Incidence, Management, Immediate and Long-Term Outcome of Guidewire and Device Related Grade III Coronary Perforations (from G3CAP - Cardiogroup VI Registry).

Ellis grade III coronary artery perforations (G3-CAP) remain a life-threatening complication of percutaneous coronary intervention (PCI), with high morbidity and mortality and lack of consensus regarding optimal treatment strategies. We reviewed all PCIs performed in 10 European centers from 1993 to 2019 recording all G3-CAP along with management strategies, in-hospital and long-term outcome according to Device-related perforations (DP) and Guidewire-related perforations (WP). Among 106,592 PCI (including 7,773 chronic total occlusions), G3-CAP occurred in 311 patients (0.29%). DP occurred in 194 cases (62.4%), more commonly in proximal segments (73.2%) and frequently secondary to balloon dilatation (66.0%). WP arose in 117 patients (37.6%) with chronic total occlusions guidewires involved in 61.3% of cases. Overall sealing success rate was 90.7% and usually required multiple maneuvers (80.4%). The most commonly adopted strategies to obtain hemostasis were prolonged balloon inflation (73.2%) with covered stent implantation (64.4%) in the DP group, and prolonged balloon inflation (53.8%) with coil embolization (41%) in the WP group.  Procedural or in-hospital events arose in 38.2% of cases: mortality was higher after DP (7.2% vs 2.6%, p = 0.05) and acute stent thrombosis 3-fold higher (3.1% vs 0.9%, p = 0.19). At clinical follow-up, median 2 years, a major cardiovascular event occurred in one-third of cases (all-cause mortality 8.2% and 7.1% respectively, without differences between groups). In conclusion, although rare and despite improved rates of adequate perforation sealing G3-CAP cause significant adverse events. DP and WP result in different patterns of G3-CAP and management strategies should be based on this classification.

Thirty-day readmission rates after PCI in a metropolitan center in Europe: incidence and impact on prognosis.

INTRODUCTION: Thirty-day readmission rates after percutaneous coronary intervention (PCI) have been related to adverse prognosis, and represent one of the most investigated indicators of quality of care. These data, however, derive from non-European centers evaluating all-cause readmissions, without stratification for diagnosis. METHODS: All consecutive patients undergoing PCI at our center from January 2009 to December 2011 were enrolled. Thirty-day readmissions related to postinfarction angina, myocardial infarction, unstable angina or heart failure were defined as acute coronary syndrome (ACS) or heart failure rehospitalizations. Major cardiac adverse event (MACE) was the primary outcome, and its single components (death, myocardial infarction and repeated revascularization) the secondary ones. RESULTS: A total of 1192 patients were included; among them, 53 (4.7%) were readmitted within 30 days, and 25 (2.1%) were classified as ACS/heart failure related. During hospitalization, patients with ACS/heart failure readmissions were more likely to suffer a periprocedural myocardial infarction (22 vs. 4%; P = 0.012), and to undergo PCI at 30 days (52 vs. 0.5%; P < 0.001). Logistic regression analysis indicated that periprocedural myocardial infarction represented the only independent predictor of an ACS/heart failure readmission [odds ratio (OR) 4.5; 1.1-16.8; P = 0.047]. After a median follow-up of 787 days (434-1027; first and third quartiles), patients with a 30-day ACS/heart failure readmission experienced higher rates of MACE, all-cause death and myocardial infarction (64 vs. 21%, P < 0.001; 28 vs. 6%, P = 0.017; and 20 vs. 2.7%, P < 0.001, respectively). Cox multivariate analysis indicated that ACS/heart failure 30-day readmissions were independently related to an increased risk of all-cause death (OR 3.3; 1.1-8.8; P = 0.02), differently from 30-day non-ACS/heart failure readmissions (OR 3.1; 0.7-12.9; P = 0.12). CONCLUSION: Thirty-day readmissions after PCI in an Italian center are infrequent, and only those patients with ACS/heart failure show a detrimental impact on prognosis who have periprocedural myocardial infarction as the only independent predictor.

