Randomized comparison of 6- versus 24-month clopidogrel therapy after balancing anti-intimal hyperplasia stent potency in all-comer patients undergoing percutaneous coronary intervention

Valgimigli, Marco; Campo, Gianluca; Percoco, Gianfranco; Monti, Monia; Ferrari, Fabrizio; Tumscitz, Carlo; Zuffi, Andrea; Colombo, Federico; Kubbajeh, Moh'd; Cavazza, Caterina; Cangiano, Elisa; Tebaldi, Matteo; Minarelli, Monica; Arcozzi, Chiara; Scalone, Antonella; Frangione, Alice; Borghesi, Marco; Marchesini, Jlenia; Parrinello, Giovanni; Ferrari, Roberto

doi:10.1016/j.ahj.2010.07.034

Cited by 60 publications

(37 citation statements)

References 22 publications

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“…6 The reduction of VLST is particularly important because the increased risk of VLST with early-generation DES stirred a debate regarding the need of prolonged dual antiplatelet therapy. 27 Because of the low rate of VLST observed with EES with a prescription time for clopidogrel that was limited to 1 year and the relatively low number of EES patients on dual antiplatelet therapy at the time of last follow-up (24.1%), it appears unlikely that a prolonged regimen of dual antiplatelet therapy in patients treated with EES can further improve on stent-related outcomes. This has recently been corroborated by 2 randomized controlled trials showing no reduction in ischemic end points, including ST, when dual antiplatelet therapy is prolonged beyond 6 or 12 months.…”

Section: Discussionmentioning

confidence: 99%

Very Late Coronary Stent Thrombosis of a Newer-Generation Everolimus-Eluting Stent Compared With Early-Generation Drug-Eluting Stents

Räber

Magro²,

Stefanini³

et al. 2012

Circulation

348

182

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Background-Early-generation drug-eluting stents releasing sirolimus (SES) or paclitaxel (PES) are associated with increased risk of very late stent thrombosis occurring Ͼ1 year after stent implantation. It is unknown whether the risk of very late stent thrombosis persists with newer-generation everolimus-eluting stents (EES). Methods and Results-We assessed the risk of stent thrombosis in a cohort of 12 339 patients with unrestricted use of drug-eluting stents (3819 SES, 4308 PES, 4212 EES). Results are incidence rates per 100 person-years after inverse probability of treatment weighting to adjust for group differences. During follow-up of up to 4 years, the overall incidence rate of definite stent thrombosis was lower with EES (1.4 per 100 person-years) compared with SES (2.9; hazard ratio, 0.41; 95% confidence interval, 0.27-0.62; PϽ0.0001) and PES (4.4; hazard ratio, 0.33; 95% confidence interval, 0.23-0.48; PϽ0.0001). The incidence rate per 100 person-years of early (0 -30 days), late (31 days-1 year), and very late stent thrombosis amounted to 0.6, 0.1, and 0.6 among EES-treated patients; 1.0, 0.3, and 1.6 among SES-treated patients; and 1.3, 0.7, and 2.4 among PES-treated patients. Differences in favor of EES were most pronounced beyond 1 year, with a hazard ratio of 0.

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Section: Discussionmentioning

confidence: 99%

Very Late Coronary Stent Thrombosis of a Newer-Generation Everolimus-Eluting Stent Compared With Early-Generation Drug-Eluting Stents

Räber

Magro²,

Stefanini³

et al. 2012

Circulation

348

182

View full text Add to dashboard Cite

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“…The design and main findings of the PRODIGY trial have been previously reported 17, 18, 19. PRODIGY is a 4‐by‐2 randomized, multicenter, open‐label clinical trial designed to evaluate the efficacy and safety of prolonging the duration of clopidogrel therapy for up to 24 months in all‐comer patients receiving a balanced mixture of stents with various anti‐intimal hyperplasia potency and belonging to both first‐ and second‐generation drug‐eluting stent.…”

Section: Methodsmentioning

confidence: 99%

“…The planned sample size was finally increased up to 2000 to allow for fatalities occurring within the first 30 days, noncompliance, and loss to follow‐up as previously described 17, 18, 19…”

Section: Methodsmentioning

confidence: 99%

Stent and Dual Antiplatelet Therapy Duration Comparisons in the Setting of a Multicenter Randomized Controlled Trial: Can the Operator Experience Affect the Study Results?

