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.

Mortality in STEMI Patients With Cardiogenic Shock: Results From a Nationwide PCI Registry and Focus on Left Main PCI.

BACKGROUND: The study aims to assess real-life short- and long-term outcomes of patients undergoing primary percutaneous coronary intervention (PCI) for ST-segment elevation myocardial infarction (STEMI) complicated with cardiogenic shock (CS). Outcome after left main (LM) PCI is of particular interest. METHODS: Procedural, 30-day, and >30-day mortality rates were assessed in 2744 CS-STEMI patients enrolled between 2012 and 2019 in a nationwide registry involving 49 centers. RESULTS: Procedural, 30-day, and >30-day mortality rates were 6.9%, 39.8%, and 12.6%, respectively. The mortality rates were significantly higher in the 348 patients (12.7%) who underwent LM-PCI (13.5%, 59.5%, and 18.4%, respectively). LM-PCI, a suboptimal PCI result, and transfemoral access were independent predictors of procedural and 30-day mortality. Operator experience was an independent predictor of procedural mortality, but not 30-day mortality. CONCLUSIONS: Mortality remains high in CS-STEMI patients, especially within the first month. Patients undergoing LM-PCI are particularly at risk. Operator experience is predictive of procedural mortality.

Practice and long-term outcome of unprotected left main PCI: real-world data from a nationwide registry.

BACKGROUND: Percutaneous coronary intervention (PCI) is increasingly performed in significant left main (LM) lesions. Left untreated, the prognosis is poor, but PCI and coronary bypass surgery (CABG) behold risks as well. Additional long-term outcome data might guide future treatment decisions. METHODS: Between 2012 and 2019, all 6783 patients who underwent LM PCI were prospectively enrolled in a national registry. Patients with prior CABG or prior LM PCI, and patients presenting in cardiogenic shock or after out-of-hospital cardiac arrest were excluded. From the remaining 5284 patients, baseline and procedural data as well as long-term survival were assessed. RESULTS: The annual rate of LM PCI increased from 422 (2.2% of PCIs) in 2012 to 868 in 2018 (3.0%). By 2018, 71% of the interventional cardiologists performed at least 1 LM PCI a year, though only 5 on average. Use of transradial access (TRA) in LM PCI increased from 20.4% in 2012 to 59.5% in 2019. All-cause mortality was 6.0% at 30 days and 18.5% at a mean follow-up of 33.5 months. Independent predictors of higher long-term mortality were older age, diabetes, multivessel disease, an urgent indication, a suboptimal angiographical result, and non-exclusive use of drug-eluting stents. TRAand higher operator and centre LM PCI experience were independent predictors of a lower long-term mortality. CONCLUSION: LM PCI is associated with high short- and long-term mortality. Use of TRA and higher expertise in LM PCI were associated with better survival.

Impact of COVID-19-related public containment measures on the ST elevation myocardial infarction epidemic in Belgium: a nationwide, serial, cross-sectional study.

AIMS: The current study assessed the impact of COVID-19-related public containment measures (i.e. lockdown) on the ST elevation myocardial infarction (STEMI) epidemic in Belgium. METHODS AND RESULTS: Clinical characteristics, reperfusion therapy modalities, COVID-19 status and in-hospital mortality of consecutive STEMI patients who were admitted to Belgian hospitals for percutaneous coronary intervention (PCI) were recorded during a three-week period starting at the beginning of the lockdown period on 13 March 2020. Similar data were collected for the same time period for 2017-2019. An evaluation of air quality revealed a 32% decrease in ambient NO2 concentrations during lockdown (19.5 µg/m³ versus 13.2 µg/m³, p < .001). During the three-week period, there were 188 STEMI patients admitted for PCI during the lockdown versus an average 254 STEMI patients before the lockdown period (incidence rate ratio = 0.74, p = .001). Reperfusion strategy was predominantly primary PCI in both time periods (96% versus 95%). However, there was a significant delay in treatment during the lockdown period, with more late presentations (>12 h after onset of pain) (14% versus 7.6%, p = .04) and with longer door-to-balloon times (median of 45 versus 39 min, p = .02). Although the in-hospital mortality between the two periods was comparable (5.9% versus 6.7%), 5 of the 7 (71%) COVID-19-positive STEMI patients died. CONCLUSION: The present study revealed a 26% reduction in STEMI admissions and a delay in treatment of STEMI patients. Less exposure to external STEMI triggers (such as ambient air pollution) and/or reluctance to seek medical care are possible explanations of this observation.

