Clinical trial NCT03023020: Management of High Bleeding Risk Patients Post Bioresorbable Polymer Coated Stent Implantation With an Abbreviated Versus Prolonged DAPT Regimen
Official title: Management of High Bleeding Risk Patients Post Bioresorbable Polymer Coated Stent Implantation With an Abbreviated Versus Prolonged DAPT Regimen
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: High Bleeding Risk
Coronary Artery Disease
PCI
Keywords: Dual Antiplatelet Therapy
Lead sponsor: ECRI bv
Sponsor class: INDUSTRY
Collaborators: name: Cardialysis B.V.
name: European Cardiovascular Research Center
name: University of Bern
name: Terumo Medical Corporation
First posted: 2017-01-18
Enrollment: 4579
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study compares two lengths of medication therapy (a shortened versus a prolonged dual antiplatelet therapy) in order to prevent thrombus (blood cloth) formation after the successfully treatment for coronary heart disease with a drug covered stent (metallic tube).

This comparison will be done in patients who, compared to the average patient, are more likely to suffer from complications on antiplatelet therapy (bleeding). Both durations are within the current medical recommendations. The aim of this study is to help improve further standard antiplatelet duration guidelines.

Detailed description: The study objective is to determine in a high bleeding risk patient population undergoing PCI under standardized treatment (within current guidelines and instructions for use and including the bioresorbable polymer coated Ultimaster sirolimus-eluting stent), whether abbreviated DAPT is non-inferior to prolonged DAPT regimen in terms of NACE within 12 months, whether abbreviated DAPT is non-inferior to prolonged DAPT regimen in terms of MACCE within 12 months and whether abbreviated DAPT is superior to prolonged DAPT regimen in terms of MCB within 12 months.

There are two treatment strategies:

* abbreviated dual anti-platelet therapy: dual antiplatelet therapy is discontinued and a single antiplatelet agent is continued until at least 11 months post randomization (i.e. 12 months post stent implantation). In patients on oral anticoagulants, dual antiplatelet therapy is discontinued and either Aspirin or Clopidogrel is continued until 5 months post randomization (i.e. 6 months post stent implantation). Oral anticoagulation is continued until at least 11 months post randomization (i.e. 12 months post stent implantation) OR
* prolonged dual anti-platelet therapy: aspirin is continued for at least 11 months post randomization (i.e. 12 months post stent implantation), the P2Y12 inhibitor being taken at the time of randomization is continued for at least 5 months and up to 11 months post randomization (i.e. 12 months post stent implantation). In patients on oral anticoagulants, aspirin and Clopidogrel are continued for at least 2 months post randomization (i.e. 3 months post stent implantation) and up to 11 months post randomization (i.e. 12 months after stent implantation). Therefore either aspirin or Clopidogrel is continued up to 11 months post randomization (i.e. 12 months post stent implantation)

The study design is an investigator-initiated, randomized, multi-center, clinical trial to be conducted in approximately 100 interventional cardiology centers in across the globe excluding USA. The study includes 2 x 2150 patients (i.e. 4300 patients) Randomization will occur at one month after the PCI procedure. The expected duration of participation for each patient is 14 months.

Eligibility criteria: Inclusion Criteria:

After index PCI, patients aged 18 years or more are eligible for inclusion into the study if the following criteria are met.

1. At least one among the HBR criteria (as defined below) is met.
2. All lesions are successfully treated with Ultimaster stent in the context of routine clinical care, i.e. post-procedural angiographic diameter stenosis \<20% by visual estimation
3. Free from any flow-limiting angiographic complications (i.e. significant untreated dissection or major side-branch occlusion), which require prolonged DAPT duration based on operator's opinion.
4. All stages of PCI are complete (if any) and no further PCI is planned.