The EUROpean and Chinese cardiac and renal Remote Ischemic Preconditioning Study (EURO-CRIPS): study design and methods.

AIMS: Contrast-induced nephropathy (CIN) and periprocedural myocardial infarction (PMI) represent frequent complications of percutaneous coronary intervention (PCI) and negatively impact subsequent length of hospitalization, costs of adjunctive diagnostic-therapeutic measures and mid-term cardiovascular events. The aim of the EURO-CRIPS trial is to test whether remote ischemic preconditioning (RIPC) may reduce the incidence of these complications and improve mid-term outcome. METHODS: This will be a double-blind, randomized, placebo-controlled multicentre study. Patients will be allocated 1 : 1 to RIPC or standard therapy if they were younger than 85 years old, with a renal clearance in the interval 30-60 ml/min/1.73 m and candidate to PCI for all clinical indications except for primary PCI in ST segment elevation myocardial infarction (STEMI), unstable haemodynamic presentations or ongoing severe arrhythmias. Incidence of CIN will be the primary end point and the amount of periprocedural cardiac enzyme leakage will be the secondary end point. In addition, we will evaluate whether the preconditioned patients will have a reduction of MACCE at 6 months (major adverse cardiac and cerebrovascular event). CONCLUSION: The EURO-CRIPS Study will be the first large-scale, multicentre clinical trial to test the role of RIPC in current clinical practice. The results of this randomized trial will provide important insights to optimize management strategy of patients undergoing PCI and to improve their outcome.

Laboratory aspirin resistance reversibility in diabetic patients: a pilot study using different pharmaceutical formulations.

PURPOSE: Aspirin resistance occurs most frequently in diabetic patients and is associated with poor prognosis. The purpose of this study was to evaluate the prevalence of aspirin resistance in a cohort of diabetic patients and whether it can be reversed using more bioavailable aspirin formulations. METHODS: Platelets function of 163 diabetic patients taking acetyl salicylic acid (ASA) 100 mg daily has been evaluated with PFA100 and VerifyNow. Patients found resistant by at least one test received an infusion of 288 mg of lysine acetylsalicylate (Flectadol®) corresponding to ASA 160 mg. Platelets function was measured again after 1 and 24 h. Patients whose the resistance was reversed received 288 mg of soluble salt of lysine acetylsalicylate (Cardirene 160®) corresponding to ASA160 mg instead of aspirin and their aggregation status was re-evaluated after 1 month of therapy. RESULTS: Prevalence of aspirin resistance in our population was 18,4 % (30/163). In 27 out of 30 patients (90 %) aspirin resistance was reversed within 24 h from the infusion. 25 out of 27 patients (92 %) were found fully aspirin-sensitive after 1 month of oral therapy with soluble salt; two patients were found with borderline value. No adverse reactions were observed. CONCLUSIONS: A significant number of diabetic patients are resistant to aspirin therapy. A single intravenous dose of lysine acetylsalicylate can reverse the platelet hyper-aggregability and laboratory aspirin resistance in large majority of patients. The efficacy of antiaggregation can be maintained by chronic therapy with an oral drug with a more favourable pharmacokinetic profile.

Cardiac remote ischaemic preconditioning reduces periprocedural myocardial infarction for patients undergoing percutaneous coronary interventions: a meta-analysis of randomised clinical trials.