Early prognosis and predictor analysis for positive coronary angiography after out-of-hospital cardiac arrest (OHCA).

BACKGROUND: Key predictors of survival after OHCA have been described in the literature. Current guidelines recommend emergency angiography in patients without an obvious extra-cardiac cause of arrest. However, the value of this strategy is debated. Moreover, diagnosis of acute coronary ischaemia after OHCA remains challenging, especially in patients without ST-segment elevation. OBJECTIVES: The primary objective was to identify qualitative variables associated with an increased chance of 30-d survival after OHCA. The secondary objective was to identify predictors of 30-d survival among patients with ischaemic cardiomyopathy and patients without ST-segment elevation. Afterwards, we sought to identify parameters associated with acute coronary ischaemia and positive coronary angiography in patients without ST-segment elevation. METHODS: Retrospective single-centre study including 123 patients resuscitated from OHCA. Baseline characteristics, resuscitation settings and angiographic findings were analysed. RESULTS: The predictors of 30-d survival after OHCA included witnessed cardiac arrest, haemodynamic instability and coronary angiography. Convertible cardiac rhythm, history of coronary disease and presence of at least two cardiovascular risk factors were associated with acute coronary ischaemia. Predictors for a positive angiography in patients without ST-segment elevation included history of coronary disease, gender, diabetes, dyslipidaemia and presence of at least two cardiovascular risk factors (all p < .05). CONCLUSIONS: We identified qualitative predictors of 30-day survival after OHCA. Our findings suggest that the recognition of acute coronary ischaemia after OHCA might be improved. The identification of risk criteria may help to select the best candidates for emergency angiography.

Quality assessment in percutaneous coronary interventions: the QERMID Belgian PCI registry.

BACKGROUND: The recent increase in the number of interventional cathlabs that followed a moratorium of several years has resulted in an abrupt increase in the number of PCI and a dilution of the experience per centre and per operator. METHODS: Based on data extracted from the national "Quality Oriented Electronic Registration of Medical Implant Devices" (QERMID) database, we compared the characteristics and outcome of patients treated in 2015 in the 21 newly (<3 years) approved PCI centres with those of patients treated in the 28 historical PCI centres. RESULTS: The proportion of acute coronary syndromes was slightly higher in new than in historical centres (48% vs. 44%; p < 0.01) but few differences in co-morbidities were observed. Considering separately the patients treated for an acute coronary syndrome or for stable ischaemia, no significant difference in the overall in-hospital or 30-days mortality and in the proportion of same week bypass surgery was observed between newly approved and historical centres. In a substantial proportion (39%) of patients treated for stable angina or silent ischaemia, no test confirming the presence of ischaemia before PCI is reported, without significant difference between new and historical centres. CONCLUSIONS: Pending the limitations of the QERMID database, including a limited dataset and the absence of systematic on-site monitoring, no significant difference in the rate of major complications was identified between new and historical Belgian PCI centres.

Case report: osteogenesis imperfecta, internal mammary artery graft & nitinol clips.

BACKGROUND: Osteogenesis imperfecta is a genetic disorder of connective tissue causing mostly left-sided heart valves and aortic root pathologies, but a coronary artery involvement reflecting an increased sensitivity to cardiovascular risk factors is also suspected in this patient population. CASE PRESENTATION: We report a 38-year-old patient with an osteogenesis imperfecta and a typical presentation of an acute myocardial infarction. The coronary angiogram showed a coronary 3-vessel disease. The patient underwent a bypass grafting surgery with the internal mammary artery. The sternum was closed using four nitinol clips and had totally stabilized at 4 months with excellent bone healing. CONCLUSIONS: With the successful clinical outcome in this patient severely affected by its osteogensis imperfecta, we underline the safe use of the LIMA, if precaution is taken towards the sternal bone, and its closure with nitinol clips.

Usefulness of a Gentle and Short Hemostasis Using the Transradial Band Device after Transradial Access for Percutaneous Coronary Angiography and Interventions to Reduce the Radial Artery Occlusion Rate (from the Prospective and Randomized CRASOC I, II, and III Studies).

