Stent Thrombosis With DES in Real-World PCI
Stent Thrombosis With DES in Real-World PCI
Background and Aims. When compared to their firstgeneration (1stGEN) counterparts, second-generation (2GEN) drugeluting stents (DESs) have been associated with better clinical outcomes in randomized clinical trials, namely by reducing the rates of stent thrombosis (ST). Our goal was to investigate whether or not the broad use of newer devices would translate into higher safety in a real-world population. For that purpose, we compared the occurrence of definite ST at 12 months between two patient subsets from a large-volume single-center registry, according to the type of DES used. Total mortality was a secondary endpoint.
Methods and Results. Between January 2003 and December 2010, a total of 3806 patients were submitted to percutaneous coronary intervention (PCI) with only 1stGEN or 2GEN DES: 2388 patients (62.7%) were treated with 1stGEN DES only (sirolimus-eluting stent [SES] = 1295 [34.0%]; paclitaxel-eluting stent [PES] = 943 [24.8%]; both stent types were used in 150 patients) and 1418 patients (37.3%) were treated with 2GEN DESs only. The total incidence of definite ST (as defined by the Academic Research Consortium) at 12 months was 1.2% (n = 46). After correction for baseline differences between study groups and other variables deemed to influence the occurrence of ST, the use of 1stGEN DES was associated with a significant 2.4-fold increase in the risk of definite ST (95% confidence interval [CI], 1.05–5.42; P=.039) at 12 months; adjusted risk was higher with PES (hazard ratio [HR], 3.6; 95% CI, 1.48–8.70; P=.005) than with SES (HR, 2.3; 95% CI, 0.92–5.65; P=.074). Total mortality (3.7% vs 3.5%) did not differ significantly between groups (adjusted HR, 1.2; 95% CI, 0.81–1.84, P=.348).
Conclusions. Our data suggest that in the real-world setting of contemporary PCI, the unrestricted use of newer 2GEN DESs translates into an improvement in PCI safety (relative to 1stGEN DESs), with a significantly lower risk of definite ST at 12 months.
Stent thrombosis (ST) is a serious and often fatal event limiting the efficacy of percutaneous coronary intervention (PCI). The pathophysiology of ST is multifactorial, and underlying causes including stent-, procedure-, lesion-, and patient-related factors seem to play different roles at different time points after the index procedure. When compared to first-generation (1GEN) drug-eluting stents (DESs), newer DESs have been associated with a lower rate of ST in several randomized clinical trials, subsequent meta-analyses, and also in some registries, such as the recently published Swedish Coronary Angiography and Angioplasty Registry (SCAAR). New, second-generation (2GEN) DESs have been developed with improved design and materials, both of which may contribute to overcome some of the limitations of the older DESs. Decreased strut thickness — resulting in higher flexibility, conformability, and deliverability — and optimized polymer biocompatibility and drug delivery kinetics have been shown to contribute to a low lateloss rate and to a lower thrombotic risk. Despite the evidence pointing in this direction, most of the data comes from post hoc analysis and meta-analysis, mainly because studies defining ST as a primary endpoint are scarce.
We aimed to assess whether or not the systematic use of a 2GEN DES, relative to the 1GEN DES, translates into a higher safety rate in a real-world population where DES implantation was indicated. For that purpose, we conducted an analysis of a single-center prospective registry, evaluating the incidence of definite ST, as defined by the Academic Research Consortium (ARC), at 12 months of follow-up as the primary outcome measure.
Abstract and Introduction
Abstract
Background and Aims. When compared to their firstgeneration (1stGEN) counterparts, second-generation (2GEN) drugeluting stents (DESs) have been associated with better clinical outcomes in randomized clinical trials, namely by reducing the rates of stent thrombosis (ST). Our goal was to investigate whether or not the broad use of newer devices would translate into higher safety in a real-world population. For that purpose, we compared the occurrence of definite ST at 12 months between two patient subsets from a large-volume single-center registry, according to the type of DES used. Total mortality was a secondary endpoint.
Methods and Results. Between January 2003 and December 2010, a total of 3806 patients were submitted to percutaneous coronary intervention (PCI) with only 1stGEN or 2GEN DES: 2388 patients (62.7%) were treated with 1stGEN DES only (sirolimus-eluting stent [SES] = 1295 [34.0%]; paclitaxel-eluting stent [PES] = 943 [24.8%]; both stent types were used in 150 patients) and 1418 patients (37.3%) were treated with 2GEN DESs only. The total incidence of definite ST (as defined by the Academic Research Consortium) at 12 months was 1.2% (n = 46). After correction for baseline differences between study groups and other variables deemed to influence the occurrence of ST, the use of 1stGEN DES was associated with a significant 2.4-fold increase in the risk of definite ST (95% confidence interval [CI], 1.05–5.42; P=.039) at 12 months; adjusted risk was higher with PES (hazard ratio [HR], 3.6; 95% CI, 1.48–8.70; P=.005) than with SES (HR, 2.3; 95% CI, 0.92–5.65; P=.074). Total mortality (3.7% vs 3.5%) did not differ significantly between groups (adjusted HR, 1.2; 95% CI, 0.81–1.84, P=.348).
Conclusions. Our data suggest that in the real-world setting of contemporary PCI, the unrestricted use of newer 2GEN DESs translates into an improvement in PCI safety (relative to 1stGEN DESs), with a significantly lower risk of definite ST at 12 months.
Introduction
Stent thrombosis (ST) is a serious and often fatal event limiting the efficacy of percutaneous coronary intervention (PCI). The pathophysiology of ST is multifactorial, and underlying causes including stent-, procedure-, lesion-, and patient-related factors seem to play different roles at different time points after the index procedure. When compared to first-generation (1GEN) drug-eluting stents (DESs), newer DESs have been associated with a lower rate of ST in several randomized clinical trials, subsequent meta-analyses, and also in some registries, such as the recently published Swedish Coronary Angiography and Angioplasty Registry (SCAAR). New, second-generation (2GEN) DESs have been developed with improved design and materials, both of which may contribute to overcome some of the limitations of the older DESs. Decreased strut thickness — resulting in higher flexibility, conformability, and deliverability — and optimized polymer biocompatibility and drug delivery kinetics have been shown to contribute to a low lateloss rate and to a lower thrombotic risk. Despite the evidence pointing in this direction, most of the data comes from post hoc analysis and meta-analysis, mainly because studies defining ST as a primary endpoint are scarce.
We aimed to assess whether or not the systematic use of a 2GEN DES, relative to the 1GEN DES, translates into a higher safety rate in a real-world population where DES implantation was indicated. For that purpose, we conducted an analysis of a single-center prospective registry, evaluating the incidence of definite ST, as defined by the Academic Research Consortium (ARC), at 12 months of follow-up as the primary outcome measure.
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