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Over the past few decades, percutaneous coronary intervention (PCI) has undergone significant advancements as a result of the combination of device-based and drug-based therapies. These iterations have led to the development of polymer-free drug-eluting stents. However, there is a scarcity of data regarding their clinical performance. Furthermore, while various risk scores have been proposed to determine the optimal duration of dual antiplatelet therapy (DAPT), none of them have undergone prospective validation within the context of randomized trials. The PARTHENOPE trial is a phase IV, prospective, randomized, multicenter, investigator-initiated, assessor-blind study being conducted at 14 centers in Italy (NCT04135989). It includes 2,107 all-comers patients with minimal exclusion criteria, randomly assigned in a 2-by-2 design to receive either the Cre8 amphilimus-eluting stent or the SYNERGY everolimus-eluting stent, along with either a personalized or standard duration of DAPT. Personalized DAPT duration is determined by the DAPT score, which accounts for both bleeding and ischemic risks. Patients with a DAPT score <2 (indicating higher bleeding than ischemic risk) receive DAPT for 3 or 6 months for chronic or acute coronary syndrome, respectively, while patients with a DAPT score ≥2 (indicating higher ischemic than bleeding risk) receive DAPT for 24 months. Patients in the standard DAPT group receive DAPT for 12 months. The trial aims to establish the noninferiority between stents with respect to a device-oriented composite end point of cardiovascular death, target-vessel myocardial infarction, or clinically-driven target-lesion revascularization at 12 months after PCI. Additionally, the trial aims to demonstrate the superiority of personalized DAPT compared to a standard approach with respect to a net clinical composite of all-cause death, any myocardial infarction, stroke, urgent target-vessel revascularization, or type 2 to 5 bleeding according to the Bleeding Academic Research Consortium criteria at 24-months after PCI. The PARTHENOPE trial is the largest randomized trial investigating the efficacy and safety of a polymer-free DES with a reservoir technology for drug-release and the first trial evaluating a personalized duration of DAPT based on the DAPT score. The study results will provide novel insights into the optimizing the use of drug-eluting stents and DAPT in patients undergoing PCI. [ABSTRACT FROM AUTHOR]

Background: Monotherapy with P2Y12 inhibitors (P2Y12i) is emerging as alternative strategy to dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI). However, early withdrawal of aspirin as part of P2Y12i monotherapy regimens may pose concerns in high-risk patients, such as those undergoing complex PCI. Our aim was to evaluate the efficacy and safety of P2Y12i monotherapy after a short course of DAPT (1-3-month) compared with standard DAPT (≥12-month) according to PCI complexity.Methods: We performed a meta-analysis of randomized trials using random effects models to combine hazard ratios (HRs) with 95% confidence intervals (CIs). Within-trial interactions were pooled to estimate heterogeneity between complex and noncomplex PCI strata. The study protocol was registered in the PROSPERO (CRD42021291027).Results: We identified 5 trials including 31,627 patients, of whom 8,328 (26.3%) underwent complex PCI. P2Y12i monotherapy compared with standard DAPT was associated with a similar risk of all-cause death, stent thrombosis, and stroke, with no evidence for interaction between complex and noncomplex PCI. We found heterogeneity in the treatment effect of P2Y12i monotherapy vs standard DAPT with respect to myocardial infarction (P-interaction = 0.027). Compared with standard DAPT, P2Y12i monotherapy decreased the risk of myocardial infarction in complex PCI (HR 0.77, 95%CI 0.60-0.99, P = .042), but not in noncomplex PCI patients (HR 1.09, 95%CI 0.90-1.30, P = .382). The risk of major bleeding was significantly reduced by P2Y12i monotherapy with a consistent treatment effect (P-interaction = 0.699) in both complex and noncomplex PCI strata.Conclusions: Patients undergoing complex PCI may derive more benefit and less harm from P2Y12i monotherapy after early aspirin withdrawal compared with standard DAPT. [ABSTRACT FROM AUTHOR]

Background: Newest generation drug-eluting stents combine biodegradable polymers with ultrathin stent platforms in order to minimize vessel injury and inflammatory response. Evidence from randomized controlled trials suggested that differences in stent design translate into differences in clinical outcome. The aim of the present study was to evaluate the safety and efficacy of ultrathin strut, biodegradable polymer sirolimus eluting stents (BP SES) compared with thin strut, durable polymer everolimus-eluting stents (DP EES) among patients undergoing percutaneous coronary intervention (PCI).Methods: We pooled individual participant data from 5 randomized trials (NCT01356888, NCT01939249, NCT02389946, NCT01443104, NCT02579031) including a total of 5,780 patients, and performed a one-stage meta-analysis using a mixed effects Cox regression model.Results: At a median duration of follow-up of 739 days (interquartile range 365-1,806 days), target-lesion failure occurred in 337 (10.3%) and 304 (12.2%) patients treated with BP SES and DP EES (HR 0.86, 95%CI 0.71-1.06, P = .16). There were no significant differences between BP SES and DP EES with regards to cardiac death (111 (3.4%) vs 102 (4.1%); HR 1.05, 95%CI 0.80-1.37, P = .73), target-vessel myocardial infarction (136 (4.1%) vs 126 (5.0%), HR 0.79, 95%CI 0.62-1.01, P = .061), and clinically-driven target-lesion revascularization (163 (5.0%) vs 147 (5.9%); HR 0.94, 95%CI 0.75-1.18, P = .61). The effect was consistent across major subgroups. In a landmark analysis, there was no significant interaction between treatment effect and timing of events.Conclusions: In this patient-level meta-analysis of 5 randomized controlled trials, BP SES were associated with a similar risk of target-lesion failure compared with DP EES among patients undergoing PCI.Study Registration: PROSPERO registry (CRD42018109098). [ABSTRACT FROM AUTHOR]

Abstract Objectives The purpose of this study was to investigate the association between right ventricular dysfunction (RVD) and cardiovascular death after transcatheter aortic valve replacement (TAVR). Background There is conflicting evidence on the effect of RVD on clinical outcomes after TAVR. Methods A total of 1,116 TAVR patients (age 82 ± 6 years; 51% female) who were consecutively enrolled into a prospective registry underwent detailed pre-operative assessment of right ventricular (RV) function and were dichotomized into 2 groups for the purposes of the present retrospective analysis. RVD was assessed using fractional area change (<35%), tricuspid annular plane systolic excursion (<1.7 cm), and systolic movement of the RV lateral wall by tissue Doppler imaging (<9.5 cm/s). RVD was found in 325 (29.1%) patients. The primary outcome was cardiovascular death at 1 year. Results After adjustment for comorbidities, patients with RVD had a higher risk of cardiovascular death at 1 year compared with patients with normal RV function (20.1% vs. 7.1%; adjusted hazard ratio [HR adj ]: 2.94; 95% confidence interval [CI]: 2.02 to 4.27; p < 0.001). The difference emerged within the first 30 days after TAVR (9.0% vs. 2.2%; HR adj : 4.62; 95% CI: 2.51 to 8.50; p < 0.001). Normalization of RV function after TAVR was found in 57.4% of patients with RVD at baseline. There was a gradient of increasing risk of cardiovascular death among patients with normal RV function, RVD recovery (HR adj : 2.16; 95% CI: 1.16 to 4.02), new RVD (HR adj : 3.93; 95% CI: 2.09 to 7.39), and maintained RVD (HR adj : 8.74; 95% CI: 5.33 to 14.3), respectively. Conclusions RVD at baseline was associated with a more than 2-fold increased risk of cardiovascular death at 1 year after TAVR, with a gradient of risk according to RVD recovery. (Swiss TAVI Registry; NCT01368250) Graphical abstract [ABSTRACT FROM AUTHOR]

