Paclitaxel Drug-eluting Stents Research Articles

Use of a Paclitaxel Drug-Eluting Stent for the Treatment of Hemodialysis Access Outflow Stenosis

PurposeTo evaluate the outcomes and durability of drug-eluting stents (DESs) for the treatment of hemodialysis access outflow stenosis. Material and MethodsA single-center retrospective analysis was conducted of all patients with hemodialysis vascular access outflow stenosis treated with a paclitaxel-coated DES (Eluvia; Boston Scientific, Marlborough, Massachusetts) between January 2020 and July 2022. A total of 34 DESs were implanted to treat outflow stenosis in 32 patients. Primary target lesion patency after stent deployment was the main outcome. Comparison between the time interval free from target lesion reintervention (TLR) after previous plain balloon angioplasty (PBA) and that after stent deployment for the same target lesion was considered a secondary outcome. ResultsThe primary patency at 6, 12, and 18 months was 63.1%, 47.6%, and 41.7%, respectively. The secondary patency rate was 100% at 18 months. The median time interval free from TLR increased from 4.1 to 11.9 months (P < .001). No adverse events were observed during the median follow-up period of 387 days. ConclusionsThe patency rates after use of DES for hemodialysis access outflow stenosis were comparable with results for drug-coated balloons and stent grafts, addressing recoil and minimizing the risk of jailing by a covered stent.

Evaluation of Efficacy and Safety of Paclitaxel and Cilostazol Dual Drug-eluting Coronary Stents

Evaluation of Efficacy and Safety of Paclitaxel and Cilostazol Dual Drug-eluting Coronary Stents

Evidence-based progress for the risk events of paclitaxel devices in treatment of peripheral artery disease

With the development of endovascular technology for peripheral arterial diseases, paclitaxel drug-eluting stents and drug-coated balloons have been widely used in recent years. It has been proved that paclitaxel-coated devices have good clinical effects in reducing vascular restenosis. However, the clinical safety of paclitaxel devices has encountered challenges, some of the studies have shown that paclitaxel-coated devices may increase long-term mortality. In addition, some studies have confirmed the effectiveness and safety of paclitaxel devices, leading to this topic becoming the focus and hot spot of global attention. Whether paclitaxel-coated devices increase the risk of long-term death, whether paclitaxel doses are related to mortality, and the pharmacokinetics of paclitaxel devices should be examined.

Usage and Efficiency of Drug Eluting Stents in Vertebral Ostial Stenosis

Objectives: Extracranial vertebral artery atherosclerosis is an insidious and hazardous disease. With technological development and accumulating experience, antiproliferative drug eluting stents became a viable option for reducing the instent restenosis of the origin of the vertebral artery. Here, we evaluated the technical success rates, efficiency, clinical and angiographic results of the usage of drug eluting stents in vertebral ostial stenosis. Patients and Methods: 28 stents were implanted in 24 patients with vertebral artery origin stenosis. Digital substraction angiographic or CT angiographic follow-up was made at 6, 12 and 24 months. Results: Paclitaxel eluting stents were placed with high technical success for the treatment of vertebral artery origin stenosis. There was no procedure related mortality. However one patient scummed to death due to aspiration pneumonia for a basiller artery stroke with successful stenting and thrombolysis procedure. There was only one limited subclavian artery dissection in a patient (%4.1) during the procedure which was managed conservatively. One stent (%3.7) had instent restenosis on early period (6th month) and one patient (%4.1) had recurrent neurological symptoms on follow-up (9th month). In a median follow-up of 13 months (6-25 months) none of the patients had late stent thrombosis. Conclusion: Vertebral artery ostial stenosis can be treated effectively and safely with high technical success and low instent restenosis rates with paclitaxel drug eluting stents. With low restenosis rates the antiproliferative drug eluting stents are an option for reducing the vertebral artery instent restenosis.

