Short term outcomes of Impella circulatory support for high-risk percutaneous coronary intervention a systematic review and meta-analysis.

OBJECTIVE: Aim of this study is to evaluate short term safety and efficacy of Impella in high risk percutaneous coronary intervention (HR-PCI) population. BACKGROUND: While several studies demonstrated the clinical significance of Impella in HR-PCI, few data exist about its impact on short term outcome. METHODS: All studies reporting short term outcomes of PCI with any Impella device were included. The primary endpoint was either in-hospital or 30-day mortality, while vascular complications, post-procedural stroke, post-procedural dialysis and bleeding complications were assessed as secondary outcomes. RESULTS: Nine studies with 7448 patients were included. Median age was 69.5 years old (67-73), with a mean ejection fraction of 29.7% (20%-39%) and a Syntax score of 30.2 (25. 5-33, interquartile [IQR]). Impella 2.5 was the most commonly used axial flow pump used to support these PCIs (88.7%). In-hospital death was observed in 5.09% of patients (95% confidence interval [CI] 3.69-6.49, I2  = 78%), while vascular complications in 2.53% of patients (1.07-4.00, I2  = 89%) and post-procedural stroke in 2.77% of patients (0.50-6.05, I2  = 98%). Major bleeding occurred in 5.98% of patients (3.66-8.31, I2  = 90%) and post-procedural dialysis in 4.44% of patients (1.50-7.37, I2  = 93% all CI 93%). CONCLUSION: Use of Impella in high risk PCI appears to have an acceptable rate of complication, especially regarding vascular complications and major bleedings.

Determinants and long-term outcomes of largely uncovered struts in thin-struts drug-eluting stents assessed by optical coherence tomography.

BACKGROUND: Uncovered struts are a determinant of stent failure. The impact of plaque composition and procedural factors on the occurrence, evolution, and outcomes of uncovered struts in a high-risk setting has not been investigated. OBJECTIVE: To investigate the determinants and long-term clinical impact of largely uncovered struts (LUS) in thin-struts drug-eluting stents (DES) implanted in complex lesions by intracoronary optical coherence tomography (OCT). METHODS: Ninety patients with multivessel disease undergoing staged complete revascularization were randomly assigned to bioabsorbable or durable polymer DES. OCT were serially performed during the index procedure, at 3- and 18-month follow-up, and analyzed by an independent core lab. Struts were defined uncovered by OCT if no tissue was visible above the struts. LUS were defined as ≥30% of uncovered struts at 3-month follow-up. Clinical outcomes were the occurrence of target vessel failure (TVF) and major adverse cardiac and cerebrovascular events (MACCE) at 5-year follow-up. RESULTS: LUS occurred in 31 patients (34.4%) regardless of stent platform. At 5 years, no differences were observed in the rate of TVF (12.7% vs. 13.4%; p = 0.91) and MACCE (23.9% vs. 24.9%; p = 0.88) between the two groups. At multivariate logistic regression, plaque rupture, mean lumen diameter, proximal reference vessel area, and maximum stent deployment pressure were independent predictors of LUS. CONCLUSIONS: LUS are a frequent finding in complex coronary lesions treated with thin-struts DES, especially in the presence of plaque rupture. However, in this study, no significant safety signal related to LUS emerged in long-term follow-up.

Cerebral protection in left atrial appendage closure in the presence of appendage thrombosis.