At randomization visit (one month after index PCI), the following criteria must be met:

1. Fulfilment of at least one HBR criterion (as defined below), or on the basis of post-PCI actionable (i.e. requiring medical attention) non-access site related bleeding episode
2. Uneventful 30-day clinical course, i.e. free from spontaneous MI, symptomatic restenosis, stent thrombosis, stroke and any revascularization (coronary and non-coronary) requiring prolonged DAPT
3. If not on OAC,

   1. Patient is on a DAPT regimen of aspirin and a P2Y12 inhibitor
   2. Patient with one type of P2Y12 inhibitor for at least 7 days (i.e. no switching between oral P2Y12 inhibitors has occurred in the previous 7 days)
4. If on OAC

   1. Patient is on the same type of OAC (e.g. Vitamin K antagonist or NOAC) for at least 7 days
   2. Patient is on clopidogrel for at least 7 days

Definition of HBR

Post-PCI patients are at HBR if at least one of the following criteria applies:

* Clinical indication for treatment with oral anticoagulants (OAC) for at least 12 months
* Recent (\<12 months) non-access site bleeding episode(s), which required medical attention (i.e. actionable bleeding).
* Previous bleeding episode(s) which required hospitalization if the underlying cause has not been definitively treated (i.e. surgical removal of the bleeding source)
* Age equal or greater than 75 years
* Systemic conditions associated with an increased bleeding risk (e.g. haematological disorders, including a history of or current thrombocytopaenia defined as a platelet count \<100,000/mm3 (\<100 x 109/L), or any known coagulation disorder associated with increased bleeding risk.
* Documented anaemia defined as repeated haemoglobin levels \<11 g/dl or transfusion within 4 weeks before randomization.
* Need for chronic treatment with steroids or non-steroidal anti-inflammatory drugs
* Diagnosed malignancy (other than skin) considered at high bleeding risk including gastro-intestinal, genito-urethral/renal and pulmonary.
* Stroke at any time or TIA in the previous 6 months
* PRECISE DAPT score of 25 or greater

Exclusion Criteria:

1. Treated with stents other than Ultimaster stent within 6 months prior to index procedure
2. Treated for in-stent restenosis or stent thrombosis at index PCI or within 6 months before
3. Treated with a bioresorbable scaffold at any time prior to index procedure
4. Cannot provide written informed consent
5. Under judicial protection, tutorship or curatorship
6. Unable to understand and follow study-related instructions or unable to comply with study protocol
7. Active bleeding requiring medical attention (BARC≥2) on randomization visit
8. Life expectancy less than one year
9. Known hypersensitivity or allergy for aspirin, clopidogrel, ticagrelor, prasugrel, cobalt chromium or sirolimus
10. Any planned and anticipated PCI
11. Participation in another trial
12. Pregnant or breast feeding women

