PITT PCI Xience Registry
| Status: | Completed |
|---|---|
| Conditions: | Peripheral Vascular Disease, Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | August 2011 |
| End Date: | December 2015 |
PITT PCI Xience Registry: A Prospective Evaluation of Dual Antiplatelet Therapy Compliance and Outcomes After Treatment With the Xience Stent
Stents are devices utilized to treat cholesterol blockages of the coronary (heart) arteries.
The introduction of drug-eluting (coated) stents into clinical practice is regarded as a
revolutionary breaktrhough, as it has reduced the incidence of re-narrowing of the arteries
after percutaneous coronary interventions are performed. There has been, however, concerns
of increased risk for clot formation in the heart arteries of patients treated with
drug-eluting stents. Therefore, in order to lower the risk of clot formation, it is
recommended that patients receiving these types of stents, be treated with dual antiplatelet
therapy (blood thinning medication) for one year. The effect of this strategy, however, on
clot formation and bleeding complications when utilizing "newer generation" stents, such as
the Xience: Everolimus-eluting Stent, have not been well described.
Therefore, the aim of this registry study is to evaluate the risk of adverse cardiovascular
events, including mortality, non-fatal myocardial infarction, stent thrombosis, hemorrhagic
stroke, and severe bleeding in relation to the timing and discontinuation of dual
antiplatelet therapy in patients treated with Xience drug-eluting stents, and compare it to
patients that do not discontinue dual antiplatelet therapy.
The introduction of drug-eluting (coated) stents into clinical practice is regarded as a
revolutionary breaktrhough, as it has reduced the incidence of re-narrowing of the arteries
after percutaneous coronary interventions are performed. There has been, however, concerns
of increased risk for clot formation in the heart arteries of patients treated with
drug-eluting stents. Therefore, in order to lower the risk of clot formation, it is
recommended that patients receiving these types of stents, be treated with dual antiplatelet
therapy (blood thinning medication) for one year. The effect of this strategy, however, on
clot formation and bleeding complications when utilizing "newer generation" stents, such as
the Xience: Everolimus-eluting Stent, have not been well described.
Therefore, the aim of this registry study is to evaluate the risk of adverse cardiovascular
events, including mortality, non-fatal myocardial infarction, stent thrombosis, hemorrhagic
stroke, and severe bleeding in relation to the timing and discontinuation of dual
antiplatelet therapy in patients treated with Xience drug-eluting stents, and compare it to
patients that do not discontinue dual antiplatelet therapy.
The introduction of drug-eluting stents (DES) into clinical practice is universally regarded
as a revolutionary breakthrough in reducing the incidence of restenosis following
percutaneous coronary intervention (PCI). The coating of stents with antiproliferative
properties addresses a fundamental limitation of the earlier generation bare metal
(uncoated) stents (BMS) - the in-growth of tissue through the struts of the stent that may
eventually narrow the coronary artery resulting in recurrent ischemia. DES have greatly
reduced the need for repeat revascularization, and thus, use of DES has rapidly become the
de facto standard of care in the US.
The first two FDA-approved DES in the United States were the Cypher: Sirolimus-Eluting
Coronary Stent and the TaxusExpress2™: Paclitaxel-Eluting Coronary Stent. Since then, the
so-called 2nd generation DES which have come to market include the Xience:
Everolimus-Eluting Coronary Stent and the Medtronic: Zotarolimus-Eluting Coronary Stent.
Data from recent studies released in September of 2009 showed that Xience/Promus
outperformed Boston's Taxus. Just prior to the release of this data, US market share was
Xience 30%, Promus 24%, Taxus 22%, Endeavor 13%, and Cypher 11%. However, data was also
released regarding Endeavor outperforming the Taxus stent as well, suggesting an upsurge is
likely in US and world market share for Medtronic's Endeavor stent.
In the data recently presented from the SPIRIT IV trial, a randomized study between Xience
and Taxus, significant benefits of Xience were found in comparison to the Taxus stent. There
was a 38% reduction in target lesion failure and a 46% reduction in target lesion
revascularization compared to Taxus. Notably, in this study of nearly 3700 patients, Xience
had a low rate of stent thrombosis at 1-year of only 0.17%, compared to 0.85% for Taxus. The
COMPARE study in higher-risk patients, also confirmed these results showing significant
benefits of Xience V over Taxus Liberte at 1-year with regard to major adverse cardiac
events and stent thrombosis.
