Sirolimus Drug-eluting Stents Research Articles

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.

Use of drug-eluting stents in patients with critical limb ischemia and infrapopliteal arterial disease: a real-world single-center experience

BackgroundAlthough no drug-eluting stent (DES) has been approved by the Food and Drug Administration to treat infrapopliteal arterial disease, several industry-sponsored trials have reported the outcomes with the use of paclitaxel or sirolimus DESs. To the best of our knowledge, only one study to date has reported on the use of everolimus DESs for infrapopliteal arterial disease. In the present study, we analyzed the clinical outcomes with everolimus DESs in our real-world, single-center experience. MethodsA total of 107 limbs with critical limb threatening ischemia (98 patients; 118 lesions) treated with DESs (Xience; Abbott Vascular, Santa Clara, Calif) were analyzed. The postoperative early outcomes, major adverse limb events (above the ankle limb amputation or major intervention at 1 year), and major adverse events (death, amputation, target lesion thrombosis or reintervention) were analyzed. Kaplan-Meier analysis was used to estimate the primary patency rates (using duplex ultrasound), amputation-free rates, and amputation-free survival rates. ResultsOf the 118 lesions treated, 33% were in the anterior tibial artery, 28% were in the tibioperoneal (TP) artery, 21% were in the posterior tibial artery, 8% were in the peroneal artery, 5% were in the TP/posterior tibial artery, 4% were in the TP artery/PA, and 1% were in the TP/anterior tibial artery. The mean lesion length was 41 mm, and 59% were totally occluded (41% stenotic). The mean follow-up was 18.5 months (range, 1-70 months). The overall postoperative complication rate was 11% (2% major amputations), with 2% mortality. Late symptom improvement of one or more Rutherford category was obtained in 71%. The major adverse events rate at 30 days and 1 year was 12% and 45%, respectively. The major adverse limb events rate at 1 year was 15%. The overall primary patency rate was 42%. The primary patency rate at 1, 2, and 3 years was 57%, 45%, and 33%, respectively. The major amputation-free and overall amputation-free survival rates were 87%, 80%, and 77% and 76%, 65%, and 61% at 1, 2, and 3 years, respectively. ConclusionsThe clinical outcomes after DES (Xience; Abbott Vascular) for infrapopliteal lesions were somewhat satisfactory at 1 year but inferior to the previously reported outcomes, especially at 3 years. Further data with long-term follow-up are needed.

P2806A novel sirolimus drug eluting stent for Small-Vessel Disease: results from en-ABL e-registry

Abstract Objective The aim of the study was to assess the clinical outcome of Abluminus DES in patients with small vessels. Background Percutaneous coronary intervention (PCI) of small coronary vessel (≤2.75 mm) associated with more chances of restenosis and repeat revascularization even when drug eluting stent employed. Methods A total of 2,500 patients enrolled in en-ABL e-registry which is a prospective, multicentre observational post market registry. Out of 2,500 patients, 1,253 patients had small vessel (SV, ≤2.75 mm) while 1,247 had large vessel (LV, >3mm) disease. The primary endpoint was major adverse cardiac events (MACE) which is composite of cardiac death, target vessel myocardial infraction (TV-MI) and target lesion/vessel revascularization (TLR) at 1 year follow up. The secondary endpoint were stent thrombosis and MACE up to 2 years. Results Baseline characteristics were well matched in both groups. In the SV group had higher prevalence of diabetes as compared to large vessel 43.0% vs 25.7%. Total 1,400 lesions treated with 1,612 Abluminus DES and 1,569 lesions treated with 1,675 Abluminus DES in SV and LV groups respectively. The mean diameter of stent was 2.61±0.23 and 3.3±0.3 mm in SV and LV groups respectively. There was a significant difference in MACE in treatment groups (3.7% vs. 1.4%, p=0.004 respectively) at 1 year. No significant differences were observed between SV and LV groups in terms of death/myocardial infarction or stent thrombosis. There were increment of only one TLR and no stent thrombosis reported at 2-year follow-up. Conclusion This result suggests the efficacy and safety of novel Abluminus DES in small vessel disease.

