Search

OBJECTIVES To evaluate the effectiveness of anticoagulant therapies in patients with clinical transcatheter heart valve (THV) thrombosis, to describe complications, and to assess their risk profile was the objectives. BACKGROUND Little research has been conducted on clinical THV thrombosis. METHODS Patients with clinical THV thrombosis were identified based on greater than 50% increased transvalvular gradient on transthoracic echocardiogram confirmed by 4-dimensional computed tomography, transesophageal echocardiogram, or regression with anticoagulant therapy. A cohort free from thrombosis for more than 1,100 days postprocedure was used for comparison. RESULTS Fifty-four patients with clinical THV thrombosis were identified. Most subjects (98.1%) received anticoagulant therapy which was effective (≥50% reduction in transvalvular gradient or return to postprocedure value) in 96%. The rate of serious hemodynamic or embolic complications in the thrombosis population was 31.5%. A multivariate analysis of subjects with and without thrombosis indicated a significantly increased risk of thrombosis from preexisting thrombocytopenia (odds ratio [OR] 9.96), absence of predilatation (OR = 5.67), renal insufficiency (OR = 4.84), and >10 mmHg mean transvalvular gradient postprocedure (OR = 3.36). No recurrence of thrombosis was identified during on average 685 days follow-up. CONCLUSIONS These data, from one of the largest cohorts with clinical THV thrombosis confirm anticoagulants appear effective. The rate of serious associated complications was high. The findings underline the importance of recognizing risk factors for thrombosis.

Objectives We sought to evaluate the efficacy and safety of bivalirudin versus heparin in patients with coronary artery disease undergoing transradial artery coronary intervention (TRI). Background Bivalirudin and radial artery access are independently associated with improved cardiovascular outcomes. However, data supporting a strategy of combining both to achieve additive improvements in cardiovascular outcomes provide conflicting results. Methods A systematic search was performed to identify randomized controlled trials (RCTs) of bivalirudin, in which vascular access sites were reported. The primary outcome was net adverse clinical events (NACE) at 30 days. Secondary outcomes were long-term NACE, short-, and long-term major adverse cardiovascular events, all-cause mortality, myocardial infarction, unplanned revascularization, stent thrombosis, and major bleeding. Results We identified 10 RCTs, including 16,328 patients who underwent TRI (mean age 64.6 ± 15.7 years, 72.5% male). Bivalirudin use was associated with decreased 30-day NACE compared with heparin (6.3 vs. 7.4%; risk ratio [RR] = 0.87; 95% confidence interval [CI] = 0.76-0.99; p = .04; number needed to treat = 91). No significant interactions were observed based on clinical presentation, administration of P2Y12 inhibitors, or glycoprotein IIb/IIIa-receptor inhibitors (GPI) use. There were no significant differences between groups in any prespecified secondary outcomes. There was, however, a significant reduction of major bleeding in the bivalirudin group compared with heparin when used in combination with routine GPI (RR = 0.41; 95% CI = 0.19-0.90; p = .03). Conclusions Among patients undergoing TRI, use of bivalirudin was associated with significantly reduced 30-day NACE compared with heparin. There was no significant difference in long term NACE, ischemic, or bleeding events compared with heparin.

Objectives We sought to describe the outcomes of BVS use from a single-center experience in which scaffold implantation was guided by intravascular imaging (ultrasound and/or optical coherence tomography) to identify and treat mechanical factors potentially related to BVS failure. Background The Absorb bioresorbable vascular scaffold (BVS) has been associated with an unexpectedly high incidence of thrombosis. Methods Between 11/2014 and 10/2016, 100 patients were treated with BVS. Intravascular imaging assessment before and after BVS implantation was performed in all cases. Results Mean age was 58.1 years; 88% were male, 31% had diabetes, and 28% presented with acute coronary syndromes. A total of 171 lesions in 141 vessels were treated with 190 BVS (mean 1.9 scaffolds/patient). Further intervention following intravascular imaging to optimize BVS implantation was required in 31% of patients. Procedure success was 100%. All patients completed a 1-year follow-up. The 1-year rate of target lesion failure was 4%, and there were no cases (0%) of scaffold thrombosis, myocardial infarction, or death. Conclusions In this real-world experience, the use of intravascular imaging to guide BVS implantation was associated with a high 1-year event-free survival rate, with no scaffold thrombosis.

Background: Patients with acute coronary syndrome (ACS) might represent a specific subgroup, in which bioresorbable scaffold implantation in percutaneous coronary intervention (PCI), might lead to better outcomes when compared to conventional treatment with metallic drug eluting stents. In this prespecified subgroup analysis of the Amsterdam Investigator-Initiated Absorb Strategy All-Comers (AIDA) trial, we evaluated the clinical outcomes of Absorb bioresorbable vascular scaffold (BVS) versus Xience everolimus eluting stent (EES) treated patients presenting either with or without ACS. Methods and results: We classified AIDA patients on the basis of clinical presentation of ACS or of no-ACS. The rate of the 2-year primary endpoint of target vessel failure (TVF) was similar after treatment with Absorb BVS or Xience EES in ACS patients (10.2% versus 9.0% respectively; P = 0.49) and in no-ACS patients (11.7% versus 10.7%, respectively; P = 0.67) Definite or probable device thrombosis occurred more frequently with Absorb BVS compared to Xience EES in ACS patients (4.3% versus 1.7%, respectively, P = 0.03) as well as in no-ACS patients (2.4% versus 0.2%, respectively; P = 0.002). There were no statistically significant interactions between clinical presentation and randomized device modality for TVF (P = 0.80) and for the endpoint of definite or probable device thrombosis (P = 0.17). Conclusion: In the AIDA trial, the 2-year outcomes of PCI with Absorb BVS versus Xience EES were consistent in ACS and no-ACS patients: similar rates for TVF and consistently higher rates of definite or probable stent thrombosis under Absorb BVS versus Xience EES. There were no statistically significant interactions between clinical presentation and randomized device modality.

Aims We compared long-term clinical outcomes between patients treated with Orsiro sirolimus-eluting stent (O-SES) and those treated with durable biocompatible polymer Resolute Integrity zotarolimus-eluting stent (R-ZES). Methods and results The ORIENT trial was a randomized controlled noninferiority trial to compare angiographic outcomes between O-SES and R-ZES. We performed a post hoc analysis of 3-year clinical outcomes and included 372 patients who were prospectively enrolled and randomly assigned to O-SES (n = 250) and R-ZES (n = 122) groups in a 2:1 ratio. The primary endpoint was target lesion failure defined as a composite of cardiac death, nonfatal myocardial infarction, and target lesion revascularization. At 3 years, target lesion failure occurred in 4.7% and 7.8% of O-SES and R-ZES groups, respectively (hazard ratio, 0.58; 95% confidence intervals, 0.24-1.41; p = .232 by log-rank test). Secondary endpoints including cardiac death, myocardial infarction, and target lesion revascularization showed no significant differences between the groups. Stent thrombosis occurred in two patients in R-ZES group (0.0% vs. 1.6%, p = .040). Conclusion This study confirms long-term safety and efficacy of the two stents. We found a trend for lower target lesion failure with O-SES compared to R-ZES, although statistically insignificant.

