Short Duration of DAPT Versus De-Escalation After Percutaneous Coronary Intervention for Acute Coronary Syndromes

Laudani, Claudio; Greco, Antonio; Occhipinti, Giovanni; Ingala, Salvatore; Calderone, Dario; Scalia, Lorenzo; Agnello, Federica; Legnazzi, Marco; Mauro, Maria Sara; Rochira, Carla; Buccheri, Sergio; Mehran, Roxana; James, Stefan; Angiolillo, Dominick J.; Capodanno, Davide

doi:10.1016/j.jcin.2021.11.028

Cited by 84 publications

(57 citation statements)

References 40 publications

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“…DAPT duration differs according to clinical presentation. In patients presenting with acute coronary syndrome, DAPT is suggested for 12 months in patients randomized to receive DES and for 6 months in patients allocated to the DCB group; both durations can be potentially shortened to 3 months (or even 1 month) if concerns about the bleeding risk prevail 20 . In chronic coronary syndrome patients, DAPT is recommended for 6 months (susceptible to shortening in high‐bleeding risk patients) or 1 month in patients randomized to DES or DCB, respectively 17–19 …”

Section: Methodsmentioning

confidence: 99%

Sirolimus‐coated balloon versus everolimus‐eluting stent in de novo coronary artery disease: Rationale and design of the TRANSFORM II randomized clinical trial

Greco

Sciahbasi

Abizaid

et al. 2022

Cathet Cardio Intervent

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Background: Percutaneous coronary intervention (PCI) with drug-eluting stent (DES) implantation is a widely adopted strategy for the treatment of de novo coronary artery disease. DES implantation conveys an inherent risk for short-and long-term complications, including in-stent restenosis and stent thrombosis. Drug-coated balloons are emerging as an alternative approach to fulfill the "leaving nothing behind" principle and avoid long-term DES-related complications.Design: TRANSFORM II is an investigator-initiated, multicenter, noninferiority, randomized clinical trial, testing a sirolimus-coated balloon (SCB) versus the standard of care for native coronary vessels with a 2-3 mm diameter, in terms of 12-month target lesion failure (TLF; primary endpoint) and net adverse cardiovascular events (coprimary endpoint). Patients undergoing PCI will be randomized to be treated with either SCB or new-generation everolimus-eluting stent and will be followed up clinically for up to 60 months. Assuming a TLF rate of 8% at 12 months with DES, a sample size of 1325 patients was chosen to ensure an 80% power to detect a 1.5% lower incidence in the SCB group with a type I error rate of 0.05. The TRANSFORM II trial is registered on clinicaltrials.gov (identification number NCT04893291).Several substudies, including an optical coherence tomography assessment at 9 months (intracoronary imaging substudy), will investigate the study device in different clinical and lesion settings. Conclusions:The randomized TRANSFORM II trial will determine whether a novel SCB is noninferior to a current everolimus-eluting stent when adopted for the treatment of de novo lesions in coronary vessels with a diameter between 2 and 3 mm.

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Section: Methodsmentioning

confidence: 99%

Sirolimus‐coated balloon versus everolimus‐eluting stent in de novo coronary artery disease: Rationale and design of the TRANSFORM II randomized clinical trial

Greco

Sciahbasi

Abizaid

et al. 2022

Cathet Cardio Intervent

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“…The main features and pitfalls of RCTs testing a de-escalation of antiplatelet therapy among ACS patients are summarized in Table 1 . Although the comparative effects of different de-escalation strategies seem to favor the mitigation of P2Y 12 inhibition for efficacy and short DAPT for safety, these findings are mostly based on indirect comparisons and require further investigations ( 23 ).…”

Section: De-escalation: How?mentioning

confidence: 99%

De-escalation of antiplatelet therapy in acute coronary syndromes: Why, how and when?

Galli

Angiolillo

2022

Front. Cardiovasc. Med.

