Drug-Eluting Coronary Stent Very Late Thrombosis Revisited (original) (raw)
Related papers
Clinical research in cardiology : official journal of the German Cardiac Society, 2018
Old-generation drug-eluting coronary stents (o-DES) have despite being safe and effective been associated with an increased propensity of late stent thrombosis (ST). We evaluated ST rates in o-DES, new-generation DES (n-DES) and bare metal stents (BMS) the first year (< 1 year) and beyond 1 year (> 1 year). We evaluated all implantations with BMS, o-DES (Cordis Cypher, Boston Scientific Taxus Liberté and Medtronic Endeavor) and n-DES in the Swedish coronary angiography and angioplasty registry (SCAAR) between 1 January 2007 and 8 January 2014 (n = 207 291). All cases of ST (n = 2 268) until 31 December 2014 were analyzed. The overall risk of ST was lower in both n-DES and o-DES compared with BMS up to 1 year (n-DES versus BMS: adjusted risk ratio (RR) 0.48 (0.41-0.58) and o-DES versus BMS: 0.56 (0.46-0.67), both p < 0.001). From 1 year after stent implantation and onward, the risk for ST was higher in o-DES compared with BMS [adjusted RR, 1.82 (1.47-2.25], p < 0.001). N-...
Late stent thrombosis: the Damocle's sword of drug eluting stents?
EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology, 2007
As a result of the introduction of drug eluting stents (DES) to clinical practice, angiographic and clinical parameters of restenosis have been significantly improved. However, several recent publications have raised concerns about long-term safety of this technology. They include a potential risk of inducing chronic inflammation within the coronary artery, delayed healing and late stent thrombosis.Recently, late stent thrombosis, a rare but often life threatening event, has been reported to occur more frequently following DES placement. The mechanism of this phenomenon has not been fully elucidated.What is the true incidence of stent thrombosis after DES therapy? Is it similar or higher than with bare metal stents? Are randomised trials with DES therapy overestimating the benefits of this therapy? Which are the potential limitations of these studies? Are DES increasing rates of death and myocardial infarction from randomised trials and registries a true fact? In the following pages...
American Journal of Cardiology, 2006
Despite concerns regarding the long-term safety of drug-eluting stent (DES) implantation because of late-onset stent thrombosis, the actual incidence of stent thrombosis after 1 year is unknown. We investigated the incidence, risk factors, and association of antiplatelet therapy interruption for the development of stent thrombosis after DES implantation during long-term follow-up. A total of 1,911 consecutive patients with DES implantation were enrolled (sirolimus-eluting stents in 1,545 patients, 2,045 lesions; paclitaxel-eluting stents in 366 patients, 563 lesions). During long-term follow-up (median 19.4 months, interquartile range 15.3 to 24.3), 15 patients (0.8%, 95% confidence interval 0.5% to 1.3%) developed stent thrombosis within 6 hours to 20.4 months. Eleven patients (0.6%, 95% confidence interval 0.3% to 1.0%) had late thrombosis (median 6.1 months). The incidence of stent thrombosis was 3.3% (4 of 121 patients) in patients with complete interruption of antiplatelet therapy (vs 0.6% in those without, p = 0.004) and 7.8% (5 of 64 patients) with premature interruption of aspirin or clopidogrel, or both (vs 0.5% in those without, p <0.001). Independent predictors of stent thrombosis were premature antiplatelet therapy interruption, primary stenting in acute myocardial infarction, and total stent length. Stent thrombosis also developed while patients were on dual antiplatelet therapy (all patients with acute/subacute stent thrombosis and 36% of those with late stent thrombosis; 47% of total with stent thrombosis). In conclusion, stent thrombosis occurred in 0.8% after DES implantation during long-term follow-up. The incidence of late stent thrombosis was 0.6%, similar to that for bare metal stents. The predictors of stent thrombosis were premature antiplatelet therapy interruption, primary stenting in acute myocardial infarction, and total stent length.
Stent thrombosis in real-world patients: a comparison of drug-eluting with bare metal stents
Netherlands Heart Journal, 2007
Background. Although the introduction of drugeluting stents (DES) has been associated with an impressive reduction in target vessel revascularisation, there has been concern about the safety profile. The aim of this study was to determine the incidence of stent thrombosis in real-world patients and evaluate the contribution of drug-eluting stents. Methods. A prospective observational cohort study was conducted at a high-volume centre in Utrecht, the Netherlands. All patients who underwent a percutaneous coronary intervention (PCI) between 1 January and 31 December 2005 were evaluated. The patients were pretreated with aspirin and clopidogrel, which was continued for six months in bare metal stents (BMS) and 12 months in DES. Results. In 2005, 1309 patients underwent a percutaneous coronary intervention procedure with stent implantation. After a median follow-up of nine months, 1.8% (n=23) of the patients had suffered from stent thrombosis. Two cases could be attributed to incorrect use of antiplatelet agents. In 8/23 cases, a technical reason was found such as an unrecognised dissection or stent underexpansion. The timing of stent thrombosis was acute in 1/23 patients, subacute in 20/23 patients and late in 2/23 patients. In both cases of late stent thrombosis, a BMS had been used. There were no differences in stent thrombosis rates between DES and BMS (1.4 vs. 1.9%, ns.). This is remarkable since DES were used in more complex and longer lesions. Conclusion. The use of DES in routine daily practice does not appear to be associated with a higher rate of stent thrombosis than BMS. (Neth Heart J 2007;15:382-6).
