Revascularization in P-PCI for STEMI and Multivessel Disease
Revascularization in P-PCI for STEMI and Multivessel Disease
Background The optimal management of patients found to have multivessel disease while undergoing primary percutaneous coronary intervention (P-PCI) for ST-segment elevation myocardial infarction is uncertain.
Objectives CvLPRIT (Complete versus Lesion-only Primary PCI trial) is a U.K. open-label randomized study comparing complete revascularization at index admission with treatment of the infarct-related artery (IRA) only.
Methods After they provided verbal assent and underwent coronary angiography, 296 patients in 7 U.K. centers were randomized through an interactive voice-response program to either in-hospital complete revascularization (n = 150) or IRA-only revascularization (n = 146). Complete revascularization was performed either at the time of P-PCI or before hospital discharge. Randomization was stratified by infarct location (anterior/nonanterior) and symptom onset (≤3 h or >3 h). The primary endpoint was a composite of all-cause death, recurrent myocardial infarction (MI), heart failure, and ischemia-driven revascularization within 12 months.
Results Patient groups were well matched for baseline clinical characteristics. The primary endpoint occurred in 10.0% of the complete revascularization group versus 21.2% in the IRA-only revascularization group (hazard ratio: 0.45; 95% confidence interval: 0.24 to 0.84; p = 0.009). A trend toward benefit was seen early after complete revascularization (p = 0.055 at 30 days). Although there was no significant reduction in death or MI, a nonsignificant reduction in all primary endpoint components was seen. There was no reduction in ischemic burden on myocardial perfusion scintigraphy or in the safety endpoints of major bleeding, contrast-induced nephropathy, or stroke between the groups.
Conclusions In patients presenting for P-PCI with multivessel disease, index admission complete revascularization significantly lowered the rate of the composite primary endpoint at 12 months compared with treating only the IRA. In such patients, inpatient total revascularization may be considered, but larger clinical trials are required to confirm this result and specifically address whether this strategy is associated with improved survival. (Complete Versus Lesion-only Primary PCI Pilot Study [CvLPRIT]; ISRCTN70913605)
Primary percutaneous coronary intervention (P-PCI) is the standard of care for patients with ST-segment elevation myocardial infarction (STEMI). In up to 30% of such patients, significant stenoses are seen in 1 or more non–infarctrelated arteries (N-IRA) during index angiography.
It remains unresolved whether complete revascularization should be undertaken in this setting, with historical data providing conflicting evidence on the benefit and safety of immediate complete revascularization versus delayed complete revascularization versus revascularization as clinically required. In registry series, delayed complete revascularization appears to confer benefit, whereas observational studies to date have generally suggested no benefit and possible harm from immediate complete revascularization. The prevailing uncertainty regarding optimal management has persisted despite the recent PRAMI (Preventive Angioplasty in Myocardial Infarction) trial, which demonstrated benefit from complete revascularization during the index procedure.
CvLPRIT (Complete Versus Lesion-Only Primary PCI trial) is a U.K. multicenter, randomized, open-label trial, which set out to test the feasibility, safety, and potential benefit of undertaking in-hospital complete revascularization of angiographically significant N-IRA lesions in patients presenting with P-PCI for STEMI compared with percutaneous coronary intervention (PCI) of the infarct-related artery (IRA) alone. The hypothesis was that early treatment of significant N-IRA lesions during the index admission would reduce global ischemic burden and protect against short- and medium-term recurrent ischemic events. CvLPRIT and PRAMI ask a similar question but were initiated independently and with definitive differences in trial design.
Abstract and Introduction
Abstract
Background The optimal management of patients found to have multivessel disease while undergoing primary percutaneous coronary intervention (P-PCI) for ST-segment elevation myocardial infarction is uncertain.
Objectives CvLPRIT (Complete versus Lesion-only Primary PCI trial) is a U.K. open-label randomized study comparing complete revascularization at index admission with treatment of the infarct-related artery (IRA) only.
Methods After they provided verbal assent and underwent coronary angiography, 296 patients in 7 U.K. centers were randomized through an interactive voice-response program to either in-hospital complete revascularization (n = 150) or IRA-only revascularization (n = 146). Complete revascularization was performed either at the time of P-PCI or before hospital discharge. Randomization was stratified by infarct location (anterior/nonanterior) and symptom onset (≤3 h or >3 h). The primary endpoint was a composite of all-cause death, recurrent myocardial infarction (MI), heart failure, and ischemia-driven revascularization within 12 months.
Results Patient groups were well matched for baseline clinical characteristics. The primary endpoint occurred in 10.0% of the complete revascularization group versus 21.2% in the IRA-only revascularization group (hazard ratio: 0.45; 95% confidence interval: 0.24 to 0.84; p = 0.009). A trend toward benefit was seen early after complete revascularization (p = 0.055 at 30 days). Although there was no significant reduction in death or MI, a nonsignificant reduction in all primary endpoint components was seen. There was no reduction in ischemic burden on myocardial perfusion scintigraphy or in the safety endpoints of major bleeding, contrast-induced nephropathy, or stroke between the groups.
Conclusions In patients presenting for P-PCI with multivessel disease, index admission complete revascularization significantly lowered the rate of the composite primary endpoint at 12 months compared with treating only the IRA. In such patients, inpatient total revascularization may be considered, but larger clinical trials are required to confirm this result and specifically address whether this strategy is associated with improved survival. (Complete Versus Lesion-only Primary PCI Pilot Study [CvLPRIT]; ISRCTN70913605)
Introduction
Primary percutaneous coronary intervention (P-PCI) is the standard of care for patients with ST-segment elevation myocardial infarction (STEMI). In up to 30% of such patients, significant stenoses are seen in 1 or more non–infarctrelated arteries (N-IRA) during index angiography.
It remains unresolved whether complete revascularization should be undertaken in this setting, with historical data providing conflicting evidence on the benefit and safety of immediate complete revascularization versus delayed complete revascularization versus revascularization as clinically required. In registry series, delayed complete revascularization appears to confer benefit, whereas observational studies to date have generally suggested no benefit and possible harm from immediate complete revascularization. The prevailing uncertainty regarding optimal management has persisted despite the recent PRAMI (Preventive Angioplasty in Myocardial Infarction) trial, which demonstrated benefit from complete revascularization during the index procedure.
CvLPRIT (Complete Versus Lesion-Only Primary PCI trial) is a U.K. multicenter, randomized, open-label trial, which set out to test the feasibility, safety, and potential benefit of undertaking in-hospital complete revascularization of angiographically significant N-IRA lesions in patients presenting with P-PCI for STEMI compared with percutaneous coronary intervention (PCI) of the infarct-related artery (IRA) alone. The hypothesis was that early treatment of significant N-IRA lesions during the index admission would reduce global ischemic burden and protect against short- and medium-term recurrent ischemic events. CvLPRIT and PRAMI ask a similar question but were initiated independently and with definitive differences in trial design.