These results suggest that there may be significant differences in outcomes favoring the use
of 2nd generation DES, specifically as it relates to their superiority to 1st generation DES
in reducing the need for repeat revascularization. There is, however, limited data examining
the long-term safety of these devices when used in routine clinical practice. Furthermore,
these DES have still not been fully studied in specific patient populations commonly
encountered in routine clinical practice, including those with diabetes, chronic kidney
disease, long-lesions, small vessels, and left main disease, among others. The outcomes
revolve not only around efficacy of these stents in different clinical and angiographic
scenarios, but also around the safety profiles. In particular, there has been great
attention placed not only on the risk of stent thrombosis but also the timing of these
events with the various DES, and how to reduce the incidence of them. The data available to
date suggest favorable safety results for the Xience stent. However, in the ever changing
world of dual antiplatelet therapy, and the duration of it, further understanding of these
interactions are required. Currently, the majority of our efforts in reducing stent
thrombosis have been channeled through more aggressive and longer duration of dual
antiplatelet therapy. The effect of such strategies on other endpoints, such as bleeding
complications after PCI, is unknown. These treatment strategies are based on our
understanding of the need for dual antiplatelet therapy with 1st generation DES. Whether
these same paradigms apply to 2nd generation DES, such as the Xience stent, is unclear.
Furthermore, given that there continue to be significant questions regarding the precise
rates of relatively rare clinical events, such as stent thrombosis and bleeding, strategies
that allow us to estimate these rates when these devices are used in routine clinical
practice, are warranted.
Specifically, the clinical impact of transient or permanent discontinuation of
dual-antiplatelet therapy on these endpoints at various intervals after Xience implantation
in routine clinical practice, has not been well characterized. As such, there continues to
be considerable variability regarding the duration of dual antiplatelet therapy in routine
clinical practice, regardless of the type of DES utilized. Therefore, a registry with
rigorous long-term follow-up of patients treated with the Xience stent, that collects
information on rare events, compliance with dual antiplatelet therapy, and relationships
between use/non-use of dual antiplatelet therapy and adverse events would address these
goals.
Accordingly, to better understand the long-term safety profile of the Xience stent in the
overall population, as well as in those in whom dual antiplatelet therapy is discontinued,
we propose to evaluate integrated patient data from the University of Pittsburgh Medical
Center (UPMC) network system using two well-established institutions: the UPMC clinical
sites and the University of Pittsburgh's Epidemiology Data Center (EDC). In brief, we
propose to create the UPMC PCI-XIENCE registry, which will integrate the large-volume UPMC
clinical sites with the well-established EDC as the data coordinating center. This will
allow us to further investigate the long-term safety of the Xience stent as it is used in
routine clinical practice.
Thus, the Specific Aims are to:
1. Evaluate the risk of stent thrombosis, hemorrhagic stroke, and severe bleeding in
relation to the timing and discontinuation of dual anti-platelet therapy in patients
treated with Xience drug-eluting stents.
2. Study the safety and efficacy of the Xience stent within specific understudied patient
(diabetes mellitus, chronic kidney disease, women, minorities, etc) and angiographic
(left main, bifurcation, saphenous vein graft, and small vessel disease) subgroups,
among others.
as a revolutionary breakthrough in reducing the incidence of restenosis following
percutaneous coronary intervention (PCI). The coating of stents with antiproliferative
properties addresses a fundamental limitation of the earlier generation bare metal
(uncoated) stents (BMS) - the in-growth of tissue through the struts of the stent that may
eventually narrow the coronary artery resulting in recurrent ischemia. DES have greatly
reduced the need for repeat revascularization, and thus, use of DES has rapidly become the
de facto standard of care in the US.
The first two FDA-approved DES in the United States were the Cypher: Sirolimus-Eluting
Coronary Stent and the TaxusExpress2™: Paclitaxel-Eluting Coronary Stent. Since then, the
so-called 2nd generation DES which have come to market include the Xience:
Everolimus-Eluting Coronary Stent and the Medtronic: Zotarolimus-Eluting Coronary Stent.