Angiographic and clinical performance of a paclitaxel-coated balloon compared to a second-generation sirolimus-eluting stent in patients with in-stent restenosis: the BIOLUX randomised controlled trial.

Although several studies have shown positive outcomes after the use of drug-coated balloons (DCB) for in-stent restenosis (ISR), data on randomised controlled trials versus latest-generation drug-eluting stents (DES) are limited. Therefore, in this randomised trial, we sought to evaluate whether a butyryl-tri-hexyl citrate (BTHC)-based paclitaxel DCB is non-inferior to a biodegradable polymer sirolimus-eluting stent (BP-SES) therapy in patients with ISR in either a bare metal stent (BMS) or DES. A total of 229 patients with ISR in BMS or DES from 13 German centres and one Latvian centre were 2:1 randomly allocated to DCB (n=157) or DES (n=72). The primary efficacy endpoint was defined as in-stent late lumen loss (LLL) at six months, and the primary safety endpoint was target lesion failure (TLF) at 12 months. LLL in the DCB arm was 0.03±0.40 mm compared to 0.20±0.70 mm in the DES arm (p=0.40). DCB proved to be non-inferior to DES (Δ = -0.17±0.52 mm, 97.5% CI -∞; -0.01]; p<0.0001). At 12 months, Kaplan-Meier TLF estimates were 16.7% in the DCB arm and 14.2% in the DES arm (p=0.65) and remained similar at 18 months (DCB versus DES: 17.4% versus 19.5%, p=0.88). In patients with DES or BMS ISR, treatment with a paclitaxel DCB showed similar LLL at six months and TLF rates up to 18 months compared to a second-generation sirolimus DES.

Single or dual antiplatelet therapy after PCI.

The optimal duration and type of antiplatelet therapy after implantation of a drug-eluting stent (DES) remains uncertain. At the time of the first-in-man implantation of the sirolimus DES in 1999, the protocol-defined dual antiplatelet therapy (DAPT) duration was only 2 months. Subsequently, DAPT duration was extended to 1 year on the basis of anecdotal historical data, and this practice was then incorporated into clinical guidelines. For >1 decade, trialists have sought to compare the safety and efficacy of abbreviated (<6 months) and prolonged (>12 months) DAPT regimens. However, the body of evidence is limited by the heterogeneity of end points, time of randomization, and bleeding criteria used in each trial. Pharmaceutical advances led to the introduction of new ADP-receptor antagonists, which are thought to be more effective than clopidogrel. The ADP-receptor antagonists moved the focus from the optimal duration of DAPT to the potential efficacy of single antiplatelet therapy after DES implantation. In this Review, we summarize the current evidence on the duration of DAPT and the risk of bleeding and adverse cardiac events after DES implantation, and describe the pitfalls of trial interpretation. The ongoing, prospective trials to test single antiplatelet therapy after DES implantation are also discussed.

Clinical, angiographic, and intravascular ultrasound results of the VestSaync II trial

