Fractional flow reserve guided versus angiographic guided surgical revascularization: A meta-analysis.

BACKGROUND: Clinical benefits of FFR (Fraction Flow Reserve) driven CABG (Coronary Artery Bypass Graft) remain to be established. METHODS: All randomized controlled trials (RCTs) and observational studies with multivariable adjustement were included. MACE (Major Adverse Cardiac Events) was the primary end point, while its single components (death, myocardial infarction, and total vessel revascularization [TVR]) along with number of anastomoses, on pump procedures and graft occlusion at angiographic follow-up were the secondary ones. Each analysis was stratified for RCTs versus observational studies. RESULTS: Four studies (two RCTs and two observational) were included, enrolling 983 patients, 542 angio-guided and 441 FFR-guided. Mean age was 68.45 years, 79% male, with a mean EuroSCORE I of 2.7. Coronary lesions were located in 37% of patients in the left anterior descending artery, 32% in the circumflex artery, and 26% in the right coronary artery. After a mean follow-up of 40 months, risk of MACE did not differ (OR 0.86 [0.63-1.18]) as that of all cause death (OR 0.86 [0.59-1.25]), MI (OR 0.57 [0.30-1.11]) and TVR (OR 1.10 [0.65-1.85]). FFR-driven CABG reduced on-pump procedures (OR 0.58 [0.35-0.93]) and number of anastomoses (-0.40 [-0.80: -0.01]) while incidence of graft occlusion at follow-up did not differ (OR 0.59 [0.30-1.15], all CI 95%). CONCLUSION: Fraction flow reserve driven CABG reduced the number of anastomoses and of on-pump procedures without increasing risk of MACE and without reducing graft occlusion at angiographic follow-up. ID CRD42020211945.

Percutaneous vs. surgical revascularization for patients with unprotected left main stenosis: a meta-analysis of 5-year follow-up randomized controlled trials.

AIMS: A 5-year survival of patients with unprotected left main (ULM) stenosis according to the choice of revascularization (percutaneous vs. surgical) remains to be defined. METHODS AND RESULTS: Randomized controlled trials (RCTs) comparing percutaneous coronary intervention (PCI) vs. coronary artery bypass graft (CABG) with a follow-up of at least 5 years were included. All-cause death was the primary endpoint. MACCE [a composite endpoint of all-cause mortality, myocardial infarction (MI), stroke, and repeat revascularization] along with its single components and cardiovascular (CV) death were the secondary ones. Analyses were stratified according to the use of first- vs. last-generation coronary stents. Subgroup comparisons were performed according to SYNTAX score (below or above 33) and to age (using cut-offs of each trial's subgroup analysis). Four RCTs with 4394 patients were identified: 2197 were treated with CABG, 657 with first generation, and 1540 with last-generation stents. At 5-year rates of all-cause death did not differ [odds ratio (OR) 0.93, 95% confidence interval (CI) 0.71-1.21], as those of CV death and stroke. Coronary artery bypass graft reduced rates of MACCE (OR 0.69, 95% CI 0.60-0.79), mainly driven by MI (OR 0.48, 95% CI 0.36-0.65) and revascularization (OR 0.53, 95% CI 0.45-0.64). Benefit of CABG for MACCE was consistent, although with different extent, across values of SYNTAX score (OR 0.76, 95% CI 0.59-0.97 for values < 32 and OR 0.63, 95% CI 0.47-0.84 for values ≥ 33) while was not evident for 'younger' patients (OR 0.83, 95% CI 0.65-1.07 vs. OR 0.65, 95% CI 0.51-0.84 for 'older' patients). CONCLUSION: For patients with ULM disease followed-up for 5 years, no significant difference was observed in all-cause and cardiovascular death between PCI and CABG. Coronary artery bypass graft reduced risk of MI, revascularization, and MACCE especially in older patients and in those with complex coronary disease and a high SYNTAX score.

Impact of structural features of very thin stents implanted in unprotected left main or coronary bifurcations on clinical outcomes.

