Clinical outcomes of drug‐eluting versus bare‐metal in‐stent restenosis

In‐stent restenosis (ISR) is a challenging syndrome that affects drug‐eluting stents and bare‐metal stents. However, data comparing the outcomes of drug‐eluting versus bare‐metal ISR are limited. Our objective was to evaluate the long‐term clinical outcomes of drug‐eluting versus bare‐metal ISR. Patients who underwent percutaneous coronary intervention at Cleveland Clinic for ISR from 05/1999 to 06/2007 were included. Unadjusted outcomes were tested using Kaplan‐Meier curves followed by multivariable adjusted Cox proportional hazards analyses. Twenty seven variables, including type of stent used to treat ISR and procedural date, were included. The primary end point was a composite of death, myocardial infarction (MI), or target lesion revascularization (TLR). The secondary endpoints were components of the primary endpoint. Of 931 patients identified, 225 had drug‐eluting ISR and 706 had bare‐metal ISR. There were 279 cumulative events for a median follow‐up of 3.2 years. The primary endpoint was not different between drug eluting and bare‐metal ISR (22% versus 33%, adjusted hazard ratio [HR] 1.14; 95% confidence interval [CI], 0.79–1.66; P = 0.49). The secondary endpoints of death (8% versus 16%, adjusted HR 1.05; 95% CI, 0.56–1.98; P = 0.88), MI (4% versus 5%, adjusted HR 1.48; 95% CI, 0.54–4.04; P = 0.45), and TLR (15% versus 16%, adjusted HR 1.30; 95% CI, 0.81–2.11; P = 0.28) were also not different. This study represents the largest analysis comparing drug‐eluting to bare‐metal ISR. On multivariable Cox proportional hazard analyses, drug‐eluting and bare‐metal ISR have similar long term outcomes. © 2009 Wiley‐Liss, Inc.     

A comparative analysis of major clinical outcomes using drug‐eluting stents versus bare‐metal stents in a large consecutive patient cohort

Objectives : To ascertain the long‐term safety, efficacy, and pattern of use of drug‐eluting stents (DES) in routine clinical practice. Methods : We analyzed a registry of 6,583 consecutive patients undergoing percutaneous coronary intervention (PCI), of whom 2,633 were treated using DES (DES group) and 3,950 were treated using bare‐metal stents (BMS group). Propensity score was used for stratified analysis of outcomes and for matching. Outcomes were total mortality, myocardial infarction (MI), repeat target vessel revascularization (TVR) rates, and risk‐adjusted event‐free survival. Results : Follow‐up time was 6 months to 5.18 years (mean: 3 years). Patients in the DES group were more likely to be diabetic and had use of longer or more stents, treatment of more lesions and of more proximal main vessels. After propensity score matching, the cumulative mortality was 12.85% in the DES group versus 14.14% in the BMS group (P = 0.001). Use of DES reduced the occurrence of MI (5.17% vs.5.83%, P = 0.046), of clinically driven TVR (9.76% vs. 12.28%, P < 0.001) and of the composite endpoint of death/MI/TVR (23.38% vs. 26.07%; P < 0.001). Conclusions : Our risk‐adjusted event‐free survival analysis indicates a prognostic benefit for DES utilization that sustains up to 5 years following PCI. © 2010 Wiley‐Liss, Inc.     

Comparing long‐term outcomes between drug‐eluting and bare‐metal stents in the treatment of cardiac allograft vasculopathy

Background: Cardiac allograft vasculopathy (CAV) is the leading cause of death after the first year following heart transplantation. We compared restenosis rates, mortality, and other major adverse cardiac events (MACE) between transplant recipients treated with DES and BMS for CAV. Methods: All patients from our heart transplant registry undergoing PCI with stenting for CAV were identified. Procedural data, baseline clinical characteristics, yearly coronary angiography, cardiac events and death were prospectively collected. Primary outcome was in‐stent restenosis (ISR). Secondary outcomes were in‐segment restenosis, target vessel revascularization (TVR), all‐cause mortality and combined MACE. Results: 36 lesions in 25 patients treated with DES were compared with 31 BMS‐treated lesions in 19 patients. There were no significant differences in baseline characteristics. 12‐month incidence of ISR was 0% with DES vs. 12.9% with BMS, P = 0.03. Over mean (±standard error) follow‐up of 51.1 ± 7.5 months this difference was significant for vessels ≤3 mm in diameter, hazard ratio (HR) DES vs. BMS 0.37 (95% CI 0.11 to 0.95) P = 0.037; but not for vessels >3 mm P = 0.45. However, there was no difference in overall longterm patency because of similar rates of in‐segment restenosis between DES and BMS, HR 1.13 (95% CI 0.43 to 2.97) P = 0.81. Also, the rates of TVR, death from any cause and combined MACE were similar; log rank P 0.88, 0.67, and 0.85, respectively. Conclusion: This study suggests that after PCI for cardiac allograft vasculopathy, despite a lower in‐stent restenosis rate in DES compared with BMS, in‐segment restenosis and clinical cardiac endpoints are similar. © 2009 Wiley‐Liss, Inc.     

