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Fighting Restenosis:Fighting Restenosis:Tips and TricksTips and Tricks
SCRIPPS CLINIC
Paul S. Teirstein
Chief of Cardiology
Director, Interventional Cardiology
Scripps Clinic
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Disclosure Statement of Financial InterestDisclosure Statement of Financial Interest
Within the past 12 months, I or my spouse/partner have had a financialinterest/arrangement or affiliation with the organization(s) listed below.
Affiliation/Financial Relationship Company
Grant/Research Support Boston, Abbott, Medtronic, Edwards
Consulting Fees/Honoraria Boston, Abbott, Medtronic, Edwards
President (unpaid) NBPAS
SCRIPPS CLINIC
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Treating DES Restenosis
• Get over feeling guiltyIt’s not your fault, it’s the technology’s faultPatients are very grateful, even the Platinum Frequent Flyers
• Be prepared to WORK. The greater acute gain you get the less chance offuture restenosis or at least a longer time interval for recurrence
• Dealing with ISR takes time and energy. The lesions are often very
SCRIPPS CLINIC
• Dealing with ISR takes time and energy. The lesions are often veryrecalcitrant with non-expandable scarring around the stent.
• Use ultra-high balloon pressures. Test your balloons on the back table. MostNC balloons now rupture closer to 30 atm. Its hard to get adequate results atjust 20 atm
• Use IVUS to adequately size high pressure balloons.• Longer inflations (>3min) seem to really help achieve the desired gorgeous
angiographic appearance
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Treating DES Restenosis
• Use longer balloons so they don’t slip as much
• Consider Wolverine, AngioSculpt and Chocolate balloons taken tohigh pressures. BUT, these specialty balloons can be very difficult todeliver
• If you do not get full balloon expansion, move quickly to laser. Most
SCRIPPS CLINIC
• If you do not get full balloon expansion, move quickly to laser. Mostoften I use the 0.09” laser set at 80/80 with contrast injections. If yousee cavitation (bubbles) that is a good sign, BUT, beware, you can getno-reflow from the cavitation. If you see bubbles, limit laser runs toonly 2-3 and keep an eye on flow
• Try to avoid Rotablation of unexpanded stents. The burr can get stuckand then it’s a nightmare.
• Shockwave (lithotripsy) may be a real help for the non-dilatable stent
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Treating DES Restenosis
• Oral therapies for restenosis have been disappointing. Oral rapamycin isavailable but high toxicity, high cost, and marginal efficacy
• Peripheral drug eluting balloons are available but the smallest diameter is4.0mm x 40mm long. Can be used for some RCA ISR lesions and SVG ISRlesions. Use 3 parallel stiff 0.014” guidewires. Obtain special consent!
• Coronary drug eluting balloon (DEB) for ISR trials will begin shortly
SCRIPPS CLINIC
• Coronary drug eluting balloon (DEB) for ISR trials will begin shortly• Restenting is always an option but we worry about more than two layers of
stent, especially in smaller (<3.0) vessels• Data does not support changing DES brands, but it seems logical to try
something different.• Newer Osiro stent has thinner struts in the 3.0mm and below iterations.
Might be a good choice if a 3rd or 4th layer is needed.• Brachytherapy use is on the increase. Scripps does >100 brachy cases per
year.
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Undilatable CalcificCoronary StenosisCausing StentUnderexpansion andLate Stent ThrombosisA Complex ScenarioSuccessfully ManagedWithIntravascular LithotripsyCarlos Salazar, JavierEscaned, GabrielaTirado and NievesTirado and NievesGonzalo
JACC: CardiovascularInterventionsAugust2019DOI: 10.1016/j.jcin.2019.02.010
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Undilatable CalcificCoronary StenosisCausing StentUnderexpansion andLate Stent ThrombosisA Complex ScenarioSuccessfully ManagedWithIntravascular LithotripsyCarlos Salazar, JavierEscaned, GabrielaTirado and NievesTirado and NievesGonzalo
JACC: CardiovascularInterventionsAugust2019DOI: 10.1016/j.jcin.2019.02.010
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Platinum Card Frequent Flyer:Platinum Card Frequent Flyer:TwentyTwenty--one Cines from One Patientone Cines from One Patient
The CardiovascularResearch FoundationThe CardiovascularResearch Foundation
Lenox Hill Heart and VascularInstitute of New York
Lenox Hill Heart and VascularInstitute of New York
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SCRIPPS CLINIC
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Intracoronary Brachytherapy forMulti-Drug Resistant In-Stent
Restenosis
Paul Teirstein M.D.Paul Teirstein M.D.
