotarolimus-eluting stent, were combined. The risk ofischemic events, cardiovascular death/non-periprocedural myocardial infarction (MI)/definite or probable stent thrombosis, and bleeding events, Global Use of Strategies to Open Occluded Arteries moderate or severe bleed, were predicted using logistic regression. At median follow-up of 4.1years, major bleeding occurred in 260 subjects (2.8%) and ischemic events in 595 (6.3%). Multivariate predictors of bleeding were older age, smoking, diabetes mellitus, congestive heart failure, and chronic kidney disease (all p <0.05). Ischemic events shared all the same predictors with bleeding events and gender, body mass index, previous MI, previous coronary artery bypass graft surgery, ST-segment elevation MI on presentation, stent length, and sirolimus-eluting stent use (all p <0.05). Within individual subjects, bleeding and ischemic risks were strongly correlated; 97% of subjects had a greater risk of ischemic events than bleeding. In conclusion, individual patient risks of ischemia and bleeding are related to many common risk factors, yet the predicted risks of ischemic events are greater than those of major bleeding in the large majority of patients in long-term follow-up.

Late clinical outcomes of diabetic patients treated with sirolimus or everolimus drug-eluting stents: an analysis of the DESIRE registry

BackgroundDespite the better clinical performance of second-generation drug-eluting stents (DES) when compared to first-generation DES in controlled trials, mainly due to reduction in thrombosis rate, it remains unclear whether this benefit extends to diabetic patients treated in the daily practice. We sought to compare the clinical outcomes of unselected diabetic patients treated with either sirolimus eluting stents - SES (first-generation DES) or everolimus-eluting stents - EES (second-generation DES). MethodsBetween January 2007 and October 2014 a total of 798 diabetic patients were treated with SES (n = 414) and EES (n = 384). Long-term clinical follow-up was achieved in 99,4% of the population and the groups were compared regarding the occurrence of major adverse cardiac events (MACE) and stent thrombosis. ResultsIn both cohorts age was similar, and most patients were male. Stable coronary disease was the most frequent clinical presentation. The number of treated vessels (1.50 ± 0.62 vs. 1.52 ± 0.72; p = 0.88) and the total stent length (36.1 ± 20.4 vs. 37.7 ± 22.2mm; p = 0.32) were similar between groups. Patients treated with EES showed lower rates of MACE (15% vs. 6.8%, p < 0.001), mainly due to a lower cardiac death (5.3% vs. 1.3%, p < 0.001). There was also less definitive/ probable thrombosis with the second generation DES (3.4% vs. 0.5%, p = 0.004). ConclusionsIn this single center experience, the use of EES was associated with reduced cardiac death and stent thrombosis. This benefit was mostly observed in the long-term follow-up.

Stent fracture and closure of the aneurysm in post drug eluting stent implantation

A male patient with a history of anterior wall myocardial infarction was referred to us. Coronary angiogram revealed two-vessel disease in LAD and ramus. He was implanted with Sirolimus stent (Pronova) in LAD. A pseudoaneurysm with thrombus was observed in CT. Angiography and CT angiogram showed instent restenosis of LAD, stent fracture, migration of stent strut and closure of pseudoaneurysm. Cardiac MRI and CT confirmed absence of viable portion in anterior wall and no expansion in aneurysm size. Asymptomatic condition of the patient prompted us to institute medical management. Since last four and half years, the patienthas no uneventful events.

Erdheim-Chester disease: an uncommon cause of upper urinary tract obstruction

Erdheim-Chester disease is a rare non-Langerhans form of systemic histiocytosis of unknown origin. We describe a 45-year-old man presenting with bilateral hydronephrosis suggestive of extrinsic urinary tract obstruction. Computed tomography revealed extensive hypodense soft tissue infiltration in the retroperitoneum surrounding the kidneys. Needle biopsy of the retroperitoneal soft tissue revealed aggregates of lipid-laden histiocytes expressing CD68 but negative for CD1a and S100 protein. The diagnosis of Erdheim-Chester disease was supported by typical radionuclide bone scinitigraphic findings. Treatment with prednisolone, sirolimus, and regular ureteric stent revision was initiated to achieve adequate urinary tract drainage. To our knowledge, this is the second patient with Erdheim-Chester disease reported in Hong Kong. A high index of suspicion is required to avoid delay in the diagnosis of this rare disease.