Little is known about temporary Left Bundle Branch Block (LBBB) after transcatheter aortic valve replacement (TAVR). We aim to evaluate the incidence, prognostic impact and predictors of temporary LBBB in TAVR patients. Electrocardiograms (ECGs) obtained before and after TAVR, at discharge and at 30-day follow-up were anonymously analyzed by 5 cardiologists. Temporary LBBB included transient LBBB or persistent LBBB. The primary endpoint was all-cause mortality at 1-year after TAVR. Out of 198 patients, 55 (27.7%) developed temporary LBBB. No differences between groups were observed in primary endpoint. Left ventricular ejection fraction (LVEF) was identified as predictive factor of transient LBBB. Temporary LBBB has no significant impact on survival at 1 year after the procedure. [ABSTRACT FROM AUTHOR]

Objectives The study sought to evaluate the presence of a clinically relevant rebound phenomenon after dual antiplatelet therapy (DAPT) discontinuation in randomized trials. Background It is currently unknown whether clopidogrel discontinuation after short-term DAPT is associated with an early hazard of ischemic events. Methods The authors performed an individual participant data analysis and aggregate meta-analysis. The primary outcome was major adverse cardiac and cerebrovascular events (MACCE), defined as the composite of cardiac death, myocardial infarction (MI), or stroke. Results The study included 11,473 PCI patients with individual participant data from 6 randomized trials comparing short-term DAPT (3 or 6 months) versus long-term DAPT (12 months or more). During the first 90 days following clopidogrel discontinuation, there was no significant increase in the risk of MACCE between patients randomized to short-term DAPT compared with long-term DAPT (hazard ratio [HR]: 1.18; 95% confidence interval [CI]: 0.71 to 1.98; p = 0.52; absolute risk difference 0.10%; 95% CI: −0.16% to 0.36%). The risk of MI or stent thrombosis was similar among patients randomized to short-term DAPT versus long-term DAPT (HR: 0.93; 95% CI: 0.46 to 1.90; p = 0.85). In the aggregate data meta-analysis of 11 trials including 38,919 patients, a higher risk of early MACCE was observed after long-term (≥12 months) DAPT duration (HR: 2.28; 95% CI: 1.69 to 3.09; p < 0.001) but not short-term (<12 months) DAPT duration (HR: 1.08; 95% CI: 0.67 to 1.74; p for interaction = 0.036). Conclusions Among patients undergoing PCI with predominantly new-generation DES, discontinuation of clopidogrel after 3 or 6 months DAPT duration was not associated with an early increase in adverse clinical events. An early increase in MACCE was observed after long-term (≥12 months) DAPT exposure. [ABSTRACT FROM AUTHOR]

Objectives The aim of this study was to examine the frequency, timing, and association of access-site and non–access-site bleeding with mortality in the setting of transcatheter aortic valve replacement (TAVR) during long-term follow-up. Background Bleeding is frequent and associated with impaired prognosis in patients undergoing TAVR. It is currently unknown whether the site of bleeding differentially influences the outcomes of TAVR patients. Methods In total, 926 consecutive patients undergoing TAVR from 2007 through 2014 were evaluated. Bleeding was assessed according to the Valve Academic Research Consortium 2 criteria. The primary outcome of interest was all-cause mortality up to 5 years of follow-up. Results A total of 285 patients (30.7%) experienced at least 1 (minor, major, or life-threatening) bleeding event up to 5 years. Compared with patients not experiencing bleeding, the adjusted risk for all-cause mortality was significantly increased among patients with access-site (hazard ratio: 1.34; 95% confidence interval: 1.01 to 1.76; p = 0.04) and non–access-site bleeding (hazard ratio: 2.08; 95% confidence interval: 1.60 to 2.71; p < 0.001). However, non–access-site bleeding conferred a significantly higher risk for mortality compared with access-site bleeding (hazard ratio: 1.56; 95% confidence interval: 1.12 to 2.18; p = 0.009). At multivariate analysis, female sex was a significant correlate of access-site bleeding, whereas chronic kidney disease and the Society of Thoracic Surgeons score were significantly associated with non–access-site bleeding. Conclusions Among patients with severe aortic stenosis undergoing TAVR, access-site and non–access-site bleeding were independently associated with an increased risk for mortality, with the greatest risk related to non–access-site bleeding during long-term follow-up. [ABSTRACT FROM AUTHOR]

Objectives This study sought to summarize available evidence on transcatheter aortic valve replacement (TAVR) for the treatment of native pure aortic regurgitation (AR). Background Surgical aortic valve replacement (SAVR) is the gold standard for the treatment of AR. However, case series of high-risk patients undergoing TAVR for native pure AR were reported. Methods We systematically searched Medline, Embase, and Scopus for reports of at least 5 patients with native pure AR undergoing TAVR. Patients’ and procedural characteristics were summarized. The primary outcome of interest was all-cause mortality. Pooled estimates were calculated using a random-effects meta-analysis. The study protocol was registered in PROSPERO ( CRD42016038422 ). Results Thirteen reports including 237 patients were included in the analysis. Self-expandable prostheses were used in 79% of patients, whereas 21% of the patients were treated with a balloon-expandable valve. Device success ranged between 74% and 100%. Seventeen patients (7%) required the implantation of a second valve. Conversion to SAVR was reported in 6 (2.5%) cases. The rate of all-cause mortality at 30 days amounted to 7% (95% confidence interval [CI]: 3% to 13%; I 2 = 37%). Cerebrovascular events were rare (0%, 95% CI: 0% to 1%; I 2 = 0); major bleeding and vascular complications occurred in 2% (95% CI: 0% to 7%; I 2 = 41%), and 3% (95% CI: 1% to 7%; I 2 = 0%), respectively. Permanent pacemaker implantation was required in 11% of patients (95% CI: 5% to 19%; I 2 = 50%). The rate of moderate or severe post-procedural AR amounted to 9% (95% CI: 0% to 28%; I 2 = 90%). Conclusions Among selected patients with native pure AR deemed at high risk for SAVR, TAVR is technically feasible and associated with an acceptable risk of early mortality. [ABSTRACT FROM AUTHOR]

