Preventive Percutaneous Coronary Intervention Research Articles

Preventive percutaneous coronary intervention versus optimal medical therapy alone for the treatment of vulnerable atherosclerotic coronary plaques (PREVENT): a multicentre, open-label, randomised controlled trial

Acute coronary syndrome and sudden cardiac death are often caused by rupture and thrombosis of lipid-rich atherosclerotic coronary plaques (known as vulnerable plaques), many of which are non-flow-limiting. The safety and effectiveness of focal preventive therapy with percutaneous coronary intervention of vulnerable plaques in reducing adverse cardiac events are unknown. We aimed to assess whether preventive percutaneous coronary intervention of non-flow-limiting vulnerable plaques improves clinical outcomes compared with optimal medical therapy alone. PREVENT was a multicentre, open-label, randomised controlled trial done at 15 research hospitals in four countries (South Korea, Japan, Taiwan, and New Zealand). Patients aged 18 years or older with non-flow-limiting (fractional flow reserve >0·80) vulnerable coronary plaques identified by intracoronary imaging were randomly assigned (1:1) to either percutaneous coronary intervention plus optimal medical therapy or optimal medical therapy alone, in block sizes of 4 or 6, stratified by diabetes status and the performance of percutaneous coronary intervention in a non-study target vessel. Follow-up continued annually in all enrolled patients until the last enrolled patient reached 2 years after randomisation. The primary outcome was a composite of death from cardiac causes, target-vessel myocardial infarction, ischaemia-driven target-vessel revascularisation, or hospitalisation for unstable or progressive angina, assessed in the intention-to-treat population at 2 years. Time-to-first-event estimates were calculated with the Kaplan-Meier method and were compared with the log-rank test. This report is the principal analysis from the trial and includes all long-term analysed data. The trial is registered at ClinicalTrials.gov, NCT02316886, and is complete. Between Sept 23, 2015, and Sept 29, 2021, 5627 patients were screened for eligibility, 1606 of whom were enrolled and randomly assigned to percutaneous coronary intervention (n=803) or optimal medical therapy alone (n=803). 1177 (73%) patients were men and 429 (27%) were women. 2-year follow-up for the primary outcome assessment was completed in 1556 (97%) patients (percutaneous coronary intervention group n=780; optimal medical therapy group n=776). At 2 years, the primary outcome occurred in three (0·4%) patients in the percutaneous coronary intervention group and in 27 (3·4%) patients in the medical therapy group (absolute difference -3·0 percentage points [95% CI -4·4 to -1·8]; p=0·0003). The effect of preventive percutaneous coronary intervention was directionally consistent for each component of the primary composite outcome. Serious clinical or adverse events did not differ between the percutaneous coronary intervention group and the medical therapy group: at 2 years, four (0·5%) versus ten (1·3%) patients died (absolute difference -0·8 percentage points [95% CI -1·7 to 0·2]) and nine (1·1%) versus 13 (1·7%) patients had myocardial infarction (absolute difference -0·5 percentage points [-1·7 to 0·6]). In patients with non-flow-limiting vulnerable coronary plaques, preventive percutaneous coronary intervention reduced major adverse cardiac events arising from high-risk vulnerable plaques, compared with optimal medical therapy alone. Given that PREVENT is the first large trial to show the potential effect of the focal treatment for vulnerable plaques, these findings support consideration to expand indications for percutaneous coronary intervention to include non-flow-limiting, high-risk vulnerable plaques. The CardioVascular Research Foundation, Abbott, Yuhan Corp, CAH-Cordis, Philips, and Infraredx, a Nipro company.