Gargiulo

Heg

Ferrari

et al. 2017

JAHA

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BackgroundOperator experience influences outcomes after percutaneous coronary intervention, but this association in the controlled setting of a randomized, clinical trial is unclear.Methods and ResultsWe investigated operator‐related outcomes (30‐day and 2‐year efficacy and safety end points) among patients undergoing percutaneous coronary intervention and randomized to different dual antiplatelet therapy durations and stent types. A total of 2003 patients were analyzed, and 7 operator groups were compared. The majority of preprocedural and postprocedural characteristics were imbalanced. The primary end point of the study, the composite of death, myocardial infarction, or cerebrovascular accidents, did not differ among operators at 30 days or 2 years. There were no significant differences also for all other individual and composite end points analyzed at 30 days and 2 years, except for 2‐year stent thrombosis (P=0.048) and bleeding events (P=0.022 for Bleeding Academic Research Consortium type 2, 3, or 5). Adjusted comparisons for the main end points showed slight differences among operators at 30 days, but not at 2 years. There was no interaction of operator with dual antiplatelet therapy duration (P=0.112) or stent type (P=0.300). Results remained entirely consistent when operators were stratified by their experience.ConclusionsThere was a weak signal of heterogeneity across study operators for the 30‐day, but not the 2‐year, main study outcomes. No clear effect of operator or operator experience was observed for the comparative efficacy and safety profile of the randomized stent types or dual antiplatelet therapy duration regimens.Clinical Trial Registration URL: http://www.clinicaltrials.gov. Unique identifier: NCT00611286.

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“…Moreover, because treatment effects begin after PCI, starting randomization 1 year after the procedure may not account for imbalances in prognostic factors at the time of PCI, which may have an influence on long-term outcomes. Currently, there is insufficient evidence from the clinical trial literature to support the routine use of extended dual antiplatelet therapy in patients with CAD past 1 year following ACS; and several clinical trials are underway to clarify the appropriate duration of dual antiplatelet therapy following PCI with DES [31,32].…”

Section: Antiplatelet Therapy In Ischemic Heart Diseasementioning

confidence: 98%

Optimal Medical Therapy, Lifestyle Intervention, and Secondary Prevention Strategies for Cardiovascular Event Reduction in Ischemic Heart Disease

Joseph

Teo

2011

Curr Cardiol Rep

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Medical and lifestyle secondary prevention strategies are essential components for reducing cardiovascular risk, irrespective of whether revascularization is performed. In patients with coronary artery disease (CAD), recent clinical trials have further clarified the management of lipid optimization, renin-angiotensin-aldosterone system inhibition, antiplatelet therapy, and diabetes. Still, many questions remain with regard to optimal secondary prevention strategies in patients with CAD. Despite the significant reductions in cardiovascular morbidity and mortality with secondary prevention therapies demonstrated in clinical trials, long-term adherence to these interventions remains relatively low, with reasons being multifactorial. One promising method to improve compliance is the use of trained nurses/case managers to routinely follow medications, and provide both lifestyle and behavioral counseling. Implementation of this strategy led to significant improvements in medication compliance and risk factor optimization, although these results require confirmation in a randomized clinical study. Given that poor compliance has been associated with worsening cardiovascular outcomes, effective CAD management should include strategies for improving patient adherence to therapies that have proven benefits.

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Randomized comparison of 6- versus 24-month clopidogrel therapy after balancing anti-intimal hyperplasia stent potency in all-comer patients undergoing percutaneous coronary intervention

Cited by 60 publications

References 22 publications

Very Late Coronary Stent Thrombosis of a Newer-Generation Everolimus-Eluting Stent Compared With Early-Generation Drug-Eluting Stents

Very Late Coronary Stent Thrombosis of a Newer-Generation Everolimus-Eluting Stent Compared With Early-Generation Drug-Eluting Stents

Stent and Dual Antiplatelet Therapy Duration Comparisons in the Setting of a Multicenter Randomized Controlled Trial: Can the Operator Experience Affect the Study Results?

Optimal Medical Therapy, Lifestyle Intervention, and Secondary Prevention Strategies for Cardiovascular Event Reduction in Ischemic Heart Disease

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