Effect and Significant of Hyperlipoproteinemia on Stent Thrombosis in Patients with Implanted Drug-Eluting Stents: The 5-Year Follow Up Study

Introduction: Drug eluting stents (DES) significantly reduce target lesion revascularization (TLR) compared to bare metal stents (BMS) within 1 year of follow-up, however they increase late stent thrombosis. The effect of DES on the need for late revascularization is unclear. Hypothesis: We sought to evaluate the safety and efficacy of DES compared to BMS early after intervention (< 1 year) and late (> 1 year) among both stable patients and acute coronary syndromes. Methods: We searched the Medline database for randomized clinical trials with long-term follow-up, from 2000 to 2007. We also searched relevant journal supplements for abstracts and obtained trial presentations from cardiology meetings. Results: We identified 24 trials (17% acute coronary syndrome patients) with a total of 10,278 patients. The weighted mean duration of follow-up was 28 months. For early outcomes (< 1 year); the incidence of all-cause mortality for DES vs. BMS was 2% vs. 2.1%, RR=0.95, 95%CI (0.70–1.27), p=0.7, cardiovascular mortality was 1.4% vs. 1.5%, RR=0.95 (0.73–1.24), p=0.72, Q-wave myocardial infarction (MI) was 0.8% vs. 0.6%, RR= 1.24 (0.7–2.2), p=0.45, non-Q-wave MI was 3% vs. 4%, RR=0.73 (0.55–0.96), p=0.024, TLR was 5.9% vs. 17.8%, RR=0.29 (0.24–0.34), p<0.001, and stent thrombosis was 0.94% vs. 1.1%, RR=0.83 (0.55–1.27), p=0.4. For late outcomes (>1 year); the incidence of all-cause mortality for DES vs. BMS was 3.9% vs. 3.8%, RR=1.04 (0.79–1.38), p=0.7, cardiovascular mortality 1.4% vs. 1.5%, RR=0.95 (0.73–1.24), p=0.72, Q-wave MI was 0.7% vs.0.6%, RR=1.05 (0.54–2.05), p=0.87, non-Q-wave MI was 1.6% vs. 1.2%, RR=1.39 (0.87–2.21), p=0.16, TLR was 2.6% vs. 3.2%, RR=0.82 (0.59–1.13), p=0.23, and stent thrombosis was 0.59% vs. 0.15%, RR=3.2 (1.22–8.36), p=0.018. Conclusions: Within 1 year of follow-up, DES appears to be safe and efficacious with similar mortality, similar stent thrombosis, decreased TLR, and decreased non-Q-wave MI compared to BMS. After 1 year, DES still has similar mortality compared to BMS, however TLR, while low, is no longer reduced, stent thrombosis is increased, and there is a numerical excess of non-Q-wave MI.

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Real-world cost-effectiveness of drug-eluting stents vs. bare-metal stents for coronary heart disease—A five-year follow-up study

Health Policy ◽

10.1016/j.healthpol.2018.11.010 ◽

2019 ◽

Vol 123 (2) ◽

pp. 229-234

Author(s):

Hao-Min Cheng ◽

Ling-Jan Chiou ◽

Tzu-Ching Chen ◽

Shih-Hsien Sung ◽

Chen-Huan Chen ◽

...

Keyword(s):

Coronary Heart Disease ◽

Heart Disease ◽

Cost Effectiveness ◽

Bare Metal Stents ◽

Drug Eluting Stents ◽

Metal Stents ◽

Bare Metal ◽

Follow Up Study ◽

Drug Eluting

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Safety and Efficacy of Second-Generation Drug-Eluting Stents in Real-World Practice: Insights from the Multicenter Grand-DES Registry

Journal of Interventional Cardiology ◽

10.1155/2020/3872704 ◽

2020 ◽

Vol 2020 ◽

pp. 1-9 ◽

Cited By ~ 1

Author(s):

You-Jeong Ki ◽

Kyung Woo Park ◽

Jeehoon Kang ◽

Chee-Hoon Kim ◽

Jung-Kyu Han ◽

...