Preventive PCI or medical therapy alone for vulnerable atherosclerotic coronary plaque: Rationale and design of the randomized, controlled PREVENT trial

Acute coronary syndromes are commonly caused by the rupture of vulnerable plaque, which often appear angiographically not severe. Although pharmacologic management is considered standard therapy for stabilizing plaque vulnerability, the potential role of preventive local treatment for vulnerable plaque has not yet been determined. The PREVENT trial was designed to compare preventive percutaneous coronary intervention (PCI) plus optimal medical therapy (OMT) with OMT alone in patients with functionally nonsignificant high-risk vulnerable plaques. The PREVENT trial is a multinational, multicenter, prospective, open-label, active-treatment-controlled randomized trial. Eligible patients have at least 1 angiographically significant stenosis (diameter stenosis >50% by visual estimation) without functional significance (fractional flow reserve [FFR] >0.80). Target lesions are assessed by intracoronary imaging and must meet at least 2 imaging criteria for vulnerable plaque; (1) minimal lumen area <4.0 mm2; (2) plaque burden >70%; (3) maximal lipid core burden index in a 4 mm segment >315 by near infrared spectroscopy; and (4) thin cap fibroatheroma as determined by virtual histology or optical coherence tomography. Enrolled patients are randomly assigned in a 1:1 ratio to either preventive PCI with either bioabsorbable vascular scaffolds or metallic everolimus-eluting stents plus OMT or OMT alone. The primary endpoint is target-vessel failure, defined as the composite of death from cardiac causes, target-vessel myocardial infarction, ischemic-driven target-vessel revascularization, or hospitalization for unstable or progressive angina, at 2 years after randomization. Enrollment of a total of 1,608 patients has been completed. Follow-up of the last enrolled patient will be completed in September 2023 and primary results are expected to be available in early 2024. The PREVENT trial is the first large-scale, randomized trial to evaluate the effect of preventive PCI on non-flow-limiting vulnerable plaques containing multiple high-risk features that is appropriately powered for clinical outcomes. PREVENT will provide compelling evidence as to whether preventive PCI of vulnerable plaques plus OMT improves patient outcomes compared with OMT alone. URL: https://www. gov. Unique identifier: NCT02316886. The PREVENT trial is the first, large-scale randomized clinical trial to evaluate the effect of preventive PCI on non-flow-limiting vulnerable plaque with high-risk features. It will provide compelling evidence to determine whether PCI of focal vulnerable plaques on top of OMT improves patient outcomes.

Status of coronary disease and results from early endovascular aneurysm repair after preventive percutaneous coronary revascularization.

The incidence of coronary artery disease (CAD) is high in patients with an aortic aneurysm but preoperative routine coronary angiography and preventive coronary revascularization are not recommended to reduce cardiac events in patients with severe CAD. This study evaluated the safeness and efficacy of preventive percutaneous coronary intervention (PCI) in patients with severe CAD scheduled for endovascular aneurysm repair (EVAR). All patients with descending thoracic aneurysm (DTA) or abdominal aortic aneurysm (AAA) scheduled for EVAR underwent preliminary coronary angiography. Based on coronary angiography results, 917 patients (40.7%) had significant CAD and were treated by percutaneous coronary intervention (PCI; CAD group) and 1337 patients (59.3%) were without or with mild/moderate CAD and were considered as controls (no-CAD group). To evaluate the safeness and efficacy of preventive PCI in patients with severe CAD undergoing EVAR, groups were compared for hospital and 12-monthcardiac adverse events. CAD was present in 1210 patients (53.6%): significant in 917 patients (38%) and mild to moderate in 293 patients (5.3%). Hospital and 12-monthcardiac events occurred in 15 (1.6%) and 13 (1.4%) CAD group patients and in 9 (0.7%) and 8 (0.4%) no-CAD group patients (p = .05 and p = .08), respectively. Hospital and 12-monthcardiac deaths occurred in 3 (0.3%) and 2 (0.2%) CAD group patients and in 3 (0.2%) and 2 (0.2%) no-CAD group patients (p = .9 and p = .9), respectively. The strategy to treat severe CAD preoperatively by PCI and early subsequent EVAR brings a similar outcome to that in patients without or with mild/moderate CAD.

Management of non-culprit coronary plaques in patients with acute coronary syndrome.