We sought to assess the long term efficacy of the novel VESTAsync™ Eluting Stent (VES) combining a Cro-Co platform with a nanothin-microporous hydroxyapatite surface coating impregnated with a polymer-free low-dose of Sirolimus (55 μg). The Vestasync II trial was a randomized (2:1), double-blinded, multicenter comparison of the VES to its platform, the Gen X stent, with microporous hydroxyapatite surface coating without sirolimus. Patients were eligible if they presented de novo lesions in native coronary arteries with 3.0-3.5 mm diameter and ≤ 14 mm in length. Primary endpoint was 8-month in-stent late loss and % of stent obstruction. Lifelong aspirin and 6-month clopidogrel were prescribed to all patients. Seventy-five patients were enrolled (VES = 50 pts). Baseline characteristics included mean age of 58 years and 29% of diabetics. Reference vessel diameter and lesion length were 2.8 ± 0.4 mm and 13.0 ± 2.0 mm, respectively. In-stent late loss (0.39 ± 0.20 vs. 0.74 ± 0.52, P = 0.03) and % of neointima hyperplasia (9.3 ± 6.6% vs. 17.6 ± 9.4%, P = 0.0016) were significantly reduced in the VES cohort. Up to 1 year, there was a single case of myocardial infarction and one target lesion revascularization (TLR) (2%) in the VES group while in the control cohort there were one TLR (4%) and one cardiac death (4%). The VestSync II trial is a proof-of-concept study and demonstrates the sustained efficacy of this novel polymer-free sirolimus drug-eluting stents. A larger trial, with more complex lesions, clinical endpoints and longer FU period is warranted. © 2013 Wiley Periodicals, Inc.

Biochemical regulatory mechanism of asiaticoside in preventing and treating stent restenosis

To discuss whether asiaticosides could effectively reduce the endothelial cell damage as a biochemical modulator, so as to further inhibit the post-stenting intima-media membrane hyperplasia. Human aortic smooth muscle cells and aortic fibroblasts were selected and divided into the blank group, the rapamycin group and the asiaticoside group and the rapamycin and asiaticoside group. The expressions of muscle cells and fibroblasts TGF-beta1, Smad7 and I-collagen gene were determined by RT-PCR. The expression quantity of I-collagen protein was assayed by ELISA. The coefficient of drug interaction (CDI) between rapamycin and asiaticoside was calculated. Additionally, 16 Chinese mini-swines were randomly divided into group A and group B. One sirolimus drug-eluting stent of the same type was implanted after the high-pressure pre-expansion of anterior descending artery balloon. After the operation, the group A was intravenously injected with normal saline 30 mL x d(-1). Whereas the group B was intravenously injected with asiaticoside 30 mg x kg(-1) x d(-1)(diluted to 30 mL). The expressions of plasma vWF of the two groups were measured at the 7th and 14th days after the operation. At the 28th day after the operation, tissues of the stented vessel segments were sliced and stained to calculate the vessel area, inner stent area, lumen area and neointima area Compared with the control group, the combination group showed significant up-regulation in smooth muscle cells and fibroblast Smad7 gene, down-regulation in TGF-beta, and obvious inhibition of I-collagen gene expression (P < 0.01). As for smooth muscle cells, there was no difference in the expression of I-collagen between the combination group and the rapamycin group, with CDI at 0. 83. As for fibroblasts, there was a significant difference in the expression of I-collagen between the combination group and the rapamycin group (P < 0.05), with CDI at 0.77. Plasma vWF of the group B was significantly lower than that of the group A (P < 0.05) at the 7th and 14th days after the operation. At the 28th day after the operation, no difference was observed in vessel area and stent area between the two groups. However, the lumen area in the group B was significantly larger than that of the group A(P < 0.05), and the neointima area of the group B was significantly smaller than that of the group A (P < 0.05). As an effective biochemical modulator for rapamycin, asiaticosides could inhibit TGF-beta expression, significantly decrease the synthesis and secretion of extracellular matrix, further inhibit the post-stenting intima-media membrane hyperplasia and reduce the endothelial cell damage by effectively up-regulate the expression of Smad7 protein.

Chitosan/heparin sirolimus drug-eluting stent system improves anticoagulation and promotes early re-endothelialization in porcine coronary artery

