Efficacy Of Bare Metal Stents Research Articles

Abstract 13590: Comparative Efficacy and Safety of Bare-Metal versus Drug-Eluting Stents in Managing Saphenous Venous Graft Disease: A Meta-Analysis and Systematic Review

Introduction: Current understanding of the relative safety and efficacy of bare metal stents (BMS) vs. drug eluting stents (DES) in patients with saphenous venous graft disease (SVGD) relies on analysis of small datasets. Methods: Literature search was performed using PubMed, Embase and Web of Science to identify relevant articles on outcomes of BMS vs. DES in patients with SVGD. A random effects model was used to calculate odds ratios (ORs) for several safety and efficacy outcomes including major adverse cardiovascular events (MACE), target lesion revascularization (TLR), total vessel revascularization (TVR), in-stent restenosis, and stent thrombosis. Results: Of 3644 total citations on the initial search, 40 studies comprising 83,151 (33,306 BMS, 49,845 DES) patients qualified for quantitative analysis. The mean age was 72 years, and the mean ejection fraction was 47%. The inter group proportion of hypertension was 78% vs. 83%, diabetes mellitus was 37% vs. 14%, and hyperlipidemia was 69% vs. 78% in patients with BMS vs. DES, respectively (Table). Patients receiving DES had significantly lower odds of MACE (OR 0.63, 95% CI 0.52-0.77), and its components; TLR (OR 0.67, 95% CI 0.49-0.92), TVR (OR 0.61, 95% CI 0.46-0.81); and stent restenosis (OR 0.61, 95% CI 0.45-0.84) compared with BMS (Figure). The risk of stent thrombosis (OR 0.84, 95% CI 0.61-1.15) was similar between the two groups. Conclusions: Compared with BMS, patients receiving DES for SVGD demonstrated a lower risk of adverse events, stent stenosis, and need for revascularization.

Efficacy of bare metal stent for treating focal coronary artery aneurysm complicating with severe stenosis in single coronary artery

Objective: To investigate the efficacy of bare metal stent for treating focal coronary artery aneurysm complicating with severe stenosisin single coronary artery. Methods: This retrospective analysis was performed in 7 patients who were diagnosed as local coronary artery aneurysm complicating with severe stenosis(≥70%) in single coronary artery and treated with bare metal stent during the period from December 2012 to June 2015 in Fuwai Hospital. All 7 patients were male with age of (62±11) years old. During the interventional operation, the narrow parts were pre-expanded,and all patients received bare metal stents implantation to cover aneurysms.The clinical and imaging data of patients immediately post procedure and at postoperative follow-up were collected to evaluate the clinical efficacy. Results: There were 5 cases of left anterior descending aneurysms and 2 cases of right coronary artery aneurysms. The diameter of aneurysm was (5.21±1.28)mm, and the length was (13.71±3.88)mm. There was intracranial vortex in coronary arteriography immediately after intervention.Proximalstenosis of coronary artery aneurysm was disappeared,and the distal blood flow was TIMI class 3.There were no signs of aortic dissection and thrombus formation.During 6(6 16) months follow-up, the aneurysms were disappeared,and there were no major adverse cardiovascular events which including myocardial ischemia, acute myocardial infarction, revascularization,bleeding,and death for all patients. Conclusion: Initial experience shows that double-layer bare metal stents implantation for patients with localized coronary artery aneurysm complicating with severe stenosis in single vessel is safe and effective.

Long-term outcome of patients with very small coronary artery disease: A comparison of drug-eluting and bare metal stents

BackgroundAmong patients with very small vessel disease and chronic kidney disease (CKD), the comparative efficacy of bare metal stents (BMSs) versus drug-eluting stents (DESs) is not frequently addressed. This study aimed to evaluate the long-term outcomes of patients with very small vessel disease managed with percutaneous coronary intervention. MethodsOur study included 158 consecutive patients undergoing percutaneous coronary intervention from January 2003 to December 2013. The primary end points were cardiovascular death and target vessel failure, which consisted of cardiovascular death, target vessel-related myocardial infarction, and ischemia-driven target vessel revascularization. ResultsBMSs were used in 37 patients, while DESs were utilized in 121 patients. During the mean follow-up period of 2.7 ± 2.2 years (median 2.1 years; interquartile range, 1.3−4.2 years), the target vessel failure rate was 48.6% versus 28.1% (BMS vs. DES, p = 0.020) and the cardiovascular death rate was 27% versus 18.2% (BMS vs. DES, p = 0.241). The use of a DES (hazard ratio: 0.44, 95% confidence interval: 0.24–0.79, p = 0.006) remained the most significant predictor of target vessel failure after multivariate analysis. In CKD subgroup analysis, the benefit of a 2.25 mm DES was evident only in the subgroup with CKD, but such a benefit disappeared in those without CKD. ConclusionCompared with BMSs, implantation of DESs in a patient population with very small vessel disease effectively reduced target vessel failure. However, the beneficial effects of DESs appeared to be evident only in the subgroup with CKD.