OBJECTIVES We sought to compare clinical outcomes after percutaneous coronary intervention (PCI) in patients on versus not on hemodialysis (HD) and examine whether high on-treatment platelet reactivity (HPR) further impacts outcomes among patients on HD. BACKGROUND Both chronic kidney disease (CKD) and HPR are predictors of major adverse cardiac events (MACE) after PCI. METHODS Two-year outcomes of patients from the prospective, multicenter ADAPT-DES study (N = 8,582) were analyzed according to HD status at enrollment. All patients underwent platelet function testing with the VerifyNow assay; HPR on clopidogrel was defined as P2Y12 reaction units (PRU) >208. RESULTS Compared with non-HD patients, patients on HD (n = 85) had significantly higher baseline PRU (median 254 vs. 188, p = .001) and more frequently had HPR (61.7% vs. 42.5%, p

In this review, we report a contemporary appraisal of the available evidence focusing on adjunctive antithrombotic therapy and technical aspects of percutaneous coronary interventions (PCI) in patients with acute myocardial infarction and cardiogenic shock (AMICS). Only few randomized trials have been conducted to evaluate the optimal arterial access choice, antithrombotic therapy, stent type, or the role of aspiration thrombectomy in this population. Observational data suggest that a transradial approach should be preferred for experienced operators, although knowledge and experience of transfemoral access is required to place any mechanical support device. In the absence of high-quality evidence to guide choice of the adjunctive antithrombotic drugs to support PCI in patients with AMICS, knowledge of the altered pharmacokinetics and pharmacodynamics in shock is required to inform decisions. Drug-eluting stents should be favored over bare-metal stents, and routine thrombectomy is not encouraged. Owing to the challenges inherent to the conduct of randomized trials in this acutely ill patient population, concerted multicenter, and international efforts are paramount to orchestrate the development of high-quality evidence to guide clinical practice.

Objective This meta-analysis sought to evaluate the outcomes of absorb bioresorbable vascular scaffolds (BVS) compared with second-generation drug-eluting stents (DES) after 3 years, the approximate time of complete polymer bioresorption. Background BVS were found to be inferior to second-generation DES in early and mid-term outcomes with a higher rate of target vessel myocardial infarction (TV-MI) and device thrombosis (DT). Improper implantation techniques and incomplete bioresorption of the poly-l-lactide (PLLA) polymer were sighted as possible reasons. Methods We conducted an electronic database search for all randomized control trials that compared absorb BVS to second-generation DES and reported outcomes of interest after 3 years of absorb BVS implantation. Assuming interstudy heterogeneity, a random-effects analysis was conducted with odds ratio as the effect size of choice to compare the event rates between the two groups. Results A total of four studies (n = 3,245, BVS = 2075, DES = 1,170) were included in the final analysis. Pooled analysis revealed that there was no difference between absorb BVS and second-generation DES with respect to target lesion failure (TLF) (OR = 1.23, 95% CI = 0.73-2.07, p = 0.44), TV-MI (OR = 1.03, 95% CI = 0.42-2.53, p = 0.95), target lesion revascularization (TLR) (OR = 1.61, 95% CI = 0.77-3.33, p = 0.20) and definite/probable DT (OR = 0.71, 95% CI = 0.10-5.07, p = 0.74). Also, there was no difference in cardiac mortality (OR = 0.66, 95% CI = 0.22-1.94, p = 0.45). Conclusions Between 3 and 4 years of follow-up, patients receiving absorb BVS did not have significantly different outcomes, in terms of TLF, TV-MI, TLR, DT, and cardiac mortality, compared to DES.

Objectives We aimed to compare the coronary angioscopic appearance of neointimal coverage (NIC) over durable-polymer everolimus-eluting stents (XIENCE-EES) and bioresorbable-polymer everolimus-eluting stents (SYNERGY-EES) 1 year after implantation. Background XIENCE-EES and SYNERGY-EES have been developed to prevent delayed arterial healing associated with first generation drug-eluting stents. However, the process of arterial healing after XIENCE-EES and SYNERGY-EES implantation has not been clarified. Methods Patients who underwent implantation of XIENCE-EES (n = 20) or SYNERGY-EES (n = 20) were enrolled in this study. Coronary angiography and coronary angioscopy were performed 12 ± 1 months after stent implantation. The NIC over the stent was classified into four grades: grade 0, stent struts fully exposed; grade 1, stent struts bulging into the lumen and, still visible; grade 2, stent struts embedded in neointima but still visible; and grade 3, stent struts fully embedded and invisible. Stents exhibiting more than one NIC grade was defined as heterogeneous. Moreover, presence of thrombi was investigated. Results The distribution of dominant NIC grade (XIENCE-EES: grade 0, 0%; grade 1, 25%; grade 2, 50%; grade 3, 25%; SYNERGY-EES: grade 0, 0%; grade 1, 5%; grade 2, 15%; grade 3, 80%; P = 0.002) and NIC heterogeneity was significantly different (P = 0.004). Thrombi were more frequent in XIENCE-EES than in SYNERGY-EES (40 versus 10%, respectively; P = 0.03). Conclusion Compared with XIENCE-EES, SYNERGY-EES were well covered by neointima and accompanied by fewer thrombi. These findings implied arterial healing of SYNERGY-EES was better than that of XIENCE-EES.

Objectives To assess the efficacy and safety of bivalirudin during percutaneous coronary intervention (PCI) for chronic total occlusion (CTO) in high-bleeding-risk elderly patients. Background Bivalirudin reduces PCI-related bleeding; however, its efficacy and safety in patients with CTO, especially elderly patients with a high bleeding risk, remain unclear. Methods This single-center prospective randomized controlled trial assigned 123 high-bleeding-risk elderly patients with CTO to either the unfractionated heparin (UFH) group (n = 55) or the bivalirudin group (n = 68). The primary efficacy endpoint was the incidence of major adverse cardiac events (MACEs) during hospitalization and at the 6-month follow-up. The safety endpoint was bleeding or procedure (access)-related complications after PCI. Results MACE incidence was 17.6% and 20.0% in the bivalirudin and UFH groups, respectively (P = 0.82). Bleeding Academic Research Consortium (BARC) type 1-2 bleeding events during hospitalization were comparable between the groups (UFH: 10.9% vs. bivalirudin: 8.8%, P = 0.77). No BARC type 3-5 bleeding events or severe procedure (access)-related complications (subcutaneous hematoma >5 cm) occurred in either group. At the 6-month follow-up, MACE incidence was comparable between the groups (UFH: 3.6% vs. bivalirudin: 1.5%, P = 0.59). The Kaplan-Meier analysis revealed that MACE-free survival rates were comparable between the groups (P = 0.43). One case of BARC type 3-5 bleeding (fatal intracranial hemorrhage) was observed in the UFH group at the 6-month follow-up. Conclusions Bivalirudin and UFH showed comparable efficacy and safety in elderly patients with a high bleeding risk, undergoing PCI for CTO lesions.

