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.     

Lack of clinical long‐term benefit with the use of a drug eluting stent compared to use of a bare metal stent in saphenous vein grafts

Background: Small randomized trials have shown short‐term improved outcome with drug‐eluting stents (DES) over bare metal stent (BMS) in saphenous vein graft (SVG) interventions by reducing in‐stent restenosis and target vessel revascularization (TVR). It is not clear, however, if these benefits are maintained long term. The aim of this study is to compare the outcome in a larger cohort of patients undergoing SVG stent implantation with DES or BMS, at 2 years. Methods: From among 250 patients who underwent SVG stenting, 225 patients with available follow‐up were selected from data bases at the three participating institutions. One‐hundred‐six patients had DES (sirolimus, paclitaxel or tacrolimus eluting stent) and 119 patients had any available BMS from April 2002 to December 2006. The primary endpoint was MACE rate, a combination of cardiac death, S‐T elevation myocardial infarction (STEMI) and target lesion revascularization. Secondary end points were the individual components of the primary endpoint. Follow‐up was obtained by mailed interviews or telephone calls and review of the hospital chart. Results: The DES and BMS groups had similar age (71 ± 8 years vs. 70 ± 7 years, P = 1.0), diabetes (45% vs. 36%, P = 0.3), history of MI (58% vs. 51%, P = 0.6), EF (44% vs. 47%, P = 0.2) and previous PCI (40% vs. 35%, P = 0.4). Reference vessel diameter (3.15 ± 0.5 mm vs. 3.5 ± 0.5 mm. P = 0.001) and stent size (3.3 ± 0.4 mm vs. 3.9 ± 0.5 mm, P = 0.001) were smaller in the DES group; however, the BMS were longer (24 ± 10 mm vs. 21 ± 6 mm, P = 0.05). At one year there was a trend (P = 0.1) for lower MACE rate in the DES group, but at two years there was no difference in MACE free survival between the DES and BMS groups (81 % vs. 82%, P = 0.9). The death rate was similar (6% each) with three patients having STEMI (two in the DES and one in the BMS). TVR was also similar (14% in each group). Conclusion: In patients undergoing treatment of SVG disease with a stent, the marginal benefit of DES seen at 1 year was lost at 2‐year follow‐up. © 2008 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.     

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.     

Clinical Outcomes of Biodegradable Polymer Drug‐Eluting Stents for Percutaneous Coronary Intervention: An Updated Meta‐analysis of Randomized Controlled Trials

Biodegradable polymer drug‐eluting stents (DES) are innovative concepts in the era of percutaneous coronary intervention. We systematically reviewed the latest randomized evidence on the efficacy and safety of biodegradable polymer DES as compared to durable polymer DES. MEDLINE, Embase, and the Cochrane database were searched in August 2013 for eligible randomized controlled trials (RCTs) comparing biodegradable polymer DES with durable polymer DES. Clinical outcomes of interest were mortality, myocardial infarction (MI), target lesion revascularization (TLR), target vessel revascularization (TVR), and stent thrombosis. A total of 20 RCTs randomizing 20 021 participants were included, of whom 11 045 were allocated to biodegradable polymer DES and 8976 to durable polymer DES. Treatment of biodegradable polymer DES was not associated with a significant reduction of any of the clinical outcomes (all‐cause mortality, odds ratio [OR]: 0.94, 95% confidence interval [CI]: 0.80 to 1.10, P = 0.42; cardiovascular mortality, OR: 0.97, 95% CI: 0.79 to 1.19, P = 0.74; MI, OR: 1.07, 95% CI: 0.91 to 1.26, P = 0.41; TLR, OR: 0.87, 95% CI: 0.69 to 1.08, P = 0.20; TVR, OR: 1.05, 95% CI: 0.85 to 1.28, P = 0.67; definite/probable stent thrombosis, OR: 0.80, 95% CI: 0.59 to 1.07, P = 0.14). Current randomized data indicate that clinical efficacy and safety profiles of biodegradable polymer DES are comparable to those of durable polymer DES. Findings from large‐scale studies with rigorous methodology and long follow‐up duration are needed.     