BACKGROUND: Presence of thrombus in the left atrial appendage (LAA) remains a severe contraindication to the percutaneous left atrial appendage closure procedure (LAAC), due to increased embolic risk. Recently, the experience developed in cerebral protection device in transcatheter aortic valve implantation (TAVI) procedure was translated in LAAC to address this issue. AIM: To evaluate efficacy and safety of Sentinel cerebral protection system (CPS) in supporting LAAC in real-world patient with persistent LAA thrombus. METHODS AND RESULTS: The study retrospectively enrolled consecutive patients with non-valvular atrial fibrillation (NVAF) and thrombus in LAA who underwent LAAC supported by Sentinel CPS in seven European high-volume centres. Twenty-seven patients were included with a median age of 69.1 ± 9.7 years old, with median CHA2 DS2 -VASc and HAS-BLEED scores 3 [2-5] and 3 [2.75-4], respectively. Technical and procedural success was achieved in all patients. No periprocedural TIA, stroke, or supra-aortic trunks dissection was recorded. CONCLUSIONS: In this multicenter registry, LAAC supported by Sentinel CPS in patients with LAA persistent thrombus seems to be a safe and efficacious treatment.

Accuracy of the PARIS score and PCI complexity to predict ischemic events in patients treated with very thin stents in unprotected left main or coronary bifurcations.

BACKGROUND: The PARIS risk score (PARIS-rs) and percutaneous coronary intervention complexity (PCI-c) predict clinical and procedural residual ischemic risk following PCI. Their accuracy in patients undergoing unprotected left main (ULM) or bifurcation PCI has not been assessed. METHODS: The predictive performances of the PARIS-rs (categorized as low, intermediate, and high) and PCI-c (according to guideline-endorsed criteria) were evaluated in 3,002 patients undergoing ULM/bifurcation PCI with very thin strut stents. RESULTS: After 16 (12-22) months, increasing PARIS-rs (8.8% vs. 14.1% vs. 27.4%, p < .001) and PCI-c (15.2% vs. 11%, p = .025) were associated with higher rates of major adverse cardiac events ([MACE], a composite of death, myocardial infarction [MI], and target vessel revascularization), driven by MI/death for PARIS-rs and target lesion revascularization/stent thrombosis for PCI-c (area under the curves for MACE: PARIS-rs 0.60 vs. PCI-c 0.52, p-for-difference < .001). PCI-c accuracy for MACE was higher in low-clinical-risk patients; while PARIS-rs was more accurate in low-procedural-risk patients. ≥12-month dual antiplatelet therapy (DAPT) was associated with a lower MACE rate in high PARIS-rs patients, (adjusted-hazard ratio 0.42 [95% CI: 0.22-0.83], p = .012), with no benefit in low to intermediate PARIS-rs patients. No incremental benefit with longer DAPT was observed in complex PCI. CONCLUSIONS: In the setting of ULM/bifurcation PCI, the residual ischemic risk is better predicted by a clinical risk estimator than by PCI complexity, which rather appears to reflect stent/procedure-related events. Careful procedural risk estimation is warranted in patients at low clinical risk, where PCI complexity may substantially contribute to the overall residual ischemic risk.

Ticagrelor or Clopidogrel After an Acute Coronary Syndrome in the Elderly: A Propensity Score Matching Analysis from 16,653 Patients Treated with PCI Included in Two Large Multinational Registries.

PURPOSE: Higher risk of bleeding with ticagrelor over clopidogrel in elderly patients with acute coronary syndrome (ACS) who underwent percutaneous coronary intervention (PCI) has been suggested. We assessed the incidence of major bleedings (MB), reinfarction (re-MI), and all-cause death to evaluate safety and efficacy of ticagrelor versus clopidogrel in such population. METHODS: Real-world registries RENAMI and BleeMACS were merged. The pooled cohort was divided into two groups, clopidogrel versus ticagrelor. Statistical analysis considered patients <75 versus ≥75 years old. Endpoints were BARC 3-5 MB, re-MI, and all-cause death at 1-year follow-up. The study included 16,653 patients (13,153 < 75 and 3500 ≥ 75 years). Ticagrelor was underused in elderly patients (16.3% versus 20.8%, P < 0.001). Using propensity score matching (PSM), two treatment groups of 1566 patients were included in the final analysis. RESULTS: Ticagrelor was able to prevent re-MI (hazard ratio [HR], 0.31; 95% confidence interval [CI], 0.2-0.6; P < 0.001) and all-cause death (HR, 0.60; 95% CI, 0.4-0.9; P = 0.026) irrespective of age. In patients ≥75 years, ticagrelor reduced all-cause death (HR, 0.32; 95% CI, 0.1-0.8; P = 0.012) and re-MI (HR, 0.25; 95% CI, 0.1-1.1, P = 0.072). Moreover, even with the limit of the low number of events, ticagrelor did not significantly increase the incidence of MB (HR, 1.49; 95% CI, 0.70-3.0; P = 0.257). At multiple Cox regression, age (HR, 1.03; 95% CI, 1.02-1.05; P < 0.001) resulted an independent risk factor for bleeding. CONCLUSION: In our study, reflecting the results from two large retrospective, real-world registries, Ticagrelor did not significantly increase MB compared with clopidogrel in elderly patients with ACS treated with PCI, while significantly improving 1-year survival. Further studies on elderly patients are suggested.