Objective To evaluate efficacy, safety and feasibility of targeted intracoronary injection using pro-urokinase combined with anisodamine (TCA) versus thrombus aspiration (TA) in ST-elevation myocardial infarction (STEMI) patients with high thrombus loads. Background The best method of avoiding thrombus detachment and stroke in PCI patients with high thrombus loads has not yet been established. Methods STEMI patients receiving coronary artery angiography or percutaneous coronary intervention (CAG/PCI) with thrombus grade ≥ 3 from January 1, 2017 to June 30, 2018 were randomly assigned to targeted intracoronary thrombolysis (pro-urokinase and anisodamine via catheter (TCA) group), or the TA group which followed the standard thrombus aspiration procedure. Parameters compared included thrombus grade, index of microcirculatory resistance (IMR), postoperative myocardial SPECT, thrombosis in myocardial infarction (TIMI) scores including flow grade, corrected TIMI frame counts (CTFCs), and TIMI myocardial perfusion grade (TMPG). Adverse events were followed up within 3 months. Results Thirty-nine patients were finally enrolled. In primary CAG/PCI, the TCA group had higher percentages of TIMI 3 flow and lower IMR values compared with the TA group. The ratio of TMPG 3 grade in the TCA group was higher in repeat CAG, and the perfusion descending area (PDA) presented by SPECT was lower than in the TA group. No significant difference was seen in major adverse coronary events (MACEs) or bleeding events at follow-up. Conclusions TCA appears to be effective, safe, and feasible for repatency and reduction of high thrombus burden in primary PCI and may protect myocardial microcirculation with improved outcomes.

An infant with hypoplastic left heart syndrome (HLHS) presented with complete heart block and severe myocardial dysfunction requiring ECMO support due to complete left main coronary artery (LMCA) thrombosis. Current guidelines for managing coronary artery thrombosis in infants with single ventricle physiology are inadequate. We describe successful LMCA and branch recanalization via intra coronary infusion of recombinant tissue plasminogen activator and discuss management of acute coronary thrombosis in children with single ventricle physiology.

Objective We evaluated 1-year outcomes after platinum chromium everolimus-eluting stents (PtCr-EES) in small versus non-small coronary arteries within a large, diverse sample of men, women, and minorities. Background There exists limited outcomes data on the use of second-generation drug-eluting stent to treat small diameter coronary arteries. Methods We pooled patients from the PLATINUM Diversity and PROMUS Element Plus stent registries. Small-vessel percutaneous coronary intervention (SV-PCI) was defined as ≥1 target lesion with reference vessel diameter (RVD) ≤2.5 mm. Endpoints included major adverse cardiac event (MACE; death, myocardial infarction [MI] or target vessel revascularization [TVR]), target vessel failure (TVF; death related to the target vessel, target vessel MI or TVR) and definite/probable stent thrombosis (ST). Multivariable Cox regression was used to risk-adjust outcomes. Results We included 4,155/4,182 (99%) patients with available RVD, of which 1,607 (39%) underwent small-vessel PCI. SV-PCI was not associated with increased MACE (adjHR 1.02; 95%CI 0.81-1.30) or TVF (adjHR 1.07; 95%CI 0.82-1.39). MI risk was lower in white men compared to women and minorities, both in the setting of SV-PCI (adjHR 0.41; 95%CI 0.23-0.74 and adjHR 0.39; 95%CI 0.20-0.75, respectively) and for non-SV-PCI (adjHR 0.61; 95%CI 0.38-0.99 and adjHR 0.45; 95%CI 0.27-0.74, respectively). There was no significant interaction between RVD and sex or minority status for any endpoint. Conclusion In a large diverse contemporary PCI outcomes database, SV-PCI with PtCr-EES was not associated with increased MACE or TVR and did not account for the increased MI risk noted in women and minorities compared to white men.

This is a case report of a 60‐year‐old male, without any cardiovascular risk factor and no cardiac history admitted to hospital with a diagnosis of interstitial pneumonia caused by coronavirus disease 2019 (COVID‐19). After 7 days, the blood tests showed a significant rise of inflammatory and procoagulant markers, along with a relevant elevation of high‐sensitivity Troponin I. Electrocardiogram and transthoracic echocardiogram (TTE) were consistent with a diagnosis of infero‐posterolateral acute myocardial infarction and the patient was transferred to the isolated Cath Lab for primary percutaneous coronary intervention (PCI). The angiography showed an acute massive thrombosis of a dominant right coronary artery without clear evidence of atherosclerosis. Despite the optimal pharmacological therapies and different PCI techniques, the final TIMI flow was 0/1 and after 3 hr the clinical condition evolved in cardiac arrest for pulseless electric activity. Acute coronary syndrome–ST‐elevation myocardial infarction is a relevant complication of COVID‐19. Due to high levels of proinflammatory mediators, diffuse coronary thrombosis could occur even in patients without cardiac history or comorbidities. This clinical case suggests that coronary thrombosis in COVID‐19 patients may be unresponsive to optimal pharmacological (GP IIb–IIIa infusion) and mechanical treatment (PCI).

We describe a case in which a 29‐year‐old male with no medical history presented with ST‐segment elevation myocardial infarction as his presentation of coronavirus disease. During cardiac catheterization, he was found to have total occlusion of his left anterior descending artery by thrombus. Laboratory testing revealed markedly elevated inflammatory markers as well as evidence of a hypercoagulable state in the setting of severe acute respiratory syndrome coronavirus 2 infection, which was suspected to be the inciting factor for his acute coronary event.

COVID‐19 is a new viral infection that has a significant impact on global health and economy. Because of its rapid spread worldwide, it may influence the prognosis of other medical conditions, such as ST‐segment elevation myocardial infarction (STEMI). We report a case of a 58‐year female patient admitted with an infero‐posterior STEMI on the background of recently positive COVID‐19 swab. Reperfusion was attempted through primary PCI but unfortunately failed to restore coronary blood flow due to massive thrombotic burden despite several attempts of balloon dilatation and aspiration thrombectomy. She sadly died later on because of hemodynamic deterioration. This scenario raises concerns about Neutrophil Extracellular Traps (NETS) which might potentially have propagated inflammation and thrombosis via platelets' aggregation leading to enhanced coagulopathy and massive coronary thrombosis. Therefore, we suggest primary PCI as the first‐choice of revascularization in patients with combined COVID‐19 and STEMI. Additionally, we emphasize on the importance of using the potent new generation P2Y12 inhibitors along with GPIIb/IIIa inhibitors in every STEMI patient with COVID‐19 to achieve favorable conditions for primary PCI as well as favorable outcomes after stent implantation.