Drug-Eluting Versus Bare Metal Stents in Saphenous Vein Graft Intervention: An Updated Comprehensive Meta-Analysis of Randomized Trials

BackgroundDrug eluting stents (DES) are preferred over bare metal stents (BMS) for native coronary artery revascularization unless contraindicated. However, the preferred stent choice for saphenous venous graft (SVG) percutaneous coronary interventions (PCI) is unclear due to conflicting results.MethodsPubMed, Clinical trials registry and the Cochrane Center Register of Controlled Trials were searched through June 2018. Seven studies (n = 1639) comparing DES versus BMS in SVG-PCI were included. Endpoints were major adverse cardiac events (MACE), cardiovascular mortality, all-cause mortality, myocardial infarction (MI), target vessel revascularization (TVR), target lesion revascularization (TLR), in-stent thrombosis, binary in-stent restenosis, and late lumen loss (LLL).ResultsOverall, during a mean follow up of 32.1 months, there was no significant difference in the risk of MACE, cardiovascular mortality, all-cause mortality, MI, stent thrombosis, TVR and TLR between DES and BMS. However, short-term follow up (mean 11 months) showed lower rate of MACE (OR 0.66 [0.51, 0.85]; p = 0.002), TVR (OR 0.47 [0.23, 0.97]; p = 0.04) and binary in-stent restenosis (OR 0.14 [0.06, 0.37]; p < 0.0001) in DES as compared with BMS. This benefit was lost on long-term follow up with a mean follow up 35.5 months.ConclusionIn this meta-analysis of SVG-PCI, DES use was associated with similar MACE, cardiovascular mortality, all-cause mortality, MI, in-stent thrombosis, TVR and TLR compared with BMS during long-term follow up. There was high incidence of MACE noted in both DES and BMS suggesting a need for exploring novel strategies to treat SVG disease to improve clinical outcomes.     

Clinical impact of sirolimus‐eluting stent in ST‐segment elevation myocardial infarction: A meta‐analysis of randomized clinical trials

Objectives: To evaluate outcome of patients undergoing sirolimus‐eluting stent (SES) as compared to bare‐metal stent (BMS) implantation during primary angioplasty for ST‐segment elevation myocardial infarction (STEMI). Background: The role of SES in primary percutaneous coronary intervention setting is still debated. Methods: We searched Medline, EMBASE, CENTRAL, scientific session abstracts, and relevant Websites for studies in any language, from the inception of each database until October 2008. Only randomized clinical trials with a mean follow‐up period >6 months and sample size >100 patients were included. Primary endpoint for efficacy was target‐vessel revascularization (TVR) and primary endpoint for safety was stent thrombosis. Secondary endpoints were cardiac death and recurrent myocardial infarction (MI). Results: Six trials were included in the meta‐analysis, including 2,381 patients (1,192 randomized to SES and 1,189 to BMS). Up to 12‐month follow‐up, TVR was significantly lower in patients treated with SES as compared to patients treated with BMS (4.53% vs. 12.53%, respectively; odds ratio [OR] 0.33; 95% confidence interval [CI] 0.24–0.46; P < 0.00001). There were no significant differences in the incidence of stent thrombosis (3.02% vs. 3.70%, OR = 0.81 [95% CI, 0.52–1.27], P = 0.81), cardiac death (2.77% vs. 3.28%, OR = 0.84 [95% CI, 0.52–1.35], P = 0.47), and recurrent MI (2.94% vs. 4.04%, OR = 0.71 [95% CI, 0.45–1.11], P = 0.13) between the two groups. Conclusion: SES significantly reduces TVR rates as compared to BMS in STEMI patients up to 1 year follow‐up. Further studies with larger population and longer follow‐up time are needed to confirm our findings. © 2009 Wiley‐Liss, Inc.     

Clinical outcomes following drug-eluting versus bare metal stent implantation for lesion subsets excluded from pivotal clinical trials: findings from the GHOST Study (Guthrie Health System Off-Label StenT Study)