OBJECTIVES: To evaluate the independent clinical impact of stent structural features in a large cohort of patients undergoing unprotected left main (ULM) or coronary bifurcation percutaneous coronary intervention (PCI) with a range of very thin strut stents. BACKGROUND: Clinical impact of structural features of contemporary stents remains to be defined. METHODS: All consecutive patients enrolled in the veRy thin stents for patients with left mAIn or bifurcatioN in real life (RAIN) registry were included. The following stent structural features were studied: antiproliferative drugs (everolimus vs. sirolimus vs. zotarolimus), strut material (platinum-chromium vs. cobalt-chromium), polymer (bioresorbable vs. durable), number of crowns (<8 vs. ≥8) and number of connectors (<3 vs. ≥3). For small diameter stents (≤2.5 mm), struct thickness (74 vs. 80/81 µm) was also tested. Target lesion failure (TLF), a composite of target lesion revascularization and stent thrombosis, was the primary endpoint. Multivariate analysis was performed with Cox regression models. RESULTS: Out of 2,707 patients, 110 (4.1%) experienced a TLF event after 16 months (12-18). After adjustment for confounders, an increased number of connectors (adjusted hazard ratio [adj-HR] 0.62, 95% confidence interval (CI) 0.39-0.99, p = .04) reduced risk of TLF, driven by stents with ≥2.5 mm diameter (HR 0.54, 95% CI 0.32-0.93, p = .02). This independent relationship was lost for stents with diameter <2.5 mm, where only strut thickness appeared to impact. Conversely, no independent relationship of polymer type, number of crowns, and the specific limus-family eluted drug with outcomes was observed. CONCLUSIONS: Among a range of contemporary very thin stent models, an increased number of connectors improved device-related outcomes in this investigated high-risk procedural setting.

Daily risk of adverse outcomes in patients undergoing complex lesions revascularization: A subgroup analysis from the RAIN-CARDIOGROUP VII study (veRy thin stents for patients with left mAIn or bifurcatioN in real life).

INTRODUCTION: Percutaneous coronary intervention (PCI) for complex lesions, including unprotected left main (ULM) and bifurcations, is gaining a relevant role in treating coronary artery disease with good outcomes, also thanks to new generation stents. The daily risk of adverse cardiovascular events and their temporal distribution after these procedures is not known. METHODS: All consecutive patients presenting with a critical lesion of ULM or bifurcation treated with very thin struts stents, enrolled in the RAIN-Cardiogroup VII study, were analyzed. The daily risk of major acute cardiovascular events (MACE), target lesion revascularization (TLR) and stent thrombosis (ST) and their temporal distribution in the first year of follow-up was the primary endpoint. Differences among subgroups (ULM, patient presentation, kind of stent polymer) were the secondary endpoint. RESULTS: 2745 patients were included, mean age 68 ±â€¯11 years, 33.3% diabetics, 54.5% had an acute coronary syndrome (ACS); 88.5% of treated lesions were bifurcations, 27.2% ULM. Average daily risk was 0.022% for MACE, 0.005% for TLR and 0.004% for ST, in the first year. Bimodal distribution of adverse events, especially TLR, with an early peak in the first 50 days and a late one after 150 days, was observed. Patients with ULM presented a significantly higher daily risk of events, and ACS patients presented higher MACE risk. No difference emerged according to the type of stent polymer. CONCLUSIONS: The daily risk of adverse events in the first year after complex PCI in our study is acceptably low. PCI on ULM carries a higher risk of complications.

Meta-Analysis Comparing Complete or Culprit Only Revascularization in Patients With Multivessel Disease Presenting With Cardiogenic Shock.