Objectives The aim of this study was to assess the impact of sex on 2-year outcomes after percutaneous coronary intervention (PCI) in patients randomly allocated to 24-month versus 6-month dual-antiplatelet therapy (DAPT). Background The optimal duration of DAPT after PCI is highly debated. Whether sex per se should drive decision making on DAPT duration remains unclear. Methods The primary efficacy endpoint of PRODIGY (Prolonging Dual Antiplatelet Treatment After Grading Stent-Induced Intimal Hyperplasia Study) was the composite of death, myocardial infarction, or cerebrovascular accident at 24-month follow-up. The key safety endpoint was type 2, 3, or 5 bleeding according to the Bleeding Academic Research Consortium criteria. Results Women (n = 459 [23.3%]) were older and more likely to have hypertension, lower creatinine clearance, and acute coronary syndrome but had a lower severity of coronary artery disease. After adjustment, prolonged DAPT, compared with 6-month treatment, did not reduce the primary endpoint in both men (adjusted hazard ratio: 1.080; 95% confidence interval: 0.766 to 1.522; p = 0.661) and women (adjusted hazard ratio: 1.013; 95% confidence interval: 0.588 to 1.748; p = 0.962) (interaction p = 0.785). No sex disparity was identified across multiple secondary ischemic endpoints, including overall or cardiovascular mortality, myocardial infarction, and stent thrombosis. There was also no clear sex-related effect on clinically relevant bleeding, including Bleeding Academic Research Consortium type 3 or 5, TIMI (Thrombolysis in Myocardial Infarction), and GUSTO (Global Use of Strategies to Open Occluded Coronary Arteries) scales. Conclusions The present findings suggest that men and women undergoing PCI have similar adjusted 2-year ischemic and bleeding outcomes, despite being characterized by different clinical presentation. Sex failed to emerge as a treatment modifier with respect to DAPT duration, suggesting that decision making on DAPT duration in female patients should weigh ischemic versus bleeding risks. [ABSTRACT FROM AUTHOR]

Background: Diabetic patients are at increased risk for future cardiovascular events after ST-segment elevation myocardial infarction (STEMI). Administration of an intracoronary abciximab bolus during primary percutaneous coronary intervention (PCI) may be beneficial in this high-risk subgroup.Objectives: This study sought to report the 1-year clinical outcomes and cardiac magnetic resonance (CMR) findings in STEMI patients with and without diabetes randomized to intracoronary or intravenous abciximab bolus at the time of primary PCI.Methods: Patient-level data from 3 randomized trials were pooled. The primary endpoint was the composite of death or reinfarction. Comprehensive CMR imaging was performed in 1 study.Results: Of 2,470 patients, 473 (19%) had diabetes and 1,997 (81%) did not. At 1 year, the primary endpoint was significantly reduced in diabetic patients randomized to intracoronary abciximab compared with those randomized to intravenous bolus (9.2% vs. 17.6%; hazard ratio [HR]: 0.49; 95% confidence interval [CI]: 0.28 to 0.83; p = 0.009). The intracoronary abciximab bolus did not reduce the primary endpoint in patients without diabetes (7.4% vs. 7.5%; HR: 0.95; 95% CI: 0.68 to 1.33; p = 0.77), resulting in a significant interaction (p = 0.034). Among diabetic patients, intracoronary versus intravenous abciximab bolus was associated with a significantly reduced risk of death (5.8% vs. 11.2%; HR: 0.51; 95% CI: 0.26 to 0.98; p = 0.043) and definite/probable stent thrombosis (1.3% vs. 4.8%; HR: 0.27; 95% CI: 0.08 to 0.98; p = 0.046). At CMR (n = 792), the myocardial salvage index was significantly increased only in diabetic patients randomized to intracoronary compared with intravenous abciximab (54.4; interquartile range: 35.1 to 78.2 vs. 39.0, interquartile range: 24.7 to 61.7; p = 0.011; p for interaction vs. no diabetes = 0.016).Conclusions: In diabetic patients with STEMI, the administration of intracoronary abciximab improved the effectiveness of primary PCI compared with the intravenous bolus. [ABSTRACT FROM AUTHOR]

Objectives This study evaluated the most appropriate percutaneous coronary intervention (PCI) for the treatment of stenoses in small coronary arteries. Background PCI in small coronary arteries is associated with an increased risk of lesion failure and restenosis. Methods Randomized trials comparing different PCI strategies were identified through a broad search of published reports. Primary angiographic outcome was %DS (%DS). A pairwise meta-analysis was performed by using random effects model, followed by a network meta-analysis synthesizing direct and indirect evidence. Results Overall, 19 trials were eligible, which included 5,072 patients comprising a network without closed loops among 5 identified interventions (early generation sirolimus-eluting stents [SES], paclitaxel-eluting stents [PES], drug-coated balloons [DCB], bare-metal stents [BMS], and balloon angioplasty [BA]). No dedicated trial was identified evaluating new generation drug-eluting stents. Early generation SES yielded the best angiographic results according to %DS. For %DS, SES was ranked as the most effective treatment, followed by PES (standardized mean differences [SMD]: –0.44; 95% confidence interval [CI]: –0.92 to 0.05 vs. SES) and DCB (SMD: –0.89; 95% CI: –1.53 to –0.25 vs. SES). In terms of absolute differences, SES yielded a reduction of 18% in diameter stenosis compared to DCB. SES significantly reduced the risk of target-lesion revascularization compared to PES (odds ratio [OR]: 0.39; 95% CI: 0.16 to 0.93), DCB (OR: 0.34; 95% CI: 0.10 to 0.97), BMS (OR: 0.21; 95% CI: 0.13 to 0.36), and BA (OR: 0.16; 95% CI: 0.09 to 0.29). Conclusions Early generation SES yielded the most favorable angiographic and clinical outcomes for the treatment of stenoses in small coronary arteries. New generation DES need to be evaluated against this standard in future randomized trials. [ABSTRACT FROM AUTHOR]

