Prasugrel Versus Clopidogrel for PCI Wthout Stent Implantation
Prasugrel Versus Clopidogrel for PCI Wthout Stent Implantation
Background: Prasugrel led to a significant reduction in ischemic cardiovascular events among patients with acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI) with stent implantation compared to clopidogrel. Whether this benefit extends to patients undergoing PCI without stent implantation is unknown.
Methods: In TRial to assess Improvement in Therapeutic Outcomes by optimizing platelet inhibitioN with prasugrel (TRITON)-Thrombolysis in Myocardial Infarction (TIMI) 38, patients (n = 13 608) undergoing PCI for ACS were randomized to aspirin plus clopidogrel or prasugrel. This postrandomization analysis of a prespecified subgroup was restricted to patients who underwent PCI without stent implantation (n = 569).
Results: Patients who underwent PCI without stent implantation were older and had a higher incidence of hypertension, diabetes, prior myocardial infarction (MI), prior coronary artery bypass (CABG) surgery, and renal dysfunction than patients who underwent stent implantation. In the group that did not undergo stent implantation, baseline characteristics were similar between patients receiving clopidogrel and prasugrel. The composite of cardiovascular death, nonfatal MI, and nonfatal stroke occurred in 14.2% of patients receiving prasugrel and 17.1% of patients receiving clopidogrel (HR 0.82, P = .27). There were significant reductions favoring prasugrel in the rates of urgent target vessel revascularization (TVR; HR 0.46, P = .040) and any TVR (HR 0.40, P = .009) and a trend toward a reduction in the incidence of nonfatal MI (HR 0.65, P = .11). CABG-related TIMI major bleeding was more frequent among patients receiving prasugrel. There were no significant interactions between treatment and PCI type.
Conclusion: Among ACS patients who underwent PCI without stent implantation, prasugrel therapy tended to reduce clinical ischemic events and to increase bleeding events to a similar magnitude as among patients who received stents.
Dual antiplatelet therapy with aspirin and clopidogrel is associated with a reduction in cardiovascular events across the spectrum of management of acute coronary syndromes (ACS). The Trial to Assess Improvement in Therapeutic Outcomes by Optimizing Platelet Inhibition with Prasugrel (TRITON)-Thrombolysis in Myocardial Infarction (TIMI) 38 demonstrated a further reduction in cardiovascular (CV) events among patients with moderate- to high-risk ACS who underwent percutaneous coronary intervention (PCI) and who were treated with prasugrel compared with clopidogrel. The combination of aspirin and prasugrel led to a significant 19% relative reduction in the primary composite outcome of CV death, nonfatal myocardial infarction (MI) and nonfatal stroke compared with aspirin and clopidogrel among patients who underwent PCI with stent implantation for ACS.
In the Clopidogrel in Unstable Angina to Prevent Recurrent Events (CURE) trial, in which less than a quarter of patients with non–ST-segment elevation MI (NSTEMI) and unstable angina underwent PCI, the addition of clopidogrel to aspirin monotherapy was associated with a significant 20% relative risk reduction in the composite of CV death, nonfatal MI, and stroke. Whether greater, more consistent and rapid platelet inhibition with prasugrel, a novel thienopyridine, further reduces CV events among ACS patients who do not undergo stent implantation is unknown.
The goal of this postrandomization analysis of a prespecified subgroup was to determine whether prasugrel therapy was associated with a similar reduction in CV events among patients who did not receive intracoronary stents as it did among those who underwent stent implantation.
Abstract and Introduction
Abstract
Background: Prasugrel led to a significant reduction in ischemic cardiovascular events among patients with acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI) with stent implantation compared to clopidogrel. Whether this benefit extends to patients undergoing PCI without stent implantation is unknown.
Methods: In TRial to assess Improvement in Therapeutic Outcomes by optimizing platelet inhibitioN with prasugrel (TRITON)-Thrombolysis in Myocardial Infarction (TIMI) 38, patients (n = 13 608) undergoing PCI for ACS were randomized to aspirin plus clopidogrel or prasugrel. This postrandomization analysis of a prespecified subgroup was restricted to patients who underwent PCI without stent implantation (n = 569).
Results: Patients who underwent PCI without stent implantation were older and had a higher incidence of hypertension, diabetes, prior myocardial infarction (MI), prior coronary artery bypass (CABG) surgery, and renal dysfunction than patients who underwent stent implantation. In the group that did not undergo stent implantation, baseline characteristics were similar between patients receiving clopidogrel and prasugrel. The composite of cardiovascular death, nonfatal MI, and nonfatal stroke occurred in 14.2% of patients receiving prasugrel and 17.1% of patients receiving clopidogrel (HR 0.82, P = .27). There were significant reductions favoring prasugrel in the rates of urgent target vessel revascularization (TVR; HR 0.46, P = .040) and any TVR (HR 0.40, P = .009) and a trend toward a reduction in the incidence of nonfatal MI (HR 0.65, P = .11). CABG-related TIMI major bleeding was more frequent among patients receiving prasugrel. There were no significant interactions between treatment and PCI type.
Conclusion: Among ACS patients who underwent PCI without stent implantation, prasugrel therapy tended to reduce clinical ischemic events and to increase bleeding events to a similar magnitude as among patients who received stents.
Introduction
Dual antiplatelet therapy with aspirin and clopidogrel is associated with a reduction in cardiovascular events across the spectrum of management of acute coronary syndromes (ACS). The Trial to Assess Improvement in Therapeutic Outcomes by Optimizing Platelet Inhibition with Prasugrel (TRITON)-Thrombolysis in Myocardial Infarction (TIMI) 38 demonstrated a further reduction in cardiovascular (CV) events among patients with moderate- to high-risk ACS who underwent percutaneous coronary intervention (PCI) and who were treated with prasugrel compared with clopidogrel. The combination of aspirin and prasugrel led to a significant 19% relative reduction in the primary composite outcome of CV death, nonfatal myocardial infarction (MI) and nonfatal stroke compared with aspirin and clopidogrel among patients who underwent PCI with stent implantation for ACS.
In the Clopidogrel in Unstable Angina to Prevent Recurrent Events (CURE) trial, in which less than a quarter of patients with non–ST-segment elevation MI (NSTEMI) and unstable angina underwent PCI, the addition of clopidogrel to aspirin monotherapy was associated with a significant 20% relative risk reduction in the composite of CV death, nonfatal MI, and stroke. Whether greater, more consistent and rapid platelet inhibition with prasugrel, a novel thienopyridine, further reduces CV events among ACS patients who do not undergo stent implantation is unknown.
The goal of this postrandomization analysis of a prespecified subgroup was to determine whether prasugrel therapy was associated with a similar reduction in CV events among patients who did not receive intracoronary stents as it did among those who underwent stent implantation.
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