Approximately 50% of patients with ST-segment elevation myocardial infarction (STEMI) have multivessel coronary artery disease, a condition associated with an increased incidence of recurrent ischaemic events and higher mortality. Based on recent evidences, a strategy of staged percutaneous coronary intervention (PCI) of obstructive non-culprit lesions should be considered the gold standard for the management of these patients. However, several issues remain still unresolved. Indeed, what is the optimal timing of staged PCI is not completely defined. Moreover, assessment of intermediate non-culprit lesions represent still a clinical conundrum, as pressure-wire indexes do not seem able to correctly identify those patients in whom deferral is safe. Intracoronary imaging may help to identify untreated non-culprit lesions containing vulnerable plaques that may portend a higher risk of future cardiovascular events. However, there are hitherto no studies demonstrating that preventive PCI of vulnerable plaques or more intensive pharmacological treatment is associated with an improved clinical outcome. In this review, we discuss the recent evolving concepts about management of non-culprit plaques in STEMI patients, proposing a diagnostic and therapeutic algorithm to guide physicians in clinical practice. We also underscore the several knowledge gaps to address in future studies.

Ultra-low contrast coronary angiography and zero-contrast percutaneous coronary intervention for prevention of contrast-induced nephropathy: step-by-step approach and review.

Contrast-induced nephropathy is a serious complication after intravascular administration of iodinated contrast media and is associated with numerous adverse outcomes. Its prevalence is particularly high in patients with multiple comorbidities who undergo coronary angiography and percutaneous coronary intervention (PCI). Currently, the only effective method to prevent contrast-induced kidney injury is adequate hydration and a reduction of contrast volume during the intervention. Recently, new approaches aiming to minimize contrast usage have been proposed, i.e., ultra-low contrast angiography and zero-contrast PCI. However, neither tutorials for these techniques nor reviews of their outcomes exist in the literature, and therefore dissemination of these approaches among the interventional community may be limited. This article presents a step-by-step description on how to perform ultra-low coronary angiography and zero-contrast PCI, which should help invasive cardiologists to adopt these techniques in daily practice. A review of clinical studies, case series and single case reports regarding these methods is also provided. Despite the promising results, such procedures still require some improvements and confirmation of their effectiveness as well as safety in large clinical studies. This article aims to spread these new techniques throughout the interventional community, which is paramount for their further development and wider utilization.

Short Term Follow up for Diabetic Patients Presented with Acute STEMI Undergoing Preventive Versus Culprit Lesion in Primary Percutaneous Coronary Intervention

Objectives: This study aimed to evaluate the short term follow up for diabetic patients presented with acute STEMI underwent preventive percutaneous coronary intervention. Background: preventive PCI appears to be safe as culprit artery PCI with effective reduction of refractory angina and repeated revascularization in selected patients but no benefit on mortality or recurrent MI. Methods: Our study was a prospective, observational study conducted at multicenter hospitals included 120 diabetic patients admitted with acute STEMI and multivessels CAD at National Heart Institute, Menofia university hospital, police academy center and some private hospitals patients from June 2017 to august 2018, group (A) Consisted of 70 diabetic patients with acute STEMI undergone preventive PCI in whom PCI will be done for culprit & non culprit lesions, group (B) Consisted of 50 diabetic patients with acute STEMI undergone PCI for culprit lesion only. Results: The total revascularization group were significantly less suffering from refractory angina 5 (7.1%) vs 15 (30.0%), p= <0.001 and less re-hospitalized for cardiac causes 14 (20.0%) vs 22 (44.0%), p= 0.005, cardiac mortality was 2 patients 0 (0.0%) vs 2 (4%) p= 0.092. Conclusion: The preventive PCI appears to be safe as culprit artery PCI with effective reduction of refractory angina and repeated revascularization but no benefit on mortality or recurrent MI in selected hemodynamically stable STEMI diabetic patients with multivessel disease.

The optimal strategy of percutaneous coronary intervention for ST-elevation myocardial infarction patients with multivessel disease: an updated meta-analysis of 9 randomized controlled trials.