Safety and efficacy of drug eluting stents compared with bare metal stents for saphenous vein graft interventions: A comprehensive meta‐analysis of randomized trials and observational studies comprising 7,994 patients

Background: Saphenous vein graft (SVG) lesions remain amongst the most challenging lesions for percutaneous coronary intervention (PCI). It is unknown whether drug eluting stents (DES) are superior to bare metal stents (BMS) for such lesions. Our objective is to determine the safety and efficacy of DES compared with BMS for SVG lesions by performing a meta‐analysis of clinical trials and observational studies. Data Sources: PubMed, Cochrane Register of Controlled Trials, conference proceedings, and internet‐based resources of clinical trials. Study Selection: Studies comparing DES vs. BMS for SVG lesions with at least > 30 patients in each study reporting the outcomes of interest [death, myocardial infarction (MI), target vessel revascularization (TVR), stent thrombosis (ST), and the composite of death, TVR and MI (major adverse cardiac events; MACE)] with at least 6 months clinical follow‐up. The primary outcome of interest was death. Results: Two randomized trials, one subgroup analysis of a randomized trial and 26 observational studies comprising a total of 7,994 patients (4,187 patients in DES and 3,807 patients in BMS group) were included in the analysis .Mean follow‐up duration was 21 ± 11 months (6–48 months). In the overall population, MACE events were 19% in DES and 28% in BMS with a risk ratio (RR) of 0.7 (0.6, 0.8) P < 0.00001. This effect of MACE was sustained in studies with >2 years follow‐up with RR of 0.77 (0.65, 0.91) P = 0.003. Death rate was 7.8% in DES and 9% in BMS with a RR of 0.82 (0.7, 0.97) P = 0.02. MI rate was 5.7% in DES and 7.6% in BMS with RR of 0.72 (0.57, 0.91) P = 0.007. TVR was 12% in DES and 17% in BMS with RR of 0.71 (0.59, 0.85) P = 0.0002. ST was 1% in DES and 1.7 % in BMS RR of 0.61 (0.35, 1.06) P = 0.08. Specifically in randomized controlled trials, DES were associated with no significant differences in overall mortality [RR = 1.97; 95% confidence interval (CI), 0.17–23; P = 0.58] or MI (RR = 1.24; 95% CI, 0.3–5.5; P = 0.78) compared with BMS. Conclusions: Based on the results of this meta‐analysis, DES may be considered as a safe and efficacious option for the percutaneous intervention of SVG lesions. © 2010 Wiley‐Liss, Inc.     

Drug eluting versus bare metal stents in cardiac allograft vasculopathy

Background : Cardiac allograft vasculopathy (CAV) is a distinct pathological condition characterized by diffuse and progressive arteriopathy and it is an important determinant of long‐term graft survival. Definitive CAV treatment is retransplantation but palliation with stenting might temporarily alleviate it. The benefit of drug eluting stents (DES) over bare metal stents (BMS) in the treatment of such lesions is debatable. We therefore sought to do a literature search to review the available evidence comparing DES to BMS. Methods : We conducted Pub Med, EMBASE, Cochrane database review, Web of Science search of studies comparing DES with BMS in CAV. Available studies were retrospective in nature with either direct comparison groups (n = 5) or historical controls (n = 1). The main outcomes analyzed were in stent restenosis (ISR) during follow‐up and clinical outcomes. Results : A total of 312 patients from six studies were included in the review (1995–2007). Most commonly used DES were sirolimus eluting stent. DES appeared to reduce the long‐term risk of ISR compared with BMS. Three of the five studies showed a statistically significant reduction in ISR at 12 months while the one study assessing ISR at 6 months showed no significant difference. Clinical endpoints such as death and major adverse cardiac events were not statistically different. Conclusion : DES appear to reduce the incidence of ISR in CAV as compared with BMS. Prospective randomized clinical trials are needed to determine the clinical benefit of DES beyond a reduction in ISR. © 2011 Wiley‐Liss, Inc.     

