Lesion Complexity and Outcomes of Extended Dual Antiplatelet Therapy After Percutaneous Coronary Intervention

Q: What are the key findings of this study?

Continued thienopyridine beyond 12 months reduced MI or stent thrombosis similarly in patients with and without complex lesions.

Q: What is the clinical evidence from this study?

Study design: RCT. Population: Coronary artery disease treated with percutaneous coronary intervention and coronary stenting (with vs without anatomically complex target lesions) (n=11554). Intervention: Continued thienopyridine (clopidogrel or prasugrel) plus aspirin vs. Placebo plus aspirin. Primary outcome: Combined myocardial infarction (MI) or stent thrombosis in subjects with anatomically complex lesions at 12-30 months (HR 0.55, 95% CI 0.38-0.79, p=0.001).

Q: What does this research mean for the field?

Continued dual antiplatelet therapy beyond 12 months reduces myocardial infarction or stent thrombosis to a similar extent in patients with and without anatomically complex coronary lesions. Novelty: ClaimNovelty.INCREMENTAL. Consensus alignment: ConsensusAlignment.NEUTRAL.

Robert W. Yeh; Philippe Gabríel Steg; Donald E. Cutlip; Kevin Croce; Joseph M. Massaro; Laura Mauri

doi:10.1016/j.jacc.2017.09.011

October 1, 2017Journal of the American College of CardiologyOpen Access

Lesion Complexity and Outcomes of Extended Dual Antiplatelet Therapy After Percutaneous Coronary Intervention

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Key result

Continued thienopyridine beyond 12 months cuts MI or stent thrombosis ~45% regardless of lesion complexity.

HR 0.55
95% CI 0.38-0.79
P=0.001
n=11,554

Why the study?

Patients undergoing coronary stenting with complex lesion anatomy may experience different risks and benefits from prolonged dual antiplatelet therapy after PCI.

Does extending dual antiplatelet therapy with a thienopyridine plus aspirin from 12 to 30 months reduce myocardial infarction or stent thrombosis and MACCE differently in patients with versus without anatomically complex coronary lesions who are event-free at 12 months?

Key Points

To assess the benefits and risks of 30 versus 12 months of dual antiplatelet therapy after percutaneous coronary intervention in patients with and without anatomically complex target lesions.
Post hoc analysis of the double-blind, international, multicenter, randomized, placebo-controlled DAPT Study (NCT00977938) evaluating N=25416 enrolled and N=11554 randomized subjects after coronary stenting.
Patients event-free and adherent after 12 months of aspirin plus thienopyridine were randomized to continue thienopyridine or receive placebo for 18 additional months.
Anatomically complex lesions were defined by unprotected left main, >2 lesions per vessel, length ≥30 mm, bifurcation with side branch ≥2.5 mm, vein bypass graft, or thrombus.
During the first 12 months, enrolled subjects with complex lesions had higher rates of MI or stent thrombosis than those without (3.9% vs. 2.4%, P<0.001), but rates between 12 and 30 months were similar (3.5% vs. 2.9%, P=0.07).
Extended thienopyridine similarly reduced MI or stent thrombosis in patients with complex lesions (2.5% vs. 4.5%, HR 0.55, 95% CI 0.38–0.79; P=0.001) and without complex lesions (2.0% vs. 3.8%, HR 0.52, 95% CI 0.39–0.69; P<0.001; Pinteraction=0.81), with no interaction for bleeding (Pinteraction=0.44).
Among patients with complex anatomy, those with DAPT scores ≥2 had greater reductions in MI or stent thrombosis with extended therapy (3.0% vs. 6.1%, P<0.001) than those with scores <2 (1.7% vs. 2.3%, P=0.42; P comparing risk differences=0.03).

Study Design

Type

RCT (n=11,554)

Blinding

Double-blind

Randomization

Stratified by stent type (DES vs BMS), hospital site, thienopyridine type, and presence or absence of at least 1 prespecified clinical or anatomical characteristic for complexity

Multicenter

Yes

Structured PICO

Does extending dual antiplatelet therapy with a thienopyridine plus aspirin from 12 to 30 months reduce myocardial infarction or stent thrombosis and MACCE differently in patients with versus without anatomically complex coronary lesions who are event-free at 12 months?

P

Population

11,554 randomized patients (from 25,416 enrolled) with coronary artery disease undergoing PCI (3,730 with and 7,824 without complex target lesion anatomy) who were event-free and compliant after 12 months of open-label DAPT, followed from 12 to 33 months.

I

Intervention

Continued thienopyridine (clopidogrel or prasugrel) oral therapy in addition to aspirin for an additional 18 months (from 12 to 30 months post-PCI)

C

Comparator

Matching placebo added to continued aspirin therapy from 12 to 30 months post-PCI (after 12 months of open-label thienopyridine plus aspirin in both groups)

O

Outcome

Incidence of combined myocardial infarction or Academic Research Consortium-defined stent thrombosis, and incidence of major adverse cardiovascular and cerebrovascular events (MACCE) at 12 to 30 months post-index procedure, adjudicated by a blinded independent Clinical Events Committeecomposite

Main Result

Hazard Ratio: 0.55 (95% CI 0.38–0.79)

Absolute Event Rate: 2.5% vs 4.5%

p-value: p=0.001

Among patients who are event-free 1 year after PCI, anatomical lesion complexity does not modify the relative benefit of extending DAPT to 30 months, whereas a DAPT score >=2 effectively identifies patients who derive the greatest net benefit regardless of lesion complexity.