Background: We aimed to compare differences in risk and timing of recurrent ischemic events among patients with stable ischemic heart disease (SIHD), non-ST-segment elevation acute coronary syndrome (NSTE-ACS), and ST-segment elevation myocardial infarction (STEMI) undergoing percutaneous coronary intervention (PCI).Methods: We performed an individual data pooled analysis of 5 randomized controlled all-comer trials including a total of 8,859 patients and investigated the risk and timing of recurrent ischemic events among patients with SIHD (n = 3,543), NSTE-ACS (n = 3,364), and STEMI (n = 1,952) throughout 2 years of follow-up.Results: At 2 years, all-cause mortality was higher among patients with STEMI (6.4%) and NSTE-ACS (6.1%) compared with those with SIHD (4.2%) (STEMI vs SIHD: hazard ratio [HR] 1.40, 95% CI 1.09-1.78, P = .007; NSTE-ACS vs SIHD: 1.40, 95% CI 1.13-1.73, P = .002). In a landmark analysis, the risk of mortality among patients with STEMI compared with those with SIHD was confined to the first 30 days after PCI (HR 6.19, 95% CI 3.15-12.16, P < .001) but was similar between 30 days and 2 years (HR 1.00, 95% CI 0.76-1.33, P = .974) (Pinteraction < .001). Conversely, patients with NSTE-ACS had a higher risk of mortality compared with those with SIHD both within the first 30 days (HR 2.19, 95% CI 1.08-4.47, P = .031) and beyond (HR 1.34, 95% CI 1.07-1.67, P = .012) (Pinteraction < .001). A similar pattern in the differential timing of events was observed for cardiac death. Beyond 30 days, the risk of myocardial infarction was comparable in patients with STEMI and SIHD, whereas the risk in patients with NSTE-ACS was increased (HR 1.65, 95% CI 1.23-2.21, P = .001).Conclusion: Whereas patients with NSTE-ACS are at increased risk for death at any time after PCI, the mortality of STEMI patients is higher during the first 30 days after PCI but not thereafter compared with patients with SIHD. [ABSTRACT FROM AUTHOR]

Objectives The purpose of this study was to compare the 2-year safety and effectiveness of new- versus early-generation drug-eluting stents (DES) according to the severity of coronary artery disease (CAD) as assessed by the SYNTAX (Synergy between Percutaneous Coronary Intervention with Taxus and Cardiac Surgery) score. Background New-generation DES are considered the standard-of-care in patients with CAD undergoing percutaneous coronary intervention. However, there are few data investigating the effects of new- over early-generation DES according to the anatomic complexity of CAD. Methods Patient-level data from 4 contemporary, all-comers trials were pooled. The primary device-oriented clinical endpoint was the composite of cardiac death, myocardial infarction, or ischemia-driven target-lesion revascularization (TLR). The principal effectiveness and safety endpoints were TLR and definite stent thrombosis (ST), respectively. Adjusted hazard ratios (HRs) with 95% confidence intervals (CIs) were calculated at 2 years for overall comparisons, as well as stratified for patients with lower (SYNTAX score ≤11) and higher complexity (SYNTAX score >11). Results A total of 6,081 patients were included in the study. New-generation DES (n = 4,554) compared with early-generation DES (n = 1,527) reduced the primary endpoint (HR: 0.75 [95% CI: 0.63 to 0.89]; p = 0.001) without interaction (p = 0.219) between patients with lower (HR: 0.86 [95% CI: 0.64 to 1.16]; p = 0.322) versus higher CAD complexity (HR: 0.68 [95% CI: 0.54 to 0.85]; p = 0.001). In patients with SYNTAX score >11, new-generation DES significantly reduced TLR (HR: 0.36 [95% CI: 0.26 to 0.51]; p < 0.001) and definite ST (HR: 0.28 [95% CI: 0.15 to 0.55]; p < 0.001) to a greater extent than in the low-complexity group (TLR p int = 0.059; ST p int = 0.013). New-generation DES decreased the risk of cardiac mortality in patients with SYNTAX score >11 (HR: 0.45 [95% CI: 0.27 to 0.76]; p = 0.003) but not in patients with SYNTAX score ≤11 (p int = 0.042). Conclusions New-generation DES improve clinical outcomes compared with early-generation DES, with a greater safety and effectiveness in patients with SYNTAX score >11. [ABSTRACT FROM AUTHOR]

Background Although intracoronary abciximab failed to improve prognosis compared with intravenous route in unselected ST-segment elevation myocardial infarction (STEMI) patients, little is known about the role of intracoronary abciximab in diabetic patients. Objectives To evaluate the efficacy of intracoronary abciximab administration in diabetic patients with STEMI undergoing primary percutaneous coronary intervention (PCI). Methods Reperfusional and clinical outcomes of intracoronary abciximab compared with intravenous bolus abciximab according to diabetic status were evaluated in a pooled analysis of five randomized trials including 3158 STEMI patients. The primary clinical endpoint of the study was the composite of death or reinfarction at 30-day follow-up. Results Among 584 diabetic patients (18.5%), the composite of death or reinfarction was significantly reduced with intracoronary abciximab compared to intravenous abciximab (4.7% vs. 8.8%; rate ratio [RR], 0.50; 95% confidence intervals [CI], 0.26–0.99; p = 0.04), driven by numerically lower deaths (3.7% vs. 6.4%; RR, 0.56; 95% CI, 0.26–1.20; p = 0.13). Moreover, a significant reduction in definite or probable stent thrombosis was observed in patients receiving intracoronary abciximab (1% vs. 3.5%; RR, 0.27; 95% CI, 0.07–0.99; p = 0.04). Although formal tests for interaction were not significant, no clinical benefit was apparent in the cohort of STEMI patients without diabetes (n = 2574). Conclusions In diabetic patients with STEMI undergoing primary PCI, intracoronary abciximab may improve clinical outcomes as compared with standard intravenous use. These findings require confirmation in a dedicated randomized trial. [ABSTRACT FROM AUTHOR]

The investigators performed a network meta-analysis of randomized trials comparing the effectiveness of currently available strategies for the treatment of drug-eluting stent (DES) restenosis. Despite the widespread use of DES in patients who undergo percutaneous coronary intervention, the optimal treatment for DES restenosis remains poorly defined. A systematic search of electronic resources was performed. The primary end point was diameter stenosis at follow-up angiography. Seven trials were included, enrolling a total of 1,586 patients with 1,728 restenotic lesions. The following treatment options were found: balloon angioplasty (BA) in 343 patients (19.3%), iopromide-based paclitaxel-eluting balloons (PEB) in 343 (21.6%), sirolimus-eluting stents in 441 (27.8%), paclitaxel-eluting stents in 462 (29.1%), and everolimus-eluting stents in 34 (2.2%). Compared with BA, PEB (-17.74%, 95% credible interval [CI] -25.17% to -11.31%), everolimus-eluting stents (-14.93%, 95% CI -33.47% to 1.16%), paclitaxel-eluting stents (-15.3%, 95% CI -22.96% to -8.35%), and sirolimus-eluting stents (-11.08%, 95% CI -17.89% to - 3.4%) had similar reductions in diameter stenosis at follow-up angiography. PEB (85%) and everolimus-eluting stents (68%) had the greatest probabilities for being the best treatment option. Furthermore, PEB were the best treatment in terms of late luminal loss (85%) and binary restenosis (85%). BA had the lowest efficacy with respect to all study end points. In conclusion, in patients with DES restenosis, repeat DES implantation and iopromide-based PEB are valid alternatives. However, PEB had greater angiographic efficacy and therefore should be considered the new benchmark comparator in the treatment of DES restenosis. The use of BA should be discouraged in patients with DES restenosis. [ABSTRACT FROM AUTHOR]