Average daily ischemic versus bleeding risk in patients with ACS undergoing PCI: Insights from the BleeMACS and RENAMI registries.

BACKGROUND: The risk of recurrent ischemia and bleeding after percutaneous coronary intervention (PCI) for acute coronary syndrome (ACS) may vary during the first year of follow-up according to clinical presentation, and medical and interventional strategies. METHODS: BleeMACS and RENAMI are 2 multicenter registries enrolling patients with ACS treated with PCI and clopidogrel, prasugrel, or ticagrelor. The average daily ischemic and bleeding risks (ADIR and ADBR) in the first year after PCI were the primary end points. The difference between ADBR and ADIR was calculated to estimate the potential excess of bleeding/ischemic events in a given period or specific subgroup. RESULTS: A total of 19,826 patients were included. Overall, in the first year after PCI, the ADBR was 0.008085%, whereas ADIR was 0.008017% (P = .886). In the first 2 weeks ADIR was higher than ADBR (P = .013), especially in patients with ST-segment elevation myocardial infarction or incomplete revascularization. ADIR continued to be, albeit non-significantly, greater than ADBR up to the third month, whereas ADBR became higher, although not significantly, afterward. Patients with incomplete revascularization had an excess in ischemic risk (P = .003), whereas non-ST-segment elevation ACS patients and those on ticagrelor had an excess of bleeding (P = .012 and P = .022, respectively). CONCLUSIONS: In unselected ACS patients, ADIR and ADBR occurred at similar rates within 1 year after PCI. ADIR was greater than ADBR in the first 2 weeks, especially in ST-segment elevation myocardial infarction patients and those with incomplete revascularization. In the first year, ADIR was higher than ADBR in patients with incomplete revascularization, whereas ADBR was higher in non-ST-segment elevation ACS patients and in those discharged on ticagrelor.

Assessment of residual thrombus burden in patients with ST-segment elevation myocardial infarction undergoing bivalirudin versus unfractionated heparin infusion: The MATRIX (minimizing adverse hemorrhagic events by transradial access site and angioX) OCT study.