Objective To construct a sirolimus loaded drug-eluting stent(DES)using chitosan/heparin coating membrane and to explore its effect on anticoagulation and early re-endothelialization in porcine coronary artery.Methods Chitosan/heparin layer-by-layer self-assembly coating was applied to sirolimus DES,and the asymmetric applicator was used to allow for the stent blood surface to be chitosan/heparin coated and the stent vascular surface to be polylactic acid(PLA)-sirolimus.The experiment was divided into bare metal stent(BMS)group,chitosan/heparin stent group,sirolimus DES group and chitosan/heparin sirolimus DES group.The anticoagulation effect of chitosan/heparin sirolimus DES was tested by arteriovenous shunt model and high load thrombosis model.The effect of chitosan/heparin sirolimus DES on early reendothelialization was tested by 1-week long balloon injury to porcine coronary artery.Results No thrombus was found on the surfaces of chitosan/heparin sirolimus DES and chitosan/heparin stent in the arteriovenous shunt model,while the surfaces of BMS and sirolimus DES were covered with thrombus.No stent thrombosis was found in the high load thrombosis model test of chitosan/heparin sirolimus DES and chitosan/heparin stent within 6hours,and stent thrombosis was found in BMS at(59.0± 8.5)min and in sirolimus DES at(67.0±7.8)min(P0.01).The early re-endothelialization test showed endothelial coverage rates of chitosan/heparin sirolimus DES and chitosan/heparin stent after 7dimplantation were(82.7±16.4)% and(80.7±14.1)%, significantly higher than those of BMS and sirolimus DES([64.3±11]%and[59.8±8.4]%,respectively;P0.01).Conclusion Chitosan/heparin-coated-sirolimus DES has satisfactory anticoagulation property and it can accelerate early re-endothelialization.

Drug-eluting stents and acute myocardial infarction: A lethal combination or friends?

Primary percutaneous coronary intervention is the preferred reperfusion strategy for patients presenting with ST-segment elevation myocardial infarction (STEMI). First generation drug-eluting stents (DES), (sirolimus drug-eluting stents and paclitaxel drug-eluting stents), reduce the risk of restenosis and target vessel revascularization compared to bare metal stents. However, stent thrombosis emerged as a major safety concern with first generation DES. In response to these safety issues, second generation DES were developed with different drugs, improved stent platforms and more biocompatible durable or bioabsorbable polymeric coating. This article presents an overview of safety and efficacy of the first and second generation DES in STEMI.

Stent thrombosis after switch from nongeneric to generic clopidogrel

The U.S. Food and Drug Administration recently approved generic versions of clopidogrel bisulfate which should lower the cost and improve compliance in patients requiring dual antiplatelet therapy post stent placement. However, there is marked inter-individual variability in the metabolism and intestinal absorption of clopidogrel. The different binders and fillers used in the generic versions can possibly affect absorption and reduce the bioavailability of the drug. We report a case of very late stent thrombosis in a patient eight days after the switch to generic clopidogrel bisulfate from branded clopidogrel (Plavix). The patient had received a sirolimus drug eluting stent almost three years prior to presentation and was on chronic dual antiplatelet therapy. Subsequent to the event, she was found to be a poor metabolizer of clopidogrel. Although in most cases the use of generic clopidogrel is efficacious and safe, certain individuals, such as poor metabolizers, might be susceptible to increased clinical events when switching. We suggest any suspected cases should be reported to Medwatch so the clinical relevance could be determined.

Costo-efectividad de los stents liberadores de fármacos versus

Background The purpose of this study was to perform a systematic literature review to determine whether coronary disease endovascular therapy with drug eluting stents (DES) compared with bare metal stents (BMS) is cost-effective. Methods A systematic review was performed in Pubmed/Medline, Embase, CDRS, NCBI, Hinari, CRD, DARE, NHSEED, HTA, HSRPROJ, HSTAT electronic databases to identify full economic evaluation studies with healthcare system perspective reporting the relationship between cost/absolute risk reduction and cost/QALY, without date or language limitations. Results Sixteen studies were included (21807 participants). Paclitaxel or sirolimus DES compared with BMS were evaluated in five studies (31.25%), 31.25% assessed only sirolimus eluting stents, 25% only paclitaxel eluting stents and 12.5% zotarolimus eluting stents. Health care payment perspective was explicit in 93.75% of the studies. The distribution of patient characteristics was similar in all groups and balanced in observational studies. Six of the 16 studies concluded that DES was not costeffective in their population, but that in subgroups at greater risk of restenosis or with multiple vessel disease the therapy was cost-effective. Conclusions The studies were consistent in the reduction of target vessel revascularization frequency with DES compared to BMS without affecting mortality at 12 month follow-up. The intervention was cost-effective in studies at greater risk of restenosis or with multiple vessel disease.