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The synergistic blockade of the key platelet signaling pathways of cyclooxygenase-1 blockade and P2Y12 signaling by combining aspirin plus a potent P2Y12 inhibitor (prasugrel or ticagrelor), the so called dual antiplatelet treatment (DAPT), has represented the antithrombotic regimen of choice in patients with acute coronary syndrome (ACS) for nearly a decade. Nevertheless, the use of such antiplatelet treatment regimen, while reduced the risk of thrombotic complications, it is inevitably associated with increased bleeding and this risk may outweigh the benefit of a reduction of ischemic events in specific subgroup of patients. In light of the adverse prognostic implications of a bleeding complication, there has been a great interest in the development of antiplatelet regimens aimed at reducing bleeding without any trade-off in ischemic events. The fact that the ischemic risk is highest in the early phase after an ACS while the risk of bleeding remains relatively stable over time has represented the rationale for the implementation of a more intense antithrombotic regimen early after an ACS, followed by a less intense antithrombotic regimen thereafter. This practice, known as a “de-escalation” strategy, represents one of the more promising approaches for personalization of antithrombotic therapy in ACS. In this review we discuss the rationale, appraise the evidence and provide practical recommendations on the use of a de-escalation strategy of antiplatelet therapy in patients with an ACS.

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“…Fourth, four out seven trials used clopidogrel as the main P2Y 12 inhibitor, platelet function testing or CYP2C19 genotyping to assess the probability of HPR was not performed in any of these trials and it is unclear if adverse events could be related to clopidogrel poor responders [ 41 , 83 ]. Ultimately, P2Y 12 monotherapy has been mainly compared with standard DAPT regimens and it is unknown how this strategy compares with other bleeding avoidance strategies, including short DAPT with discontinuation of P2Y 12 inhibitor and maintaining aspirin or de-escalation DAPT approaches (e.g., switching from ticagrelor/prasugrel to clopidogrel or reducing the dose of ticagrelor/prasugrel) [ 84 ]. The current gaps in knowledge and ongoing trials are summarized in Table 4 .…”

Section: Gaps In Evidencementioning

confidence: 99%

“…It should be underscored that these trials are heterogeneous in terms of enrolled populations (Western countries vs. East Asian countries) which could impact the thrombotic and bleeding risk profiles of the studied populations. Furthermore, previous studies have shown that different bleeding avoidance strategies (i.e., abbreviated DAPT vs. de-escalation) are associated with different impact on clinical outcomes, suggesting that the selected strategy should be tailored according to patient characteristics and desired outcomes [ 84 ]. Moreover, procedural characteristics could also raise the concern about the outcomes in patients treated with complex PCI.…”

Section: Practical Implicationsmentioning

confidence: 99%

P2Y12 Inhibitor Monotherapy after Percutaneous Coronary Intervention

Zhou

Angiolillo

Ortega‐Paz

2022

JCDD

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In patients with acute and chronic coronary artery disease undergoing percutaneous coronary intervention (PCI), dual antiplatelet therapy (DAPT) has been the cornerstone of pharmacotherapy for the past two decades. Although its antithrombotic benefit is well established, DAPT is associated with an increased risk of bleeding, which is independently associated with poor prognosis. The improvement of the safety profiles of drug-eluting stents has been critical in investigating and implementing shorter DAPT regimens. The introduction into clinical practice of newer generation oral P2Y12 inhibitors such as prasugrel and ticagrelor, which provide more potent and predictable platelet inhibition, has questioned the paradigm of standard DAPT durations after coronary stenting. Over the last five years, several trials have assessed the safety and efficacy of P2Y12 inhibitor monotherapy after a short course of DAPT in patients treated with PCI. Moreover, ongoing studies are testing the role of P2Y12 inhibitor monotherapy immediately after PCI in selected patients. In this review, we provide up-to-date evidence on the efficacy and safety of P2Y12 inhibitor monotherapy after a short period of DAPT compared to DAPT in patients undergoing PCI as well as outcomes associated with P2Y12 inhibitor monotherapy compared to aspirin for long-term prevention.

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Short Duration of DAPT Versus De-Escalation After Percutaneous Coronary Intervention for Acute Coronary Syndromes

Cited by 84 publications

References 40 publications

Sirolimus‐coated balloon versus everolimus‐eluting stent in de novo coronary artery disease: Rationale and design of the TRANSFORM II randomized clinical trial

Sirolimus‐coated balloon versus everolimus‐eluting stent in de novo coronary artery disease: Rationale and design of the TRANSFORM II randomized clinical trial

De-escalation of antiplatelet therapy in acute coronary syndromes: Why, how and when?

P2Y12 Inhibitor Monotherapy after Percutaneous Coronary Intervention

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