BACKGROUND: Residual stent strut thrombosis after primary percutaneous coronary intervention (PCI), negatively affects myocardial perfusion, may increase stent thrombosis risk, and it is associated with neointima hyperplasia at follow-up. OBJECTIVES: To study the effectiveness of any bivalirudin infusion versus unfractionated heparin (UFH) infusion in reducing residual stent strut thrombosis in patients with ST-elevation myocardial infarction (STEMI). METHODS: Multi-vessel STEMI patients undergoing primary PCI and requiring staged intervention were selected among those randomly allocated to two different bivalirudin infusion regimens in the MATRIX (Minimizing Adverse Haemorrhagic Events by TRansradial Access Site and angioX) Treatment-Duration study. Those receiving heparin only were enrolled into a registry arm. Optical coherence tomography (OCT) of the infarct-related artery was performed at the end of primary PCI and 3-5 days thereafter during a staged intervention. The primary endpoint was the change in minimum flow area (ΔMinFA) defined as (stent area + incomplete stent apposition [ISA] area) - (intraluminal defect + tissue prolapsed area) between the index and staged PCI. RESULTS: 123 patients in bivalirudin arm and 28 patients in the UFH arm were included. Mean stent area, percentage of malapposed struts, and mean percent thrombotic area were comparable after index or staged PCI. The ΔMinFA in the bivalirudin group was 0.25 versus 0.05 mm2 in the UFH group, which resulted in a between-group significant difference of 0.36 [95% CI: (0.05, 0.71); p = .02]. This was mostly related to a decrease in tissue protrusion in the bivalirudin group (p = .03). There was a trend towards more patients in the bivalirudin group who achieved a 5% difference in the percentage of OCT frames with the area >5% (p = .057). CONCLUSIONS: The administration of bivalirudin after primary PCI significantly reduces residual stent strut thrombosis when compared to UFH. This observation should be considered hypothesis-generating since the heparin-treated patients were not randomly allocated.

Real-world reasons and outcomes for 1-month versus longer dual antiplatelet therapy strategies with a polymer-free BIOLIMUS A9-coated stent.

BACKGROUND: A large trial established the favorable profile of a new polymer-free biolimus A9-eluting stent (PF-BES) with a 1-month dual antiplatelet therapy (DAPT) in high bleeding risk (HBR) patients. This is the first study comparing outcomes for a 1-month versus longer DAPT strategies following PF-BES-percutaneous coronary intervention (PCI). METHODS: All patients undergoing PF-BES-PCI (January 2016 to July 2018) were included in the multicenter CHANCE registry. Patients were stratified according to DAPT strategy at discharge (planned 1-month vs. planned >1-month). Primary outcomes were the 390-day estimates of a patient-oriented and of a device-oriented composite endpoints (POCE: death, myocardial infarction [MI] or target vessel revascularization; DOCE: cardiac death, target vessel-MI or ischemia-driven target lesion revascularization). Landmark analyses from 1-month post-PCI were carried. RESULTS: Following PF-BES-PCI, 328(40.3%) and 485(59.6%) patients were discharged with 1-month and longer DAPT (12 months [6-12]), respectively. Patients with a previous or index MI were less likely to be discharged on 1-month DAPT. Patients prescribed with 1-month DAPT were more likely to be at HBR than those with longer DAPT (90.2% vs. 69.9%, p = .001). No between-groups differences in the primary outcomes (planned 1-month vs. planned >1-month DAPT: POCE 11.9% vs. 13.2%, p = .747; DOCE: 4.8% vs. 8.1%, p = .500) were observed, also after adjusting for confoundings (POCE: adjusted-hazard ratio [adj-HR] 1.26, 95%CI 0.74-2.13; DOCE: adj-HR 1.00, 95%CI 0.49-1.99). Landmark analyses showed similar results. CONCLUSIONS: In a large all-comers registry of PF-BES PCI, no interaction of planned DAPT strategy (1-month vs. >1-month) with outcomes was found. This observation warrants investigation in adequately powered randomized studies (ClinicalTrials.gov NCT03622203).

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

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

Comparison of bioresorbable vs durable polymer drug-eluting stents in unprotected left main (from the RAIN-CARDIOGROUP VII Study).