The optimal strategy of percutaneous coronary intervention (PCI) for patients with ST-elevation myocardial infarction (STEMI) and multivessel disease (MVD) still remains controversial. This study sought to explore the optimal PCI strategy for those patients. Medline, EMBASE and the Cochrane Controlled Trials Registry were searched for relevant studies. We analyzed the comparison of major adverse cardiac events (MACEs) as the primary end point between the preventive PCI strategy and the culprit only PCI strategy (CV-PCI). The further analysis of two subgroups described as the complete multivessel PCI strategy during primary procedure (CMV-PCI) and the staged PCI strategy (S-PCI) was also performed. Nine randomized trials were identified. The risk of MACEs was reduced significantly regarding to preventive PCI strategy (OR=0.41, 95% CI: 0.31-0.53, P<0.001) compared to CV-PCI strategy. There were lower risks of long-term mortality, reinfarction and repeat revascularization in the preventive PCI group compared to the CV-PCI group (OR=0.41, 95% CI: 0.27-0.62, P<0.001; OR=0.54, 95% CI: 0.32-0.91, P=0.021; OR=0.37, 95% CI: 0.26-0.51, P<0.001). Subgroup analysis showed that staged PCI strategy reduced the incidence of long-term mortality versus CMV-PCI strategy. The preventive PCI is associated with the lower risk of MACEs in STEMI patients with MVD compared to the CV-PCI strategy, and the S-PCI strategy seems to be an optimal choice for these patients rather than the CMV-PCI.

Infarct size and left ventricular remodelling after preventive percutaneous coronary intervention

ObjectiveWe hypothesised that, compared with culprit-only primary percutaneous coronary intervention (PCI), additional preventive PCI in selected patients with ST-elevation myocardial infarction with multivessel disease would not be associated with iatrogenic...

Preventive percutaneous coronary intervention and aspiration thrombectomy—updates in the management of ST-elevation myocardial infarction

The management of patients with acute ST-elevation myocardial infarction (STEMI) has undergone change in recent years with associated reductions in mortality (1). The short-term goal of treatment is to restore blood flow to the occluded infarct artery. Prompt percutaneous coronary intervention (PCI) and stenting of the stenosis causing the occlusion reduces the risk of cardiac death and recurrent infarction (2). Recently, the American College of Cardiology and American Heart Association (ACC/AHA) recommended preventive PCI and to stop using aspiration thrombectomy (3).

Clinical impact of non-culprit lesions on 1-year mortality in very elderly patients with acute coronary syndrome.

Preventive percutaneous coronary intervention (PCI) for non-culprit lesions after primary PCI remains controversial in patients with acute coronary syndrome (ACS). We analyzed whether PCI for non-culprit lesions would be associated with a better long-term prognosis in very elderly (≥85years) patients. This study included 91 consecutive patients with ACS (mean age, 88.2±3.0, 52% male). We investigated the association of residual lesions with 1-year mortality. Culprit lesions affected the left anterior descending artery (LAD) in 50 patients, the left circumflex artery (LCx) in 29, and the right coronary artery (RCA) in 31. Residual lesions affected LAD in 20 cases, LCx in 22, and RCA in 21 patients. Residual lesions in LAD were associated with a higher 1-year mortality (p=0.013), whereas residual lesions in LCx or RCA were not (p=0.547 and 0.473, respectively). A Cox regression model demonstrated that patients with residual lesions in LAD had an increased risk of 1-year mortality compared with those without residual lesions (hazard ratio, 2.39; 95% confidence interval, 1.16-4.96; p=0.019). Therefore, the option to not treat residual lesions in LAD of patients with PCI may be associated with a higher 1-year mortality. Further studies are needed to confirm these findings.

Impact of minimum contrast media volumes during elective percutaneous coronary intervention for prevention of contrast-induced nephropathy in patients with stable coronary artery disease.

Contrast-induced nephropathy (CIN) is an important complication following percutaneous coronary intervention (PCI). The clinical importance of a minimum contrast media volume (CMV) for PCI to prevent CIN has not been well evaluated. The purpose of this study was to evaluate the impact of minimum CMV to prevent CIN after PCI. In this study, 2052 consecutive patients who underwent elective PCI in our institute were analyzed. We divided patients into two groups according to CMV: a minimum CMV PCI group [CMV ≤50 ml (n = 94)] and a non-minimum CMV PCI group [CMV >50 ml (n = 1958)]. CIN occurred in 160 (7.8 %) patients. The incidence of CIN was significantly lower in the minimum CMV PCI group than in the non-minimum CMV PCI group (2.1 vs. 8.1 %; P = 0.03). According to multivariate analysis, elderly patients and diabetes mellitus patients were at high risk of developing CIN in this study population. When analyzing only high-risk patients, the incidence of CIN was also significantly lower in the minimum CMV group than in the non-minimum CMV group (2.6 vs. 10.3 %; P = 0.03). Minimum CMV PCI could reduce the incidence of CIN, particularly in high-risk patients; as such, defining the minimum CMV clinical cut-off values may be useful for the prevention of CIN.