Several studies have highlighted the prognostic role of preprocedural Thrombolysis In Myocardial Infarction (TIMI) flow in the infarct-related artery (IRA) in patients with ST-segment elevation myocardial infarction (STEMI). However, the impact of preprocedural IRA occlusion in patients with diabetes with STEMI has been insufficiently studied. The aim of this study was to evaluate the effects of baseline IRA occlusion and diabetic status in patients with STEMI who underwent primary percutaneous coronary intervention by using data from a pooled analysis of randomized trials comparing intracoronary with intravenous abciximab bolus administration. A total of 3,046 patients with STEMI who underwent primary percutaneous coronary intervention were included. Diabetes was present in 578 patients (19%). The primary outcome was mortality after a median follow-up period of 375 days. Secondary end points were reinfarction and stent thrombosis. In patients without diabetes, IRA occlusion versus no occlusion was not associated with increased rates of mortality (4.3% vs 2.7%, p = 0.051) and reinfarction (3.3% vs 2.5%, p = 0.33). Patients with diabetes with IRA occlusion compared with those without occlusion showed higher rates of mortality (10.6% vs 4.6%, p = 0.01) and reinfarction (5.6% vs 2.1%, p = 0.03). Baseline IRA occlusion increased the rate of stent thrombosis in the nondiabetic (2.1% vs 1.0%, p = 0.04) and diabetic (3.2% vs 0.8%, p = 0.05) cohorts. Interaction analysis demonstrated that the risk for death and reinfarction was significantly increased when diabetes and IRA occlusion occurred concomitantly. In conclusion, patients with STEMI with diabetes and baseline IRA occlusion had disproportionately higher rates of death and reinfarction. Preprocedural IRA occlusion increased the risk for stent thrombosis, irrespective of diabetic status. [ABSTRACT FROM AUTHOR]

We evaluated the relation between reperfusion indexes and right ventricular (RV) dysfunction in patients with inferior ST-segment elevation myocardial infarction (STEMI). We included patients with inferior STEMI undergoing percutaneous coronary intervention and right coronary artery as infarct-related artery. Myocardial reperfusion was evaluated by Thrombolysis In Myocardial Infarction (TIMI) flow, TIMI frame count, myocardial blush grade, and STsegment resolution. RV dysfunction was defined as tricuspid annular plane systolic excursion ≤16 mm in M-mode imaging. RV dysfunction was present in 58 of 141 patients (41.1%) and was more frequent in patients achieving suboptimal postprocedural TIMI flow grade (66.7% vs 36.7%, grades 0 to 2 vs 3, p = 0.01), TIMI frame count (63.2% vs 37.7%, 40 vs <40 frames, p = 0.04), and myocardial blush grade (33.3% vs 56.2%, grade 0 or 1 vs 2 or 3, p = 0.001). RV dysfunction rates did not differ according to ST-segment resolution. Patients with RV dysfunction had increased rates of cardiac death (13.2% vs 2.6%, p = 0.03), reinfarction (24.5% vs 10.3%, p = 0.03), and stent thrombosis (22.6% vs 6.4%, p = 0.01) at 2-year follow-up. Postprocedural TIMI flow grade 3 (odds ratio 0.25, 95% confidence interval 0.09 to 0.68, p = 0.007) was the only reperfusion correlate of RV dysfunction at multivariate analysis. In an independent cohort of 84 patients with STEMI, postprocedural TIMI flow grade 3 had a limited sensitivity (52%), with a high specificity (74.5%) and negative predictive value (71%) for excluding RV dysfunction. In conclusion, in patients with inferior STEMI undergoing coronary revascularization, RV dysfunction is associated with a worse long-term prognosis. Postprocedural TIMI flow grade may be a useful tool to predict RV dysfunction. [ABSTRACT FROM AUTHOR]

Abstract: Objective: High on-treatment platelet reactivity (HPR) is a well-known risk factor for adverse events in patients undergoing percutaneous coronary intervention (PCI). However, whether reducing platelet reactivity can lead to a lower incidence of ischemic events after PCI is still controversial. Therefore, we sought to investigate this issue by a meta-regression analysis of randomized trials. Methods: We collected randomized trials reporting HPR rates in patients receiving different antiplatelet therapies. ΔHPR was defined as the difference between HPR rates achieved in control vs. experimental arms, and the relationship between ΔHPR and clinical outcomes was evaluated. Results: Thirty trials totalling 6683 patients with a mean follow-up of 3-month were included. Reducing platelet reactivity was associated to a decreased risk of major adverse cardiac events (MACE), with a linear relationship between ΔHPR and MACE (change in tau2 = −2.50; p = 0.023). Particularly, achieving a 10% difference in HPR rates resulted in a parallel risk reduction in MACE of about 11% (Exp(b) = 0.98; 95% CI, 0.97–0.99). Changes in HPR predict the risk of ischemic events in patients with acute coronary syndrome (change in tau2 = −2.52; Exp(b) = 0.98; 95% CI, 0.97–0.99; p = 0.03), but not in patients with poor response to clopidogrel (change in tau2 = −1.44; Exp(b) = 0.98; 95% CI, 0.96–1.01; p = 0.19) or stable coronary artery disease (change in tau2 = −0.14; Exp(b) = 0.99; 95% CI, 0.94–1.05; p = 0.89). Conclusion: Reducing HPR occurrence decreases the risk of ischemic events in patients with acute coronary syndrome undergoing PCI, whereas a strategy of reducing platelet reactivity does not improve clinical outcomes in patients with poor response to clopidogrel or stable coronary artery disease. [Copyright &y& Elsevier]

Objectives: The purpose of this study was to determine clinical and echocardiographic correlates of acute heart failure, cardiogenic shock and in-hospital mortality in a large cohort of tako-tsubo cardiomyopathy (TTC) patients. Background: Despite good long-term prognosis, life-threatening complications due to hemodynamic instability can occur early in TTC patients. Methods: The study population consisted of 227 patients (66.2 ± 12.2 years of age; females, 90.3%) enrolled in the Tako-tsubo Italian Network, undergoing transthoracic two-dimensional echocardiography on admission and at short-term follow-up (4.3 [4 to 6] weeks). Patients were divided into two groups according to the presence or absence of major adverse events, a composite of acute heart failure, cardiogenic shock, and in-hospital mortality. Results: Major adverse events occurred in 59 patients (25.9%). The variables for elderly patients ≥75 years of age (42.4% vs. 23.8%; p = 0.011): left ventricular (LV) ejection fraction (35.1 ± 5.9% vs. 38.4 ± 4.6%, p < 0.001), wall motion score index (1.9 ± 0.2 vs. 1.7 ± 0.2, p < 0.001), E/e′ ratio (13.5 ± 4.3 vs. 9.9 ± 3.3 [where E/e′ is ratio of mitral E peak velocity and averaged e′ velocity], p < 0.001), LV outflow tract obstruction (23.7 vs. 8.9%, p = 0.006), pulmonary artery systolic pressure (47.4 ± 12.3 mm Hg vs. 38.0 ± 9.2 mm Hg; p < 0.001), right ventricular involvement (28.8 vs. 9.5%; p < 0.001), and reversible moderate-to-severe mitral regurgitation (49.1 vs. 11.9%; p < 0.001), were significantly different between groups and were associated with adverse events. At multivariate analysis, LV ejection fraction (HR: 0.92; 95% CI: 0.89 to 0.95; p < 0.001), E/e′ ratio (HR: 1.13; 95% CI: 1.02 to 1.24; p = 0.011), reversible moderate to severe mitral regurgitation (HR: 3.25; 95% CI: 1.16 to 9.10; p = 0.025), and age ≥75 years (HR: 2.81; 95% CI: 1.05 to 7.52; p = 0.039) were independent correlates of major adverse events. Conclusions: Echocardiographic parameters provide additional information compared to other variables routinely used in clinical practice to identify patients at higher risk of hemodynamic deterioration and poor in-hospital outcome, allowing prompt institution of appropriate pharmacological treatment and adequate mechanical support. [Copyright &y& Elsevier]

