Cobalt-chromium Bare-metal Stents Research Articles

PRECLINICAL EVALUATION OF THE VASCULAR EFFECTS OF REJUVENATE® COBALT CHROMIUM CORONARY STENT SYSTEM IMPLANTED IN THE PORCINE CORONARY IN STENT RESTENOSIS MODEL

Objectives: The main objective of the study was to evaluate the implantation, safety, and vascular tissue effects of REJUVENATE® Cobalt Chromium Bare Metal Stent in the Porcine Coronary Restenosis model at short, mid and long-term follow up.
 Methodology: A total of 18 REJUVENATE® bare metal stents (CoCr, 95 µm strut thickness) were implanted into the coronary arteries (RCA, LCX and LAD) of the six pigs. Throughout the study period, stent patency, vascular response, percent stenosis, late lumen loss and performance of stent were evaluated by angiography, optical coherence tomography (OCT), and Histopathology (includes both Histopathology and histomorphometry) at 30, 90, and 180 days and compared with the results of control Bare Metal Stent Coflexus®. The mean, variance and standard deviation was analyzed using SPSS software.
 Results: OCT and QCA analysis demonstrated two cases of binary restenosis at 30 days follow-up and two at 90 days follow-up (33%). The mean area stenosed for Rejuvenate® was 34% as compared to 24% of Coflexus® and at 180 days follow up, it decreased to 21%. The histopathology analysis demonstrated favorable safety with acceptable levels of neointimal formation, with decreased levels of inflammation and complete endothelialization in 180 days.
 Conclusion: This study proved the potential safety of REJUVENATE® in porcine model and supports that this stent can move forward for the human trials.

Efficacy of Drug Eluting Stent Versus Cobalt-Chromium Bare-Metal Stent in Small Artery Stenosis in Non Diabetic Patients with acute coronary syndrome

Coronary artery disease (CAD) is the most common cause of morbidity and mortality in the world, This study aimed to compare cobalt-chromium BMS with DES in small artery stenosis in non-diabetic patients with ACS according to patients’ clinical characteristics, acute and late results. the examination was led on 100 non-diabetic patients conceded with intense coronary condition and alluded to Cath. As per kind of stent utilized in mediation, the patients were arranged into: DES gathering: included 50 patients with sedate eluting stents to treat all over again coronary sores. BMS gathering: included 50 patients with cobalt chromium stents to treat anew coronary injuries. Every patient was exposed to full history taking, total clinical assessment, ECG, echocardiography, and serum creatinine. 5% of patients had composite end point, ISR and MI following a half year of development while 4% of patients had TVR and 1% of patients had CABG. Just a single patient passed on in our examination. There was no noteworthy contrast among DES and BMS bunch with respect to coronary angiographic, procedural information and clinical results during development. the utilization of medication eluting stent versus cobalt chromium stent was related with a decrease in target vessel revascularization in little supply route stenosis through half year catch up with no distinction in death and nonfatal myocardial dead tissue.

One-Year Follow-Up Results From the Observational, Multicenter, Prospective, and Controlled Registry: The WALTZ All-Comers Study

The aim of this study was to evaluate 1-year follow-up results in an all “comers” population treated with a new cobalt chromium bare-metal stent (BMS) design. Since August 2016 to March 2017, 201 (9.7% of screening population) consecutive patients undergoing coronary stent implantation in 11 centers in Argentina were prospectively included in our registry. The inclusion criteria were multiple-vessel disease and/or unprotected left main disease, acute coronary syndromes (ACS) with at least one severe (⩾70%) stenosis in any of major epicardial vessel. In-stent restenosis, protected left main stenosis, or impossibility to receive dual-antiplatelet therapy was an exclusion criterion. Major adverse cardiac events (MACE) were the primary endpoint and included cardiac death, myocardial infarction (MI), and target lesion revascularization (TLR); also, all components of the primary endpoint were separately analyzed. Completeness of revascularization was analyzed as post hoc data using residual SYNTAX or ERACI risk scores. Demographic characteristics showed that 6.5% of patients were very elderly, 22.5% have diabetes, 47% have multiple-vessel disease, 67% have ACS, and 32% have ST elevation MI. At a mean of 376 ± 18.1 days of follow-up, MACE was observed in 10.4% of patients: death + MI + cardiovascular accident (CVA) in 3% (6 of 201) and cardiac death + MI + CVA in 1.5% (3 of 201). Residual ERACI score ⩽5 was associated with 98% of event-free survival (P < .04). In conclusion, this prospective, multicenter, and observational all-comers registry with this novel BMS design showed a low incidence of adverse events at 1 year mainly due to coronary restenosis.

