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Objectives: The aim of this study was to investigate the efficacy and safety of currently used drug-eluting stents (DES). Background: Head-to-head comparisons among newer DES have shown conflicting results. Methods: For this network meta-analysis, randomized controlled trials comparing different types of currently used DES were searched in PubMed, Scopus, and proceedings of international meetings. The primary endpoint was target lesion failure (TLF) at 1 year and at long-term follow-up. Results: Seventy-seven trials with 99,039 patients were selected for this network meta-analysis. Among the 10 DES included in the meta-analysis, 4 received the most extensive investigation: Orsiro, XIENCE, Nobori/BioMatrix, and Resolute. At 1 year, the Orsiro stent was associated with lower rates of TLF compared with XIENCE (odds ratio [OR]: 0.84; 95% confidence interval [CI]: 0.71 to 0.98; p = 0.03), Resolute (OR: 0.81; 95% CI: 0.68 to 0.95; p = 0.01), and Nobori/BioMatrix (OR: 0.81; 95% CI: 0.67 to 0.98; p = 0.03). Orsiro had the highest probability to be the best (70.8%), with a surface under the cumulative ranking curve value of 95.9%. However, after a median follow-up period of 50 months (range: 24 to 60 months), no significant difference was apparent in the rates of TLF between any DES, although Orsiro still ranked as the best stent (58.6% probability to be the best). In addition, Orsiro had a lower rate of long-term definite stent thrombosis compared with Nobori/BioMatrix (OR: 0.60; 95% CI: 0.36 to 0.98; p = 0.04) and lower rates of definite and probable stent thrombosis compared with Resolute (OR: 0.66; 95% CI: 0.45 to 0.99; p = 0.04). No differences in cardiac mortality between any DES were observed. Conclusions: Orsiro is associated with a lower 1-year rate of TLF compared with XIENCE, Resolute, and Nobori/BioMatrix but with an attenuation of the efficacy signal at long-term follow-up.

Background: We sought to determine whether the risks and benefits of prolonging dual-antiplatelet therapy (DAPT) beyond 1 year after drug-eluting stent implantation depend on clinical presentation in a meta-analysis of randomized controlled trials. Methods and Results: Randomized controlled trials comparing ≤1- versus >1-year DAPT after drug-eluting stent placement were searched through MEDLINE, EMBASE, Cochrane databases, and proceedings of international meetings. The primary efficacy end point was myocardial infarction, whereas the primary safety end point was major bleeding. Net clinical benefit was defined as the composite of myocardial infarction or major bleeding. Outcomes were analyzed according to patient presentation with stable ischemic heart disease versus acute coronary syndromes. The meta-analysis included 6 trials with a total of 21 457 patients, including 14 132 with stable ischemic heart disease and 7325 with acute coronary syndrome. After a median follow-up of 19.5 months, ≤1-year DAPT was associated with higher rates of myocardial infarction compared with >1-year DAPT (hazard ratio [HR], 1.63; 95% CI, 1.37–1.95), with no interaction apparent between treatment effect and clinical presentation. Shorter DAPT was associated with reduced rates of major bleeding compared with longer DAPT (HR, 0.64; 95% CI, 0.42–0.99) with no significant interaction between treatment effect and clinical presentation. However, a net clinical benefit of >1-year DAPT was present in patients with acute coronary syndrome (HR of shorter versus longer DAPT, 1.59; 95% CI, 1.24–2.02) but not in those with stable ischemic heart disease (HR, 1.15; 95% CI, 0.89–1.51; P interaction =0.04). Shorter DAPT was also associated with lower rates of noncardiac mortality compared with longer DAPT (HR, 0.71; 95% CI, 0.52–0.96), with no significant interaction between treatment effect and clinical presentation ( P interaction =0.12). Conclusions: Compared with ≤1-year DAPT, >1-year DAPT reduces the risk of myocardial infarction but increases the risk of major bleeding and noncardiac mortality. A net clinical benefit of extended DAPT was apparent for patients with acute coronary syndrome but not for those with stable ischemic heart disease.

