Safety Of Drug-eluting Stents Research Articles

Long-term clinical and angiographic outcomes of diabetic patients after revascularization with early generation drug-eluting stents

Early generation drug-eluting stents (DESs) reduce restenosis and repeat revascularization procedures. However, the long-term safety and efficacy of early generation DES according to diabetic status are poorly established. A total of 1,012 patients were randomly assigned to treatment with sirolimus-eluting (n = 503) or paclitaxel-eluting stents (n = 509). Serial angiographic follow-up at baseline, 8 months, and 5 years was available in 293 patients with 382 lesions. The primary end point was a composite of major adverse cardiac events (cardiac death, myocardial infarction, and ischemia-driven target lesion revascularization). Clinical and angiographic outcomes through 5-year follow-up were compared between diabetic and nondiabetic patients. Major adverse cardiac events were more common among diabetic than nondiabetic patients at 5 years (25.9% vs 19.2%, hazard ratio [HR] 1.45, 95% CI 1.06-1.99, P = .02). The difference in disfavor of diabetic patients was largely determined by a higher rate of cardiac mortality (11.4% vs 4.3%, HR 2.86, 95% CI 1.69-4.84, P < .0001), whereas the risk of myocardial infarction (6.5% vs 6.8%, HR 1.00, 95% CI 0.55-1.84, P = .99) and ischemia-driven target lesion revascularization (14.4% vs 14.1%, HR 1.09, 95% CI 0.73-1.64, P = .67) was comparable. The risk of stent thrombosis was similar among diabetic and nondiabetic patients (definite or probable: 6.0% vs 4.6%, HR 1.36, 95% CI 0.71-2.67, P = .35). Among 293 patients undergoing serial angiography, very-late lumen loss amounted to 0.42 ± 0.63 mm in diabetic patients and 0.44 ± 0.68 mm in nondiabetic patients (P = .79). Diabetic patients remain at increased risk for mortality after revascularization with early generation DES during long-term follow-up. Conversely, diabetes is no longer associated with an increased risk of clinical and angiographic restenosis after revascularization with early generation DES.

Drug-Eluting vs Bare-Metal Stents in Primary Angioplasty

Concerns have emerged regarding a higher risk of stent thrombosis after drug-eluting stent (DES) implantation, especially in the setting of ST-segment elevation myocardial infarction (STEMI). Our objective was to perform a meta-analysis using individual patient data to evaluate the long-term safety and effectiveness of DES compared with bare-metal stents (BMS) in patients undergoing primary percutaneous coronary intervention for STEMI. Formal searches of electronic databases (MEDLINE and CENTRAL) and scientific session presentations from January 2000 to June 2011. We examined all completed randomized trials of DES for STEMI. Individual patient data. Individual patient data were obtained from 11 of 13 trials identified, including a total of 6298 patients (3980 [63.2%] randomized to DES [99% sirolimus-eluting or paclitaxel-eluting stents] and 2318 [36.8%] randomized to BMS). At long-term follow-up (mean [SD], 1201 [440] days), DES implantation significantly reduced the occurrence of target-vessel revascularization (12.7% vs 20.1%; hazard ratio [95% CI], 0.57 [0.50-0.66]; P<.001, P value for heterogeneity, .20), without any significant difference in terms of mortality, reinfarction, and stent thrombosis. However, DES implantation was associated with an increased risk of very late stent thrombosis and reinfarction. The present pooled patient-level meta-analysis demonstrates that among patients with STEMI undergoing primary percutaneous coronary intervention, sirolimus-eluting and paclitaxel-eluting stents compared with BMS are associated with a significant reduction in target-vessel revascularization at long-term follow-up. Although there were no differences in cumulative mortality, reinfarction, or stent thrombosis, the incidence of very late reinfarction and stent thrombosis was increased with these DES.