Safety and efficacy of second‐generation drug‐eluting stents compared with bare‐metal stents: An updated meta‐analysis and regression of 9 randomized clinical trials

The efficacy of second‐generation drug‐eluting stents (DES; eg, everolimus and zotarolimus) compared with bare‐metal stents (BMS) in patients undergoing percutaneous coronary intervention was challenged recently by new evidence from large clinical trials. Thus, we aimed to conduct an updated systematic review and meta‐analysis of randomized clinical trials (RCTs) evaluating the efficacy and safety of second‐generation DES compared with BMS . Electronic databases were systematically searched for all RCTs comparing second‐generation DES with BMS and reporting clinical outcomes. The primary efficacy outcome was major adverse cardiac events (MACE); the primary safety outcome was definite stent thrombosis. The DerSimonian and Laird method was used for estimation of summary risk ratios (RR). A total of 9 trials involving 17 682 patients were included in the final analysis. Compared with BMS, second‐generation DES were associated with decreased incidence of MACE (RR: 0.78, 95% confidence interval [CI]: 0.69‐0.88), driven by the decreased incidence of myocardial infarction (MI) (RR: 0.67, 95% CI: 0.48‐0.95), target‐lesion revascularization (RR: 0.47, 95% CI: 0.42‐0.53), definite stent thrombosis (RR: 0.57, 95% CI: 0.41‐0.78), and definite/probable stent thrombosis (RR: 0.54, 95% CI: 0.38‐0.80). The incidence of all‐cause mortality was similar between groups (RR: 0.94, 95% CI: 0.79‐1.10). Meta‐regression showed lower incidences of MI with DES implantation in elderly and diabetic patients (P = 0.026 and P < 0.0001, respectively). Compared with BMS, second‐generation DES appear to be associated with a lower incidence of MACE, mainly driven by lower rates of target‐lesion revascularization, MI, and stent thrombosis. However, all‐cause mortality appears similar between groups.     

Comparison of long‐term outcomes of drug‐eluting stents and bare metal stents for saphenous vein graft stenosis

Objective : Our aim was to compare the long‐term outcomes between drug‐eluting stents and bare‐metal stents for saphenous vein graft stenosis. Background : The ideal type of stent to treat saphenous vein graft stenosis has not been clearly established. Short‐term randomized controlled trial results comparing drug‐eluting stents with bare‐metal stents for saphenous vein graft stenosis are conflicting, intermediate‐term retrospective studies and meta‐analyses at two years suggest no difference in outcomes, and there are no long term follow‐up studies. The need for long term follow‐up data has become emerged with concern over late stent thrombosis. Methods : 246 saphenous vein graft patients undergoing stenting from August 2002–December 2008 were studied. Overall survival and event‐free survival were compared by Kaplan‐Meier method. Hazard ratios (HR) were calculated by Cox‐proportional hazards models. Results : We treated 133 patients with DES (median follow‐up four years) and 113 patients with BMS (median follow‐up four years) for SVG stenosis. Overall survival (77.0% ± 3.9% vs. 70.6% ± 4.6%, log‐rank P = 0.60) and MACE‐free survival (57.5% ± 4.6% vs. 56.8% ± 4.9, log‐rank P = 0.70) were not significantly different between the DES and BMS groups. Although BMS was associated with increased risk of target lesion revascularization (TLR) (freedom from TLR 85.2% ± 3.5% vs. 90.0% ± 3.0%, HR 2.07, 95% CI 0.97–4.42, log‐rank P = 0.05), there was no significant difference in the freedom from myocardial infarction (86.7% ± 3.3% vs. 88.7% ± 3.2%, log‐rank P = 0.39) or target vessel revascularization (77.1% ± 4.2% vs. 76.1% ± 4.2%, log‐rank P = 0.33) between the two groups. Conclusions : Although mortality is not statistically different between DES and BMS for SVG stenosis, BMS is associated with increased risk of revascularization, thus suggesting the superiority of DES over BMS in the long term. © 2011 Wiley Periodicals, Inc.     