Stent Thrombosis in the Era of the Drug-Eluting Stent
Korean Circulation Journal, 2005
Coronary stent thrombosis (ST) has been regarded as a rare but catastrophic complication of bare-metal stent (BMS) implantation that normally occurs during the first few weeks after stenting. In the drug-eluting stent (DES) era, there has been increasing concern regarding higher rates of ST due to delayed endothelialization. However, a pooled meta-analysis of randomized clinical trials and registry studies showed rates of ST (0.4-1.5%) after DES to be similar to those of BMS. The rate of ST did not differ between sirolimus-and paclitaxel-eluting stents. Additionally, the rates of late ST were similar between DES and BMS. Remarkably, very late occurrence of ST, which develops up to 1-2 years after DES implantation, was significantly associated with complete cessation of antiplatelet therapy. Further large-scale studies are needed to determine the optimal combination and duration for antiplatelet therapy in order to prevent these serious thrombotic events.
Late Coronary Stent Thrombosis
Circulation, 2007
I ntroduced Ͼ20 years ago, 1 coronary artery stents have improved the safety and particularly the efficacy of percutaneous coronary interventions (PCIs). 2 Abrupt vessel closure, complicating 6% to 8% of balloon angioplasty procedures, was associated with a 5% mortality, 40% rate of myocardial infarction (MI), and 40% rate of emergency coronary artery bypass grafting. 3 Stents significantly reduced these adverse events ( ). 4,5 The reduction of restenosis afforded by bare metal stents (BMS) was modest (30% to 40%). Repeat revascularization still occurred in 15% to 20% of cases. 6 Drug-eluting stents (DES) with antiproliferative drugs attached via polymers on the stent surface to minimize smooth muscle proliferation have reduced restenosis and rates of target lesion revascularization by 50% to 70% compared with BMS across nearly all lesion and patient subsets. 7 Initially 8 and again more recently, 9 -16 safety concerns were raised about DES, particularly about late stent thrombosis (ST).
Clinical Research in Cardiology, 2009
Introduction A limitation of drug-eluting stent (DES) use to FDA-approved indications has been suggested to reduce the risk of stent thrombosis. This study evaluated predictors of stent thrombosis in clinical practice after the use of drugeluting as well as bare-metal stents (BMS), including adherence to the FDA indications for DES. Methods Between July 2002 and October 2006 percutaneous coronary intervention (PCI) was performed on 5,945 patients using BMS (68%) or DES (32%). Patients had 1-year follow-up for definitive stent thrombosis (ARC criteria). 76 patients (1.27%) developed definitive stent thrombosis. Clinical, procedural, and angiographic parameters were related to those of 786 patients without stent thrombosis to define predictors of stent thrombosis. Off-label or on-label implantation of stents according to the FDA-approved indications for DES was included as parameter in the analysis. Results In 434 patients, stent implantation was performed within FDA-approved indications and in 428 patients outside of FDA-approved indications for DES. Predictors of stent thrombosis were PCI in acute myocardial infarction (OR = 4.51, P \ 0.001), treatment of bifurcation lesions (OR = 4.43, P \ 0.001), stent length per mm (OR = 1.07, P \ 0.001), implantation of multiple stents (OR = 3.67, P \ 0.001), and stent implantation outside of FDA indications (OR = 6.13, P \ 0.001). The risk was increased for DES as well as BMS. In a multivariate analysis, PCI in acute myocardial infarction (OR = 2.56, P = 0.014), LV-EF \ 30% (OR = 3.60, P \ 0.001), treatment of bifurcation lesion (OR = 3.65, P = 0.004), stent length in mm (OR = 1.04, P = 0.015), and implantation of multiple stents (OR = 2.64, P = 0.002) remained predictors of stent thrombosis. Off-label stent implantation was no independent additional predictor as it is a combined parameter of the above-mentioned predictors. Conclusions Implantation of coronary stents outside of the FDA-approved indications for DES is associated with an increased risk of stent thrombosis using DES and BMS.