Immediate versus staged complete revascularisation in patients presenting with acute coronary syndrome and multivessel coronary disease (BIOVASC): a prospective, open-label, non-inferiority, randomised trial.

BACKGROUND: In patients with acute coronary syndrome and multivessel coronary disease, complete revascularisation by percutaneous coronary intervention (PCI) is associated with improved clinical outcomes. We aimed to investigate whether PCI for non-culprit lesions should be attempted during the index procedure or staged. METHODS: This prospective, open-label, non-inferiority, randomised trial was done at 29 hospitals across Belgium, Italy, the Netherlands, and Spain. We included patients aged 18-85 years presenting with ST-segment elevation myocardial infarction or non-ST-segment elevation acute coronary syndrome and multivessel (ie, two or more coronary arteries with a diameter of 2·5 mm or more and ≥70% stenosis based on visual estimation or positive coronary physiology testing) coronary artery disease with a clearly identifiable culprit lesion. A web-based randomisation module was used to randomly assign patients (1:1), with a random block size of four to eight, stratified by study centre, to undergo immediate complete revascularisation (PCI of the culprit lesion first, followed by other non-culprit lesions deemed to be clinically significant by the operator during the index procedure) or staged complete revascularisation (PCI of only the culprit lesion during the index procedure and PCI of all non-culprit lesions deemed to be clinically significant by the operator within 6 weeks after the index procedure). The primary outcome was the composite of all-cause mortality, myocardial infarction, any unplanned ischaemia-driven revascularisation, or cerebrovascular events at 1 year after the index procedure. Secondary outcomes included all-cause mortality, myocardial infarction, and unplanned ischaemia-driven revascularisation at 1 year after the index procedure. Primary and secondary outcomes were assessed in all randomly assigned patients by intention to treat. Non-inferiority of immediate to staged complete revascularisation was considered to be met if the upper boundary of the 95% CI of the hazard ratio (HR) for the primary outcome did not exceed 1·39. This trial is registered with ClinicalTrials.gov, NCT03621501. FINDINGS: Between June 26, 2018, and Oct 21, 2021, 764 patients (median age 65·7 years [IQR 57·2-72·9] and 598 [78·3%] males) were randomly assigned to the immediate complete revascularisation group and 761 patients (median age 65·3 years [58·6-72·9] and 589 [77·4%] males) were randomly assigned to the staged complete revascularisation group, and were included in the intention-to-treat population. The primary outcome at 1 year occurred in 57 (7·6%) of 764 patients in the immediate complete revascularisation group and in 71 (9·4%) of 761 patients in the staged complete revascularisation group (HR 0·78, 95% CI 0·55-1·11, pnon-inferiority=0·0011). There was no difference in all-cause death between the immediate and staged complete revascularisation groups (14 [1·9%] vs nine [1·2%]; HR 1·56, 95% CI 0·68-3·61, p=0·30). Myocardial infarction occurred in 14 (1·9%) patients in the immediate complete revascularisation group and in 34 (4·5%) patients in the staged complete revascularisation group (HR 0·41, 95% CI 0·22-0·76, p=0·0045). More unplanned ischaemia-driven revascularisations were performed in the staged complete revascularisation group than in the immediate complete revascularisation group (50 [6·7%] patients vs 31 [4·2%] patients; HR 0·61, 95% CI 0·39-0·95, p=0·030). INTERPRETATION: In patients presenting with acute coronary syndrome and multivessel disease, immediate complete revascularisation was non-inferior to staged complete revascularisation for the primary composite outcome and was associated with a reduction in myocardial infarction and unplanned ischaemia-driven revascularisation. FUNDING: Erasmus University Medical Center and Biotronik.

Low-dose colchicine for the prevention of cardiovascular events after percutaneous coronary intervention: Rationale and design of the COL BE PCI trial.

INTRODUCTION: Patients with coronary artery disease (CAD) remain vulnerable to future major atherosclerotic events after revascularization, despite effective secondary prevention strategies. Inflammation plays a central role in the pathogenesis of CAD and recurrent events. To date, there is no specific anti-inflammatory medicine available with proven effective, cost-efficient, and favorable benefit-risk profile, except for colchicine. Initial studies with colchicine have sparked major interest in targeting atherosclerotic events with anti-inflammatory agents, but further studies are warranted to enforce the role of colchicine role as a major treatment pillar in CAD. Given colchicine's low cost and established acceptable long-term safety profile, confirming its efficacy through a pragmatic trial holds the potential to significantly impact the global burden of cardiovascular disease. METHODS: The COL BE PCI trial is an investigator-initiated, multicenter, double-blind, event-driven trial. It will enroll 2,770 patients with chronic or acute CAD treated with percutaneous coronary intervention (PCI) at 19 sites in Belgium, applying lenient in- and exclusion criteria and including at least 30% female participants. Patients will be randomized between 2 hours and 5 days post-PCI to receive either colchicine 0.5 mg daily or placebo on top of contemporary optimal medical therapy and without run-in period. All patients will have baseline hsCRP measurements and a Second Manifestations of Arterial Disease (SMART) risk score calculation. The primary endpoint is the time from randomization to the first occurrence of a composite endpoint consisting of all-cause death, spontaneous non-fatal myocardial infarction, non-fatal stroke, or coronary revascularization. The trial is event-driven and will continue until 566 events have been reached, providing 80% power to detect a 21 % reduction in the primary endpoint taking a premature discontinuation of 15% into account. We expect a trial duration of approximately 44 months. CONCLUSION: The COL BE PCI Trial aims to assess the effectiveness and safety of administering low-dose colchicine for the secondary prevention in patients with both chronic and acute coronary artery disease undergoing PCI. TRIAL REGISTRATION: ClinicalTrials.gov: NCT06095765.