Extremely Late In-Stent Thrombosis 12 Years After Implantation of a Drug-Eluting Stent

Stent thrombosis is one of the most feared complications of percutaneous coronary intervention. Most commonly it occurs within the first few days after the deployment of the stent. Once the stent is completely endothelialized, this complication becomes extremely rare. Few cases of very late stent thrombosis were reported in the literature with the longest interval being around 11 years after the initial intervention. We report here the case of a 78-year-old male patient who presented with acute onset chest pain found to have acute inferior ST-segment elevation myocardial infarction due to thrombotic occlusion of a prior paclitaxel drug-eluting stent placed 12 years prior. This is, to our knowledge, the first case of stent thrombosis occurring after this long duration since stent implantation.

Primary Patency of Long-Segment Femoropopliteal Artery Lesions in Patients with Peripheral Arterial Occlusive Disease Treated with Paclitaxel-Eluting Technology

The aim of this study is to evaluate the performance and predictors of failure of paclitaxel drug-eluting stents and paclitaxel-coated balloons in the treatment of long-segment femoropopliteal disease. We report a retrospective cohort analysis of patients treated with paclitaxel-eluting stents and paclitaxel-coated balloons in lesions >100mm, which were not included in any of the pivotal trials. Ninety-seven patients with peripheral vascular disease (Rutherford III-VI) underwent long-segment (≥100mm) femoropopliteal drug-eluting stent (DES) implantation or angioplasty with drug-coated balloons (DCB). Patients were followed after their initial procedure for target lesion restenosis, defined as a reduction in lumen diameter by greater than 50% as measured by duplex ultrasonography (ratio >2). The median length of the affected arterial segments was 110mm (interquartile range [IQR] 100-150, absolute range 100-260) using up to 4 overlapping stents. During the median 13-month follow-up (IQR 7-16), no early thrombotic occlusions occurred within 30days, but 28 (29%) patients developed a target lesion restenosis after 1year. Cumulative primary patency at 6 and 12months was 87% and 71% overall, respectively. The cumulative patency during the same follow-up periods varied between patients treated with different paclitaxel modalities with 88% and 80% primary patency in patients treated with DES (n=63) versus 81% and 49% in patients treated with DCB (n=21) (adjusted hazard ratio 2.46, P=0.03). Lesion length, concurrent tibial intervention, and recurrent target lesions were not associated with restenosis. Short-term outcomes in patients treated with paclitaxel-eluting stents and paclitaxel-coated balloons in long lesions, mirror results from the clinical trials. The primary patency observed in patients treated with DES was significantly higher than in patients treated with DCB.

Coronary Stents in Diabetic Patients: State of the Knowledge.

This review article aims to summarize the findings of the most relevant research that compared the use of paclitaxel vs. "limus" based drug eluting stent (DES) in diabetic patients and to define the current state of knowledge with new stent technologies in this patient population. Since drug eluting stents (DES) were introduced, it has been of great interest to establish whether paclitaxel or sirolimus eluting stents have the same safety and efficacy features for patients with coronary artery disease. The answer to this question is particularly relevant for diabetic patients. Several randomized trials, registry-based studies, and meta-analyses have assessed the performance of these different DES in diabetic patients. The most recently published data favors limus over paclitaxel DES in diabetic patients, but most of these studies compared first vs. second generation DES with the inherent caveats of comparing different platforms, alloys, and drug delivery vehicles. In this literature review, we found that there is robust evidence favoring the use of DES over bare metal stents in diabetic patients with coronary artery disease. We also found that the current state of knowledge is that the everolimus eluting stents have better safety and efficacy than paclitaxel eluting stents in diabetic patients and hence should be the preferred choice. New revascularization strategies including bio-absorbable scaffolds, polymer free stents, and bio-degradable polymers are being studied in diabetic patients with encouraging results.

Paclitaxel Drug-eluting Tracheal Stent Could Reduce Granulation Tissue Formation in a Canine Model.