Abstract: Background: It is well established that both PES and SES reduce the need for reintervention as compared with bare-metal stents. Whether everolimus-eluting stent (EES) a “second-generation” drug-eluting stent, further improves clinical outcomes compared to PES and SES still remains uncertain. The aim of this study was to perform a meta-analysis of randomized trials evaluating safety and efficacy of EES compared with paclitaxel- (PES) and sirolimus-eluting stent (SES), in patients undergoing percutaneous coronary intervention (PCI). Methods: We undertook a literature search using Medline, EMBASE, the Cochrane Central Register of Controlled Trials, scientific session abstracts and relevant websites, until August 2010. Included studies comprised randomized trials evaluating EES vs PES/SES, in patients undergoing PCI, at 1-year follow-up. Results: Five studies, enrolling 8058 patients, were included. At 12-month follow-up, patients treated with EES, as compared with PES/SES, experienced lower target-lesion revascularization (OR [95% CI]=0.56 [0.45–0.70], p <0.00001) and myocardial infarction rates (OR [95% CI]=0.57 [0.43–0.77], p =0.0002), without difference in mortality (OR [95% CI]=0.88 [0.62–1.24], p =0.46). A trend towards lower stent thrombosis rates in favour of EES vs PES/SES was found (OR [95% CI]=0.45 [0.20–1.01], p =0.05). However, after the exclusion of SES, EES significantly reduced stent thrombosis as compared with PES (OR [95% CI]=0.35 [0.14–0.86], p =0.02). Conclusions: At 12-month follow-up, treatment with EES is associated with decreased target-lesion revascularization and myocardial infarction rates, without differences in mortality, as compared with PES/SES. EES vs PES/SES use is associated with a trend towards lower stent thrombosis rates. Moreover, EES significantly reduce stent thrombosis with respect to PES. [Copyright &y& Elsevier]

Abstract: Background: Despite short-term outcomes of patients with ST-segment elevation myocardial infarction (STEMI) indicate a benefit of DES in terms of reintervention, limited information is available on the long-term safety and efficacy of DES in these patients. Our aim was to perform a meta-analysis of randomized trials evaluating the long-term outcomes of drug-eluting stents (DES) versus bare-metal stents (BMS) in patients with STEMI. Methods and results: A systematic literature search of MEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials, scientific session abstracts and relevant websites, through September 2010, was performed using specific search terms. Included trials were randomized studies comparing DES to BMS in patients presenting with STEMI, with a follow-up ≥3 years. Ten of the 1496 studies initially identified met inclusion criteria, with a total of 6774 patients enrolled. At a mean follow-up of 3.6 years, DES significantly reduced target-vessel revascularization compared with BMS (odds ratio [OR], 0.51; 95% confidence interval [CI], 0.43–0.59; p <0.0001), without increasing mortality (OR, 0.88; 95% CI, 0.72–1.06; p =0.18), reinfarction (OR, 1.02; 95% CI, 0.81–1.27; p =0.88) and overall stent thrombosis (OR, 1.06; 95% CI, 0.83–1.35; p =0.66). Very late stent thrombosis, occurring 1 year after revascularization, was significantly increased with DES (OR, 1.71; 95% CI, 1.05–2.79; p =0.03). Conclusions: At long-term follow-up, percutaneous coronary intervention with DES reduces need for target-vessel revascularization, without increasing the risk for death and reinfarction. However, the strong reduction in reintervention with DES trades off a slight but significant increase in very late stent thrombosis. [Copyright &y& Elsevier]

Angina pectoris may arise from obstructive coronary artery disease (CAD) or in the absence of significant CAD (ischemia with nonobstructed coronary arteries [INOCA]). Therapeutic strategies for patients with angina and obstructive CAD focus on reducing cardiovascular events and relieving symptoms, whereas in INOCA the focus shifts toward managing functional alterations of the coronary circulation. In obstructive CAD, coronary revascularization might improve angina status, although a significant percentage of patients present angina persistence or recurrence, suggesting the presence of functional mechanisms along with epicardial CAD. In patients with INOCA, performing a precise endotype diagnosis is crucial to allow a tailored therapy targeted toward the specific pathogenic mechanism. In this expert opinion paper, we review the evidence for the management of angina, highlighting the complementary role of coronary revascularization, optimal medical therapy, and lifestyle interventions and underscoring the importance of a personalized approach that targets the underlying pathobiology. • Angina pectoris may arise from obstructive CAD or in the absence of significant CAD. • Functional mechanisms may be involved in determining angina both in obstructive CAD and in ischemia with nonobstructed coronary arteries. • Revascularization and medical therapy play complementary roles in achieving optimal outcomes for patients with angina. • Management of angina is shifting toward a more personalized approach, moving away from the traditional one-size-fits-all strategy. [ABSTRACT FROM AUTHOR]

Abstract: We present the case of a 57 year-old patient that presented to our Institution with a positive treadmill stress test. Coronary angiography revealed an intermediate stenosis of the right coronary artery evaluated with a fractional flow reserve (FFR), complicated by torsade de pointes. Despite this being a very rare arrhythmic complication during FFR, its prompt recognition and treatment are of utmost importance. [Copyright &y& Elsevier]