Cyclic strain amplitude dictates the growth response of vascular smooth muscle cells in vitro: role in in-stent restenosis and inhibition with a sirolimus drug-eluting stent

The putative effects of changes in mean strain and cyclic strain amplitude on vascular smooth muscle cell (vSMC) growth (proliferation and apoptosis) were examined. Subsequently, a quantitative measure of vSMC growth was obtained to determine the prolonged effect of changes in mechanical burden following bare-metal stent (BMS) and sirolimus drug-eluting stent (DES) deployment in vitro. Bovine aortic vSMCs were exposed to prolonged cyclic strain using a Flexercell(TM) Tension system and a novel Sylgard(TM) phantom vessel following stent implantation before the level of vSMC proliferation and apoptosis was assessed by FACS analysis, cell counting, and immunocytochemistry. Physiological cyclic strain (5%) decreased vSMC proliferation and increased apoptosis in a temporal manner. There was no significant difference in cell growth following exposure to varying mean strains with similar amplitude. In contrast, exposure to varying strain amplitudes with similar mean strains resulted in significant differences in cell proliferation and apoptosis. In parallel studies, the level of vSMC proliferation and cell survival was significantly increased within low amplitude, high mean strain regions of a phantom vessel following BMS implantation when compared to regions of higher strain amplitude upstream and downstream of the stent, respectively. Moreover, the level of vSMC growth within the stented region was significantly attenuated following implantation of a sirolimus-coated DES independent of significant changes in cell survival. Cyclic strain amplitude is an important regulator of vSMC growth capacity within a stent and is a target for inhibition using a sirolimus-coated DES.

Cost-Effectiveness of Drug Eluting Stents Versus Bare Metal Stents in Coronary Heart

Objective The purpose of this study was to perform a systematic literature review to determine whether coronary disease endovascular therapy with drug eluting stents (DES) compared with bare metal stents (BMS) is cost-effective. Methods A systematic review was performed in Pubmed/Medline, Embase, CDRS, NCBI, Hinari, CRD, DARE, NHSEED, HTA, HSRPROJ, HSTAT electronic databases to identify full economic evaluation studies with health care perspective reporting the relationship between cost/absolute risk reduction and cost/QALY, without date or language limitations. Results Sixteen studies were included (21807 participants). Paclitaxel or sirolimus DES compared with BMS were evaluated in five studies (31.25%), 31.25% assessed only sirolimus eluting stents, 25% only paclitaxel eluting stents and 12.5% zotarolimus eluting stents. Health care payment perspective was explicit in 93.75% of the studies. The distribution of patient characteristics was similar in all groups and balanced in observational studies. Six of the 16 studies concluded that DES were not cost-effective in their population, but that in subgroups at greater risk of restenosis or with multiple vessel disease the therapy was cost-effective. Conclusions The studies were consistent in the reduction of target vessel revascularization frequency with DES compared to BMS without affecting mortality at 12 month follow-up. The intervention was cost-effective in studies at greater risk of restenosis or with multiple vessel disease.

What do you do with the antiplatelet agents in patients with drug eluting stents who then receive a mechanical valve?

