Comparison of a novel biodegradable polymer sirolimus-eluting stent with a durable polymer everolimus-eluting stent: results of the randomized BIOFLOW-II trial.
Comparison of a novel biodegradable polymer sirolimus-eluting stent with a durable polymer everolimus-eluting stent: results of the randomized BIOFLOW-II trial.
- 2015
Available online from MWHC library: 2008 - present
BACKGROUND: Biodegradable polymers for release of antiproliferative drugs from drug-eluting stents aim to improve vascular healing. We assessed noninferiority of a novel ultrathin strut drug-eluting stent releasing sirolimus from a biodegradable polymer (Orsiro, O-SES) compared with the durable polymer Xience Prime everolimus-eluting stent (X-EES) in terms of the primary end point in-stent late lumen loss at 9 months. CLINICAL TRIAL REGISTRATION URL: http://www.clinicaltrials.gov. Unique identifier: NCT01356888.Copyright � 2013 American Heart Association, Inc. CONCLUSIONS: Compared with durable polymer X-EES, novel biodegradable polymer-based O-SES was found noninferior for the primary end point in-stent late lumen loss at 9 months. Clinical event rates were comparable without cases of stent thrombosis throughout 1 year of follow-up. METHODS AND RESULTS: A total of 452 patients were randomly assigned 2:1 to treatment with O-SES (298 patients, 332 lesions) or X-EES (154 patients, 173 lesions) in a multicenter, noninferiority trial. The primary end point was in-stent late loss at 9 months. O-SES was noninferior to X-EES for the primary end point (0.10+/-0.32 versus 0.11+/-0.29 mm; difference=0.00063 mm; 95% confidence interval, -0.06 to 0.07; Pnoninferiority<0.0001). Clinical outcome showed similar rates of target-lesion failure at 1 year (O-SES 6.5% versus X-EES 8.0%; hazard ratio=0.82; 95% confidence interval, 0.40-1.68; log-rank test: P=0.58) without cases of stent thrombosis. A subgroup of patients (n=55) underwent serial optical coherence tomography at 9 months, which demonstrated similar neointimal thickness among lesions allocated to O-SES and X-EES (0.10+/-0.04 mm versus 0.11+/-0.04 mm; -0.01 [-0.04, -0.01]; P=0.37). Another subgroup of patients (n=56) underwent serial intravascular ultrasound at baseline and 9 months indicating a potential difference in neointimal area at follow-up (O-SES, 0.16+/-0.33 mm(2) versus X-EES, 0.43+/-0.56 mm(2); P=0.04).
English
1941-7640
*Angioplasty, Balloon, Coronary/is [Instrumentation]
*Cardiovascular Agents/ad [Administration & Dosage]
*Coronary Artery Disease/th [Therapy]
*Coronary Restenosis/pc [Prevention & Control]
*Coronary Vessels/de [Drug Effects]
*Drug-Eluting Stents
*Polymers
*Sirolimus/aa [Analogs & Derivatives]
Aged
Angioplasty, Balloon, Coronary/ae [Adverse Effects]
Coronary Artery Disease/di [Diagnosis]
Coronary Restenosis/di [Diagnosis]
Coronary Restenosis/et [Etiology]
Coronary Vessels/pa [Pathology]
Coronary Vessels/us [Ultrasonography]
Europe
Female
Humans
Kaplan-Meier Estimate
Male
Middle Aged
Neointima
Predictive Value of Tests
Prosthesis Design
Risk Factors
Sirolimus/ad [Administration & Dosage]
Time Factors
Tomography, Optical Coherence
Treatment Outcome
Ultrasonography, Interventional
MedStar Heart & Vascular Institute
Available online from MWHC library: 2008 - present
BACKGROUND: Biodegradable polymers for release of antiproliferative drugs from drug-eluting stents aim to improve vascular healing. We assessed noninferiority of a novel ultrathin strut drug-eluting stent releasing sirolimus from a biodegradable polymer (Orsiro, O-SES) compared with the durable polymer Xience Prime everolimus-eluting stent (X-EES) in terms of the primary end point in-stent late lumen loss at 9 months. CLINICAL TRIAL REGISTRATION URL: http://www.clinicaltrials.gov. Unique identifier: NCT01356888.Copyright � 2013 American Heart Association, Inc. CONCLUSIONS: Compared with durable polymer X-EES, novel biodegradable polymer-based O-SES was found noninferior for the primary end point in-stent late lumen loss at 9 months. Clinical event rates were comparable without cases of stent thrombosis throughout 1 year of follow-up. METHODS AND RESULTS: A total of 452 patients were randomly assigned 2:1 to treatment with O-SES (298 patients, 332 lesions) or X-EES (154 patients, 173 lesions) in a multicenter, noninferiority trial. The primary end point was in-stent late loss at 9 months. O-SES was noninferior to X-EES for the primary end point (0.10+/-0.32 versus 0.11+/-0.29 mm; difference=0.00063 mm; 95% confidence interval, -0.06 to 0.07; Pnoninferiority<0.0001). Clinical outcome showed similar rates of target-lesion failure at 1 year (O-SES 6.5% versus X-EES 8.0%; hazard ratio=0.82; 95% confidence interval, 0.40-1.68; log-rank test: P=0.58) without cases of stent thrombosis. A subgroup of patients (n=55) underwent serial optical coherence tomography at 9 months, which demonstrated similar neointimal thickness among lesions allocated to O-SES and X-EES (0.10+/-0.04 mm versus 0.11+/-0.04 mm; -0.01 [-0.04, -0.01]; P=0.37). Another subgroup of patients (n=56) underwent serial intravascular ultrasound at baseline and 9 months indicating a potential difference in neointimal area at follow-up (O-SES, 0.16+/-0.33 mm(2) versus X-EES, 0.43+/-0.56 mm(2); P=0.04).
English
1941-7640
*Angioplasty, Balloon, Coronary/is [Instrumentation]
*Cardiovascular Agents/ad [Administration & Dosage]
*Coronary Artery Disease/th [Therapy]
*Coronary Restenosis/pc [Prevention & Control]
*Coronary Vessels/de [Drug Effects]
*Drug-Eluting Stents
*Polymers
*Sirolimus/aa [Analogs & Derivatives]
Aged
Angioplasty, Balloon, Coronary/ae [Adverse Effects]
Coronary Artery Disease/di [Diagnosis]
Coronary Restenosis/di [Diagnosis]
Coronary Restenosis/et [Etiology]
Coronary Vessels/pa [Pathology]
Coronary Vessels/us [Ultrasonography]
Europe
Female
Humans
Kaplan-Meier Estimate
Male
Middle Aged
Neointima
Predictive Value of Tests
Prosthesis Design
Risk Factors
Sirolimus/ad [Administration & Dosage]
Time Factors
Tomography, Optical Coherence
Treatment Outcome
Ultrasonography, Interventional
MedStar Heart & Vascular Institute