optimal dapt after brs - bifurc.net · a.o.u. policlinico-vittorio emanuele catania, italy d....

Ferrarotto Hospital A.O.U. Policlinico-Vittorio EmanueleCatania, Italy

D. Capodanno EBC 2016, October 15, 2016 – Slide 1

Davide Capodanno, MD, PhDFerrarotto Hospital, University of Catania, Italy

European Bifurcation Club 2016 – Rotterdam October 15, 2016

Optimal DAPT after BRS



Trials of Shorter vs Longer DAPT after PCI15 studies, ~40,000 patients randomized

RESET JACC 2012 N=2,117 3 months noninferior to 12 monthsOPTIMIZE JAMA 2013 N=2,199 3 months noninferior to 12 monthsSECURITY JACC 2016 N=1,399 6 months noninferior to 12 monthsISAR SAFE EHJ 2015 N=4,000 6 months similar to 12 monthsI-LOVE-IT 2 CIRC CV 2016 N=1,829 6 months noninferior to 12 monthsOPTIMA-C TCTAP 2015 N=1,368 6 months noninferior to 12 monthsEXCELLENT Circulation 2015 N=1,443 6 months noninferior to 12 monthsIVUS XPL NEW! JACC: CI 2016 N=1,400 6 months similar to 12 monthsNIPPON NEW! ESC 2016 N=2,772 6 months noninferior to 18 monthsITALIC JACC 2015 N=1,822 6 months similar to 24 monthsPRODIGY Circulation 2012 N=1,970 6 months noninferior to 24 monthsDES LATE Circulation 2014 N=5,045 12 months similar to 18-30 monthsARCTIC NEJM 2012 N=1,259 12 months noninferior to 12 monthsDAPT NEJM 2014 N=9,961 12 months inferior to 30 monthsOPTIDUAL EHJ 2015 N=1,385 12 months similar to 48 months



DAPT Duration in Clinical GuidelinesPopulation ESC Guidelines ACCF/AHA/SCAI 2016Acute Coronary Syndrome (BMS or DES)

Maximum of 12 months (Class I-A)

Shorter or longer durations may be considered (Class IIb-A)

At least 12 months (Class I-BR)

Shorter (Class IIb-C-LD) or longer (Class IIb-ASR) durations may be considered

Stable Ischemia and BMS At least 1 month(Class I-A)

At least 1 month (Class I-A)>1 month if no HBR (Class IIb-A)

Stable Ischemia and DES 6 months (Class I-B) At least 6 months (Class I-B-NR)>6 months if no HBR (Class IIb-A)HBR: 3 months (Class IIb-C-LD)

Secondary Prevention Selected patients at high ischemic risk

Prior MI (1-3 yrs), no HBR: May be reasonable (Class IIb-A)

Roffi M, et al. 2015 ESC Guidelines for Management of ACS. EHJ 2015 (Online Aug 29, 2015). Windecker S, et al. 2014 ESC/EACTS Guidelines on Myocardial Revascularization. EHJ 2014;35:3541-619. Amsterdam EA, et al. 2014 AHA/ACC Guideline for Management of NSTE-ACS. JACC 2014;64:e139-228. Montalescot G, et al. 2013 ESC Guidelines on Management of Stable CAD. EHJ 2013;34:2949-3003. Levine GN, et al. 2011 ACCF/AHA/SCAI Guidelines for PCI. JACC 2011;58:e44-122. Smith SC Jr, et al. 2011 AHA/ACCF Secondary Prevention Guidelines. JACC 2011;58:2342-46. Levine GN, et al. 2016 ACC/AHA Guidelines for DAPT. JACC AOP



Evolution of Coronary DES TechnologyBetter Platforms, Polymers and Drugs = êST

Capodanno D. Eur Heart J 2016 [Epub ahead of print]



Current Landscape of CE-Marked BRSABSORB GT1 bioresorbable vascular scaffold (BVS)PLLA, everolimus-elutingStrut thickness 150 µm, coat thickness 3 µm/sideFull mass loss at approximately 3 yearsCE mark in October 2011

DESsolve bioresorbable coronary scaffold (BCS)PLLA, novolimus-elutingStrut thickness 150 µm, coat thickness <3 µm/sideFull mass loss at approximately 1 yearSelf-correcting property, overexpansion without fractureCE mark in May 2014

MAGMARIS resorbable magnesium scaffold (RMS)Magnesium, sirolimus-elutingFull mass loss at approximately 1 yearStrut thickness 150 µm, coat thickness 8 µm/sideGreater tensile strength and ductilityCE mark in June 2016



Capodanno D. JACC Cardiovasc Interv. 2016;9:1213-5

The ABSORB scaffold holds a number of promises, but promises are not enough when comparisons versus metallic DESs initiate.