Primary outcomes:
measure: Net adverse clinical endpoints (NACE) defined as a composite of all-cause death, myocardial infarction, stroke and bleeding events defined as BARC 3 or 5
timeFrame: 11 months
measure: Major adverse cardiac and cerebral events (MACCE) defined as a composite of all-cause death, myocardial infarction and stroke
timeFrame: 11 months
measure: Major or clinically relevant non-major bleeding (MCB) defined as a composite of type 2, 3 and 5 BARC bleeding events
timeFrame: 11 months
Secondary outcomes:
measure: All cause death
timeFrame: 14 months
measure: Death from cardiovascular causes
timeFrame: 14 months
measure: Myocardial infarction
timeFrame: 14 months
measure: Stroke
timeFrame: 14 months
measure: Bleeding events
timeFrame: 14 months
measure: Definite or probable stent thrombosis
timeFrame: 14 months
measure: Any target vessel revascularization
timeFrame: 14 months
measure: Urgent target vessel revascularization
timeFrame: 14 months
measure: Urgent non-target vessel revascularization
timeFrame: 14 months
measure: Clinically indicated non-target vessel revascularization
timeFrame: 14 months
measure: Transfusion rates both in patients with and/or without clinically detected over bleeding
timeFrame: 14 months
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Buenos Aires Research center
city: Buenos Aires
country: Argentina
facility: Interventional Cardiology Sanatorio
city: Chermside
country: Australia
facility: The Prince Charles Hospital
city: Melbourne
country: Australia
facility: St Vincents Hospital Melbourne
city: Perth
country: Australia
facility: Research Center Perth
city: Sydney
country: Australia
facility: Research Center Sydney
city: Wollongong
country: Australia
facility: Wollongong Research Center
city: Wien
country: Austria
facility: Research Center , 043-02
city: Wien
country: Austria
facility: Research Center, 043-01
city: Manama
country: Bahrain
facility: Research Centre Manama
city: Dhaka
country: Bangladesh
facility: Dhaka Research Center
city: Aalst
country: Belgium
facility: Research Center Aalst
city: Bonheiden
country: Belgium
facility: Research Center Bonheiden
city: Bruxelles
country: Belgium
facility: CHU st.Pierre
city: Charleroi
country: Belgium
facility: Research Centre Charleroi
city: Hasselt
country: Belgium
facility: Research Center Hasselt
city: Liège
country: Belgium
facility: Research Centre Liège
city: Plovdiv
country: Bulgaria
facility: MHAT Sveta Karidad Plovdiv
city: Sofia
country: Bulgaria
facility: Sofia Resaerch Center, 359-02
city: Sofia
country: Bulgaria
facility: Sofia Research Center, 359-01
city: Sofia
country: Bulgaria
facility: Sofia Research Center, 359-03
city: Brno
country: Czechia
facility: Research Center Brno
city: Praha
country: Czechia
facility: Research Center Phraha
city: Roskilde
country: Denmark
facility: Research Center Roskilde
city: Tallinn
country: Estonia
facility: Research Center Tallinn
city: Annecy
country: France
facility: Research Center Annecy
city: Caen
country: France
facility: Hospital Prive Saint Martin
city: Caen
country: France
facility: Research Centre Caen
city: Créteil
country: France
facility: Research Centre Créteil
city: Dijon
country: France
facility: Research Center Dijon
city: Marseille
country: France
facility: Hopital de la Timone
city: Massy
country: France
facility: Research Center Massy
city: Metz
country: France
facility: Hospital de Mercy
city: Montauban
country: France
facility: Research Center Montauban
city: Montpellier
country: France
facility: Research Centre Montpellier
city: Nantes
country: France
facility: Research Center Nantes
city: Nîmes
country: France
facility: CHU Nimes
city: Paris
country: France
facility: Research Center Paris, 033-05
city: Paris
country: France
facility: Research Center Paris, 033-06
city: Rouen
country: France
facility: Research Centre Rouen
city: Saint-Denis
country: France
facility: Research Center Saint-Denis
city: Homburg
country: Germany
facility: Saarland University
city: Landshut
country: Germany
facility: Cardiology Clinic
city: Budapest
country: Hungary
facility: Research Centre Budapest
city: Szeged
country: Hungary
facility: Research Center Szeged
city: Chennai
country: India
facility: Research Center Chennai, 091-01
city: Chennai
country: India