Very Late Pathological Responses to Cobalt-Chromium Everolimus-Eluting, Stainless Steel Sirolimus-Eluting, and Cobalt-Chromium Bare Metal Stents in Humans.

BackgroundThe “very late” clinical outcomes for durable polymer drug‐eluting stents and bare metal stents (BMSs) have been shown to be dissimilar in clinical studies. Conceptually, the long‐term vascular compatibility of BMSs is still regarded to be superior to drug‐eluting stents; however, no pathologic study to date has specifically addressed this issue. We evaluated the very late (≥1 year) pathologic responses to durable polymer drug‐eluting stents (cobalt–chromium [CoCr] everolimus‐eluting stents [EESs] and stainless steel sirolimus‐eluting stents [SS‐SESs]) versus BMSs (CoCr‐BMSs).Methods and ResultsFrom the CVPath stent registry, we studied a total of 119 lesions (40 CoCr‐EESs, 44 SS‐SESs, 35 CoCr‐BMSs) from 92 autopsy cases with a duration ranging from 1 to 5 years. Sections of stented coronary segments were pathologically analyzed. Inflammation score and the percentage of struts with giant cells were lowest in CoCr‐EESs (median inflammation score: 0.6; median percentage of struts with giant cells: 3.8%) followed by CoCr‐BMSs (median inflammation score: 1.3 [P<0.01]; median percentage of struts with giant cells: 8.9% [P=0.02]) and SS‐SESs (median inflammation score: 1.7 [P<0.01]; median percentage of struts with giant cells: 15.3% [P<0.01]). Polymer delamination was observed exclusively in SS‐SESs and was associated with increased inflammatory and giant cell reactions. The prevalence of neoatherosclerosis with CoCr‐EESs (50%) was significantly less than with SS‐SESs (77%, P=0.02) but significantly greater than with CoCr‐BMSs (20%, P<0.01).ConclusionsCoCr‐EESs, SS‐SESs, and BMSs each demonstrated distinct vascular responses. CoCr‐EESs demonstrated the least inflammation, near‐equivalent healing to BMSs, and lower neointimal formation. These results challenge the belief that BMSs have superior biocompatibility compared with some polymeric coated drug‐eluting stents and may have implications for future stent design.

The outcomes of patients with very small coronary artery disease treated with thin strut cobalt chromium bare metal stents: an observational study.

BackgroundPercutaneous coronary interventions (PCI) in coronary artery disease (CAD) with very small vessel diameters remains controversial and challenging. These lesions are usually more diffuse, calcified and tortuous. The usage of thin strut bare metal stents (BMS) with excellent crossing profiles in a very small caliber coronary lesions has increased the likelihood of procedural success.ObjectivesThis observational study assessed the 9-month clinical outcomes in an ‘all-comers’ population with very small caliber CAD after implantation of thin strut cobalt chromium BMS.MethodsThin strut cobalt chromium BMS implantation in a priori pre-defined subgroups was investigated in a non-randomized, international, multi-center ‘all-comers’ observational study. Primary end-point was the 9-month clinically driven target lesion revascularization (TLR) rate. Secondary end-points included the 9-month major adverse cardiac event (MACE) and procedural success rates. Data collection was done using an established electronic data acquisition form with built-in plausibility checks.ResultsA total of 783 patients with a mean age of 70.4 ± 12.8 years were enrolled, 205 (26.2 %) of them had vessel diameters of 2.5 mm and smaller which was defined as CAD with very small reference vessel calibers. Older age and diabetics were associated with higher incidences of very small caliber vessels. The mean reference vessel diameter in the very small vessel group was 2.05 ± 0.27 mm and mean diameter for vessels >2.5 mm was 3.41 ± 0.55 mm. Pre-dilatation was performed more often in the very small vessel patients (52.2 vs. 42.2 %; p value 0.007). There was no difference in the overall technical success rates in very small vessel disease group (97.9 vs. 97.7 %). The 9-month TLR rate was 6.3 % for the very small vessels and 3.7 % for vessels >2.5 mm (p = 0.129). The 9-month and in-hospital MACE rates in the very small vessel group and patient with vessel diameters >2.5 mm were not significantly different (13.1 vs. 9.2 %; p = 0.1265 and 5.2 vs. 3.7 %; p = 0.349) respectively.ConclusionThis study has demonstrated that the use of thin strut cobalt chromium BMS in very small vessel CAD was reasonably safe and efficacious in the context of ‘real-world’ practice.

