Key result
Prolonged 24-month DAPT caused harm in patients with low DAPT scores but reduced ischemic events in patients with high scores receiving paclitaxel-eluting stents (RD -7.55%; 95% CI -12.85 to -2.25).
Why the study?
Does 24-month versus 6-month dual-antiplatelet therapy improve ischemic outcomes without excessive bleeding in patients undergoing percutaneous coronary intervention, stratified by DAPT score?
RCT (n=1,970)
Does 24-month versus 6-month dual-antiplatelet therapy improve ischemic outcomes without excessive bleeding in patients undergoing percutaneous coronary intervention, stratified by DAPT score?
Effect estimate: RD -2.05 percentage points (score ≥2) / 2.91 percentage points (score <2) (95% CI -5.04 to 0.95 (score ≥2) / -0.43 to 6.25 (score <2))
p-value: p=0.030
Prolonged DAPT (24 months) reduces ischemic events in PCI patients with high DAPT scores (≥2) receiving paclitaxel-eluting stents, but increases bleeding harm in those with low scores (<2).
Prolonged DAPT may benefit high-score patients with paclitaxel stents yet harm low-score patients; leaves open confirmation in randomized trials of modern stents.
BACKGROUND: The dual-antiplatelet therapy (DAPT) score was developed to identify patients more likely to derive harm (score <2) or benefit (score ≥2) from prolonged DAPT after percutaneous coronary intervention (PCI). OBJECTIVE: To evaluate the safety and efficacy of DAPT duration according to DAPT score. DESIGN: Retrospective assessment of DAPT score-guided treatment duration in a randomized clinical trial. (ClinicalTrials.gov: NCT00611286). SETTING: PCI patients. PATIENTS: 1970 patients undergoing PCI. INTERVENTION: DAPT (aspirin and clopidogrel) for 24 versus 6 months. MEASUREMENTS: Primary efficacy outcomes were death, myocardial infarction, or cerebrovascular accident. The primary safety outcome was type 3 or 5 bleeding according to the Bleeding Academic Research Consortium definition. Outcomes were assessed between 6 and 24 months. RESULTS: 884 patients (44.9%) had a DAPT score of at least 2, and 1086 (55.1%) had a score less than 2. The reduction in the primary efficacy outcome with 24- versus 6-month DAPT was greater in patients with high scores (risk difference [RD] for score ≥2, -2.05 percentage points [95% CI, -5.04 to 0.95 percentage points]; RD for score <2, 2.91 percentage points [CI, -0.43 to 6.25 percentage points]; P = 0.030). However, the difference by score for the primary efficacy outcome varied by stent type; prolonged DAPT with high scores was effective only in patients receiving paclitaxel-eluting stents (RD, -7.55 percentage points [CI, -12.85 to -2.25 percentage points]). The increase in the primary safety outcome with 24- versus 6-month DAPT was greater in patients with low scores (RD for score ≥2, 0.20 percentage point [CI, -1.20 to 1.60 percentage points]; RD for score <2, 2.58 percentage points [CI, 0.71 to 4.46 percentage points]; P = 0.046). LIMITATION: Retrospective calculation of the DAPT score. CONCLUSION: Prolonged DAPT resulted in harm in patients with low DAPT scores undergoing PCI but reduced risk for ischemic events in patients with high scores receiving paclitaxel-eluting stents. Whether prolonged DAPT benefits patients with high scores treated with contemporary drug-eluting stents requires further study. PRIMARY FUNDING SOURCE: None.
No takes yet. Share an insight, caveat, or question.
Piccolo et al. (2017) conducted an RCT in percutaneous coronary intervention (n=1,970). Dual-antiplatelet therapy (aspirin and clopidogrel) vs. 6 months of dual-antiplatelet therapy was evaluated on death, myocardial infarction, or cerebrovascular accident (RD -2.05 percentage points (score ≥2) / 2.91 percentage points (score <2), 95% CI -5.04 to 0.95 (score ≥2) / -0.43 to 6.25 (score <2), p=0.030). Prolonged 24-month DAPT caused harm in patients with low DAPT scores but reduced ischemic events in patients with high scores receiving paclitaxel-eluting stents (RD -7.55%; 95% CI -12.85 to -2.25).
Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context: