Impact of Left Ventricular Ejection Fraction on Procedural and Long-Term Outcomes of Bifurcation Percutaneous Coronary Intervention.

The association of left ventricular ejection fraction (LVEF) with procedural and long-term outcomes after state-of-the-art percutaneous coronary intervention (PCI) of bifurcation lesions remains unsettled. A total of 5,333 patients who underwent contemporary coronary bifurcation PCI were included in the intercontinental retrospective combined insights from the unified RAIN (veRy thin stents for patients with left mAIn or bifurcatioN in real life) and COBIS (COronary BIfurcation Stenting) III bifurcation registries. Of 5,003 patients (93.8%) with known baseline LVEF, 244 (4.9%) had LVEF <40% (bifurcation with reduced ejection fraction [BIFrEF] group), 430 (8.6%) had LVEF 40% to 49% (bifurcation with mildly reduced ejection fraction [BIFmEF] group) and 4,329 (86.5%) had ejection fraction (EF) ≥50% (bifurcation with preserved ejection fraction [BIFpEF] group). The primary end point was the Kaplan-Meier estimate of major adverse cardiac events (MACEs) (a composite of all-cause death, myocardial infarction, and target vessel revascularization). Patients with BIFrEF had a more complex clinical profile and coronary anatomy. No difference in procedural (30 days) MACE was observed across EF categories, also after adjustment for in-study outcome predictors (BIFrEF vs BIFmEF: adjusted hazard ratio [adj-HR] 1.39, 95% confidence interval [CI] 0.37 to 5.21, p = 0.626; BIFrEF vs BIFpEF: adj-HR 1.11, 95% CI 0.25 to 2.87, p = 0.883; BIFmEF vs BIFpEF: adj-HR 0.81, 95% CI 0.29 to 2.27, p = 0.683). BIFrEF was independently associated with long-term MACE (median follow-up 21 months, interquartile range 10 to 21 months) than both BIFmEF (adj-HR 2.20, 95% CI 1.41 to 3.41, p <0.001) and BIFpEF (adj-HR 1.91, 95% CI 1.41 to 2.60, p <0.001) groups, although no difference was observed between BIFmEF and BIFpEF groups (adj-HR 0.87, 95% CI 0.61 to 1.24, p = 0.449). In conclusion, in patients who underwent PCI of a coronary bifurcation lesion according to contemporary clinical practice, reduced LVEF (<40%), although a strong predictor of long-term MACEs, does not affect procedural outcomes.

Performance of Thin-Strut Stents in Non-Left Main Bifurcation Coronary Lesions: A RAIN Subanalysis.

OBJECTIVES: This study assesses the safety and efficacy of thin-strut stents in non-left main (non-LM) bifurcation coronary lesions. BACKGROUND: Thinner struts of recent drug-eluting stent (DES) devices are associated with improved outcomes, but data about their performance in challenging scenarios are scant. METHODS: RAIN was a retrospective multicenter registry enrolling patients with coronary bifurcation lesions or left main (LM) disease treated with thin-strut DESs. Target-lesion revascularization (TLR) was the primary endpoint, while major adverse clinical event (MACE) rate, a composite of all-cause death, myocardial infarction (MI), target-vessel revascularization (TVR), TLR, and stent thrombosis (ST), and its single components were the secondary endpoints. Multivariable analysis was performed to identify predictors of TLR. Outcome incidences according to stenting strategy (provisional vs 2-stent technique), use of final kissing balloon (FKB), and intravascular ultrasound/optical coherence tomography optimization were further investigated in prespecified subanalyses. RESULTS: A total of 1803 patients (59% acute coronary syndrome, 41% stable coronary artery disease) with non-LM bifurcations were enrolled. After a median follow-up of 12 months, TLR incidence was 2.5% (2.2% for provisional stenting and 3.5% for 2-stent technique). MACE rate was 9.4% (all-cause death, 4.1%; MI, 3.2%; TVR, 3.7%; definite ST, 1.1%). After multivariable adjustment, postdilation (hazard ratio [HR], 0.32; 95% confidence interval [CI], 0.15-0.71; P<.01) and provisional stenting (HR, 0.62; 95% CI, 0.55-0.89; P=.03) were associated with lower TLR rates. FKB was associated with a lower incidence of TLR in the 2-stent subgroup (P=.03). Intracoronary imaging had no significant impact on the primary endpoint. CONCLUSIONS: Thin-strut DES options represent an effective choice in bifurcation lesions. Postdilation and provisional stenting are associated with a reduced risk of TLR. FKB should be recommended in 2-stent techniques.