While the list of competitors enriches and new iterations of the device appear at the horizon, it is interesting to realize how the first generation ABSORB positions itself in the ranking.“



One-year Thrombosis in the Scaffold EraNetwork meta-analysis of 147 RCTs and 126,526 patients

Kang SH, et al. JACC Cardiovasc Interv. 2016;9:1203-12

Network geometry BVS vs. Comparators



Very Late Scaffold Thrombosis: ~1%

Collet C, et al. Minerva Cardioangiol. 2016 [Epub ahead of print]



Predictors of 1-Year BVS Thrombosis42 ScT in 1,305 patients from 4 German and Swiss centers

Puricel S, et al. J Am Coll Cardiol. 2016;67:921-31

1-Y ScT (Definite/Probable/Possible) HR (95% CI) p-value

LVEF (5% increase) 0.82 (0.70–0.97) 0.019

Ostial lesion 2.59 (1.01–6.64) 0.049

MLD* 0.05 (0.01–0.28) 0.001

RVD* 0.13 (0.04–0.46) 0.002

Maximum footprint, %* 1.20 (1.08–1.33) 0.001

Scaled residual stenosis* 1.71 (20–146) 0.001The following variables were entered into the model for device thrombosis: diabetes, LVEF (5% increase), number of vessels treated, total BVS surface, ticagrelor use, ostial lesions. *Adjusted data obtained from 1:2 matched patients with and without ScT. Scaled residual stenosis = MLD divided by the nominal BVS diameter. Maximum footprint = % of the vascular circumference occupied by struts at the level of the MLD



Putative Factors of Very Late ScT

Capodanno D, et al. (Personal communication)



Minimum DAPT duration By Study Protocol in Landmark Trials of BVS

1 month 3 months 6 months 9 months 12 months

ABSORB Japann = ~400, Japan Pivotal RCT

ABSORB Chinan = ~440, China Pivotal RCT

ABSORB IIn = ~501, International RCT

ABSORB Cohort Bn = 101; FIM

ABSORB Cohort An = 30; FIM

ABSORB IIIn = ~2,250, US Pivotal RCT

ABSORB IVn = ~3,000, US RCT

PCI

PCI

PCI

PCI

PCI

PCI

PCI

AIDAn = ~2,700, EU RCT

PCI



Is 12 months DAPT enough for BVS?

Capodanno D. (Personal communication)

0,5%

1,0%

0,7%

1,0%

Acute Subacute Late Very Late 0-24 hours 24 hours-30 days 30 days-1 year 1-2 year

Landmark scaffold thrombosis rates (with 95% CIs)Numbers are from Collet C, et al. Minerva Cardioangiol. 2016 [Epub ahead of print]

Discontinuity?

Procedure factors

Device factors

Patient/lesion factors

Malapposition?

Strut uncoverage?



DAPT Duration for Complex PCIPatient-level meta-analysis of 9,577 pts from 6 PCI trials of DAPT duration

Giustino G, et al. J Am Coll Cardiol. 2016 [Epub ahead of print]

0,8%0,5%

1,6%

0,5%

Complex PCI Noncomplex PCI

Definite or probable stent thrombosis

Long DAPT Short DAPT

P for interaction = 0.08

Complex PCI was defined as having at least 1 of the following features: 3 vessels treated, ≥3 stents implanted, ≥3 lesions treated, bifurcation with 2 stents implanted, total stent length >60 mm, or chronic total occlusion



Practical Considerations #11. Strut thickness and thrombosis of current BRS approximate

those of first-generation DES. Therefore, the currently recommended approach to 6-mo DAPT does not apply to this context.

2. In ACS patients who are not pretreated with P2Y12 inhibitors, it is not unreasonable to consider the use of an intravenous agent (either a glycoprotein IIb/IIIa inhibitor or cangrelor) as a bridge to the full onset of action of prasugrel or ticagrelor.

3. In elective PCI, being the rate of early BVS thrombosis ~1.5%, some operators prescribe off-label prasugrel or ticagrelor, followed by de-escalation to clopidogrel after 30 days. Whether this strategy is safe ad effective is unknown.



Practical Considerations #1

[email protected]

4. BVS promise to cancel long-term device thrombosis but the rate of this complication is still ~1% between 1 and 2 years, generally as a consequence of regional suboptimal flow conditions and delayed healing in some patients.

5. As such, DAPT should be maintained for 12 months after BVS implantation, with an option to prolong up to 24 months and beyond in selected patients and lesions (i.e., patients with ACC/AHA B2/C lesions, >1 BVS implanted on lesions of any ACC/AHA type, or in presence of any other unfavorable clinical, angiographic and procedural characteristic, including complex bifurcation lesions) if no bleeding issues arise during the first year.

optimal dapt after brs - bifurc.net · a.o.u. policlinico-vittorio emanuele catania, italy d....

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