生物聚合物DES vs BMS
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*Formerly known as Escorts Heart Institute and Research Center
Post CABG, old native disease beyond the LIMA.
CASE 1
78 Yr Old man, CABG ,Chronic Stable Angina
What are the limitations of BVS ??
Sub optimal experience with this device in countries other Europe & Asia Pacific. Visibility sub optimal hence overlapping/multiple stents in same vessel becomes a technical challenge. Strut thickness of 160microns is a concern in overlapping and small vessels (As we loose 0.3mm & 0.6mm of the lumen) It’s a bulky device compared to conventional stents..(it feels like PS153 in 1991 and perfusion balloon in the 80s) A 3.5 scaffold in a guideliner is a challenge.
Same lesion was present angiogram 3 years prior Cutting Balloon
Final Result
Case 2
Venous Graft
Final Result
Case 3
Bifurcation
Bifurcation case involving LAD D1
Absorb BRS- Indian Experience: What We Have Learned?
ABSORB EXTEND
Non-Randomized, Single-Arm, Continued Access Trial
ENROLLMENT COMPLETE 814 Subjects Enrolled Up to 100 International Sites
DES BVS
Long-term findings on OCT: the final golden tube
75 micron
Marker bead covered in a thin layer of tissue
Images courtesy of Thoraxcenter, Erasmus MC, Rotterdam, The Netherlands, ABSORB A 5 yr
9
Open Issues with conventional DES:
Prolonged antiplatelet therapy* duration Interference with Future CABG anastomotic sites Stent Fracture Interference with non-invasive imaging Very late Stent Thrombosis Long term T L F is 2.2 per year.
Brodie et al, J Interven Cardiol 2014:27: 21-28
BEST Trial: MV XV DES v CABG
After 1 year, TLF occurs at a rate of 2.2% per year, year after year, with no flattening of the slope
Participating Indian Sites
l Dr. Ajit Sankardas Mullasari, Madras Medical Mission, Institute of Cardiovascular Disease, Chennai, India l Dr. Pravin Goel Sanjay Gandhi Post Graduate Institute of Medical Sciences, Lucknow, India l Dr. Tejas Madhusudan Patel, SAL Hospital and Medical Institute, Ahmedabad, India l Dr. Ashok Seth, Fortis Escorts Heart Institute, New Delhi, India* l Dr. Anuj Kapadiya, Care Hospital, Hyderabad, India l Dr. Mathew Kalarickal, Apollo Hospital, Chennai, India l Dr. Praveen Chandra, Medanta-The Medicity, Gurgaon, India l Dr. Keyur Parikh, Care Institute of Medical Sciences, Ahmedabad, India
Restenosis is a process limited in time
(Absence of a permanent implant)
How Would Our Patients Benefit from a Bioresorbable Vascular Scaffold?
Restore vasomotion properties Could possibly add options in DAPT selection or duration? May improve long term clinical outcome?
1. in vitro drug elution model. 2. J. Lane, et. al., Long Term Vascular Safety of an Everolimus-eluting BVS With Benign Positive Remodeling and Late Luminal Gain in Porcine Coronary Arteries as Assessed by OCT , IVUS, and Histology. Poster, PCR 2013. Note: Histology images are porcine artery models. Pictures taken by and on file at Abbott Vascular.
Bioresorbable DES Update CCVVC 2015
Mathew Samuel, MD, DM Apollo Hospitals, Chennai, Lilavati Hospital, Mumbai, India
CONFLICT OF INTEREST:
I, Dr Samuel Mathew DO NOT have a financial interest/arrangement or affiliation with one or more organizations that could be perceived as a real or apparent conflict of interest in the context of the subject of this presentation.
Procedural Parameters (Indian ITT population)
EXTEND (N = 100)
Number of Target Lesions (%) 1 lesion subjects 2 lesion subjects Planned Overlapping (%) – per subject Bailout (%) – total Device Usage (%) – per scaffold 2.5 x 18 mm Absorb 3.0 x 18 mm Absorb 3.0 x 28 mm Absorb 10 76 14 87 13 6 3
The Future in PCI is to Move Away from Permanent Implants to
Fully Resorbable Devices
®
1
2
Caution: Investigational device. Limited by Federal U.S. law to investigational use only.
