Culprit-Only vs. Complete Revascularization During ST-Segment Elevation Myocardial Infarction

doi:10.1016/j.pcad.2015.07.006

Progress in Cardiovascular Diseases

Volume 58, Issue 3, November–December 2015, Pages 260-266

https://doi.org/10.1016/j.pcad.2015.07.006 Get rights and content

Abstract

Primary percutaneous intervention (PCI) is the treatment of choice for ST-segment elevation myocardial infarction (STEMI). Patients with STEMI frequently have obstructive non-culprit lesions. In addition, STEMI patients with multivessel disease are at increased risk of major adverse cardiac events. However, current guidelines do not recommend revascularization of non-culprit lesions unless complicated by cardiogenic shock. Prior observational and small randomized controlled trials (RCTs) have demonstrated conflicting results pertaining to the optimal revascularization strategy in STEMI patients with multivessel disease undergoing primary PCI. Recent randomized studies, PRAMI, CvLPRIT, and DANAMI‐3-PRIMULTI, provide encouraging data that suggest potential benefit with complete revascularization in STEMI patients with obstructive non-culprit lesions. However, further data from large RCTs are needed to investigate the impact of this strategy on recurrent myocardial infarction/death and to determine the best timing of staged procedures for complete revascularization. Until then, a personalized approach should be taken to optimize the revascularization strategy in STEMI patients with obstructive non-culprit lesions.

Section snippets

PRAMI

In the Preventive Angioplasty in Acute Myocardial Infarction (PRAMI) trial, 465 patients with STEMI and multivessel CAD were randomly assigned to undergo treatment of the culprit-lesion alone or revascularization of all obstructive (≥ 50% stenosis) non-culprit lesions as well during index procedure (preventive PCI).¹⁸ The investigators found a 65% reduction in the primary endpoint composite of CV death, myocardial infarction (MI), or refractory angina within 23 months with complete

CvLPRIT

In the Complete versus Lesion-only Primary PCI Trial (CvLPRIT), Gershlick and colleagues randomized 296 patients with STEMI to either in-hospital complete revascularization or culprit-lesion only revascularization. ¹⁹ Complete revascularization was performed either at the time of the index procedure or before hospital discharge. The investigators found a significant 53% reduction in the primary endpoint composite of all-cause mortality, recurrent MI, heart failure (HF), or ischemia driven

DANAMI‐3-PRIMULTI

In the Third Danish Study of Optimal Acute Treatment of Patients with ST-segment Elevation Myocardial Infarction Primary PCI in Multivessel Disease (DANAMI‐3-PRIMULTI) trial, 627 STEMI patients with multivessel CAD were randomized to receive treatment of the culprit-lesion alone or fractional flow reserve (FFR) guided complete revascularization of all obstructive (≥ 50% stenosis) non-culprit lesions staged during the index hospitalization.²⁰ The investigators demonstrated a significant 44%

STEMI with multivessel disease and cardiogenic shock

In STEMI patients with cardiogenic shock, current guidelines recommend complete revascularization during primary PCI.5., 6. In a subgroup analysis of 82 STEMI patients with cardiogenic shock who received primary PCI in the Should We Emergently Revascularize Occluded Coronaries for Cardiogenic Shock (SHOCK) trial, complete revascularization was surprisingly associated with reduced survival at one year compared to culprit-lesion only revascularization.²⁵ However, the investigators attributed this

STEMI with multivessel disease and chronic total occlusion (CTO)

In STEMI patients with multivessel CAD, presence of a CTO in a non-culprit artery is associated with poor prognosis. In a retrospective analysis of 1819 STEMI patients with multivessel CAD who underwent primary PCI, CTO in a non-culprit artery was seen in 36.6% of the patients. The investigators found the presence of a CTO to be an independent predictor of short-and long-term mortality, whereas multivessel CAD without CTO was not associated with increased mortality.²⁷ The ongoing Evaluating

Complete revascularization in non-ST-segment elevation MI (NSTEMI)