Background:Currently available silicone and metallic stents for tracheal stenosis are associated with many problems. Granulation proliferation is one of the main complications. The present study aimed to evaluate the efficacy of paclitaxel drug-eluting tracheal stent in reducing granulation tissue formation in a canine model, as well as the pharmacokinetic features and safety profiles of the coated drug.Methods:Eight beagles were randomly divided into a control group (bare-metal stent group, n = 4) and an experimental group (paclitaxel-eluting stent group, n = 4). The observation period was 5 months. One beagle in both groups was sacrificed at the end of the 1st and 3rd months, respectively. The last two beagles in both groups were sacrificed at the end of 5th month. The proliferation of granulation tissue and changes in tracheal mucosa were compared between the two groups. Blood routine and liver and kidney function were monitored to evaluate the safety of the paclitaxel-eluting stent. The elution method and high-performance liquid chromatography were used to characterize the rate of in vivo release of paclitaxel from the stent.Results:Compared with the control group, the proliferation of granulation tissue in the experimental group was significantly reduced. The drug release of paclitaxel-eluting stent was the fastest in the 1st month after implantation (up to 70.9%). Then, the release slowed down gradually. By the 5th month, the release reached up to 98.5%. During the observation period, a high concentration of the drug in the trachea (in the stented and adjacent unstented areas) and lung tissue was not noted, and the blood test showed no side effect.Conclusions:The paclitaxel-eluting stent could safely reduce the granulation tissue formation after stent implantation in vivo, suggesting that the paclitaxel-eluting tracheal stent might be considered for potential use in humans in the future.

Real-World Performance of Paclitaxel Drug-Eluting Bare Metal Stenting (Zilver PTX) for the Treatment of Femoropopliteal Occlusive Disease

The aim of this study was to evaluate the performance and predictors of stent failure of paclitaxel drug-eluting stents for the treatment of femoropopliteal disease. A retrospective review of clinical and angiographic data was performed for patients treated for femoropopliteal disease with the Zilver PTX (Cook Medical, Bloomington, IN) stent by a single operator between 2012 and 2015 at a tertiary referral center. Clinical grading was determined by both Rutherford classification and the Society for Vascular Surgery's Wound, Ischemia, and Foot Infection (WIFi) scoring system, and lesions were classified anatomically by the TransAtlantic Intersociety Consensus (TASC) II criteria. Treated lesions included those with prior in-stent restenosis and long-segment disease. Primary clinical end points were stent failure, need for reintervention, and major adverse limb events (MALE). Kaplan-Meier methods and Cox proportional hazard models were used to evaluate factors affecting outcomes. Zilver PTX stents were placed in 52 limbs among 46 patients (71.1% male, mean age 72.6years) with a median follow-up of 11.1 (range 1-26) months. Limbs were treated for life-disabling claudication in 76.9% and critical limb ischemia in 23.1%. Disease severity was highly variable, with 21 (40.4%) limbs with TASC C or D lesions and 16 (30.7%) treated for restenosis after prior endovascular treatment. During follow-up, 6 (12.7%) limbs experienced loss of stent patency (5 occlusions, one >50% restenosis). Four limbs underwent target lesion revascularization, 2 required open bypass, 2 underwent thrombolysis, and no patients required major amputation. Primary patency was 88.9%, 81.6%, and 81.6% at 6, 12, and 18months, respectively. Treated lesion length (hazard ratio [HR] 4.99, 95% confidence interval [CI] 1.14-21.75) was the only independent predictor of patency loss. Freedom from target lesion revascularization at 6, 12, and 18months was 94.2%, 87.8%, and 87.8%, respectively. Freedom from MALE (composite of thrombolysis, major amputation, and bypass operation) was 97.5%, 90.9%, and 79.6% at 6, 12, and 18months, respectively. Chronic renal insufficiency was the only factor that trended toward increased risk of MALE (HR 9.92, 95% CI 0.86-113.35) within a multivariate model. Our real-world experience supports the continued use of the Zilver PTX for the treatment of both de novo lesions and lesions with prior endovascular revascularization in the femoropopliteal segment. Routine follow-up between 6 and 12 months postoperatively is essential for detecting early restenosis and guiding reintervention. Careful attention when treating complex lesions and long-segment disease remains important for selecting the optimal revascularization strategy for individual patients and optimizing stent patency.