The aim of this study was to investigate the safety and efficacy of coronary protection by preventive coronary wiring and stenting across the coronary ostia in patients at high risk for coronary obstruction after transcatheter aortic valve replacement (TAVR).Coronary obstruction following TAVR is a life-threatening complication with high procedural and short-term mortality.Data were collected retrospectively from a multicenter international registry between April 2011 and February 2019.Among 236 patients undergoing coronary protection with preventive coronary wiring, 143 had eventually stents implanted across the coronary ostia after valve deployment. At 3-year follow-up, rates of cardiac death were 7.8% in patients receiving stents and 15.7% in those not receiving stents (adjusted hazard ratio: 0.42; 95% confidence interval: 0.14 to 1.28; p = 0.13). There were 2 definite stent thromboses (0.9%) in patients receiving stents, both occurring after TAVR in "valve-in-valve" procedures. In patients not receiving stents, there were 4 delayed coronary occlusions (DCOs) (4.3%), occurring from 5 min to 6 h after wire removal. Three cases occurred in valve-in-valve procedures and 1 in a native aortic valve procedure. Distance between the virtual transcatheter valve and the protected coronary ostia 4 mm was present in 75.0% of patients with DCO compared with 30.4% of patients without DCO (p = 0.19).In patients undergoing TAVR at high risk for coronary obstruction, preventive stent implantation across the coronary ostia is associated with good mid-term survival rates and low rates of stent thrombosis. Patients undergoing coronary protection with wire only have a considerable risk for DCO.

International audience; ObjectivesTo evaluate the long-term impact of coronary artery disease (CAD) and heart team-guided incomplete coronary revascularization in patients undergoing transcatheter aortic valve implantation (TAVI).BackgroundRevascularization strategy of CAD diagnosed with routine coronary angiography before TAVI is uncertain.MethodsFive hundred and forty consecutive TAVI patients were classified as having CAD or normal coronary arteries (no-CAD). Within the CAD group, patients were further classified as those with complete (CR) versus incomplete revascularization (IR). Revascularization strategy was guided by the Heart Team following an algorithm largely based on current guidelines. Main outcome of interest was the incidence of 5-year cardiovascular (CV) death.ResultsPrevalence of CAD was 53.9%. CAD patients showed significantly lower left ventricular ejection fraction (LVEF: 55.8 ± 13.4% CAD vs. 61.4% ± 12.1 no-CAD, p

Objectives: This study sought to investigate the impact of nonemergent, uncomplicated target lesion revascularization (TLR) on the risk of long-term mortality after percutaneous coronary intervention (PCI). Background: Restenosis requiring TLR after PCI is generally considered a benign event. Methods: The study pooled patient-level data from 21 randomized trials. Subjects dying the same day as or the day after the TLR procedure as well as those with myocardial infarction (MI) the day before, the same day as or the day after TLR were excluded. The primary endpoint of the study was all-cause mortality. Results: The dataset included 32,524 patients who were stratified according to whether repeat TLR was performed during follow-up. During a median follow-up of 37 months, 2,330 (7.2%) patients underwent a nonemergent, uncomplicated TLR procedure. After adjusting for potential confounders, TLR was an independent predictor of mortality (hazard ratio: 1.23, 95% confidence interval: 1.04 to 1.45; p = 0.02). Patients undergoing nonemergent, uncomplicated TLR had significantly higher rates of non–procedure-related MI compared with those without TVR. Among patients undergoing elective TLR, MI occurring after TLR was an independent predictor of mortality (hazard ratio: 3.82; 95% confidence interval: 2.44 to 5.99; p < 0.0001). Conclusions: Nonemergent, uncomplicated TLR after PCI is an independent predictor of long-term mortality, an association in part explained by higher rates of MI occurring after TLR. Efforts aimed at reducing TLR risk may translate into prognostic benefits including reduced rates of MI and survival.