Long-term (≥15 years) Follow-up of Percutaneous Coronary Intervention of Unprotected Left Main (From the GRAVITY Registry).

Long term survival and its determinants after Percutaneous Coronary Intervention (PCI) on Unprotected Left Main Coronary Artery (ULMCA) remain to be appraised. In 9 European Centers 470 consecutive patients performing PCI on ULMCA between 2002 and 2005 were retrospectively enrolled. Survival from all cause and cardiovascular (CV) death were the primary end points, while their predictors at multivariate analysis the secondary ones. Among the overall cohort 81.5% of patients were male and mean age was 66 ± 12 years. After 15 years (IQR 13 to 16), 223 patients (47%) died, 81 (17.2%) due to CV etiology. At multivariable analysis, older age (HR 1.06, 95%CI 1.02 to 1.11), LVEF < 35% (HR 2.97, 95%CI 1.24 to 7.15) and number of vessels treated during the index PCI (HR 1.75, 95%CI 1.12 to 2.72) were related to all-cause mortality, while only LVEF <35% (HR 4.71, 95%CI 1.90 to 11.66) to CV death. Repeated PCI on ULMCA occurred in 91 (28%) patients during the course of follow up and did not significantly impact on freedom from all-cause or CV mortality. In conclusion, in a large, unselected population treated with PCI on ULMCA, 47% died after 15 years, 17% due to CV causes. Age, number of vessels treated during index PCI and depressed LVEF increased risk of all cause death, while re-PCI on ULMCA did not impact survival.

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.

Italian Multicenter Registry of Bare Metal Stent Use in Modern Percutaneous Coronary Intervention Era (AMARCORD): A multicenter observational study.

OBJECTIVES: We aimed to evaluate the use of bare metal stent (BMS) implantation in current percutaneous coronary intervention (PCI) era, focusing on indications for use and clinical outcomes. BACKGROUND: Limited data on BMS usage in current clinical practice are available. METHODS: All patients who underwent PCI with at least one BMS implantation in 18 Italian centers from January 1, 2013 to December 31, 2017, were included in our registry. Rates of BMS use and reasons for BMS implantations were reported for the overall study period and for each year. Primary outcomes were mortality, bleeding (Bleeding Academic Research Consortium-BARC and Thrombolysis in Myocardial Infarction-TIMI non-CABG definitions), and major adverse cardiac events (MACE) defined as the composite of all-cause and cardiac death, any myocardial infarction, target vessel revascularization, or any stent thrombosis. RESULTS: Among 58,879 patients undergoing PCI in the study period, 2,117 (3.6%) patients (mean age 73 years, 69.7% males, 73.3% acute coronary syndrome) were treated with BMS implantation (2,353 treated lesions). The rate of BMS implantation progressively decreased from 10.1% (2013) to 0.3% (2017). Main reasons for BMS implantation were: ST-elevation myocardial infarction (STEMI) (23.1%), advanced age (24.4%), and physician's perception of high-bleeding risk (34.0%). At a mean follow-up of 2.2 ± 1.5 years, all-cause and cardiac mortality were 25.6 and 12.7%, respectively; MACE rate was 35.3%, any bleeding rate was 13.0% (BARC 3-5 bleeding 6.3%, TIMI non-CABG major bleeding 6.1%). CONCLUSION: In a large, contemporary, real-world, multicenter registry, BMS use progressively reduced over the last 5 years. Main reasons for BMS implantation were STEMI, advanced age, and physician's perception of high-bleeding risk. High rates of mortality and MACE were observed in this real-world high-risk population.

Side Branch is the Main Determinant Factor of Bifurcation Lesion Complexity: Critical Review with a Proposal Based on Single-centre Experience.

Although bifurcation stenting can be often managed with a simple provisional approach, in some settings, more complex techniques are appropriate. Based on our clinical experience and on data from literature, we propose a simple algorithm that may assist in selecting cases for elective double stenting. We found that, when the side branch is of adequate dimensions and affected by significant disease (longer than 10 mm and/or with presence of ostial calcifications), double stenting is associated with a lower incidence of adverse events, compared with provisional stenting.

Impact of stent thickness on clinical outcomes in small vessel and bifurcation lesions: a RAIN-CARDIOGROUP VII sub-study.