A patient with coronavirus disease 19 (COVID‐19) developed acute myocardial infarction (AMI) complicated by extensive coronary thrombosis and cardiogenic shock. She underwent percutaneous coronary intervention and placement of a mechanical circulatory support device but subsequently died from shock. This report illustrates the challenges in managing patients with COVID‐19, AMI, and cardiogenic shock.

Important health resources are dedicated worldwide to the management of COVID‐19. This new disease, due to its large diffusion, may significantly hamper the prognosis of other pathologies, such as ST‐segment elevation myocardial infarction (STEMI) because of (a) a possible direct negative impact and (b) shortage of first response medical resources and increased delays to reperfusion. We report the case of a 68‐year‐old man admitted for anterior STEMI and asymptomatic COVID‐19. Due to extended transportation delays to a cathlab, he received intravenous fibrinolytic therapy, which failed. Reperfusion was achieved with rescue coronary angioplasty, but the patient experienced two episodes of acute stent thrombosis at 2‐ and 36‐hr following admission and despite optimal medical therapy. He finally died because of cardiogenic shock. This raises concerns about a possible increase in platelet aggregability associated with COVID‐19 leading to an increased risk of stent thrombosis, particularly in the context of STEMI. This pleads for the promotion of primary coronary angioplasty as the first‐choice revascularization technique in this population and the use of new generation P2Y12 inhibitors. In addition, the use of GPIIb/IIIa inhibitors may be considered in every STEMI patient with COVID‐19 to prevent the risk of acute stent thrombosis.

Background: The bio-engineered COMBO stent (OrbusNeich Medical BV, The Netherlands) is a dual-therapy pro-healing stent. This novel technology may allow a shorter duration of dual antiplatelet therapy (DAPT) after stenting. We present the first 3 year clinical outcomes of patients treated with COMBO stent. Methods and results: The prospective, multicenter, investigator-initiated, all-comers REMEDEE Registry evaluates clinical outcomes after COMBO stent treatment. A 1,000 patients were enrolled between June 2013 and March 2014. Patients had a mean of 65 years ±11, 26% of the patients were females and 18% diabetics. More than 50% of patients presented with acute coronary syndrome, 60% of treated lesions were AHA/ACC lesion type B2 or C. Target lesion failure (TLF) at 3 year follow-up occurred in 10.7% of patients (N = 105). The separate components cardiac death, target vessel myocardial infarction and target lesion revascularization occurred in 4.1%, 2.0%, and 7.1%, respectively of patients. Definite stent thrombosis (ST) was observed in 0.7% of all patients. At 3-year follow-up there were only 73 patients taking DAPT. Conclusions: At 3-year follow-up, patients treated with COMBO stent in the present large prospective all-comers cohort, continue to show good clinical outcomes. Clinicaltrials.gov identifier: NCT01874002. Condensed abstract: The COMBO stent is a sirolimus-eluting stent with a luminal anti-CD34-antibody layer, that binds endothelial progenitor cells. These cells can differentiate to endothelial cells and stimulate early endothelialization of the stent. The REMEDEE Registry is the first large, multicenter, prospective, cohort study evaluating the clinical outcomes of 1,000 all-comers patients treated with COMBO stent. Target lesion failure at 3 year follow-up was 10.7% and the rate of definite ST was 0.7%.

OBJECTIVES To evaluate the effect of prior stroke on long-term outcomes in patients undergoing percutaneous coronary interventions (PCI). BACKGROUND Patients with coronary heart disease (CHD) and prior stroke history have more serious clinical and angiographic conditions, which make the choice of treatment strategy complex. METHODS A total of 10,724 consecutive patients who underwent PCI from January 2013 to December 2013 were enrolled. 2-Year clinical outcomes between patients with prior stroke (n = 1150) and those with no prior stroke (n =9574) were compared. RESULTS The proportion of patients with prior stroke was 10.72%. These patients had higher clinical risks (age, sex, and cardiovascular risk factors) and more extensive coronary disease (higher pre-PCI and residual SYNTAX scores). During the 2-year follow-up, patients with prior stroke had a higher incidence of major adverse cardiac and cerebrovascular events (MACCE), all-cause death, stent thrombosis and stroke than those without prior stroke (14.3% vs. 11.8%, p = 0.02; 2.3% vs. 1.1%, p

Objectives The goal of this analysis was to evaluate the final 5-year safety and effectiveness of the PROMUS Element platinum-chromium everolimus-eluting stent in unselected patients treated in routine clinical practice. Background The prospective, open-label PROMUS Element™ European Post-Approval Surveillance Study (PE-PROVE) enrolled 1,010 "real-world" patients who received the PROMUS Element stent. Adverse event rates were low at 1-year, and the incidence of stent thrombosis was 0.6%. Methods The primary endpoint was target vessel failure (TVF; overall and PE stent-related), a composite of cardiac death, myocardial infarction (MI) related to the target vessel, or target vessel revascularization (TVR) at 1-year post-implantation. Five-year clinical outcomes were evaluated in overall as well as high-risk patient subgroups. Results The overall 5-year TVF rate was 14.9%, with 7.0% being related to the study stent. Cardiac death, MI and TVR related to the study stent occurred in 0.5%, 3.2%, and 5.7%, respectively. Stent thrombosis through 5-year follow-up was 1.0%. The rates of overall and study stent related TVF were numerically higher in patients with medically treated diabetes, long lesions (≥28 mm), and small diameter vessels (≤2.5 mm) compared to the overall study population. Additionally, favorable stent thrombosis rates through 5 years were reported for the PROMUS Element stent in these high-risk subgroups. Conclusions The final 5-year data from the PE-PROVE study demonstrate favorable outcomes and low rates of adverse events with the PE stent when used in "real-world" patients with coronary artery disease.

Background There is still limited data on the very long term clinical outcomes after ABSORB BRS in daily practice. We sought to evaluate the 3 year-performance of the Absorb bioresorbable vascular scaffolds for the treatment of low/moderate complexity patients enrolled in the ABSORB EXTEND trial. Methods ABSORB EXTEND is a prospective, single-arm, open-label clinical study in which 812 patients were enrolled at 56 sites. This study allowed the treatment of lesions ≤28 mm in length and reference vessel diameter of 2.0-3.8 mm (as assessed by on-line QCA). To determine the independent predictors of MACE, a multivariable logistic regression model was built using a stepwise (forward/backward) procedure. Results Average population age was 61 years and 26.5% had diabetes. Most patients had single target lesion (92.4%). Adequate scaffold deployment (PSP) was achieved in 14.2% of the cases. At three years, the composite endpoints of MACE and ischemia-driven target vessel failure were 9.2% and 10.6%, respectively. The cumulative rate of ARC definite/probable thrombosis was 2.2%, with 1.2% of the cases occurring after the 1st year. Independent predictors of MACE were hypertension and the need for "bail out" stent. Conclusion At three-year follow-up, the use of ABSORB in low/moderate complex PCI was associated with low and acceptable rates of major adverse clinical events, despite the infrequent use of the recommended contemporary scaffold deployment technique. However, scaffold thrombosis rate was higher than reported with current generation of metallic DES. The study is registered on clinicaltrials.gov (unique identifier NCT01023789).