Objectives: We assessed outcomes of patients undergoing drug-eluting stent (DES) vs. bare metal stent (BMS) implantation for complex lesions excluded from pivotal clinical trials of DES.
Background: Although DES improve target vessel revascularization (TVR) and major adverse cardiovascular events (MACE) compared to BMS in randomized trials, data on safety and efficacy of DES in complex lesions are insufficient.
Methods: In a single-center registry of 1,354 patients who underwent stent implantation for complex lesions between July 2001 and December 2005, we compared the incidence of death, death or myocardial infarction (MI), stent thrombosis [definite or probable by the Academic Research Consortium (ARC) criteria], TVR, and MACE between patients who received DES (n = 483) versus those who received BMS (n = 871). Mean duration of follow-up was 494 versus 838 days in DES and BMS groups, respectively.
Results: Clinical outcomes in DES versus BMS groups were as follows: death 5.2% versus 11.5% (log-rank P = 0.042); death/MI 11.2% versus 16.7% (P = 0.47), stent thrombosis 2.9% versus 2.6% (P = 0.61), TVR 6.6 versus 18.5% (P < 0.0001), MACE 14.9% versus 29.7% (P = 0.0002), respectively. After adjustment for baseline differences, DES implantation was associated with lower TVR (adjusted hazards ratio HR = 0.38, 95% CI 0.26–0.56, P < 0.0001) and MACE (HR = 0.56, CI 0.42–0.74, P < 0.0001) without significant impact on other outcomes. In 933 patients who underwent DES (n = 483) or BMS (n = 450) implantation in the year 2003 or later, DES implantation similarly lowered TVR and MACE without affecting other outcomes.
Conclusions: Our findings support the safety and efficacy of DES in patient subsets excluded from pivotal randomized clinical trials of DES.     

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 versus bare‐metal stents for treatment of bare‐metal in‐stent restenosis

Objectives : We compared the long‐term outcomes of drug‐eluting stents (DES) versus bare‐metal stents (BMS) for treatment of bare‐metal in‐stent restenosis (ISR). Background : There are no randomized trials or observational studies directly comparing the safety and efficacy of DES versus BMS for treatment of bare‐metal ISR. Methods : We examined data on all patients who underwent percutaneous coronary intervention (PCI) for ISR at Cleveland Clinic between 05/1999 and 06/2007. We compared the efficacy and safety of DES to BMS for treating bare‐metal ISR. The primary end point was a composite of death, myocardial infarction (MI), or target lesion revascularization (TLR). The secondary endpoints were individual components of the primary endpoint. Results : Of the 931 patients identified over 8 years, 706 had bare‐metal ISR and met our study criteria. Of the 706 patients with bare‐metal ISR, 362 were treated with DES and 344 with BMS. There were 230 cumulative events for a median follow‐up of 3.2 years. After adjusting for 27 variables, DES were associated with lower primary endpoint compared to BMS for treatment of bare‐metal ISR (21% vs. 45%, adjusted hazard ratio [HR] 0.63; 95% confidence interval [CI], 0.42–0.95; P = 0.03). The individual secondary endpoint of death (8% vs. 24%, P = 0.005) favored DES, but MI (3% vs. 8%, P = 0.31), and TLR (13% vs. 20%, P = 0.23) failed to reach statistical significance. Conclusions : In our multivariate analysis of patients with bare‐metal ISR, DES use was associated with significantly lower death, MI, or TLR when compared to BMS. © 2010 Wiley‐Liss, Inc.     

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.     

Polymer‐free versus permanent polymer‐coated drug eluting stents for the treatment of coronary artery disease: A meta‐analysis of randomized trials

Background

Polymer‐free drug eluting stents (PF‐DES) were developed, in part, to overcome risk of late ischemic events observed with permanent polymer‐coated DES (PP‐DES). However, trial results are inconsistent with longer‐term safety and efficacy of PF‐DES remaining unknown. We performed a meta‐analysis of randomized trials assessing outcomes of patients receiving PF‐DES versus PP‐DES for treatment of coronary artery disease (CAD).

Methods

Electronic searches were performed for randomized trials comparing outcomes between PF‐DES and PP‐DES. Trials reporting major adverse cardiovascular events (MACE), myocardial infarction (MI), stent thrombosis (ST), all‐cause death, target lesion/vessel revascularization (TLR/TVR), and late lumen loss (LLL) were included. Analyses were performed at longest follow‐up and landmarked beyond 1‐year.

Results

Twelve trials (6,943 patients) were included. There was no significant difference in MACE between PF‐DES and PP‐DES at longest follow‐up (Odds Ratio [OR] 0.96, 95%CI 0.85‐1.10, P = 0.59) or landmark analysis beyond 1‐year (OR 0.96, 95%CI 0.76‐1.20, P = 0.70). Although PF‐DES were associated with a significant reduction in all‐cause death (OR 0.85, 95%CI 0.72‐1.00, P < 0.05), this effect was not present on landmark analysis beyond 1‐year (OR 0.89, 95%CI 0.73‐1.10, P = 0.30). There were no differences observed for MI (OR 1.00, 95%CI 0.77‐1.28, P = 0.99) or ST (OR 0.95, 95%CI 0.54‐1.68, P = 0.86), with similar efficacy outcomes including TVR (OR 1.07, 95%CI 0.91‐1.26, P = 0.42), TLR (OR 1.03, 95%CI 0.88‐1.21, P = 0.68) and angiographic LLL (pooled mean difference 0.01 mm, 95%CI ?0.08 to 0.11, P = 0.76).