Clinical follow-up
30 d
MSCT follow-up (n=100) OCT follow-up (n=50)
Study Objective: Endpoints: Treatment: Device Sizes:
6 mo
12 mo
24 mo
ຫໍສະໝຸດ Baidu
36 mo
Continued Access Trial First Patient Enrolled: January 11, 2010 Enrollment Complete: October 2, 2013 No hypothesis-testing, typical PCI clinical endpoints Up to 2 de novo lesions in different epicardial vessels Planned overlapping allowed in lesions >22 and ≤ 28 mm Scaffold diameters: 2.5, 3.0, 3.5 mm Scaffold lengths: 12, 18, 28 mm Sponsor and Funding: Abbott Vascular
First: Why Do We Need BVS?
Stents vs. Balloon Angioplasty for STEMI:
Very-Late Events Greater for Metallic Stents (> 1 yr)
Stent or Lesion Thrombosis
Target Vessel Reinfarction
Deploying the D1 BVS
Only wire in D1 deploying LAD BVS
Final Result
ABSORB EXTEND – Indian Demographics and Lesion Characteristics (ITT)
EXTEND (N = 100) Male (%) Mean age (years) Prior Cardiac Intervention on Target Vessel (%) Previous MI (%) Unstable Angina (%) Diabetes mellitus (%) Dyslipidemia req. med. (%) Hypertension req. med. (%) Current smoker (%) 82 56 2 37 67 37 21 43 25 EXTEND (L = 113) Lesion Location (%) LAD LCX RCA LMCA/Ramus 43.4 16.8 38.1 1.8 ACC/AHA Lesion Classification (%) A B1 B2 C 2 68 30 1 Lesion Length (mm) Mean Range (min, max) 11.88 mm ± 4.70 (3.13, 27.02) QCA pre-procedure RVD (mm) MLD (mm) % DS (%) Proximal Dmax (mm) Distal Dmax (mm) 2.69 ± 0.37 1.06 ± 0.35 60.24 2.90 2.76 EXTEND (L = 113)
Post CABG, old native disease beyond the LIMA.
CASE 1
78 Yr Old man, CABG ,Chronic Stable Angina
What are the limitations of BVS ??
Sub optimal experience with this device in countries other Europe & Asia Pacific. Visibility sub optimal hence overlapping/multiple stents in same vessel becomes a technical challenge. Strut thickness of 160microns is a concern in overlapping and small vessels (As we loose 0.3mm & 0.6mm of the lumen) It’s a bulky device compared to conventional stents..(it feels like PS153 in 1991 and perfusion balloon in the 80s) A 3.5 scaffold in a guideliner is a challenge.
Same lesion was present angiogram 3 years prior Cutting Balloon
Final Result
Case 2
Venous Graft
Final Result
Case 3
Bifurcation
Bifurcation case involving LAD D1
Absorb BRS- Indian Experience: What We Have Learned?
ABSORB EXTEND
Non-Randomized, Single-Arm, Continued Access Trial
ENROLLMENT COMPLETE 814 Subjects Enrolled Up to 100 International Sites
DES BVS
Long-term findings on OCT: the final golden tube
75 micron
Marker bead covered in a thin layer of tissue
Images courtesy of Thoraxcenter, Erasmus MC, Rotterdam, The Netherlands, ABSORB A 5 yr
9
Open Issues with conventional DES:
Prolonged antiplatelet therapy* duration Interference with Future CABG anastomotic sites Stent Fracture Interference with non-invasive imaging Very late Stent Thrombosis Long term T L F is 2.2 per year.