The optimal strategy for patients with an acute myocardial infarction (MI) and multivessel (MV) coronary artery disease complicated by cardiogenic shock (CS) remains unknown. We conducted a meta-analysis of all randomized controlled trials and observational studies that reported adjusted effect measures to evaluate the association of MV-PCI (percutaneous coronary intervention), compared with culprit only (C)-PCI, with cardiovascular events in patients admitted for CS and MV disease. We identified 12 studies (n = 1 randomized controlled trials, n = 11 observational) that included 7,417 patients (n = 1,809 treated with MV-PCI and n = 5,608 with C-PCI). When compared with C-PCI, MV-PCI was not associated with an increased risk of short-term death (odds ratio [OR] 1.14, 95% confidence interval [CI] 0.87 to 1.48, p = 0.35 and adjusted OR [ORadj] 1.00, 95% CI 0.70 to 1.43, p = 1.00). In-hospital and/or short-term mortality tended to be higher with MV-PCI, when compared with C-PCI, for CS patients needing dialysis (ß 0.12, 95% CI from 0.049 to 0.198; p= 0.001), whereas MV-PCI was associated with lower in-hospital and/or short-term mortality in patients with an anterior MI (ß -0.022, 95% CI -0.03 to -0.01; p <0.001). MV-PCI strategy was associated with a more frequent need for dialysis or contrast-induced nephropathy after revascularization (OR 1.36, 95% CI 1.06 to 1.75, p = 0.02). In conclusion, MV-PCI seems not to increase risk of death during short- or long-term follow-up when compared with C-PCI in patients admitted for MV coronary artery disease and MI complicated by CS. Furthermore, it appears a more favorable strategy in patients with anterior MI, whereas the increased risk for AKI and its negative prognostic impact should be considered in decision-making process. Further studies are needed to confirm our hypothesis on in these subpopulations of CS patients.

Long-Term Outcomes of Different Two-Stent Techniques With Second-Generation Drug-Eluting Stents for Unprotected Left Main Bifurcation Disease: Insights From the FAILS-2 Study.

OBJECTIVES: To investigate the long-term clinical outcomes of second-generation drug-eluting stent (2G-DES) implantation for the treatment of complex unprotected left main coronary artery (ULMCA) bifurcation lesions with different two-stent techniques. BACKGROUND: Several two-stent techniques for ULMCA bifurcation lesions have been described. However, a paucity of data exists regarding the optimal strategy, especially in the 2G-DES era. METHODS: The FAILS-2 registry enrolled 1270 consecutive patients treated for ULMCA stenosis with 2G-DES. We compared long-term outcomes of different two-stent strategies in patients who underwent PCI for complex ULMCA bifurcation disease. The primary endpoints were the incidence of death and major adverse cardiac events (MACE, defined as a composite of all-cause death, myocardial infarction [MI], target-lesion revascularization [TLR], and stent thrombosis [ST]) at long-term follow-up. RESULTS: A total of 238 patients were included in the present analysis. T-stenting strategy was used in 66 patients, mini-crush in 104 patients, and culotte in 68 patients. After a median follow-up of 2.27 years, death rates were comparable for the three techniques (9.3% T-stenting vs 9.0% mini-crush vs 4.5% culotte [P=.48]). MACE rates were also similar between the three groups (22% T-stenting vs 26% mini-crush vs 31% culotte [P=.50]). Finally, we showed no differences in MI, ST, and TLR rates between groups. At multivariate analysis, no significant advantage of one technique over the others was observed. CONCLUSION: T-stenting, mini-crush, and culotte techniques using 2G-DES for ULMCA bifurcation disease showed similar clinical outcomes at long-term follow-up. MACE rates were mainly driven by in-stent restenosis at the circumflex ostium.

Percutaneous coronary intervention or coronary artery bypass graft in left main coronary artery disease: a comprehensive meta-analysis of adjusted observational studies and randomized controlled trials.