BACKGROUND: The clinical impact of stent strut thickness in coronary bifurcation lesions in small vessels has not been assessed in a real-world population. METHODS: All 506 patients enrolled in the RAIN study, undergoing PCI in a vessel with a diameter 2.5 mm or less were retrospectively evaluated and divided into two groups according to stent strut thickness: 74 µm (n = 206) versus 81 µm (n = 300); 87.1% of the lesions involved bifurcations. TLF [defined as a composite of myocardial infarction (MI) and target lesion revascularization (TLR)] was the primary endpoint, with MACE (a composite of death, MI and TLR), its components and stent thrombosis the secondary endpoint. RESULTS: After 16 (14-18) months, a lower incidence of TLF (4.3 vs. 9.8%, P = 0.026) and ST (1.0 vs. 3.0%, P = 0.042) was seen in the 74 µm group, whereas MACE occurred in 60 of 506 patients, with no statistical difference between the two groups (9.7 vs. 13.3%, P = 0.070). At multivariate analysis, chronic renal failure increased the risk of TLF while thinner strut was an independent protective factor (hazard ratio 0.51, CI 0.17-0.85, P = 0.005). CONCLUSION: In this real-world population, patients being treated for small vessels lesions with thinner strut stents had lower rates of TLF, MI and ST.

Impact of the metal-to-artery ratio on clinical outcomes in left main and nonleft main bifurcation: insights the RAIN-CARDIOGROUP VII study (veRy thin stents for patients with left mAIn or bifurcatioN in real life).

INTRODUCTION: The impact on clinical outcomes of the metal coverage on the coronary surface (namely the metal-to-artery ratio) of currently used drug-eluting stents (DESs) has not been defined. METHODS: All patients with a left main or bifurcation stenosis treated with percutaneous coronary intervention (PCI) using ultrathin stents (struts thinner than 81 µm) were enrolled with a prospective multicentre fashion. The rate of device-oriented endpoint [DOE, defined as a composite of target lesion revascularization (TLR) and stent thrombosis] was the primary endpoint, while its single components were the secondary ones, evaluated according to the metal-to-artery ratio. RESULTS: After 14 ±â€Š10.4 months 62 (7.5%) of 830 patients undergoing PCI on left main experienced a DOE without differences in the metal-to-artery ratio (14.5 ±â€Š2.1 vs. 14.4 ±â€Š1.9, P = 0.51). Fifty out (2.4%) of 2082 patients treated with PCI on a coronary bifurcation other than left main experienced a DOE, with a higher mean metal-to-artery ratio (15.3 ±â€Š2.1 vs. 14.6 ±â€Š2, P = 0.01). At multivariate analysis, together with hypertension and diabetes, the metal-to-artery ratio was an independent predictor of DOE (hazard ratio 1.7 : 1.02-1.34, P = 0.02) in nonleft main PCI. When analysed for diameter, we found a significant correlation with DOE when the stent diameter was inferior to 3.0 mm (hazard ratio 1.21: 1.06-1.38, P < 0.01, all 95% confidence interval); this result was mainly consistent for patients treated with provisional stenting. The metal-to-artery ratio does not impact on outcomes in left main PCI, both in the provisional or two-stent technique, and generally when a drug-eluting stent more than 3.5 mm in diameter is implanted. Regarding nonleft main PCI, it is independently related to DOE and TLR, especially for DES with a diameter of 3.25 mm or less. CONCLUSION: The metal-to-artery ratio does not impact on outcomes in left main PCI, both in the provisional or two-stent technique, and generally when a drug-eluting stent more than 3.5 mm in diameter is implanted. Regarding nonleft main PCI, it is independently related to DOE and TLR, especially for DES with a diameter of 3.25 mm or less.

A Sex-Based Analysis From the RAIN-CARDIOGROUP VII Study (VeRy Thin Stents for Patients With Left MAIn or BifurcatioN in Real Life) on Left Main Stenting.

