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A17 · PMID:42456136

Extended Dual Antiplatelet Therapy for Multivessel Coronary Artery Disease

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Bottom line

In stable, event-free multivessel CAD patients 12 months after drug-eluting stent placement, extending clopidogrel plus aspirin for another 12 months reduced cardiovascular death, MI, or stroke without a significant rise in clinically relevant or major bleeding.

PICO at a glance

Clinical question and design

DAPT-MVD was an open-label, randomized, multicenter trial conducted at 97 centers in China. It asked whether patients with multivessel coronary artery disease who reached the standard 12-month DAPT mark event-free gain additional protection from staying on DAPT longer, or whether the added exposure simply raises bleeding risk without added benefit. Eligible patients were 18 to 75 years old with angiographically confirmed multivessel disease who had completed 12 event-free months of DAPT after drug-eluting stent implantation.

A total of 8,250 patients were randomized 1:1 (4,125 per arm) to an additional 12 months of clopidogrel 75 mg plus aspirin 75-150 mg daily, or to aspirin 75-150 mg monotherapy, with a median follow-up of 34.3 months. The trial is registered as NCT04624854 and was funded by the National Natural Science Foundation of China, with additional support from Heilongjiang Province research grants and Chinese Society of Cardiology Clinical Research funds.

Intervention and outcomes measured

The intervention arm continued clopidogrel 75 mg daily plus aspirin 75-150 mg daily for an additional 12 months beyond the standard course. The comparator arm switched to aspirin 75-150 mg monotherapy. The primary efficacy outcome was MACCE, a composite of cardiovascular death, nonfatal MI, or nonfatal stroke; the primary safety outcome was clinically relevant or major bleeding by BARC classification.

Results

A MACCE event occurred in 222 patients on extended DAPT versus 266 patients on aspirin monotherapy, corresponding to a 36-month Kaplan-Meier cumulative incidence of 5.8% versus 6.8% (hazard ratio, 0.82; 95% CI, 0.69-0.98; P=0.03). The absolute difference was 1.0 percentage point at 36 months, corresponding to a number needed to treat of roughly 100 over that follow-up window (calculated from the reported cumulative incidences, not an author-reported statistic).

Safety and additional findings

Clinically relevant or major bleeding (BARC 2 or higher) occurred in 51 patients on extended DAPT versus 57 on aspirin monotherapy, a 36-month cumulative incidence of 1.4% versus 1.5% (hazard ratio, 0.89; 95% CI, 0.61-1.30; P=0.54), a difference that did not reach statistical significance. The composite benefit was driven by myocardial infarction. Nonfatal MI occurred in 67 patients on extended DAPT versus 97 on aspirin monotherapy (1.8% vs 2.5%; hazard ratio, 0.68; 95% CI, 0.50-0.93), while death from any cause (120 vs 116; hazard ratio, 1.02), death from cardiovascular causes (73 vs 75; hazard ratio, 0.96) and nonfatal stroke (97 vs 120; hazard ratio, 0.80) were all flat. Net adverse clinical events occurred in 255 versus 295 patients (hazard ratio, 0.85; 95% CI, 0.72-1.01), and definite or probable stent thrombosis in 0 versus 2 patients. The authors state that confidence intervals for secondary endpoints were not adjusted for multiple comparisons and should not be used to infer treatment effect, so the myocardial infarction signal is nominal, not established.

Uncertainty and limitations

DAPT-MVD was open-label with no blinding, and it was conducted entirely at Chinese centers, which may limit generalizability. Only clopidogrel was tested as the P2Y12 inhibitor, so these results do not address ticagrelor- or prasugrel-based extended DAPT. The enrolled population was deliberately selected for having already tolerated a full year of DAPT without incident, a lower-risk subset that may not represent patients who had a bleeding scare or ischemic event during their first 12 months. The specific drug-eluting stent type used was not specified. Nearly half of each arm had two-vessel disease, so this is not a three-vessel population.

Literature review and evidence synthesis

DAPT-duration evidence has moved in two directions simultaneously. The 2016 ACC/AHA guideline-focused-update systematic review established the ischemic-versus-bleeding-risk framework that still underlies individualized DAPT-duration decisions today. A 2024 Lancet individual-patient-data meta-analysis examined the opposite strategy: de-escalating to ticagrelor monotherapy versus continuing 12 months of DAPT in patients with and without acute coronary syndromes. DAPT-MVD instead tests extension, not de-escalation, in a multivessel-disease population using clopidogrel rather than a potent P2Y12 inhibitor.

How this fits with the broader evidence

DAPT-MVD adds a distinct, population-specific data point rather than resolving the broader DAPT-duration debate. For a stable, event-free multivessel CAD patient at the 12-month post-DES mark, it supports continuing clopidogrel plus aspirin for an additional year to lower the risk of cardiovascular death, MI, or stroke, without a statistically significant increase in clinically important bleeding, while leaving open how this strategy compares with more potent P2Y12-inhibitor-based approaches or applies outside a Chinese, event-free cohort.

ACPE UAN: 0683-0000-26-036-H01-P

Study source: PMID:42456136