Incidence and predictors of target lesion failure in patients undergoing contemporary DES implantation—Individual patient data pooled analysis from 6 randomized controlled trials

Konigstein, Maayan; Madhavan, Mahesh V.; Ben‐Yehuda, Ori; Rahim, Hussein; Srdanovic, Iva; Gkargkoulas, Fotis; Mehdipoor, Ghazaleh; Shlofmitz, Evan; Maehara, Akiko; Redfors, Björn; Gore, Ankita; McAndrew, Thomas; Stone, Gregg W.; Ali, Ziad A.

doi:10.1016/j.ahj.2019.03.011

Cited by 34 publications

(23 citation statements)

References 27 publications

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“…In the case of patients who underwent PCI, restenosis is also an important problem due to its relatively high incidence, especially in patients with diabetes. 5 Restenosis is not a benign event, because it can occur as acute coronary syndrome and it may not infrequently result in recurrent restenosis. 18 Therefore, interventionists and physicians should strive to prevent restenosis after PCI.…”

Section: Discussionmentioning

confidence: 99%

“… 3 However, similar to first-generation DES, late TLR after implantation of new-generation DES cannot be ignored, because it continues to occur constantly without attenuation over a long period of time, in contrast with bare metal stents (BMS) restenosis, in which TLR beyond 1 year is reportedly uncommon. 4 , 5 In particular, patients with diabetes mellitus (DM) are at higher risk of restenosis and TLR. 5 , 6 However, the importance of glycemic control in the development of restenosis has not been adequately investigated.…”

mentioning

confidence: 99%

“… 4 , 5 In particular, patients with diabetes mellitus (DM) are at higher risk of restenosis and TLR. 5 , 6 However, the importance of glycemic control in the development of restenosis has not been adequately investigated.…”

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confidence: 99%

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Effect of Glycemic Control During Follow-up on Late Target Lesion Revascularization After Implantation of New-Generation Drug-Eluting Stents in Patients With Diabetes　― A Single-Center Observational Study ―

et al. 2020

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Background: Few studies have investigated the importance of glycemic control in patients with diabetes mellitus (DM) for reducing the incidence of late target lesion revascularization (TLR) after implantation of new-generation drug-eluting stents (DES). Methods and Results: We retrospectively identified 1,568 patients who underwent new-generation DES implantation. Patients were divided into 3 groups based on diabetic status and glycemic control 1 year after the procedure: those without DM (non-DM group; n=1,058) and those with DM at follow-up with either good (HbA1c <7%; n=328) or poor (HbA1c ≥7%; n=182) control. The cumulative 5-year incidence of clinically driven late TLR after the index procedure was significantly higher in DM with poor control at follow-up than in those with good control at follow-up or non-DM (14%, 4.8%, and 2.9%, respectively; P<0.0001). Multivariate analysis revealed that poor control at follow-up was significantly associated with a higher risk of clinically driven late TLR compared with the non-DM group (hazard ratio [HR] 4.58, 95% confidence interval [CI] 2.50–8.16, P<0.0001). However, good control at follow-up group was not associated with a higher risk of clinically driven late TLR compared with the non-DM group (HR 1.35, 95% CI 0.68–2.56, P=0.38). Conclusions: DM patients with poor glycemic control at follow-up had a significantly higher risk of clinically driven late TLR than non-DM patients.

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Section: Discussionmentioning

confidence: 99%

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confidence: 99%

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Effect of Glycemic Control During Follow-up on Late Target Lesion Revascularization After Implantation of New-Generation Drug-Eluting Stents in Patients With Diabetes　― A Single-Center Observational Study ―

et al. 2020

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“…While in 1 analysis of 6 randomized controlled trials, reference vessel diameter was the only predictor of target lesion failure, there are several other high-risk lesion-related features which have been associated with worse clinical outcomes 21). Stent underexpansion, edge dissection and residual reference segment disease play a significant role in the occurrence of future ischemic events including stent thrombosis 22).…”

Section: Lesion-related Ischemic Riskmentioning

confidence: 99%

The Role of Novel Oral Anticoagulants and Antiplatelet Therapy after Percutaneous Coronary Intervention: Individualizing Therapy to Optimize Outcomes

Shlofmitz

Lee

2019

Korean Circ J

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The number of patients undergoing percutaneous coronary intervention (PCI) who mandate additional oral anticoagulant therapy has been increasing. Dual antiplatelet therapy (DAPT) is associated with reduced ischemic events including stent thrombosis, myocardial infarction and stroke following PCI. However, the tradeoff is an increased risk for bleeding while on DAPT. The addition of a novel oral anticoagulant (NOAC) further increases the likelihood of bleeding while on antiplatelet therapy. Thus, the overall risks and benefits for each patient undergoing PCI on NOAC must be assessed and therapy individualized to ensure optimal therapy for each unique situation. Patients on NOAC undergoing PCI should undergo routine assessment with intravascular imaging as the role of high-risk lesion-related features have increased importance prior to determining optimal duration of treatment with DAPT. We review the best practices for the pharmacologic management of patients requiring anticoagulation with NOAC who are treated with PCI and require antiplatelet therapy.