Background In the randomized AMIHOT-II trial, supersaturated oxygen [SSO2 ] delivered into the left anterior descending (LAD) artery via an indwelling intracoronary infusion catheter following primary percutaneous coronary intervention (PCI) significantly reduced infarct size in patients with anterior ST-segment elevation myocardial infarction (STEMI) but resulted in a numerically higher incidence of safety events. Objectives The IC-HOT study evaluated the safety of SSO2 therapy selectively delivered to the left main coronary artery (LMCA) for 60 minutes after PCI in patients with anterior STEMI. Methods SSO2 therapy was administered to the LMCA after stent implantation in 100 patients with anterior STEMI and proximal or mid-LAD occlusion presenting within 6 hours of symptom onset. The primary endpoint was the 30-day composite rate of net adverse clinical events (NACE) (death, reinfarction, clinically driven target vessel revascularization, stent thrombosis, severe heart failure, or TIMI major/minor bleeding) compared against an objective performance goal of 10.7%. Cardiac magnetic resonance imaging was performed at 4 and 30 days to assess infarct size. Results SSO2 delivery was successful in 98% of patients. NACE at 30 days occurred 7.1% of patients (meeting the primary safety endpoint of the study); there were no deaths, only one stent thrombosis and one case of severe heart failure. Median [interquartile range] infarct size was 24.1% [14.4%, 31.6%] at 4 days and 19.4% [8.8%, 28.9%] at 30 days. Conclusion Following primary PCI in acute anterior STEMI, infusion of SSO2 via the LMCA was feasible and was associated with a favorable early safety profile.

Aims: Long-term comparisons between Drug-eluting stent and bare metal stent are not well-studied. The aim of this study was to compare two stents that were previously frequently used in regard to long-term risk of restenosis and stent thrombosis (ST). Methods and results: We used data from the SCAAR registry. Consecutive procedures performed between 2004 and 2014 for stable angina, UA/NSTEMI and STEMI were included. We compared two different stents: Cordis Cypher Select (C-CS), and Boston Scientific Liberte (BS-L), modeling data with multilevel Cox proportional-hazards regression. The primary endpoint was time to first occurrence of either ST or restenosis. During the study period 2210 C-CS and 6941 B-SL were implanted in 5,314 patients. Mean follow-up time was 2,288 days for C-CS and 2,297 days for BS-L. Treatment with C-CS was associated with lower risk for restenosis or ST up to one year from index procedure (HR 0.41; 95% CI 0.32-0.52; P

BACKGROUND Despite improvements in percutaneous coronary intervention (PCI), intraprocedural thrombotic events (IPTE) and bleeding complications occur and are prognostically important. These have not been included in prior economic studies. METHODS PHOENIX ECONOMICS was a substudy of the CHAMPION PHOENIX trial, evaluating cangrelor during PCI. Hospital bills were reviewed from 1,171 patients enrolled at 22 of 63 US sites. Costs were estimated using standard methods including resource-based accounting, hospital billing data, and the Medicare fee schedule. Bleeding and IPTE, defined as abrupt vessel closure (transient or sustained), new/suspected thrombus, new clot on wire/catheter, no reflow, side-branch occlusion, procedural stent thrombosis or urgent need for CABG were identified. Costs were calculated according to whether a complication occurred and type of event. Multivariate analyses were used to estimate the incremental costs of IPTE and postprocedural events. RESULTS IPTE occurred in 4.3% and were associated with higher catheterization laboratory and overall index hospitalization costs by $2,734 (95%CI $1,117, $4,351; P = 0.001) and $6,354 (95% CI $4,122, $8,586; P

BACKGROUND Patients with small vessel disease (SVD) are at higher risk of adverse events after PCI compared to non-SVD patients. In this subset, the use of bioresorbable vascular scaffolds (BVS) has raised particular concern. OBJECTIVE We aimed to compare outcomes of Absorb BVS versus a 2nd-generation metallic everolimus-eluting stents (EES) in the SVD setting, by pooling patients from three large, prospective studies. METHODS Patients with SVD (reference vessel diameter ≤2.75 mm by QCA) and treated with Absorb BVS were identified in the Italian RAI and the MAASSTAD-Absorb registries. EES controls were identified in the COMPARE II Trial. We performed a propensity-score matching using several clinical and angiographic variables. Implantation technique was not object of matching, being device-specific. RESULTS Out of 4635 enrolled subjects, 1147 belonged to the SVD population. After matching, we obtained 337 pairs of patients. High clinical and angiographic complexity was found in both groups. Predilation and postdilation rates were significantly higher in BVS patients. No differences were found in terms of the device-oriented composite end-point at 1-year (HR = 1.08, 95%CI 0.5-2.3, P = .8) and 2-years (HR = 1.28, 95% CI: 0.68-2.43, P = .5). Notwithstanding, higher incidence of definite/probable stent thrombosis was observed in the BVS group at 1 year (HR 4.7, 95%CI 0.8-31.4, P = .08) and 2-years (HR = 8.34 95%CI 1.1-60.2, P = .04). CONCLUSION In this propensity-matched analysis pooling SVD patients of three large prospective studies, incidence of composite device-related events was comparable between BVS and EES up to 2 years follow-up. However, higher rates of stent thrombosis were found in the BVS group.

Objectives We aimed to assess the prognostic ability of the ST score, DAPT score, and PARIS score in a Chinese population. Background Recently, several risk scores predicting the long-term risk of coronary thrombotic events [CTE, defined as the composite of definite or probable stent thrombosis (ST) and myocardial infarction] and bleeding have been developed and initially validated in Western populations. Methods A total of 6,088 consecutive patients with acute coronary syndrome (mean age 58.3 ± 10.4; women 23.1%) treated with drug-eluting stents in 2013 at our single institution were enrolled. We calculated risk scores and evaluated their performance for predicting definite or probable ST, CTE and major bleeding (MB, defined as the occurrence of a Bleeding Academic Research Consortium type 3 or 5 bleed). The prognostic value of risk scores was assessed by receiver-operating characteristic curves. Results The ST score, DAPT score, and PARIS score all showed unsatisfactory discrimination to predict 2-year or 1- to 2-year ST and CTE (c-statistic = 0.51-0.59). With respect to bleeding outcomes, the PARIS score showed unsatisfactory discrimination in predicting 2-year MB (c-statistic = 0.56); the DAPT score performed slightly better than the PARIS score in predicting occurrence of later MB events between 1 and 2 years, whereas its discriminative capacity was only modest (c-statistic = 0.71). Conclusions The current three risk scores, derived and initially validated in Western populations, may not be applicable to the Chinese population, although DAPT score was determined to be a modestly accurate quantitative tool for prediction of later MB.

