Outcomes With Drug-Eluting Versus Bare-Metal Stents in Saphenous Vein Graft Intervention

Brodie, Bruce R.; Wilson, Hadley; Stuckey, Thomas; Nussbaum, Marcy; Laurent, Sherry L.; Bradshaw, Barbara; Humphrey, Angela; Metzger, Chris; Hermiller, James; Krainin, Fred; Juk, Stanley; Cheek, Barry; Duffy, Peter L.; Simonton, Charles A.

doi:10.1016/j.jcin.2009.08.020

Cited by 67 publications

(8 citation statements)

References 29 publications

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“…[19] There seems to be a more pronounced early benefit while longer-term benefits seem less pronounced as described above. Recent observational data also suggested a late “catch-up” phenomenon regarding TVR with a clear benefit for DES in the first year but similar longer term results [49]. It seems plausible that, after the coating drug has completely eluted, the beneficial effect of DES compared to BMS decreases.…”

Section: Discussionmentioning

confidence: 88%

Drug-Eluting versus Bare-Metal Stent for Treatment of Saphenous Vein Grafts: A Meta-Analysis

et al. 2010

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BackgroundSaphenous vein grafts develop an aggressive atherosclerotic process and the efficacy of drug eluting stents (DES) in treating saphenous vein graft (SVG) lesions has not been convincingly demonstrated. The aim of this study was to review and analyze the current literature for controlled studies comparing DES versus bare metal stents (BMS) for treatment of SVG stenoses.Methodology/Principal FindingsWe searched several scientific databases and conference proceedings up to March 15, 2010 for controlled studies comparing target vessel revascularization (TVR) between DES and BMS. Summary odds ratios (OR) for the primary endpoint TVR and secondary endpoints infarction, stent thrombosis and death were calculated using random-effect models. A total of 29 studies (3 randomized controlled trials RCT) involving 7549 (202 in RCT) patients were included. The need for target vessel revascularization in the DES group tended to be lower compared to BMS for the 3 RCT (OR 0.50 [0.24–1.00]; p = 0.051) and for observational studies (0.62 [0.49–0.79]; p<0.001). There was no significant difference in the risk for myocardial infarction in the RCT (OR 1.25 [0.22–6.99]; p = 0.250) but a lower risk for DES based on the observational studies 0.68 [0.49–0.95]; p = 0.023. The risk for stent thrombosis was found to be non-different in the RCT (OR 0.78 [0.03–21.73], p = 0.885) while it was in favor of DES in the observational studies (0.58 [0.38 – 0.84]; p<0.001). The mortality was not significantly different between DES and BMS in the RCT's (OR 2.22 [0.17 – 29.50]; p = 0.546) while the observation studies showed a decreased mortality in the DES group (0.69 [0.55–0.85]; p<0.001).ConclusionDES may decrease TVR rate in treatment of SVG stenoses. No differences in reinfarction rate, stent thrombosis or mortality was found between the DES and BMS groups in the RCT's while the observational data showed lower risk for myocardial infarction, stent thrombosis and death in the DES group. This may be a result of patient selection bias in the observational studies or represent a true finding that was not the detected in the RCT analysis due to limited statistical power.

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Section: Discussionmentioning

confidence: 88%

Drug-Eluting versus Bare-Metal Stent for Treatment of Saphenous Vein Grafts: A Meta-Analysis

et al. 2010

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“…A recent meta-analysis suggested that DES is associated with a lower need for reintervention and a lower mortality rate compared with BMS in patients who undergo PCI for vein bypass grafts 27 . However, DES does not show long-term advantages in these patients 28 . The sample of patients who received FMJ in vein grafts in our study was too small, thus limiting our ability to draw definite conclusions in this regard.…”

Section: Discussionmentioning

confidence: 80%

Percutaneous Coronary Intervention using a Full Metal Jacket with Drug-eluting Stents: Major Adverse Cardiac Events at One Year

