DAPT for ≤3 months after PCI effective and safe in high bleeding risk patients
Dual antiplatelet therapy duration after percutaneous coronary intervention in high bleeding risk: a meta-analysis of randomized trials
Literature - Costa F, Montalto C, Branca M, et al. - Eur Heart J. 2022 Dec 7;ehac706. doi: 10.1093/eurheartj/ehac706.Introduction and methods
Background
The optimal duration of dual antiplatelet therapy (DAPT) with aspirin and a P2Y12 inhibitor, such as clopidogrel or ticagrelor, after percutaneous coronary intervention (PCI) is an extensive topic of debate in high bleeding risk patients. Because clinical features related to high bleeding risk are also associated with the risk of ischemic events, maintaining the balance between the bleeding and ischemic risk is challenging in these patients [1,2]. International guidelines favor a conservative approach in terms of treatment duration after PCI in high bleeding risk patients [3-5]. In this group of patients, shortening DAPT to 6 months has previously been shown to reduce the risk of bleeding without an increase in ischemic events [6]. More recent studies have examined whether a treatment duration of 1 or 3 months is also sufficient [7,8].
Aim of the study
The aim of this study was to compare the efficacy and safety of abbreviated DAPT versus standard DAPT after PCI in high bleeding risk patients, using available evidence from RCTs.
Methods
In accordance with the PRISMA guideline, the investigators conducted a systematic review and meta-analysis of RCTs comparing the efficacy and safety of abbreviated DAPT (≤3 months) with standard DAPT (≥6 months) after PCI in patients with a high bleeding risk – defined as a PRECISE-DAPT score ≥25 – without indication for oral anticoagulation. Several online databases (PubMed, Embase, BioMedCentral, Google Scholar and Cochrane Centers Register of Controlled Trials) were searched for relevant RCTs with a minimum follow-up of 12 months, the results of which had been published in the period January 1, 2000-October 31, 2021. A total of 11 RCTs, including 9006 high bleeding risk patients, were identified.
Outcomes
The key outcomes were the occurrence of major or clinically relevant non-major bleeding (MCRB) and major cardiovascular events (MACE) up to 12 months after PCI. Separate analyses were performed for the 2 different definitions of MACE, namely, (a) all-cause death, myocardial infarction or stroke (MACE1); and (b) cardiovascular death, myocardial infarction or stroke (MACE2). In addition, major bleeding, fatal bleeding, net adverse clinical events (NACE), all-cause death, cardiovascular death, myocardial infarction, stroke, and stent thrombosis were examined.
Main results
- Compared with standard DAPT, abbreviated DAPT reduced the risk of MCRB (risk ratio (RR): 0.76; 95%CI: 0.61-0.94; I2=28%) and major bleeding (RR: 0.80; 95%CI: 0.64-0.99; I2=0%), but not the risk of fatal bleeding (RR: 0.63; 95%CI: 0.24-1.70; I2=0%).
- Compared with standard DAPT, abbreviated DAPT reduced the risk of cardiovascular death (RR: 0.79; 95%CI: 0.65-0.95; I2=0%), but not the risk of MACE1 (RR: 0.97; 95%CI: 0.74-1.26; I2=38%), MACE2 (RR: 0.92; 95%CI: 0.77-1.10; I2=0%), NACE (RR: 0.94; 95%CI: 0.78-1.14; I2=27%), all-cause death (RR: 0.91; 95%CI: 0.68-1.23; I2=24%), myocardial infarction (RR: 0.84; 95%CI: 0.51-1.38; I2=27%), stroke (RR: 1.15; 95%CI: 0.84-1.60; I2=0%) and stent thrombosis (RR: 0.73; 95%CI: 0.35-1.50; I2=0%).
- Results were consistent, irrespective of the definition of high bleeding risk and clinical presentation.
Conclusion
This systematic review and meta-analysis of RCTs shows that in high bleeding risk patients, abbreviated DAPT (≤3 months) after PCI is associated with lower cardiovascular death and a lower rate of major bleeding and MCRB, without increasing the rate of ischemic events, compared with standard DAPT (≥6 months).
The authors conclude: “A one-month or 3-month DAPT courses after PCI appears an appealing treatment option in HBR patients to optimize out comes. Further studies are warranted to determine how to individualize the decision between 1- and 3-month DAPT and the role of single antiplatelet therapy after DAPT.”
References
1. Urban P, Mehran R, Colleran R, et al. Defining high bleeding risk in patients undergoing percutaneous coronary intervention: a consensusdocument from the Academic Research Consortium for High Bleeding Risk. Circulation. 2019;140:240-61.
2. Costa F, Van Klaveren D, Feres F, et al. Dual antiplatelet therapy duration based on ischemic and bleeding risks after coronary stenting. J Am Coll Cardiol. 2019;73:741-54.
3. Valgimigli M, Bueno H, Byrne RA, et al. 2017 ESC focused update on dual antiplatelet therapy in coronary artery disease developed in collaboration with EACTS. Eur Heart J. 2018;39:213-60.
4. Collet JP, Thiele H, Barbato E, et al. 2020 ESC guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation. Eur Heart J. 2021;42:1289-367.
5. Marquis-Gravel G, Metha S, Valgimigli M, et al. A critical comparison of Canadian and international guidelines recommendations for antiplatelet therapy in coronary artery disease. Can J Cardiol. 2020;36:1298-307.
6. Costa F, van Klaveren D, James S, et al. Derivation and validation of the predicting bleeding complications in patients undergoing stent implantation and subsequent dual antiplatelet therapy (PRECISE-DAPT) score: a pooled analysis of individual-patient datasets from clinical trials. Lancet. 2017;389:1025-34.
7. Mehran R, Baber U, Sharma SK, et al. Ticagrelor with or without aspirin in high-risk patients after PCI. N Engl J Med. 2019;381:2032-42.
8. Valgimigli M, Frigoli E, Heg D, et al. Dual antiplatelet therapy after PCI in patients at high bleeding risk. N Engl J Med. 2021;385:1643-55.
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