Preventive versus culprit-only percutaneous coronary intervention in ST-elevation myocardial infarction patients with multivessel disease: a meta-analysis.

Although previous studies have suggested clinical benefits of complete revascularization in patients with multivessel coronary artery disease, it is still controversial whether preventive percutaneous coronary intervention (PCI) leads to better clinical outcomes in the clinical setting of ST-segment elevation myocardial infarction (STEMI). Relevant studies through September 2014 were searched and identified in the electronic databases.Primary endpoint was all-cause mortality at the longest follow-up. Secondary endpoints included myocardial infarction (MI), repeat revascularization, and major adverse cardiac events (MACE). From 836 initial citations, 7 randomized trials, and 23 observational studies with 44,256 patients (8,087 preventive and 36,169 culprit-only) were included in this study. Preventive PCI was associated with a significant reduction in repeat revascularization (odds ratios [OR]: 0.71; 95% CI: 0.51–0.99) with no differences in all-cause mortality (OR: 0.99; 95% CI: 0.76–1.29) or MI (OR: 1.08; 95% CI: 0.62–1.87) as compared with culprit-only PCI.Comparison of preventive PCI to the culprit-only PCI group revealed OR for MACE of 0.80 (95% CI: 0.57–1.12).Stratified analysis according to revascularization strategy demonstrated a significant survival benefit of culprit-only PCI over multivessel PCI during the index procedure and a significantly lower incidence of all-cause mortality with staged PCI as compared with culprit-only or multivessel PCI during the index procedure. Preventive PCI strategy appears to be effective in reducing the risk of repeat revascularization without significant benefits for mortality or MI when compared with culprit-only revascularization in STEMI patients with multivessel disease.

Preventive Percutaneous Coronary Intervention in ST-elevation Myocardial Infarction - The Primacy of Randomised Trials.

Randomised trials show a benefit of preventive (non-infarct artery) percutaneous coronary intervention in patients with acute ST elevation myocardial infarction, but non-randomised studies do not. The evidence on each is quantified and assessed. The primacy of randomised trials reveals the danger of using non-randomised studies that can, as in this case, give the wrong answer.

TCTAP A-008 Preventive Versus Culprit-only Percutaneous Coronary Intervention in ST-elevation Myocardial Infarction Patients with Multivessel Disease: A Meta-Analysis

Although previous studies have suggested clinical benefits of complete revascularization in patients with multivessel coronary artery disease, it is still controversial whether preventive percutaneous coronary intervention (PCI) leads to better clinical outcomes in the clinical setting of ST-segment

Preventive PCI versus culprit lesion stenting during primary PCI in acute STEMI: a systematic review and meta-analysis

AimThe benefit of preventive percutaneous coronary intervention (PCI) in ST elevation myocardial infarction (STEMI) has been shown in randomised trials. However, all the randomised trials are underpowered to detect benefit...