AIMS: To establish the cardioprotective effect of remote ischaemic preconditioning (RIPC) in patients undergoing percutaneous coronary intervention (PCI). METHODS AND RESULTS: Pubmed (MEDLINE), Cochrane and Embase were systematically searched for randomised controlled trials of RIPC in patients undergoing PCI. Periprocedural myocardial infarction (PMI) was the primary endpoint (defined as troponin elevation >3 times upper reference limit) and C-reactive protein (CRP) was a secondary endpoint. Five studies with 731 patients were included. The median age of the patients was 62 (59-68) years old, 25% were female (23-33), 29% (25-33) had diabetes mellitus, and 26.5% (19-31) presented with multivessel disease. RIPC significantly reduced the incidence of PMI (odds ratio: 0.58 [0.36, 0.93]; I2 43%), with a greater benefit when performed using the lower limb (0.21 [0.07-0.66]) compared to the upper limb (0.67 [0.46-0.99]). This reduction was enhanced for patients with multivessel disease (beta -0.05 [-0.09;-0.01], p=0.01) and with type C lesion (beta -0.014 [-0.04;-0.010], p=0.01) and did not vary according to age, female gender, diabetes mellitus, use of beta-blockers and of angiotensin converting enzyme inhibitors. Absolute risk difference was -0.10 [-0.19, -0.02], with a number needed to treat of 10 [6-50] patients to avoid one event. CRP -0.69 [-1.69, 0.31] was not significantly reduced by RIPC. CONCLUSIONS: RIPC reduced the incidence of PMI following PCI, especially when performed in the lower limb and for patients with multivessel disease and complex lesions.

Diffuse coronary disease: short- and long-term outcome after percutaneous coronary intervention.

AIM: The aim of this study was to evaluate short- and long-term results of PCI (percutaneous coronary intervention) in patients with small vessel coronary artery disease and the prognostic impact of the extension and the length of coronary lesions. METHODS AND RESULTS: All consecutive patients treated with PCI in our centre between July 2002 and December 2004 were included and divided into two groups according to the diameter of the implanted stents: small vessel disease was defined as requiring implantation of stents < 2.75 mm in diameter. The primary end point was the long-term incidence of major adverse cardiac events (MACE), the composite of cardiac mortality, nonfatal myocardial reinfarction, and repeated percutaneous target vessel revascularization (re-PTCA TVR). 1599 patients were treated by PCI: 419 (26.2%) were implanted with 2.75 mm or smaller stents. At both 1 and 36 months as well as at 53 + 20 months of follow-up small vessel stenting was associated with a higher rate of MACE (4.2% vs 2.1%, P= 0.028; 20.3% vs 17.9%, P <0.001; 27.5% vs 22.4%, P= 0.04, respectively). Multivariate analysis showed higher rates of revascularization for patients with small vessel disease regardless of lesion length. Rates of death were higher in patients with small vessels and long lesions. CONCLUSION: Atherosclerotic involvement of small vessels in patients with CAD confers a higher short- and long-term risk of adverse outcome after PCI.

Coronary computed tomographic angiography for detection of coronary artery disease in patients presenting to the emergency department with chest pain: a meta-analysis of randomized clinical trials.

BACKGROUND: Assessment of chest pain patients remains a clinical challenge in the emergency department (ED). Several randomized controlled trials (RCTs) have shown the additive value of coronary computed tomographic angiography (CCTA) compared with standard care. Not all of them, however, had enough power to detect differences in clinical outcomes like revascularization. Therefore, we performed a meta-analysis to test the safety and efficacy of this non-invasive diagnostic approach in low- and intermediate-risk chest pain patients. METHODS: MEDLINE/PubMed was systematically screened for RCTs comparing CCTA and non-CCTA approaches for ED patients presenting with chest pain. Baseline features, diagnostic strategies, and outcome data were appraised and pooled with random-effect methods computing summary estimates [95% confidence intervals (CIs)]. RESULTS: A total of four RCT studies including 2567 patients were identified, with similar inclusion and exclusion criteria. Patients in the CCTA group were more likely to undergo percutaneous or surgical revascularization during their index visit, with an odd ratio of 1.88 (1.21-2.92). Time to diagnosis was reduced with CCTA (-7.68 h;-12.70 to 2.66) along with costs of care in the ED (-$680; -1.060 to -270: all CI 95%). CONCLUSION: The present meta-analysis shows that a strategy with CCTA used as first imaging test for low- and intermediate-risk patients presenting to the ED with chest pain appears safe and seems not to increase subsequent invasive coronary angiographies. The approach is cost-effective although limited data and incomplete cost analyses have been performed. CCTA increases coronary revascularizations, with still an unknown effect on prognosis, especially in the long term.