The study sought to evaluate the benefit of the reduction in intensity and duration of the hemostasis obtained with the transradial (TR) Band compression device on the radial artery occlusion (RAO) rate. RAO is the most frequent complication of TR access for cardiac catheterization and limits future use of this safe route. Its occurrence must be minimized. Between 2009 and 2016, 3,616 TR accesses were randomized to TR Band hemostasis during 3 consecutive protocols: CRASOC I (Compression of Radial ArterieS without Occlusion): 13 versus 10 cc of air into the TR Band and for 4 hours of continuous compression; CRASOC II: 10 cc of air for 3 hours versus 2 hours of compression; and CRASOC III: 10 cc of air for 2 hours versus 1.5 hours of compression and virtual 4F introducer as default sheath (both arms). Radial artery patency was assessed by plethysmography at 24 hours, using Doppler for doubtful or negative plethysmography. The primary end point, 24 hours of RAO, was markedly reduced when hemostasis was soft (10 cc of air) and short (1.5 hours) and resulted in a 2.3% rate of RAO versus 9.4% for 13 cc, 4 hours. Hemostasis was obtained in 89% of patients with only 10 cc of air and in 97% of patients with less than the recommended 13 cc. About 8% of patients required more than the 1.5 hours of hemostasis time. In conclusion, short and soft hemostasis with the TR Band device leads to a low RAO rate.

Belgium: coronary and structural heart interventions from 2010 to 2015.

In a ranking of the gross domestic product per capita in 2015, Belgium ranked 19th in the world according to the International Monetary Fun1d and the World Bank. It has a Human Development Index of 0.890, in which it is preceded by only 20 other countries in the world. This is, at least in part, due to a well-developed social security system on which all citizens can rely. Over the last 5-10 years, however, this system has come under increasing pressure. This has resulted in insufficient, incomplete and late reimbursement of all technologies that were introduced over the last ten years in the cathlab: intracoronary imaging techniques are not reimbursed at all, and FFR only to a vastly insufficient degree. For several structural heart interventions, a system of limited and incomplete reimbursement has recently been set up, with a requirement to organise these procedures within the frames of hospital networks. Numbers of PCIs have risen by 15% over the last four years, coinciding with an increase in the number of cathlabs by 50%, aiming at better access to primary PCI for STEMI patients. This has also resulted in a decrease in the average procedure volume per centre. Two thirds of PCIs are performed via the radial access. DES penetration has increased to 74%, approaching 100% in some centres, while the uptake of BRS has been very limited so far.

Bilateral Internal Thoracic Artery Configuration for Coronary Artery Bypass Surgery: A Prospective Randomized Trial.

BACKGROUND: Bilateral internal thoracic arteries (BITA) have demonstrated superior patency and improved survival in patients undergoing coronary artery bypass grafting. However, the optimal configuration for BITA utilization and its effect on long-term outcome remains uncertain. METHODS AND RESULTS: We randomly assigned 304 patients undergoing coronary artery bypass grafting using BITA to either in situ or Y grafting configurations. The primary end point was 3-year angiographic patency. Secondary end points included major adverse cardiac and cerebrovascular events (ie, death from any cause, stroke, myocardial infarction, or repeat revascularization) at 7 years. More coronary targets were able to be revascularized using internal thoracic arteries in patients randomized to Y grafting versus in situ group (3.2±0.8 versus 2.4±0.5 arteries/patient; P<0.01). The primary end point did not show significant differences in graft patency between groups. Secondary end points occurred more frequently in the in situ group (P=0.03), with 7-year rates of 34±10% in the in situ and 25±12% in the Y grafting groups, driven largely by a higher incidence of repeat revascularization in the in situ group (14±4.5% versus 7.4±3.2% at 7 years; P=0.009). There were no significant differences in hospital mortality or morbidity or in late survival, myocardial infarction, or stroke between groups. CONCLUSIONS: Three-year systematic angiographic follow-up revealed no significant difference in graft patency between the 2 BITA configurations. However, compared with in situ configuration, the use of BITA in a Y grafting configuration results in lower rates of major adverse cardiovascular and cerebrovascular events at 7 years. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01666366.

Double guide double wrist 5F left coronary artery transradial percutaneous coronary intervention and the X-Kiss technique.

Percutaneous coronary intervention for bifurcated anatomy, particularly at the proximal left coronary artery site, requires guide catheters (GC) of at least 6 french and preferably larger in diameter. We describe a new trans-radial approach more suitable for small artery size: the simultaneous use of both radial arteries for double cannulation of the LMCA with 5F GC: each GC will target either the LM/LAD or the LM/CX artery (or LM-LAD/LM-LAD-1st diagonal branch) stenoses. The technique successfully was applied to 5 cases. When the technique was used for distal left main coronary artery stenoses (3 cases), a special crogss-like configuration obtained when guide catheters, coronary wires and balloons kissed was observed.