Objectives We aimed to compare the long-term outcomes of the novel biodegradable polymer cobalt-chromium sirolimus-eluting stent (BP-SES) versus the durable polymer sirolimus-eluting stent (DP-SES) in the I-LOVE-IT2 trial. Backgrounds Comparisons of the long-term safety and efficiency of the BP-DES versus the DP-DES are limited. Methods A total of 2,737 patients eligible for coronary stenting were randomized to the BP-SES or DP-SES group at a 2:1 ratio. The primary endpoint of target lesion failure (TLF) was defined as a composite of cardiac death, target vessel myocardial infarction (MI), or clinically indicated target lesion revascularization. Results A three-year clinical follow-up period was available for 2,663 (97.3%) patients. There were no significant differences in TLF (8.9% vs. 8.6%, P = 0.81), patient-oriented composite endpoint (PoCE) (15.2% vs.14.5%, P = 0.63), or individual components between the BP-SES and DP-SES. Definite/probable stent thrombosis (ST) was low and similar at 3 years (0.8% vs. 1.0%, P = 0.64). Landmark analysis of 1-3 years showed that the TLF (2.7% vs. 2.6%, P = 0.81), PoCE (6.2% vs. 5.1%, P = 0.28), and definite/probable ST (0.4% vs. 0.4%, P = 1.00) were comparable between the 2 arms. Conclusions In this prospective randomized trial, the BP-SES showed similar clinical results versus the DP-SES in terms of safety and efficacy outcomes over a 3-year follow-up period.

Background Bifurcation percutaneous coronary intervention (PCI) is a challenging procedure, but there are currently inadequate data about definite stent thrombosis (ST) rates of single-stent versus double-stent strategies (SS and DS, respectively). Methods and results Randomized clinical trials (RCTs) comparing SS and DS strategies were searched through PubMed, Embase, and the Cochrane Central Register of Controlled Trials. Fourteen RCTs involving 3,107 patients were analyzed. Owing to the high crossover rate (16.49%), both intention-to-treat (ITT) and as-treated (AT) analyses were performed. In the ITT population, there was a significantly lower rate of early definite ST in the SS group (0.26%; DS group 1.14%; P = 0.021). Similarly, in the AT population, there was a significantly lower rate of early definite ST in the SS group (0.23%, DS group 1.07%; P = 0.042). True bifurcation subgroup analysis also showed a significantly lower early definite ST in the SS group (OR = 0.36, 95% CI = 0.15-0.86, P = 0.042) in the ITT population. There was no significant difference of overall, acute, subacute, and late definite ST between the 2 groups. Conclusions Early definite ST is reduced when a SS strategy is used in bifurcation lesions.

Objectives This study aimed at assessing the performance of a new generation polymer-free biolimus-eluting stent (BES) in real-world patients with ST-segment elevation myocardial infarction (STEMI). Background Polymers components of early-generation drug-eluting stents have been implicated in the pathogenesis of delayed arterial healing, vessel remodeling, and delayed stent thrombosis. Recently, a novel polymer-free BES has shown excellent clinical performance in clinical trial setting. Methods Overall, 175 consecutive patients (64 ± 14 years, 141 men) treated with the BioFreedom (Biosensors Europe, Morges, Switzerland) polymer-free BES because of STEMI were included in this study. The primary endpoint was the rate of major adverse cardiac events (MACE), a composite of cardiac death, recurrent myocardial infarction, and ischemia-driven target vessel revascularization at 1 year follow-up. A subgroup of patients underwent 6-month angiographic follow-up. Dual antiplatelet therapy was prescribed for 12 months after STEMI. Results At 1 year, the cumulative rate of MACE was 4.6%. One patient (0.6%) had an arrhythmic cardiac death and five (2.9%) had ischemia-driven target vessel revascularization, although only three (1.7%) had target lesion revascularization. Two (1.1%) patients had acute stent thrombosis yielding nonfatal myocardial infarction. In 70 patients (63 ± 14 years, 61 men), quantitative coronary angiography at 6-month follow-up revealed diameter stenosis of 24.1 ± 13.7% and minimal lumen diameter of 2.29 ± 0.56 mm, yielding a late lumen loss of 0.13 ± 0.14 mm. Conclusions In real-world setting, implantation of a new-generation polymer-free BES during STEMI is associated with favorable clinical and angiographic results, pointing toward the overall efficacy and safety of the device in complex clinical scenarios.

Background Bivalirudin has been reported to be an alternative to unfractionated heparin (UFH) for anticoagulation during percutaneous coronary intervention (PCI) and associated with less bleeding risk. However, the feasibility of bivalirudin during PCI of chronic total occlusion lesions (CTO) remains unknown. Objective To evaluate the efficacy and safety of bivalirudin versus UFH in CTO PCI. Methods: In this prospective and randomized controlled trial in single center, CTO patients with high bleeding risk were randomized to treatment with bivalirudin (bolus 0.75 mg/kg followed by infusion of 1.75, extra bolus 0.3 mg/kg before stenting) or UFH (100 IU/kg). The primary efficacy end point was the incidence of major adverse cardiac events (MACEs, composite of all-cause mortality, cardiac death, stent thrombosis, periprocedural myocardial infarction, or additional unplanned target lesion revascularization, or any other post-PCI ischemic event) in-hospital, and at 1-year follow-up. The primary safety end point was the occurrence of any bleeding or entry-site complications after PCI. Results A total of 84 high bleeding risk patients undergoing PCI for CTO lesions were enrolled. The baseline characteristics were similar in both treatment arms. In hospital MACEs rates were 21.4% in the bivalirudin group and 14.3% in the UFH group (P = 0.393). During 1-year's follow-up, end points did not significantly differ between the groups either. Occurrence of the major bleeding events were 4.8% in the bivalirudin group and 9.5% in the UFH group (P = 0.676). No entry-site complication was observed. Conclusion In CTO patients at high risk for bleeding undergoing PCI, our data indicates that bivalirudin appears to be at least comparable in efficacy and safety to UFH. A larger clinical trial should be designed to further elucidate its efficacy and safety.

Background Early stent thrombosis (ST) remains an important complication of primary percutaneous intervention (PCI). To date, our information on angiographic and clinical predictors of early ST in ST-segment elevation myocardial infarction (STEMI) patients treated with primary PCI is limited. Methods We tried to evaluate the incidence, predictors, and outcomes of early ST in real-world patients treated with primary PCI. We identified all the patients presenting with STEMI between June 2004 and January 2011 who underwent primary PCI as the primary mode of revascularization. Diagnosis of ST was made as per the standard definition proposed by the Academic Research Consortium. Results The incidence of early ST was 1% among 2,303 patients treated with primary PCI. Definite and probable early ST occurred in 22 and 2 patients, respectively. Patients with early ST had higher in-hospital (P = 0.03) and 30-day mortality (P = 0.048). The rate of cardiogenic shock (P = 0.0006) and cerebrovascular accident (P = 0.0004) was also greater in the early ST group. Smaller stent diameter and lower use of intracoronary glycoprotein IIb/IIIa inhibitor were associated with higher rate of early ST. There was a trend of higher bivalirudin use in ST group, which did not reach significance (P = 0.07) On IVUS imaging, stent malapposition and uncovered plaque area were noted in 6 out of 11 cases. Conclusion The incidence of early ST in primary PCI cohort is low. However, it is still associated with higher mortality and morbidity. Small stent diameter and disuse of intracoronary glycoprotein IIb/IIIa inhibitor may be associated with early ST.