TCTAP A-168 Five-year Clinical Follow-up of Long Paclitaxel Drug Eluting Stents

TCTAP A-168 Five-year Clinical Follow-up of Long Paclitaxel Drug Eluting Stents

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.

Paclitaxel-coated balloon for the treatment of drug-eluting stent restenosis: subanalysis results from the Valentines I trial

To analyze the effect of paclitaxel-coated balloon (PCB) treatment on patients with drug-eluting stent (DES) restenosis. In the Valentines I trial, treatment of coronary in-stent restenosis was effective and safe with the second-generation DIOR® PCB. Valentines I prospectively enrolled 250 patients with in-stent restenosis (ISR); 76 patients (30.4%) had restenosis of a previous paclitaxel or limus DES. Patients underwent balloon angioplasty followed by PCB treatment. Clinical outcomes of patients with paclitaxel-eluting DES restenosis (n=34; 41 lesions) and limus-eluting (sirolimus, everolimus and zotarolimus) DES restenosis (n=42; 43 lesions) treated with DIOR® PCB were compared. Baseline characteristics were similar. There were more diffuse lesions >20mm treated in paclitaxel- compared to limus-eluting DES restenosis (50% vs. 26.8%, p=0.032). Number of PCB used per patient (1.08±0.31 overall), mean PCB diameter (2.99±0.42mm overall), mean PCB length (24.4±11.9mm overall), and bailout stenting (2.4% vs. 4.7%) were similar (p=NS). At mean follow-up of 231±43days, major adverse cardiac events was 0% vs. 23.8% in paclitaxel- vs. limus-eluting DES restenosis (p=0.002), driven mainly by less target vessel revascularization (0% vs. 21.4%, p=0.004). Target lesion revascularization was 0% vs. 16.7% for paclitaxel- vs. limus-eluting DES restenosis (p=0.015). In Valentines I, PCB use was more effective in patients with paclitaxel DES restenosis compared to limus DES restenosis, achieving better mid-term clinical outcomes. This suggests the efficacy of localized paclitaxel delivery to overcome paclitaxel resistance but not limus resistance due to different mechanisms of DES failure.

Drug-eluting stent or coronary artery bypass graft surgery in hemodialysis patients?

