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

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 culprit-Lesion only PRimary PCI Trial (CVLPRIT): a multicentre trial testing management strategies when multivessel disease is detected at the time of primary PCI: rationale and design.

AIMS: Primary percutaneous coronary intervention (PPCI) is the preferred strategy for acute ST-segment elevation myocardial infarction (STEMI), with evidence of improved clinical outcomes compared to fibrinolytic therapy. However, there is no consensus on how best to manage multivessel coronary disease detected at the time of PPCI, with little robust data on best management of angiographically significant stenoses detected in non-infarct-related (N-IRA) coronary arteries. CVLPRIT will determine the optimal management of N-IRA lesions detected during PPCI. METHODS AND RESULTS: CVLPRIT (Complete Versus culprit-Lesion only PRimary PCI Trial) is an open-label, prospective, randomised, multicentre trial. STEMI patients undergo verbal "assent" on presentation. Patients are included when angiographic MVD has been detected, and randomised to culprit (IRA)-only PCI (n=150) or in-patient complete multivessel PCI (n=150). Cumulative major adverse cardiac events (MACE) - all-cause mortality, recurrent MI, heart failure, need for revascularisation (PCI or CABG) will be recorded at 12 months. Secondary endpoints include safety endpoints of confirmed ischaemic stroke, intracranial haemorrhage, major non-intracranial bleeding, and repair of vascular complications. A cardiac magnetic resonance (CMR) substudy will provide mechanistic data on infarct size, myocardial salvage index and microvascular obstruction. A cost efficacy analysis will be undertaken. CONCLUSIONS: The management of multivessel coronary artery disease in the setting of PPCI for STEMI, including the timing of when to perform non-culprit-artery revascularisation if undertaken, remains unresolved. CVLPRIT will yield mechanistic insights into the myocardial consequence of N-IRA intervention undertaken during the peri-infarct period.

Longer-term follow-up of patients recruited to the REACT (Rescue Angioplasty Versus Conservative Treatment or Repeat Thrombolysis) trial.

OBJECTIVES: To evaluate the longer-term outcomes for rescue percutaneous coronary intervention (R-PCI). BACKGROUND: Thrombolysis remains an important, commonly used reperfusion therapy, yet failure to achieve complete reperfusion occurs relatively frequently. A number of recent trials have focused on the management of patients with thrombolytic failure, including the REACT (Rescue Angioplasty Versus Conservative Treatment or Repeat Thrombolysis) trial, which demonstrated a significant 6-month benefit favoring R-PCI. However, longer-term maintenance of benefit for R-PCI has not been demonstrated. METHODS: Rates of the primary composite end point (major adverse cardiac and cerebrovascular events) to 1 year and mortality to a median of 4.4 years in 427 patients included in the 3 randomized arms of the REACT trial (repeat lysis, conservative therapy, and R-PCI) were analyzed. RESULTS: One-year event-free survival for patients randomized to R-PCI was 81.5%, compared with 64.1% for repeat thrombolysis and 67.5% for conservative therapy (overall p = 0.004). Adjusted hazard ratio was 0.44 (95% confidence interval [CI]: 0.28 to 0.71; p = 0.0008) for R-PCI versus repeat thrombolysis and 0.51 (95% CI: 0.32 to 0.83; p = 0.007) for R-PCI versus conservative therapy. Adjusted hazard ratio for longer-term (median 4.4 years) overall mortality for R-PCI versus repeat thrombolysis was 0.41 (95% CI: 0.22 to 0.75; p = 0.004) and 0.43 (95% CI: 0.23 to 0.79; p = 0.006) for R-PCI versus conservative therapy. There was no difference in either analysis between repeat thrombolysis and conservative strategies. CONCLUSIONS: Rescue PCI, previously shown to be superior in the short term to both repeat thrombolysis and conservative therapy, maintains benefit in terms of long-term mortality. This strategy for failed lysis should be mandated as part of thrombolytic-based ST-segment elevation myocardial infarction protocols.