How the results of PRAMI, CvLPRIT, and DANAMI‐3-PRIMULTI should be interpreted in NSTEMI is unclear. Unlike in STEMI in which the culprit-lesion can be easily identified, in NSTEMI identifying the culprit lesion can be difficult. Like STEMI, many patients presenting with NSTEMI have multiple obstructive lesions which are amenable to PCI. There are no adequate RCTs to support either culprit-lesion only or complete revascularization in the setting of NSTEMI.²⁹ Furthermore, there are only few

Complete revascularization in stable CAD

Uncertainty pertaining to benefits of stenting stable lesions extends beyond STEMI and NSTEMI. Other than for the important goal of symptom relief, it is uncertain if PCI is of benefit in stable CAD patients with stable obstructive (≥ 50% stenosis) lesions compared with OMT only.³⁴ In the Fractional Flow Reserve versus Angiography for Mutivessel Evaluation 2 (FAME) trial, FFR guided PCI of stable lesions plus evidence-based OMT reduced the composite rate of death, MI, or need for urgent

Future studies: COMPLETE trial

Other relatively modest-sized trials are likely to report in the next few years, each with slightly different designs and target populations. The PRAGUE 13 trial was recently presented and that trial of 214 STEMI patients found no benefit of staged PCI versus culprit-only PCI in the primary endpoint of death, MI, or stroke, though there was a trend towards fewer non-culprit revascularizations.³⁹

The large ongoing Complete versus Culprit-only Revascularization to Treat Multi-vessel Disease After

Statement of Conflict of Interest

Dr. Deepak L. Bhatt discloses the following relationships – Advisory Board: Cardax, Elsevier Practice Update Cardiology, Medscape Cardiology, Regado Biosciences; Board of Directors: Boston VA Research Institute, Society of Cardiovascular Patient Care; Chair: American Heart Association Get With The Guidelines Steering Committee; Data Monitoring Committees: Duke Clinical Research Institute, Harvard Clinical Research Institute, Mayo Clinic, Population Health Research Institute (including for

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Cited by (9)