The short‐ and long‐term outcomes of percutaneous intervention with drug‐eluting stent vs bare‐metal stent in saphenous vein graft disease: An updated meta‐analysis of all randomized clinical trials

The use of drug‐eluting stents (DES) vs bare‐metal stents (BMS) in saphenous vein graft (SVG) lesions remains controversial. We conducted a meta‐analysis of all randomized clinical trials comparing the outcomes of DES with BMS in SVG percutaneous coronary interventions. A search of PubMed, Embase, the Cochrane Register of Controlled Trials, and Clinicaltrials.gov was performed for all randomized clinical trials. We evaluated the short‐ and long‐term clinical outcomes of the following: all‐cause mortality, major adverse cardiovascular events (MACE), definite/probable stent thrombosis, target lesion revascularization (TLR), and target‐vessel revascularization (TVR). From a total of 1582 patients in 6 randomized clinical trials, 797 had DES and 785 had BMS. Patients with DES had lower short‐term MACE, TLR, and TVR in comparison with BMS (odds ratio [OR]: 0.56, 95% confidence interval [CI]: 0.35–0.91, P = 0.02; OR: 0.43, 95% CI: 0.19–0.99, P = 0.05; and OR: 0.45, 95% CI: 0.22–0.95, P = 0.04, respectively). However, there were no different outcomes for all‐cause mortality (P = 0.63) or stent thrombosis (P = 0.21). With long‐term follow‐up, there were no significant reductions of MACE (P = 0.20), TLR (P = 0.57), TVR (P = 0.07), all‐cause mortality (P = 0.29), and stent thrombosis (P = 0.76). The use of DES in SVG lesions was associated with lower short‐term MACE, TLR, and TVR in comparison with BMS. However, there were no significant differences with long‐term follow‐up.     

A comparative analysis of major clinical outcomes using drug‐eluting stents versus bare metal stents in diabetic versus nondiabetic patients

Objectives: We aim to explore the clinical outcome of drug‐eluting stents (DES) versus bare‐metal stents (BMS) implantation in diabetics versus nondiabetic patients. Background: Diabetic patients sustain worse long‐term clinical outcomes after percutaneous coronary interventions (PCI) when compared with nondiabetics. The use of DES decreases the rate of repeat revascularization in this population but data concerning long‐term clinical benefits, such as myocardial infarction (MI) or mortality is scant. Methods: We analyzed data from a comprehensive registry of 6,583 consecutive patients undergoing PCI at our center. A propensity score was used for analysis of outcomes and for matching (DES vs. BMS). Outcome parameters were total mortality, MI, repeat target vessel revascularization (TVR) rates, and risk‐adjusted event‐free survival. Within this cohort, we identified 2,571 nondiabetic patients and these were compared with 1,826 diabetic coronary patients. Results: Mean and median follow up time was 3 and 3.25 years, respectively. Overall, diabetics had higher rates of major‐adverse cardiovascular events (MACE) at 4 years compared with nondiabetics (23.03 vs. 31.96 P > 0.001). DES use was associated with lower rates of TVR in both groups [diabetics hazard ratio (HR) = 0.56, 95% confidence interval (CI): 0.42–0.76, P < 0.001, nondiabetics HR = 0.73, 95% CI: 0.55–0.97, P = 0.03] while sustained decreased rates of both mortality and MI were evident solely among diabetics (HR = 0.71, 95% CI: 0.56–0.89, P = 0.004 in diabetic vs. HR = 0.88, 95% CI: 0.69–1.13, P = 0.3). Conclusions: In a “real‐world,” unselected population and extended clinical use, DES in diabetics was associated with sustained decreased rates of MI, death, TVR, and MACE while this benefit was attenuated in the nondiabetic population. © 2011 Wiley‐Liss, Inc.     

Late outcomes of drug‐eluting versus bare metal stents in saphenous vein grafts: Propensity score analysis

Objective : To compare late outcomes with the routine use of drug‐eluting stents (DES) compared with bare‐metal stents (BMS) during percutaneous intervention (PCI) of saphenous vein grafts (SVGs). Background : Safety concerns >1 year from stent implantation have been raised about DES used for PCI of SVGs in a small randomized clinical trial. However, there are few studies comparing late outcomes of DES and BMS in routine clinical practice. Methods : Clinical outcomes (nonfatal MI, cardiac mortality) were assessed in 74 consecutive patients who received BMS and 74 consecutive propensity score matched patients that received DES for PCI of SVGs. Clinical follow‐up was censored at 2 years ± 30 days for both stent groups. Results : At 2 years, the hazard ratio for DES compared with BMS for PCI of SVGs for target vessel revascularization was 0.54 (0.21–1.36), nonfatal MI or cardiac death was 0.68 (0.27–1.68), cardiac mortality 1.19 (0.32–4.45), and stent thrombosis 0.49 (0.09–2.66). Similar outcomes were observed stratified by propensity score quintile. Conclusions : The routine clinical use of DES for PCI of SVGs was associated with a safety profile that was similar to that of bare metal stents with a clear trend toward a less frequent need for reinterventions. © 2008 Wiley‐Liss, Inc.     

