The Impact of the Second Generation Everolimus-eluting Stent in Daily Clinical Practice

Clinical studies with first-generation sirolimus-eluting stents (SES) and paclitaxel- eluting stents (PES) have demonstrate a dramatic reduction in restenosis rates compared with bare-metal stents (BMS)1,2, however, reintervention rates were still high in patients with complex coronary artery disease3, and an ongoing propensity for stent thrombosis (ST) beyond one year raised further concerns regarding safety issues with these devices4. Furthermore, as both of these devices were relatively high-profile stainless steel stents, they were difficult to deliver in complex anatomy, and the SES in particular was prone to a high fracture rate, contributing to late adverse events. The everolimus-eluting stent (EES), (XIENCE V, Abbott Vascular, CA, USA; also distributed as the PROMUS stent by Boston Scientific, MA, USA) is a secondgeneration drug-eluting stent (DES) designed to overcome the limitations of earlier DES

Coronary plaque redistribution after stent implantation is determined by lipid composition: A NIRS-IVUS analysis

Background: The composition of plaque impacts the results of stenting. The following study evaluated plaque redistribution related to stent implantation using combined near-infrared spectroscopy and intravascular ultrasound (NIRS-IVUS) imaging. Methods: The present study included 49 patients (mean age 66 ± 11 years, 75% males) presenting with non-ST elevation myocardial infarction (8%), unstable angina (49%) and stable coronary artery disease (43%). The following parameters were analyzed: mean plaque volume (MPV, mm3), plaque burden (PB, %), remodeling index (RI), and maximal lipid core burden index in a 4 mm segment (maxLCBI4mm). High-lipid burden lesions (HLB) were defined as by maxLCBI4mm > 265 with positive RI. Otherwise plaques were defined as low-lipid burden lesions (LLB). Measurements were done in the target lesion and in 4 mm edges of the stent before and after stent implantation. Results: MPV and maxLCBI4mm decreased in both HLB (MPV 144.70 [80.47, 274.25] vs. 97.60 [56.82, 223.45]; maxLCBI4mm: 564.11 ± 166.82 vs. 258.11 ± 234.24, p = 0.004) and LLB (MPV: 124.50 [68.00, 186.20] vs. 101.10 [67.87, 165.95]; maxLCBI4mm: 339.07 ± 268.22 vs. 124.60 ± 160.96, p < 0.001), but MPV decrease was greater in HLB (28.00 [22.60, 57.10] vs. 13.50 [1.50, 28.84], p = 0.019). Only at the proximal stent edge of LLB, maxLCBI4mm decreased (34 [0, 207] vs. 0 [0, 45], p = 0.049) and plaque burden increased (45.48 [40.34, 51.55] vs. 51.75 [47.48, 55.76], p = 0.030). Conclusions: NIRS-IVUS defined HLB characterized more significant decreases in plaque volume by stenting. Plaque redistribution to the proximal edge of the implanted stent occurred only in LLB

Combined optical coherence tomography morphologic and fractional flow reserve hemodynamic assessment of non- culprit lesions to better predict adverse event outcomes in diabetes mellitus patients: COMBINE (OCT–FFR) prospective study. Rationale and design

Contains fulltext : 172158.pdf (publisher's version ) (Open Access)BACKGROUND: Fractional flow reserve (FFR) is a widely used tool for the identification of ischaemia-generating stenoses and to guide decisions on coronary revascularisation. However, the safety of FFR-based decisions in high-risk subsets, such as patients with Diabetes Mellitus (DM) or vulnerable stenoses presenting thin-cap fibro-atheroma (TCFA), is unknown. This study will examine the impact of optical coherence tomography (OCT) plaque morphological assessment and the identification of TCFA, in combination with FFR to better predict clinical outcomes in DM patients. METHODS: COMBINE (OCT-FFR) is a prospective, multi-centre study investigating the natural history of DM patients with >/=1 angiographically intermediate target lesion in three subgroups of patients; patients with FFR negative lesions without TCFA (group A) and patients with FFR negative lesions with TCFA (group B) as detected by OCT and to compare these two groups with each other, as well as to a third group with FFR-positive, PCI-treated intermediate lesions (group C). The study hypothesis is that DM patients with TCFA (group B) have a worse outcome than those without TCFA (group A) and also when compared to those patients with lesions FFR </=0.80 who underwent complete revascularisation. The primary endpoint is the incidence of target lesion major adverse cardiac events (MACE); a composite of cardiac death, myocardial infarction or rehospitalisation for unstable/progressive angina in group B vs. group A. CONCLUSION: COMBINE (OCT-FFR) is the first prospective study to examine whether the addition of OCT plaque morphological evaluation to FFR haemodynamic assessment of intermediate lesions in DM patients will better predict MACE and possibly lead to new revascularisation strategies. Trial Registration Netherlands Trial Register: NTR5376