TCT-171 J-DESsERT 3-Year Outcomes: Largest randomized trial stratified by diabetes mellitus presence, comparing sirolimus and paclitaxel eluting stents.

TCT-171 J-DESsERT 3-Year Outcomes: Largest randomized trial stratified by diabetes mellitus presence, comparing sirolimus and paclitaxel eluting stents.

Drug-eluting stents for treatment of left main coronary artery disease with bifurcated lesions: comparison with sirolimus, paclitaxel, zotarolimus biolimusA9, EPC capture and everolimus-eluting stent

Aim: The aim of this study is to compare the safety, efficacy and durability of Sirolimus (SES), Paclitaxel (PES), Zotarolimus (ZES-R/ Endeavor Resolute), BiolimusA9 (BES), EPC capture (ECS) and Everolimus-eluting stent (EES) on the outcome of patients with left main coronary arteries (LMT) stenosis. Methods: A prospective analysis of 1127 LMT stenosis (321 SES, 277 PES, 129 ZES-R, 172 BES, 55 ECS, 173 EES) in six high volume Asian centers after successful stenting in LMT stenosis was performed. The study endpoints were 30 days major adverse cardiac events (MACE) and 12, 24, 36 and 48 months target lesion revascularization (TLR) and MACE in those 6 groups. Results: See table for clinical results. View this table: Conclusion: The use of drug-eluting stents in patients with LMT stenosis was safe with low acute complication. Patients treated with BES and EES showed lesser rate of restenosis compared with ZES-R and ECS.

Clinical presentation and predictors of Stent thrombosis after drug-eluting stent implantation for chronic coronary occlusions

The objective of this study was to evaluate the incidence of stent thrombosis, as well as the clinical presentation and related factors in patients with chronic total coronary occlusions (CTO) treated with drug-eluting stents. Methods: The CIBELES (ChronIc coronary occlusion treated By EveroLimus Eluting Stent) trial allocated 207 patients with CTO to everolimus or sirolimus stent in 13 centers from Spain and Portugal. Stent thrombosis episodes accordingly to the Academic and Research Consortium (ARC) criteria were codified through a 12 month period. Results: During a 12 month follow-up, 3 episodes of definitive or probable stent thrombosis were diagnosed: 2 definitive thrombosis (1 and 117 days after the procedure), and 1 probable stent thrombosis (9 days after the procedure). Therefore, the incidence of definitive or probable stent thrombosis at 1 year was 1.4% (early stent thrombosis 0.9%, late stent thrombosis 0.5%). No death or Q-wave myocardial infarction occurred in these patients (clinical presentation was non-Q-wave acute myocardial infarction in 2, and unstable angina in 1 case). At univariate analysis, the risk of stent thrombosis was higher with left anterior descending coronary artery as treated vessel (3.5% vs 0.0%, p=0.037), single vessel disease (3.3% vs 0.0%, p=0.049), and treatment with sirolimus-eluting stent (3.,0% vs 0.0% in patients treated with everolimus-eluting stent, p=0.074). Patients with stent thrombosis had lower minimum lumen diamerer (1.3±0.6 mm vs. 2.6±0.5 mm, p<0.001), and higher % stenosis immediately after the procedure (43±14% vs 20±10%, p<0.001). At multivariate analysis, the only independent predictor of stent thrombosis was the minimum lumen diameter after the procedure. Conclusions: Incidence of definitive or probable stent thrombosis after drug-eluting stent implantation in CTO is low (1.5%), especially in patients treated with everolimus-eluting stents. The only independent predictor of stent thrombosis in these patients was minimum lumen diameter after stenting. Clinical presentation was relatively benign in all cases.