Impact of renal insufficiency on safety and efficacy of drug‐eluting stents compared to bare‐metal stents at 6 years

Background : There is few information on the long‐term efficacy and safety of sirolimus‐eluting stents (SES) and paclitaxel‐eluting stents (PES) compared to bare metal stents (BMS) in all‐comer percutaneous coronary intervention (PCI)—patients complicated by renal insufficiency (RI). Objective : Our aim was to assess the 6‐year clinical outcome of PCI‐patients with RI treated exclusively with BMS, SES, or PES in our academic hospital. Methods: A total of 1382 patients, included in three cohorts of consecutive PCI‐patients (BMS = 392; SES = 498; PES = 492), were categorized by creatinine clearance calculated by the Cockroft–Gault formula (normal kidney function ≥ 90; mild RI = 60–89; moderate RI < 60) and systematically followed for the occurrence of major adverse cardiac events (MACE). Results : Mortality rates were significantly higher for patients with moderate RI compared to mild RI and normal kidney function at 6 years (Kaplan–Meier estimate: moderate RI (34%) vs. mild RI (12%), P < 0.001; moderate RI (34%) vs. normal kidney function (8%), P < 0.001). After multivariate Cox‐regression analysis, SES and PES decreased the occurrence of target‐vessel revascularization (TVR) and MACE at 6 years in patients with a normal creatinine clearance compared to BMS [adjusted hazard ratio (aHR) = 0.48, 95% CI: 0.28–0.84; aHR = 0.75, 95% CI: 0.57–0.97, respectively] with no significant effect on mortality. Safety‐ and efficacy end points were comparable for the three stent types in patients with mild‐ and moderate renal function. Conclusion : Patients with a normal creatinine clearance had significant improvement in TVR and MACE rates after SES‐ or PES implantation compared to BMS at 6 years. However, there was no superiority of both drug‐eluting stents over BMS in safety and efficacy end points for patients with impaired renal function. © 2012 Wiley Periodicals, Inc.     

Decreased risk of stent fracture‐related restenosis between paclitaxel‐eluting stents and sirolimus eluting stents: Results of long‐term follow‐up

Objective: To compare the outcomes between paclitaxel‐eluting stents (PES) and sirolimus‐eluting stents (SES) for the treatment of drug‐eluting stent (DES) fracture. Background: DES fracture is considered as an important predictor of in‐stent restenosis (ISR). However, little data are available evaluating the optimal treatment for this complication of coronary stenting. Methods: From January 1, 2004 to December 31, 2008, patients with DES ISR treated with a second DES were identified and evaluated for stent fracture. Stent fracture was defined by the presence of strut separation in multiple angiographic projections, assessed by two independent reviewers. Target lesion revascularization (TLR) at 6 and 12 months were the primary end points. Results: Of 131 lesions with DES ISR treated with a second DES, we found 24 patients (24 lesions, 18.2%) with angiographically confirmed stent fracture. Of these, 20 patients (20 lesions) treated with either PES (n = 11/55%) or SES (n = 9/45%) were included in the study. TLR at 6 months occurred in 9% of patients treated with PES and 22% of those treated with SES (P = 0.41). After 12 months, TLR was 9% and 55.5%, respectively (P = 0.024). Conclusions: This study demonstrates a high incidence of stent fracture in patients presenting with DES ISR in need of further treatment with another DES. The suggested association between treatment of stent fracture‐associated DES ISR with PES as compared with SES, and better long‐term outcomes, is in need of confirmation by larger prospective registries and randomized trials. © 2011 Wiley Periodicals, Inc.     

