Ignite Creation Date:
2024-05-11 @ 8:31 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06409117
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-22
First Post:
2024-05-07
Brief Title:
3rd Generation Resorbable Magnesium Scaffolds vs Biodegradable Polymer Stents in NSTEACS
Sponsor:
Konstantinos Toutouzas
Organization:
National and Kapodistrian University of Athens
Study Overview
Official Title:
3rd Generation Resorbable Magnesium Scaffolds vs Biodegradable Polymer Drug Eluting Stents in Patients With Non ST-segment Elevation Acute Coronary Syndromes the RESORB-ACS Randomized Clinical Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a multicentre prospective randomized controlled trial that will investigate the role and performance of the 3rd generation resorbable magnesium scaffolds DREAMS 3G labeled under the name Freesolve vs contemporary biodegradable polymer scaffolds in non ST-segment elevation acute coronary syndromes Patients fulfilling the eligibility criteria will be enrolled and undergo PCI with either Freesolve or Orsiro platforms for the culprit lesion only They will be followed-up for 12 months 1 6 and 12 months The primary endopoint will be Target Lesion Failure as defined by ARC definitions
Detailed Description:
INTRODUCTION AND RATIONALE Scaffolding the coronary vessels while maintaining the physiological and rheological properties was an appealing idea resulting in the development of the bioresorbable scaffolds BRS The most thoroughly studied BRS - the poly-L-lactide acid based BRS ABSORB - evidenced increased rates of device-related adverse events in the randomized controlled trials RCT and was removed from market in 2017 ABSORB was an everolimus eluting BRS characterized by limited radial force thicker and wider struts unfavorable crossing profile and unpredictable resorption
In an effort to overcome these obstacles metallic resorbable scaffolds were developed - with the main representative being the resorbable magnesium scaffolds RMS The absorbable metal stent AMS BIOTRONIK AG Bülach Switzerland was the first device tested in the PROGRESS-AMS trial showing feasibility but necessity for improvement DREAMS 1G BIOTRONIK AG Bülach Switzerland was the first generation of the improved RMS designed to improve radial force and coated with a paclitaxel-polymer matrix It was studied in the BIOSOLVE-I and showed improved performance compared to the AMS with no probable or definite scaffold thrombosis however late-lumen-loss LLL was relatively high compared to ABSORB scaffolds and contemporary drug eluting stents DES
The second generation was the DREAMS 2G BIOTRONIK AG Bülach Switzerland gaining CE-Mark in 2016 and marketed as Magmaris It is designed with more flexible and stronger scaffold backbone targeting in improved radial force with 150x140μm strut thickness The drug-polymer coating was substituted by the sirolimus BIOlute matrix of the Orsiro DES to decrease more effectively neointimal formation Also radiopaque markers were added for enhanced x-ray visibility The outcomes of Magmaris have been investigated in the BIOSOLVE II III IV trials In summary BIOSOLVE II and III demonstrated no scaffold thrombosis with improved LLL improved to its precursor and BIOSOLVE IV exhibited low event rates in a large single-arm study
The concept of protecting the vulnerable eroded or ruptured plaque without a permanent metallic endoprosthesis finds ideal application in the acute coronary syndromes Culprit lesions present as a ruptured plaque plaque erosion or less frequently as a calcific nodule complicated by thrombotic burden and implantation of a BRS may adequately revascularize the vessel protect the lesion and be resorbed after vessel healing restoring its elastic and hydraulic properties However the high thrombotic status of an acute coronary syndrome ACS was preventing BRS of being utilized in such situations The TROFI-II RCT compared the ABSORB scaffold with DES in ST-segment elevation myocardial infarction STEMI and 6-month results were comparable The Magmaris was tested in STEMI patients in the MAGSTEMI RCT and showed significantly higher vasodilatory response at 1-year compared to Orsiro Furthermore Magmaris did not raise thrombotic concerns but resulted in higher target lesion revascularization TLR rates although not powered for those endpoints The BESTMAG trial was a small propensity-matching study providing hypothesis generating outcomes of numerically higher TLR rates with Magmaris compared to contemporary biodegradable polymer BP or durable polymer DP-DES in STEMI presentations The BIOSOLVE IV registry n206 underwent PCI because of non ST-segment elevation NSTE myocardial infarction and target vessel failure TVL was calculated at 61 in 12 months One death 05 and 2 thrombotic complications were reported 1 Smaller registries that included NSTEACS patients treated with Magmaris RMS demonstrated zero deaths and scaffold thrombosis albeit these are hypothesis generating results limited by the small sample
The BIOMAG-I first-in-human study investigated the third generation Freesolve RMS The main characteristics are a refined magnesium alloy to enhance scaffolding properties increased scaffold marker x-ray visibility larger size range thinner strut thickness and predictable full resorption in about 12 months The 1-year results of the BIOMAG-I showed lower LLL 38 lower than the BIOSOLVE II low target lesion failure TLF rates and no death target vessel myocardial infarction MI or scaffold thrombosis Of note no struts ware visible in the 1-year optical coherence tomography OCT 207 of the patients presented with NSTE myocardial infarction lesions and were treated accordingly
The current guidelines of the European Society of Cardiology recommend use of the BRS only in the context of clinical trials However more data and devices are available to hypothesize that RMS may provide a potentially reliable and safe alternative to DES This trial will further investigate and evaluate the safety and efficacy of the 3rd generation Freesolve RMS in NSTEACS patients
STUDY PROCEDURES Screening Patients who will undergo coronary angiography because of NSTEACS will be screened for eligibility criteria after signing the informed consent Demographics medical history clinical examination 12-lead electrocardiogram and per local practice blood laboratory tests will be performed For women of child-bearing potential a blood pregnancy test must be performed
Randomization - enrolment Patients screened and fulfilling eligibility criteria will be enrolled after signing the informed consent form as per RESORB-ACS enrolment and follow-up algorithms Figure 1 They will be randomly assigned in 11 ratio to receive either the Freesolve RMS or the BP DES Orsiro for the PCI of the index NSTEACS culprit vessel The Intention to Treat ITT and the Per Protocol PP population will only be based on enrolled subjects
Index PCI All patients enrolled will undergo PCI of the culprit lesion according on the local practice The instruction for use IFU will be followed for every scaffold implantation In the BP DES arm the standard DES PCI procedure per local practice will be followed
Post-procedural care Patients enrolled that have undergone PCI will receive standard NSTEACS and post-PCI care in each centre Double antiplatelet treatment is recommended for at least 12 months
Follow-up Follow-up will be performed at 1 6 12 months and annually up to 36 months follow-up visit window 10 days In case that there is no adverse event or complaint from the patient that requires physical examination the follow-up visits may be conducted through telephone or video call with the investigators
Study exit Screen failure withdrawal of the informed consent lost to follow-up and PCI without scaffold implantation will result in early termination
Study completion Subject who completes all protocol-required study procedures and follow-ups will complete the trial
Examinations Clinical examination including angina status or myocardial ischemia 12-lead electrocardiogram and per local practice blood laboratory tests including will be performed at screening and during hospitalization post-PCI Follow-ups will be clinically driven with thorough history primarily focused on any possible myocardial ischemia symptoms Based on the investigators - treating physicians clinical suspicion more examination may be performed to investigate the existence of adverse eventsendpoints
PROCEDURAL DETAILS The device The Freesolve scaffold is a Magnesium alloy fully resorbable scaffold developed by BIOTRONIC and represents the 3rd generation of RMS DREAMS 3G It is indicated for improving the luminal diameter for treatment of de novo coronary artery lesions by PCI
Freesolve is a scaffold system consisting of a balloon-expandable bioabsorbable scaffold pre-mounted on the balloon of a rapid-exchange PTCA catheter The scaffold backbone is made from bioabsorbable Magnesium and contains two permanent x-ray markers made from Tantalum on the distal and on the proximal scaffold end respectively The surface of the scaffold backbone is completely coated with bioresorbable PLLA Poly-L-Lactidic Acid which incorporates Sirolimus Sirolimus load is 14 03 μg per mm2 scaffold surface The DREAMS 3G scaffold system is packaged in a dispenser The dispenser is placed in an aluminium Tyvek pouch The device is sterilized using ethylene oxide sterilization In vivo investigations using a porcine model show that DREAMS 3G provides vessel support for about 3-6 months and releases around 70 Sirolimus from the PLLA carrier during a period of 3 months after implantation The drug coating is based on the BIOlute platform
Training The operators and the operating teams that are going to participate in this protocol and implant the RMS have to be trained on the consensus paper by Fajadet et al and follow the 4P principles
Device implantation - procedure The RMS Freesolve is available in 25mm 3mm 35mm and 4mm diameter and in 13mm 22mm length for all diameters and 26mm30mm length for the 3mm 35 mm and 4mm diameters It can be expander after post-dilatation up to 06mm in diameter Nominal pressure for implantation inflation is 10atm and rated burst pressure 16atm It is delivered through 6Fr guiding catheter and over angioplasty 0014 wires
Following intracoronary injection of nitroglycerin or isosorbide dinitrate a baseline angiography of the target vessel must be performed in at least 2 orthogonal views presenting the target lesion free of foreshortening or vessel overlap In addition to the clinical routine OCT and intravascular ultrasound IVUS documentation may be done pre-PCI per operators discretion By intravascular imaging detailed examination of the lesion as well as accurate length and reference diameter can be performed
Lesion access is up to the discretion of the investigator Pre-dilatation of the target lesion is mandatory The use of intravascular lithotripsy drug coated balloons or rotationalorbital atherectomy device is not allowed Pre-dilatation with a non-compliant balloon with a 11 balloon-to-artery ratio is mandatory The balloon should expand fully with no waist at full expansion Non-compliant balloons are more predictable and are recommended The residual stenosis before the RMS implantation is required to be 20 confirmed by any method and TIMI flow should be III
The scaffold length should cover the target lesion from normal reference vessel diameter proximally to normal vessel distally to assure full coverage of the lesion The diameter of the RMS should be chosen as following 25mm for 25-27mm distal reference diameter DRD 30mm for 27-32mm DRD 35mm for 32-37mm DRD 40mm for 37-42 DRD The length should be chosen based on the lesion length by angiography or IVUS OCT Only one clinical investigation scaffold should be used per lesion After scaffold implantation an angiography must be performed following intracoronary injection of nitroglycerine or isosorbide dinitrate Post-dilatation with a non-compliant balloon of up to 05 mm larger than the nominal scaffold size and at high pressure 16 atm is mandatory The use of cuttingscoring or drug coated balloons after RMS implantation is not allowed After post-dilatation all subjects will undergo the routine angiography and possibly OCTIVUS Intravascular imaging may evaluate expansion apposition and any possible edge or in-scaffold complication
Culprit lesion In NSTEACS identification of the culprit lesion might be challenging Investigational data with cardiac magnetic resonance imaging identification has showed that in up to 27 of the NSTEACS patients revascularization has been performed in non-culprit lesions Moreover electrocardiographic identification is neither sensitive nor specific and recent data demonstrated that in 14 of the studied patients conventional angiography failed to identify the culprit lesion In those ambiguous cases intravascular imaging with IVUS or OCT plays a critical role in the characterization and identification of the culprit lesion In the RESORB-ACS trial operators will decide about the possible culprit lesion and that decision may be assisted and guided by intravascular imaging in case it is needed
Multivessel disease Multivessel disease is not an exclusion criterion except for the cases that CABG is programmed Enrolled subjects may undergo PCI with RMS only for the culprit lesion during the index procedure However in cases that multivessel disease amenable to PCI is present operators can proceed to full revascularization with conservative DES or Freesolve RMS
Treatment failure and bailout situation For dissections occurring during or immediately after implantation of RMS a second RMS may be used not overlapping with initial one but implanted end-to- end If another stent needs to be implanted in the immediate vicinity of an already implanted RMS only a Freesolve coronary scaffold system should be used Contact of the Freesolve with an uncoated or polymer coated stent up to 120 days may result in accelerated resorption of the DREAMS 3G and undesired local and downstream effects After 120 days any other stent type may be used In case of bailout If a Freesolve is not possible to be used an Orsiro DES with its proBIO passive coating and BIOlute active coating is recommended to be implanted directly adjacent or minimally overlapping based on the consensus recommendations