COMPARATIVE EVALUATION OF STAINLESS STEEL STENT (SIROLIMUS) AND COBALT CHROMIUM STENT (SIROLIMUS) IN PATIENT WITH CORONARY ARTERY DISEASE

Coronary Artery Disease (CAD) occurs when the arteries of the heart that normally provide blood and oxygen to the heart are narrowed or even completely blocked due to clot formation. The Stenting implantation composes 84.2% of all Percutaneous coronary intervention (PCI). Despite the widespread use of these devices, bare metal stents (BMS) have been associated with a 20-30% restenosis rate which requires reintervention. In December 2006, US Food and Drug Administration cardiovascular experts concluded that for many patients, such as those with uncomplicated medical histories who undergo elective stenting of simple coronary blockages, drug-eluting stents remain a safe and appropriate therapy. Previously reports are suggestive of similar clinical outcomes for stainless steel and cobalt chromium bare metal stent. No reports are available for comparison of sirolimus eluting stainless steel stent and sirolimus eluting cobalt chromium stent. The present study was undertaken with the objective of comparative evaluation of Stainless Steel Stent (Sirolimus) and Cobalt Chromium Stent (Sirolimus) in Patient with Coronary Artery Disease. A single centric, retrospective, non-randomized study involving 118 patients who have undergone PCI from January 2011 to March 2012 implanted with either Sirolimus Stainless Steel Stent (SSSS) or Sirolimus Cobalt Chromium Stents (SCCS) were included in the study. Primary objective was to determine and compare the clinical outcome and rates of target vessel revascularization (TVR) in patients undergoing primary PCI for CAD patients who were treated with Sirolimus cobalt-chromium stents and Sirolimus stainless steel stents. The secondary outcomes of study were Major Adverse Cardiac Events, mortality at the end of 1 month, 6 month and 1 year of outcomes. At 1 month follow up there was no significant difference between two groups (p = 0.96). The individual clinical component showed no difference in occurrence of death (p = 0.29), MI (p = 0.29) and TLR (p = 0.96) at end of 6 month. The cumulative clinical outcome at 1 year rate of target vessel revascularization TVR (SSSS 1.75% versus SCCS 0%, p = 0.29), target lesion revascularization (SSSS 5.27% versus SCCS 1.63%, p = 0.27), and Major Adverse Cardiac Events (SSSS 22.80% versus SCCS 13.11%, p = 0.16). This study showed that among Coronary artery disease (CAD) patients undergoing primary percutaneous coronary intervention, sirolimus stainless steel stent showed similar efficacy and safety to sirolimus cobalt chromium stent.

Still room for improvement: Preclinical and bench testing of a thin-strut cobalt-chromium bare-metal stent with passive coating.

