Risk-stratified versus standard-duration dual antiplatelet therapy after percutaneous coronary intervention: a systematic review and critical appraisal of prospective evidence

Guidelines endorse risk-stratification tools (DAPT score, PRECISE-DAPT, ARC-HBR) to individualise dual antiplatelet therapy(DAPT) duration after PCI, yet a fixed 12-month course still imposes a uniform ischaemic-bleeding trade-off on a heterogeneous population. To our knowledge, whether these instruments have actually been tested prospectively to guide duration, has not been systematically established. We set out to identify every such study, appraise its risk of bias and certainty, and ask whether the outcomes reported are capable of detecting harm. Six databases were searched from inception to June 2026 for studies that allocated DAPT duration prospectively using a risk-stratification instrument, compared against fixed-duration controls. Risk of bias was assessed with RoB 2 and ROBINS-I, certainty with GRADE; differences in instruments, populations and follow-up ruled out meta-analysis. Of 4,610 records screened, only two studies(3,479 patients) qualified: one randomised trial and prospective registry with a retrospectively assembled, propensity-matched control cohort. Trials in which bleeding risk determined eligibility rather than allocation (e.g. MASTER DAPT, OPT-BIRISK) fell outside the primary synthesis and are summarised separately as indirect evidence. Neither review-defined co-primary outcome differed by strategy, although PARTHENOPE met its own prespecified primary endpoint (NACE 18.6% vs. 22.2%; absolute difference − 3.54% points, 95% CI: -6.99 to -0.99; P = 0.040). All-cause death was numerically higher with risk-stratified allocation in the trial(RR 1.09, 95% CI 0.78–1.52) but numerically lower in the registry(RR 0.89, 0.62–1.29). Clinically relevant bleeding was neutral in both(RR 0.96, 0.71-1.29; RR 0.73, 0.52–1.03). Both studies favoured risk-stratified allocation for net clinical benefit(RR 0.84, 0.71-1.00; RR 0.77, 0.61–0.98), with the difference relating principally to myocardial infarction and urgent target-vessel revascularisation rather than to bleeding. A post-hoc breakdown of bleeding by BARC severity in the trial revealed a gradient across grades(BARC 2 RR 0.77, 0.54–1.09; BARC 3 RR 1.20, 0.72-2.00; BARC 5 RR 2.52, 0.49-13.00). Certainty was low for net clinical benefit and very low for other outcomes. Only one randomised trial and one confounded registry have tested risk-score-guided DAPT duration prospectively, and certainty is low to very low across every outcome. These findings are hypothesis-generating rather than conclusive: whether aggregate bleeding endpoints can detect a shift in bleeding severity is untested, and warrants prespecified grade-level reporting in future trials. This systematic review was registered with PROSPERO (registration number [CRD420261380708]).