August 30, 2025Journal of the American College of Cardiology
Personalized or Standard Duration of Dual Antiplatelet Therapy After Percutaneous Coronary Intervention
Raffaele PiccoloPaolo CalabròGreta CarraraFiorenzo SimonettiAttilio VarricchioTiziana AttisanoGiovanni NapolitanoCiro De SimoneGerardo CarpinellaEugenio StabilePlinio CirilloLuigi Di SerafinoGianluca CaiazzoTullio TesorioMarco BoccalatteBernardino TuccilloMarisa AvvedimentoAttilio LeoneGennaro GalassoArturo CesaroRocco PerrottaTullio NiglioDomenico Simone CastielloMaddalena Immobile MolaroLuca BardiAlessandra SpinelliStefano CristianoMichele BellinoSergio LeonardiSimone BiscagliaFrancesco CostaSalvatore CasseseEugène McFaddenDik HegGiulio StefaniniAnna FranzoneDavide CapodannoGiovanni Esposito
Key result
Personalized DAPT duration reduces 24-month NACE by ~16% compared to standard 12-month DAPT.
- difference −3.54 pts
- 95% CI -6.99 to -0.99
- P=0.040
- n=2,107
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Why the study?
Dual antiplatelet therapy is recommended following PCI, but its optimal duration remains uncertain.
Does a personalized duration of dual antiplatelet therapy reduce net adverse clinical events compared to standard 12-month therapy in patients undergoing percutaneous coronary intervention?
Key Points
- To determine whether tailoring the duration of dual antiplatelet therapy (DAPT) to 3, 6, or 24 months based on an individual risk score improves 24-month clinical outcomes compared to standard 12-month DAPT after percutaneous coronary intervention (PCI).
- Randomized clinical trial (NCT04135989) enrolling 2,107 patients undergoing PCI assigned to either personalized DAPT (duration of 3, 6, or 24 months guided by a clinical risk score) or standard DAPT (fixed 12-month duration).
- Assessed the primary net adverse clinical end point (NACE) at 24 months, defined as a composite of all-cause death, myocardial infarction, stroke, urgent target-vessel revascularization, or BARC type 2, 3, or 5 bleeding.
- At 24 months, NACE occurred in 196 of 1,055 patients (18.6%) in the personalized group versus 232 of 1,052 patients (22.2%) in the standard group (difference, -3.54 percentage points; 95% CI, -6.99 to -0.99; P=0.040).
- Personalized DAPT significantly reduced myocardial infarction (difference, -2.29 percentage points; 95% CI, -4.43 to -0.14) and urgent target-vessel revascularization (difference, -1.30 percentage points; 95% CI, -2.55 to -0.05).
- Bleeding events occurred at similar rates between the personalized and standard groups (difference, -0.41 percentage points; 95% CI, -2.92 to 2.10).
Study Design
Type
RCT (n=2,107)
Structured PICO
Does a personalized duration of dual antiplatelet therapy reduce net adverse clinical events compared to standard 12-month therapy in patients undergoing percutaneous coronary intervention?
P
Population
2,107 patients undergoing percutaneous coronary intervention (PCI) followed for 24 months.
I
Intervention
Personalized duration of dual antiplatelet therapy (DAPT) for 3, 6, or 24 months based on a clinical risk score
C
Comparator
Standard duration of dual antiplatelet therapy (DAPT) for 12 months
O
Outcome
Net adverse clinical end point (NACE) at 24-months, defined as the composite of all-cause death, myocardial infarction, stroke, urgent target-vessel revascularization, or type 2, 3, or 5 bleeding according to the Bleeding Academic Research Consortium (BARC) criteriacomposite
Main Result
Effect estimate: difference 3.54 percentage points (95% CI -6.99 to -0.99)
Absolute Event Rate: 18.6% vs 22.2%
Absolute Risk Reduction: 3.54%
p-value: p=0.040
A personalized DAPT duration based on a clinical risk score significantly reduced net adverse clinical events compared to standard 12-month DAPT in patients undergoing PCI.
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Key expert perspectives
Captured external expert commentary on this paper, strongest first. Original sources are linked where available.
“We are used to seeing score validation based on calibration and discrimination metrics, which is great. However, a true test of a score's utility is whether randomisation to a score-guided versus unguided strategy is clinically useful. This is probably one of the principal novelties of PARTHENOPE.”
Implication
Suggests risk score-guided DAPT duration may optimize ischemic and bleeding trade-offs; extends.
Abstract
BACKGROUND Dual antiplatelet therapy (DAPT) is recommended for patients undergoing percutaneous coronary intervention (PCI), although its optimal duration remains uncertain. OBJECTIVES We performed a randomized trial comparing a personalized duration of DAPT, based on a risk score, for 3-, 6-, or 24-months with a standard duration of DAPT for 12 months after PCI. METHODS We randomly assigned 2,107 patients undergoing PCI to receive either a personalized or a standard DAPT. The primary end point was a net adverse clinical end point (NACE) at 24-months, defined as the composite of all-cause death, myocardial infarction, stroke, urgent target-vessel revascularization, or type 2, 3, or 5 bleeding according to the Bleeding Academic Research Consortium (BARC) criteria. The trial was registered in ClinicalTrials.gov (NCT04135989) RESULTS: At 24-months, NACE occurred in 196 of 1,055 patients (18.6%) in the personalized DAPT group and in 232 of 1,052 patients (22.2%) in the standard DAPT group (difference, 3.54 percentage points, 95% confidence interval [CI], -6.99 to -0.99; P=0.040). This difference was mainly related to decreased rates of myocardial infarction (difference, -2.29 percentage points, 95% CI, -4.43 to -0.14) and urgent target-vessel revascularization (difference, -1.30 percentage points, 95% CI, -2.55 to -0.05). Bleeding occurred at similar rates between the two groups (difference, -0.41 percentage points; 95% confidence interval [CI], -2.92 to 2.10). CONCLUSIONS In patients undergoing PCI, a personalized DAPT duration from 3 to 24 months based on a clinical risk score led to a lowered risk of net adverse clinical events than standard care consisting of 12 months of DAPT.
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Cite This Study
Piccolo et al. (2025) conducted an RCT in Percutaneous coronary intervention (PCI) (n=2,107). Personalized duration of DAPT (3, 6, or 24 months based on a risk score) vs. Standard duration of DAPT for 12 months was evaluated on Net adverse clinical end point (NACE) at 24-months, defined as the composite of all-cause death, myocardial infarction, stroke, urgent target-vessel revascularization, or type 2, 3, or 5 bleeding according to BARC criteria (difference 3.54 percentage points, 95% CI -6.99 to -0.99, p=0.040). Personalized DAPT duration (3-24 months) based on a clinical risk score reduced 24-month net adverse clinical events compared to standard 12-month DAPT (18.6% vs 22.2%; P=0.040).