Dual antiplatelet therapy (DAT) with aspirin and clopidogrel is a cornerstone of treatment during and after percutaneous coronary interventions with drug-eluting stent (DES) implantation. Oral anticoagulation (OAC) is the recommended treatment for patients with mechanical heart valves. When patients with DES need a mechanical heart valve or vice versa, we face the difficult choice of their antithrombotic therapy. Different institutions empirically follow a combination of OAC and single or DAT, the so-called triple antithrombotic therapy (TT) aiming to find the best balance between the thrombotic and bleeding risk for this subset of patients. A best evidence topic in cardiac surgery was written according to a structured protocol. The question addressed was whether there is an optimal antithrombotic management for patients with DES undergoing mechanical heart valve or vice versa. Altogether, more than 148 papers were found using the reported search, of which 16 represented the best evidence to answer the clinical question. The authors, journal, date and country of publication, patient group studied, study type, relevant outcomes and results of these papers are tabulated. We conclude that DES implantation in patients who could potentially need valve surgery in the future should be discouraged and bare-metal stent or an aortic bioprosthesis preferred. However, in high-risk patients with DES, the recommendation is to postpone elective surgery for 1 year and, if surgery cannot be deferred, continue aspirin during the perioperative period. Moreover, when OAC is given in combination with clopidogrel and/or low-dose aspirin, the target INR should be 2.0-2.5 (Class IIb, level of evidence C). As per the long-term management, antithrombotic management with DAT alone in mechanical aortic valve replacement might be possible, but there is not enough evidence to support it. The available evidence suggests that triple anticoagulation (OAC+DAT) is associated with the best clinical outcome compared with all the other possible strategies. The duration of TT should be 3 months after sirolimus DES implantation, and 6 months after paclitaxel DES implantation, followed by long-term therapy with OAC plus clopidogrel or aspirin with either PPIs, or H2-receptor antagonists (Class IIa Level of Evidence C).

Very late stent thrombosis due to DES fracture: Description of a case and review of potential causes

Stent fracture and subsequent stent thrombosis are known complications after stent implantation, especially in stents with closed cell design like the first generation sirolimus drug eluting stents (DES). Late stent thrombosis is very rarely encountered in our patient population, majority Chinese. We report a case of non-ST elevation myocardial infarction as a result of very late stent thrombosis (three years after implantation) due to stent fracture at the site of overlap of two first generation sirolimus DES. There were initial difficulties in restoring coronary flow by conventional reperfusion therapies but a successful outcome after implantation of an endothelial progenitor cell capture stent, with no further recurrence of ischemic event after 12 months. An attempt was made to analyze all existing factors present and contributing to the stent fracture and stent thrombosis in this case, as reported in the literature.

Response to "Sirolimus or paclitaxel drug eluting stent in left main disease: The winner is…"

Response to "Sirolimus or paclitaxel drug eluting stent in left main disease: The winner is…"

Long-term effectiveness and safety of sirolimus drug-eluting stents

The root cause of coronary artery disease is atherosclerosis, ie, intraluminal narrowing (stenosis) of the arteries that supply blood to tissues of the heart. The introduction of the drug-eluting stent over the past decade has revolutionized the field of interventional cardiology. It is used extensively in clinical practice for the treatment of coronary artery disease. The first drug-eluting stent to receive US Food and Drug Administration approval was the sirolimus-eluting stent. Recently, two other stent analogs of sirolimus were approved, ie, the zotarolimus-eluting stent and the everolimus-eluting stent. However, concern has arisen in recent years about the long-term safety and efficacy of drug-eluting stents, due to the occurrence of late adverse clinical events, such as stent thrombosis. This review focuses on clinical studies that have been performed with the sirolimus-eluting stent or its analogs. We discuss the pharmacology, safety, and various therapeutic options that exist when choosing stents for coronary artery disease. Our aim is to provide a thorough review of the long-term efficacy and safety of sirolimus drug-eluting stents, and also to discuss currently approved and promising investigational drug-eluting stents, in an effort to provide insight into how these stents are currently evolving and generate further investigation in this area.

Fracture déplacée d’un stent actif au sirolimus : à propos d’un cas et revue de la littérature

Drug-eluting stents have greatly reduced the risk of in-stent restenosis compared to bare metal stents by inhibiting neointimal growth. However, they may carry some long-term risks, especially the risk of late stent thrombosis. Recently, several cases of drug-eluting stent fracture have been also reported. The mechanisms, the diagnosis, the clinical implications and the management of this new complication are not well-known. We report the observation of a new case of displaced, sirolimus drug-eluting stent fracture. To our knowledge, this is the first reported case in France.