Comparison of long term clinical outcomes between bare metal stent versus different types of drug eluting stents for treatment of acute myocardial infarction

Purpose: To overcome the intrastent restenosis (ISR) and stent thrombosis (ST), people have tried to make a perfect stent. Accordingly, now we come to have a lot of developed type of coronary stents. However, there is paucity of data to exclusively evaluate the safety and efficacy of bare metal stent (BMS) and different types of drug-eluting stents (DES) in the setting of AMI. The purpose of this study was to compare the clinical outcome of four different types of coronary stent including BMS, 1st generation DES, 2nd generation plus new generation DES, and most recently biodegradable polymer-coated stent in treatment of acute myocardial infarction. Methods: From Korean Acute Myocardial Infarction Registry (KAMIR) database, a total of 9,919 patients with acute myocardial infarction (MI) who underwent primary percutaneous coronary intervention (PCI) with BMS or DES were enrolled in this study. The patients were divided into four groups; BMS group (n=821), 1st generation DES group (n=2,751), 2nd generation plus new generation DES group (n=5,324), and biodegradable polymer coating stent group (n=303). The primary endpoints included major adverse cardiovascular events (MACE), such as death, MI, or revascularization including re-PCI and coronary artery bypass graft surgery (CABG), and stent thrombosis at one year follow up. Results: Baseline characteristics were similar between four groups. At one year follow up, MACE rate in the BMS, 1st generation DES, 2nd generation plus new generation DES, and biodegradable DES groups were 12.3%, 8.1%, 5.3% and 3.9%, respectively (p<0.0001). There were 104 cases of stent thrombosis of all cohorts, and the incidence of stent thrombosis was the lowest in the biodegradable DES group among the 4 groups (2.5%, 2.0%, 1.4%, 0.7%, p=0.007). After the adjustment of age, male gender, ST-segment elevation myocardial infarction (SETMI), left ventricular ejection fraction, stent number and length, stent type was significant predictor for one year MACE (Odds ratio of 1st, 2nd+new generation, biodegradable polymer coated stent group compared to BMS group: 0.62, 0.37, 0.27, respectively, p<0.05 for all). Conclusion: From our result, biodegradable polymer coated stent was the most efficacious and safest stent in acute MI at one year follow up.

Three-year clinical event rates in different age groups after contemporary percutaneous coronary intervention

As the global population ages, elderly patients will form an increasing proportion of those undergoing percutaneous coronary intervention (PCI). We investigated the safety and efficacy of bare metal stents (BMS) and DES in all patients undergoing PCI at our institution, stratified by age. We investigated three sequential groups of consecutive patients treated exclusively with BMS (n=2,194; January 2000 to April 2002), sirolimus-eluting stents (SES, n=834; April 2002 to February 2003) and paclitaxel-eluting stents (PES, n=2,841; February 2003 to December 2005). The primary endpoint was all-cause mortality. Secondary endpoints included target vessel revascularisation (TVR) and composite major adverse cardiac events (MACE, defined as all-cause death, any nonfatal myocardial infarction or TVR). Patients were followed up for a median of 1,366 days. Patients were stratified into equal quintiles based on age (<51.8, 51.8-58.4, 58.4-65.4, 65.4-73.0 and >73.0 years). All-cause mortality was significantly higher in the eldest two groups, while TVR rates were similar across all age groups. DES were associated with reductions in TVR and MACE and a trend towards reduced mortality in all age groups. DES are safe and effective when compared to BMS, irrespective of age.

Bare metal stent implantation in large-sized unprotected left main coronary artery stenosis in the drug-eluting stent era

Recently, drug-eluting stent (DES) has been recommended as the first choice in those patients who need stent implantation in unprotected left main coronary artery (ULMCA) stenosis. However, the long-term safety and efficacy of this procedure is still controversial. The objective of this study was to evaluate the safety and efficacy of bare metal stent (BMS) implantation in ULMCA stenting in the DES era. We implanted BMS (mainly 4mm-diameter) in large-sized ULMCA after December 2004 when DES became available. The results of BMS implantation (n=19) were compared with those of DES implantation (n=39). There was no significant difference between the 2 groups regarding age, gender and coronary risk factors. Emergency procedures were more frequently performed in the BMS group than in the DES group (53% vs. 26%, p=0.08). The initial mortality was 10.5% (n=2) in the BMS group and 2.6% (n=1) in the DES group (p=0.25). There was no stent thrombosis, Q-wave myocardial infarction or emergent bypass surgery in either group during their hospital stay. The restenosis rate was 0% (n=45) in both groups, and the target vessel revascularization rate was 5.9% in the BMS group (1/17) and 2.6% (1/38) in the DES group (p=0.53). Therefore, there were no statistically significant differences in outcomes between the two study groups. These results indicate that BMS implantation in a large-sized ULMCA may be a safe and effective treatment even in the DES era.