BACKGROUND: There are limited data regarding the impact of bioresorbable polymer drug eluting stent (BP-DES) compared to durable polymer drug eluting stent (DP-DES) in patients treated with percutaneous coronary intervention using ultrathin stents in left main or bifurcations. METHODS: In the RAIN registry (ClinicalTrials NCT03544294, june 2018 retrospectively registered) patients with a ULM or bifurcation stenosis treated with PCI using ultrathin stents (struts thinner than 81 µm) were enrolled. The primary endpoint was the rate of target lesion revascularization (TLR); major adverse cardiovascular events (MACE, a composite of all-cause death, myocardial infarction, TLR and stent thrombosis) and its components, along with target vessel revascularization (TVR) were the secondary ones. A propensity score with matching analysis to compare patients treated with BP-DES versus DP-DES was also assessed. RESULTS: From 3001 enrolled patients, after propensity score analysis 1400 patients (700 for each group) were selected. Among them, 352 had ULM disease and 1048 had non-LM bifurcations. At 16 months (12-22), rates of TLR (3.7% vs 2.9%, p = 0.22) and MACE were similar (12.3% vs. 11.6%, p = 0.74) as well as for the other endpoints. Sensitivity analysis of outcomes after a two-stents strategy, showed better outcome in term of MACE (20.4% vs 10%, p = 0.03) and TVR (12% vs 4.6%, p = 0.05) and a trend towards lower TLR in patients treated with BP-DES. CONCLUSION: In patients with bifurcations or ULM treated with ultrathin stents BP-DES seems to perform similarly to DP-DES: the trends toward improved clinical outcomes in patients treated with the BP-DES might potentially be of value for speculating the stent choice in selected high-risk subgroups of patients at increased risk of ischemic events. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03544294. Retrospectively registered June 1, 2018.

Temporal course of vascular healing and neoatherosclerosis after implantation of durable- or biodegradable-polymer drug-eluting stents.

Aims: Delayed healing and endothelial dysfunction may occur with drug-eluting stents (DES), promoting accelerated infiltration of lipids in the neointima and development of neoatherosclerosis (NA). Pathology data suggest durable polymer (DP) of DES to play a major role in this process. Whether biodegradable polymer (BP) may address these issues is uncertain. We compared in vivo vessel healing and NA of current generation BP- or DP-DES using serial optical coherence tomography (OCT) assessments. Methods and results: Ninety patients with multivessel coronary artery disease were randomized 1:1 to BP everolimus-eluting stents (EES, Synergy) or DP zotarolimus-eluting stents (ZES, Resolute Integrity). Co-primary endpoints were the maximum length of uncovered struts at 3 months (powered for non-inferiority) and the percentage of patients presenting with frames of NA at 18 months (powered for superiority) as measured by OCT. The maximum length of uncovered struts at 3 months was 10 ± 8 mm in the BP-EES group and 11 ± 7 mm in the DP-ZES group (mean difference -1 mm; upper 97.5% confidence interval +2 mm; P = 0.05 for non-inferiority; P = 0.45 for superiority). The percentage of patients presenting with frames of NA at 18 months was low and similar between BP-EES and DP-ZES groups (11.6% vs. 15.9%; P = 0.56). There was no stent thrombosis in both groups at 24 months. Conclusion: BP-EES and DP-ZES showed a similar healing response at 3 months and a low incidence of NA at 18 months. Biocompatible polymers, regardless of whether they are durable or biodegradable, may favourably impact the long-term vascular response to current-generation DES.

Bivalirudin or Unfractionated Heparin in Acute Coronary Syndromes.