BACKGROUND: Treatment of patients with ULMCA (unprotected left main coronary artery disease) with percutaneous coronary intervention (PCI) has been compared with coronary artery bypass graft (CABG), without conclusive results. METHODS: All randomized controlled trials (RCTs) and observational studies with multivariate analysis comparing PCI and CABG for ULMCA were included. Major cardiovascular events (MACEs, composite of all-cause death, MI, definite or probable ST, target vessel revascularization and stroke) were the primary end points, whereas its single components were the secondary ones, along with stent thrombosis, graft occlusion and in-hospital death and stroke. Subgroup analyses were performed according to Syntax score. RESULTS: Six RCTs (4717 patients) and 20 observational studies with multivariate adjustment (14 597 patients) were included. After 5 (3-5.5) years, MACE rate was higher for PCI [odds ratio (OR) 1.10, 95% confidence interval (CI) 1.07-1.14], without difference in death, whereas more relevant risk of MI was because of observational studies. Coronary stenting increased risk of revascularization (OR 1.52; 95% CI 1.34-1.72). At meta-regression, performance of PCI was improved by use of intra-coronary imaging and worsened by first generation stents, whereas two arterial grafts increased benefit of CABG. For patients with Syntax score less than 22, MACE rates did not differ, whereas for higher values, CABG reduced MACE because of lower risk of revascularization. Incidence of graft occlusion was 3.24% (2.25-4.23), whereas 2.13% (1.28-2.98: all CI 95%) of patients experienced stent thrombosis. CONCLUSION: Surgical revascularization reduces risk of revascularization for ULMCA patients, especially for those with Syntax score greater than 22, with a higher risk of in-hospital death. Intra-coronary imaging and use of arterial grafts improved performance of revascularization strategies.

Impact of chronic kidney disease on mortality in patients with ST-segment elevation myocardial infarction treated with primary percutaneous coronary intervention. A long-term single-center mortality study.

BACKGROUND: Chronic kidney disease (CKD) is associated with increased risk of mortality. We examined the impact of moderate and severe CKD at presentation on short- and long-term mortality among unselected patients with ST-segment elevation myocardial infarction (STEMI) treated with primary percutaneous coronary intervention (PPCI). METHODS: The study cohort consists of 501 patients (pts), enrolled from October 2005 to December 2012. The median follow-up was 46.52±25.58 months (range 8-99). A severe CKD (estimated Glomerular Filtration Rate [eGFR] <30 mL/min/1.73 m2) was detected in 16 pts (3.19%), a moderate CKD (eGFR 30-59 mL/min/1.73 m2) in 110 (21.96%) and a normal kidney function (eGFR >60 mL/min/1.73 m2) in 375 (74.85%). RESULTS: The crude in-hospital mortality rate resulted significantly higher in pts with severe and moderate CKD compared to pts with normal renal function (50% and 19.08% versus 2.93%, P<0.0001), as well as the long-term mortality rate (57.14% and 46.34% versus 8.77%, P<0.0001). After adjustment for confounding variables, severe and moderate CKD resulted the main independent predictors of in-hospital (odds ratio [OR]=21.815, P<0.0001 for severe CKD and OR= 4.203, P=0.002 for moderate CKD) and long-term (hazard ratio [HR]= 5.272, P=0.001; HR= 1.978, P=0.006) mortality. CONCLUSIONS: CKD is a frequent condition in patients with STEMI treated with PPCI and it is associated to an excess of mortality, resulting the main independent negative prognostic predictor.

Provisional versus elective two-stent strategy for unprotected true left main bifurcation lesions: Insights from a FAILS-2 sub-study.

BACKGROUND: This study sought to investigate the optimal percutaneous coronary intervention (PCI) strategy for true unprotected left main coronary artery (ULMCA) bifurcations. METHODS: The FAILS-2 was a retrospective multi-center study including patients with ULMCA disease treated with second-generation drug-eluting stents. Of these, we compared clinical outcomes of a provisional strategy (PS; n=216) versus an elective two-stent strategy (E2S; n=161) for true ULMCA bifurcations. The primary endpoint was the incidence of major adverse cardiac events (MACEs) at 3-years. We further performed propensity-score adjustment for clinical outcomes. RESULTS: There were no significant differences between the groups in terms of patient and lesion characteristics. 9.7% of patients in the PS group crossed over to a provisional two-stent strategy. MACEs were not significantly different between groups (MACE at 3-year; PS 28.1% vs. E2S 28.9%, adjusted p=0.99). The rates of target lesion revascularization (TLR) on the circumflex artery (LCX) were numerically high in the E2S group (LCX-TLR at 3-years; PS 11.8% vs. E2S 16.6%, adjusted p=0.51). CONCLUSIONS: E2S was associated with a comparable MACE rate to PS for true ULMCA bifurcations. The rates of LCX-TLR tended to be higher in the E2S group although there was no statistical significance. CONDENSED ABSTRACT: This study sought to compare the clinical outcomes of a provisional strategy (PS) with an elective two-stent strategy (E2S) for the treatment of true unprotected left main coronary artery bifurcations. 377 Patients (PS 216 vs. E2S 161 patients) were evaluated, and 9.7% in the PS group crossed over to a two-stent strategy. E2S was associated with a similar major adverse cardiac event rate at 3-years when compared to the PS strategy (PS 28.1% vs. E2S 28.9%, p=0.99). However, the left circumflex artery TLR rate at 3-year tended to be higher in the E2S group (PS 11.8% vs. E2S 16.6%, p=0.51).