Conclusions

PF‐DES are as safe and efficacious as PP‐DES for the treatment of patients with CAD, but do not significantly reduce late ischemic complications.

     

Sirolimus‐ versus paclitaxel‐eluting stents for coronary bifurcations intervention

Backgrounds : Relative efficacy and safety of sirolimus‐eluting stents (SES) compared with paclitaxel‐eluting stents (PES) remains controversial. It is unknown whether there are different effect and safety in coronary bifurcation treatment between SES and PES. Objectives : The meta‐analysis was performed to compare the clinical outcomes of SES and PES in coronary bifurcation intervention. Methods : Five head‐to‐head clinical trials of SES versus PES in coronary bifurcation intervention were included. A total of 2,567 patients were involved in the meta‐analysis. Mean follow‐up period ranged from 6 to 35 months. The primary end points were the need for target lesion revascularization (TLR) and main‐branch restenosis. Secondary end points were target vessel revascularization (TVR), cardiac death, major adverse cardiac events (MACE), and stent thrombosis. Results : Compared with PES, SES significantly reduced the risk of TLR (5.3% vs. 10.6%, odds ratio (OR) 0.52; 95% confidence interval (CI) = 0.38–0.70, P < 0.001), main‐branch restenosis (4.59% vs. 12.59%, OR 0.31; 95% CI = 0.18–0.55, P < 0.001) and TVR (7.05% vs. 12.57%, OR 0.58; 95% CI = 0.42–0.81, P = 0.001) in coronary bifurcation intervention. In addition, SES group also had a significantly lower incidence of MACE (8.20% vs. 14.13%, OR 0.58; 95% CI = 0.40–0.84, P = 0.004) than PES group. However, there were no statistical difference with respect to the incidence of cardiac death (1.64% vs. 1.09%, P = 0.19) and stent thrombosis (0.84% vs. 1.08%, P = 0.64) between SES and PES groups. Conclusions : Compared with PES, SES reduced the incidence of TLR, main‐branch restenosis and MACE in coronary bifurcation intervention, while the risk of stent thrombosis was similar between SES and PES groups. © 2011 Wiley Periodicals, 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.     

Percutaneous intervention on the saphenous vein bypass grafts—Long‐term outcomes

Background/Objective : In this era of drug eluting stents (DES), the long‐term outcome of percutaneous intervention (PCI) on saphenous venous grafts (SVG) is unknown. The objective of the study was to compare the long‐term outcomes of DES versus bare metal stent (BMS) in this population and to determine the predictors of outcomes. Methods : We reviewed the medical records of all patients who had PCI performed during January 2003 to February 2005 to obtain data cardiac risk factors, medications at discharge, angiographic details and outcomes. Results : One hundred and nine patient had PCI to SVG; of these, 37 patients received DES and the remaining had BMS. Over a mean follow‐up of 33 months, the PCI using DES was associated with 30% restenosis, 35% target vessel revascularization (TVR) and major adverse cardiac event (MACE) rate of 46% versus 35% restenosis, 38% TVR and 50% MACE rate with BMS. There was no significant difference in long‐term outcome with DES as compared to BMS. Conclusion : There was no difference in the long‐term outcomes of PCI on SVG irrespective of the type of stent used. © 2008 Wiley‐Liss, Inc.     