First Results of the DEB-AMI (Drug Eluting Balloon in Acute ST-Segment Elevation Myocardial Infarction) Trial: A Multicenter Randomized Comparison of Drug-Eluting Balloon Plus Bare-Metal Stent Versus Bare-Metal Stent Versus Drug-Eluting Stent in Primary Percutaneous Coronary Intervention With 6-Month Angiographic, Intravascular, Functional, and Clinical Outcomes

The goal of this study was to compare angiographic, intravascular imaging, and functional parameters, as well as the clinical outcomes of patients treated with drug-eluting balloon (DEB) plus bare-metal stent (BMS) versus BMS versus drug-eluting stent (DES) for ST-segment elevated acute myocardial infarction (STEMI). Concerns remain regarding the long-term safety of DES in STEMI. DEB could provide an attractive alternative in order to achieve potentially similar effectiveness but limiting the long-term hazards related to late-acquired stent malapposition and thus stent thrombosis. In this randomized, international, 2-center, single-blinded, 3-arm study, STEMI patients were randomly assigned to group A: BMS; group B: DEB plus BMS; or group C: DES after successful thrombus aspiration. The primary endpoint was 6-month angiographic in-stent late-luminal loss. Secondary endpoints were in-stent binary restenosis, major adverse cardiac events (MACE: cardiac death, myocardial infarction, target vessel revascularization). In a subgroup of patients, stent (mal)apposition (by optical coherence tomography) and endothelial function (by acetylcholine infusion) was assessed. Overall, 150 patients were randomized. Procedural success was achieved in 96.7%. In groups A, B, and C, respectively, late-luminal loss was 0.74 ± 0.57 mm, 0.64 ± 0.56 mm, and 0.21 ± 0.32 mm (p < 0.01); binary restenosis was 26.2%, 28.6%, and 4.7% (p = 0.01); and MACE rates were 23.5%, 20.0%, and 4.1% (p = 0.02), respectively. The median percentage [25th to 75th interquartile range] of uncovered and malapposed stent struts per lesion was 0 [0 to 0.35], 2.84 [0 to 6.63], and 5.21 [3.25 to 14.5] (p < 0.01). Significant paradoxical vasoconstriction was seen in groups B and C. In STEMI patients, DEB followed by BMS implantation failed to show angiographic superiority to BMS only. Angiographic results of DES were superior to both BMS and DEB. Moreover, DEB before implantation induced more uncovered and malapposed stent struts than BMS, but less than after DES. (Drug-Eluting Balloon in Acute Myocardial Infarction [DEB-AMI]; NCT00856765).

Comparison of Additional Versus No Additional Heparin During Therapeutic Oral Anticoagulation in Patients Undergoing Percutaneous Coronary Intervention

Uninterrupted oral anticoagulation (OAC) therapy can be the preferred strategy in patients with atrial fibrillation at moderate to high risk of thromboembolism undergoing percutaneous coronary intervention (PCI). To evaluate the need for additional heparins in addition to therapeutic peri-PCI OAC, we assessed bleeding complications and major adverse cardiac and cerebrovascular events in 414 consecutive patients undergoing PCI during therapeutic (international normalized ratio 2 to 3.5) periprocedural OAC. Patients were divided into those with no (n = 196) and with (n = 218) additional use of periprocedural heparins. No differences in major adverse cardiac and cerebrovascular events (4.1% vs 3.2%, p = 0.79) or major bleeding (1.0% vs 3.7%, p = 0.11) were detected, but access site complications (5.1% vs 11.0%, p = 0.032) were less frequent in those without additional heparins. When adjusted for propensity score, patients with additional heparins had a higher risk of access site complications (odds ratio 2.6, 95% confidence interval 1.1 to 6.1, p = 0.022) without any increased risk of any other adverse event. Analysis of 1-to-1 propensity-matched pairs showed a significantly higher risk of access site complication in patients receiving additional AC (13.1% vs 5.7%, p = 0.049). In conclusion, therapeutic warfarin treatment seems to provide sufficient AC for PCI. Additional heparins are not needed and may increase access site complications.