Objective To evaluate the long term efficacy and safety of long duration DAPT (L-DAPT) compared to short duration DAPT (S-DAPT) after drug-eluting stent (DES) implantation. Methods We searched Medline, Embase, and Cochrane Central Register of Controlled Trials (CENTRAL) to identify randomized controlled trials (RCTs) assessing the clinical impact of L-DAPT versus S-DAPT after DES and have mean follow up period of at least 2 years or longer. Primary end point was stent thrombosis (ST). Secondary endpoints were all-cause mortality, cardiac mortality, myocardial infarction (MI), target vessel revascularization (TVR), thrombolysis in myocardial infarction (TIMI) major bleeding and stroke. Event rates were compared using a random effects model. Results We identified five RCTs in which 19,760 patients were randomized to S-DAPT (N = 9,810) and L-DAPT (n = 9,950), respectively. Compared with L-DAPT, S-DAPT was associated with higher rate of MI (odds ratio [OR] 1.48, 95% confidence interval [CI] [1.04, 2.10]). There were no significant differences between S-DAPT and L-DAPT in terms of all cause mortality, cardiac mortality, ST, TVR or stroke (OR 0.90, 95% CI [0.73, 1.12]; OR 1.02, 95% CI [0.80, 1.30]; OR 1.59, 95% CI [0.77, 3.27]; OR 0.87 95% CI [0.67, 1.14]; and OR 1.08 95% CI [0.81, 1.46], respectively). However, rate of TIMI major bleeding was significantly lower with S-DAPT compared to L-DAPT (OR 0.64, 95% CI [0.41, 0.99]). Conclusions In the present analysis of RCTs with longer follow up (2 years or longer), S-DAPT compared with L-DAPT, was associated with higher rate of MI and lower rate of major bleeding without any significant difference in the rates of all cause mortality, cardiac mortality, ST, TVR, and stroke.

Background Recent trials comparing PCI with CABG for unprotected left main disease yielded discrepant evidence. Objectives To perform an updated meta-analysis of randomized trials comparing percutaneous coronary intervention (PCI) with coronary artery bypass grafting (CABG) in patients with unprotected left main coronary artery disease. Methods Randomized trials comparing PCI versus CABG for patients with unprotected left main coronary artery disease were included. Summary estimates risk ratios (RRs) were performed with a DerSimonian and Laird model at short-term, intermediate and long-term follow-up periods (i.e., 30-days, 1-year, and >1-year). Outcomes evaluated were major adverse cardiac and cerebrovascular events (MACCE), all-cause mortality, myocardial infarction, stroke, revascularization and stent thrombosis or symptomatic graft occlusion. Results Six trials with 4,700 patients and a mean SYNTAX score of 23 were included. At short-term follow-up, the risk of MACCE was lower with PCI (RR 0.55, 95% confidence interval [CI] 0.39-0.76) driven by the lower risk of myocardial infarction (RR 0.67, 95% CI 0.46-0.99), and stroke (RR 0.38, 95% CI 0.16-0.90). The risk of MACCE was similar at the intermediate follow-up (RR 1.21, 95% CI 0.97-1.51). At long-term follow-up, PCI was associated with a higher risk of MACCE (RR 1.19, 95% CI 1.01-1.41), due to a higher risk of revascularization (RR 1.62, 95% CI 1.34-1.94), while the risk of all-cause mortality, myocardial infarction, and stroke were similar. Conclusions In patients with unprotected left main coronary disease and low to intermediate SYNTAX score, PCI might be an acceptable alternative to CABG. © 2017 Wiley Periodicals, Inc.

Background Patients presenting with acute coronary syndrome (ACS) are at increased risk of complications after percutaneous coronary intervention with stent placement compared to patients with stable angina (SA) treated in an elective setting. The novel pro-healing COMBO stent is a bio-engineered drug eluting stent designed to promote vessel healing. Therefore, the stent may reduce this difference in clinical outcomes between elective and ACS-patients and prevent late stent thrombosis. Methods and Results The European, prospective, multicenter, 1000 all-comers patient REMEDEE registry evaluates clinical outcomes after COMBO stent placement in ACS- and elective patients. The primary endpoint at 12 months is target lesion failure (TLF), a composite of cardiac death, target-vessel myocardial infarction and target lesion revascularization. A total of 49.9% (n = 498) of patients presented with acute coronary syndrome. TLF was 7.1% in ACS patients, definite and probable stent thrombosis was observed in 0.5% of ACS patients and in all within 9 days post stenting. We found no significant difference in TLF between ACS and non-ACS patients and a low overall rate of TLF. Conclusions The COMBO stent is a safe and efficient device for patients presenting with ACS. Low ST rate and only early stent thrombosis were observed. © 2017 Wiley Periodicals, Inc.

Background Prior randomized controlled trials (RCT) evaluating the optimal antithrombotic therapies for patients with atrial fibrillation (AF) undergoing percutaneous coronary intervention (PCI) have not been powered to evaluate ischemic outcomes. We compared double therapy with oral anticoagulation (OAC) and a P2Y12 inhibitor to triple therapy with an OAC + dual antiplatelet therapy in patients with AF requiring PCI. Methods Using PRISMA guidelines, we searched for RCTs including patients with AF as an indication for OAC and undergoing PCI or medical management of acute coronary syndrome. The results were pooled using fixed-effects and random-effects models to estimate the overall effect of double therapy versus triple therapy on ischemic and bleeding outcomes. Results We identified four RCTs, comprising 10,238 patients (5,498 double therapy, 4,740 triple therapy). Trial-reported major adverse cardiovascular events were similar between double therapy and triple therapy (fixed effect model OR 1.09, 95% CI 0.94-1.26). However, stent thrombosis (61/5,496 double therapy vs. 33/4738 triple therapy; fixed effect model OR 1.57, 95% CI 1.02-2.40; number needed to treat with triple therapy = 242) favored triple therapy. Bleeding outcomes were less frequent with double therapy (746/5470 vs. 950/4710; fixed effect model OR 0.59, 95% CI 0.53-0.65; number needed to harm with triple therapy = 16), but with significant heterogeneity (Q = 8.33, p = .04; I2 = 64%), as were intracranial hemorrhages (19/5470 vs. 30/4710; fixed effect model OR 0.54, 95% CI 0.31-0.96). Conclusions Double therapy in patients with AF requiring OAC following PCI or Acute coronary syndrome has a significantly better safety profile than triple therapy but may be associated with a modest increased risk of stent thrombosis.