Rotational atherectomy for fibro‐calcific coronary artery disease in drug eluting stent era: Procedural outcomes and angiographic follow‐up results

Objectives: The aim of this study was to examine the binary re‐stenosis rates, procedural success, and in hospital outcomes following treatment of fibro‐calcified coronary lesion with rotational atherectomy in drug eluting stent era. Background: Binary restenosis rates have remained high with the use of bare metal stents following rotational atherectomy in calcified lesions. There is limited data available following rotational atherectomy in drug eluting stent era. Methods: We evaluated the procedural and angiographic outcomes following a consecutive series of 516 procedures treated with rotational atherectomy followed by stenting. We compared the results between Rota + Drug eluting stent (DES) and Rota + bare metal stent (BMS) groups. Results: Procedural success was achieved in 97.1% of the lesions with overall low in hospital adverse events (death in 1.1%, Q MI in 1.3%, Non Q MI in 5.3%, and urgent repeat PCI in 0.4%). There was significant reduction in the binary restenosis rates following Rota + DES use as compared to Rota + BMS use (11% vs. 28.1%, P < 0.001; OR = 3.17, 95% CI: 1.76–5.93) and similar reduction was seen in the target lesion revascularization (10.6% vs. 25%, P = 0.001; OR = 2.81, 95% CI: 1.53–5.14). We have identified ostial lesions, chronic total occlusion lesions, and use of bare metal stents as independent predictors of restenosis in this group of patients. Conclusions: Rotational atherectomy can be performed with high success rates and low complications, and rotational atherectomy followed by drug eluting stent implantation significantly reduces binary restenosis rates in fibrocalcific lesions as compared to rotational atherectomy and bare metal stents. © 2010 Wiley‐Liss, Inc.     

Drug-eluting stents are associated with similar cardiovascular outcomes when compared to bare metal stents in the setting of acute myocardial infarction

BACKGROUND: Recent randomized trials have demonstrated conflicting results regarding the use of drug-eluting stents (DESs) as compared to bare metal stents (BMSs) in primary percutaneous coronary intervention (PCI). We compared outcomes among patients presenting with acute ST-elevation myocardial infarction (STEMI) who received DES with those who received BMS. METHODS: In-hospital, 30-day, 6-month, and 1-year outcomes of a cohort of 122 patients who underwent primary or facilitated PCI and received a BMS were compared to 122 propensity-matched patients who received a DES. Seventy-two patients received sirolimus-eluting stents, and 50 received paclitaxel-eluting stents. RESULTS: Baseline demographics were similar among groups. One-, 6-, and 12-month outcomes, including reinfarction, death, stent thrombosis, and target vessel revascularization (TVR), were similar among groups. At 1 year, all-cause mortality was 13.3% in the BMS group and 9.2% in the DES group [P=not significant (ns)], recurrent MI was 5.3% in the BMS group vs. 4.4% in the DES group (P=ns), and TVR was 7% in the BMS group vs. 8.7% in the DES group (P=ns). CONCLUSIONS: Our data do not support the general use of DES in the setting of STEMI given similar cardiovascular outcomes among patients receiving BMS or DES, the need for long-term dual antiplatelet therapy with DES, and the possible repercussions of very late stent thrombosis.     

Safety of drug eluting stents in patients on chronic anticoagulation using long‐term single antiplatelet treatment with clopidogrel

Background: Use of triple therapy with aspirin, clopidogrel, and anticoagulants significantly increases bleeding, thus drug eluting stents (DES) are usually avoided in patients requiring anticoagulation. We tested use of DES vs. BMS using a long‐term therapy with clopidogrel only and anticoagulants in this group of patients. Methods: We enrolled 165 consecutive patients, 79 receiving DES (age 67 ± 9 years, 84% with atrial fibrillation) and 86 receiving bare metal stents (BMS) (age 70 ± 11 years, 71% with atrial fibrillation). All patients received aspirin + clopidogrel + oral anticoagulants for 4 weeks, then aspirin was stopped and clopidogrel was continued during the 12‐month follow‐up. Primary end point was the combined incidence of major adverse coronary events and major bleedings. Results: Incidence of the primary endpoint was 10.1% in patients with DES and 26.7% in patients with BMS (P = 0.01). There was a large difference in incidence of target vessel revascularization (8.1% for DES, 23.3% for BMS, P = 0.01), whereas incidence of myocardial infarction (3.8% in DES vs. 8.1% in BMS) and major bleeding (1.3% vs. 2.3%, respectively) were not significantly different. There were no cases of stent thrombosis. On multivariate Cox regression analysis, the only factor associated with a reduced risk of the primary endpoint was use of DES (hazard ratio 0.35 with 95% confidence interval 0.14–0.85, P = 0.02). Conclusions: Results of our cohort study suggest that use of DES associated with a treatment with clopidogrel only may be safe and significantly reduce the need for new revascularization in patients requiring chronic anticoagulation.© 2009 Wiley‐Liss, Inc.     