Stent thrombosis with drug-eluting and bare-metal stents: evidence from a comprehensive network meta-analysis

The relative safety of drug-eluting stents and bare-metal stents, especially with respect to stent thrombosis, continues to be debated. In view of the overall low frequency of stent thrombosis, large sample sizes are needed to accurately estimate treatment differences between stents. We compared the risk of thrombosis between bare-metal and drug-eluting stents. For this network meta-analysis, randomised controlled trials comparing different drug-eluting stents or drug-eluting with bare-metal stents currently approved in the USA were identified through Medline, Embase, Cochrane databases, and proceedings of international meetings. Information about study design, inclusion and exclusion criteria, sample characteristics, and clinical outcomes was extracted. 49 trials including 50,844 patients randomly assigned to treatment groups were analysed. 1-year definite stent thrombosis was significantly lower with cobalt-chromium everolimus eluting stents (CoCr-EES) than with bare-metal stents (odds ratio [OR] 0·23, 95% CI 0·13-0·41). The significant difference in stent thrombosis between CoCr-EES and bare-metal stents was evident as early as 30 days (OR 0·21, 95% CI 0·11-0·42) and was also significant between 31 days and 1 year (OR 0·27, 95% CI 0·08-0·74). CoCr-EES were also associated with significantly lower rates of 1-year definite stent thrombosis compared with paclitaxel-eluting stents (OR 0·28, 95% CI 0·16-0·48), permanent polymer-based sirolimus-eluting stents (OR 0·41, 95% CI 0·24-0·70), phosphorylcholine-based zotarolimus-eluting stents (OR 0·21, 95% CI 0·10-0·44), and Resolute zotarolimus-eluting stents (OR 0·14, 95% CI 0·03-0·47). At 2-year follow-up, CoCr-EES were still associated with significantly lower rates of definite stent thrombosis than were bare-metal (OR 0·35, 95% CI 0·17-0·69) and paclitaxel-eluting stents (OR 0·34, 95% CI 0·19-0·62). No other drug-eluting stent had lower definite thrombosis rates compared with bare-metal stents at 2-year follow-up. In randomised studies completed to date, CoCr-EES has the lowest rate of stent thrombosis within 2 years of implantation. The finding that CoCr-EES also reduced stent thrombosis compared with bare-metal stents, if confirmed in future randomised trials, represents a paradigm shift. The Cardiovascular Research Foundation.

Early beneficial effects of drug‐eluting stents in vein grafts wane during long term follow‐up

The aim of the study was to compare outcomes of drug-eluting stents (DES) versus bare-metal stents (BMS) in saphenous vein graft (SVG) interventions in a case-control study with a long-term follow-up. Safety and efficacy of DES in SVG interventions are still controversial. We performed a multicenter registry assessing clinical outcomes with DES vs. BMS. We included 311 patients (239 men, age 68 ± 8 years) who underwent percutaneous coronary interventions (PCI) of SVG lesions with DES (n = 138) or BMS (n = 173) with a 2-year follow-up. The two groups were similar for age, sex, main risk factors, incidence of diabetes, use of IIb/IIIa antagonists, use of aspiration devices or filters, number of stents, and total stent length. Overall, at 9 months follow-up incidence of major adverse cardiac events (MACE) and target vessel revascularization (TVR) were significantly lower in the DES group compared with the BMS group (10.9% vs. 22.0%, P = 0.014 and 8.7% vs. 19.1% in DES and BMS respectively, P = 0.015), while there was no significant difference in incidence of myocardial infarction (5.1% vs. 5.2%, P = 0.96) or death (2.2% vs. 4%, respectively, P = 0.54). However, at 24-month follow-up incidence of MACE was 29.7% in the DES group and 37.0% in BMS group (P = 0.29); incidence of TVR (23.2% vs. 28.9% P = 0.39), myocardial infarction (9.4% vs. 9.2%), death (7.2% vs. 6.9%) were also similar in the two groups. Although DES appear safe, our findings suggest that the early benefit of DES in SVG may rapidly wane during long-term follow-up.

