Mechanism of Drug-Eluting Absorbable Metal Scaffold Restenosis: A Serial Optical Coherence Tomography Study.
Mechanism of Drug-Eluting Absorbable Metal Scaffold Restenosis: A Serial Optical Coherence Tomography Study.
- 2020
Available online from MWHC library: 2008 - present
BACKGROUND: The pathomechanisms underlying restenosis of the bioabsorbable sirolimus-eluting metallic scaffold (Magmaris) remain unknown. Using serial optical coherence tomography, we investigated causes of restenosis, including the contribution of late scaffold recoil versus neointimal hyperplasia. CONCLUSIONS: In addition to neointimal hyperplasia, late scaffold recoil contributed significantly to LLL of sirolimus-eluting absorbable metal scaffolds. The extent of late scaffold recoil was dependent on the underlying plaque morphology and was the highest among fibrotic lesions. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01960504. METHODS: Patients enrolled in BIOSOLVE-II undergoing serial angiography and optical coherence tomography (post-intervention and follow-up: 6 months and/or 1 year) were analyzed. Patients were divided into 2 groups according to angiographic in-scaffold late lumen loss (LLL) <0.5 or >=0.5 mm. End points were late absolute scaffold recoil and neointimal hyperplasia area as assessed by optical coherence tomography. RESULTS: Serial data were available for analysis from 70 patients (LLL <0.5 mm: n=41; LLL >=0.5 mm: n=29). Patient and lesion characteristics were comparable, and there was no significant difference in mean and minimal scaffold area between groups at post-intervention. Late absolute scaffold recoil was less among patients with LLL <0.5 mm (0.53+/-0.68 mm2) compared with those with LLL >=0.5 mm (1.48+/-1.20 mm2; P<0.001). Neointimal hyperplasia area was smaller among patients with LLL <0.5 mm at follow-up (1.47+/-0.33 mm2) compared with patients with LLL >=0.5 mm (1.68+/-0.34 mm2; P=0.013). In a matched-frame analysis (post-intervention and follow-up), late absolute scaffold recoil varied according to the underlying plaque type (lipid: 0.63+/-1.23 mm2; calcified: 0.81+/-1.44 mm2; and fibrous: 1.20+/-1.52 mm2; P <0.001), while there was no difference with regards to neointimal hyperplasia area (P=0.132).
English
1941-7640
10.1161/CIRCINTERVENTIONS.119.008657 [doi]
*Absorbable Implants
*Coronary Restenosis/dg [Diagnostic Imaging]
*Coronary Vessels/dg [Diagnostic Imaging]
*Metals/ch [Chemistry]
*Myocardial Ischemia/th [Therapy]
*Percutaneous Coronary Intervention/is [Instrumentation]
*Tomography, Optical Coherence
Aged
Cardiovascular Agents/ad [Administration & Dosage]
Coronary Restenosis/et [Etiology]
Female
Fibrosis
Humans
Male
Middle Aged
Myocardial Ischemia/dg [Diagnostic Imaging]
Neointima
Percutaneous Coronary Intervention/ae [Adverse Effects]
Predictive Value of Tests
Prospective Studies
Prosthesis Design
Sirolimus/ad [Administration & Dosage]
Time Factors
Treatment Outcome
MedStar Heart & Vascular Institute
Journal Article
Available online from MWHC library: 2008 - present
BACKGROUND: The pathomechanisms underlying restenosis of the bioabsorbable sirolimus-eluting metallic scaffold (Magmaris) remain unknown. Using serial optical coherence tomography, we investigated causes of restenosis, including the contribution of late scaffold recoil versus neointimal hyperplasia. CONCLUSIONS: In addition to neointimal hyperplasia, late scaffold recoil contributed significantly to LLL of sirolimus-eluting absorbable metal scaffolds. The extent of late scaffold recoil was dependent on the underlying plaque morphology and was the highest among fibrotic lesions. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01960504. METHODS: Patients enrolled in BIOSOLVE-II undergoing serial angiography and optical coherence tomography (post-intervention and follow-up: 6 months and/or 1 year) were analyzed. Patients were divided into 2 groups according to angiographic in-scaffold late lumen loss (LLL) <0.5 or >=0.5 mm. End points were late absolute scaffold recoil and neointimal hyperplasia area as assessed by optical coherence tomography. RESULTS: Serial data were available for analysis from 70 patients (LLL <0.5 mm: n=41; LLL >=0.5 mm: n=29). Patient and lesion characteristics were comparable, and there was no significant difference in mean and minimal scaffold area between groups at post-intervention. Late absolute scaffold recoil was less among patients with LLL <0.5 mm (0.53+/-0.68 mm2) compared with those with LLL >=0.5 mm (1.48+/-1.20 mm2; P<0.001). Neointimal hyperplasia area was smaller among patients with LLL <0.5 mm at follow-up (1.47+/-0.33 mm2) compared with patients with LLL >=0.5 mm (1.68+/-0.34 mm2; P=0.013). In a matched-frame analysis (post-intervention and follow-up), late absolute scaffold recoil varied according to the underlying plaque type (lipid: 0.63+/-1.23 mm2; calcified: 0.81+/-1.44 mm2; and fibrous: 1.20+/-1.52 mm2; P <0.001), while there was no difference with regards to neointimal hyperplasia area (P=0.132).
English
1941-7640
10.1161/CIRCINTERVENTIONS.119.008657 [doi]
*Absorbable Implants
*Coronary Restenosis/dg [Diagnostic Imaging]
*Coronary Vessels/dg [Diagnostic Imaging]
*Metals/ch [Chemistry]
*Myocardial Ischemia/th [Therapy]
*Percutaneous Coronary Intervention/is [Instrumentation]
*Tomography, Optical Coherence
Aged
Cardiovascular Agents/ad [Administration & Dosage]
Coronary Restenosis/et [Etiology]
Female
Fibrosis
Humans
Male
Middle Aged
Myocardial Ischemia/dg [Diagnostic Imaging]
Neointima
Percutaneous Coronary Intervention/ae [Adverse Effects]
Predictive Value of Tests
Prospective Studies
Prosthesis Design
Sirolimus/ad [Administration & Dosage]
Time Factors
Treatment Outcome
MedStar Heart & Vascular Institute
Journal Article