Suggestion for Use of Triple Antiplatelet Therapy According to Stent Length: Results from Pooled Analysis of DECLARE Trials

Background: The aim of this study was to find most beneficial patients from triple antiplatelet therapy based on association between the length of the stented segment and the risk of angiographic restenosis after drug-eluting stent (DES) implantation. Although triple antiplatelet therapy showed restenosis and repeat revascularization in complex coronary lesions after DES implantation, no practical guideline to use triple antiplatelet therapy was suggested. Methods: Pooled analysis of three randomized studies in patients with DM (DECLARE-DIABETES) and long lesion (DECLARE-LONG I and II) compared triple antiplatelet therapy (aspirin, clopidogrel and cilostazol, triple group, n1⁄4700) and dual antiplatelet therapy (aspirin and clopidogrel, standard group, n1⁄4699) receiving sirolimus(SES), paclitaxel(PES), and zotarolimus-eluting stent (ZES).We analyzed follow-up angiographic outcomes. Results: All patients (n1⁄41399) were divided into 6 categories (£20mm, 20 to 30mm, 30 to 40mm, 40 to 50mm, 50 to 60mm,>60 mm) according to stent length. In-stent restenosis rate was significantly diverged in 40 to 50 mm group (9.4% vs. 24.2%, p1⁄40.005) and 50 to 60 mm category (6.0% vs. 20.3%, p1⁄40.012) between triple and standard group. If lesions were divided into 3 category (£2.5mm, 2.5 to 3.0 mm, >3.0mm) according to post-procedural minimal lumen diameter (MLD), triple group showed lower in-stent restenosis compared to standard group in all categories.

Benefit of Long-Term Dual Anti-Platelet Therapy in Patients Treated With Drug-Eluting Stents: From the NHLBI Dynamic Registry

The optimal duration of dual-antiplatelet therapy (DAPT) after drug-eluting stent (DES) implantation is an important, unanswered question. This study was designed to evaluate the association of varying durations of DAPT on clinical outcomes after DES implantation for the treatment of coronary artery disease. Using the National Heart, Lung, and Blood Institute Dynamic Registry, patients enrolled in the last 2 waves after index percutaneous coronary intervention with DES and who were event free at the time of landmark analysis were included. Landmark analysis was performed 12 and 24 months after percutaneous coronary intervention, and patients were stratified according to continued use of DAPT or not. Subjects were evaluated for rates of death, myocardial infarction, and stent thrombosis at 4 years from their index procedures. The numbers of evaluable patients were 2,157 and 1,918 for the 12- and 24-month landmarks, respectively. In both landmark analyses, there was a significantly lower 4-year rate of death or myocardial infarction in the group that continued DAPT compared to the group that did not (12 months: 10.5% vs 14.5%, p=0.01; 24 months: 5.7% vs 8.6%, p= 0.02). Beneficial differences in the group that continued on DAPT were preserved after multivariate and propensity adjustment. There were no significant differences in definite stent thrombosis in either landmark analysis. In conclusion, at 12 and 24 months after DES implantation, continued use of DAPT was associated with lower 4-year risk for death and myocardial infarction.

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

Drug eluting stents are being used frequently because of their less restenotic properties. However, their effect on preventing neo-intimal hyperplasia may cause many adverse effects such as coronary artery aneurysm (CAA). We report a case that presented with a CAA which was the latest developed CAA after the implantation of drug eluting stents in literature so far. A 57-year-old male presented with dyspnea and typical angina on effort. Coronary angiography was performed. A large CAA was detected at the site of a drug eluting stent which was implanted in the LAD artery 5.5 years ago. It was treated with a coronary stent graft successfully.