Complete revascularization for patients with multivessel coronary artery disease and ST-segment elevation myocardial infarction after the COMPLETE trial: A meta-analysis of randomized controlled trials
2020, IJC Heart and Vasculature
Citation Excerpt :
It should be appreciated that the evidence for significant clinical benefit from CR over and above culprit-only revascularization was not clear from the older data [9–11,13,14,21–23]. Older trials and meta analyses did not support an additional benefit from CR, probably because of different inclusion criteria of patients and studies as well as different means for measuring clinical outcome [29–37]. We believe that the results of the current meta analysis are of clinical relevance based on reduced MACE at mid-term follow up which is what concerns most patients.
The recently published COMPLETE trial has demonstrated that patients with ST-segment elevation myocardial infarction (STEMI) and multivessel coronary artery disease (MVD), who underwent successful percutaneous coronary intervention (PCI) of both culprit and non-culprit (vs. culprit-only) lesions had a reduced risk of major adverse cardiac events (MACE), but not of cardiovascular or total mortality. The aim of this meta-analysis was to assess the efficacy of complete revascularization on cardiovascular or total mortality reduction using available randomized controlled trials (RCTs) including the COMPLETE trial, in hemodynamically stable STEMI patients with MVD.
PubMed, MEDLINE, Embase, Scopus, Google Scholar, CENTRAL and ClinicalTrials.gov databases search identified 10 RCTs of 7033 patients with STEMI and MVD which compared complete (n = 3420) vs. only culprit lesion (n = 3613) PCI for a median 27.7 months follow-up. Random effect risk ratios were used to estimate for efficacy and safety outcomes.
Complete revascularization reduced the risk of MACE (10.4% vs.16.6%; RR = 0.59, 95% CI: 0.47 to 0.74, p < 0.0001), CV mortality (2.87% vs. 3.72%; RR = 0.73, 95% CI: 0.56 to 0.95, p = 0.02), reinfarction (5.1% vs. 7.1%; RR = 0.67, 95% CI: 0.52 to 0.86, p = 0.002), urgent revascularization (7.92% vs.17.4%; RR = 0.47, 95% CI: 0.30 to 0.73, p < 0.001), and CV hospitalization (8.68% vs.11.4%; RR = 0.65, 95% CI: 0.44to 0.96, p = 0.03) compared with culprit only revascularization. All-cause mortality, stroke, major bleeding events, or contrast induced nephropathy were not affected by the revascularization strategy.
The findings of this meta-analysis suggest that in patients with STEMI and MVD, complete revascularization is superior to culprit-only PCI in reducing the risk of MACE outcomes, including cardiovascular mortality, without increasing the risk of adverse safety outcomes.
Multivessel Versus Culprit-Only Revascularization in STEMI and Multivessel Coronary Artery Disease: Meta-Analysis of Randomized Trials
2020, JACC: Cardiovascular Interventions
The goal of this systematic review and meta-analysis was to provide a comprehensive evaluation of contemporary randomized trials addressing the efficacy and safety of multivessel versus culprit vessel–only percutaneous coronary intervention (PCI) among patients presenting with ST-segment elevation myocardial infarction and multivessel coronary artery disease.
Multivessel coronary artery disease is present in about one-half of patients with ST-segment elevation myocardial infarction. Randomized controlled trials comparing multivessel and culprit vessel–only PCI produced conflicting results regarding the benefits of a multivessel PCI strategy.
A comprehensive search for published randomized controlled trials comparing multivessel PCI with culprit vessel–only PCI was conducted on ClinicalTrials.gov, PubMed, Web of Science, EBSCO Services, the Cochrane Central Register of Controlled Trials, Google Scholar, and scientific conference sessions from inception to September 15, 2019. A meta-analysis was performed using a random-effects model to calculate the risk ratio (RR) and 95% confidence interval (CI). Primary efficacy outcomes were all-cause mortality and reinfarction.
Ten randomized controlled trials were included, representing 7,030 patients: 3,426 underwent multivessel PCI and 3,604 received culprit vessel–only PCI. Compared with culprit vessel–only PCI, multivessel PCI was associated with no significant difference in all-cause mortality (RR: 0.85; 95% CI: 0.68 to 1.05) and lower risk for reinfarction (RR: 0.69; 95% CI: 0.50 to 0.95), cardiovascular mortality (RR: 0.71; 95% CI: 0.50 to 1.00), and repeat revascularization (RR: 0.34; 95% CI: 0.25 to 0.44). Major bleeding (RR: 0.92; 95% CI: 0.50 to 1.67), stroke (RR: 1.15; 95% CI: 0.65 to 2.01), and contrast-induced nephropathy (RR: 1.25; 95% CI: 0.80 to 1.95) were not significantly different between the 2 groups.
Multivessel PCI was associated with a lower risk for reinfarction, without any difference in all-cause mortality, compared with culprit vessel–only PCI in patients with ST-segment elevation myocardial infarction.
The Evolving Face of Myocardial Reperfusion in Acute Coronary Syndromes: A Primer for the Internist
2018, Mayo Clinic Proceedings
Citation Excerpt :
Although traditionally taught as a class III recommendation,11 practice is now evolving to revascularize all physiologically significant lesions in patients who present with ACS (class IIb recommendation), although not necessarily during the initial intervention in the acute setting. More data with larger trials that analyze staged vs simultaneous revascularization are needed to demonstrate a potential effect on repeated ACS and cardiovascular disease (CVD)–related death—not just repeated revascularization—before this is considered a class I indication.19 In anticipation of PCI, the preferred method of revascularization in STEMI, patients should receive usual guideline-driven antithrombotic and antiplatelet therapy, including a 1-time loading dose of aspirin, 325 mg, to be continued at 81 mg/d indefinitely, plus a P2Y12 inhibitor.
Acute coronary syndromes (ACSs) account for a large proportion of disease burden in the United States and worldwide, and our understanding of ACS management continues to evolve. In this review we take a practical approach to evaluating and treating a patient with ACS, focusing on the optimal timing and methods of coronary reperfusion. Beginning with initial assessment and risk stratification, a provider managing the patient with ACS must be able to expeditiously decide on and implement the correct guideline-directed pathway to optimize outcomes. With an ever-growing body and weight of knowledge in this field, the clinician is tasked with several challenges. First, there are a variety of pathways of care to be considered; second, adjunctive medical therapies are expanding; and third, when coupled with the multiple combinations of adjunctive supportive therapies for revascularization, the variety of potential therapeutic options can be overwhelming and confusing. Herein, we carefully review all the relevant guidelines and the contributing literature, taking a 4-step approach: (1) review the importance of risk stratification before engaging in a particular strategy of care, (2) define the reperfusion strategies available, (3) review the specific agents (antiplatelet and anticoagulant) that support reperfusion strategies, and (4) apply the strategies of care in the context of the clinical presentation.