The article by Baek and coworkers [1] published in this issue of the Journal of Nephrology provides valuable clinical information regarding the clinical outcome of surgical and endovascular myocardial revascularization procedures in patients with chronic kidney disease (CKD) in chronic hemodialysis. Both coronary artery bypass grafts (CABG) and percutaneous coronary interventions (PCI) were performed under elective conditions and using standard techniques as available in a time period between 1999 and 2006; this included an internal thoracic artery in surgical candidates, off-pump surgery in a minority of cases (17 %) and implantation of drug-eluting stents (DES) in patients treated with PCI. The study analyzed a population of 110 patients, 66 treated with CABG with at least one internal thoracic artery in 97 % of cases, and 44 treated with PCI and implantation of either rapamycin or paclitaxel DES in approximately 80 and 20 % of patients, respectively. Allocation of patients to CABG or PCI was a decision taken by the interventional cardiologist. Given some obvious baseline differences between the two groups, a propensitive score analysis was performed to normalize for some of such differences. Indeed, CABG patients had significantly more severe coronary artery disease, as well as some other worse comorbidities, although these did not reach statistical significance. At a mean follow-up period of 53.8 months the survival rate free of major adverse cardiac and cerebral events was better in the CABG group (HR 3.334, 95 % CI 1.482–7.498, p = 0.004); however, the overall survival did not diverge significantly even after propensitive score adjustment (HR 1.638, 95 %CI 0.555–4.839, p = 0.372). The authors therefore conclude that CABG represents a better treatment strategy compared to PCI with DES for patients in chronic hemodialysis. Publication of long-term clinical outcome of myocardial revascularization procedures in patients with advanced CKD is most welcomed since evidence of safety and efficacy in this population are scarce and often contradictory. Indeed, patients with advanced CKD are always excluded form trials testing myocardial revascularization options [2], likely because of the strong correlation that exists between heart and kidneys in determining patients survival, independently of the revascularization treatment [3]. Despite this major limitation of the available evidence, the Guidelines for Myocardial Revascularization of the European Society of Cardiology (ESC) issued in 2010 provided clear recommendations for the revascularization treatment of patients with CKD [4]. Basically, CABG was recommended as a preferred strategy compared to PCI in patients with multivessel coronary disease, moderate renal dysfunction and good general conditions with reasonable life expectancy, since the operative risk is low, and the long-term benefits of surgery appear evident with a longer follow-up [5]. On the contrary, patients with severe or end-stage CKD may derive less benefit from surgery given its most invasive nature. Indeed, a higher peri-procedural mortality and morbidity reduces the net clinical benefit and advantages of surgery at the long-term, and in the end, such a fragile population may benefit most from the less invasive PCI attempt, despite a higher recurrence of ischemic events requiring more re-interventions at the long-term [4]. F. Ribichini C. Vassanelli Department of Medicine, University of Verona, Verona, Italy

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).

A multicenter randomized comparison of drug‐eluting balloon plus bare‐metal stent versus bare‐metal stent versus drug‐eluting stent in bifurcation lesions treated with a single‐stenting technique: Six‐month angiographic and 12‐month clinical results of the drug‐eluting balloon in bifurcations trial

Percutaneous treatment of coronary bifurcation lesions remains hampered by suboptimal results, mainly in the side branch (SB), even with the use of drug-eluting stents (DES). Paclitaxel drug-eluting balloons (DEB) could provide an attractive alternative to treat bifurcations in combination with a provisional T-stenting technique in order to minimize SB restenosis. We compared angiographic and clinical outcomes of a provisional T-stenting technique with a DEB plus bare-metal stent (BMS) versus BMS versus paclitaxel DES. In this randomized, international, multicenter, single-blinded 3-arm study, 117 patients with coronary bifurcation lesions underwent treatment with: (A) DEB in both main branch (MB) and SB and BMS in MB; (B) BMS in MB and regular balloon angioplasty in SB; or (C) paclitaxel DES in MB and regular balloon in SB. All patients underwent provisional T-stenting with an identical stent platform in the MB. Paclitaxel was the drug for elution in groups A and C. The primary endpoint was 6-month angiographic late luminal loss. Secondary end points were 6-month binary restenosis and 12-month major adverse cardiac events (MACE: death, myocardial infarction, target vessel revascularization). The procedure was successful in all cases. Late luminal loss, measured respectively in the proximal MB, distal MB and SB was 0.58 ± 0.65, 0.41 ± 0.60, and 0.19 ± 0.66 mm in group A; 0.60 ± 0.65, 0.49 ± 0.85, and 0.21 ± 0.57 mm in group B; and 0.13 ± 0.45, 0.19 ± 0.64, and 0.11 ± 0.43 mm in group C (P = 0.001). Binary restenosis rates per bifurcation and MACE rates were 24.2%, 28.6%, and 15% (P = 0.45) and 20%, 29.7%, and 17.5% (P = 0.40) in groups A, B, and C, respectively. Pretreatment of both MB and SB with DEB failed to show angiographic and clinical superiority over conventional BMS, using a provisional T-stenting technique. Moreover DES showed superior angiographic results than DEB and BMS.