INTRODUCTION: There is a lack of data on clinical outcomes of percutaneous coronary intervention (PCI) with ultrathin stents on unprotected left main (ULM) coronary artery comparing women and men. METHODS: All patients treated with ULM-PCI with ultrathin stents (struts ≤81 µm) enrolled in the RAIN-CARDIOGROUP VII study were analyzed according to a sex-assessment evaluation. Major adverse cardiovascular event (MACE, a composite of all-cause death, myocardial infarction, target-lesion revascularization [TLR], and stent thrombosis) was the primary endpoint, whereas single components of MACE were the secondary endpoints. RESULTS: Out of a cohort of 793 patients, a total of 172 women (21.7%) and 621 men (78.3%) were included. Compared with men, women were older and less frequently smokers, had more frequently a history of previous PCI, and presented more frequently with an acute coronary syndrome. Among women, ostial lesions were more prevalent and mean stent diameter was lower compared with men. After 13.4 months (range, 8.4-21.6 months), 32 women (18.6%) and 106 men (17.1%) experienced MACE (P=.64). Censoring follow-up data at 3 years, no differences were observed in MACE (16.9 vs 14.7 per 100•patient-years; log-rank P=.61) and their single components between women and men. At multivariate analysis, chronic kidney disease (hazard ratio [HR], 1.91: 95% confidence interval [CI], 1.23 to -2.95; P<.01) and acute coronary syndrome presentation (HR, 1.84; 95% CI, 1.22-2.77; P=.01) were independent predictors of MACE overall. Larger stent size (HR, 0.65; 95% CI, 0.48-0.89; P<.01) and longer dual-antiplatelet therapy duration (HR, 0.95; 95% CI, 0.90-0.99; P=.03) were associated with a reduced risk of MACE during the subsequent follow-up. CONCLUSION: Ultrathin stents offer low rates of MACE and TLR in the overall population without significant differences between sexes.

Impact of Kissing Balloon in Patients Treated With Ultrathin Stents for Left Main Lesions and Bifurcations: An Analysis From the RAIN-CARDIOGROUP VII Study.

BACKGROUND: There are limited data regarding the impact of final kissing balloon (FKI) in patients treated with percutaneous coronary intervention using ultrathin stents in left main or bifurcations. METHODS: All patients undergoing left main or bifurcations percutaneous coronary intervention enrolled in the RAIN registry (Very Thin Stents for Patients With MAIN or BiF in Real Life: The RAIN, a Multicenter Study) evaluating ultrathin stents were included. Major adverse cardiac event (a composite of all-cause death, myocardial infarction, target lesion revascularization, and stent thrombosis) was the primary end point, while its components, along with target vessel revascularization, were the secondary end points. The main analysis was performed comparing patients with and without FKI after adjustment with inverse probability of treatment weighting. Subgroup analyses were performed according to FKI (short [<3 mm] versus long overlap), strategy (provisional versus 2-stent), routine versus bail-out FKI, and the use of imaging and proximal optimization technique. RESULTS: Two thousand seven hundred forty-two patients were included. At 16 months (8-20) follow-up, inverse probability of treatment weighting adjusted rates of major adverse cardiac event were similar between FKI and no-FKI group (15.1% versus 15.5%; P=0.967), this result did not change with use of imaging, proximal optimization technique, or routine versus bail-out FKI. In the 2-stent subgroup, FKI was associated with lower rates of target vessel revascularization (7.8% versus 15.9%; P=0.030) and target lesion revascularization (7.3% versus 15.2%; P=0.032). Short overlap FKI was associated with a lower rate of target lesion revascularization compared with no FKI (2.6% versus 5.4%; P=0.034), while long overlap was not (6.8% versus 5.4%; P=0.567). CONCLUSIONS: In patients with bifurcations or unprotected left main treated with ultrathin stents, short overlap FKI is associated with less restenosis. In a 2-stent strategy, FKI was associated with less target vessel revascularization and restenosis. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03544294.

Incidence of Adverse Events at 3 Months Versus at 12 Months After Dual Antiplatelet Therapy Cessation in Patients Treated With Thin Stents With Unprotected Left Main or Coronary Bifurcations.

Incidence and predictors of adverse events after dual antiplatelet therapy (DAPT) cessation in patients treated with thin stents (<100 microns) in unprotected left main (ULM) or coronary bifurcation remain undefined. All consecutive patients presenting with a critical lesion of an ULM or involving a main coronary bifurcation who were treated with very thin strut stents were included. MACE (a composite end point of cardiovascular death, myocardial infarction [MI], target lesion revascularization [TLR], and stent thrombosis [ST]) was the primary endpoint, whereas target vessel revascularization (TVR) was the secondary endpoint, with particular attention to type and occurrence of ST and occurrence of ST, CV death, and MI during DAPT or after DAPT discontinuation. All analyses were performed according to length of DAPT dividing the patients in 3 groups: Short DAPT (3-months), intermediate DAPT (3 to 12 months), and long DAPT (12-months). A total of 117 patients were discharged with an indication for DAPT ≤3 months (median 1: 1 to 2.5), 200 for DAPT between 3 and 12 months (median 8: 7 to 10), and 1,958 with 12 months DAPT. After 12.8 months (8 to 20), MACE was significantly higher in the 3-month group compared with 3 to 12 and 12-month groups (9.4% vs 4.0% vs 7.2%, p ≤0.001), mainly driven by MI (4.4% vs 1.5% vs 3%, p ≤0.001) and overall ST (4.3% vs 1.5% vs 1.8%, p ≤0.001). Independent predictors of MACE were low GFR and a 2 stent strategy. Independent predictors of ST were DAPT duration <3 months and the use of a 2-stent strategy. In conclusion, even stents with very thin strut when implanted in real-life ULM or coronary bifurcation patients discharged with short DAPT have a relevant risk of ST, which remains high although not significant after DAPT cessation.