There is a renewed interest in bare-metal stent (BMS) design as degradable polymer coatings are increasingly used as drug-delivery vehicles in drug-eluting stents (DESs), leaving it to the BMS platform to determine the long-term outcome of DES treatment. In this study comprising preclinical and bench tests, we compare two modern thin-strut BMSs of different design. Angiography, morphometry, and histopathology data were acquired in a porcine coronary artery model in a 28-day single-stent study (13 hybrid farm pigs) and in a 90-day overlapping-stent study (8 Yucatan mini-pigs). Standardized bench tests including ion release test were performed to compare mechanical performance of the two stent systems. We found that the optimized stent group induced significantly less neointimal formation and less inflammation than Multi-Link Vision in both (single stent and overlapping stent) porcine studies. The higher efficacy was also associated with a markedly reduced release of cobalt, nickel, chromium, and tungsten ions in physiological solution and better performance in mechanical delivery tests. In conclusion, a further increase in efficacy and better safety profile than the well-known Multi-Link Vision BMS can be achieved by careful optimization of the BMS backbone. © 2016 Wiley Periodicals, Inc. J Biomed Mater Res Part B: Appl Biomater, 105B: 1612-1621, 2017.

TCTAP A-139 The Use of Thin Strut Cobalt Chromium Bare Metal Stents in Very Small Vessels Coronary Artery Disease: Is There a Role for BMS in ‘Real-World’ Practice?

TCTAP A-139 The Use of Thin Strut Cobalt Chromium Bare Metal Stents in Very Small Vessels Coronary Artery Disease: Is There a Role for BMS in ‘Real-World’ Practice?

Evaluation of safety and efficacy of NexGen - an ultrathin strut and hybrid cell design cobalt-chromium bare metal stent implanted in a real life patient population - the Polish NexGen Registry.

IntroductionDespite the dominance of drug-eluting stents in modern interventional cardiology, there is still a niche for bare metal stents.AimThe aim of the Polish NexGen registry was to evaluate the safety and efficacy of a new generation cobalt-chromium NexGen stent in a real life patient population.Material and methodsA prospective multi-center registry was conducted in five clinical sites of American Heart of Poland. Three hundred and eighty-three patients who underwent percutaneous coronary intervention (PCI) with NexGen stent implantation were included. Clinical follow-up was performed at 1, 6 and 12 months. Additionally, a group of 42 randomly selected patients underwent control angiography at 6 months (10.96% of study population). The primary endpoint was occurrence of target vessel revascularization (TVR) at 6-month follow-up. Angiographic endpoints included rates of binary restenosis and late lumen loss at 6-month follow-up based on QCA analysis. Multivessel disease was present in more than 70% of patients, and 52.4% of lesions were complex. The main indications for angiography were non-ST elevation acute coronary syndromes (54.8%) and ST elevation myocardial infarction (34.99%).ResultsAt 6-month follow-up 47 (12.7%) patients reached the primary endpoint of TVR. The composite of major acute cardiac event rates at 30-day and 6- and 12-month follow-up was 6.01% (n = 23), 18.5% (n = 69) and 25.21% (n = 92) respectively. Control angiography performed after 6 months showed in-stent late loss of 0.66 ±0.71 mm and a binary restenosis rate of 16.7%.ConclusionsOur study showed that PCI with the NexGen stent is safe and effective at 6- and 12-month follow-up. Angiographic results showed a satisfactory restenosis rate and low late lumen loss.

The efficacy of everolimus-eluting stent implantation in patients with ST-segment elevation myocardial infarction: outcomes of 2-year clinical follow-up.

First-generation drug-eluting stents (DES) demonstrated delay in vascular healing and increase in incidence of late and very late stent thrombosis compared with bare-metal stents (BMS). Second-generation DES, however, have shown a reduction of late and very late stent thrombosis compared with first-generation DES. Thus, we decided to evaluate whether the second-generation everolimus-eluting stent (EES) has an advantage over BMS in Japanese patients with ST-segment elevation myocardial infarction (STEMI). This study was conducted in two centers, retrospective, non-randomized and observational design in patients with STEMI. Three-hundred eighty patients were randomly selected to receive EES (198 patients) or cobalt-chromium BMS (182 patients). The primary endpoints were cardiac death, recurrent myocardial infarction (MI), target lesion revascularization (TLR), target vessel revascularization (TVR), and stent thrombosis (ST). At 2years, the rates of TLR, TVR, and recurrent MI were significantly lower in the EES group than in the BMS group (TLR 1.5 vs. 8.3%, p<0.05; TVR 2.5 vs. 9.4%, p<0.05; recurrent MI 1.0 vs. 4.1%, p<0.05), and the rate of ST was also significantly lower in the EES group than in the BMS group (0.5 vs. 4.3%, p<0.05). Thus, major adverse cardiac events defined at the composite cardiac death, MI, TLR, TVR, or ST were significantly lower in EES group than in BMS group (3.0 vs. 9.9%, p=0.008). The rate of cardiac death, however, did not differ between both groups. In STEMI patients, EES may be associated with improved outcomes-specifically, a significant reduction in TVR, ST, and recurrent MI compared to BMS throughout 2years.

