September 15, 2021Cardiology JournalOpen Access

P2Y12 inhibitor monotherapy in complex percutaneous coronary intervention: A post-hoc analysis of SMART-CHOICE randomized clinical trial

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Why the study?

It remained unclear whether P2Y12 inhibitor monotherapy, especially clopidogrel, following short-duration DAPT is associated with favorable outcomes in patients undergoing complex PCI.

Does P2Y12 inhibitor monotherapy following 3 months of DAPT prevent MACCE in patients undergoing complex PCI compared to 12 months of DAPT?

Structured PICO

Does P2Y12 inhibitor monotherapy following 3 months of DAPT prevent MACCE in patients undergoing complex PCI compared to 12 months of DAPT?

Population

498 patients undergoing complex percutaneous coronary intervention (PCI) (defined by at least one of: 3 vessels treated, ≥ 3 stents implanted, ≥ 3 lesions treated, bifurcation with ≥ 2 stents implanted, and a total stent length of ≥ 60 mm) from the SMART-CHOICE trial (total n=2,993)

Intervention

P2Y12 inhibitor monotherapy (mostly clopidogrel, 78%) following 3 months of short-duration dual antiplatelet therapy (DAPT)

Comparator

12 months of dual antiplatelet therapy (DAPT)

Outcome

Major adverse cardiac and cerebrovascular event (MACCE), defined as the composite of all-cause death, myocardial infarction, and strokecomposite

P2Y12 inhibitor monotherapy following 3 months of DAPT does not increase ischemic events compared to 12 months of DAPT in patients undergoing complex PCI.

Implication

P2Y12 monotherapy after 3-month DAPT appears safe in complex PCI; extends SMART-CHOICE findings to this higher-risk subgroup.

Abstract

BACKGROUND: It remains unclear whether P2Y12 monotherapy, especially clopidogrel, following short-duration dual antiplatelet therapy (DAPT) is associated with favorable outcomes in patients undergoing complex percutaneous coronary intervention (PCI). Therefore, this study analyzed the efficacy and safety of P2Y12 inhibitor monotherapy, mostly clopidogrel (78%), in complex PCI following short-term DAPT. METHODS: The post-hoc analysis of the SMART-CHOICE trial involving 2,993 patients included 498 cases of complex PCIs, defined by at least one of the following features: 3 vessels treated, ≥ 3 stents implanted, ≥ 3 lesions treated, bifurcation with ≥ 2 stents implanted, and a total stent length of ≥ 60 mm. The primary endpoint was major adverse cardiac and cerebrovascular event (MACCE), defined as the composite of all-cause death, myocardial infarction, and stroke. The primary safety endpoint included bleeding, defined as Bleeding Academic Research Consortium (BARC) types 2 to 5. RESULTS: Complex PCI group had a higher risk of MACCE (4.0% vs. 2.3%, hazard ratio [HR] = 1.74, 95% confidence interval [CI]: 1.05-2.89, p = 0.033) and a similar risk of BARC types 2-5 bleeding (2.6% vs. 2.6%, HR = 1.02, 95% CI: 0.56-1.86, p = 0.939) compared with those without complex PCIs. Patients undergoing complex PCIs, followed by P2Y12 inhibitor monotherapy and 12 months of DAPT exhibited similar rates of MACCE (3.8% vs. 4.2%, HR = 0.92, 95% CI: 0.38-2.21, p = 0.853). CONCLUSIONS: P2Y12 inhibitor monotherapy, mostly clopidogrel, following 3 months of DAPT did not increase ischemic events in patients with complex PCIs.