ST-elevation Myocardial Infarction and Multivessel Coronary Artery Disease - A Critical Review of Current Practice, Evidence and Meta-analyses.

In recent years, practice and guidelines for patients with ST-elevation myocardial infarction (STEMI) have evolved from a 'culprit-only approach' to complete revascularisation; however, several issues remain, particularly regarding assessment of non-culprit lesions and timing of their revascularisation. Complete revascularisation should be performed in patients presenting with STEMI; however, available studies often present contradictory results regarding the optimal timing of non-culprit lesion percutaneous coronary intervention (PCI). The aim of this review is to provide a practical approach for the assessment of patients presenting with STEMI and multivessel coronary artery disease by analysing randomised trials, meta-analyses and our clinical experience. We recommend multivessel revascularisation at the time of primary PCI for simple cases, while we suggest deferring treatment of complex lesions; the optimal timing of staged PCI should be individualised according to clinical judgement.

Percutaneous left atrial appendage closure versus non-vitamin K oral anticoagulants in patients with non-valvular atrial fibrillation and high bleeding risk.

AIMS: A significant number of patients with non-valvular atrial fibrillation (NVAF) are ineligible for non-vitamin K oral anticoagulants (NOACs) due to previous major bleeding or because they are at high bleeding risk (HBR). In this setting the indication for percutaneous left atrial appendage closure (LAAO) is a valuable alternative. We aimed to evaluate the efficacy and safety of NOACs versus LAAO indication in NVAF patients at HBR (HAS-BLED ≥3). METHODS AND RESULTS: All consecutive patients who underwent successful LAAO (n=193) and those treated with NOACs (n=189) (dabigatran, apixaban or rivaroxaban) were included. A 1:1 propensity score matching (PSM) was used to match LAAO and NOACs patients. At baseline, patients in the LAAO group had higher HAS-BLED (4.2% vs 3.3%, p<0.001) and lower CHADS-VASc (4.3% vs 4.7%, p=0.005) scores. After 1:1 PSM, 192 patients were enrolled in the final analysis (LAAO n=96; NOACs n=96). At two-year follow-up, no significant differences in thromboembolic (7.3% vs 6.3%, p=0.966) and ISTH major bleeding event rates (6.7% vs 4.8% p=0.503) were found between the two unmatched groups. All-cause death was significantly higher in the LAAO group (18.7% vs 10.6%; p=0.049). After PSM, all-cause death, thromboembolic and ISTH major bleeding event rates were similar between the groups. Significant independent predictors of all-cause death were dialysis (HR 5.65, 95% CI: 2.16-14.85, p<0.001) and age (HR 1.08, 95% CI: 1.05-1.13, p<0.001). CONCLUSIONS: In NVAF patients at HBR, LAAO and NOACs performed similarly in terms of thromboembolic and major bleeding events up to two-year follow-up. Our findings warrant further investigation in randomised trials and therefore can be considered as hypothesis-generating.

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

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

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

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

Impact of Final Kissing Balloon and of Imaging on Patients Treated on Unprotected Left Main Coronary Artery With Thin-Strut Stents (From the RAIN-CARDIOGROUP VII Study).