Coronary aneurysm formation following biodegradable polymer drug-eluting stent implantation

Coronary aneurysm formation is a rare complication occurring after drug-eluting stent (DES) implantation, but always predisposes to the development of late stent thrombosis. Such abnormal dilatation of stented coronary artery has been documented not only with the first-generation sirolimus-/paclitaxel-eluting stents but also with the second-generation everolimus-eluting stent [1–4]. Although exact causes of aneurysm formation remain unknown, available pathological evidence supports the hypothesis that persistent hypersensitivity reaction to the permanent polymer coated on these DESs is the most likely mechanism [5]. Recently, several novel DESs with biodegradable polymers, which carry and control the drug release during a proper period of time and after that erode and vanish from the vascular surface, have been developed and used to improve DES safety and efficacy [6,7]. We report a case of multiple coronary aneurysm formation at 10-month angiographic follow-up after implantation of a biodegradable polymer sirolimus-eluting stent. To the best of our knowledge, this is the first report of coronary aneurysm formation associated with the biodegradable polymer DES. A 65-year-old male patient with a history of hypertension was admitted to our institute because of progressive exertional chest

Comparative long‐term efficacy and safety of drug‐eluting stent versus coronary artery bypass grafting in ostial left main coronary artery disease

To date, drug-eluting stent (DES) implantation has not been compared with coronary artery bypass grafting (CABG) for ostial left main coronary artery (LMCA) lesions. Of the 263 patients in the MAIN-COMPARE registry with ostial LMCA stenosis, 123 were treated with percutaneous coronary intervention (PCI) with DES and 140 with CABG. We compared their 5-year overall survival, composite outcomes of death, Q-wave myocardial infarction (MI) or stroke, and target vessel revascularization (TVR) rates. Unadjusted analysis showed no significant differences between CABG and DES in overall survival rates (95% confidence interval (CI) for hazard ratio (HR): 0.44 to 1.77, P = 0.71), composite outcomes (death, Q-wave MI, or stroke)-free survival rates (95% CI for HR: 0.41-1.63, P = 0.56), and TVR-free survival rates (95% CI for HR: 0.79-5.03, P = 0.14). Multivariate adjusted Cox regression analysis also showed no significant between-group differences in TVR (95% CI for HR: 0.52-3.79, P = 0.49), death (95% CI for HR: 0.79-2.82, P = 0.22) and the composite of death, Q-wave MI, or stroke (95% CI for HR: 0.65-2.57, P = 0.46). These results were sustained after propensity score adjustment and propensity score matching analysis. DES implantation for ostial LMCA lesions showed similar 5-year outcomes of death, major adverse events, and TVR compared with CABG. Although meticulous adjustments decreased baseline difference between the two treatments, the absence of statistical significance could be attributable to the size of the study sample and hidden bias.

Actualización en cardiología intervencionista

This article contains a review of the most important studies on interventional cardiology reported in either publications or presentations. In the area of coronary interventions, ST-elevation myocardial infarction continues to take center place: recent studies have confirmed the importance of timely intervention and the safety of drug-eluting stents. The numerous studies that have compared different generations of drugeluting stents indicate that there has been a steady improvement in safety and efficacy. In addition, the use of stents in the left main coronary artery and in multivessel disease have also been investigated in major studies. Of the different intracoronary diagnostic techniques, optical coherence tomography is highlighted by this review, particularly for its use in the study of drug-eluting stents. There is increasing interest in the percutaneous treatment of structural heart disease, specifically percutaneous aortic valve implantation, especially following the publication of the first randomized trial, which produced encouraging results.

A study to evaluate the clinical outcome of drug-eluting vs bare-metal stents for acute coronary syndrome patients during commercial use in real setting