AIM To determine the potential clinical impact of OCT (Optical Coherence Tomography) during primary percutaneous coronary intervention in patients presenting with ACS (Acute Coronary Syndrome). METHODS AND RESULTS FORMIDABLE is a multicentre retrospective registry enrolling all patients presenting with ACS and treated with an OCT-guided approach, while the USZ registry enrolled patients treated with a standard angiography guided approach. Multivariate adjustment was performed via a propensity score matching. The number stents useds was the primary outcome, while the incidence of MACE (a composite of death, myocardial infarction, target vessel revascularization, and stent thrombosis) was the secondary endpoint. A total of 285 patients OCT-guided and 1,547 angiography guided patients were enrolled, resulting in 270 for each cohort after propensity score with matching. Two stents were used in 12% versus 34%; 3 stents in 8% versus 38% of the patients (P

We propose a mechanism of how stroke may be caused by thrombus aspiration during primary percutaneous coronary intervention (PPCI), and how it may be technique-dependent. Two recent meta-analyses report increased risk of stroke in patients undergoing routine thrombus aspiration during STEMI and the value of this technique has been controversial. The mechanism of stroke has not been fully explained. This case demonstrates 2 mechanisms by which aspiration might cause thrombus embolization. We recommend that if thrombus aspiration is performed during PPCI for STEMI, it should be done selectively and carefully. It is prudent to make sure the guide catheter tip is not free in the aorta when the aspiration catheter is withdrawn, to maintain suction on the aspiration catheter as it is withdrawn (particularly if the aspiration port seems to be obstructed), and to aspirate the guide catheter after the aspiration catheter is removed to capture any fragments of thrombus that remain in the guide catheter. © 2016 Wiley Periodicals, Inc.

Objectives The aim of this study was to evaluate midterm outcomes of bioresorbable vascular scaffolds (BVS) implanted in bifurcation lesions. Background BVS have emerged as an alternative to conventional metallic drug-eluting stents for the treatment of coronary complex lesions. Methods Between November 2011 and January 2014, 1189 patients underwent percutaneous coronary intervention with BVS at 10 European centers (GHOST EU registry). Of these, 289 consecutive patients (302 bifurcation lesions) treated with either single-stenting (n = 260) or double-stenting (n = 42) were evaluated. Results True bifurcations were treated in 44.7%. Intravascular ultrasound and optical coherence tomography were utilized only in 22.2% and 21.2%, respectively. Predilation was performed in 95.4%, while postdilation of the main branch was performed in 61.3%. Final kissing inflation with no or minimal protrusion of a side-branch balloon into main branch was performed in 18.9%. Median follow-up period was 356 (IQR 191–419) days. The Kaplan–Meier estimated rates of target lesion failure and scaffold thrombosis (ST) were 6.4% and 2.5% at 360 days, respectively. Independent predictors for TLF were ACS and diabetes mellitus (HR 4.67; 95% CI: 1.78–12.3; P = 0.002 and HR 3.37; 95% CI: 1.38–8.26; P = 0.008, respectively). Conclusions BVS use for coronary bifurcation lesions in an “all-comer” population was associated with acceptable TLF rates up to midterm follow-up. However, ST rates were higher than seen with contemporary metallic stents possibly due to the low incidence of intravascular guidance and postdilation resulting in a higher likelihood of scaffold underexpansion and malapposition, further supporting the importance of meticulous implantation technique. © 2016 Wiley Periodicals, Inc.

Objectives The aim of the present study was to define the feasibility and clinical impact of complying with national consensus recommendations on perioperative management of antiplatelet therapy in patients with coronary stents undergoing cardiac and noncardiac surgery. Background There are limited evidence-based recommendations on the perioperative management of antiplatelet therapy in stented patients undergoing surgery. Methods The recommendations provided by the national consensus document were applied in a multicenter, prospective registry of consecutive patients with prior coronary stenting undergoing any type of surgery at 19 hospitals in Italy. The primary end-point was in-hospital net adverse clinical events (NACE) represented by the composite of all-cause death, myocardial infarction, probable/definite stent thrombosis and Bleeding Academic Research Consortium (BARC) grade ≥3 bleeding. Patients were followed for 30 days. Results A total of 1,082 patients were enrolled. Adherence to consensus recommendations occurred in 85% of the cases. Perioperative aspirin and dual antiplatelet therapy were maintained in 69.7 and 10.5% of the cases, respectively. In-hospital NACE rate was 12.7%, being significantly higher in patients undergoing cardiac surgery (36.3% vs. 7.3%, P

Background Patients with ST-segment elevation myocardial infarction (STEMI) undergoing drug-eluting stent (DES) implantation are at increased risk of late adverse events, partly explained by an exaggerated inflammatory reaction to durable-polymer stent coatings. Objectives We sought to investigate whether implantation of polymer-free DES would reduce this risk. Methods In the ISAR-TEST 5 (the Intracoronary Stenting and Angiographic Results: Test Efficacy of Sirolimus- and Probucol- and Zotarolimus-Eluting Stents) trial, patients were randomly allocated to receive a polymer-free sirolimus- and probucol-eluting stent or a new generation durable-polymer zotarolimus-eluting stent. We analyzed late clinical outcomes in the subgroup of patients presenting with STEMI. The primary endpoint was the combined incidence of cardiac death, target vessel-related myocardial infarction or target lesion revascularization at 5 years. Results 311 patients with STEMI were randomized to receive sirolimus- and probucol-eluting stents (n = 215) or zotarolimus-eluting stents (n = 96). At 5 years, there was no difference in the incidence of the primary endpoint in patients treated with sirolimus- and probucol-eluting stents versus zotarolimus-eluting stents (18.3% versus 20.1% respectively, hazard ratio = 0.87, 95% CI, 0.50–1.51; P = 0.62). Rates of the individual components of the primary endpoint were also comparable in both groups. The incidence of definite/probable stent thrombosis was 1.4% versus 1.0% respectively (hazard ratio = 1.35, 95% CI, 0.14–12.94, P = 0.80). Conclusions Long-term outcomes of patients with STEMI treated with polymer-free sirolimus- and probucol-eluting stents versus durable-polymer zotarolimus-eluting stents were similar. Stent thrombosis rates were low and comparable in both treatment groups, with no events beyond 12 months. Clinical Trial Registration: Registered at ClinicalTrials.gov (Identifier NCT 00598533) © 2016 Wiley Periodicals, Inc.

The Solitaire stent is a self-expanding nitinol, fully retrievable stent that was originally designed for applications in cerebral circulation. Expanded indications for its use in mechanical embolectomy during acute ischemic stroke have proven safe and effective. Herein, we describe a novel use of this stent to perform a mechanical thrombectomy of a large left main coronary artery thrombus. © 2016 Wiley Periodicals, Inc.

Objective In this study, we investigated long-term results following bioresorbable vascular scaffold (BVS) implantation in small coronary arteries. Background Management of small coronary vessel disease with percutaneous coronary interventions (PCI) is often associated with high recurrencies and an increased risk of late or very late adverse events. Currently, little is known about BVS behavior in this setting. Methods A retrospective cohort analysis in a consecutive all-comer population was performed in patients that had a BVS implanted for coronary artery disease (CAD) in vessels with reference diameter