BACKGROUND Dual antiplatelet therapy (DAPT) with aspirin plus a P2Y12 inhibitor prevents ischaemic events after coronary stenting, but increases bleeding. Guidelines support weighting bleeding risk before the selection of treatment duration, but no standardised tool exists for this purpose. METHODS A total of 14 963 patients treated with DAPT after coronary stenting-largely consisting of aspirin and clopidogrel and without indication to oral anticoagulation-were pooled at a single-patient level from eight multicentre randomised clinical trials with independent adjudication of events. Using Cox proportional hazards regression, we identified predictors of out-of-hospital Thrombosis in Myocardial Infarction (TIMI) major or minor bleeding stratified by trial, and developed a numerical bleeding risk score. The predictive performance of the novel score was assessed in the derivation cohort and validated in patients treated with percutaneous coronary intervention from the PLATelet inhibition and patient Outcomes (PLATO) trial (n=8595) and BernPCI registry (n=6172). The novel score was assessed within patients randomised to different DAPT durations (n=10 081) to identify the effect on bleeding and ischaemia of a long (12-24 months) or short (3-6 months) treatment in relation to baseline bleeding risk. FINDINGS The PRECISE-DAPT score (age, creatinine clearance, haemoglobin, white-blood-cell count, and previous spontaneous bleeding) showed a c-index for out-of-hospital TIMI major or minor bleeding of 0·73 (95% CI 0·61-0·85) in the derivation cohort, and 0·70 (0·65-0·74) in the PLATO trial validation cohort and 0·66 (0·61-0·71) in the BernPCI registry validation cohort. A longer DAPT duration significantly increased bleeding in patients at high risk (score ≥25), but not in those with lower risk profiles (pinteraction=0·007), and exerted a significant ischaemic benefit only in this latter group. INTERPRETATION The PRECISE-DAPT score is a simple five-item risk score, which provides a standardised tool for the prediction of out-of-hospital bleeding during DAPT. In the context of a comprehensive clinical evaluation process, this tool can support clinical decision making for treatment duration. FUNDING None.

ObjectivesThis study sought to validate the Logistic Clinical SYNTAX (Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery) score in patients with non–ST-segment elevation acute coronary syndromes (ACS), in order to further legitimize its clinical application.BackgroundThe Logistic Clinical SYNTAX score allows for an individualized prediction of 1-year mortality in patients undergoing contemporary percutaneous coronary intervention. It is composed of a “Core” Model (anatomical SYNTAX score, age, creatinine clearance, and left ventricular ejection fraction), and “Extended” Model (composed of an additional 6 clinical variables), and has previously been cross validated in 7 contemporary stent trials (>6,000 patients).MethodsOne-year all-cause death was analyzed in 2,627 patients undergoing percutaneous coronary intervention from the ACUITY (Acute Catheterization and Urgent Intervention Triage Strategy) trial. Mortality predictions from the Core and Extended Models were studied with respect to discrimination, that is, separation of those with and without 1-year all-cause death (assessed by the concordance [C] statistic), and calibration, that is, agreement between observed and predicted outcomes (assessed with validation plots). Decision curve analyses, which weight the harms (false positives) against benefits (true positives) of using a risk score to make mortality predictions, were undertaken to assess clinical usefulness.ResultsIn the ACUITY trial, the median SYNTAX score was 9.0 (interquartile range 5.0 to 16.0); approximately 40% of patients had 3-vessel disease, 29% diabetes, and 85% underwent drug-eluting stent implantation. Validation plots confirmed agreement between observed and predicted mortality. The Core and Extended Models demonstrated substantial improvements in the discriminative ability for 1-year all-cause death compared with the anatomical SYNTAX score in isolation (C-statistics: SYNTAX score: 0.64, 95% confidence interval [CI]: 0.56 to 0.71; Core Model: 0.74, 95% CI: 0.66 to 0.79; Extended Model: 0.77, 95% CI: 0.70 to 0.83). Decision curve analyses confirmed the increasing ability to correctly identify patients who would die at 1 year with the Extended Model versus the Core Model versus the anatomical SYNTAX score, over a wide range of thresholds for mortality risk predictions.ConclusionsCompared to the anatomical SYNTAX score alone, the Core and Extended Models of the Logistic Clinical SYNTAX score more accurately predicted individual 1-year mortality in patients presenting with non–ST-segment elevation acute coronary syndromes undergoing percutaneous coronary intervention. These findings support the clinical application of the Logistic Clinical SYNTAX score.