Two-Year Clinical, Angiographic, and Intravascular Ultrasound Follow-Up of the XIENCE V Everolimus-Eluting Stent in the Treatment of Patients With De Novo Native Coronary Artery Lesions: The SPIRIT II Trial

Two-Year Clinical, Angiographic, and Intravascular Ultrasound Follow-Up of the XIENCE V Everolimus-Eluting Stent in the Treatment of Patients With De Novo Native Coronary Artery Lesions: The SPIRIT II Trial

A multicenter, randomized study to test immunosuppressive therapy with oral prednisone for the prevention of restenosis after percutaneous coronary interventions: cortisone plus BMS or DES versus BMS alone to eliminate restenosis (CEREA-DES) – study design and rationale

Several randomized trials and registries have shown a reduction of restenosis after coronary angioplasty with drug-eluting stents (DESs) compared with bare metal stents (BMSs). However, cost-efficacy analysis and long-term outcome of DESs compared to BMSs deserve further assessment. Moreover, concern has been raised regarding adverse clinical events occurring late after DES implantation, in particular, late stent thrombosis related to the suspension of dual antiplatelet therapy. The use of a short-cycle oral treatment with prednisone at immunosuppressive dose after BMS implantation has shown remarkable efficacy in reducing restenosis in nondiabetic patients, with very low additional cost and without the need for long-term dual antiplatelet therapy. Such results are however limited by small sample size. Cortisone plus BMS or DES versus BMS alone to Eliminate Restenosis is an independent, prospective, multicenter, randomized study. It will randomize 375 nondiabetic patients with coronary artery disease in three different arms to BMS (control group), DES (DES group) or BMS followed by a 40-day prednisone treatment (prednisone group). The DES and the prednisone groups will be compared to the control group to investigate the expected clinical advantage. The primary endpoint of the study is the event-free survival of cardiovascular death, myocardial infarction and recurrence of ischemia-needing repeated target vessel revascularization at 1 year. Secondary endpoints are the event-free survival analysis at 2 and 3 years, the restenosis rate at 9 months, and cost-effectiveness at 1, 2 and 3 years. The expected primary endpoint rates are 90% for DESs and for prednisone-treated patients and 77% for BMSs. The study was designed as a superiority trial, to compare DES, and BMS and prednisone, with BMS alone. A sample size of 118 patients per group provides an 80% power, assuming a complete 12-month follow-up information available for each patient. To obviate for cases of drop out, the sample size was increased to 375 patients to be enrolled in five Italian hospitals. This study will provide a magnitude of the net clinical and economic benefits of DES and of the safety and efficacy of BMS and cortisone compared to the standard use of BMS alone in nondiabetic patients with coronary artery disease.

Paclitaxel-Eluting Coronary Stents in Patients With Diabetes Mellitus: Pooled Analysis From 5 Randomized Trials

We sought to examine the safety and efficacy of paclitaxel-eluting stents (PES) in patients with diabetes mellitus (DM). Compared with patients without DM, patients with DM undergoing percutaneous coronary intervention are at increased risk for mortality and restenosis. The safety of drug-eluting stents in diabetic patients has recently been called into question by a published meta-analysis of randomized trials. Patient-level data were pooled from 5 prospective, double-blind, randomized trials of PES versus bare-metal stents (BMS) (n = 3,513). Safety and efficacy outcomes through 4 years of follow-up were assessed among the 827 randomized patients (23.6%) with DM. Patients treated with PES and BMS has similar baseline characteristics among both the diabetic and nondiabetic cohorts within these trials. At 4-year follow-up, there were no significant differences between PES and BMS among diabetic patients in the rates of death (8.4% vs. 10.3%, respectively, p = 0.61), myocardial infarction (6.9% vs. 8.9%, p = 0.17), or stent thrombosis (1.4% vs. 1.2%, p = 0.92). Treatment of diabetic patients with PES compared with treatment with BMS was associated with a significant and durable reduction in target lesion revascularization over the 4-year follow-up period (12.4% vs. 24.7%, p < 0.0001). The relative safety and efficacy of PES compared with the relative safety and efficacy of BMS in diabetic patients extended to both those requiring and not requiring insulin. In these 5 randomized trials in which patients with single, primarily noncomplex lesions were enrolled, treatment with PES compared with treatment with BMS was safe and effective, resulting in markedly lower rates of target lesion revascularization at 4 years, with similar rates of death, myocardial infarction, and stent thrombosis.