Calé¹,

Teles²,

Almeida³

et al. 2013

Arquivos Brasileiros De Cardiologia

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BackgroundThe clinical benefit of percutaneous coronary intervention (PCI) for long coronary lesions is unclear; furthermore, concerns have been raised about its safety.ObjectivesTo evaluate the predictors of major adverse cardiac events (MACE) associated with PCI using a full metal jacket (FMJ), defined as overlapping drug-eluting stents (DES) measuring > 60 mm in length, for very long lesions.MethodsWe enrolled 136 consecutive patients with long coronary lesions requiring FMJ in our single-center registry. The primary endpoint included the combined occurrence of all-cause death, myocardial infarction (MI), and target vessel revascularization (TVR). Demographic, clinical, angiographic, and procedural variables were evaluated using stepwise Cox regression analysis to determine independent predictors of outcome.ResultsThe mean length of stent per lesion was 73.2 ± 12.3 mm and the mean reference vessel diameter was 2.9 ± 0.6 mm. Angiographic success was 96.3%. Freedom from MACE was 94.9% at 30 days and 85.3% at one year. At the one-year follow-up, the all-cause mortality rate was 3.7% (1.5% cardiac deaths), the MI rate was 3.7%, and the incidence of definite or probable stent thrombosis (ST) was 2.9%. Female gender [hazard ratio (HR), 4.40; 95% confidence interval (CI), 1.81-10.66; p = 0.001) and non-right coronary artery PCI (HR, 3.49; 95%CI, 1.42-8.59; p = 0,006) were independent predictors of MACE at one year. Freedom from adverse events at one year was higher in patients with stable angina who underwent PCI (HR, 0.33; 95%CI, 0.13-0.80; p = 0.014).ConclusionsPCI using FMJ with DES for very long lesions was efficacious but associated with a high rate of ST at the one-year follow-up. However, the rate of cardiac mortality, nonprocedure-related MI, and MACE was relatively low. Target coronary vessel PCI, clinical presentation, and female gender are new contemporary clinical factors that appear to have adverse effects on the outcome of PCI using FMJ for long lesions.

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“…Multiple investigators have suggested a survival benefit of DES using conventional methods, such as propensity scores. 7, 9, 29, 30 In contrast, others using IV and related methods have generally shown no difference in mortality and stronger impacts on repeated revascularization than is observed with propensity scores. 31–35 A natural question that emerges from these disparate lines of evidence is, “which one should be believed?” While the extensive trial data available for the DES versus BMS comparison are consistent with the IV results in this analysis, reliance on clinical trial results to validate any particular methodology (IV or PS in this case) is not necessarily appropriate in most applications.…”

Section: Discussionmentioning

confidence: 96%

Evaluating the effectiveness of a rapidly adopted cardiovascular technology with administrative data: The case of drug-eluting stents for acute coronary syndromes

Federspiel

Stearns²,

Sheridan

et al. 2012

American Heart Journal

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Background Instrumental variable (IV) methods can correct for unmeasured confounding when using administrative (claims) data for cardiovascular outcomes research, but difficulties identifying valid IVs have limited their use. We evaluated the safety and efficacy of drug-eluting coronary stents (DES) compared to bare metal stents (BMS) for Medicare beneficiaries with acute coronary syndromes (ACS) using the rapid uptake of DES in clinical practice as an instrument. We compared results from IV to those from propensity score matching (PSM) and multivariable regression models. Methods Retrospective cohort study involving 62,309 fee-for-service beneficiaries aged 66 and older treated with coronary stenting between May 2003 and February 2004. Outcomes were measured for 46 months after revascularization using claims data. Results DES recipients were younger, had lower prevalence of myocardial infarction, and had fewer comorbidities compared to BMS recipients. Use of DES was associated with lower rates of mortality by PSM (HR 0.80, CI: [0.77, 0.83]) but not by IV (HR 0.99, CI: [0.87, 1.11]). IV models estimated a larger reduction in repeat revascularization (HR 0.76, CI: [0.63, 0.89]) than did PSM (HR 0.90, CI: [0.87, 0.93]). Conclusions Based on IV analysis, the increased utilization of DES relative to BMS among Medicare beneficiaries with ACS is associated with reduced rates of repeat revascularization and no difference in mortality. IV approaches provide a useful complement to conventional approaches to cardiovascular outcomes research with administrative data.

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Outcomes With Drug-Eluting Versus Bare-Metal Stents in Saphenous Vein Graft Intervention

Cited by 67 publications

References 29 publications

Drug-Eluting versus Bare-Metal Stent for Treatment of Saphenous Vein Grafts: A Meta-Analysis

Drug-Eluting versus Bare-Metal Stent for Treatment of Saphenous Vein Grafts: A Meta-Analysis

Percutaneous Coronary Intervention using a Full Metal Jacket with Drug-eluting Stents: Major Adverse Cardiac Events at One Year

Evaluating the effectiveness of a rapidly adopted cardiovascular technology with administrative data: The case of drug-eluting stents for acute coronary syndromes

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