FFR-guided multivessel stenting reduces urgent revascularization compared with infarct-related artery only stenting in ST-elevation myocardial infarction: A meta-analysis of randomized controlled trials
2018, International Journal of Cardiology
Citation Excerpt :
Approximately 50% of patients with ST-elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI) have multivessel disease with involvement of non-infarct related artery (IRA) [1]. Several randomized controlled trials (RCTs) have evaluated the efficacy and safety of PCI of angiographically severe non-culprit lesion(s) either during the index procedure or as a staged procedure [2–5]. Previous synthesis of evidence from these trials demonstrated that multivessel PCI, whether at the time of the index procedure or staged, leads to a reduction in the composite of death, reinfarction, or repeat revascularizations compared with IRA-only PCI [6,7].
Randomized controlled trials (RCTs) have shown fractional flow reserve-guided (FFR) multivessel stenting to be superior to infarct-related artery (IRA) only stenting in patients with ST-elevation myocardial infarction (STEMI) and multivessel disease. This effect was mainly driven by a reduction in overall repeat revascularization. However, the ability to assess the effect of this strategy on urgent revascularization or reinfarction was underpowered in individual trials.
We searched Pubmed, EMBASE, Cochrane CENTRAL, and Web of Science for RCTs of FFR-guided multivessel stenting versus IRA-only stenting in STEMI with multivessel disease. The outcomes of interest were death, reinfarction, urgent, and non-urgent repeat revascularization. Risk ratios (RR) were pooled using the DerSimonian and Laird random-effects model.
After review of 786 citations, 2 RCTs were included. The pooled results demonstrated a significant reduction in the composite of death, reinfarction, or revascularization in the FFR-guided multivessel stenting group versus IRA-only stenting group (RR [95%, Confidence Interval]: 0.49 [0.33–0.72], p < 0.001). This risk reduction was driven mainly by a reduction in repeat revascularization, both urgent (0.41 [0.24–0.71], p = 0.002) and non-urgent revascularization (0.31 [0.19–0.50], p < 0.001). Pooled RR for reinfarction was lower in the FFR-guided strategy, but was not statistically significant (0.71[0.39–1.31], p = 0.28).
This systematic review and meta-analysis suggests that a strategy of FFR-guided multivessel stenting in STEMI patients reduces not only overall repeat revascularization but also urgent revascularization. The effect on reinfarction needs to be evaluated in larger trials.
Reperfusion therapies for acute ST elevation myocardial infarction
2018, Cardiac Intensive Care
Complete or Culprit-Only Revascularization for Patients With Multivessel Coronary Artery Disease Undergoing Percutaneous Coronary Intervention: A Pairwise and Network Meta-Analysis of Randomized Trials
2017, JACC: Cardiovascular Interventions
Citation Excerpt :
These findings support that future trials are required to determine the impact of a complete revascularization strategy on hard outcomes such as all-cause mortality. Two ongoing trials: COMPARE ACUTE (Comparison Between FFR Guided Revascularization Versus Conventional Strategy in Acute STEMI Patients With MVD; NCT01399736), which is comparing a complete revascularization strategy at the time of primary PCI versus a culprit-only revascularization strategy, and COMPLETE (Complete vs Culprit-Only Revascularization to Treat Multi-Vessel Disease After Primary PCI for STEMI; NCT01740479), which is comparing complete revascularization as a staged procedure versus a culprit-only revascularization strategy, will help to further clarify the impact of a complete revascularization on hard outcomes and the role of fractional flow reserve in these situations (44,45). First, there was a moderate degree of heterogeneity observed with MACE in the pairwise meta-analysis, which could be explained by the variable revascularization strategies (i.e., complete revascularization at the index procedure vs. as a staged procedure), the variation in MACE definition, the difference in the follow-up time, and the different type of stents used.
The authors sought to compare the effectiveness of the different revascularization strategies in ST-segment elevation myocardial infarction (STEMI) patients with multivessel coronary artery disease undergoing primary percutaneous coronary intervention (PCI).
Recent randomized trials have suggested that multivessel complete revascularization at the time of primary percutaneous coronary intervention (PCI) is associated with better outcomes, however; the optimum timing for nonculprit PCI is unknown.
Trials that randomized STEMI patients with multivessel disease to any combination of the 4 different revascularization strategies (i.e., complete revascularization at the index procedure, staged procedure during the hospitalization, staged procedure after discharge or culprit-only revascularization) were included. Random effect risk ratios (RRs) were conducted. Network meta-analysis was constructed using mixed treatment comparison models, and the 4 revascularization strategies were compared.
A total of 10 trials with 2,285 patients were included. In the pairwise meta-analysis, complete revascularization (i.e., at the index procedure or as a staged procedure) was associated with a lower risk of major adverse cardiac events (MACE) (RR: 0.57; 95% confidence interval [CI]: 0.42 to 0.77), due to lower risk of urgent revascularization (RR: 0.44; 95% CI: 0.30 to 0.66). The risk of all-cause mortality (RR: 0.76; 95% CI: 0.52 to 1.12), and spontaneous reinfarction (RR: 0.54; 95% CI: 0.23 to 1.27) was similar. The reduction in the risk of MACE was observed irrespective of the timing of nonculprit artery revascularization in the mixed treatment model.
Current evidence from randomized trials suggests that the risk of all-cause mortality and spontaneous reinfarction is not different among the various revascularization strategies for multivessel disease. Complete revascularization at the index procedure or as a staged procedure (either during the hospitalization or after discharge) was associated with a reduction of MACE due to reduction in urgent revascularization with no difference between these 3 strategies. Future trials are needed to determine the impact of complete revascularization on the risk of all-cause mortality and spontaneous reinfarction.