Preventive angioplasty in ST-segment elevation myocardial infarction

To the EditorWereadwithgreatinterest,arecentrandomizedtrialinBritishpop-ulation by Wald et al. [1] titled “Randomized Trial of Preventive Angio-plasty in Myocardial Infarction (PRAMI trial)” published on September19, 2013 in “New England Journal of Medicine”.PatientswithST-segment elevation myocardial infarction were randomly assigned toeither “preventive percutaneous coronary intervention” (PCI) or “nopreventive PCI” arm soon after they underwent infarct-artery PCI. Wehave the following comments on their randomized study. PreventivePCI was performed on lesions with stenosis ≥50%. However, theAmerican College of Cardiology and the American Heart Associationconsider lesions with stenosis ≥70% as significant [2]. Furthermore,Fractional Flow Reserve Versus Angiography in Multivessel Evaluation(FAME) study [3] showed that only a third of lesions with 50–70% ste-nosis are functionally significant, in comparison to over 80% of lesionswith stenosis N70%.Hence,wehypothesizethatreducedriskofadverseoutcomes in thepreventive-PCI arm wasprimarily dueto PCI of lesionswith stenosis ≥70%. Authors should have assessed for the risk of ad-verse outcomes after categorizing the preventive-PCI arm according totheseverityoflesions(50–70%vs. ≥70%stenosis),toseeifthefavorableoutcomeswerepredominantly in participants with ≥70% stenosis.Thiscan potentially help in curtailing healthcare costs by avoiding unneces-sary PCI for coronary lesions with 50–70% stenosis.Participantsin “NoPreventive-PCI”armdidnotgetPCIuntiltheypre-sented with refractory angina, even if they had severe stenosis at thetime of randomization. However, ideally patients with noninfarct arterylesionsshouldundergostagedPCIiffoundtohaveintermediate-orhigh-riskfeatures onnon-invasive testing [4], and not wait until one becomessymptomatic.This bringstothefore the denialof standard of care inthispatient subgroup.Furthermore, although baseline characteristics of the “Preventive-PCI” and “No Preventive-PCI” arm look fairly similar, authors haveexcluded the vital information regarding the infarct-artery door-to-balloon times. Prolonged door-to-balloon-times are associated withhigher long-term mortality [5]. If the mean door-balloon-time was sig-nificantlydifferentbetweenthetwoarms,itcouldhaveeasilyin fluencedmortality data, thereby either overestimating or underestimating themortality benefit in the preventive-PCI group.References

Randomized Trial of Preventive Angioplasty in Myocardial Infarction

BackgroundIn acute ST-segment elevation myocardial infarction (STEMI), the use of percutaneous coronary intervention (PCI) to treat the artery responsible for the infarct (infarct, or culprit, artery) improves prognosis. The value of PCI in noninfarct coronary arteries with major stenoses (preventive PCI) is unknown.MethodsFrom 2008 through 2013, at five centers in the United Kingdom, we enrolled 465 patients with acute STEMI (including 3 patients with left bundle-branch block) who were undergoing infarct-artery PCI and randomly assigned them to either preventive PCI (234 patients) or no preventive PCI (231 patients). Subsequent PCI for angina was recommended only for refractory angina with objective evidence of ischemia. The primary outcome was a composite of death from cardiac causes, nonfatal myocardial infarction, or refractory angina. An intention-to-treat analysis was used.ResultsBy January 2013, the results were considered conclusive by the data and safety monitoring committee, which recommended that the trial be stopped early. During a mean follow-up of 23 months, the primary outcome occurred in 21 patients assigned to preventive PCI and in 53 patients assigned to no preventive PCI (infarct-artery-only PCI), which translated into rates of 9 events per 100 patients and 23 per 100, respectively (hazard ratio in the preventive-PCI group, 0.35; 95% confidence interval [CI], 0.21 to 0.58; P<0.001). Hazard ratios for the three components of the primary outcome were 0.34 (95% CI, 0.11 to 1.08) for death from cardiac causes, 0.32 (95% CI, 0.13 to 0.75) for nonfatal myocardial infarction, and 0.35 (95% CI, 0.18 to 0.69) for refractory angina.ConclusionsIn patients with STEMI and multivessel coronary artery disease undergoing infarct-artery PCI, preventive PCI in noninfarct coronary arteries with major stenoses significantly reduced the risk of adverse cardiovascular events, as compared with PCI limited to the infarct artery. (Funded by Barts and the London Charity; PRAMI Current Controlled Trials number, ISRCTN73028481.)

Does Preventive PCI Work?

Treatments are designed to make people feel better or live longer. Percutaneous coronary intervention (PCI) is effective at reducing angina in patients with symptomatic coronary artery disease and at reducing mortality in patients who have acute myocardial infarction with ST-segment elevation and in those who have high-risk acute coronary syndromes without ST-segment elevation.1 Such successes have often been extrapolated in support of more widespread use of PCI in patients with stable coronary artery disease in hopes of reducing subsequent cardiac events. With the increasing availability of noninvasive imaging of coronary artery disease, asymptomatic patients are often referred for PCI. But . . .