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William Wijns - One of the best experts on this subject based on the ideXlab platform.

  • improved safety and reduction in stent thrombosis associated with biodegradable polymer based biolimus eluting stents versus durable polymer based sirolimus eluting stents in patients with coronary artery disease final 5 year report of the leaders li
    Jacc-cardiovascular Interventions, 2013
    Co-Authors: Patrick W Serruys, Vasim Farooq, Bindu Kalesan, Ton De Vries, Pawel Buszman, Axel Linke, Thomas Ischinger, Volker Klauss, Franz R Eberli, William Wijns
    Abstract:

    Objectives This study sought to report the final 5 years follow-up of the landmark LEADERS (Limus Eluted From A Durable Versus ERodable Stent Coating) trial. Background The LEADERS trial is the first randomized study to evaluate biodegradable polymer–based drug-eluting stents (DES) against durable polymer DES. Methods The LEADERS trial was a 10-center, assessor-blind, noninferiority, “all-comers” trial (N = 1,707). All patients were centrally randomized to treatment with either biodegradable polymer biolimus-eluting stents (BES) (n = 857) or durable polymer sirolimus-eluting stents (SES) (n = 850). The Primary Endpoint was a composite of cardiac death, myocardial infarction (MI), or clinically indicated target vessel revascularization within 9 months. Secondary Endpoints included extending the Primary Endpoint to 5 years and stent thrombosis (ST) (Academic Research Consortium definition). Analysis was by intention to treat. Results At 5 years, the BES was noninferior to SES for the Primary Endpoint (186 [22.3%] vs. 216 [26.1%], rate ratio [RR]: 0.83 [95% confidence interval (CI): 0.68 to 1.02], p for noninferiority Conclusions The safety benefit of the biodegradable polymer BES, compared with the durable polymer SES, was related to a significant reduction in very late ST (>1 year) and associated composite clinical outcomes. (Limus Eluted From A Durable Versus ERodable Stent Coating [LEADERS] trial; NCT00389220 )

  • improved safety and reduction in stent thrombosis associated with biodegradable polymer based biolimus eluting stents versus durable polymer based sirolimus eluting stents in patients with coronary artery disease final 5 year report of the leaders li
    Jacc-cardiovascular Interventions, 2013
    Co-Authors: Patrick W Serruys, Vasim Farooq, Bindu Kalesan, Ton De Vries, Pawel Buszman, Axel Linke, Thomas Ischinger, Volker Klauss, Franz R Eberli, William Wijns
    Abstract:

    OBJECTIVES This study sought to report the final 5 years follow-up of the landmark LEADERS (Limus Eluted From A Durable Versus ERodable Stent Coating) trial. BACKGROUND The LEADERS trial is the first randomized study to evaluate biodegradable polymer-based drug-eluting stents (DES) against durable polymer DES. METHODS The LEADERS trial was a 10-center, assessor-blind, noninferiority, "all-comers" trial (N = 1,707). All patients were centrally randomized to treatment with either biodegradable polymer biolimus-eluting stents (BES) (n = 857) or durable polymer sirolimus-eluting stents (SES) (n = 850). The Primary Endpoint was a composite of cardiac death, myocardial infarction (MI), or clinically indicated target vessel revascularization within 9 months. Secondary Endpoints included extending the Primary Endpoint to 5 years and stent thrombosis (ST) (Academic Research Consortium definition). Analysis was by intention to treat. RESULTS At 5 years, the BES was noninferior to SES for the Primary Endpoint (186 [22.3%] vs. 216 [26.1%], rate ratio [RR]: 0.83 [95% confidence interval (CI): 0.68 to 1.02], p for noninferiority <0.0001, p for superiority = 0.069). The BES was associated with a significant reduction in the more comprehensive patient-orientated composite Endpoint of all-cause death, any MI, and all-cause revascularization (297 [35.1%] vs. 339 [40.4%], RR: 0.84 [95% CI: 0.71 to 0.98], p for superiority = 0.023). A significant reduction in very late definite ST from 1 to 5 years was evident with the BES (n = 5 [0.7%] vs. n = 19 [2.5%], RR: 0.26 [95% CI: 0.10 to 0.68], p = 0.003), corresponding to a significant reduction in ST-associated clinical events (Primary Endpoint) over the same time period (n = 3 of 749 vs. n = 14 of 738, RR: 0.20 [95% CI: 0.06 to 0.71], p = 0.005). CONCLUSIONS The safety benefit of the biodegradable polymer BES, compared with the durable polymer SES, was related to a significant reduction in very late ST (>1 year) and associated composite clinical outcomes. (Limus Eluted From A Durable Versus ERodable Stent Coating [LEADERS] trial; NCT00389220).