Keyword(s):

Propensity Score ◽

Stent Thrombosis ◽

Real World ◽

Coronary Intervention ◽

Drug Eluting Stents ◽

Drug Eluting Stent ◽

Safety And Efficacy ◽

Drug Eluting ◽

Composite Outcomes

Objective. In this study, we sought to compare the efficacy and safety of the Xience Prime/Xience V/Promus EES and Biomatrix/Biomatrix Flex/Nobori BES with resolute integrity/resolute ZES using the grand drug-eluting stent (Grand-DES) registry. Background. Currently, new-generation drug-eluting stents (DESs) are used as the standard of care in patients undergoing percutaneous coronary intervention. No study has simultaneously compared everolimus-eluting stent (EES), biolimus-eluting stent (BES), and zotarolimus-eluting stent (ZES). Methods. Stent-related composite outcomes (target lesion failure) and patient-related composite outcomes were compared in crude and propensity score-matched analysis. Results. Of the 17,286 patients in the Grand-DES group, 5,137, 2,970, and 4,990 patients in the EES, BES, and ZES groups completed a three-year follow-up. In the propensity score-matched cohort, the stent-related outcome (EES vs. BES vs. ZES; 5.9% vs. 6.7% vs. 7.1%, P=0.226) and patient-related outcomes (12.7% vs. 13.5% vs. 14.3%, P=0.232) were similar among the three groups, at 3 years. The rate of definite or probable stent thrombosis (0.6% vs. 0.8% vs. 0.5%, P=0.549) was similar. In the multivariate analysis, chronic kidney disease was the strongest predictor of stent thrombosis (adjusted hazard ratio 3.178; 95% confidence interval 1.621–6.229; P<0.001). Conclusions. In this robust real-world registry with unrestricted use of EES, BES, and ZES, the three stent groups showed comparable safety and efficacy at the 3-year follow-up.

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Abstract 2534: Long-term (up To 6 Years) Results Of Drug-eluting Stents For The Treatment Of Diabetic Patients - Insights From The Drug Eluting Stents In The Real World(desire) Registry

Circulation ◽

10.1161/circ.118.suppl_18.s_740-a ◽

2008 ◽

Vol 118 (suppl_18) ◽

Author(s):

Adriana Moreira ◽

Amanda Sousa ◽

José Costa ◽

Ricardo Costa ◽

Manuel Cano ◽

...

Keyword(s):

Diabetes Mellitus ◽

Stent Thrombosis ◽

Multivariate Logistic Regression Analysis ◽

Drug Eluting Stents ◽

Diabetic Patients ◽

Diabetes Status ◽

Drug Eluting ◽

The Impact

Background: Diabetic patients are traditionally related to higher rates of major adverse cardiac events (MACE) after percutaneous coronary intervention even in the drug-eluting stent (DES) era. We sought to evaluate the impact of diabetes status in the very long-term clinical outcomes after DES implantation in a complex, non-selected diabetic cohort. Methods and Results: Between May/2002 and May/2007, 2,500 patients treated exclusively with DES were consecutively enrolled in the non-randomized, single-center DESIRE Registry. Among them, 1,705 elective patients have completed 6 month-follow-up and were divided into 3 groups according to their Diabetes mellitus status. Primary endpoint was long-term combined MACE and stent thrombosis rate classified according to ARC definitions. Clinical follow-up was obtained at 1, 6 and 12 months and then annually up to 6 years. Mean follow-up time was 2.6±1.2 years and was achieved in 98% of the eligible cohort. Baseline clinical and procedure characteristics as well as late outcomes are displayed in the table . In the multivariate logistic regression analysis, Diabetes mellitus (OR=1.45; 95%Confidence interval-CI 1.00 –2.11) and moderate/severe calcification at lesion site (OR=3.06;95%CI,1.47– 6.34) were independent predictors of MACE . Conclusions: In the DESIRE registry both insulin and non-insulin requiring diabetics carried poorer long-term outcomes (MACE) when compared to non-diabetic patients. Importantly, there was a tendency for higher stent thrombosis among diabetics. However, the type of diabetes (insulin vs. non-insulin) did not seem to impact the prognosis of PCI with DES.

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Vertebral Artery Origin Stents Revisited

Neurosurgery ◽

10.1227/01.neu.0000370010.09419.23 ◽

2010 ◽

Vol 67 (1) ◽

pp. 41-48 ◽

Cited By ~ 17

Author(s):

Min S. Park ◽

David Fiorella ◽

Michael F. Stiefel ◽

Shervin R. Dashti ◽

L. Fernando Gonzalez ◽

...