Abstract Background The impact of coronary artery disease (CAD) extension/complexity on outcomes and on the comparative benefits/risks of zotarolimus-eluting stent (ZES) versus bare-metal stents (BMS) remains unclear in patients at high risk of bleeding or thrombosis or at low restenosis risk. Methods We performed a post-hoc analysis of the ZEUS trial. The impact of coronary anatomic complexity measured by the SYNTAX score on the differences in outcomes following ZES and BMS was assessed at 1 year. Results The mean SYNTAX score was 16.3 ± 13.1 with a median of 12 (IQR: 7 to 22). We stratified patients according to SYNTAX tertiles (0–8: n = 563; >8–19 n = 532; >19: n = 511), and observed that the higher the score, the correspondingly higher was the rate of the primary endpoint of major adverse cardiovascular events (MACE) and other ischemic events, but not bleeding after adjustment. The superior efficacy of ZES versus BMS for MACE was consistent across SYNTAX tertiles (tertile 1: HR 0.71, 95% CI 0.44–1.13; tertile 2: HR 0.71, 95% CI 0.46–1.09; tertile 3: HR 0.83, 95% CI 0.61–1.10) without significant heterogeneity (p for trend = 0.55). This between-groups difference mainly reflected a reduction in MI and TVR without effect on mortality. There was no significant interaction between the SYNTAX score and allocated stent type with respect to ischemic and bleeding endpoints. Conclusions The SYNTAX score was predictor of major adverse cardiovascular events but not bleeding and ZES provided superior efficacy and safety than BMS across the whole spectrum of CAD complexity. SYNTAX score may be routinely used for the assessment of the ischemic risk (but not bleeding) after PCI and should not guide the decision-making for DES versus BMS in patients undergoing PCI. Highlights • SYNTAX score quantifies the complexity of coronary artery disease (CAD) in patients undergoing coronary revascularization. • SYNTAX assists in deciding the optimal revascularization strategy and predicts ischemic events and mortality after PCI. • The impact of angiographic complexity in patients at high risk of bleeding or thrombosis or at low restenosis risk is unknown. • In this study SYNTAX score was associated with MACE but not bleeding and did not affect the superiority of ZES over BMS. • SYNTAX score and new generation DES should be recommended also in these specific subsets of patients. [ABSTRACT FROM AUTHOR]

Background Cardiac resynchronization therapy (CRT) is an effective treatment for left ventricular reverse remodeling (LVRR) in patients with congestive heart failure (HF) and ventricular dyssynchrony. Melatonin is a secretory product of the pineal gland with highly beneficial effects from any tissues including the heart. Herein, we investigated whether the response to CRT is associated with levels of melatonin before CRT implantation in patients with HF and ventricular dyssynchrony. Methods Diurnal melatonin levels were performed in serum from 93 patients with HF and ventricular dyssynchrony before CRT implantation. Moreover, we calculated the MADIT-CRT score. Evaluation of patients at 1-year follow-up included an echocardiographic study since the patients were categorized as responders if they presented both a reduction in left ventricular end-systolic volume index > 10% and an increase in left ventricular ejection fraction > 10%. Results At 1-year, 34 patients (36.5%) were considered responders to CRT according to the predefined criteria. The diurnal melatonin levels were significantly lower in the non-responder group (9.9 ± 2.84 vs 14.7 ± 2.32 pg/mL). After adjustment by multivariate analysis, diurnal serum melatonin levels ( P < 0.001) and diabetes mellitus ( P = 0.03) were predictors of LVRR. On Cox regression analysis, diurnal serum melatonin levels ( P < 0.001) and left atrial volume < 40 mL/m 2 ( P = 0.04) remained independent predictors of the adverse clinical events. The area under of curve for the prediction LVRR of melatonin (0.91, 95%CI 0.85–0.97; P < 0.001) was significantly higher compared to MADIT-CRT score (0.69, 95%CI 0.58–0.80; P = 0.002). Conclusion Diurnal levels of melatonin before CRT implantation are associated with LVRR at 12 month follow-up. [ABSTRACT FROM AUTHOR]

Background: We compared the prognostic value of the ADDED Index with visually estimated diameter (DS) of residual coronary stenosis (RS) in STEMI patients after successful PCI of the culprit lesion. Even though associated with a positive outcome, the functional assessment of non-culprit stenosis remains largely underused, especially in STEMI patients. The Angiography-DeriveD hEmoDynamic index (ADDED index) showed high accuracy to predict FFR and it might be used to better guide the diagnostic and therapeutic work-up of such patients.Methods: We retrospectively included 596 patients grouped on the basis of either the ADDED Index (ADDED Negative (<2.23, n = 153) vs ADDED Positive (≥2.23, n = 129)) or the DS of the RS (RS Negative (<50%, n = 177) vs RS Positive (≥50%, n = 105)). Patients without any RS served as control (n = 314). Primary endpoints were: 1) major adverse cardiac events (MACE), composite of all-cause death, myocardial infarction (MI), clinically driven revascularizations (CDR); 2) non-culprit vessel oriented clinical events (VOCE), composite of all-cause death, non-culprit vessel related MI and CDR.Results: At 24 months the rate of both MACE and VOCE was significantly higher in both the ADDED Positive and RS Positive groups. However, differently from patients in whom complete revascularization was deferred on the basis of the angiography (RS Negative), no additional risk was found for patients in the ADDED Negative group.Conclusions: In STEMI patients with MVD deferring treatment of RS on the basis of the ADDED index, rather than the visually estimated DS, is associated with a favorable clinical outcome. [ABSTRACT FROM AUTHOR]

Background: The GLOBAL LEADERS (GLOBAL LEADERS: A Clinical Study Comparing Two Forms of Anti-platelet Therapy After Stent Implantation) study randomly assigned 15,991 patients undergoing percutaneous coronary intervention to 1-month dual antiplatelet therapy (DAPT) followed by 23-month ticagrelor monotherapy or conventional 12-month DAPT followed by 12-month aspirin. Apart from Q-wave myocardial infarction (MI), all study endpoints were analyzed as investigator reported.Objectives: This was a pre-specified ancillary study assessing whether experimental therapy is noninferior, and if met, superior, to conventional treatment for the coprimary efficacy endpoint of all-cause death, nonfatal MI, nonfatal stroke, or urgent target vessel revascularization and superior in preventing BARC 3 (Bleeding Academic Research Consortium) or 5 bleeding (coprimary safety endpoint) at 2 years with a 0.025 significance level to preserve nominal 5% alpha error.Methods: An independent clinical event committee adjudicated investigator-reported and eventually unreported events of 7,585 patients from the 20 top-enrolling participating sites.Results: The 2-year coprimary efficacy endpoint occurred in 271 (7.14%) and in 319 (8.41%) patients in the experimental and conventional groups, respectively (rate ratio [RR]: 0.85; 95% confidence interval [CI]: 0.72 to 0.99), fulfilling noninferiority (p noninferiority <0.001), but not superiority (p superiority = 0.0465). The rates of BARC 3 or 5 bleeding did not differ (RR: 1.00; 95% CI: 0.75 to 1.33; p = 0.986). A time-dependent treatment effect was observed with the experimental strategy being associated with a lower risk of MI (RR: 0.54; 95% CI: 0.33 to 0.88; p interaction = 0.062) and definite stent thrombosis (RR: 0.14; 95% CI: 0.03 to 0.63; p interaction = 0.007) after 1-year post-percutaneous coronary intervention.Conclusions: Ticagrelor monotherapy after 1-month DAPT was noninferior, but not superior, to conventional treatment in the prevention of ischemic events, and it did not decrease major bleeding risk as compared with conventional treatment. (GLOBAL LEADERS Adjudication Sub-Study [GLASSY]; NCT03231059). [ABSTRACT FROM AUTHOR]

