Date Published: January 20, 2017
Publisher: Public Library of Science
Author(s): Zhenwei Li, Yijiang Zhou, Qingqing Xu, Xiaomin Chen, Chiara Lazzeri.
In patients with acute ST-elevation myocardial infarction (STEMI), the preferred intervention is percutaneous coronary intervention (PCI).Whether staged PCI (S-PCI) or one-time complete PCI (MV-PCI) is more beneficial and safer in terms of treating the non-culprit vessel during the primary PCI procedure is unclear. We performed a meta-analysis of all randomized and non-randomized controlled trials comparing S-PCI with MV-PCI in patients with acute STEMI and MVD.
Studies of STEMI with multivessel disease receiving primary PCI were searched in PUBMED, EMBASE and The Cochrane Register of Controlled Trials from January 2004 to December 2014. The primary end points were long-term rates of major adverse cardiovascular events and their components—mortality, reinfarction, and target-vessel revascularization. Data were combined using a fixed-effects model.
Of 507 citations, 10 studies (4 randomized, 6 nonrandomized; 820 patients, 562 staged PCI and 347 one-time, complete multi-vessel PCI) were included. S-PCI compared to MV-PCI significantly reduced mortality both long-term (OR 0.44, 95% CI 0.29–0.66, P<0.0001, I2 = 0%) and short-term (OR 0.23, 95% CI 0.1–0.51, P = 0.0003, I2 = 0%). There was a trend toward reduced risk of MACE with s-PCI compared with MV-PCI (OR 0.83, 0.62–1.12, P = 0.22, I2 = 0%). No difference between S-PCI and MV-PCI was observed in reinfarction (OR 0.97, 0.61–1.55, P = 0.91, I2 = 0%), or target vessel revascularization (OR1.17, 95% CI 0.81–1.69, P = 0.40, I2 = 8%). The staged strategy for non-culprit lesions improved short- and long-term survival and should remain the standard approach to primary PCI in patients with STEMI; one-time complete multivessel PCI may be associated with greater mortality risk. However, additional large, randomized trials are required to confirm the optimal timing of a staged procedure on the non-culprit vessel in STEMI.
Percutaneous coronary intervention (PCI) has become the preferred reperfusion strategy in patients with acute ST-elevation MI (STEMI) compared to intravenous thrombolytic therapy [1–3]. Approximately 40–50% of patients with STEMI have at least 1 additional severe stenosis lesion of >50% in the non-culprit vessel [4,5]. Patients with multivessel disease (MVD) have worse clinical outcomes in terms of major adverse cardiovascular events (mortality, reinfarction, and target-vessel revascularization) than patients with single-vessel disease [4,6,7]. One-time, multivessel PCI may contribute to a higher risk of complications such as stent thrombosis [8–10], inflammatory burden , and contrast-induced nephropathy  associated with STEMI. Previous guidelines recommended that patients presenting with STEMI without hemodynamic instability undergo PCI of the culprit vessel (CV-PCI) rather than PCI of the non-infarct related artery (IRA) [13,14]. However, recent advancements in interventional cardiology to reduce procedure time, the improvement in strategies to reduce the risk of acute kidney injury, the widespread use of new types of drug-eluting stents, and novel antiplatelet therapy to reduce the risk of stent thrombosis have all made multi-vessel PCI more reliable, predictable, and reproducible [15,16]. Performing one-time, multi-vessel PCI at the time of primary PCI may be safe and beneficial in patients with STEMI [17–20]. The PRAMI (Preventive Angioplasty in Acute Myocardial Infarction) trial and CvLPRIT (Complete versus Lesion-only Primary PCI) trial demonstrated that MV-PCI significantly reduced adverse cardiovascular events compared to CV-PCI [18,19]. Multivessel-completed PCI guided by FFR (fractional flow reserve) significantly reduced the risk of further events (such as repeat revascularization, all-cause death, and nonfatal MI) compared to culprit artery–only PCI in the DANAMI 3 PRIMULTI (Third Danish Study of Optimal Acute Treatment of Patients with ST-segment Elevation Myocardial Infarction) trial . No differences in all-cause death, nonfatal MI, and stroke in staged PCI or culprit-only PCI were observed in the PRAGUE-13 (Primary Angioplasty in Patients Transferred From General Community Hospitals to Specialized PTCA Units With or Without Emergency Thrombolysis) trial . Based on these findings, the American College of Cardiology (ACC)/American Heart Association (AHA)/Society for Cardiovascular Angiography and Interventions (SCAI) currently recommend consideration of multivessel PCI either at the time of primary PCI or as a staged procedure(Class IIb), modified from culprit vessel PCI (CV-PCI) in the absence of hemodynamic instability (Class III). However, it is unknown whether staged PCI (S-PCI) or one-time complete PCI (MV-PCI) is the safer and more beneficial procedure to treat the non-culprit vessel during the primary PCI procedure. Therefore, we conducted a meta-analysis of all randomized controlled trials (RCTs) and non-randomized controlled trials (non-RCTs) to compare the cure effects of S-PCI and MV-PVI in STEMI patients with multivessel disease.
The present meta-analysis of randomized and observational studies is one of the largest to support staged multivessel PCI as feasible and safe in the context of STEMI. The main findings are that, compared with MV-PCI, S-PCI is (1) associated with a trend toward reduced risk of the composite primary endpoint of MACE odds and (2) associated with lower short-term and long-term mortality odds.
In our meta-analysis, we were forced to include observational non-randomized studies due to a lack of randomized data. We performed randomized vs nonrandomized stratified analyses for the pooled estimate. However, many selection biases and confounding factors remained in the observational studies, even after statistical adjustment. Unpublished abstracts were also included to reduce publication bias. The data of the original included studies were limited to analysis at the trial level rather than the patient level. Therefore, we could not adjust the baseline characteristics of the included patients and multivariate factors; the follow-up and admission medications were also not captured. Moreover, the impact of chronic total occlusions was not fully evaluated due to the absence of reports in most selected studies. A staged and planned strategy for non-culprit vessel PCI may be preferable for these patients given the risk and difficulties in attempting a chronic total occlusion. In addition, when patients wait for staged or planned PCI, clinical events may occur; these events were not adequately described in the included studies. In addition, The exact mechanisms linking staged PCI with better short and long mortality can not be elucidated by the provided data since non-fatal reinfarcion rates were similar, the specific causes of deaths are unknown. Ochala’ study even said MV-PCI in patients with STEMI and MVD leads to quicker and more substantial improvement of LVEF in comparison to S-PCI, However, Horizon’ study said stent thrombosis and bleeding(Major or minor) complications rates were significantly increased in MV-PCI versus S-PCI groups. Maybe the less such complications made staged PCI with better short and long mortality. Finally, survival selection bias in staged PCI patients can potentially affect long-term survival. Therefore, we excluded patients in cardiogenic shock and performed a sensitivity analysis of all studies, which confirmed the survival benefit.
Our meta-analysis provides new insights on the efficacy and safety of staged PCI compared with one-time complete PCI in patients with STEMI. We observed reduced short- and long-term mortality with a strategy of staged PCI. The results of our study suggest that PCI of the non-culprit vessel should be staged and that many factors and conditions influence the decision of when to stage PCI. However, our findings require additional large-scale, multicenter, randomized controlled studies for confirmation.