August 3, 2023Open Access

P2Y12 inhibitor monotherapy after complex percutaneous coronary intervention: a systematic review and meta-analysis of randomized clinical trials

Q: What is the clinical evidence from this study?

Study design: Meta-Analysis. Population: Complex and non-complex percutaneous coronary intervention (PCI) (n=36206). Intervention: Short DAPT followed by P2Y12 inhibitor monotherapy vs. Conventional DAPT (6-12 months). Primary outcome: 1-year Net Adverse Clinical Event (NACE) in complex PCI patients (OR 0.76, 95% CI 0.63-0.91, p=0.003).

Key Result

Short DAPT followed by P2Y12 inhibitor monotherapy significantly reduced the risk of 1-year Net Adverse Clinical Events (OR 0.76) compared to conventional DAPT in patients undergoing complex PCI.

Study Design

Type

Meta-Analysis (n=36,206)

Multicenter

Yes

Structured PICO

Does short DAPT followed by P2Y12 inhibitor monotherapy reduce 1-year NACE in patients undergoing complex and non-complex PCI compared to conventional DAPT?

Population

36,206 patients undergoing complex or non-complex percutaneous coronary intervention across 6 randomized trials, followed for 1 year to compare short DAPT followed by P2Y12 inhibitor monotherapy versus conventional DAPT.

Intervention

Short dual antiplatelet therapy (DAPT) followed by P2Y12 inhibitor monotherapy

Comparator

Conventional dual antiplatelet therapy (DAPT)

Outcome

1-year Net Adverse Clinical Event (NACE)composite

A strategy of short DAPT followed by P2Y12 inhibitor monotherapy significantly reduces the risk of 1-year Net Adverse Clinical Events in patients undergoing complex PCI compared to conventional DAPT.

Main Result

Odds Ratio: 0.76 (95% CI 0.63–0.91)

Absolute Event Rate: 7.6% vs 9.8%

p-value: p=0.003

Limitations

Study designs of the 6 included trials differed in their use of placebo, choice of P2Y12 inhibitor, use of oral anticoagulation, and timing of randomization.
The study was conducted as a study-level meta-analysis rather than a patient-level meta-analysis.
The definition of the primary endpoint (NACE) differed slightly among the included trials, with some including revascularization.
The TWILIGHT trial did not provide NACE, requiring a non-hierarchical computation of event numbers that likely overestimated events.
The TICO trial divided patients into high-ischemic vs non-high-ischemic risk groups using a definition that included clinical risk factors alongside complex PCI.
Around 10% of patients in the standard DAPT arm in the MASTER-DAPT trial crossed over to receive short DAPT and subsequent P2Y12 inhibitor monotherapy.

Abstract

It remains unknown whether the recent trend of short dual antiplatelet therapy (DAPT) followed by P2Y12 inhibitor monotherapy can simply be applied to patients undergoing complex percutaneous coronary intervention (PCI). We performed a systematic review and meta-analysis to evaluate P2Y12 inhibitor monotherapy vs. conventional DAPT in patients undergoing complex PCI and non-complex PCI (PROSPERO: CRD42022335723). Primary endpoint was the 1-year Net Adverse Clinical Event (NACE). Among 5,323 screened studies, six randomized trials fulfilled the eligibility criteria. A total of 10,588 complex PCI patients (5,269 vs. 5,319 patients) and 25,618 non-complex PCI patients (12,820 vs 12,798 patients) were randomly assigned to P2Y12 inhibitor monotherapy vs. conventional DAPT. In complex PCI patients, P2Y12 inhibitor monotherapy was associated with a lower risk of NACE than conventional DAPT Odds ratio (OR) 0.76, 95% confidence interval (CI) 0.63-0.91, P = 0.003, whereas in non-complex PCI patients, P2Y12 inhibitor monotherapy was associated with a trend toward lowering the risk of NACE (OR 0.86, 95% CI 0.72-1.02, P = 0.09). This meta-analysis across randomized trials demonstrated that a strategy of short DAPT followed by P2Y12 inhibitor monotherapy reduces the risk of 1-year NACE in patients undergoing complex PCI.

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