Comparison of Long-Term Outcomes of Bare Metal or Drug-Eluting Stent Implantation in Standard Versus Off-Label Coronary Narrowings

Harjai, Kishore J.; Orshaw, Pamela; Boura, Judith; Sporn, Daniel

doi:10.1016/j.amjcard.2009.02.017

Cited by 12 publications

(13 citation statements)

References 28 publications

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“…Our results show the implementation of a higher number of drug-coated stents among the diabetic population and a 56% of unlabelled use indications, which is accompanied by a lower restenosis rate. These results are generally consistent with the recorded results of the authors mentioned above [18][19][20][21][22][23][24][25] . Related to the restenosis rate and the emergence of new ischemic episodes, those were higher in the non-diabetic group.…”

Section: Discussionsupporting

confidence: 83%

Clinical Evaluation of Different Revascularization Strategies: Unlabelled Use

Quezada-Feijoó

Mangas

Rodriguez

et al. 2015

Journal of Cardiology and Therapy

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AIMS:Coronary diseases are the main cause of mortality in the West. Several factors may affect successful percutaneous revascularization, such as the type of stent used or the cardiovascular risk factors associated with the patient. The systolic function of the left ventricle has usually been disregarded in restenosis scores. Our aim is to evaluate restenosis while taking into account the kind of stent used and the systolic function of the left ventricle. METHODS: A prospective, observational and population study. A total of 209 patients with percutaneous revascularization were recruited between March 2011 and January 2013 and monitored every six months. Their clinical data was collected and transthoracic echocardiograms were performed. RESULTS: The average age was 67±11 years old, 64.6% were men. Regarding cardiovascular risk factors, 55.6% were diabetics, 84.2% had hypertension and 81.3% were dyslipemic. A combined revascularization strategy was more often used among the general population than in the diabetic subgroup. The diabetic patient subgroup received a larger number of drug-coated stents. The systolic function was present among 84% of the general population compared to 80% of the diabetic patient subgroup. Both the general population Journal of Cardiology and Therapyas well as the diabetic patient subgroup presented a significant decreased sistolic function of the left ventricle when the restenosis rate was greater (p<0.001 respectively). Similarly, we observe that there is a significant connection between the ejection fraction and the emergence of a new symptoms. CONCLUSION:The non-combined strategy was used more frequently in the diabetic population with the use of a superior drugeluting stent Furthermore, systolic function evaluation stratifies the restenosis risk, especially in patients with a depressed ventricular function.© 2015 ACT. All rights reserved.

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Section: Discussionsupporting

confidence: 83%

Clinical Evaluation of Different Revascularization Strategies: Unlabelled Use

Quezada-Feijoó

Mangas

Rodriguez

et al. 2015

Journal of Cardiology and Therapy

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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: 94%

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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“…A recent paper by Harjai et al investigated the safety of DES vs BMS in a prospective, observational, single-center, contemporaneous “real-world” study over a 3 to 4 year period [12]. This study compared 1180 BMS patients with 1165 DES patients segregated into groups according to on and off label use.…”

Section: Discussionmentioning

confidence: 99%

Extended Outcomes of Complex Coronary Disease in the Drug Eluting Stent Era

et al. 2011

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BackgroundSeveral randomized trials comparing bare-metal stents to Drug-Eluting Stents (DES) have demonstrated a significant reduction in Target Vessel Revascularization (TVR) and Target Lesion Revascularization (TLR) exists with the use of drug-eluting stents, without compromising survival. These conclusions are based on restricted inclusion criteria for patients and lesion. It is unknown if these results can be generalized to an unselected patient population and more complex disease. The objective of this study was to determine to what extent the availability of DES has impacted survival, TVR, and TLR in a large regional experience without the restriction of on-label indications.MethodsPatients registered with the Northern New England Cardiovascular Disease Study Group’s PCI registry with single vessel coronary disease undergoing a first PCI were sorted according to the Bare-Metal stent (BMS) era (2001 - 2002) or the Drug-Eluting stent (DES) era (2004 - 2005) based on the time period their first PCI took place. Totally, 6,093 BMS and 5,651 DES patients were identified. Outcomes of survival, TLR and TVR were measured after one year.ResultsAfter 1 year, survival was comparable, TLR was reduced by 4.9% (absolute) and TVR was reduced by 5.4% (absolute) in the DES era compared to the BMS era. The TLR/TVR differences remained significant after propensity matching in the DES era vs BMS era (Mortality: HR 1.00, 95% CI: 0.83 - 1.28; TLR: HR 0.40, 95% CI 0.32 - 0.46; TVR: HR 0.44, 95% CI 0.38 - 0.51).ConclusionsIn large regional experience with a consecutive series of patients representing the contemporary practice of PCI, including both on and off label use, the frequent use of DES reduces the risk of TVR and TLR without compromising survival.

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Comparison of Long-Term Outcomes of Bare Metal or Drug-Eluting Stent Implantation in Standard Versus Off-Label Coronary Narrowings

Cited by 12 publications

References 28 publications

Clinical Evaluation of Different Revascularization Strategies: Unlabelled Use

Clinical Evaluation of Different Revascularization Strategies: Unlabelled Use

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

Extended Outcomes of Complex Coronary Disease in the Drug Eluting Stent Era

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