Sex-related differences in patients with ST-elevation myocardial infarction undergoing primary PCI: A long-term mortality study.

OBJECTIVES: To assess sex differences in clinical presentation, in-hospital and long-term outcome in ST-elevated myocardial infarction (STEMI) patients undergoing primary PCI (PPCI). BACKGROUND: Several studies have shown higher rates of mortality in women. These differences are not always confirmed after adjusting for confounding variables. METHODS: From January 2007 to December 2011, 325 consecutive patients (23.1% females and 76.9% males) were prospectively treated and retrospectively analyzed. Primary outcome was in-hospital and long-term mortality. RESULTS: Women were older (71.8±11.7 vs. 62.5±12.6years; p<0.0001), presented more renal failure (45.3% vs. 20.8%; p<0.0001) and severe haemodynamic impairment (9.3% vs. 3.6%; p=0.04). In-hospital overall mortality (14.7% vs. 4.8%; p=0.003) and cardiac death (12% vs. 2%; p=0.002) were significantly higher in women. The multivariate analysis identified age (OR 1.07; 95% CI: 1.01-1.13), resuscitated cardiac arrest (CCA) and cardiogenic shock (CS) (OR 15.31; 95% CI: 4.30-61.75), renal failure (OR 0.20; 95% CI: 0.06-0.68), but not sex (OR 1.49; 95% CI: 0.53-4.22) as independent prognostic factors of in-hospital mortality. During a median follow-up of 46.5months (IQR range 32.7-63.1months), long-term overall mortality (24.2% vs. 11.0%; p=0.007) and cardiac death (4.8% vs. 1.7%; p=0.02) were significantly higher in women. The multivariate analysis identified age (HR 1.06; 95% CI: 1.02-1.11), previous AMI (HR 3.9; 95% CI: 1.63-9.35), renal failure (HR 5.21; 95% CI: 2.12-12.85), technical success (HR 0.35; 95% CI: 0.14-0.84) but not sex (HR 0.90; 95% CI: 0.42-1.94) as independent prognostic factors of long-term mortality. CONCLUSIONS: Worse clinical presentation rather than sex may explain the excess of mortality in women with STEMI undergoing PPCI.

Fracture of coronary artery sirolimus eluting stent with formation of four aneurysms.

Coronary stent fracture is a relatively rare but potentially serious complication of coronary artery stenting, in particular with sirolimus-eluting stents. It has been recognized as one possible cause of in-stent restenosis as well as acute stent thrombosis. The formation of coronary artery aneurysm is one of the critical complications after percutaneous coronary intervention and it has been described after a stent fracture too. We report here a case of formation of four coronary artery aneurysms associated with the fracture of a sirolimus-eluting stent.

[Feasibility and safety of same-day discharge after percutaneous coronary intervention with femoral access and AngioSeal closure device: a single-center experience]. / Fattibilità e sicurezza di procedure diagnostico- interventistiche coronariche con accesso femorale e chiusura con AngioSeal in regime di day-surgery: esperienza di un singolo centro.