Impact of gender difference in hospital outcomes following percutaneous coronary intervention. Results of the Belgian Working Group on Interventional Cardiology (BWGIC) registry.

AIMS: To determine whether there are gender-based differences in in-hospital outcomes among patients undergoing percutaneous coronary intervention (PCI). METHODS AND RESULTS: We studied a large cohort using clinical data from a registry of 130,985 PCI procedures in Belgium, from January 2006 to February 2011. Compared to males, females were significantly older (70.3 vs. 64.8 years), and were more frequently diabetic or hypertensive. Men smoked more and more frequently had previous myocardial infarction (MI), previous PCI or previous coronary artery bypass graft (CABG) surgery. Coronary artery disease (CAD) was less severe in women, and PCI to the left anterior descending artery was more common in female patients. Unadjusted in-hospital mortality rates were higher in females versus males (2.5% for women and 1.6% for men, p<0.0001). After multivariable analysis, female gender remained an independent predictor of mortality (odds ratio 1.35, 95% CI: 1.22-1.49, p<0.0001). CONCLUSIONS: Gender-based differences in hospital mortality rates after PCI were observed in this large registry. Female sex remained an independent predictor of mortality after multivariable adjustment.

Elevation of biomarkers and long-term outcome after percutaneous coronary intervention.

BACKGROUND/OBJECTIVES: The impact of an elevation of cardiac biomarkers occurring after percutaneous coronary intervention (PCI) on long-term outcome remains controversial. Most available data are based on observational registries using multivariable analysis. In this study, a case-control approach was used to assess separately the impact of post-PCI elevation of CK-MB on the short-term in-hospital outcome and on the long-term outcome after hospital discharge. METHODS: Between 1 January 1996 and 31 December 2008, a postprocedural rise of CK-MB was observed in 363 among 8346 consecutive PCI procedures (4·3%). The overall in-hospital mortality for patients with or without CK-MB elevation after PCI was 8·5% and 1·5%, respectively (P < 0·001). For 245 hospital survivors with CK-MB elevation, we found 245 control cases matched for 9 relevant clinical parameters in our PCI database during the same period. The long-term survival of these patients was assessed by KM estimates. RESULTS: Despite an increased in-hospital mortality among patients with periprocedural elevation of CK-MB, the long-term outcome of patients who are discharged alive is independent of CK-MB release, curves of overall survival and of survival free of recurrence of myocardial infarction being similar up to 10 years after hospital discharge. CONCLUSIONS: In our population, the elevation of CK-MB after PCI identified a high-risk subgroup for in-hospital mortality but had no impact on the long-term prognosis, once the patient is discharged alive from the hospital.

Chronic competitive flow from a patent arterial or venous graft to the circumflex system does not impair the long-term patency of internal thoracic artery to left anterior descending grafts in patients with isolated predivisional left main disease: long-term angiographic results of 2 different revascularization strategies.

OBJECTIVE: To compare 2 different surgical approaches to treatment of patients with isolated predivisional stenosis of the left main coronary artery (IOSLM) and to evaluate the effect of chronic competitive flow from a patent arterial or venous graft to the circumflex system on the long-term patency of internal thoracic artery (ITA) to left anterior descending grafts. METHODS: Thirty-two patients with IOSLM were treated at our institutions during a 9-year period: 14 patients received double ITA grafts, whereas 18 underwent ITA graft plus saphenous vein (SV) bypass. All patients were reviewed clinically and angiographically at long-term follow-up. RESULTS: No patient died during hospitalization. At a mean follow-up of 96±9 months 7 patients had died (6 from noncardiac causes) and 5 had experienced angina/ischemia recurrence, without differences between the 2 revascularization strategies. At control reangiography all ITA and SV grafts were found to be fully patent, without evidence of caliber reduction or string sign in the ITA. CONCLUSIONS: In patients with IOSLM, long-term ITA to left anterior descending artery patency is not jeopardized by chronic flow competition from a concomitant arterial or venous graft to the circumflex system. Notably, the addition of a second ITA graft or of a SV to the first ITA does not lead to differences in long-term angiographic patency. Our results minimize the role of flow competition in this setting and should be kept in mind when choosing the appropriate graft configuration.

Five-year follow-up of drug-eluting stents implantation vs minimally invasive direct coronary artery bypass for left anterior descending artery disease: a propensity score analysis.