Background: This study compared clinical outcome of Drug Eluting Stents (DES) versus Bare Metal Stents (BMS) in coronary arteries in patients with Acute Coronary Syndromes. Methods: A retrospective, observational study was carried out in an inpatient setting of the private tertiary care hospital. Patients with &gt;18 years, diagnosed for Acute Coronary Syndromes (ACS), required intervention in coronary artery with implantation of Drug Eluting Stents (DES) or Bare Metal Stents (BMS) were recruited in the study. The data had been collected from file or database of the hospital. All subjects were followed for major adverse cardiac event. Results: A total of 202 patients who underwent percutaneous coronary intervention (PCI) were enrolled into DES group ( n =101) and BMS group ( n =101). All patients were followed up at 1 month, 3 months, 6 months &amp; 12 months for Major Adverse Cardiac Events (MACE). Clinical outcomes during 12 months were compared between DES group &amp; BMS group. Overall MACE rates were reported non-significantly high in BMS group patients (14.85%) compare to DES group patients (8.91%) (p=0.458). However, DES group had lower rates of death (0.99% vs 1.98%, p=0.57), rate of MI (3.96% vs 4.95% p=0.73), rate of revascularization (1.98% vs 3.96% p=0.42) &amp; rate of sub acute thrombosis (1.98% vs 3.96% p=0.42) and higher rate of bleeding (1.98% vs 0.99% p=0.57) compare to cohort-II. Conclusions: The use of DES in the setting of Acute Coronary Syndrome is associated with lower Major Adverse Cardiac Event (MACE) rate compared to BMS without compromising the overall safety over the course of one-year follow-up. The long-term safety of drug-eluting stents needs to be ascertained in large, randomized trials.

Comparison of drug-eluting versus bare-metal stents after rotational atherectomy for the treatment of calcified coronary lesions

Calcified coronary lesions are a well-known risk factor for short and long-term failure after both bare metal stent (BMS) [ 1 Tan K. Sulke N. Taub N. Sowton E. Clinical and lesion morphologic determinants of coronary angioplasty success and complications: current experience. J Am Coll Cardiol. 1995; 25: 855-865 Google Scholar , 2 Hoffmann R. Mintz G.S. Popma J.J. et al. Treatment of calcified coronary lesions with Palmaz–Schatz stents. An intravascular ultrasound study. Eur Heart J. 1998; 19: 1224-1231 Google Scholar ] and drug eluting stent (DES) implantation [ 3 Moussa I. Ellis S.G. Jones M. et al. Impact of coronary culprit lesion calcium in patients undergoing paclitaxel-eluting stent implantation (a TAXUS-IV sub study). Am J Cardiol. 2005; 96: 1242-1247 Google Scholar , 4 Berenguer A. Mainar V. Bordes P. Valencia J. Gomez S. Lozano T. Incidence and predictors of restenosis after sirolimus-eluting stent implantation in high-risk patients. Am Heart J. 2005; 150: 536-542 Google Scholar , 5 Migliorini A. Shehu M. Carrabba N. et al. Predictors of outcome after sirolimus-eluting stent implantation for complex in-stent restenosis. Am J Cardiol. 2005; 96: 1110-1112 Google Scholar ]. Rotational atherectomy facilitates the delivery of stents in severely calcified coronary lesions by modifying plaque anatomy and smoothing inner vascular lumen. Recent reports suggest that the use of rotational atherectomy in combination with DES implantation for the treatment of severely calcified lesions might result in high procedural success and acceptable restenosis rate [ 6 Clavijo L.C. Steinberg D.H. Torguson R. et al. Sirolimus-eluting stents and calcified coronary lesions: clinical outcomes of patients treated with and without rotational atherectomy. Catheter Cardiovasc Interv. 2006; 68: 873-878 Google Scholar , 7 Garcia de Lara J. Pinar E. Ramon Gimeno J. et al. Percutaneous coronary intervention in heavily calcified lesions using rotational atherectomy and paclitaxel-eluting stents: outcomes at one year. Rev Esp Cardiol. 2010; 63: 107-110 Google Scholar , 8 Furuichi S. Sangiorgi G.M. Godino C. et al. Rotational atherectomy followed by drug-eluting stent implantation in calcified coronary lesions. EuroIntervention. 2009; 5: 370-374 Google Scholar , 9 Mezilis N. Dardas P. Ninios V. Tsikaderis D. Rotablation in the drug eluting era: immediate and long-term results from a single center experience. J Interv Cardiol. 2010; 23: 249-253 Google Scholar , 10 Benezet J. de la Llera LS Diaz Cubero J.M. Villa M. Fernandez-Quero M. Sanchez-Gonzalez A. Drug-eluting stents following rotational atherectomy for heavily calcified coronary lesions: long-term clinical outcomes. J Invasive Cardiol. 2011; 23: 28-32 Google Scholar ]. However, the long-term efficacy and safety of DES compared to BMS, in combination with rotational atherectomy in patients with calcified coronary lesions is limited.