We sought to evaluate the association between C-reactive protein (CRP) sampled on admission and short- and long-term mortality in patients with acute coronary syndromes (ACS) undergoing early invasive treatment. Baseline levels of CRP were determined in 2,974 patients with moderate and high-risk ACS undergoing an early invasive treatment strategy in the large-scale randomized ACUITY trial. The relationship of CRP to 30-day and 1-year clinical outcomes were assessed according to quartiles of CRP values. Patients with CRP levels in the fourth quartile compared to the first quartile had significantly higher 30-day mortality (2.3 vs. 0.3%, P = 0.0004) and 1-year mortality (5.5 vs. 2.8%, P = 0.0003). CRP level as a continuous variable was associated with 30-day mortality (OR [95% CI] for one unit increase in logarithmically transformed CRP level = 1.42 [1.08-1.89], P = 0.01) and 1-year mortality (OR [95% CI] = 1.24, [1.04-1.47], P = 0.02). By multivariable analysis, higher baseline CRP levels independently predicted 30-day and 1-year mortality, a relationship that was particularly strong for patients with the highest quartile of CRP (OR [95% CI] = 5.19 [1.14-23.68], P = 0.009). In troponin-positive patients, increasing quartiles of CRP were associated with a trend for 30-day mortality (P trend = 0.08) and a significant increase in 1-year mortality (P trend = 0.02); this relationship was not present in troponin-negative patients. Baseline CRP level is a powerful independent predictor of both early and late mortality in patients with ACS being treated with an early invasive strategy, especially in troponin positive patients. © 2010 Springer Science+Business Media, LLC.

First-generation drug-eluting stents (DES), which impart the controlled release of sirolimus or paclitaxel from durable polymers to the vessel wall, have been consistently shown to reduce the risk of restenosis and target vessel revascularization compared with bare metal stents (BMS). However, stent thrombosis (ST) emerged as a major safety concern with first-generation DES early after their adoption in clinical practice, requiring prolonged dual antiplatelet therapy. Pathological studies have shown that first-generation DES are associated with delayed arterial healing and polymer hypersensitivity reactions resulting in chronic inflammation, predisposing to late and very late ST. Second-generation DES have been developed to overcome these issues with improved stent designs and construction and the use of biocompatible and bioabsorbable polymers. Meta-analyses have shown that the thin-strut, fluoropolymer-coated cobalt-chromium everolimus-eluting stent (CoCr-EES) may be associated with lower rates of definite ST than other DES and, unexpectedly, even lower than BMS. The thin-strut structure of the stent platform, the thromboresistant properties of the fluoropolymer, and the reduced polymer and drug load may contribute to the low rate of ST with CoCr-EES. The notion of DES being safer than BMS represents a paradigm shift in the evolution of percutaneous coronary intervention. The relative safety and efficacy of fluoropolymer-coated CoCr-EES, DES with bioabsorbable polymers, and fully bioresorbable scaffolds are the subject of numerous ongoing large-scale trials.