Sex‐specific outcomes following revascularization with zotarolimus‐eluting stents: Comparison of angiographic and late‐term clinical results

Objectives: We examined angiographic and late‐term clinical outcomes according to sex in recent percutaneous coronary intervention (PCI) trials involving zotarolimus‐eluting stents (ZES). Background. Differences in outcome between men and women undergoing PCI have been inconsistently described with bare metal and first‐generation drug‐eluting stents. Methods. Clinical and angiographic outcomes among ZES‐treated patients were evaluated by sex using propensity score modeling in a patient‐level systematic overview of six trials and were also compared to patients receiving bare metal stents (BMS). Results. Among 2,132 patients, 608 were female (28.5%). Compared to men, women were older and more frequently had diabetes, hypertension, and a smaller reference vessel diameter (P < 0.05 for all). For both sexes, the relative reductions in 8‐month angiographic binary restenosis and late lumen loss were statistically significant and of similar extent with ZES compared to BMS. By 2 years, treatment with ZES resulted in significantly lower target vessel revascularization (TVR) and target vessel failure (TVF; 10.0% vs. 21.5%, P = 0.0003) among women that paralleled risk reductions for men. However, among ZES‐treated patients, 2‐year rates of TVR (8.2% vs. 10.4%, P = 0.005) and TVF (9.9% vs. 12.8%, P = 0.004) were significantly lower among women, although rates of death and myocardial infarction were similar. Conclusions. Despite greater baseline clinical and angiographic risk than men, women undergoing PCI with ZES compared to BMS experienced significant reductions in angiographic restenosis and repeat revascularization yet similar safety. Among all patients treated with ZES, late‐term safety and efficacy outcomes are similar, if not lower, among women compared to men. © 2010 Wiley‐Liss, Inc.     

Drug eluting stents are superior to bare metal stents to reduce clinical outcome and stent‐related complications in CKD patients,a systematic review,meta‐analysis and network meta‐analysis

Aims

To compare clinical outcome in Chronic kidney disease (CKD) patients receiving coronary stents according to stent type BMS versus DES and 1st generation versus 2nd generation DES.

Methods and Results

PubMed, Cinhal, Cochrane, Embase, and Web of Science were searched for studies including CKD patients. CKD was defined as eGFR < 60 mL/min. We selected n = 35 articles leading to 376 169 patients, of which 76 557 CKD patients receiving BMS n = 35,807, 1st generation DES n = 37,650, or 2nd generation DES n = 3100. Patient receiving DES, compared to BMS, had a 18% lower all‐cause mortality (RR 0.82, 95%CI 0.71‐0.94). The composite of death or myocardial infarction (MI) was lower in DES patients (RR 0.78, 95%CI 0.67‐0.91), as was stent thrombosis (ST) (RR 0.57, 95%CI 0.34‐0.95), target vessel/lesion revascularization (TVR/TLR) (RR 0.69, 95%CI 0.57‐0.84) and death for cardiovascular cause (RR 0.43, 95%CI 0.25‐0.74). We also found a gradient between 1st and 2nd generation DES, through BMS. Second, compared to 1st generation DES, were associated with further relative risk (RR) reduction of ?18% in of all‐cause death, and lower incidence of stent‐related clinical events: ?39% RR of ST risk; ?27 RR of TVR/TLR risk.

Conclusions

DES in CKD patients undergoing PCI were superior to BMS in reducing major adverse clinical events. This was possibly explained, by a lower risk of stent‐related events as ST and TVR or TLR. Second, compared to 1st generation DES may furtherly reduce clinical events.

     

Long-term clinical outcomes in patients treated with drug-eluting compared to bare-metal stents for the treatment of transplant coronary artery disease

