Dataset Information

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.

SUBMITTER: Gershlick AH

PROVIDER: S-EPMC4359051 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundRecently, several randomized trials have noted improved outcomes with staged percutaneous coronary intervention (PCI) of nonculprit vessels in patients with ST-segment elevation myocardial infarction (STEMI) and multivessel disease. However, it remains unclear whether diabetes status affects the outcomes after different revascularization strategies. This study thus compared the impact of diabetes status on long-term outcomes after staged complete revascularization with that after culprit-only PCI.MethodsFrom January 2006 to December 2015, 371 diabetic patients (staged PCI: 164, culprit-only PCI: 207) and 834 nondiabetic patients (staged PCI: 412, culprit-only PCI: 422) with STEMI and multivessel disease were enrolled. The primary endpoint was 5-year major adverse cardiac and cerebrovascular event (MACCE), defined as a composite of all-cause death, myocardial infarction (MI), stroke or unplanned revascularization.ResultsThe rate of the 5-year composite primary endpoint for diabetic patients was close to that for nondiabetic patients (34.5% vs. 33.7%; adjusted hazard ratio [HR] 1.012, 95% confidence interval [CI] 0.815-1.255). In nondiabetic patients, the 5-year risks of MACCE (31.8% vs. 35.5%; adjusted HR 0.638, 95% CI 0.500-0.816), MI (4.6% vs. 9.2%; adjusted HR 0.358, 95% CI 0.200-0.641), unplanned revascularization (19.9% vs. 24.9%; adjusted HR 0.532, 95% CI 0.393-0.720), and the composite of cardiac death, MI or stroke (11.4% vs. 15.2%; adjusted HR 0.621, 95% CI 0.419-0.921) were significantly lower after staged PCI than after culprit-only PCI. In contrast, no significant difference was found between the two groups with respect to MACCE, MI, unplanned revascularization, and the composite of cardiac death, MI or stroke in diabetic patients. Significant interactions were found between diabetes status and revascularization assignment for the composite of cardiac death, MI or stroke (Pinteraction?=?0.013), MI (Pinteraction?=?0.005), and unplanned revascularization (Pinteraction?=?0.013) at 5 years. In addition, the interaction tended to be significant for the primary endpoint of MACCE (Pinteraction?=?0.053). Moreover, the results of propensity score-matching analysis were concordant with the overall analysis in both diabetic and nondiabetic population.ConclusionsIn patients with STEMI and multivessel disease, diabetes is not an independent predictor of adverse cardiovascular events at 5 years. In nondiabetic patients, an approach of staged complete revascularization is superior to culprit-only PCI, whereas the advantage of staged PCI is attenuated in diabetic patients. Trial registration This study was not registered in an open access database.

Project description:ObjectiveWe sought to assess the relative merits of different revascularization strategies in patients with ST-segment elevation myocardial infarction (STEMI) and multivessel coronary artery disease complicated by cardiogenic shock or chronic total occlusion (CTO).BackgroundRecent randomized trials and meta-analysis have suggested that multivessel percutaneous coronary intervention (PCI) is associated with better outcomes in patients with STEMI and multivessel coronary artery disease, however, patients complicated by cardiogenic shock or CTO were excluded.MethodsStudies that compared multivessel PCI (immediate or staged) with culprit-only PCI in patients with STEMI and multivessel coronary artery disease complicated by cardiogenic shock or CTO were included. Random odd ratio (OR) and 95% confidence interval (CI) were conducted.ResultsSixteen studies with 8695 patients complicated by cardiogenic shock and eight studies with 2259 patients complicated by CTO were included. In patients complicated by cardiogenic shock, a strategy of CO-PCI was associated with lower risk for short-term renal failure (OR: 0.75; 95% CI: 0.61-0.93; I2 = 0.0%), with no significant difference in MACE, all-cause mortality, re-infarction, revascularization, cardiac death, heart failure, major bleeding, or stroke compared with an immediate MV-PCI strategy. In patients complicated by CTO, a strategy of CO-PCI was associated with higher risk for long-term MACE (OR: 2.06; 95% CI: 1.39-3.06; I2 = 54.0%), all-cause mortality (OR: 2.89; 95% CI: 2.09-4.00; I2 = 0.0%), cardiac death (OR: 3.12; 95% CI: 2.05-4.75; I2 = 16.8%), heart failure (OR: 1.99; 95% CI: 1.22-3.24; I2 = 0.0%), and stroke (OR: 2.80; 95% CI: 1.04-7.53; I2 = 0.0%) compared with a staged MV-PCI strategy, without any difference in re-infarction, revascularization, or major bleeding.ConclusionsFor patients with STEMI and multivessel coronary artery disease complicated by cardiogenic shock, an immediate multivessel PCI was not advocated due to a higher risk for short-term renal failure, whereas for patients complicated by CTO, a staged multivessel PCI was advocated due to reduced risks for long-term MACE, all-cause mortality, cardiac death, heart failure, and stroke.

Project description:Background For patients with ST-segment-elevation myocardial infarction (STEMI) and multivessel coronary artery disease, the optimal treatment of the non-infarct-related artery has been controversial. This up-to-date meta-analysis focusing on individual clinical end points was performed to further evaluate the benefit of complete revascularization with percutaneous coronary intervention for patients with STEMI and multivessel coronary artery disease. Methods and Results We systematically identified all randomized trials comparing complete revascularization with percutaneous coronary intervention to culprit-only revascularization for multivessel disease in STEMI and performed a random-effects meta-analysis. The primary efficacy end point was cardiovascular death analyzed on an intention-to-treat basis. Secondary end points included all-cause mortality, myocardial infarction, and unplanned revascularization. Ten studies (7542 patients) were included: 3664 patients were randomized to complete revascularization and 3878 to culprit-only revascularization. Across all patients, complete revascularization was superior to culprit-only revascularization for reduction in the risk of cardiovascular death (relative risk [RR], 0.68; 95% CI, 0.47-0.98; P=0.037; I2=21.8%) and reduction in the risk of myocardial infarction (RR, 0.65; 95% CI, 0.54-0.79; P<0.0001; I2=0.0%). Complete revascularization also significantly reduced the risk of unplanned revascularization (RR, 0.37; 95% CI, 0.28-0.51; P<0.0001; I2=64.7%). The difference in all-cause mortality with percutaneous coronary intervention was not statistically significant (RR, 0.85; 95% CI, 0.69-1.04; P=0.108; I2=0.0%). Conclusions For patients with STEMI and multivessel disease, complete revascularization with percutaneous coronary intervention significantly improves hard clinical outcomes including cardiovascular death and myocardial infarction. These data have implications for clinical practice guidelines regarding recommendations for complete revascularization following STEMI.