Few data are available about the impact on outcomes of procedural strategies for percutaneous coronary intervention with thin-struts stents on unprotected left main (ULM): 792 patients with an ULM stenosis treated with percutaneous coronary intervention with thin-strut stents were enrolled in the present multicenter registry. Target lesion revascularization (TLR) was the primary end point. MACE (a composite of all-cause death, myocardial infarction, TLR, and stent thrombosis) and its single components, along with target vessel revascularization were the secondary end points. Subgroup analyses were performed according to complex versus noncomplex bifurcation lesions. After 16 months, 5.5% of patients experienced a TLR. At multivariate analysis, provisional stenting (odds ratio [OR] 0.46: 0.85 to 0.23, p = 0.006), use of imaging (OR 0.45: 0.23 to 0.98, p = 0.003) and final kissing balloon (FKB) (OR 0.41: 0.83 to 0.21, p = 0.001) reduced risk of TLR. FKB reduced risk of overall TLR only for 2 stents-strategy (6.2% vs 32.4%, p <0.05), but not for provisional strategy (3.8% vs 3.7%, p = 0.67). Intracoronary imaging reduced risk of overall TLR both for provisional (2.2% vs 5.4%) and for 2-stents strategy (7.3% vs 14.1% p <0.05 for both, all confidence interval 95%). In conclusion, TLR for ULM patients treated with thin-strut stents is infrequent. Provisional stenting was noninferior compared with 2-stents apart from complex lesions. Benefit from intracoronary imaging is consistent for different strategies, whereas that from FKB persists only for 2-stents.

Use of Stent Enhancement Technique During Percutaneous Coronary Intervention - A Case Series.

Stent enhancement allows clear visualisation of implanted stents. This method, originally intended to assess stent under-expansion, can prove extremely valuable in several other situations. We present three cases illustrating its potential uses in assessment of stent failure, intraprocedural stent disruption and treatment of aorto-ostial and bifurcation lesions. Whilst stent enhancement cannot replace intravascular imaging, compared to simple angiography it can significantly improve percutaneous coronary intervention outcomes with no additional cost and with minimal procedural time.

Long-term results of a sirolimus-eluting stent with biodegradable polymer (RAPSTROM™) in de novo coronary stenoses.

OBJECTIVES: To report long-term results of a novel sirolimus-eluting stent with biodegradable polymer BACKGROUND: Newer generation drug-eluting stents are characterized by thin struts, improved platform design and highly biocompatible polymer carrying the antiproliferative drug. The RapstromTM stent, sharing these features, showed promising outcomes in preclinical models and in a first-in-man trial. METHODS: The present study is a multicenter, non-randomized post-market registry, including patients with de novo coronary artery disease treated with implantation of one or more Rapstrom stents. Primary endpoint of the study was the rate of major adverse cardiac events (MACE) at three-year follow-up. RESULTS: 1073 patients were enrolled, with a high prevalence of diabetes (35%) and acute coronary syndrome at presentation (82%); at three-year follow up, MACE rate was 14.8%, with a low incidence of definite or probable stent thrombosis (0.75%). CONCLUSIONS: These data confirm the good clinical performance of the Rapstrom stent, supporting the concept that the combination of thin struts and biodegradable polymer is associated with positive clinical outcomes.

Left atrial appendage closure: A single center experience and comparison of two contemporary devices.

OBJECTIVES: To compare indications and clinical outcomes of two contemporary left atrial appendage (LAA) percutaneous closure systems in a "real-world" population. BACKGROUND: Percutaneous LAA occlusion is an emerging therapeutic option for stroke prevention in atrial fibrillation. Some questions however remain unanswered, such as the applicability of results of randomized trials to current clinical practice. Moreover, currently available devices have never been directly compared. METHODS: We retrospectively analyzed consecutive patients who underwent LAA closure at San Raffaele Hospital, Milan, Italy between 2009 and 2015. Clinical indications and device selection were left to operators' decision; routine clinical and transesophageal echocardiography (TEE) follow-up was performed. RESULTS: One-hundred and sixty-five patients were included in the study, of which 99 were treated with the Amplatzer Cardiac Plug (ACP) and 66 with the Watchman system. During the follow-up period (median 15 months, interquartile range 6-26 months) five patients died. The incidence of ischemic events was low, with one patient suffering a transient ischemic attack and no episodes recorded of definitive strokes. Twenty-six leaks ≥1 mm were detected (23%); leaks were less common with the ACP and with periprocedural three-dimensional TEE evaluation, but were not found to correlate with clinical events. Clinical outcomes were comparable between the two devices. CONCLUSIONS: Our data show excellent safety and efficacy of LAA closure, irrespectively of the device utilized, in a population at high ischemic and hemorrhagic risk. The use of ACP and 3D-TEE minimized the incidence of residual leaks; however, the clinical relevance of small peri-device flow warrants further investigation. © 2016 Wiley Periodicals, Inc.