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“…Despite improved results with drug-based technologies, a limitation of these endovascular devices is still restenosis. Patient-level data of coronary DES have been pooled to analyze which factors are predictors for revascularization [ 7 ]. In terms of risk factors for revascularization after femoropopliteal DES therapy, including patient demographic and clinical variables, limited data exist.…”

Section: Introductionmentioning

confidence: 99%

Prediction Model for Freedom from TLR from a Multi-study Analysis of Long-Term Results with the Zilver PTX Drug-Eluting Peripheral Stent

Dake

Fanelli

Lottes

et al. 2020

Cardiovasc Intervent Radiol

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Purpose Develop a prediction model to determine the impact of patient and lesion factors on freedom from target lesion revascularization (ffTLR) for patients who are candidates for Zilver PTX drug-eluting stent (DES) treatment for femoropopliteal lesions. Methods Patient factors, lesion characteristics, and TLR results from five global studies were utilized for model development. Factors potentially associated with TLR (sex, age, diabetes, hypertension, hypercholesterolemia, renal disease, smoking status, Rutherford classification, lesion length, reference vessel diameter (RVD), popliteal involvement, total occlusion, calcification severity, prior interventions, and number of runoff vessels) were analyzed in a Cox proportional hazards model. Probability of ffTLR was generated for three example patient profiles via combinations of patient and lesion factors. TLR was defined as reintervention performed for ≥ 50% diameter stenosis after recurrent clinical symptoms. Results The model used records from 2227 patients. The median follow-up time was 23.9 months (range: 0.03–60.8). The Kaplan–Meier estimates for ffTLR were 90.5% through 1 year and 75.2% through 5 years. In a multivariate analysis, sex, age, Rutherford classification, lesion length, RVD, total occlusion, and prior interventions were significant factors. The example patient profiles have predicted 1-year ffTLRs of 97.4, 92.3, and 86.0% and 5-year predicted ffTLRs of 92.8, 79.5, and 64.8%. The prediction model is available as an interactive web-based tool (https://cooksfa.z13.web.core.windows.net). Conclusions This is the first prediction model that uses an extensive dataset to determine the impact of patient and lesion factors on ffTLR through 5 years and provides an interactive web-based tool for expected patient outcomes with the Zilver PTX DES. Clinical Trial Registrations Zilver PTX RCT unique identifier: NCT00120406; Zilver PTX single-arm study unique identifier: NCT01094678; Zilver PTX China study unique identifier: NCT02171962; Zilver PTX US post-approval study unique identifier: NCT01901289; Zilver PTX Japan post-market surveillance study unique identifier: NCT02254837. Levels of Evidence Zilver PTX RCT: Level 2, randomized controlled trial; Single-arm study: Level 4, large case series; China study: Level 4, case series; US post-approval study: Level 4, case series Japan PMS study: Level 4, large case series.

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Incidence and predictors of target lesion failure in patients undergoing contemporary DES implantation—Individual patient data pooled analysis from 6 randomized controlled trials

Cited by 34 publications

References 27 publications

Effect of Glycemic Control During Follow-up on Late Target Lesion Revascularization After Implantation of New-Generation Drug-Eluting Stents in Patients With Diabetes　― A Single-Center Observational Study ―

Effect of Glycemic Control During Follow-up on Late Target Lesion Revascularization After Implantation of New-Generation Drug-Eluting Stents in Patients With Diabetes　― A Single-Center Observational Study ―

The Role of Novel Oral Anticoagulants and Antiplatelet Therapy after Percutaneous Coronary Intervention: Individualizing Therapy to Optimize Outcomes

Prediction Model for Freedom from TLR from a Multi-study Analysis of Long-Term Results with the Zilver PTX Drug-Eluting Peripheral Stent

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Incidence and predictors of target lesion failure in patients undergoing contemporary DES implantation—Individual patient data pooled analysis from 6 randomized controlled trials

Cited by 34 publications

References 27 publications

Effect of Glycemic Control During Follow-up on Late Target Lesion Revascularization After Implantation of New-Generation Drug-Eluting Stents in Patients With Diabetes ― A Single-Center Observational Study ―

Effect of Glycemic Control During Follow-up on Late Target Lesion Revascularization After Implantation of New-Generation Drug-Eluting Stents in Patients With Diabetes ― A Single-Center Observational Study ―

The Role of Novel Oral Anticoagulants and Antiplatelet Therapy after Percutaneous Coronary Intervention: Individualizing Therapy to Optimize Outcomes

Prediction Model for Freedom from TLR from a Multi-study Analysis of Long-Term Results with the Zilver PTX Drug-Eluting Peripheral Stent

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Effect of Glycemic Control During Follow-up on Late Target Lesion Revascularization After Implantation of New-Generation Drug-Eluting Stents in Patients With Diabetes　― A Single-Center Observational Study ―

Effect of Glycemic Control During Follow-up on Late Target Lesion Revascularization After Implantation of New-Generation Drug-Eluting Stents in Patients With Diabetes　― A Single-Center Observational Study ―