Medication Every patient included in this trial must be able to receive 12-month DAPT with aspirin and clopidogrel or ticagrelor or prasugrel The timing and necessity in case the patient was already under antiplatelet treatment will be at the discretion of the treating physician At all cases DAPT must be present at the time of the implantation based on the ESC guidelines doses for the management of ACS The use of anticoagulation during PCI heparin or enoxaparine at therapeutic dose for PCI will be chosen by the operators IIbIIIa glycoprotein inhibitors as well as vasomotor medications will be left at operators discretion After the PCI all patients must receive at least 12-month DAPT After 12 months DAPT may be changed to single treatment with aspirinclopidogrelticagrelorprasugrel or prolonged based on the balance of ischemichemorrhagic risk of the patient Regarding patients receiving oral anticoagulation eg atrial fibrillation prosthetic valve thrombophilia we recommend that DAPT should be maintained until 1-month follow-up Afterwards DAPT can be downsized to either aspirin or clopidogrel alone combined with oral anticoagulant for the remaining time period up to 12 months After 12 months monotherapy with oral anticoagulant may be prescribed and continued indefinitely
In an effort to overcome these obstacles metallic resorbable scaffolds were developed - with the main representative being the resorbable magnesium scaffolds RMS The absorbable metal stent AMS BIOTRONIK AG Bülach Switzerland was the first device tested in the PROGRESS-AMS trial showing feasibility but necessity for improvement DREAMS 1G BIOTRONIK AG Bülach Switzerland was the first generation of the improved RMS designed to improve radial force and coated with a paclitaxel-polymer matrix It was studied in the BIOSOLVE-I and showed improved performance compared to the AMS with no probable or definite scaffold thrombosis however late-lumen-loss LLL was relatively high compared to ABSORB scaffolds and contemporary drug eluting stents DES
The second generation was the DREAMS 2G BIOTRONIK AG Bülach Switzerland gaining CE-Mark in 2016 and marketed as Magmaris It is designed with more flexible and stronger scaffold backbone targeting in improved radial force with 150x140μm strut thickness The drug-polymer coating was substituted by the sirolimus BIOlute matrix of the Orsiro DES to decrease more effectively neointimal formation Also radiopaque markers were added for enhanced x-ray visibility The outcomes of Magmaris have been investigated in the BIOSOLVE II III IV trials In summary BIOSOLVE II and III demonstrated no scaffold thrombosis with improved LLL improved to its precursor and BIOSOLVE IV exhibited low event rates in a large single-arm study
The concept of protecting the vulnerable eroded or ruptured plaque without a permanent metallic endoprosthesis finds ideal application in the acute coronary syndromes Culprit lesions present as a ruptured plaque plaque erosion or less frequently as a calcific nodule complicated by thrombotic burden and implantation of a BRS may adequately revascularize the vessel protect the lesion and be resorbed after vessel healing restoring its elastic and hydraulic properties However the high thrombotic status of an acute coronary syndrome ACS was preventing BRS of being utilized in such situations The TROFI-II RCT compared the ABSORB scaffold with DES in ST-segment elevation myocardial infarction STEMI and 6-month results were comparable The Magmaris was tested in STEMI patients in the MAGSTEMI RCT and showed significantly higher vasodilatory response at 1-year compared to Orsiro Furthermore Magmaris did not raise thrombotic concerns but resulted in higher target lesion revascularization TLR rates although not powered for those endpoints The BESTMAG trial was a small propensity-matching study providing hypothesis generating outcomes of numerically higher TLR rates with Magmaris compared to contemporary biodegradable polymer BP or durable polymer DP-DES in STEMI presentations The BIOSOLVE IV registry n206 underwent PCI because of non ST-segment elevation NSTE myocardial infarction and target vessel failure TVL was calculated at 61 in 12 months One death 05 and 2 thrombotic complications were reported 1 Smaller registries that included NSTEACS patients treated with Magmaris RMS demonstrated zero deaths and scaffold thrombosis albeit these are hypothesis generating results limited by the small sample
The BIOMAG-I first-in-human study investigated the third generation Freesolve RMS The main characteristics are a refined magnesium alloy to enhance scaffolding properties increased scaffold marker x-ray visibility larger size range thinner strut thickness and predictable full resorption in about 12 months The 1-year results of the BIOMAG-I showed lower LLL 38 lower than the BIOSOLVE II low target lesion failure TLF rates and no death target vessel myocardial infarction MI or scaffold thrombosis Of note no struts ware visible in the 1-year optical coherence tomography OCT 207 of the patients presented with NSTE myocardial infarction lesions and were treated accordingly