ObjectivesThe purpose of this study was to quantify the extent and complexity of residual coronary stenoses following percutaneous coronary intervention (PCI) and to evaluate its impact on adverse ischemic outcomes.BackgroundIncomplete revascularization (IR) after PCI is common, and most studies have suggested that IR is associated with a worse prognosis compared with complete revascularization (CR). However, formal quantification of the extent and complexity of residual atherosclerosis after PCI has not been performed.MethodsThe baseline Synergy Between PCI With Taxus and Cardiac Surgery (SYNTAX) score (bSS) from 2,686 angiograms from patients with moderate- and high-risk acute coronary syndrome (ACS) undergoing PCI enrolled in the prospective ACUITY (Acute Catheterization and Urgent Intervention Triage Strategy) trial was determined. The SS after PCI was also assessed, generating the “residual” SS (rSS). Patients with rSS >0 were defined as having IR and were stratified by rSS tertiles, and their outcomes were compared to the CR group.ResultsThe bSS was 12.8 ± 6.7, and after PCI the rSS was 5.6 ± 2.2. Following PCI, 1,084 patients (40.4%) had rSS = 0 (CR), 523 (19.5%) had rSS >0 but ≤2, 578 (21.5%) had rSS >2 but ≤8, and 501 patients (18.7%) had rSS >8. Age, insulin-treated diabetes, hypertension, smoking, elevated biomarkers or ST-segment deviation, and lower ejection fraction were more frequent in patients with IR compared with CR. The 30-day and 1-year rates of ischemic events were significantly higher in the IR group compared with the CR group, especially those with high rSS. By multivariable analysis, rSS was a strong independent predictor of all ischemic outcomes at 1 year, including all-cause mortality (hazard ratio: 1.05, 95% confidence interval: 1.02 to 1.09, p = 0.006).ConclusionsThe rSS is useful to quantify and risk-stratify the degree and complexity of residual stenosis after PCI. Specifically, rSS >8.0 after PCI in patients with moderate- and high-risk ACS is associated with a poor 30-day and 1-year prognosis. (Comparison of Angiomax Versus Heparin in Acute Coronary Syndromes; NCT00093158)

We prospectively investigated whether plasma homocysteine (HCY) concentrations are related to target lesion revascularization (TLR) rates in patients with unstable angina undergoing stenting.We enrolled 196 consecutive patients with at least one successful coronary stent implantation for unstable angina.The mean vessel diameter was 3.1 +/- 0.5 mm. At follow-up (17.8 +/- 7.5 months), patients with higher HCY levels (17 micromol/l, 4th quartile) had similar TLR rates to the rest of the sample (11.1 vs 13.2%, p = 0.90). On the other hand, high HCY levels did seem to be associated with higher total (13.3 vs 0.7%, p = 0.001) and cardiac (6.7 vs 0%, p = 0.01) mortality rates. At multivariate analysis, only target vessel diameter independently predicted TLR, while both HCY levels and target vessel size predicted late total mortality.At least in patients with a mean vessel diameter3 mm, HCY levels cannot be taken as a prognostic indicator of in-stent restenosis for patients with unstable angina. However, in spite of successful percutaneous revascularization, HCY values do seem to strongly influence late mortality.

This report describes 2 cases of aortic valvuloplasty performed as emergency treatment in patients with critical aortic stenosis presenting with cardiogenic shock. This procedure can be life-saving, and allows the patients to undergo further evaluation for aortic valve replacement, or other definitive treatments such as the recently developed percutaneous heart valve implantation for patients with unacceptably high surgical risk.

AIMS: To investigate gender difference in mortality among patients with ST-segment elevation myocardial infarction (STEMI) treated with primary percutaneous angioplasty (PPCI). METHODS: We analyzed data from the prospective registries of two hub PPCI centres over a 10-year period to assess the role of female gender as an independent predictor of both all-cause and cardiac death at 30 days and 1 year. To account for all confounding variables, a propensity score (PS)-adjusted multivariable Cox regression model and a PS-matched comparison between the male and female were used. RESULTS: Among 4370 consecutive STEMI patients treated with PPCI at participating centres, 1188 (27.2%) were women. The survival rate at 30 days and 1 year were significantly lower in women (Log-rank P-value