Safety and efficacy of biodegradable vs. durable polymer drug-eluting stents: evidence from a meta-analysis of randomised trials

Drug-eluting stents (DES) are a major advance in interventional cardiology; however concerns have been raised regarding their long-term safety due to the permanent nature of the polymer. New generation stents with biodegradable polymers (BDS) have recently been developed. The aim of this study was to perform a meta-analysis of randomised controlled trials (RCTs) comparing the safety and efficacy profile of BDS vs. durable polymer DES. The MEDLINE/CENTRAL and Google Scholar databases were searched for RCTs comparing safety and efficacy of BDS vs. DES. Safety endpoints were mortality, myocardial infarction (MI), and stent thrombosis (ST). Efficacy endpoints were target vessel revascularisation (TVR), target lesion revascularisation (TLR) and six-month in-stent late loss (ISLL). The meta-analysis included eight RCTs (n=7,481). At a median follow-up of nine months, as compared to DES, BDS use did not increase mortality (OR [95% CI] = 0.91 [0.69-1.22], p=0.53) or MI (OR [95% CI] = 1.14 [0.90-1.44], p=0.29). Rate of late/very late ST was significantly reduced in BDS patients (OR [95% CI] = 0.60 [0.39-0.91], p=0.02), as was six-month ISLL (mean difference [95% CI] = -0.07 [-0.12; -0.02] mm, p=0.004) in comparison with DES patients. Rates of TVR and TLR were comparable between BDS and DES. BDS are at least as safe as standard DES with regard to survival and MI, and more effective in reducing late ST, as well as six-month ISLL. Further large RCTs with long-term follow-up are warranted to definitively confirm the potential benefits of BDS.

Translational research on novel drug-eluting stents in percutaneous coronary intervention

Although first-generation drug-eluting stents (DES) have markedly reduced restenosis, complications of late and very late in-stent thrombosis have emerged as prime limitations to this technology. The development of new DES is a key process to prevent these complications. Translational research plays a very important role in experiments which determine the safety and efficacy of DES before human clinical trials. The present review focuses on translational research of novel DES, including drug discovery, creation of preclinical research models, planning and conducting of first-in-man studies, and developing next-generation DES systems.

One-year clinical outcomes in patients with chronic renal failure treated by percutaneous coronary intervention with drug-eluting stent

It is unknown whether the efficacy and safety of drug-eluting stents (DES) apply in patients with chronic renal failure (CRF). To compare DES with bare metal stents (BMS) for percutaneous coronary intervention (PCI) in CRF patients. Consecutive patients treated by PCI were allocated to four groups according to type of stent used (DES versus BMS) and creatinine clearance (CrCl). CRF was defined as CrCl less than 60 mL/minute. Cardiovascular death, major adverse cardiac events (MACE, defined as cardiovascular death, myocardial infarction, stroke and target lesion revascularization [TLR]), TLR and definite stent thrombosis (ST) were recorded at 1 year. We note that 1376 consecutive patients underwent PCI with stent within 18 months: 534 (39%) and 492 (36%) patients without CRF and 224 (16%) and 126 (9%) patients with CRF were treated with BMS and DES, respectively. In the entire cohort, patients treated with DES had a higher restenosis risk profile. BMS were predominantly (87%) used for ST-segment elevation myocardial infarction. At 1 year, 6.2% had cardiovascular death, 15.8% MACE, 7.3% TLR and 1.5% ST. Cardiovascular death and MACE occurred less frequently in DES groups. The TLR rate was not significantly different in the CRF groups (BMS 9.8% vs DES 7.1%; P=0.44). No excess of ST was observed in the DES groups and use of DES was independently associated with absence of MACE and TLR. In patients with CRF, DES appear to be at least as effective as BMS--despite a higher restenosis risk profile--with no excess of ST at 1 year.