Keyword(s):

Stent Thrombosis ◽

Bare Metal Stents ◽

High Rate ◽

Drug Eluting Stents ◽

Metal Stents ◽

Stent Restenosis ◽

Drug Eluting ◽

Low Incidence ◽

Angioplasty And Stenting

Abstract BACKGROUND Vertebral origin angioplasty and stenting (VOAS) with bare metal stents is associated with a high rate of in-stent restenosis (ISR). OBJECTIVE We evaluated the rate of ISR after VOAS with drug-eluting stents. METHODS Twenty patients (15 men, 5 women; age range, 36–88 years; mean, 63.7 years) were treated for VOAS with a paclitaxel-eluting stent (Taxus Express2, Boston Scientific, Natick, Massachusetts). Stenosis at follow-up was quantified as insignificant (0%–24%), mild (25%–49%), moderate (50%–74%), and severe (75%–100%). ISR was defined using a binary criteria of > 50% stenosis at follow-up angiography. RESULTS All procedures were technically successful with no periprocedural complications. Follow-up angiography (range, 4–48 months; mean, 14.7 months) showed insignificant stenosis in 9 patients, mild in 6, moderate in 4, and severe in 1. In 1 patient with “moderate” stenosis, the stent migrated distally; therefore, the lesion restenosis was not within the stent. Thus, 4 of 19 patients (21%) exhibited binary moderate or severe ISR, and 5 of 20 showed restenosis at the lesion (25%). The patient with severe stenosis developed stent thrombosis > 3 years after VOAS. CONCLUSION VOAS with drug-eluting stents was associated with a low incidence of periprocedural complications. Although the rate of restenosis was half that seen with the use of bare metallic stents, 21% of patients still developed moderate or severe ISR. These patients may require ≥ 1 revascularization procedures. The risk of delayed stent thrombosis may necessitate lifelong dual antiplatelet medications.

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Sustained risk of stent thrombosis and restenosis in first generation drug-eluting Stents after One Decade of Follow-up: A Report from the Swedish Coronary Angiography and Angioplasty Registry (SCAAR)

Catheterization and Cardiovascular Interventions ◽

10.1002/ccd.27655 ◽

2018 ◽

Vol 92 (6) ◽

pp. E403-E409 ◽

Cited By ~ 4

Author(s):

Sebastian Völz ◽

Oskar Angerås ◽

Jacob Odenstedt ◽

Dan Ioanes ◽

Inger Haraldsson ◽

...

Keyword(s):

Coronary Angiography ◽

Stent Thrombosis ◽

First Generation ◽

Drug Eluting Stents ◽

Drug Eluting

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Drug-eluting stents for treatment of focal infrapopliteal lesions

VASA ◽

10.1024/0301-1526/a000170 ◽

2012 ◽

Vol 41 (2) ◽

pp. 90-95 ◽

Cited By ~ 10

Author(s):

Rastan ◽

Noory ◽

Zeller

Keyword(s):

Limb Salvage ◽

Bare Metal Stents ◽

Target Lesion ◽

Drug Eluting Stents ◽

Metal Stents ◽

Target Lesion Revascularisation ◽

Randomized Studies ◽

Drug Eluting ◽

The Mean

We have investigated the role of drug-eluting stents on patency rates after treatment of focal infrapopliteal lesions in patients with intermittent claudication and critical limb ischemia. Reports indicate that drug-eluting stents reduce the risk of restenosis after percutaneous infrapopliteal artery revascularization. A Pub Med, EMBASE, Cochrane database review search of non-randomized studies investigating patency rates, target lesion revascularisation rates, limb salvage rates and mortality rates in an up to 3-year follow-up period after drug-eluting stent placement was conducted. In addition, preliminary results of randomized studies comparing drug-eluting stents with bare-metal stents and plain balloon angioplasty in treatment of focal infrapopliteal lesions were included in this review. A total of 1039 patients from 10 non-randomized and randomized studies were included. Most commonly used drug-eluting stents were sirolimus-eluting. The mean follow-up period was 12.6 (range 8 - 24). The mean 1-year primary patency rate was 86 ± 5 %. The mean target lesion revascularization rate and limb salvage rate was 9.9 ± 5 % and 96.6 %±4 %, respectively. Results from non-randomized and preliminary results from prospective, randomized trials show a significant advantage for drug-eluting stents in comparison to plain balloon angioplasty and bare-metal stents concerning target lesion patency and in parts target lesion revascularisation. No trial reveals an advantage for drug-eluting stents with regard to limb salvage and mortality.