Abstract 16775: Efficacy and Safety of a Thinner-strut Silicon Carbide-coated Cobalt Chromium Bare-metal Stent Compared to a Thin-strut Uncoated Cobalt Chromium Bare-metal Stent in Large Vessel Stenting: Insights From Two Prospective Randomised All-comers Trials

Introduction: The new generation thinner-strut silicon carbide (SiC) coated cobalt chromium (CoCr) bare-metal stents (BMS) are designed to accelerate rapid endothelialisation and reduce thrombogenicity when implanted in coronary arteries. However, smaller studies suggest reduced efficacy with higher rates of symptomatic restenosis in patients receiving the newer generation BMS. Objective: We investigated the efficacy and safety of a new generation thinner-strut SiC coated CoCr BMS (SCC-BMS) as compared to an older thin-strut uncoated CoCr BMS (UC-BMS) in patients presenting with coronary artery disease requiring stenting of large vessels (≥3.0mm) and thus at low risk of restenosis. Methods: We included all patients randomized to SCC- (n=761) or UC-BMS (n=765) in the BASKET-PROVE II and I trials, respectively. Design, patients, interventions and follow-up were similar between trials except differing regimens of dual antiplatelet therapy. The primary endpoint was clinically driven target-vessel revascularization within 24 months. Safety endpoints of cardiac death, non-fatal myocardial infarction (MI), and definite/probable stent thrombosis were also assessed. We used Cox proportional hazards regressions to estimate relative hazards adjusting for known confounders. Results: Demographics, clinical presentation, and risk factors were comparable between the groups, but patients receiving SCC-BMS underwent less complex procedures. Rates of the primary endpoint were 10.4% in the SCC-BMS group and 8.4% among patients receiving UC-BMS yielding an adjusted relative hazard (HR) of 1.46 ([1.03-2.07], p=0.032). Estimates for the safety endpoints were: cardiac death (1.8% vs. 2.4% ; HR 0.77 [0.36-1.59], p=0.46), non-fatal MI (3.2% vs. 2.5% ; HR 1.68 [0.88-3.21], p=0.11), and definite/probable stent thrombosis (0.8% vs. 1.0% ; HR 0.97 [0.32-3.00], p=0.96). We detected no particular subgroups driving the increased risk of target-vessel revascularization in the SCC-BMS group. Conclusions: In patients requiring stenting of large coronary arteries, use of the newer generation SCC-BMS was associated with a higher risk of symptomatic restenosis despite less complex procedures compared to the UC-BMS with no signs of an offsetting safety benefit.

The MGuard coronary stent: safety, efficacy, and clinical utility.

Atheromatous and thrombotic embolization during percutaneous coronary revascularization is a feared complication that may cause impaired myocardial reperfusion even with a patent epicardial vessel. The MGuard stent is a cobalt chromium bare metal stent with a porous net attached to its outer surface that has been designed to prevent thrombus fragmentation and distal embolization during stent implantation. This review summarizes the available evidence supporting the use of the MGuard stent in different scenarios such as lesions with high thrombus burden, saphenous vein graft interventions, coronary perforations, or carotid lesions.

Ultra-thin strut cobalt chromium bare metal stent usage in a complex real-world setting. (SOLSTICE registry).