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…"

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

We read with interest the paper by Park et al. [ [1] Park K.W. Kang S.H. Park K.H. et al. Sirolimus- vs. paclitaxel-eluting stents for the treatment of unprotected left main coronary artery stenosis: complete 2-year follow-up of a two-center registry. Int J Cardiol. 2011 Aug 18; 151: 89-95 Abstract Full Text Full Text PDF PubMed Scopus (7) Google Scholar ]. The authors conclude that, in the treatment of left main coronary artery (LMCA) stenosis, paclitaxel eluting stents (PES) and sirolimus eluting stents (SES) provide comparable 2 year-clinical results with respect to hard endpoints and major adverse cardiac events.

Intermediate term outcomes with bifurcation coronary stenting using the paclitaxel drug-eluting stent: A single centre experience

Percutaneous treatment of bifurcation coronary artery disease (BCD) is complex and, in the era of bare metal stents (BMS), was reported to have a high rate of repeat target lesion revascularization (TLR). Paclitaxel drug-eluting stents (PES) have been used in the treatment of BCD, with better overall outcomes than BMS. Also, acute stent thrombosis (AST), with an incidence ranging from 2.7% to 4.3%, has been reported with the use of bifurcation PES, and remains a concern in treating these patients. In the present report, intermediate term outcomes with BCD stenting using TAXUS Express (Boston Scientific, USA) PES are presented from the Genesis Medical Center. In the present retrospective study, 518 consecutive de novo bifurcation stenting procedures are reported. They were performed in 2005 at the present institution using the TAXUS Express PES. Follow-up data on 312 patients (60.2%) was achieved through telephone interviews and reviews of medical records after a mean of 6.7 months. The primary end point of the present study was the combined end points of cardiac death, nonfatal myocardial infarction (MI) and TLR. Secondary outcomes included the individual end points of death, cardiac death, AST, target vessel revascularization (TVR), TLR, ST elevation MI and non-ST elevation MI on intermediate term follow-up. The mean (± SD) age of the patients was 66±12 years. Acute procedural success was 95% (main branch, 99%; side branch, 95.9%). The following intermediate term outcomes with bifurcation drug-eluting stents were: TLR, 6.7%; TVR, 12.2%; definite and probable AST, 1.6%; death, 6.7%; cardiac death, 2.9%; non-ST elevation MI, 0.7%; ST elevation MI, 2.0%; and the combined primary end point, 9.9%. The outcomes for patients who underwent main branch stenting were not statistically different from those with bifurcation stenting, with an overall combined end point favouring main branch stenting alone (5.8% versus 10.8%, P not significant). The TAXUS Express PES carry acceptable intermediate term outcomes in the treatment of BCD compared with historic controls with BMS, with low TLR, TVR and overall primary combined end point. Main branch stenting alone is safe, with a trend toward fewer adverse events than bifurcation stenting.

Drug-eluting stents and glycoprotein IIbIIIa inhibitors in the pharmacoinvasive management of ST elevation MI

Evaluation of: Sanchez, P, Gimeno F, Ancillo P et al.: Role of the paclitaxel-eluting stent and tirofiban in patients with ST elevation myocardial infarction undergoing postfibrinolysis angioplasty (GRACIA 3 Trial). Circ. Cardiovasc. Interv. 3, 297–307 (2010). In ST elevation myocardial infarction patients presenting to nonpercutaneous coronary intervention (PCI)-capable hospitals, a pharmacoinvasive strategy utilizing fibrinolysis with early but not immediate angiography is a reasonable reperfusion strategy. The optimal antiplatelet regimen and stent type has not been defined in this clinical setting. The article by Sanchez et al. reported a 2 × 2 factorial design trial of 436 ST segment elevation myocardial infarction patients treated with full-dose tenecteplase and adjunctive PCI, comparing outcomes in patients randomized to the glycoprotein IIbIIIa inhibitor tirofiban versus placebo 2 h after fibrinolysis and the paclitaxel drug-eluting stent versus the bare-metal stent. The median time between fibrin...

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.