BACKGROUND: Conflicting evidence exists on the efficacy and safety of bivalirudin administered as part of percutaneous coronary intervention (PCI) in patients with an acute coronary syndrome. METHODS: We randomly assigned 7213 patients with an acute coronary syndrome for whom PCI was anticipated to receive either bivalirudin or unfractionated heparin. Patients in the bivalirudin group were subsequently randomly assigned to receive or not to receive a post-PCI bivalirudin infusion. Primary outcomes for the comparison between bivalirudin and heparin were the occurrence of major adverse cardiovascular events (a composite of death, myocardial infarction, or stroke) and net adverse clinical events (a composite of major bleeding or a major adverse cardiovascular event). The primary outcome for the comparison of a post-PCI bivalirudin infusion with no post-PCI infusion was a composite of urgent target-vessel revascularization, definite stent thrombosis, or net adverse clinical events. RESULTS: The rate of major adverse cardiovascular events was not significantly lower with bivalirudin than with heparin (10.3% and 10.9%, respectively; relative risk, 0.94; 95% confidence interval [CI], 0.81 to 1.09; P=0.44), nor was the rate of net adverse clinical events (11.2% and 12.4%, respectively; relative risk, 0.89; 95% CI, 0.78 to 1.03; P=0.12). Post-PCI bivalirudin infusion, as compared with no infusion, did not significantly decrease the rate of urgent target-vessel revascularization, definite stent thrombosis, or net adverse clinical events (11.0% and 11.9%, respectively; relative risk, 0.91; 95% CI, 0.74 to 1.11; P=0.34). CONCLUSIONS: In patients with an acute coronary syndrome, the rates of major adverse cardiovascular events and net adverse clinical events were not significantly lower with bivalirudin than with unfractionated heparin. The rate of the composite of urgent target-vessel revascularization, definite stent thrombosis, or net adverse clinical events was not significantly lower with a post-PCI bivalirudin infusion than with no post-PCI infusion. (Funded by the Medicines Company and Terumo Medical; MATRIX ClinicalTrials.gov number, NCT01433627.).

Planned angiographic control versus clinical follow-up for patients with unprotected left main stem stenosis treated with second generation drug-eluting stents: A propensity score with matching analysis from the FAILS (failure in left main with second generation stents-Cardiogroup III Study).

BACKGROUND: The value of angiographic follow-up in unprotected left main (ULM) stenting remains undefined. METHODS: The FAILS-2 registry included consecutive patients presenting with a critical lesion of an ULM treated with second generation drug eluting stents in 6 centers from June 2007 to January 2015. Patients were stratified into two groups: those discharged with planned angiographic follow-up and those with clinical follow-up. MACE (Major Adverse Clinical Events, a composite end point of death, myocardial infarction, TLR, and ST) was the primary end point, while each component was a secondary endpoint Sensitivity analysis was performed for patients treated with a provisional or a two-stent strategy. A propensity score analysis was used to compare the outcomes in the two groups. RESULTS: After multivariate adjustment, 220 patients per group were selected. Planned angiographic follow up was performed after a median of 7 (6-10) months. After 16 (14-21) months, rates of MACE were similar between the two groups (24 vs. 21%, P = 0.29) with lower rates of all cause and cardiovascular death in the angiographic control group (6 vs. 14%, P = 0.01 and 3 vs. 6%, P = 0.04) but with higher rates of TLR (15 vs. 5%, P < 0.001). The same trend was seen irrespective of the stent strategy. CONCLUSION: planned angiographic control results in more TLR but may reduce mortality. These findings need to be confirmed by adequately powered randomized controlled trial.

Clinical impact of optical coherence tomography findings on culprit plaque in acute coronary syndrome: The OCT-FORMIDABLE study registry.

BACKGROUND: Aim of this study was to evaluate the clinical impact of the culprit plaque features assessed by optical coherence tomography (OCT) in patients with acute coronary syndrome (ACS). METHODS: The OCT-FORMIDABLE register enrolled retrospectively all consecutive patients who perform OCT on culprit plaque in patients with ACS in nine European centres. The primary endpoint was the prevalence of culprit plaque rupture (CPR) in patients experiencing major adverse cardiovascular events (MACEs). Secondary endpoint was the prevalence necrotic core with macrophage infiltrations (NCMI) in the patients experiencing MACEs. RESULTS: Two-hundred and nine patients were included in the study. Mean age was 60.1 ± 12.9 years old, 19.1% were females. Main clinical presentation was ST-elevation myocardial infarction (55%). At OCT analysis, CPR was observed in 71.8% patients, while 31.6% presented NCMI. During follow-up (12.6 ± 14.5 months), 11% of the patients experienced MACEs. The presence of CPR (HR 3.7,1.4-9.8, P < .01) and NCMI (HR 3.3,1.6-6.6, P < .01) were independent predictors for MACEs, while dual antiplatelet therapy with prasugrel/ticagrelor at discharge (HR 0.2,0.1-0.6, P < .01) were protective. The protective impact of new antiplatelet drugs was reported only in patients with CPR while in patients without any of the baseline clinical or procedural features impacted on MACEs. CONCLUSIONS: CPR and the presence of NCMI are independent predictors of worse outcome. Patients with CPR seem to benefit more of an intensive therapy, both from a pharmacological and interventional point of view. (NCT02486861).