AimTo report clinical follow-up at 6 months after implantation of the ultra-thin strut cobalt chromium SolarFlex stent in a real-world setting.Methods and resultsPatients (n = 240) with single or multiple vessel coronary artery disease undergoing percutaneous coronary intervention (PCI) at four sites in Europe were enrolled in the SOLSTICE (SolarFlex Stent in Routine Clinical Practice) registry. Follow-up at 6 months was 100 %. Diabetes was present in 29 % of the patients, 30 % presented with acute myocardial infarction and 17 % had unstable angina. Of the patients, 27 % had previously undergone PCI or coronary artery bypass surgery. Lesion complexity was high (50 % B2 + C type lesions). Device success was achieved in 99.7 % of cases and the major adverse cardiac event (MACE) rate was 5.8 % at 6 months of follow-up. Target lesion revascularisation (TLR) was 5.0 % at 6 months.ConclusionsThe SOLSTICE registry showed that in a complex real-world setting the SolarFlex bare metal stent, with ultra-thin struts and customised scaffolding, provided low clinical MACE and TLR rates. These results provide support for the use of the latest generation bare metal stent in contemporary European practice.

Prospective, multi-center evaluation of a silicon carbide coated cobalt chromium bare metal stent for percutaneous coronary interventions: two-year results of the ENERGY Registry.

Novel bare metal stents with improved stent design may become a viable alternative to drug-eluting stents in certain patient groups, particularly, when long-term dual antiplatelet therapy should be avoided. The ENERGY registry aimed to assess the safety and benefits of a cobalt-chromium thin strut bare metal stent with a passive coating in a large series of patients under real-world conditions. This prospective registry recruited 1016 patients with 1074 lesions in 48 centers from April to November 2010. The primary endpoint was the rate of major adverse cardiac events (MACEs), a composite of cardiac death, myocardial infarction and clinically driven target lesion revascularization. More than half of the lesions (61.0%) were type A/B1 lesions, mean lesion length was 14.5±6.5mm and mean reference vessel diameter 3.2±0.5mm. MACE rates at 6, 12 and 24months were 4.9%, 8.1% and 9.4%, target lesion revascularization rates 2.8%, 4.9% and 5.4% and definite stent thrombosis rates 0.5%, 0.6% and 0.6%. Subgroups showed significant differences in baseline and procedural characteristics which did not translate into significantly different clinical outcomes. Specifically, MACE rates at 24months were 13.5% in diabetics, 8.6% in small stents and 9.6% in acute coronary syndrome patients. The population of ENERGY reflects real-world conditions with bare metal stents being mainly used in simple lesions. In this setting, percutaneous coronary intervention using a cobalt-chromium thin strut bare metal stent with a passive coating showed very good results up to 24months. (ClinicalTrials.gov:NCT01056120) SUMMARY FOR ANNOTATED TABLE OF CONTENTS: The ENERGY international registry evaluated the safety and benefits of a cobalt-chromium thin strut bare metal stent with passive coating in 1016 patients under real-world conditions until 2years. Results were encouraging with a low composite rate of cardiac death, myocardial infarction and clinically driven target lesion revascularization, even in the pre-defined high risk groups of diabetes, stents ≤2.75mm and acute coronary syndrome.

Real world experience with an indigenously manufactured stent Cobal C – A retrospective study

BackgroundSecond generation bare metal stents made of cobalt chromium alloy are superior to first generation stain less steel stents. The thin struts are shown to reduce clinical and angiographic adverse outcomes. ObjectiveTo study the long term clinical and angiographic outcomes in patients who underwent coronary angioplasty with an indigenously made cobalt chromium bare metal stents with thin strut Cobal+C™ (Relisys). MethodsA total of 268 consecutive patients who underwent coronary angioplasty with Cobal+C stents were studied retrospectively. Clinical follow up was done after a minimum period of nine months through telephonic interview and angiographic follow up was done in 80 patients chosen randomly. The end points analyzed included major adverse cardiac events (MACE) at nine months and the rate of binary restenosis at follow up angiogram done between 9 and 15 months post angioplasty. ResultsThirty four percent were diabetic and 33% had acute myocardial infarction. Females constituted 17%. Mean stent diameter was 2.88 ± 0.28 and mean stent length 18.8 ± 4.2. MACE at nine months was 4.5% with TLR 0.3%. The rate of binary restenosis was 21%. Patients with longer stent lengths and non-compliance with medications had significantly higher rates of binary restenosis. ConclusionsThe use of Relisys Cobal+C stents was associated with good long term clinical and angiographic outcomes as evidenced by low incidence of MACE and binary restenosis rates for a bare metal stent.