BACKGROUND: Same-day discharge after coronary angiography or percutaneous coronary interventions (PCI) is safe. It allows a decrease in length of hospital stay, waiting list and operating expenses with increased patient satisfaction. The aim of this study was to evaluate the feasibility and safety of this approach in our center. METHODS: 798 selected patients considered suitable for same-day discharge were enrolled in our study and underwent coronary angiography and/or PCI procedures over a period of 5 years. All procedures were performed by femoral approach using the 6-8F AngioSeal closure device. A follow-up telephone interview was carried out in all patients after 7-10 days from discharge with particular regard to bleeding/vascular complications. RESULTS: After PCI procedures, 738 patients (92.4%) were discharged as day cases. The remaining 60 patients (7.6%) were kept in hospital for longer observation. Procedural success was achieved in 100% of patients. Hemostasis with the AngioSeal closure device was successfully obtained in 98.4% of cases. At follow-up, 6 patients developed mild size hematoma on femoral access site, without any other vascular complications or major bleeding needing blood transfusion. CONCLUSIONS: In our experience same-day discharge after coronary angiography or PCI was found to be feasible and safe in selected patients undergoing uncomplicated procedures performed by femoral approach using a closure device.

Percutaneous closure of patent foramen ovale in patients with anatomical and clinical high-risk characteristics: long-term efficacy and safety.

BACKGROUND: Transcatheter closure of patent foramen ovale (PFO) is a widespread procedure, but no randomized study on its outcome in high-risk patients is available. Our aims were to determine the efficacy and safety of this procedure in a cohort of high-risk patients through the observation of clinical adverse events and residual shunt, to evaluate the impact of transesophageal echocardiography (TEE) guidance during the procedure, and investigate the relationship between the anatomical and clinical characteristics and the outcome. METHODS AND RESULTS: Ninety-five patients underwent PFO closure for cryptogenic cerebral ischemia; each of them presented one or more of the following risk factors: recurrent cerebral ischemia (9.5%), atrial septum aneurysm (ASA, 74.5%), prominent Eustachian valve (EV, 23.2%), severe basal shunt (9.5%), thrombophilic factors (20%), deep vein thrombosis (4.2%). The procedure was performed successfully in all patients. On median follow-up of 18 months, the neurologic recurrent events rate was 1.1% and the major adverse cardiac event (MACE) rate was 1.1%. At 6-month TEE follow-up, the residual shunt rate was 12.6% (3.1% moderate to severe). A significant correlation was found between residual shunt and prominent EV alone (P = 0.036) or in association with ASA (P = 0.021). All adverse events occurred in the first 8 months, and the event-free survival rate was 86.2%. CONCLUSIONS: Our study suggests that transcatheter PFO closure is a safe procedure even in a selected population of high-risk patients, presenting satisfactory efficacy and safety. The presence of a prominent EV alone or with ASA correlates positively with the occurrence of residual shunt.

Percutaneous coronary interventions with an endothelial progenitor cell capture stent (EPC) for high risk patients with no option for drug eluting stents: long term clinical outcomes of a single centre registry.

AIMS: Drug eluting stents (DES) are currently considered the gold standard for reducing restenosis of coronary artery lesions. Owing to their effect on the healing process, DES use requires mandatory prolonged dual antiplatelet therapy (DAT). The endothelial progenitor cell (EPC) capture stent, attracting circulating EPCs, promotes vascular healing and allows a short post-procedural period of DAT. The aim of the present study was to evaluate the short and long term clinical outcomes of the use of the Genos R stent™ in a selected high risk population with "no option" for DES. METHODS AND RESULTS: From December 2005 to October 2008, 61 high risk patients with clear contraindications to a prolonged period of DAT who underwent PCI with EPC capture stent implantation in our institution were prospectively selected and analysed. Technical success rate was 100%. Procedural success rate was 95.1%. After two years, major adverse cardiovascular events (MACE) free survival was 80.6%. According to the Academic Research Consortium definitions, cardiac death occurred in 1.6% of patients, and re-infarction, target lesion revascularisation (TLR), and target vessel revascularisation (TVR) occurred in 6.6%, 9.8%, and 11.5% of patients, respectively. Definite stent thrombosis occurred in one patient (specifically at 0 days). In patients who underwent surgery, no post-procedural MACE and no stent thrombosis were recorded. CONCLUSIONS: EPC capture stent implantation in high-risk patients with no option for DES seems encouraging, with satisfactory clinical outcomes both at short and at long term follow-up.