Patrick W Serruys - One of the best experts on this subject based on the ideXlab platform.

  • improved safety and reduction in stent thrombosis associated with biodegradable polymer based biolimus eluting stents versus durable polymer based sirolimus eluting stents in patients with coronary artery disease final 5 year report of the leaders li
    Jacc-cardiovascular Interventions, 2013
    Co-Authors: Patrick W Serruys, Vasim Farooq, Bindu Kalesan, Ton De Vries, Pawel Buszman, Axel Linke, Thomas Ischinger, Volker Klauss, Franz R Eberli, William Wijns
    Abstract:

    Objectives This study sought to report the final 5 years follow-up of the landmark LEADERS (Limus Eluted From A Durable Versus ERodable Stent Coating) trial. Background The LEADERS trial is the first randomized study to evaluate biodegradable polymer–based drug-eluting stents (DES) against durable polymer DES. Methods The LEADERS trial was a 10-center, assessor-blind, noninferiority, “all-comers” trial (N = 1,707). All patients were centrally randomized to treatment with either biodegradable polymer biolimus-eluting stents (BES) (n = 857) or durable polymer sirolimus-eluting stents (SES) (n = 850). The Primary Endpoint was a composite of cardiac death, myocardial infarction (MI), or clinically indicated target vessel revascularization within 9 months. Secondary Endpoints included extending the Primary Endpoint to 5 years and stent thrombosis (ST) (Academic Research Consortium definition). Analysis was by intention to treat. Results At 5 years, the BES was noninferior to SES for the Primary Endpoint (186 [22.3%] vs. 216 [26.1%], rate ratio [RR]: 0.83 [95% confidence interval (CI): 0.68 to 1.02], p for noninferiority Conclusions The safety benefit of the biodegradable polymer BES, compared with the durable polymer SES, was related to a significant reduction in very late ST (>1 year) and associated composite clinical outcomes. (Limus Eluted From A Durable Versus ERodable Stent Coating [LEADERS] trial; NCT00389220 )

  • improved safety and reduction in stent thrombosis associated with biodegradable polymer based biolimus eluting stents versus durable polymer based sirolimus eluting stents in patients with coronary artery disease final 5 year report of the leaders li
    Jacc-cardiovascular Interventions, 2013
    Co-Authors: Patrick W Serruys, Vasim Farooq, Bindu Kalesan, Ton De Vries, Pawel Buszman, Axel Linke, Thomas Ischinger, Volker Klauss, Franz R Eberli, William Wijns
    Abstract:

    OBJECTIVES This study sought to report the final 5 years follow-up of the landmark LEADERS (Limus Eluted From A Durable Versus ERodable Stent Coating) trial. BACKGROUND The LEADERS trial is the first randomized study to evaluate biodegradable polymer-based drug-eluting stents (DES) against durable polymer DES. METHODS The LEADERS trial was a 10-center, assessor-blind, noninferiority, "all-comers" trial (N = 1,707). All patients were centrally randomized to treatment with either biodegradable polymer biolimus-eluting stents (BES) (n = 857) or durable polymer sirolimus-eluting stents (SES) (n = 850). The Primary Endpoint was a composite of cardiac death, myocardial infarction (MI), or clinically indicated target vessel revascularization within 9 months. Secondary Endpoints included extending the Primary Endpoint to 5 years and stent thrombosis (ST) (Academic Research Consortium definition). Analysis was by intention to treat. RESULTS At 5 years, the BES was noninferior to SES for the Primary Endpoint (186 [22.3%] vs. 216 [26.1%], rate ratio [RR]: 0.83 [95% confidence interval (CI): 0.68 to 1.02], p for noninferiority <0.0001, p for superiority = 0.069). The BES was associated with a significant reduction in the more comprehensive patient-orientated composite Endpoint of all-cause death, any MI, and all-cause revascularization (297 [35.1%] vs. 339 [40.4%], RR: 0.84 [95% CI: 0.71 to 0.98], p for superiority = 0.023). A significant reduction in very late definite ST from 1 to 5 years was evident with the BES (n = 5 [0.7%] vs. n = 19 [2.5%], RR: 0.26 [95% CI: 0.10 to 0.68], p = 0.003), corresponding to a significant reduction in ST-associated clinical events (Primary Endpoint) over the same time period (n = 3 of 749 vs. n = 14 of 738, RR: 0.20 [95% CI: 0.06 to 0.71], p = 0.005). CONCLUSIONS The safety benefit of the biodegradable polymer BES, compared with the durable polymer SES, was related to a significant reduction in very late ST (>1 year) and associated composite clinical outcomes. (Limus Eluted From A Durable Versus ERodable Stent Coating [LEADERS] trial; NCT00389220).