Treatment of coronary artery disease with bare metal stents followed by paclitaxel- coated balloon catheter versus paclitaxel-eluting stents- randomized trial

Purpose: The aim of the study is to compare single dose of Paclitaxel delivered from Paclitaxel-coated Balloon Catheter - SeQuent Please (DEB) after implantation of the cobalt chromium bare metal stent- Coroflex Blue (BMS) versus the slow release of Paclitaxel from the drug eluting stent - Coroflex Please (DES). Method: We included 202 patients with stable or unstable angina and coronary artery stenosis > 50% in native vessels from 2.5 to 3.5 mm in diameter. All patients were randomized 1:1 to either DES or BMS+ DEB (DEB) group. In-hospital, 30 day and 6 month clinical data were collected after the randomization and index procedure. Primary endpoint was: target lesion failure (TLF) defined as cardiac death, myocardial infraction (MI), repeat percutaneous coronary intervention (PCI) or coronary artery by-pass (CABG) related to the target vessel. Angiographic endpoints were late loss and binary restenosis measured in 9 month angiograpy control in 50% of patients. In stent thrombosis (ST) (definite according to ARC definition) was recorded as additional safety endpoint. Results: Stent placement of DES or BMS postdilated with DEB was successful in 202 patients (100 DES vs. 102 DEB) There was no patient lost to follow up. Before discharge the primary endpoint was met in 5 patients. (two in DES vs three in DEB group; p= ns). ST occurred in 4 patients (one in DES vs three in DEB; p=ns). During 30 days follow up, primary endpoint occurred in 7 patients (2 in DES vs. 5 in DEB; p=ns). ST was noted in 6 patients (1 in DES vs 5 in DEB; p=ns). In the 6 months follow-up, the primary endpoint occurred in 11 patients (3 in DES vs. 8 in DEB; p=ns). There were more statisticaly non-significant ST in DEB group (1in DES vs. 6 in DEB; p=0.1). Concusions: SeQuent Please (DEB) after implantation the cobalt chromium bare metal stent- Coroflex Blue (BMS) is comparable with Coroflex Please (DES) treatment, nevertheless stent thrombosis was more frequent (not statistically significant) in Coroflex Blue (BMS) plus SeQuent Please (DEB) group.

Additional side branch stent placement in patients with long side branch lesions treated with the Tryton dedicated bifurcation side branch stent

Treatment of bifurcation lesions account for approximately 20% of all percutaneous coronary interventions (PCI) and is associated with increased risk of adverse cardiac events when compared with percutaneous treatment of non-bifurcation lesions [1,2]. Therefore, several dedicated bifurcation stents, such as the Tryton Side Branch Stent™ (Tryton Medical, Durham, NC, USA), have been developed to improve clinical outcomes after PCI of bifurcation lesions. The Tryton stent is a balloon-expandable cobalt–chromium bare-metal stent conceived specifically to treat bifurcation lesions.

Predictors and clinical implications of stent thrombosis in patients with ST-segment elevation myocardial infarction

Few data are available about safety of second generation drug eluting stents in an all-comer ST elevation myocardial infarction (STEMI) population. We sought to investigate the predictors and clinical implications of 1-year stent thrombosis (ST) in patients with STEMI, included in the EXAMINATION trial. The EXAMINATION trial is an all-comer prospective, randomized 1:1 controlled trial, testing everolimus-eluting stent (EES) vs. cobalt chromium bare metal stent (BMS) in STEMI patients. It included 1498 patients, randomized to EES (n = 751) or BMS (n = 747). At 1 year, definite/probable stent thrombosis, defined according to ARC criteria, occurred in 26 patients (1.73%), including 18 definite and 8 probable events. The incidence of ST was lower in patients treated with EES than in those treated with BMS (HR 0.16, 95% CI 0.03-0.29, p = 0.017). Patients with ST have higher 1-year rates of cardiac death (30.8% vs. 2.5%, p<0.001), myocardial infarction (30.8% vs. 0.5%, p<0.001) and target vessel revascularization (65.4% vs. 4.2%, p<0.001) compared with those without. Independent predictors of 1-year definite/probable ST were BMS implantation at the index procedure (HR 3.41, 95% CI 1.35-8.60), ST segment resolution of at least 70% in the EKG post-PCI (HR 0.30, 95% CI 0.13-0.70) and Killip class on admission (HR 2.57, 95% CI 1.70-3.90). ST had low frequency in the first year after implantation of EES/BMS in STEMI patients, but it is associated with adverse events. BMS implantation, lack of ST-segment resolution and high Killip class on admission were independent predictors of 1-year ST.