Long‐term clinical outcomes after drug‐eluting stent implantation in unprotected left main coronary artery disease

Objective: To investigate long‐term outcomes of unprotected left main coronary artery (ULMCA) disease treatment using drug‐eluting stents (DES). Background: In several studies, DES implantation in ULMCA appeared safe and effective at mid‐term; however, to date, there is limited long‐term data. Methods : All consecutive patients undergoing sirolimus‐ or paclitaxel‐eluting stent implantation in ULMCA disease at a single institution were evaluated. The primary endpoint was long‐term major adverse cardiac events (MACE) defined as cardiac death, nonfatal myocardial infarction, or target lesion revascularization (TLR). Stent thrombosis (ST), according to Academic Research Consortium definitions, was also evaluated. Results: A total of 210 patients were assessed. In‐hospital MACE rate was 1%. During a mean follow‐up of 28.0 ± 14.5 months, MACE occurred in 26 patients (12.5%): cardiac death in nine patients (4.3%) and TLR in 17 patients (8.2%). The cumulative MACE‐free survival rate was 89.0, 87.4, and 85.4% at 1, 2, and 3 years, respectively. ST occurred in three patients (1.4%): one case was definite and the other two were probable/possible ST; there were no cases of very late ST. Binary restenosis occurred in 8.3%. The EuroScore >6 was the only independent predictor of MACE [hazard ratio (HR) 2.24, 95% confidence interval (CI) 1.05–4.77, P = 0.04]. There was a trend toward an increased risk of MACE associated with distal ULMCA location (HR 2.14, 95% CI 0.87–5.29, P = 0.10). Conclusions: Our study showed DES implantation in ULMCA to be feasible, safe, and effective at long term. Randomized trials comparing percutaneous versus surgical revascularization are warranted to define the treatment of choice for ULMCA disease. © 2009 Wiley‐Liss, Inc.     

A comparison of drug-eluting stents versus bare metal stents in saphenous vein graft PCI outcomes: a meta-analysis

Aims: Studies demonstrate that percutaneous coronary intervention (PCI) with drug‐eluting stents (DES) is associated with reduced revascularization and major adverse cardiac events (MACE) rates compared to bare metal stents (BMS) in native coronary vessels. Optimal PCI treatment of saphenous vein graft (SVG) lesions remains unclear despite SVG procedures representing up to 10% of PCI cases. We therefore performed a meta‐analysis to compare outcomes between BMS and DES in SVG PCI. Methods and Results: A search (2004–2009) of MEDLINE and conference proceedings for all relevant studies comparing mortality and MACE outcomes in DES versus BMS in SVG PCI and meta‐analysis of the data was performed. Twenty studies were identified from 2005 to 2009 enrolling a total of 5,296 patients. Meta‐analysis revealed a decrease in mortality associated with DES use, odds ratio (OR) 0.68; 95% confidence interval (CI) 0.53–0.88; P = 0.004. Similarly, MACE (OR 0.64; 95% CI 0.51–0.82; P < 0.001), total lesion revascularization (OR 0.60; 95% CI 0.43–0.83; P = 0.002), and total vessel revascularization (OR 0.57; 95% CI 0.41–0.80; P = 0.001) were significantly decreased in the patients in which DES were used compared to BMS. This reduction in mortality and MACE events associated with DES use appears to be limited to registry studies and not randomized controlled studies. Conclusions: Our meta‐analysis suggests DES use to be safe in SVG PCI and associated with reduced mortality and MACE rates with reductions in revascularization also observed. (J Interven Cardiol 2011;24:172–180)     

Treatment of saphenous vein graft lesions with drug-eluting stents: immediate and midterm outcome

OBJECTIVES: The purpose of the present report was to evaluate clinical and angiographic outcomes of drug-eluting stent (DES) implantation in saphenous vein graft (SVG) lesions. BACKGROUND: The safety and efficacy of DES implantation for the treatment SVG lesions remains uncertain. METHODS: We evaluated in-hospital and six-month outcomes in 61 consecutive patients treated with DES in SVG lesions from March 2002 to March 2004 (DES group), as compared to 89 consecutive patients treated with bare-metal stents (BMS) in the 24 months immediately before the introduction of DES (BMS group). Major adverse cardiac events (MACE) including death, myocardial infarction, target lesion revascularization (TLR), and target vessel revascularization (TVR) were recorded in-hospital and at six-month follow-up. RESULTS: The rate of in-hospital MACE was similar between the two groups (6.6% vs. 5.6%, p = 1.0). Cumulative MACE at six months was 11.5% in the DES group and 28.1% in the BMS group (p = 0.02). The DES group had a significantly lower incidence of in-segment restenosis (10.0% vs. 26.7%, p = 0.03), TLR (3.3% vs. 19.8%, p = 0.003), and TVR (4.9% vs. 23.1%, p = 0.003). By Cox regression analysis, diabetes (hazard ratio [HR]: 3.03; 95% confidence interval [CI]: 1.33 to 6.90; p = 0.008), usage of BMS (HR: 2.53; 95% CI: 1.07 to 5.97; p = 0.03), and age of SVG (HR: 1.10; 95% CI: 1.02 to 1.19; p = 0.02) were identified as predictors of MACE at six-month follow-up. CONCLUSIONS: Compared to BMS implantation, DES implantation in SVG lesions appears safe with favorable and improved mid-term outcomes.     