  • long term outcome of alcohol septal ablation in patients with obstructive hypertrophic cardiomyopathy a word of caution
    Circulation-heart Failure, 2010
    Co-Authors: Folkert Ten J Cate, Osama Ibrahim Ibrahim Soliman, Michelle Michels, Dominic A M J Theuns, Peter L De Jong, Marcel L Geleijnse, Patrick W Serruys
    Abstract:

    Background —The impact of alcohol septal ablation (ASA)-induced scar is not known. This study sought to examine the long-term outcome of ASA among patients with obstructive hypertrophic cardiomyopathy (HCM). Methods and Results —Ninety-one consecutive patients (aged 54±15 years) with obstructive HCM underwent ASA. Primary study Endpoint was a composite of cardiac death and aborted sudden cardiac death (SCD) including appropriate cardioverter-defibrillator (ICD) discharges for fast VT/VF. Secondary Endpoints were non-cardiac death and other non-fatal complications. Outcomes of ASA patients were compared with 40 HCM patients who underwent septal myectomy. During 5.4±2.5 years Primary and/or secondary Endpoints were seen in 35 (38%) ASA patients, of whom 19 (21%) patients met the Primary Endpoint. The 1-, 5-, and 8-year survival-free from the Primary Endpoint was 96%, 86%, and 67%, respectively in ASA patients versus 100%, 96%, and 96%, respectively in myectomy patients during 6.6±2.7 years (log rank, P =0.01). ASA patients had a ~4 fold increase in the estimated annual Primary Endpoint rate (4.4% vs. 0.9%) compared with myectomy patients. In a multivariable model including a propensity score, ASA was an independent predictor of the Primary Endpoint unadjusted HR 5.2: 95% CI 1.2 to 22.1, P =0.02; propensity score-adjusted HR 6.1: 95% CI 1.4 to 27.1, P =0.02. Conclusions —This study shows that ASA has potentially unwanted long-term effects. This poses special precaution given the fact that ASA is practiced worldwide at increasing rate. We recommend myectomy as the preferred intervention in patients with obstructive HCM.

Bindu Kalesan - One of the best experts on this subject based on the ideXlab platform.

  • improved safety and reduction in stent thrombosis associated with biodegradable polymer based biolimus eluting stents versus durable polymer based sirolimus eluting stents in patients with coronary artery disease final 5 year report of the leaders li
    Jacc-cardiovascular Interventions, 2013
    Co-Authors: Patrick W Serruys, Vasim Farooq, Bindu Kalesan, Ton De Vries, Pawel Buszman, Axel Linke, Thomas Ischinger, Volker Klauss, Franz R Eberli, William Wijns
    Abstract:

    Objectives This study sought to report the final 5 years follow-up of the landmark LEADERS (Limus Eluted From A Durable Versus ERodable Stent Coating) trial. Background The LEADERS trial is the first randomized study to evaluate biodegradable polymer–based drug-eluting stents (DES) against durable polymer DES. Methods The LEADERS trial was a 10-center, assessor-blind, noninferiority, “all-comers” trial (N = 1,707). All patients were centrally randomized to treatment with either biodegradable polymer biolimus-eluting stents (BES) (n = 857) or durable polymer sirolimus-eluting stents (SES) (n = 850). The Primary Endpoint was a composite of cardiac death, myocardial infarction (MI), or clinically indicated target vessel revascularization within 9 months. Secondary Endpoints included extending the Primary Endpoint to 5 years and stent thrombosis (ST) (Academic Research Consortium definition). Analysis was by intention to treat. Results At 5 years, the BES was noninferior to SES for the Primary Endpoint (186 [22.3%] vs. 216 [26.1%], rate ratio [RR]: 0.83 [95% confidence interval (CI): 0.68 to 1.02], p for noninferiority Conclusions The safety benefit of the biodegradable polymer BES, compared with the durable polymer SES, was related to a significant reduction in very late ST (>1 year) and associated composite clinical outcomes. (Limus Eluted From A Durable Versus ERodable Stent Coating [LEADERS] trial; NCT00389220 )