Background Incidence and long-term clinical consequences of prosthesis-patient mismatch (PPM) after transcatheter aortic valve replacement (TAVR) are still unclear. Methods We enrolled 710 consecutive patients who underwent TAVR. PPM was defined as absent if the index orifice area (iEOA) was >0.85 cm2/m2, moderate if the iEOA was between 0.65 and 0.85 cm2/m2 or severe if the iEOA was Results Among the 566 patients fulfilling the study criteria, the distribution of PPM was as follows: 50.5% none (n = 286), 43% moderate PPM (n = 243) and 6.5% severe PPM (n = 37). At 5-year follow-up, patients with severe PPM had a significantly higher incidence of the combined endpoint of cardiovascular death, acute myocardial infarction and stroke (p = .025) compared with the other patients. After adjusting the results for possible confounders, severe PPM remained an independent predictor of long-term adverse outcome (HR: 2.46; 95% Confidence Interval: 1.10–5.53). The independent predictors of severe PPM were valve-in-valve procedure and body mass index. Balloon-expandable valves were not associated with higher rates of severe PPM in comparison with self-expandable valves (8% vs. 5%, respectively, p = .245). Conclusions In our study severe PPM emerged as a risk factor for long-term major adverse cardiac and cerebrovascular events.

This study sought to investigate the impact of elective, uncomplicated target lesion revascularization (TLR) on long-term cardiac mortality after percutaneous coronary intervention (PCI) of unprotected left main coronary artery (ULMCA) disease. Consecutive patients undergoing PCI for ULMCA disease between January 2003 and December 2015 in 1 interventional center in Northern Italy were included. Patients presenting with cardiogenic shock, ST-segment elevation myocardial infarction (MI), as well as those undergoing urgent or complicated TLR were excluded. The primary endpoint of the study was cardiac mortality. Among the 418 patients fulfilling the study criteria, 79 (18.46%) underwent elective, uncomplicated TLR. After a median follow-up of 5.5 years, there were 23 cardiac deaths among patients undergoing elective, uncomplicated TLR versus 50 in patients not undergoing TLR. After adjusting for possible confounders, TLR was an independent predictor of cardiac mortality (Hazard ratio [HZ] = 1.92, 95% confidence interval [CI]: 1.05 to 3.49; p = 0.03). Patients undergoing TLR had also significantly higher rates of the composite of cardiac death, MI and stroke compared with the no TLR group (adjusted HR = 1.76, 95% CI 1.14 to 2.72). In conclusion, elective, uncomplicated TLR after PCI of ULMCA disease is associated with increased risk of long-term cardiac mortality. Reducing the risk of TLR after PCI of ULMCA disease may potentially improve the survival of these patients.

Background To assess whether coronary bypass (CABG) or stenting reduce the risk of mortality and myocardial infarction (MI) compared with optimal medical therapy (OMT) in stable coronary artery disease (CAD). Methods We performed a systematic review and network meta-analysis of contemporary randomized controlled trials comparing OMT, CABG and different stent types in stable CAD. All-comer trials were included if the rate of patients with acute myocardial infarction (AMI) was≤20%. Endpoints were all-cause mortality and MI. Results Ninety-seven trials including 75,754 patients were analyzed at a weighted mean follow up of 42.5 months. Compared to OMT, CABG was associated with a lower risk of death (OR = 0.84; 95%CI:0.71–0.97). After exclusion of trials in left main and/or multivessel disease(LM/MVD) this benefit was not statistically significant (OR = 0.89; 95%CI:0.74–1.06). CABG was associated with a lower risk of MI (OR = 0.67;95%CI: 0.49–0.91) showing, however, a certain degree of inconsistency (p=0.10). None of the stent types included was associated with a lower risk of death. However, durable-polymer-CoCr-everolimus-eluting stent, by mixed evidence, after exclusion of either LM/MVD (OR = 0.73;95%CI: 0.54–0.98) or all-comer/post-MI trials (OR = 0.62;95%CI:0.39–0.98) was associated with a lower risk of MI than OMT. Similar findings, by indirect evidence, were confirmed for bio-absorbable-polymer-CoCr-sirolimus eluting stent (LMV/MVD trials excluded OR = 0.46; 95%CI = 0.29–0.74, all-comer/post-MI trials excluded: OR = 0.41;95%CI:0.22–0.79). Conclusions In stable CAD, CABG reduces the risk of mortality and MI compared to OMT, especially in patients with higher extent of CAD. Our study suggests that some of second and latest-generation drug-eluting stents may reduce the risk of MI. Future research should confirm these latter findings.