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Angiographic control versus ischaemia-driven management of patients undergoing percutaneous revascularisation of the unprotected left main coronary artery with second-generation drug-eluting stents: rationale and design of the PULSE trial

Open Heart ◽

10.1136/openhrt-2020-001253 ◽

2020 ◽

Vol 7 (2) ◽

pp. e001253

Author(s):

Ovidio De Filippo ◽

Matteo Bianco ◽

Matteo Tebaldi ◽

Mario Iannaccone ◽

Luca Gaido ◽

...

Keyword(s):

Second Generation ◽

Controlled Trial ◽

Drug Eluting Stents ◽

Major Adverse Cardiovascular Events ◽

Relative Reduction ◽

Left Main ◽

Bleeding Events ◽

Open Label ◽

Drug Eluting

BackgroundThe role of planned angiographic control (PAC) over a conservative management driven by symptoms and ischaemia following percutaneous coronary intervention (PCI) of the unprotected left main (ULM) with second-generation drug-eluting stents remains controversial. PAC may timely detect intrastent restenosis, but it is still unclear if this translated into improved prognosis.Methods and analysisPULSE is a prospective, multicentre, open-label, randomised controlled trial. Consecutive patients treated with PCI on ULM will be included, and after the index revascularisation patients will be randomised to PAC strategy performed with CT coronary after 6 months versus a conservative symptoms and ischaemia-driven follow-up management. Follow-up will be for at least 18 months from randomisation. Major adverse cardiovascular events at 18 months (a composite endpoint including death, cardiovascular death, myocardial infarction (MI) (excluding periprocedural MI), unstable angina, stent thrombosis) will be the primary efficacy outcome. Secondary outcomes will include any unplanned target lesion revascularisation (TLR) and TLR driven by PAC. Safety endpoints embrace worsening of renal failure and bleeding events. A sample size of 550 patients (275 per group) is required to have a 80% chance of detecting, as significant at the 5% level, a 7.5% relative reduction in the primary outcome.Trial registration numberNCT04144881

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The comparison of the chronic-phase vascular healing between bioabsorbable and durable polymer drug eluting stent by using optical coherence tomography

European Heart Journal ◽

10.1093/ehjci/ehaa946.2472 ◽

2020 ◽

Vol 41 (Supplement_2) ◽

Author(s):

Y Yamakami ◽

S Kimura ◽

K Hara ◽

M Ohmori ◽

R Tateishi ◽

...

Keyword(s):

Optical Coherence Tomography ◽

Acute Coronary Syndrome ◽

Clinical Presentation ◽

Neointimal Hyperplasia ◽

Chronic Phase ◽

Drug Eluting Stents ◽

Coronary Syndrome ◽

Durable Polymer ◽

Drug Eluting

Abstract Background Bioabsorbable polymer drug eluting stents (BP-DESs) were designed to reduce a vascular inflammatory reaction compared to durable polymer drug eluting stents (DP-DESs). However, few studies have compared vascular responses to BP-DESs and DP-DESs. Methods We enrolled 88 consecutive patients with single culprit coronary artery lesions (31 lesions with acute coronary syndrome) undergoing a single stent-implantation. BP-DESs and DP-DESs were implanted in 50 (57%) and 38 patients (43%), respectively. All lesions underwent optical coherence tomography examination at chronic phase and intrastent OCT findings at the follow-up were evaluated in every 1-mm cross-sections (CSs). Results A total of 1887 CSs (BP-DES: 1096, DP-DES: 791) were analyzed. The median period of follow-up OCT was 293 (250–374) days. There were no differences in the patient, lesion, and initial clinical presentation of acute coronary syndrome (ACS). BP-DESs had significantly higher percent neointimal hyperplasia area, defined as neointimal hyperplasia area divided by stent area x 100 (18.4±9.0% vs. 16.1±9.9%, p<0.001), fewer malapposed struts (1.7% vs. 3.9%, p=0.005), fewer uncovered struts (3.6% vs. 5.8%, p=0.02) but higher frequency of superficial low intensity neointima (LIN) (7.7% vs. 3.4%, p<0.001). Multivariate logistic analysis showed that BP-DES (OR: 2.5, 95% CI: 1.49–4.08, p<0.001) and the initial clinical presentation of ACS (OR: 2.31, 95% CI: 1.47–3.62, p<0.001) are independent predictive factors for LIN. Conclusion BP-DESs showed homogenous neointimal growth and complete stent coverage quantitatively. Meanwhile, the significant relationships of BP-DES with LIN may suggest that the neointimal quality remains immature in BP-DESs in this period. Funding Acknowledgement Type of funding source: None

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