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: Statement of Conflict of Interest: see page 265.

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Culprit-Only vs. Complete Revascularization During ST-Segment Elevation Myocardial Infarction

Abstract

Section snippets

PRAMI

CvLPRIT

DANAMI‐3-PRIMULTI

STEMI with multivessel disease and cardiogenic shock

STEMI with multivessel disease and chronic total occlusion (CTO)

Complete revascularization in non-ST-segment elevation MI (NSTEMI)

Complete revascularization in stable CAD

Future studies: COMPLETE trial

Statement of Conflict of Interest

Am J Cardiol

J Am Coll Cardiol

Int J Cardiol

Am J Cardiol

Am J Cardiol

Am J Cardiol

JACC Cardiovasc Interv

J Am Coll Cardiol

J Am Coll Cardiol

J Am Coll Cardiol

JACC Cardiovasc Interv

J Am Coll Cardiol

Am Heart J

J Am Coll Cardiol

Timely PCI, for STEMI – still the treatment of choice

N Engl J Med

Extent, location, and clinical significance of non-infarct-related coronary artery disease among patients with ST –elevation myocardial infarction

JAMA

Impact of multivessel disease on reperfusion success and clinical outcomes in patients undergoing primary percutaneous coronary intervention for acute myocardial infarction

Eur Heart J

ESC Guidelines for the management of acute myocardial infarction in patients presenting with ST-segment elevation

Eur Heart J

A randomized trial of target-vessel versus multi-vessel revascularization in ST- elevation myocardial infarction: major adverse cardiac events during long-term follow-up

Heart