Chief of Cardiology
Scripps Clinic
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Disclosure Statement of Financial Interest
• Grant/Research Support
• Consulting Fees/Honoraria
• Medtonic
• Abbott
• Boston Sci
Within the past 12 months, I or my spouse/partner have had a financialinterest/arrangement or affiliation with the organization(s) listed below.
Affiliation/Financial Relationship Company
• Boston Sci
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Background
In-stent restenosis (ISR), althoughinfrequent with current generation drug-eluting stents (DES), is a major limitation ofthe long-term efficacy of percutaneousthe long-term efficacy of percutaneouscoronary intervention (PCI).
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Treatment Options
Medical Management Balloon angioplasty Scoring balloon Cutting balloon Another DES used for DES ISR (off label) Another DES used for DES ISR (off label) Laser or rotational atherectomy (off-label) Drug eluting balloon Bypass surgery Brachytherapy (off-label)
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Rational for Study
DES reduces ISR
Brachytherapy is effective treatment for bare metalstent (BMS) ISRstent (BMS) ISR
No approved percutaneous treatment for DES ISR
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Hypothesis – SCRIPPS V
To determine the safety and efficacy ofcoronary brachytherapy for the treatment ofrecurrent ISR within DES
Single center, observational, non-placebo trial
Approved by Scripps IRB
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Inclusion Criteria At least 18 years old and eligible for PCI
Target lesion with recurrent restenosis (>50%)previously treated with 2 or more layers of differentDES
Signs and/or symptoms of ischemia attributable totarget lesion or stenosis > 50%
Target lesion in native artery or bypass graft
Able to understand and sign informed consent
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Exclusion Criteria Confirmed pregnancy
Allergies to dual anti-platelet therapy of anyanticoagulation required during procedure
Life expectancy < 1yr Life expectancy < 1yr
Unsuccessful coronary revascularization (residualstenosis >30%)
Angiographic evidence of thrombus
Previous brachytherapy to target artery
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Primary endpoints
At 30 days and 8 months
All-cause death
Myocardial infarction
Target vessel revascularization (TVR)
Secondary endpoints @ 2 years
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Enrollment
May 2006 – September 2013
65 patients enrolled65 patients enrolled
100% follow-up at 8 months +/- 2 weeks
98.5% follow-up at 2 years
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Baseline Characteristics
Hypertension 60 (92%)
Hyperlipidemia 65 (100%)
Diabetes 33 (50%)
Non-insulin dependent diabetes 21 (32%)
Insulin-dependent diabetes 12 (18%)
Chronic kidney disease 13 (20%)
COPD 4 (6%)
Previous CABG 29 (45%)
Tobacco use history 35 (54%)
Family history CAD 29 (45%)
Peripheral artery disease 8 (12%)
Heart failure 5 (8%)COPD – chronic obstructive pulmonary diseaseCABG – coronary artery bypass graftingCAD – coronary artery disease
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Medications
Aspirin 64 (98%)
Clopidogrel 53 (82%)
Prasugrel 12 (18%)
ACEI 31 (48%)
ARB 14 (22%)ARB 14 (22%)
Beta blocker 49 (75%)
Calcium channel blocker 23 (35%)
Nitrates 24 (37%)
Ranolazine 14 (22%)
Statin 50 (77%)
ACIE – Angiotension converting enzyme inhibitorARB – Angiotension receptor blocker
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Stentology
Layers of stent*
1 0
2 43 (66%)
3 9 (14%)
4 3 (5%)
Unknown 10 (15%)
Number of previous procedures = lost in translation
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Stentology
Prior Type of Drug Eluting Stent
Cypher + Taxus and/or secondgeneration DES
51 (77%)generation DES
Second generation DES only 5 (8%)
Unknown 10 (15%)
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Interventional Tools
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Restenosis Location
19%
39%21%
Ramus 2%LIMA-LAD 5%SVG 14%
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Intracoronary Radiation
FDA approved Novoste™ Beta-Cath™ system
Strontium/yttrium-90 beta radiation
Median dose 23 Gy Median dose 23 Gy
Radius dose of 2mm
Median time 4 min 26 sec
Treatment length 40-60 mm
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Follow Up
Telephone contact with patient at 30 days and 8months and 2 years Review symptoms, medications, allergies, any adverse
events, repeat procedures
If unable to reach patient, questionnaire is sent bycertified mail
Ultimately, 100% follow up at 8 mos +/-2 weeks,98.5% follow up at 2 years
Obtain all records of medical events during the followup
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Results
N = 6530
days8 months
Target vessel revascularization 0 15 (23%)
Non-Target Vessel2 (3%) 7 (11%)
Non-Target VesselRevascularization
2 (3%) 7 (11%)
Any Revascularization 2 (3%) 22 (34%)
TVR CABG 0 3 (5%)
Stent Thrombosis 0 0
Myocardial infarction 0 5 (8%)
Death 0 0
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Results
N = 658 months
N = 652 yearsN = 64
Target vessel revascularization 15 (23%) 22 (34%)
Non-Target Vessel7 (11%) 9 (14%)
Non-Target VesselRevascularization
7 (11%) 9 (14%)
Any Revascularization 22 (34%) 32 (50%)
TVR CABG 3 (5%) 4 (6%)
Stent Thrombosis 0 0
Myocardial infarction 5 (8%) 5 (8%)
Death 0 3* (5%)
*Cardiac death = 1
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• 186 Patients undergoing VBT for recurrent DES-ISR were enrolled
Negi et al. J Am Coll Cardiol Int. 2016;9(12): 1259-1265
• 186 Patients undergoing VBT for recurrent DES-ISR were enrolledfrom a percutaneous coronary intervention registry.