Data from recent studies released in September of 2009 showed that Xience/Promus
outperformed Boston's Taxus. Just prior to the release of this data, US market share was
Xience 30%, Promus 24%, Taxus 22%, Endeavor 13%, and Cypher 11%. However, data was also
released regarding Endeavor outperforming the Taxus stent as well, suggesting an upsurge is
likely in US and world market share for Medtronic's Endeavor stent.
In the data recently presented from the SPIRIT IV trial, a randomized study between Xience
and Taxus, significant benefits of Xience were found in comparison to the Taxus stent. There
was a 38% reduction in target lesion failure and a 46% reduction in target lesion
revascularization compared to Taxus. Notably, in this study of nearly 3700 patients, Xience
had a low rate of stent thrombosis at 1-year of only 0.17%, compared to 0.85% for Taxus. The
COMPARE study in higher-risk patients, also confirmed these results showing significant
benefits of Xience V over Taxus Liberte at 1-year with regard to major adverse cardiac
events and stent thrombosis.
These results suggest that there may be significant differences in outcomes favoring the use
of 2nd generation DES, specifically as it relates to their superiority to 1st generation DES
in reducing the need for repeat revascularization. There is, however, limited data examining
the long-term safety of these devices when used in routine clinical practice. Furthermore,
these DES have still not been fully studied in specific patient populations commonly
encountered in routine clinical practice, including those with diabetes, chronic kidney
disease, long-lesions, small vessels, and left main disease, among others. The outcomes
revolve not only around efficacy of these stents in different clinical and angiographic
scenarios, but also around the safety profiles. In particular, there has been great
attention placed not only on the risk of stent thrombosis but also the timing of these
events with the various DES, and how to reduce the incidence of them. The data available to
date suggest favorable safety results for the Xience stent. However, in the ever changing
world of dual antiplatelet therapy, and the duration of it, further understanding of these
interactions are required. Currently, the majority of our efforts in reducing stent
thrombosis have been channeled through more aggressive and longer duration of dual
antiplatelet therapy. The effect of such strategies on other endpoints, such as bleeding
complications after PCI, is unknown. These treatment strategies are based on our
understanding of the need for dual antiplatelet therapy with 1st generation DES. Whether
these same paradigms apply to 2nd generation DES, such as the Xience stent, is unclear.
Furthermore, given that there continue to be significant questions regarding the precise
rates of relatively rare clinical events, such as stent thrombosis and bleeding, strategies
that allow us to estimate these rates when these devices are used in routine clinical
practice, are warranted.
Specifically, the clinical impact of transient or permanent discontinuation of
dual-antiplatelet therapy on these endpoints at various intervals after Xience implantation
in routine clinical practice, has not been well characterized. As such, there continues to
be considerable variability regarding the duration of dual antiplatelet therapy in routine
clinical practice, regardless of the type of DES utilized. Therefore, a registry with
rigorous long-term follow-up of patients treated with the Xience stent, that collects
information on rare events, compliance with dual antiplatelet therapy, and relationships
between use/non-use of dual antiplatelet therapy and adverse events would address these
goals.
Accordingly, to better understand the long-term safety profile of the Xience stent in the
overall population, as well as in those in whom dual antiplatelet therapy is discontinued,
we propose to evaluate integrated patient data from the University of Pittsburgh Medical
Center (UPMC) network system using two well-established institutions: the UPMC clinical
sites and the University of Pittsburgh's Epidemiology Data Center (EDC). In brief, we
propose to create the UPMC PCI-XIENCE registry, which will integrate the large-volume UPMC
clinical sites with the well-established EDC as the data coordinating center. This will
allow us to further investigate the long-term safety of the Xience stent as it is used in
routine clinical practice.
Thus, the Specific Aims are to:
1. Evaluate the risk of stent thrombosis, hemorrhagic stroke, and severe bleeding in
relation to the timing and discontinuation of dual anti-platelet therapy in patients
treated with Xience drug-eluting stents.
2. Study the safety and efficacy of the Xience stent within specific understudied patient
(diabetes mellitus, chronic kidney disease, women, minorities, etc) and angiographic
(left main, bifurcation, saphenous vein graft, and small vessel disease) subgroups,
among others.
Inclusion Criteria:
- Undergoing a coronary stenting procedure with the Xience drug-eluting stent
- Signed informed consent
Exclusion Criteria:
- Inability to sign informed consent.
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