Rationale and design of the EXAMINATION trial: a randomised comparison between everolimus-eluting stents and cobalt-chromium bare-metal stents in ST-elevation myocardial infarction

To assess the performance of the everolimus-eluting stent (EES) versus cobalt chromium bare-metal stent (BMS) in the setting of primary percutaneous coronary intervention for treatment of patients presenting with ST-segment elevation myocardial infarction (STEMI). The implantation of a drug-eluting stent in the setting of an acute myocardial infarction is still controversial. In several registries this clinical scenario has been associated with the development of stent thrombosis. The EES has demonstrated to reduce the stent thrombosis rate as compared to paclitaxel-eluting stent in randomised controlled trials, mainly performed in patients in stable clinical conditions. There are however few data regarding the effectiveness of EES in the context of STEMI. This is an investigator-driven, prospective, multicentre, multinational, randomised, single blind, two-arm, controlled trial (ClinicalTrials.gov number: NCT00828087). This trial, with an all comer design, randomises approximately 1,500 patients 1:1 to EES or BMS. Overall, any patient presenting with STEMI up to 48 hours who requires emergent percutaneous coronary intervention can be included. The primary endpoint is the patient-oriented combined endpoint of all-cause death, any myocardial infarction and any revascularisation at 1-year according to the Academic Research Consortium. Clinical follow-up will be scheduled at 30 days, six months, one year and yearly up to five years. No angiographic follow-up is mandated per protocol. This trial with broad inclusion and few exclusion criteria will shed light on the performance of the second generation EES in the complex scenario of STEMI.

Long-Term Clinical Outcome of Thin-Strut Cobalt-Chromium Stents in the Drug-Eluting Stent Era: Results of the COBALT (Comparison of Bare-Metal Stents in All-Comers’ Lesion Treatment) Registry

Despite widespread penetration of drug-eluting stents (DES) in clinical practice, a relevant percentage of patients with coronary artery disease are still treated with bare-metal stents (BMS). Contemporary BMS, however, are less well investigated and comparative data on clinical outcome are lacking. This single-center registry aimed to assess characteristics and outcome of patients treated with 2 different new-generation cobalt-chromium BMS, the MULTI-LINK VISION and PRO-Kinetic stents. During the study, adopted criteria for BMS selection were: (1) limited compliance to dual antiplatelet therapy, (2) ST-elevation myocardial infarction (MI) or saphenous vein graft (SVG) interventions, and (3) noncomplex lesions located either in the right coronary artery or in the nonproximal segments of the left coronary artery. During a 24-month period 1,176 patients were treated with the VISION (n = 438) or PRO-Kinetic stent (n = 738). Median duration of follow-up was 549.5 and 528.5 days, respectively. Target lesion revascularization (TLR) and target vessel revascularization were numerically lower in the VISION group (10.4 vs. 12.3% and 11.9 vs. 15.2%, P = 0.24 and 0.11). Death (4.1 vs. 4.3%, P = 0.85), MI (2 vs. 2.3%, P = 0.78), and ARC definite stent thrombosis (0.5 vs. 0.5%, P = 0.84) were similar. By multivariate analysis, variables associated with TLR were SVG interventions (HR 2.21, 95% CI 1.26-3.86), total stent length (HR 1.01, 95% CI 1.00-1.02), and smoking (HR 1.51, 95% CI 1.05-2.16). In the DES era, the use of last-generation thin-strut BMS in selected patients is associated with acceptable clinical outcome, with similar clinical results for both the MULTI-LINK VISION and PRO-Kinetic stents.