Five-year outcomes of percutaneous coronary intervention compared to bypass surgery in patients with multivessel disease involving the proximal left anterior descending artery: an ARTS-II sub-study

The aim of this study was to compare the 5-year outcomes of patients with multivessel disease (MVD) involving the proximal left anterior descending (LAD) artery who were treated with sirolimus drug-eluting stents (SES), bare metal stents (BMS) and coronary artery bypass surgery (CABG). Clinical outcomes were compared between the 682 patients enrolled in the ARTS-I and ARTS-II study who had MVD involving the proximal LAD, and were treated with BMS (27.4%), CABG (30.2%), and SES (42.4%). At 5-year follow-up the primary endpoint of major adverse cardiovascular and cerebrovascular events (MACCE) occurred in 33.7%, 18.0% and 24.9% of patients treated with BMS, CABG and SES, respectively (BMS vs. SES p=0.04, CABG vs. SES p=0.07). Unadjusted and adjusted rates of mortality and death/stroke/myocardial infarction (safety) were comparable between all three treatments. Repeat revascularisation was significantly lower following CABG irrespective of adjustment. The absolute difference in MACCE between patients with a logistic EuroSCORE above and below the mean (i.e., 2.09%) was 18.8% (p=0.001), and 1.9% (p=0.28) for CABG and SES, respectively. In patients with a high EuroSCORE, SES was a significantly safer treatment (p=0.04) whilst repeat revascularisation remained lower with CABG irrespective of the EuroSCORE. At 5-year follow-up CABG has comparable safety, and superior efficacy in terms of reducing repeat revascularisation compared to BMS and SES in the treatment of patients with MVD involving the proximal LAD however, appropriate patient selection remains imperative.

Drug eluting stents for the treatment of bare metal in-stent restenosis: long-term outcomes in real world practice

Drug eluting stents (DES) have had a great impact in reducing in-stent restenosis (ISR) in de novo lesions. However, long-term data regarding effectiveness and safety of these stents in treating bare metal stent (BMS) ISR are limited. We report long-term clinical outcomes in a cohort of patients with BMS-ISR treated with DES between April 2002 and December 2003 at our institution. Sixty-nine consecutive patients with significant BMS-ISR were treated with DES implantation. Sirolimus DES were used in 43 patients and paclitaxel DES in 26. All patients were followed up to determine the incidence of major adverse cardiac event (MACE) rates (all-cause death, myocardial infarction, or target vessel revascularisation [TVR]), angina class and the need for clinically driven angiography. The mean age of the cohort was 58.6 ± 10.8 years; 68% were male, 33% were diabetic, 50% had hypertension, 78% were on statin therapy and 59% were current (19%) or previous (41%) smokers. The clinical presentation of ISR was with chronic stable angina in 54 patients, 12 had a non-ST elevation acute coronary syndrome and three presented with ST-elevation myocardial infarction. Multivessel stenting was performed in 21 patients and bifurcation stenting in seven patients. Over a mean follow period of 4.9 years, the first event MACE rate was 20% (17 events in 14 patients - eight deaths of which three were cardiac, two non-fatal myocardial infarctions and seven TVR). Excluding non-cardiac death, the adjusted MACE rate was 14.5% (12 events in 10 patients). At long-term follow-up, mean Canadian angina class decreased from 2.3 ± 0.7 pre-procedure to 1.2 ± 0.4, 65% of patients were angina free and 80% were free of MACE. No differences in long-term outcomes were observed between patients receiving paclitaxel and sirolimus DES. The use of DES for the treatment of BMS-ISR is safe and effective over a mean follow-up period of nearly five years. To our knowledge, this represents the longest follow-up data of real world patients treated in a single interventional centre.