Randomized trial of complete versus lesion-only revascularization in patients undergoing primary percutaneous coronary intervention for STEMI and multivessel disease: the CvLPRIT trial

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.

Keywords: complete revascularization; non-infarct-related lesion; primary percutaneous coronary angioplasty.

Figure 1

Patient Flow Diagram CONSORT (Consolidated Standards of Reporting Trials) diagram of recruitment to the CvLPRIT study. From 850 patients with ST-segment elevation myocardial infarction, 296 were randomized to receive complete (150) or culprit lesion–only (146) revascularization. Randomized patients were followed up for 12 months, and analysis was by intention-to-treat. CABG = coronary artery bypass grafting; CMR = cardiac magnetic resonance; IRA = infarct-related artery; ITT = intention-to-treat; MACE = major adverse cardiovascular event(s); MPS = myocardial perfusion scintigraphy; MVD = multivessel disease; N-IRA = non–infarct-related artery; PCI = percutaneous coronary intervention.

Central Illustration

Complete Versus Lesion-Only Revascularization in Acute MI Overview of the CvLPRIT trial showing the randomization strategy and main results. CI = confidence interval; CvLPRIT = Complete Versus Lesion-Only Primary PCI trial; HR = hazard ratio; IRA = infarct-related artery; MACE = major adverse cardiac event(s); MI = myocardial infarction; N-IRA = non–infarct-related artery.

Figure 2

Kaplan-Meier Curves Cumulative event rate for IRA-only versus complete revascularization groups. CI = confidence interval; other abbreviations as in Figure 1.