Brodie et al, J Interven Cardiol 2014:27: 21-28
BEST Trial: MV XV DES v CABG
After 1 year, TLF occurs at a rate of 2.2% per year, year after year, with no flattening of the slope
Participating Indian Sites
l Dr. Ajit Sankardas Mullasari, Madras Medical Mission, Institute of Cardiovascular Disease, Chennai, India l Dr. Pravin Goel Sanjay Gandhi Post Graduate Institute of Medical Sciences, Lucknow, India l Dr. Tejas Madhusudan Patel, SAL Hospital and Medical Institute, Ahmedabad, India l Dr. Ashok Seth, Fortis Escorts Heart Institute, New Delhi, India* l Dr. Anuj Kapadiya, Care Hospital, Hyderabad, India l Dr. Mathew Kalarickal, Apollo Hospital, Chennai, India l Dr. Praveen Chandra, Medanta-The Medicity, Gurgaon, India l Dr. Keyur Parikh, Care Institute of Medical Sciences, Ahmedabad, India
Restenosis is a process limited in time
(Absence of a permanent implant)
How Would Our Patients Benefit from a Bioresorbable Vascular Scaffold?
Restore vasomotion properties Could possibly add options in DAPT selection or duration? May improve long term clinical outcome?
1. in vitro drug elution model. 2. J. Lane, et. al., Long Term Vascular Safety of an Everolimus-eluting BVS With Benign Positive Remodeling and Late Luminal Gain in Porcine Coronary Arteries as Assessed by OCT , IVUS, and Histology. Poster, PCR 2013. Note: Histology images are porcine artery models. Pictures taken by and on file at Abbott Vascular.
Bioresorbable DES Update CCVVC 2015
Mathew Samuel, MD, DM Apollo Hospitals, Chennai, Lilavati Hospital, Mumbai, India
CONFLICT OF INTEREST:
I, Dr Samuel Mathew DO NOT have a financial interest/arrangement or affiliation with one or more organizations that could be perceived as a real or apparent conflict of interest in the context of the subject of this presentation.
Procedural Parameters (Indian ITT population)
EXTEND (N = 100)
Number of Target Lesions (%) 1 lesion subjects 2 lesion subjects Planned Overlapping (%) – per subject Bailout (%) – total Device Usage (%) – per scaffold 2.5 x 18 mm Absorb 3.0 x 18 mm Absorb 3.0 x 28 mm Absorb 10 76 14 87 13 6 3
The Future in PCI is to Move Away from Permanent Implants to
Fully Resorbable Devices
®
1
2
Caution: Investigational device. Limited by Federal U.S. law to investigational use only.
Clinical follow-up
30 d
MSCT follow-up (n=100) OCT follow-up (n=50)
Study Objective: Endpoints: Treatment: Device Sizes:
6 mo
12 mo
24 mo
ຫໍສະໝຸດ Baidu
36 mo
Continued Access Trial First Patient Enrolled: January 11, 2010 Enrollment Complete: October 2, 2013 No hypothesis-testing, typical PCI clinical endpoints Up to 2 de novo lesions in different epicardial vessels Planned overlapping allowed in lesions >22 and ≤ 28 mm Scaffold diameters: 2.5, 3.0, 3.5 mm Scaffold lengths: 12, 18, 28 mm Sponsor and Funding: Abbott Vascular
First: Why Do We Need BVS?
Stents vs. Balloon Angioplasty for STEMI:
Very-Late Events Greater for Metallic Stents (> 1 yr)
Stent or Lesion Thrombosis
Target Vessel Reinfarction
Deploying the D1 BVS
Only wire in D1 deploying LAD BVS
Final Result
ABSORB EXTEND – Indian Demographics and Lesion Characteristics (ITT)
EXTEND (N = 100) Male (%) Mean age (years) Prior Cardiac Intervention on Target Vessel (%) Previous MI (%) Unstable Angina (%) Diabetes mellitus (%) Dyslipidemia req. med. (%) Hypertension req. med. (%) Current smoker (%) 82 56 2 37 67 37 21 43 25 EXTEND (L = 113) Lesion Location (%) LAD LCX RCA LMCA/Ramus 43.4 16.8 38.1 1.8 ACC/AHA Lesion Classification (%) A B1 B2 C 2 68 30 1 Lesion Length (mm) Mean Range (min, max) 11.88 mm ± 4.70 (3.13, 27.02) QCA pre-procedure RVD (mm) MLD (mm) % DS (%) Proximal Dmax (mm) Distal Dmax (mm) 2.69 ± 0.37 1.06 ± 0.35 60.24 2.90 2.76 EXTEND (L = 113)