  • improved safety and reduction in stent thrombosis associated with biodegradable polymer based biolimus eluting stents versus durable polymer based sirolimus eluting stents in patients with coronary artery disease final 5 year report of the leaders li
    Jacc-cardiovascular Interventions, 2013
    Co-Authors: Patrick W Serruys, Vasim Farooq, Bindu Kalesan, Ton De Vries, Pawel Buszman, Axel Linke, Thomas Ischinger, Volker Klauss, Franz R Eberli, William Wijns
    Abstract:

    OBJECTIVES This study sought to report the final 5 years follow-up of the landmark LEADERS (Limus Eluted From A Durable Versus ERodable Stent Coating) trial. BACKGROUND The LEADERS trial is the first randomized study to evaluate biodegradable polymer-based drug-eluting stents (DES) against durable polymer DES. METHODS The LEADERS trial was a 10-center, assessor-blind, noninferiority, "all-comers" trial (N = 1,707). All patients were centrally randomized to treatment with either biodegradable polymer biolimus-eluting stents (BES) (n = 857) or durable polymer sirolimus-eluting stents (SES) (n = 850). The Primary Endpoint was a composite of cardiac death, myocardial infarction (MI), or clinically indicated target vessel revascularization within 9 months. Secondary Endpoints included extending the Primary Endpoint to 5 years and stent thrombosis (ST) (Academic Research Consortium definition). Analysis was by intention to treat. RESULTS At 5 years, the BES was noninferior to SES for the Primary Endpoint (186 [22.3%] vs. 216 [26.1%], rate ratio [RR]: 0.83 [95% confidence interval (CI): 0.68 to 1.02], p for noninferiority <0.0001, p for superiority = 0.069). The BES was associated with a significant reduction in the more comprehensive patient-orientated composite Endpoint of all-cause death, any MI, and all-cause revascularization (297 [35.1%] vs. 339 [40.4%], RR: 0.84 [95% CI: 0.71 to 0.98], p for superiority = 0.023). A significant reduction in very late definite ST from 1 to 5 years was evident with the BES (n = 5 [0.7%] vs. n = 19 [2.5%], RR: 0.26 [95% CI: 0.10 to 0.68], p = 0.003), corresponding to a significant reduction in ST-associated clinical events (Primary Endpoint) over the same time period (n = 3 of 749 vs. n = 14 of 738, RR: 0.20 [95% CI: 0.06 to 0.71], p = 0.005). CONCLUSIONS The safety benefit of the biodegradable polymer BES, compared with the durable polymer SES, was related to a significant reduction in very late ST (>1 year) and associated composite clinical outcomes. (Limus Eluted From A Durable Versus ERodable Stent Coating [LEADERS] trial; NCT00389220).

Vasim Farooq - One of the best experts on this subject based on the ideXlab platform.

  • improved safety and reduction in stent thrombosis associated with biodegradable polymer based biolimus eluting stents versus durable polymer based sirolimus eluting stents in patients with coronary artery disease final 5 year report of the leaders li
    Jacc-cardiovascular Interventions, 2013
    Co-Authors: Patrick W Serruys, Vasim Farooq, Bindu Kalesan, Ton De Vries, Pawel Buszman, Axel Linke, Thomas Ischinger, Volker Klauss, Franz R Eberli, William Wijns
    Abstract:

    Objectives This study sought to report the final 5 years follow-up of the landmark LEADERS (Limus Eluted From A Durable Versus ERodable Stent Coating) trial. Background The LEADERS trial is the first randomized study to evaluate biodegradable polymer–based drug-eluting stents (DES) against durable polymer DES. Methods The LEADERS trial was a 10-center, assessor-blind, noninferiority, “all-comers” trial (N = 1,707). All patients were centrally randomized to treatment with either biodegradable polymer biolimus-eluting stents (BES) (n = 857) or durable polymer sirolimus-eluting stents (SES) (n = 850). The Primary Endpoint was a composite of cardiac death, myocardial infarction (MI), or clinically indicated target vessel revascularization within 9 months. Secondary Endpoints included extending the Primary Endpoint to 5 years and stent thrombosis (ST) (Academic Research Consortium definition). Analysis was by intention to treat. Results At 5 years, the BES was noninferior to SES for the Primary Endpoint (186 [22.3%] vs. 216 [26.1%], rate ratio [RR]: 0.83 [95% confidence interval (CI): 0.68 to 1.02], p for noninferiority Conclusions The safety benefit of the biodegradable polymer BES, compared with the durable polymer SES, was related to a significant reduction in very late ST (>1 year) and associated composite clinical outcomes. (Limus Eluted From A Durable Versus ERodable Stent Coating [LEADERS] trial; NCT00389220 )

  • improved safety and reduction in stent thrombosis associated with biodegradable polymer based biolimus eluting stents versus durable polymer based sirolimus eluting stents in patients with coronary artery disease final 5 year report of the leaders li
    Jacc-cardiovascular Interventions, 2013
    Co-Authors: Patrick W Serruys, Vasim Farooq, Bindu Kalesan, Ton De Vries, Pawel Buszman, Axel Linke, Thomas Ischinger, Volker Klauss, Franz R Eberli, William Wijns
    Abstract:

    OBJECTIVES This study sought to report the final 5 years follow-up of the landmark LEADERS (Limus Eluted From A Durable Versus ERodable Stent Coating) trial. BACKGROUND The LEADERS trial is the first randomized study to evaluate biodegradable polymer-based drug-eluting stents (DES) against durable polymer DES. METHODS The LEADERS trial was a 10-center, assessor-blind, noninferiority, "all-comers" trial (N = 1,707). All patients were centrally randomized to treatment with either biodegradable polymer biolimus-eluting stents (BES) (n = 857) or durable polymer sirolimus-eluting stents (SES) (n = 850). The Primary Endpoint was a composite of cardiac death, myocardial infarction (MI), or clinically indicated target vessel revascularization within 9 months. Secondary Endpoints included extending the Primary Endpoint to 5 years and stent thrombosis (ST) (Academic Research Consortium definition). Analysis was by intention to treat. RESULTS At 5 years, the BES was noninferior to SES for the Primary Endpoint (186 [22.3%] vs. 216 [26.1%], rate ratio [RR]: 0.83 [95% confidence interval (CI): 0.68 to 1.02], p for noninferiority <0.0001, p for superiority = 0.069). The BES was associated with a significant reduction in the more comprehensive patient-orientated composite Endpoint of all-cause death, any MI, and all-cause revascularization (297 [35.1%] vs. 339 [40.4%], RR: 0.84 [95% CI: 0.71 to 0.98], p for superiority = 0.023). A significant reduction in very late definite ST from 1 to 5 years was evident with the BES (n = 5 [0.7%] vs. n = 19 [2.5%], RR: 0.26 [95% CI: 0.10 to 0.68], p = 0.003), corresponding to a significant reduction in ST-associated clinical events (Primary Endpoint) over the same time period (n = 3 of 749 vs. n = 14 of 738, RR: 0.20 [95% CI: 0.06 to 0.71], p = 0.005). CONCLUSIONS The safety benefit of the biodegradable polymer BES, compared with the durable polymer SES, was related to a significant reduction in very late ST (>1 year) and associated composite clinical outcomes. (Limus Eluted From A Durable Versus ERodable Stent Coating [LEADERS] trial; NCT00389220).

Franz R Eberli - One of the best experts on this subject based on the ideXlab platform.