Timing of Complete Multivessel Revascularization in Patients Presenting With Non-ST-Segment Elevation Acute Coronary Syndrome.

BACKGROUND: Complete revascularization of the culprit and all significant nonculprit lesions in patients with non-ST-segment elevation acute coronary syndrome (NSTE-ACS) and multivessel disease (MVD) reduces major adverse cardiac events, but optimal timing of revascularization remains unclear. OBJECTIVES: This study aims to compare immediate complete revascularization (ICR) and staged complete revascularization (SCR) in patients presenting with NSTE-ACS and MVD. METHODS: This prespecified substudy of the BIOVASC (Percutaneous Complete Revascularization Strategies Using Sirolimus Eluting Biodegradable Polymer Coated Stents in Patients Presenting With Acute Coronary Syndrome and Multivessel Disease) trial included patients with NSTE-ACS and MVD. Risk differences of the primary composite outcome of all-cause mortality, myocardial infarction (MI), unplanned ischemia-driven revascularization (UIDR), or cerebrovascular events and its individual components were compared between ICR and SCR at 1 year. RESULTS: The BIOVASC trial enrolled 1,525 patients; 917 patients presented with NSTE-ACS, of whom 459 were allocated to ICR and 458 to SCR. Incidences of the primary composite outcome were similar in the 2 groups (7.9% vs 10.1%; risk difference 2.2%; 95% CI: -1.5 to 6.0; P = 0.15). ICR was associated with a significant reduction of MIs (2.0% vs 5.3%; risk difference 3.3%; 95% CI: 0.9 to 5.7; P = 0.006), which was maintained after exclusion of procedure-related MIs occurring during the index or staged procedure (2.0% vs 4.4%; risk difference 2.4%; 95% CI: 0.1 to 4.7; P = 0.032). UIDRs were also reduced in the ICR group (4.2% vs 7.8%; risk difference 3.5%; 95% CI: 0.4 to 6.6; P = 0.018). CONCLUSIONS: ICR is safe in patients with NSTE-ACS and MVD and was associated with a reduction in MIs and UIDRs at 1 year.

Early surgical repair of an acute post-infarction left ventricular pseudoaneurysm complicated by second pseudoaneurysm formation.

We present a case of an acute myocardial infarction complicated by an acute left ventricular pseudoaneurysm (LVPA). Surgical correction in the subacute phase was complicated by development of a second larger LVPA due to tearing of the sutures of the first surgical repair. Our case demonstrates the difficult decision-making regarding the timing of surgical intervention, which remains a debatable issue. The literature on diagnostics, prognosis and treatment of the LVPA is also discussed.

Assessing the landscape of percutaneous coronary chronic total occlusion treatment in Belgium and Luxembourg: the Belgian Working Group on Chronic Total Occlusions (BWGCTO) registry.

Background: Important developments in materials, devices, and techniques have improved outcomes of chronic total occlusion (CTO) percutaneous coronary intervention (PCI), and resulted in a growing interest in CTO-PCI. The Belgian Working Group on Chronic Total Occlusions (BWGCTO) working group aims to assess the evolution within the CTO-PCI landscape over the next years. Methods: From May 2016 onwards, patients undergoing CTO-PCI were included in the BWGCTO registry by 15 centres in Belgium and Luxemburg. Baseline, angiographic, and procedural data were collected. Here, we report on the one-year in-hospital outcomes. Results: Over the course of one year, 411 procedures in 388 patients were included with a mean age of 64 ± 11 years. The majority were male (81%). Relatively complex CTOs were treated (Japanese CTO score =2.2 ± 1.2) with a high procedure success rate (82%). Patient- and lesion-wise success rates were 83 and 85%, respectively. Major adverse in-hospital events were acceptably low (3.4%). Antegrade wire escalation technique was applied most frequently (82%). On the other hand, antegrade dissection and re-entry and retrograde strategies were more frequently applied in higher volume centres and successful for lesions with higher complexity. Conclusion: Satisfactory procedural outcomes and a low rate of adverse events were obtained in a complex CTO population, treated by operators with variable experience levels. Antegrade wire escalation was the preferred strategy, regardless of operator volume.

Auto-intoxication with flecainide and quinapril: ECG-changes, symptoms and treatment.

Flecainide acetate is a sodium channel blocker and a class Ic antiarrhythmic agent with potential life-threatening proarrhythmic and cardioinhibitory properties when taken in overdose. Quinapril is an angiotensin-converting enzyme inhibitor (ACE-inhibitor) and overdose can lead to prolonged hypotension and, less frequently, transient renal impairment. We describe the first published case of intoxication with both drugs. The patient developed a broad-QRS-tachycardia and severe hypotension. Treatment with volume expansion, hypertonic sodium bicarbonate, inotropic support with norepinephrine and insertion of an intra-aortic balloon pump led to complete recovery after 72 hours. We assume that the clinical picture was mainly dictated by flecainide intoxication. Relevant literature data are discussed.