facility: Research Center Chennai, 091-05
city: Coimbatore
country: India
facility: Research Center Coimbatore
city: Sūrat
country: India
facility: Research Center Surat
city: Haifa
country: Israel
facility: Research Center Haifa
city: Jerusalem
country: Israel
facility: Research Center Jerusalem
city: Petah tikva
country: Israel
facility: Rabin MC
city: Safed
country: Israel
facility: Research Center Safed
city: Andria
country: Italy
facility: Ospedale Lorenzo Bonomo
city: Cagliari
country: Italy
facility: Azienda Ospedaliera Brotzu
city: Caserta
country: Italy
facility: Second university of Naples Monaldi Hospital
city: Catania
country: Italy
facility: Research Center Catania
city: Messina
country: Italy
facility: AOU Policlinico Gaetano Martino
city: Milan
country: Italy
facility: Niguarda
city: Milan
country: Italy
facility: Research Center Milan, 039-01
city: Milan
country: Italy
facility: Research Center Milan, 039-04
city: Milan
country: Italy
facility: Research Center Milan, 039-11
city: Milan
country: Italy
facility: San Donato Hospital
city: Roma
country: Italy
facility: Ospedale Sandro Pertini
city: Rome
country: Italy
facility: Policlinico Casilino
city: Rome
country: Italy
facility: Policlinico Umberto I
city: Rozzano
country: Italy
facility: Research Center Rozzano
city: Treviglio
country: Italy
facility: Clinic Cardiology
city: Vimercate
country: Italy
facility: Research Center Vimercate
city: Fukuoka
country: Japan
facility: Kokura Memorial Hospital
city: Gifu
country: Japan
facility: Research Center Gifu
city: Ichinomiya
country: Japan
facility: Ichinomiya Municipal Hospital
city: Kawasaki
country: Japan
facility: St.Marianna University School of Medicine
city: Nagakute
country: Japan
facility: Aichi Medical University Hospital
city: Nagoya
country: Japan
facility: Japan Red Cross Nagoya Daiichi Hospital (1st)
city: Nagoya
country: Japan
facility: Japan Red Cross Nagoya Daini Hospital (2nd)
city: Nagoya
country: Japan
facility: Nagoya University Hospital
city: Osaka
country: Japan
facility: Osaka police Hospital
city: Tokyo
country: Japan
facility: St.Luke's International Hospital
city: Toyoake
country: Japan
facility: Research Center Toyoake
city: Seoul
country: Korea, Republic of
facility: Research Center Seoul
city: 's Hertogenbosch
country: Netherlands
facility: Research Center Den Bosch
city: Arnhem
country: Netherlands
facility: Research Centre Arnhem
city: Breda
country: Netherlands
facility: Research Center Breda
city: Dordrecht
country: Netherlands
facility: Research Centre Dordrecht
city: Eindhoven
country: Netherlands
facility: Research Centre Eindhoven
city: Emmen
country: Netherlands
facility: Research Center Emmen
city: Enschede
country: Netherlands
facility: Research Centre Enschede
city: Nieuwegein
country: Netherlands
facility: Antonius ziekenhuis
city: Rotterdam
country: Netherlands
facility: Research Center Rotterdam
city: Terneuzen
country: Netherlands
facility: Research Centre Terneuzen
city: The Hague
country: Netherlands
facility: Haga Hospital
city: Skopje
country: North Macedonia
facility: Research Center Skopje
city: Krakow
country: Poland
facility: University Hospital Krakow
city: Kraków
country: Poland
facility: Research Center Krakow
city: Lubin
country: Poland
facility: Miedziowe Centrum Zdrowia SA
city: Poznań
country: Poland
facility: Research Center Poznan
city: Wrocław
country: Poland
facility: Research Centre Wroclaw
city: Jeddah
country: Saudi Arabia
facility: Research Center Jeddah
city: Riyadh
country: Saudi Arabia
facility: Research Center Riyadh
city: Belgrade
country: Serbia
facility: Researcg Center Belgrade, 381-02
city: Belgrade
country: Serbia
facility: Research Center of Serbia, 381-01
city: Sremska Kamenica
country: Serbia
facility: Research Center Sremska Kamenica
city: Singapore
country: Singapore
facility: Singapore Research Center
city: Singapore
country: Singapore
facility: Tan Tock Seng Hospital
city: Ljubljana
country: Slovenia
facility: Ljubljana Research Center
city: Alicante
country: Spain
facility: Research Center Alicante
city: Barcelona
country: Spain
facility: Research Center Barcelona, 034-07
city: Barcelona
country: Spain
facility: Research Center Barcelona, 034-09
city: El Palmar
country: Spain
facility: Universitario Virgen de la Arrixaca
city: Huelva