Limitations

Post hoc analysis of the DAPT study.
Included only patients who completed 12 months of dual antiplatelet therapy without experiencing a major bleeding or ischemic event, limiting applicability to patients not reaching that time point.
Coronary anatomy lesion complexity characteristics were site-reported and not reviewed by an angiographic core laboratory, and may not have included all angiographic markers of complexity.
Not sufficiently powered to evaluate treatment effect heterogeneity across individual lesion complexity factors in very small subgroups.
Post hoc analysis of the DAPT Study
Population included only patients who tolerated 12 months of DAPT without experiencing a major bleeding or ischemic event
Coronary anatomy lesion complexity characteristics were site-reported without angiographic core laboratory review
Insufficiently powered to evaluate heterogeneity across individual lesion complexity factors in small subgroups

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Answers are grounded in this paper and cite their sources.

Implication

Extended DAPT reduces ischemic events similarly regardless of lesion complexity; extends DAPT Study evidence and favors DAPT score over anatomy for selection.

Abstract

Background: Subjects undergoing coronary stenting with complex lesion anatomy may experience different risks and benefits with prolonged dual antiplatelet therapy. Objective: The authors assessed the effect of 30 versus 12 months of dual antiplatelet therapy after percutaneous coronary intervention (PCI) based on the presence or absence of anatomically-complex target lesions. Methods: In the Dual Antiplatelet Therapy (DAPT) Study, combined myocardial infarction (MI) or stent thrombosis and moderate/severe bleeding were assessed in enrolled (N=25416) and randomized (N=11554) subjects. Complex lesions had any of the following characteristics: unprotected left main, >2 lesions per vessel, length ≥30 mm, bifurcation with side branch ≥2.5 mm, vein bypass graft, or thrombus-containing lesion. Events were evaluated according to increasing number of complexity characteristics and compared according to DAPT score. Results: Enrolled subjects with more complex target lesions had higher rates of MI or stent thrombosis in the first 12 months after PCI (3.9% vs. 2.4%, P<0.001). Among those event-free at 12 months, rates of MI or stent thrombosis between 12–30 months were similar between those with versus without complex anatomy (3.5% vs. 2.9%, P=0.07). Reduction of MI or stent thrombosis with continued thienopyridine beyond 12 months vs. placebo was similar for subjects with (2.5% vs. 4.5%, HR 0.55, 95% CI 0.38–0.79; P=0.001) and without (2.0% vs. 3.8%, HR 0.52, 95% CI 0.39–0.69; P<0.001) anatomic complexity (Pinteraction=0.81), as was increase in moderate/severe bleeding (Pinteraction=0.44). Among subjects with anatomic complexity, those with DAPT scores ≥2 randomized to continued thienopyridine had greater reductions in MI or stent thrombosis (3.0% vs. 6.1%; P<0.001) compared with subjects with scores <2 (1.7%= vs. 2.3%, P=0.42, P comparing risk differences=0.03). Conclusions: Complex target-lesion anatomy is associated with increased ischemic events, particularly within the first year after PCI. Among those without events in the first 12 months, the benefits of extending dual antiplatelet therapy were similar in subjects with and without complex lesions. High DAPT score identified those experiencing the most benefit from extended treatment among patients with and without complex anatomy.

Discussion

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Cite This Study

Yeh et al. (2017) conducted an RCT in Coronary artery disease treated with percutaneous coronary intervention and coronary stenting (with vs without anatomically complex target lesions) (n=11,554). Continued thienopyridine (clopidogrel or prasugrel) plus aspirin vs. Placebo plus aspirin was evaluated on Combined myocardial infarction (MI) or stent thrombosis in subjects with anatomically complex lesions at 12-30 months (HR 0.55, 95% CI 0.38-0.79, p=0.001). Continued thienopyridine beyond 12 months reduced MI or stent thrombosis similarly in patients with and without complex lesions.

synapsesocial.com/papers/6af583bb9bdf96f60ddb0897 https://doi.org/10.1016/j.jacc.2017.09.011

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Lesion Complexity and Outcomes of Extended Dual Antiplatelet Therapy After Percutaneous Coronary Intervention

Key Points

Study Design

Structured PICO

Main Result

Limitations

Ask about this paper

Implication

Abstract

Discussion

Cite This Study

Lesion Complexity and Outcomes of Extended Dual Antiplatelet Therapy After Percutaneous Coronary Intervention

Key Points

Study Design

Structured PICO

Main Result

Limitations

Ask about this paper

Implication

Abstract

Discussion

Cite This Study

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