  • improved safety and reduction in stent thrombosis associated with biodegradable polymer based biolimus eluting stents versus durable polymer based sirolimus eluting stents in patients with coronary artery disease final 5 year report of the leaders li
    Jacc-cardiovascular Interventions, 2013
    Co-Authors: Patrick W Serruys, Vasim Farooq, Bindu Kalesan, Ton De Vries, Pawel Buszman, Axel Linke, Thomas Ischinger, Volker Klauss, Franz R Eberli, William Wijns
    Abstract:

    Objectives This study sought to report the final 5 years follow-up of the landmark LEADERS (Limus Eluted From A Durable Versus ERodable Stent Coating) trial. Background The LEADERS trial is the first randomized study to evaluate biodegradable polymer–based drug-eluting stents (DES) against durable polymer DES. Methods The LEADERS trial was a 10-center, assessor-blind, noninferiority, “all-comers” trial (N = 1,707). All patients were centrally randomized to treatment with either biodegradable polymer biolimus-eluting stents (BES) (n = 857) or durable polymer sirolimus-eluting stents (SES) (n = 850). The Primary Endpoint was a composite of cardiac death, myocardial infarction (MI), or clinically indicated target vessel revascularization within 9 months. Secondary Endpoints included extending the Primary Endpoint to 5 years and stent thrombosis (ST) (Academic Research Consortium definition). Analysis was by intention to treat. Results At 5 years, the BES was noninferior to SES for the Primary Endpoint (186 [22.3%] vs. 216 [26.1%], rate ratio [RR]: 0.83 [95% confidence interval (CI): 0.68 to 1.02], p for noninferiority Conclusions The safety benefit of the biodegradable polymer BES, compared with the durable polymer SES, was related to a significant reduction in very late ST (>1 year) and associated composite clinical outcomes. (Limus Eluted From A Durable Versus ERodable Stent Coating [LEADERS] trial; NCT00389220 )

  • improved safety and reduction in stent thrombosis associated with biodegradable polymer based biolimus eluting stents versus durable polymer based sirolimus eluting stents in patients with coronary artery disease final 5 year report of the leaders li
    Jacc-cardiovascular Interventions, 2013
    Co-Authors: Patrick W Serruys, Vasim Farooq, Bindu Kalesan, Ton De Vries, Pawel Buszman, Axel Linke, Thomas Ischinger, Volker Klauss, Franz R Eberli, William Wijns
    Abstract:

    OBJECTIVES This study sought to report the final 5 years follow-up of the landmark LEADERS (Limus Eluted From A Durable Versus ERodable Stent Coating) trial. BACKGROUND The LEADERS trial is the first randomized study to evaluate biodegradable polymer-based drug-eluting stents (DES) against durable polymer DES. METHODS The LEADERS trial was a 10-center, assessor-blind, noninferiority, "all-comers" trial (N = 1,707). All patients were centrally randomized to treatment with either biodegradable polymer biolimus-eluting stents (BES) (n = 857) or durable polymer sirolimus-eluting stents (SES) (n = 850). The Primary Endpoint was a composite of cardiac death, myocardial infarction (MI), or clinically indicated target vessel revascularization within 9 months. Secondary Endpoints included extending the Primary Endpoint to 5 years and stent thrombosis (ST) (Academic Research Consortium definition). Analysis was by intention to treat. RESULTS At 5 years, the BES was noninferior to SES for the Primary Endpoint (186 [22.3%] vs. 216 [26.1%], rate ratio [RR]: 0.83 [95% confidence interval (CI): 0.68 to 1.02], p for noninferiority <0.0001, p for superiority = 0.069). The BES was associated with a significant reduction in the more comprehensive patient-orientated composite Endpoint of all-cause death, any MI, and all-cause revascularization (297 [35.1%] vs. 339 [40.4%], RR: 0.84 [95% CI: 0.71 to 0.98], p for superiority = 0.023). A significant reduction in very late definite ST from 1 to 5 years was evident with the BES (n = 5 [0.7%] vs. n = 19 [2.5%], RR: 0.26 [95% CI: 0.10 to 0.68], p = 0.003), corresponding to a significant reduction in ST-associated clinical events (Primary Endpoint) over the same time period (n = 3 of 749 vs. n = 14 of 738, RR: 0.20 [95% CI: 0.06 to 0.71], p = 0.005). CONCLUSIONS The safety benefit of the biodegradable polymer BES, compared with the durable polymer SES, was related to a significant reduction in very late ST (>1 year) and associated composite clinical outcomes. (Limus Eluted From A Durable Versus ERodable Stent Coating [LEADERS] trial; NCT00389220).