• Clinical, procedural, VBT, and outcome data were collected forDES-ISR treated with radiation.
• Follow-up was obtained by phone call and clinic visits.
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Baseline Characteristic N=186
Age (years) 65±11
Male (%) 62
Body Mass Index (kg/m2) 30.1±6.2
Hypertension (%) 95
Smoking (%) 62
Baseline Characteristics
Smoking (%) 62
Diabetes (%) 46.5
Dyslipidemia (%) 94
Previous CABG (%) 55
Presentation with unstable angina (%) 30
STEMI (%) 3
Negi et al. J Am Coll Cardiol Int. 2016;9(12): 1259-1265
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ISR Details
Angiographic and Lesion-Specific Characteristics
Number of previous ISR episodes
• 1-2 (%) 4
• 3-4 (%) 63
• >4 (%) 25
• Unknown (%) 8
Negi et al. J Am Coll Cardiol Int. 2016;9(12): 1259-1265
• Unknown (%) 8
Pattern of restenosis
Focal (%) 73
Diffuse (%) 23
Proliferative (%) 4
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30 days 6-months 1-year 2-years 3-years
TLR 1 (0.5%) 6 (3.3%) 22 (12.1%) 31 (17.2%) 30 (19.4%)
Surgical TLR 0 0 0 3 (1.6%) 5 (2.8%)
Outcomes at 30 days, 6 months, 1, 2,and 3 years
TVR 3 (1.6%) 13 (7.1%) 35 (19.1%) 54 (30%) 55 (30.5%)
Surgical TVR 0 0 0 3 (1.6%) 5 (2.8%)
MI 0 1 (0.5%) 3 (1.5%) 10 (5.6%) 11 (6.7%)
LST 0 0 1 (0.5%) 1 (0.5%) 1 (0.5%)
Death 1 (0.5%) 7 (3.8%) 10 (5.4%) 18 (9.8%) 23 (13.2%)
LST, late stent thrombosis; MI, myocardial infarction; TLR, target lesion revascularization; TVR, target vessel revascularization
Negi et al. J Am Coll Cardiol Int. 2016;9(12): 1259-1265
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Kaplan-Meier Estimates of Target Lesionand Vessel Failure
TLR TLF
Negi et al. J Am Coll Cardiol Int. 2016;9(12): 1259-1265
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Washington Hospital Center
57% of Multiple (recurrent) ISR grouptreated with brachytherapy vs 17% ofthe group presenting with first episodethe group presenting with first episodeof ISR (p<0.01).
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Washington Hospital Center
~15% MACE
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Conclusions Multi-drug resistant ISR is infrequent but the absolute
# of patients with DES ISR is growing.
Intracoronary brachytherapy is a safe treatment forrecurrent DES ISR
TVR rates following brachytherapy for multi-drugresistant ISR are favorable at 8 months (23%) andacceptable at 2 years (34%) in this challenging patientgroup.
While brachytherapy reduces and slows thetimeframe of ISR following DES, restenosis is noteliminated.
PT1
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Slide 37
PT1 Paul Teirstein, 9/14/2018
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Coronary Brachytherapy Caveats
• Call for radiation oncologist when passing guidewire• Work hard to get a great result. Use cutting, scoring, laser,
and very high balloon pressures (ie 28-30 atm).• Use longer inflation times: 3-4 minutes, if tolerated• All brachy trials were done immediately after PCI of
significant ISR. We don’t have data on PCI, followed by
SCRIPPS CLINIC
significant ISR. We don’t have data on PCI, followed bybrachytherapy a week or month later.
• In the initial SCRIPPS trial, 1/3 of patients had a new BMSat the time of brachytherapy and no thrombosis signalobserved. In the larger RCTs, new stent during brachyprocedure was associated with a 7% early stentthrombosis rate.
• All data comes from trials using 1 year of DAPT. Shorter islikely okay but has not been studied.