Atherosclerotic coronary plaque regression and the risk of adverse cardiovascular events: a meta-regression of randomized clinical trials.

INTRODUCTION: Atherosclerotic coronary plaques represent the main substrate for coronary artery disease (CAD), and changes in plaque volume, investigated with intravascular ultrasound (IVUS), have been used as surrogate end-points in several clinical trials. However, no conclusive data are available to support the exploitation of IVUS-based plaque changes as a measure of clinically meaningful treatment's effect. METHODS: Biomed Central, CENTRAL, and Medline/PubMed were searched for randomized clinical trials investigating IVUS variations of plaque and reporting clinical events. End-points of interest were major adverse cardiovascular events (MACE, a composite of death, myocardial infarction [MI] or revascularization), and the rates of MI or revascularization combined. Meta-regression analysis was performed to appraise the association between plaque changes and clinical events during follow-up. RESULTS: Eleven studies (2 focusing on patients with ACS) with 7864 patients were included. After a median follow-up of 18 months, percentage of atheroma volume (PAV) was 0.50 (95% confidence interval -0.25; 1.00), with a 15.0% (95% CI 9.6%; 22.5%) rate of MACE and a 14.1% (95% CI 10.2%; 19.5%) rate of MI or revascularization. Rates of plaque volume regression were significantly associated with the incidence of MI or revascularization (Beta = 6.3; p = 0.006) but not with MACE (Beta = 0.42; p = 0.208). CONCLUSION: Regression of atherosclerotic coronary plaque volume may represent a surrogate for myocardial infarction and repeat revascularization but not for MACE. These results derive largely from stable patients, and should consequently be applied only to this population.

Prevalence and non-invasive predictors of left main or three-vessel coronary disease: evidence from a collaborative international meta-analysis including 22 740 patients.

BACKGROUND: Left main disease (LMD) and three-vessel disease (3VD) have important prognostic value in patients with coronary artery disease. However, uncertainties still exist about their prevalence and predictors in patients with acute coronary syndrome (ACS) and also in patients with stable coronary disease. Thus the aim of this study was to perform an international collaborative systematic review and meta-analysis to appraise the prevalence and predictors of LMD and 3VD. METHODS: Medline/PubMed were systematically searched for eligible studies published up to 2010, reporting multivariate predictors of LMD or 3VD. Study features, patient characteristics, and prevalence and predictors of LMD and 3VD were abstracted and pooled with random-effect methods (95% CIs). RESULTS: 17 studies (22 740 patients) were included, 11 focusing on ACS (17 896 patients) and six on stable coronary disease (4844 patients). In the ACS subgroup, LMD or 3VD occurred in 20% (95% CI 7.2% to 33.4%), LMD in 12% (95% CI 10.5% to 13.5%), and 3VD in 25% (95% CI 23.1% to 27.0%). Heart failure at admission and extent of ST-segment elevation in lead aVR on 12-lead ECG were the most powerful predictors of LMD or 3VD. In the stable disease subgroup, LMD or 3VD was found in 36% (95% CI 18.5% to 48.8%), with the most powerful predictors being transient ischaemic dilation during the imaging stress test, extent of ST-segment elevation in aVR and V1 during the stress test, and hyperlipidaemia. CONCLUSIONS: This meta-analysis demonstrated that severe coronary disease-that is, LMD or 3VD-is more common in patients with ACS or stable coronary disease than generally perceived, and that simple and low-cost tools may help in the selection of the most appropriate therapeutic approach.