Impact of an optical coherence tomography guided approach in acute coronary syndromes: A propensity matched analysis from the international FORMIDABLE-CARDIOGROUP IV and USZ registry.

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 < 0.001). After a follow up of 700 days (450-890), there was no difference in myocardial infarction (6% vs. 6%, P = 0.86), while MACE (11% vs. 16%, P = 0.06), target vessel revascularization (2% vs. 4%, P = 0.15) and stent thrombosis rates (0% vs. 2.7%, P = 0.26) were numerically lower for the OCT-guided cohort but none of these endpoints did reach statistical significance. CONCLUSIONS: An OCT-guided approach reduced the number of stents used, number of patients treated with more than one stent, while there was no statistically significant difference in clinical endpoints while most of them were numerically lower, including stent thrombosis rates. © 2016 Wiley Periodicals, Inc.

Rotational atherectomy in very long lesions: Results for the ROTATE registry.

BACKGROUND: Rotational atherectomy (RA) is relatively contraindicated in patients with lesions ≥25 mm of length. Aim of this study was to evaluate RA safety and efficacy in this subset of patients with new technology and devices. METHODS AND RESULTS: From April 2002 to August 2013, the ROTATE registry included all consecutive patients undergoing RA in 8 centres. They were divided into shorter lesion group (SLG, lesions < 25 mm) and longer lesion group (LLG, lesions ≥ 25 mm). The angiographic success (AS) was the primary end point. Procedural complications (PC), a composite end point of procedural perforation, slow flow/no flow, and in-hospital major acute cardiovascular events (MACE), were secondary end points, along with death, nonfatal MI, target lesion revascularization, and MACE during follow-up. Sensitivity analysis was performed according to generation of DES. 1186 patients were included: 51.5% in SLG and 48.4% in LLG. Mean age was 70.4 ± 9.3 years, 64.5% were male. AS and PC did not differ between the two groups (93% vs 91%, p = 0.24 and 9.8 vs 9.4%, p = 0.84). During follow-up (27.6 ± 22.9 months), MACE did not differ between the two groups (28% vs 29.1%, p = 0.95). At multivariate analysis chronic kidney disease, male gender increased risk of MACE (HR 1.94, IQR 1.29-2.0, p = 0.01, HR 0.52, IQR 0.34-0.79, p = 0.01) while second-generation DES seemed protective (HR 0.53, IQR 0.31-0.88, p = 0.02). Data were confirmed at sensitivity analysis for second-generation DES (759 pts, 63.9%). No differences were found in this subpopulation between the two groups in term of AS, PC, and long-term MACE (93.6% vs 93.5%, p = 0.28, 11.9% vs 9.4%, p = 0.32 and 25.5% vs 23.9%, p = 0.72, respectively). CONCLUSIONS: Treating coronary lesions ≥ 25 mm length with RA does not impact short- and long-term outcome, in particular, in patients with second-generation DES. © 2016 Wiley Periodicals, Inc.

Planned versus provisional rotational atherectomy for severe calcified coronary lesions: Insights From the ROTATE multi-center registry.