country: Spain
facility: Research Center Huelva
city: Madrid
country: Spain
facility: Hospital Universitario Puerta de hierro
city: Madrid
country: Spain
facility: Research Center Madrid, 034-06
city: Madrid
country: Spain
facility: Research Center Madrid, 034-10
city: Santander
country: Spain
facility: Hospital Universitario Valdecilla
city: Vigo
country: Spain
facility: Research Center Vigo
city: Gävle
country: Sweden
facility: Research Center Gavle
city: Örebro
country: Sweden
facility: Research Center Orebro
city: Bern
country: Switzerland
facility: Lindenhofspital
city: Bern
country: Switzerland
facility: Research Centre Bern
city: Fribourg
country: Switzerland
facility: Research Centre Fribourg
city: Geneva
country: Switzerland
facility: University Hospital Geneva
city: Liestal
country: Switzerland
facility: Research Centre Liestal
city: Lugano
country: Switzerland
facility: Research Centre Lugano
city: Zürich
country: Switzerland
facility: Research Centre Zürich
city: Blackburn
country: United Kingdom
facility: Research Center Blackburn
city: Bournemouth
country: United Kingdom
facility: Research Center Bournemouth
city: Brighton
country: United Kingdom
facility: Research Centre Brighton
city: Bristol
country: United Kingdom
facility: Bristol Heart Institute
city: Derry
country: United Kingdom
facility: Altnagelvin Hospital
city: London
country: United Kingdom
facility: St George's Hospital
city: Manchester
country: United Kingdom
facility: Manchester Research Center
city: Newcastle Upon Tyne
country: United Kingdom
facility: Research Center Newcastle
city: Stevenage
country: United Kingdom
facility: Research Center Stevenage
city: Stoke-on-Trent
country: United Kingdom
facility: Research Centre Stoke-on-Trent
city: Wolverhampton
country: United Kingdom
facility: Research Centre Wolverhampton
city: Worcester
country: United Kingdom
facility: Research Centre Worcester
city: Hanoi
country: Vietnam
facility: Vietnam National Heart Institute
Study officials:
affiliation: Cardiocentro Ticino Foundation, Lugano, Switzerland
name: M. Valgimigli, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Maasstad Ziekenhuis Rotterdam, The Netherlands
name: P. Smits, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: ECRI bv
name: E. Spitzer, Dr.
role: STUDY_DIRECTOR
References:
citation: Authors/Task Force members; Windecker S, Kolh P, Alfonso F, Collet JP, Cremer J, Falk V, Filippatos G, Hamm C, Head SJ, Juni P, Kappetein AP, Kastrati A, Knuuti J, Landmesser U, Laufer G, Neumann FJ, Richter DJ, Schauerte P, Sousa Uva M, Stefanini GG, Taggart DP, Torracca L, Valgimigli M, Wijns W, Witkowski A. 2014 ESC/EACTS Guidelines on myocardial revascularization: The Task Force on Myocardial Revascularization of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS)Developed with the special contribution of the European Association of Percutaneous Cardiovascular Interventions (EAPCI). Eur Heart J. 2014 Oct 1;35(37):2541-619. doi: 10.1093/eurheartj/ehu278. Epub 2014 Aug 29. No abstract available.
citation: Roffi M, Patrono C, Collet JP, Mueller C, Valgimigli M, Andreotti F, Bax JJ, Borger MA, Brotons C, Chew DP, Gencer B, Hasenfuss G, Kjeldsen K, Lancellotti P, Landmesser U, Mehilli J, Mukherjee D, Storey RF, Windecker S; ESC Scientific Document Group. 2015 ESC Guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation: Task Force for the Management of Acute Coronary Syndromes in Patients Presenting without Persistent ST-Segment Elevation of the European Society of Cardiology (ESC). Eur Heart J. 2016 Jan 14;37(3):267-315. doi: 10.1093/eurheartj/ehv320. Epub 2015 Aug 29. No abstract available.
citation: Levine GN, Bates ER, Bittl JA, Brindis RG, Fihn SD, Fleisher LA, Granger CB, Lange RA, Mack MJ, Mauri L, Mehran R, Mukherjee D, Newby LK, O'Gara PT, Sabatine MS, Smith PK, Smith SC, Jr. 2016 ACC/AHA Guideline Focused Update on Duration of Dual Antiplatelet Therapy in Patients With Coronary Artery Disease: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines: An Update of the 2011 ACCF/AHA/SCAI Guideline for Percutaneous Coronary Intervention, 2011 ACCF/AHA Guideline for Coronary Artery Bypass Graft Surgery, 2012 ACC/AHA/ACP/AATS/PCNA/SCAI/STS Guideline for the Diagnosis and Management of Patients With Stable Ischemic Heart Disease, 2013 ACCF/AHA Guideline for the Management of ST-Elevation Myocardial Infarction, 2014 AHA/ACC Guideline for the Management of Patients With Non-ST-Elevation Acute Coronary Syndromes, and 2014 ACC/AHA Guideline on Perioperative Cardiovascular Evaluation and Management of Patients Undergoing Noncardiac Surgery. Circulation 2016