The Italian Elderly ACS study was the first randomized controlled trial comparing an early aggressive with an initially conservative strategy in patients with non-ST-segment elevation acute coronary syndromes aged = 75 years, with the results showing no significant benefit of early aggressive therapy. The aim of this study was to evaluate the outcomes of trial patients, according to the treatment actually received during hospitalization. The trial enrolled 313 patients. The primary end point was the composite of death, myocardial infarction (MI), disabling stroke, and repeat hospital stay for cardiovascular causes or bleeding within 1 year. All patients in whom coronary angiography was performed during initial hospitalization were defined as having undergone invasive treatment (182 patients), whereas all patients who did not undergo coronary angiography were classified as medically managed (conservative treatment [CT] group, 131 patients). The primary end point occurred in 53 patients (40.5%) in the CT group and 45 patients (24.7%) in the invasive treatment group (hazard ratio 0.56, 95% confidence interval 0.37 to 0.83, p = 0.003). The invasive treatment group showed significantly lower rates of MI (6% vs 13% in the CT group; hazard ratio 0.43, 95% confidence interval 0.20 to 0.92, p = 0.034) and the aggregate of death and MI (14.3% vs 27.5% CT group; hazard ratio 0.48, 95% confidence interval 0.29 to 0.81, p = 0.004). In conclusion, elderly patients with non-ST-segment elevation acute coronary syndromes treated invasively experienced significantly better survival free from the composite of all-cause mortality, nonfatal MI, disabling stroke, and repeat hospitalization for cardiovascular causes or bleeding. [ABSTRACT FROM AUTHOR]

Abstract: Background: To investigate the safety and efficacy of Genous Bio-engineered R stent (GRS) with ≤15-day or >15-day dual antiplatelet therapy (DAT), in patients undergoing percutaneous coronary intervention (PCI), with known or expected low compliance to long-term DAT (Antiplatelet theRapy after Genous EPC-capturing coroNary stenT implantatiOn — ARGENTO Study). Methods: Consecutive patients without ≤12-month revascularization history, known statins allergy, known hypersensitivity reaction or previous or concomitant monoclonal and/or recombinant antibodies therapy, treated with single- or multivessel PCI plus GRS, were prospectively enrolled, at four PCI centers. Major adverse cardiac events (MACEs), the composite of cardiac death, any myocardial infarction (MI) and target vessel revascularization (TVR), and stent thrombosis (ST) cumulative incidences were evaluated. Results: Between March 2008 and March 2010, 384 patients (70.3% male, 423 lesions) were enrolled. At follow-up (22.8±13.6months), 8.6% MACEs, 3.4% cardiac death, 3.4% any MI, 4.7% TVR and 2.3% overall ST (definite/probable ST 1.3%) rates were reported, without differences between ≤15-day and >15-day DAT groups. At Cox multivariable-adjusted regression analysis (Hosmer–Lemeshow statistic, p=0.50) female sex, diabetes, previous PCI history, <45% left ventricular ejection fraction at admission and lesion length were identified as independent MACE predictors. DAT time duration (hazard ratio 1.98; 95% confidence interval 0.57–6.80, p=0.27) was not independent risk factor for MACEs. Conclusions: In consecutive, prospectively enrolled patients with PCI indication and known or supposed low compliance to long-term DAT, GRS implantation might be a safe and effective option regardless of DAT duration after stenting (≤15days or >15days). [Copyright &y& Elsevier]

Abstract: Background: Optimal strategy for patients who need coronary revascularization before undeferrable non-cardiac surgery is still unknown. We performed a pilot study of dual antiplatelet therapy discontinuation followed by major non-cardiac surgery and endovascular aortic repair early after successful endothelial-progenitor cell-capture coronary stent deployment. Methods and results: Thirty consecutive patients underwent coronary angioplasty plus stenting, before upcoming endovascular or surgical procedures requiring early interruption of antiplatelet therapy. An optimal acute procedural result was observed in all patients. Antiplatelet therapy was stopped before surgery in all patients, achieving an average antiplatelet therapy time of 12.2±3.9days. Surgery was performed after antiplatelet therapy interruption at an average time interval from revascularization of 17.2±3.9days. No patient suffered cardiac events during the perioperative period. At thirty day follow-up after surgery there were no cardiac events in all patients. Conclusions: Our preliminary data might suggest a role for EPC-capture stent in patients requiring surgical procedures early after coronary stent placement. Further studies on larger population are needed to confirm the clinical impact of our findings. [ABSTRACT FROM AUTHOR]

Objectives: This study investigated the relationship between beta2-adrenergic receptor (B2AR) Ile164 polymorphism and coronary artery disease (CAD). Background: B2ARs are crucial to the regulation of vascular tone, and neoangiogenesis is impaired in the presence of isoleucine at position 164 (Ile164) B2AR gene polymorphism. No data deal with the role of the variants at position 164 of the B2AR gene in the setting of CAD. Methods: The study population consisted of 330 patients undergoing percutaneous coronary intervention (PCI). Results: The Ile164 polymorphism frequency was higher in CAD (12.1% vs. 3%, p = 0.008) with respect to the control population. We divided our population into 2 groups: group 1 (290 patients, threonine/threonine genotype at position 164 [164Thr/Thr]) and group 2 (40 patients, threonine/isoleucine genotype at position 164 [164Thr/Ile]). Patients of group 2 presented an earlier onset of CAD (56.7 ± 7.8 vs. 59.5 ± 10, p = 0.04) and a higher incidence of multivessel disease (25.4% vs. 41%, p = 0.044). At follow-up, group 2 showed a higher incidence of new acute myocardial infarction (17.5% vs. 4.5%, p = 0.001), new PCI (37.5% vs. 13.1%, p < 0.0001), and cardiac death (10% vs. 3.1%, p = 0.036). Cox regression analysis identified Ile164 as an independent predictor of cardiac death (odds ratio [OR]: 3.731, 95% confidence interval [CI]: 1.004 to 13.867, p = 0.049) and an overall major adverse cardiac event (OR: 4.100, 95% CI: 1.945 to 8.640, p = 0.0001). A replication study was done on a population of 150 patients with peripheral artery disease. The presence of the Ile164 allele was associated with a higher incidence of acute myocardial infarction (54.5% vs. 25.2%, p = 0.035) or combined events (acute myocardial infarction, PCI, or coronary artery bypass graft) (63.6% vs. 30.9%, p = 0.027). Conclusions: Our study suggests that the B2AR Ile164 mutant is associated with a more aggressive CAD and adversely affects prognosis in patients undergoing PCI. [Copyright &y& Elsevier]