Safety and Efficacy of Drug-Eluting Stents in Older Patients With Chronic Kidney Disease: A Report From the Linked CathPCI Registry–CMS Claims Database

The purpose of this study was to determine the safety and efficacy of drug-eluting stents (DES) compared with bare-metal stents (BMS) in older patients with chronic kidney disease (CKD). DES may be associated with late death and myocardial infarction (MI) secondary to stent thrombosis. However, data on outcomes in older patients with CKD are limited. We estimated the glomerular filtration rate (GFR) of 283,593 patients 65 years of age and older who underwent stent implantation between 2004 and 2007. In propensity-matched cohorts grouped by GFR, the association between DES and BMS and the risk of death, MI, revascularization, and major bleeding was examined. A total of 121,446 patients (42.8%) had CKD (GFR <60 ml/min/1.73 m(2)). The 30-month mortality rate for patients on long-term dialysis was 52.0%. In propensity-matched pairs, placement of a DES compared with a BMS in patients with normal renal function was associated with significant reductions in 30-month revascularization (hazard ratio [HR]: 0.91; 95% confidence interval [CI]: 0.86 to 0.95), MI (HR: 0.77; 95% CI: 0.71 to 0.83), and death (HR: 0.73; 95% CI: 0.69 to 0.77), but no difference in bleeding (HR: 0.89; 95% CI: 0.79 to 1.00). Lower MI and mortality rates were also observed after DES compared with BMS implantation in all CKD subgroups with the exception of MI in the long-term dialysis group. Decreased rates of revascularization did not extend to any subgroup of patients with CKD. The safety of DES compared with BMS is observed in all patients regardless of renal function and is associated with reduced rates of MI and death in some subsets of patients with CKD.

One-year clinical outcomes in patients with previous coronary artery bypass graft surgery treated by using percutaneous revascularization with domestically made drug-eluting stent

Objective To evaluate the immediate and 1-year outcomes of percutaneous coronary intervention (PCI) with domestically made drug-eluting stent (DES) in patients with previous coronary bypass graft surgery (post-CABG) in order to determine the relationship between related factors and major adverse cardiovascular and cerebral events (MACCE) after PCI. Methods From September 2008 to October 2009, 83 consecutive post-CABG patients had implantation of 176 domestically made DES for 126 coronary lesions. Each patient was followed up at least for 1 year after the procedure done for the evaluation of the efficacy and safety of DES implanted in post-CABG patients. Logistic regression analysis was used to determine the relationship between major factors and MACCE. Results The success rate of operation procedure was 97. 5％. MACCE occurred in 10 patients including death in 1 patient, stroke in 1 patient,myocardial infarction in 1 patient, and those were treated with repeated coronary revascularization in 8patients and target lesion revascularization (TLR) in 1 patient. Conclusions Immediate and medium-term results showed the safety and efficacy of revascularization with domestically made DES in post-CABG patients. Complete revascularization was an independent predictor of MACCE. Key words: Drug-eluting stent; Coronary artery bypass grafting; Clincal outcomes

Comparison of Bare-Metal and Drug-Eluting Stents in Patients with Chronic Kidney Disease (from the NHLBI Dynamic Registry)

Patients with chronic kidney disease (CKD) have a disproportionate burden of coronary artery disease and commonly undergo revascularization. The role and safety of percutaneous coronary intervention (PCI) using drug-eluting stents (DESs) verses bare-metal stents in patients with CKD not on renal replacement therapy has not been fully evaluated. This study investigated the efficacy and safety of DES in patients with CKD not on renal replacement therapy. Patients were drawn from the National Heart, Lung, and Blood Institute Dynamic Registry and were stratified by renal function based on estimated glomerular filtration rate (GFR). Of the 4,157 participants, 1,108 had CKD ("low GFR" <60 ml/min/1.73 m(2)), whereas 3,049 patients had normal renal function ("normal GFR" ≥60 ml/min/1.73 m(2)). For each stratum of renal function we compared risk of death, myocardial infarction, or repeat revascularization between subjects who received DESs and bare-metal stents at the index procedure. Patients with low GFR had higher 1-year rates of death and myocardial infarction and a decreased rate of repeat revascularization compared to patients with normal GFR. Use of DESs was associated with a decreased need for repeat revascularization in the normal-GFR group (adjusted hazard ratio 0.63, 95% confidence interval 0.50 to 0.79, p <0.001) but not in the low-GFR group (hazard ratio 0.69, 95% confidence interval 0.45 to 1.06, p = 0.09). Risks of death and myocardial infarction were not different between the 2 stents in either patient population. In conclusion, presence of CKD predicted poor outcomes after PCI with high rates of mortality regardless of stent type. The effect of DES in decreasing repeat revascularization appeared to be attenuated in these patients.