Long-term safety and effectiveness of drug-eluting stents compared to bare metal stents following successful PCI in non-ST-elevation myocardial infarction: findings from the Guthrie Health Off-Label StenT (GHOST) Registry

Background: The long‐term safety and effectiveness of drug‐eluting stents (DES) versus bare metal stents (BMS) in non‐ST‐segment elevation myocardial infarction (NSTEMI) beyond 2 years after percutaneous coronary intervention (PCI) is unknown. Methods: We studied 674 NSTEMI patients who underwent successful PCI with DES (n = 323) or BMS (n = 351). The primary study end‐points were time to occurrence of death or nonfatal recurrent myocardial infarction (MI), and stent thrombosis (ST). Secondary end‐points included time to occurrence of target vessel revascularization (TVR) and any major adverse cardiovascular event (MACE, defined as the composite of death, MI, ST, TVR). Results: The DES and BMS groups were well matched except that DES patients received dual antiplatelet therapy for a longer duration and had smaller final vessel diameter. In survival analysis, at a mean follow‐up of 1333 ± 659 days after PCI, the DES group had similar incidence of death/myocardial infarction (24% vs. 27%, log rank p = 0.23) and ST (4.0% vs. 2.6%, p = 0.18) as the BMS group. The DES patients had lower incidence of TVR (8.1% vs. 17%, p = 0.0018) but similar MACE (26% vs. 37%, p = 0.31). In multivariable analysis, DES vs. BMS implantation showed no significant impact on death/myocardial infarction [adjusted hazards ratio (HR) 1.0, 95% confidence intervals (CI) 0.7–1.4], ST (HR 1.7; CI 0.7 – 4.0), or MACE (HR 0.8; CI 0.6 – 1.1). However, TVR was lower in the DES group (HR 0.4; CI 0.3 – 0.7). Conclusion: In patients presenting with NSTEMI, DES implantation appears to be as safe as BMS implantation at long‐term follow‐up. In addition, DES are effective in reducing TVR compared to BMS. (J Interven Cardiol 2012;25:28–36)     

Long-term safety and effectiveness of drug-eluting stents compared to bare metal stents in ST elevation myocardial infarction: findings from the Guthrie Health Off-label Stent (GHOST) Registry

Background: Multiple randomized trials and observational studies have shown drug‐eluting stents (DES) to be safe and effective at 3‐year follow‐up in stent thrombosis (ST)‐segment elevation myocardial infarction (STEMI) treated with primary percutaneous coronary intervention (PCI). However, outcomes data beyond 3–4 years after DES implantation are sparse. Methods: We studied 554 STEMI patients who underwent successful PCI with either DES or bare metal stent (BMS). Primary study end‐points were time to occurrence of ST and the composite of death or myocardial infarction (MI). Secondary end‐points were time to occurrence of major adverse cardiac events (MACEs) and discrete events that comprise MACE (death, MI, and target vessel revascularization [TVR]). Outcomes of the DES and BMS groups were assessed by survival analysis and multivariable Cox regression. Results: There were 205 (37%) patients who received DES and 349 (63%) patients who received BMS. At a median follow‐up of 41.4 months after PCI, there were no differences in the unadjusted incidence of ST (ST, 3.4 vs. 4.3%, log‐rank P = 0.61) and MI (6.8% vs. 8%, P = 0.61) between DES versus BMS groups, respectively. However, DES implantation was associated with lower unadjusted incidence of death or MI (11% vs. 23.5%, P = 0.0002), MACE (16% vs. 34%, P < 0.0001), death (6.3% vs. 17%, P = 0.0004), and TVR (9.8% vs. 18%, P = 0.008) than BMS implantation. In multivariable analyses, DES implantation was associated with significantly lower incidence of MACE (adjusted HR = 0.47 [95% CI: 0.31–0.76], P = 0.0007) than BMS implantation. Conclusion: In our study of STEMI patients, DES implantation was safer than BMS implantation and was associated with lower MACE at long‐term follow‐up. (J Interven Cardiol 2012;25:118–125)