OBJECTIVES: We aimed to investigate procedural feasibility and outcomes associated with planned rotational atherectomy (RA) for severely calcified coronary lesions. BACKGROUND: Limited data are available addressing the benefits of planned RA compared to provisional RA. METHODS: Between 2002 and 2013, all patients with calcified lesions treated by RA were enrolled. Of these, patients treated with planned RA (358 patients) were compared to those treated with provisional RA (309 patients). RESULTS: In-hospital major adverse cardiovascular events (MACE) were tended to be better in the planned RA group (unadjusted OR: 0.76; 95% CI: 0.44-1.31, P = 0.32, and adjusted OR: 0.59; 95% CI: 0.33-1.05, P = 0.07). The number of pre-dilation balloon catheters was significantly lower in the planned RA group (1.17 ± 0.60 vs. 1.47 ± 0.76, P < 0.001). Procedure time, fluoroscopy time, and contrast volume used were all significantly reduced in the planned RA group compared to the provisional RA group (procedure time; 65.2 ± 36.8min vs. 84.4 ± 43.1min, P < 0.001, fluoroscopy time; 33.1 ± 22.9min vs. 51.2 ± 29.6min, P < 0.001, and contrast volume; 232.9 ± 141.6ml vs. 302.9 ± 150.3ml, P < 0.001). The incidence of MACE at 1-year was significantly higher amongst the unadjusted population, whereas the difference was less marked between groups after propensity-score adjustment (unadjusted HR: 1.78; 95% CI: 1.16-2.74, P = 0.01, and adjusted HR: 1.44; 95% CI: 0.92-2.26, P = 0.11). CONCLUSIONS: Planned RA appears to be safe and was associated with a reduction in procedural and fluoroscopy times, contrast volume, and the number of pre-dilation balloon catheters used. If there is a strong likelihood of requiring RA for the treatment of severely calcified lesions, operators should have a low threshold for adopting a planned RA strategy. © 2016 Wiley Periodicals, Inc.

Long-term clinical follow-up of the multicentre, randomized study to test immunosuppressive therapy with oral prednisone for the prevention of restenosis after percutaneous coronary interventions: Cortisone plus BMS or DES veRsus BMS alone to EliminAte Restenosis (CEREA-DES).

AIMS: To analyse the clinical outcome at 4 years in patients with coronary artery disease treated with bare metal stents (BMS) vs. BMS and oral prednisone, or drug-eluting stents (DES), all assuming similar adjunctive medical treatment. METHODS AND RESULTS: Five Italian hospitals enrolled 375 non-diabetic, ischaemic patients without contraindications to dual anti-platelet treatment or corticosteroid therapy in a randomized controlled study. The primary endpoint was the event-free survival of cardiovascular death, myocardial infarction, and recurrence of ischaemia needing repeated target vessel revascularization at 1 year, and this was significantly lower in the BMS group (80.8%) compared with the prednisone (88.0%) and DES group (88.8%, P = 0.04 and 0.006, respectively). The long-term analysis of the primary endpoint was a pre-specified aim of the trial, and was performed at 1447 days (median, IQ range = 1210-1641). Patients receiving BMS alone had significantly lower event-free survival (75.3%) compared with 84.1% in the prednisone group (HR: 0.447; 95% CI: 0.25-0.80, P = 0.007) and 80.6% in DES patients (HR: 0.519; 95% CI: 0.29-0.93, P = 0.03). Prednisone-treated patients did not develop new treatment-related clinical problems. Drug-eluting stents patients suffered more very late stent thrombosis as a cause of spontaneous myocardial infarction. The need for target vessel revascularization remained lower in the prednisone and DES groups (13.6 and 15.2%, respectively), compared with BMS (23.2%). CONCLUSIONS: The clinical benefits of prednisone compared with BMS only persisted almost unchanged at 4 years. Drug-eluting stents performed better than BMS at long-term, although the advantages observed at 1 year were in part attenuated because of the occurrence of very late stent thrombosis and late revascularizations. Clinical Trial NCT 00369356.