The current guidelines of the European Society of Cardiology recommend use of the BRS only in the context of clinical trials However more data and devices are available to hypothesize that RMS may provide a potentially reliable and safe alternative to DES This trial will further investigate and evaluate the safety and efficacy of the 3rd generation Freesolve RMS in NSTEACS patients
STUDY PROCEDURES Screening Patients who will undergo coronary angiography because of NSTEACS will be screened for eligibility criteria after signing the informed consent Demographics medical history clinical examination 12-lead electrocardiogram and per local practice blood laboratory tests will be performed For women of child-bearing potential a blood pregnancy test must be performed
Randomization - enrolment Patients screened and fulfilling eligibility criteria will be enrolled after signing the informed consent form as per RESORB-ACS enrolment and follow-up algorithms Figure 1 They will be randomly assigned in 11 ratio to receive either the Freesolve RMS or the BP DES Orsiro for the PCI of the index NSTEACS culprit vessel The Intention to Treat ITT and the Per Protocol PP population will only be based on enrolled subjects
Index PCI All patients enrolled will undergo PCI of the culprit lesion according on the local practice The instruction for use IFU will be followed for every scaffold implantation In the BP DES arm the standard DES PCI procedure per local practice will be followed
Post-procedural care Patients enrolled that have undergone PCI will receive standard NSTEACS and post-PCI care in each centre Double antiplatelet treatment is recommended for at least 12 months
Follow-up Follow-up will be performed at 1 6 12 months and annually up to 36 months follow-up visit window 10 days In case that there is no adverse event or complaint from the patient that requires physical examination the follow-up visits may be conducted through telephone or video call with the investigators
Study exit Screen failure withdrawal of the informed consent lost to follow-up and PCI without scaffold implantation will result in early termination
Study completion Subject who completes all protocol-required study procedures and follow-ups will complete the trial
Examinations Clinical examination including angina status or myocardial ischemia 12-lead electrocardiogram and per local practice blood laboratory tests including will be performed at screening and during hospitalization post-PCI Follow-ups will be clinically driven with thorough history primarily focused on any possible myocardial ischemia symptoms Based on the investigators - treating physicians clinical suspicion more examination may be performed to investigate the existence of adverse eventsendpoints
PROCEDURAL DETAILS The device The Freesolve scaffold is a Magnesium alloy fully resorbable scaffold developed by BIOTRONIC and represents the 3rd generation of RMS DREAMS 3G It is indicated for improving the luminal diameter for treatment of de novo coronary artery lesions by PCI
Freesolve is a scaffold system consisting of a balloon-expandable bioabsorbable scaffold pre-mounted on the balloon of a rapid-exchange PTCA catheter The scaffold backbone is made from bioabsorbable Magnesium and contains two permanent x-ray markers made from Tantalum on the distal and on the proximal scaffold end respectively The surface of the scaffold backbone is completely coated with bioresorbable PLLA Poly-L-Lactidic Acid which incorporates Sirolimus Sirolimus load is 14 03 μg per mm2 scaffold surface The DREAMS 3G scaffold system is packaged in a dispenser The dispenser is placed in an aluminium Tyvek pouch The device is sterilized using ethylene oxide sterilization In vivo investigations using a porcine model show that DREAMS 3G provides vessel support for about 3-6 months and releases around 70 Sirolimus from the PLLA carrier during a period of 3 months after implantation The drug coating is based on the BIOlute platform
Training The operators and the operating teams that are going to participate in this protocol and implant the RMS have to be trained on the consensus paper by Fajadet et al and follow the 4P principles
Device implantation - procedure The RMS Freesolve is available in 25mm 3mm 35mm and 4mm diameter and in 13mm 22mm length for all diameters and 26mm30mm length for the 3mm 35 mm and 4mm diameters It can be expander after post-dilatation up to 06mm in diameter Nominal pressure for implantation inflation is 10atm and rated burst pressure 16atm It is delivered through 6Fr guiding catheter and over angioplasty 0014 wires
Following intracoronary injection of nitroglycerin or isosorbide dinitrate a baseline angiography of the target vessel must be performed in at least 2 orthogonal views presenting the target lesion free of foreshortening or vessel overlap In addition to the clinical routine OCT and intravascular ultrasound IVUS documentation may be done pre-PCI per operators discretion By intravascular imaging detailed examination of the lesion as well as accurate length and reference diameter can be performed