Objective : We aimed to compare the long‐term clinical outcomes of first‐vessel percutaneous coronary intervention (PCI) with drug‐eluting stents (DES) and bare metal stents (BMS) for the treatment of transplant coronary artery disease (TCAD). Background : TCAD is the leading cause of late death in orthotopic heart transplantation (OHT) recipients. PCI is associated with worse clinical outcomes compared with non‐OHT patients. Our institution previously reported superior angiographic outcomes with DES compared with BMS in OHT patients. However, long‐term clinical outcomes comparing PCI with DES versus BMS are lacking. Methods : The data on 105 OHT recipients who underwent first‐vessel PCI with DES (n = 58) or BMS (n = 47) at UCLA Medical Center between 1995 and 2009 were retrospectively analyzed. Results : Five‐year clinical outcomes were not significantly different with DES and BMS in terms of the composite of death, myocardial infarction (MI), or target vessel revascularization (TVR) [(40.8 ± 7.2)% vs. (59.6 ± 7.2)%, log‐rank P = 0.33], death [(31.8 ± 7.8)% vs. (40.4 ± 7.2)%, log‐rank P = 0.46], MI [(12.2 ± 6.2)% vs. (11.3 ± 5.4)%, log rank P = 0.98], TVR [(25.5 ± 6.9)% vs. (26.5 ± 7.3)%, log rank P = 0.76], and time to repeat OHT [(2.27 ± 1.79) vs. (3.22 ± 3.34), P = 0.98]. Conclusions : At long‐term follow‐up, PCI with DES and BMS provided similar clinical outcomes in OHT. Long‐term mortality remains high in OHT recipients after PCI with either DES or BMS. Randomized clinical trials are required to determine the optimal treatment strategy for OHT recipients with TCAD. © 2012 Wiley Periodicals, Inc.     

Outcomes of diabetics receiving bare‐metal stents versus drug‐eluting stents

Objectives : We sought to determine if differences existed in in‐hospital outcomes, long‐term rates of target vessel revascularization (TVR), and/or long‐term mortality trends between patients with diabetes mellitus undergoing percutaneous coronary intervention (PCI) with either a drug‐eluting stent(s) (DES) or a bare metal stent(s) (BMS). Background : Short‐ and long‐term clinical outcomes of patients with diabetes mellitus undergoing PCI with DES versus BMS remain inconsistent between randomized‐controlled trials (RCTs) and observational studies. Methods : Data were collected prospectively on diabetics undergoing PCI with either DES or BMS from January 2000 to June 2008. Demographic information, medical histories, in‐hospital outcomes, and long‐term TVR and mortality trends were obtained for all patients. Results : A total of 1,319 patients were included in the study. Diabetics receiving DES had a significant reduction in index admission MACE compared to diabetics receiving BMS. Using multivariable adjustment, after a mean follow‐up of 2.5 years (maximum 5 years), diabetics who received DES had a 38% decreased risk of TVR compared to diabetics with BMS [HR 0.62 (95% CI: 0.43–0.90)]; diabetics with DES had an insignificant adjusted improvement in long‐term survival compared to diabetics with BMS [HR 0.72 (95% CI: 0.52–1.00)]. These long‐term survival and TVR rates were confirmed using propensity scoring. Conclusions : The use of DES when compared with BMS among diabetics undergoing PCI is associated with significant improvement in long‐term TVR, with an insignificant similar trend in all‐cause mortality. The long‐term results of this observational study are consistent with prior RCTs after adjusting for confounding variables. © 2010 Wiley‐Liss, Inc.     

Drug‐eluting stents in patients with end‐stage renal disease: Meta‐analysis and systematic review of the literature

Objective : The study sought to examine the total weight of evidence regarding the use of drug eluting (DES) and bare metal stents (BMS) in patients with end stage renal disease (ESRD). Background : The potential superiority of DES over BMS in reducing target lesion or vessel revascularization (TLR or TVR) in patients with ESRD on dialysis has not been established. Small studies comparing DES to BMS in this population have yielded inconclusive results mainly due to the small sample size. Methods : We searched MEDLINE, EMBASE, Science Citation Index, CINAHL, and the Cochrane CENTRAL database of controlled clinical trials (December 2009) for controlled trials comparing DES to BMS in ESRD patients. We conducted a fixed‐effects meta‐analysis across seven eligible studies (n = 869 patients). Results : Compared with BMS‐treated patients, DES‐treated patients had significantly lower TLR/TVR (OR 0.55 CI: 0.39–0.79) and major adverse cardiac events (MACE) (OR 0.54; CI: 0.40–0.73). The absolute risk reduction (ARR) with DES in TLR/TVR was ?0.09 (CI: ?0.14 to ?0.04; NNT 11) and in MACE was ?0.13 (CI: ?0.19 to ?0.07; NNT 8). A trend towards lower incidence of all cause mortality was also noted with DES (OR 0.68; CI: 0.45–1.01). No significant differences were noted between both groups in the relative or absolute risk of myocardial infarction. Conclusion : The use of DES in patients with ESRD is safe and yields significant reduction in the risk of TLR/TVR and MACE. Larger randomized studies are needed to confirm the results of this meta‐analysis and establish the appropriate stent choice in this high risk population. © 2010 Wiley‐Liss, Inc.