Drug-eluting coronary stents in clinical practice: lessons from the «BAsel Stent Kosten-Effektivitäts Trials» (BASKET)

In this review of the BAsel Stent Kosten-Effektivitäts Trial (BASKET) the trials and their impact on coronary stenting practice were examined, basing the clinical questions of each study on the findings of the previous study. Are the new drug-eluting stents (DES) cost-effective compared to standard bare-metal stents (BMS) if used in all patients? No. Are there specific subgroups of patients with a particular benefit? Yes. A "targeted stent use" was proposed for daily practice. What is the long-term safety of DES? Unexpected safety problems were observed. Was this a chance finding? No. However, with improved stenting techniques, newer stents and intensified antiplatelet regimens late problems were minimised as shown in the BASKET-PROspective Validation Examination (BASKET-PROVE). Further stent developments? Wait and see! - Many additional questions were raised and answered or are still under investigation. Obviously, answers were not always simple and needed a closer look and this is discussed. The BASKET trials proceeded not only from one question to the other, but also in size and methodology. From the restricted single-centre "local" BASKET study to multicentre international long-term trials, all prospective, randomized and investigator-driven. Their relevance was acknowledged by publications in major medical journals as well as by their impact on US and European practice guidelines and on DES research. These aspects are summarised in the present review, highlighting lessons learned from each study and commenting on the possibilities and difficulties of performing such clinical research in Switzerland.

The BASKET study program: continued evaluation of the efficacy and safety of drug-eluting stents

Since the introduction of drug-eluting stents (DES) in 2000, there has been much debate whether these more expensive devices are cost effective when compared with bare-metal stents (BMS). The initial enthusiasm in the use of DES due to a markedly reduced rate of restenosis compared with BMS was hampered in the following years by reports of increased rates of late-stent thromboses, which raised the concern about a possible late harm after implantation of a DES. The Basel Stent Kosten-Effektivitats Trial (BASKET) study program was initiated to answer some of these questions in a real-world setting. The original BASKET study tested the cost–effectiveness of DES compared with BMS and found cost–effectiveness of DES in high-risk subgroups only. BASKET Late Thrombotic Events (BASKET-LATE), the observational follow-up study of the randomized controlled BASKET trial, found an increased late harm in large native vessels treated with DES, which was attributed to an increased rate of late-stent thromboses. BASKET-Pr...

Bare-Metal Stents Versus Drug-Eluting Stents for Primary Angioplasty: Long-Term Outcome

Percutaneous transluminal coronary intervention (PCI) is the most used myocardial revascularization technique for patients with coronary artery disease. Primary PCI with stent implantation is widely considered the gold standard for the treatment of ST-elevation myocardial infarction patients. Coronary stents, compared with balloon angioplasty, have reduced focal lesion restenosis. To reduce in-stent restenosis, drug-eluting stents (DES) were designed to locally release drugs inhibiting neointimal growth. Recent concerns have emerged on the potential higher risk of stent thrombosis with DES that might be even more pronounced among myocardial infarction patients. For these reasons, DES for primary PCI remains an "off-label" use. In the last several years, a number of randomized trials and registries have tested the safety and efficacy of DES in primary PCI. Data from these studies were analyzed in several meta-analyses, reasonably consistently demonstrating that the use of DES significantly decreased the need for revascularization without an increase in the incidence of death, recurrent infarction, or stent thrombosis at long-term follow-up.