Lesion access is up to the discretion of the investigator Pre-dilatation of the target lesion is mandatory The use of intravascular lithotripsy drug coated balloons or rotationalorbital atherectomy device is not allowed Pre-dilatation with a non-compliant balloon with a 11 balloon-to-artery ratio is mandatory The balloon should expand fully with no waist at full expansion Non-compliant balloons are more predictable and are recommended The residual stenosis before the RMS implantation is required to be 20 confirmed by any method and TIMI flow should be III
The scaffold length should cover the target lesion from normal reference vessel diameter proximally to normal vessel distally to assure full coverage of the lesion The diameter of the RMS should be chosen as following 25mm for 25-27mm distal reference diameter DRD 30mm for 27-32mm DRD 35mm for 32-37mm DRD 40mm for 37-42 DRD The length should be chosen based on the lesion length by angiography or IVUS OCT Only one clinical investigation scaffold should be used per lesion After scaffold implantation an angiography must be performed following intracoronary injection of nitroglycerine or isosorbide dinitrate Post-dilatation with a non-compliant balloon of up to 05 mm larger than the nominal scaffold size and at high pressure 16 atm is mandatory The use of cuttingscoring or drug coated balloons after RMS implantation is not allowed After post-dilatation all subjects will undergo the routine angiography and possibly OCTIVUS Intravascular imaging may evaluate expansion apposition and any possible edge or in-scaffold complication
Culprit lesion In NSTEACS identification of the culprit lesion might be challenging Investigational data with cardiac magnetic resonance imaging identification has showed that in up to 27 of the NSTEACS patients revascularization has been performed in non-culprit lesions Moreover electrocardiographic identification is neither sensitive nor specific and recent data demonstrated that in 14 of the studied patients conventional angiography failed to identify the culprit lesion In those ambiguous cases intravascular imaging with IVUS or OCT plays a critical role in the characterization and identification of the culprit lesion In the RESORB-ACS trial operators will decide about the possible culprit lesion and that decision may be assisted and guided by intravascular imaging in case it is needed
Multivessel disease Multivessel disease is not an exclusion criterion except for the cases that CABG is programmed Enrolled subjects may undergo PCI with RMS only for the culprit lesion during the index procedure However in cases that multivessel disease amenable to PCI is present operators can proceed to full revascularization with conservative DES or Freesolve RMS
Treatment failure and bailout situation For dissections occurring during or immediately after implantation of RMS a second RMS may be used not overlapping with initial one but implanted end-to- end If another stent needs to be implanted in the immediate vicinity of an already implanted RMS only a Freesolve coronary scaffold system should be used Contact of the Freesolve with an uncoated or polymer coated stent up to 120 days may result in accelerated resorption of the DREAMS 3G and undesired local and downstream effects After 120 days any other stent type may be used In case of bailout If a Freesolve is not possible to be used an Orsiro DES with its proBIO passive coating and BIOlute active coating is recommended to be implanted directly adjacent or minimally overlapping based on the consensus recommendations
Medication Every patient included in this trial must be able to receive 12-month DAPT with aspirin and clopidogrel or ticagrelor or prasugrel The timing and necessity in case the patient was already under antiplatelet treatment will be at the discretion of the treating physician At all cases DAPT must be present at the time of the implantation based on the ESC guidelines doses for the management of ACS The use of anticoagulation during PCI heparin or enoxaparine at therapeutic dose for PCI will be chosen by the operators IIbIIIa glycoprotein inhibitors as well as vasomotor medications will be left at operators discretion After the PCI all patients must receive at least 12-month DAPT After 12 months DAPT may be changed to single treatment with aspirinclopidogrelticagrelorprasugrel or prolonged based on the balance of ischemichemorrhagic risk of the patient Regarding patients receiving oral anticoagulation eg atrial fibrillation prosthetic valve thrombophilia we recommend that DAPT should be maintained until 1-month follow-up Afterwards DAPT can be downsized to either aspirin or clopidogrel alone combined with oral anticoagulant for the remaining time period up to 12 months After 12 months monotherapy with oral anticoagulant may be prescribed and continued indefinitely
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None