citation: Smits PC, Frigoli E, Vranckx P, Ozaki Y, Morice MC, Chevalier B, Onuma Y, Windecker S, Tonino PAL, Roffi M, Lesiak M, Mahfoud F, Bartunek J, Hildick-Smith D, Colombo A, Stankovic G, Iniguez A, Schultz C, Kornowski R, Ong PJL, Alasnag M, Rodriguez AE, Paradies V, Kala P, Kedev S, Al Mafragi A, Dewilde W, Heg D, Valgimigli M; MASTER DAPT Investigators. Abbreviated Antiplatelet Therapy After Coronary Stenting in Patients With Myocardial Infarction at High Bleeding Risk. J Am Coll Cardiol. 2022 Sep 27;80(13):1220-1237. doi: 10.1016/j.jacc.2022.07.016.
citation: Valgimigli M, Frigoli E, Vranckx P, Ozaki Y, Morice MC, Chevalier B, Onuma Y, Windecker S, Delorme L, Kala P, Kedev S, Abhaichand RK, Velchev V, Dewilde W, Podolec J, Leibundgut G, Topic D, Schultz C, Stankovic G, Lee A, Johnson T, Tonino PAL, Klotzka A, Lesiak M, Lopes RD, Smits PC, Heg D; MASTER DAPT Investigators. Impact of Medication Nonadherence in a Clinical Trial of Dual Antiplatelet Therapy. J Am Coll Cardiol. 2022 Aug 23;80(8):766-778. doi: 10.1016/j.jacc.2022.04.065.
citation: Valgimigli M, Smits PC, Frigoli E, Bongiovanni D, Tijssen J, Hovasse T, Mafragi A, Ruifrok WT, Karageorgiev D, Aminian A, Garducci S, Merkely B, Routledge H, Ando K, Diaz Fernandez JF, Cuisset T, Nesa Malik FT, Halabi M, Belle L, Din J, Beygui F, Abhyankar A, Reczuch K, Pedrazzini G, Heg D, Vranckx P; MASTER DAPT Investigators. Duration of antiplatelet therapy after complex percutaneous coronary intervention in patients at high bleeding risk: a MASTER DAPT trial sub-analysis. Eur Heart J. 2022 Sep 1;43(33):3100-3114. doi: 10.1093/eurheartj/ehac284.
citation: Smits PC, Frigoli E, Tijssen J, Juni P, Vranckx P, Ozaki Y, Morice MC, Chevalier B, Onuma Y, Windecker S, Tonino PAL, Roffi M, Lesiak M, Mahfoud F, Bartunek J, Hildick-Smith D, Colombo A, Stankovic G, Iniguez A, Schultz C, Kornowski R, Ong PJL, Alasnag M, Rodriguez AE, Moschovitis A, Laanmets P, Heg D, Valgimigli M; MASTER DAPT Investigators. Abbreviated Antiplatelet Therapy in Patients at High Bleeding Risk With or Without Oral Anticoagulant Therapy After Coronary Stenting: An Open-Label, Randomized, Controlled Trial. Circulation. 2021 Oct 12;144(15):1196-1211. doi: 10.1161/CIRCULATIONAHA.121.056680. Epub 2021 Aug 29.
citation: Valgimigli M, Frigoli E, Heg D, Tijssen J, Juni P, Vranckx P, Ozaki Y, Morice MC, Chevalier B, Onuma Y, Windecker S, Tonino PAL, Roffi M, Lesiak M, Mahfoud F, Bartunek J, Hildick-Smith D, Colombo A, Stankovic G, Iniguez A, Schultz C, Kornowski R, Ong PJL, Alasnag M, Rodriguez AE, Moschovitis A, Laanmets P, Donahue M, Leonardi S, Smits PC; MASTER DAPT Investigators. Dual Antiplatelet Therapy after PCI in Patients at High Bleeding Risk. N Engl J Med. 2021 Oct 28;385(18):1643-1655. doi: 10.1056/NEJMoa2108749. Epub 2021 Aug 28.
citation: Vlieger S, Danzi GB, Kauer F, Oemrawsingh RM, Stojkovic S, IJsselmuiden AJJ, Routledge H, Laanmets P, Roffi M, Frobert O, Baello P, Wlodarczak A, Puentes A, Polad J, Hildick-Smith D. One-year performance of thin-strut cobalt chromium sirolimus-eluting stent versus thicker strut stainless steel biolimus-eluting coronary stent: a propensity-matched analysis of two international all-comers registries. Coron Artery Dis. 2021 Aug 1;32(5):391-396. doi: 10.1097/MCA.0000000000000958.
citation: Frigoli E, Smits P, Vranckx P, Ozaki Y, Tijssen J, Juni P, Morice MC, Onuma Y, Windecker S, Frenk A, Spaulding C, Chevalier B, Barbato E, Tonino P, Hildick-Smith D, Roffi M, Kornowski R, Schultz C, Lesiak M, Iniguez A, Colombo A, Alasnag M, Mullasari A, James S, Stankovic G, Ong PJL, Rodriguez AE, Mahfoud F, Bartunek J, Moschovitis A, Laanmets P, Leonardi S, Heg D, Sunnaker M, Valgimigli M. Design and rationale of the Management of High Bleeding Risk Patients Post Bioresorbable Polymer Coated Stent Implantation With an Abbreviated Versus Standard DAPT Regimen (MASTER DAPT) Study. Am Heart J. 2019 Mar;209:97-105. doi: 10.1016/j.ahj.2018.10.009. Epub 2018 Nov 22.