OBJECTIVES: The spread of drug-eluting stents (DES) has reduced the incidence of early restenosis following percutaneous coronary interventions (PCI). Meanwhile, development of minimally invasive coronary artery bypass surgery (MIDCAB) has offered a valuable alternative to conventional sternotomy with preservation of the benefit of the internal mammary artery use. Therefore, the revascularization of the left anterior descending (LAD) artery is suitable for both techniques. However, few data with long-term comparison of these two techniques exist. METHODS: Prospective data were collected for 456 patients undergoing isolated LAD revascularization between 1997 and 2011. Two hundred and sixty patients were treated with MIDCAB and 196 with first-generation DES implantation. A propensity score model was created to adjust for 19 relevant confounding variables. Primary and secondary end-points were, respectively, 5-year survival and freedom from major adverse cerebro-cardiovascular events (MACCE). RESULTS: Both groups were similar in age, EuroSCORE and mean duration of follow-up. Five-year survival was similar after MIDCAB or DES (hazard ratio (HR): 0.95; P = 0.89). Freedom from MACCE was significantly in favour of the MIDCAB group (HR: 0.32, P < 0.0001), mainly triggered by high subsequent need for revascularization of the targeted vessel in the DES group (HR: 0.17, P < 0.0001). CONCLUSIONS: MIDCAB and DES implantation showed similar rates of survival but despite an expected lower rate of reintervention on the targeted vessel with DES use, a highly significant higher MACCE rate was observed in the PCI group at 5-year follow-up.

Competitive flow in coronary bypass surgery: is it a problem?

PURPOSE OF REVIEW: Competition flow is a common finding in arterial grafting. This phenomenon can lead to graft occlusion. RECENT FINDINGS: Internal thoracic arteries are the best equipped arterial conduit to withstand the competition flow thanks to their endothelial function. Radial as well as right gastroepiploic arteries support much less flow competition because of their different anatomy, histology and endothelial function than that of internal thoracic artery, leading to spasm and occlusion. Therefore, these two arterial conduits should be used only in case of critical lesion to avoid graft occlusion. Saphenous vein graft is the only conduit that is not significantly affected by flow competition, mainly because of its nonresistivity and common reimplantation in the aorta. Graft configuration is the second important factor influencing the equation between graft flow and native coronary flow. Therefore, composite grafting should be reserved for the case of severely stenotic coronary target, especially if multiple arterial sequential anastomoses have to be performed on the lateral-inferior wall of the heart. Finally, an accurate tool such as the fractional flow reserve to evaluate the stenosis severity should be the milestone of coronary surgery in order to decrease the rate of flow competition and improve arterial grafting functionality. CONCLUSION: Competition flow plays a crucial role in arterial grafting functionality. Grafting strategy should address this by appropriate graft choice and configuration in order to avoid graft attrition.

Angiographic predictors of 3-year patency of bypass grafts implanted on the right coronary artery system: a prospective randomized comparison of gastroepiploic artery, saphenous vein, and right internal thoracic artery grafts.

OBJECTIVE: Saphenous vein, in situ right gastroepiploic artery, and right internal thoracic artery grafts are routinely used to revascularize the right coronary artery. Little is known about the predictive value of objective preoperative angiographic parameters on midterm graft patency. METHODS: We prospectively enrolled 210 consecutive patients undergoing coronary revascularization. Revascularization of the right coronary artery was randomly performed with the saphenous vein grafts in 81 patients and the right gastroepiploic artery in 92 patients. During the same study period, 37 patients received right coronary artery revascularization with the right internal thoracic artery used in a Y-composite fashion. All patients underwent a protocol-driven coronary angiogram 3 years after surgery. Preoperative angiographic parameters included minimum lumen diameter percent stenosis measured by quantitative angiography. A graft was considered "not functional" with patency scores of 0 to 2 and "functional" with patency scores of 3 or 4. RESULTS: Angiographic follow-up was 100% complete. A significant difference in the distribution of flow patterns was observed in the 3 groups. In multivariate analysis, the use of a saphenous vein graft was associated with superior graft functionality compared with the other conduits (odds ratio, 6.1; 95% confidence interval, 2.4-15). Graft function was negatively influenced by the minimum lumen diameter (odds ratio, 0.11; confidence interval, 0.05-0.25). In the right gastroepiploic artery and right internal thoracic artery groups, the proportion of functional grafts was higher when the minimum lumen diameter was below a threshold value in the third minimum lumen diameter quartile (0.64-1.30 mm). CONCLUSIONS: Preoperative angiography predicts graft patency in the right gastroepiploic artery and right internal thoracic artery, whereas the flow pattern in saphenous vein grafts is significantly less influenced by quantitative angiographic parameters.