Optimal Timing of Coronary Invasive Strategy in Non–ST-Segment Elevation Acute Coronary Syndromes

Background: The optimal timing of coronary intervention in patients with non–ST-segment elevation acute coronary syndromes (NSTE-ACSs) is a matter of debate. Conflicting results among published studies partly relate to different risk profiles of the studied populations. Purpose: To do the most comprehensive meta-analysis of current evidence on early versus delayed invasive treatment in NSTE-ACS. Data Sources: MEDLINE, PubMed Central, and Google Scholar databases; conference proceedings; ClinicalTrials.gov registry; and Current Controlled Trials registry through May 2012. Study Selection: Available randomized, controlled trials (RCTs) and observational studies comparing early versus delayed intervention in the NSTE-ACS population. Data Extraction: Data were extracted for populations, interventions, outcomes, and risk of bias. All-cause mortality was the prespecified primary end point. The longest follow-up available in each study was chosen. The odds ratio with 95% CI was the effect measure. Data Synthesis: Seven RCTs (5370 patients) and 4 observational studies (77 499 patients) were included. Early intervention was less than 20 hours after hospitalization or randomization for RCTs and 24 hours or less for observational studies. Meta-analysis of the RCTs was inconclusive for a survival benefit associated with the early invasive strategy (odds ratio, 0.83 [95% CI, 0.64 to 1.09]; P 0.180); a similar result emerged from the observational studies. With early versus late intervention, the odds ratios in the RCTs were 1.15 (CI, 0.65 to 2.01; P 0.63) and 0.76 (CI, 0.56 to 1.04; P 0.090) for myocardial infarction and major bleeding during follow-up, respectively. Limitation: Current evidence from RCTs is limited by the small overall sample size, low numbers of events in some trials, and heterogeneity in the timing of intervention and in patient risk profiles. Conclusion: At present, there is insufficient evidence either in favor of or against an early invasive approach in the NSTE-ACS population. A more definitive RCT is warranted to guide clinical practice. Primary Funding Source: None

Paclitaxel Drug-Coated Balloon for the Treatment of De Novo Small-Vessel and Restenotic Coronary Artery Lesions: 12-Month Results of the Prospective, Multicenter, Single-Arm PREVAIL Study.

peer reviewedOBJECTIVES: The PREVAIL study evaluated the safety and effectiveness of a paclitaxel-coated percutaneous transluminal coronary angioplasty balloon catheter for the treatment of coronary de novo and in-stent restenosis (ISR) lesions in patients with symptomatic ischemic heart disease. METHODS: PREVAIL was a prospective, multicenter, single-arm study that enrolled patients with clinical evidence of ischemia who had coronary lesions (de novo or first ISR) amenable to treatment with a drug-coated balloon (DCB). The study included 50 subjects (53 target lesions) who were treated with a Prevail DCB (Medtronic) during the index procedure and followed for 12 months. Mean lesion length was 14.5 ± 7.6 mm. The primary endpoint was in-stent (in-balloon) late lumen loss (LLL) by quantitative coronary angiography at 6 months post procedure. If the mean in-stent (in-balloon) LLL was less than the maximum acceptance rate of 0.50 mm at 6 months, then the study was considered successful. RESULTS: Mean in-stent (in-balloon) LLL was 0.05 ± 0.44 mm at 6 months post procedure. There were no deaths, myocardial infarctions, or stent (lesion) thrombosis events within 12 months. The incidence of clinically driven target-lesion revascularization was 6.0% at 12 months and clinically driven target-vessel revascularization was 10.0%. CONCLUSIONS: Paclitaxel DCB treatment of coronary de novo and first ISR lesions led to low LLL at 6 months and low rates of revascularization and safety events through 12 months

Safety and efficacy of embolic protection devices in saphenous vein graft interventions : a propensity score analysis-multicenter SVG PCI PROTECTA study

Background: Evidence concerning the efficacy of the embolic protection devices (EPDs) in saphenous vein graft (SVG) percutaneous coronary intervention (PCI) is sparse. The study was designed to compare major cardiovascular events of all-comer population of SVG PCI with and without EPDs at one year of follow-up. Methods and results: A multi-center registry comparing PCI with and without EPDs in consecutive patients undergoing PCI of SVG. The group comprised 792 patients, among which 266 (33.6%) had myocardial infarction (MI). The primary composite endpoint was major adverse cardiac and cerebrovascular event (MACCE) defined as death, MI, target vessel revascularization (TVR), and stroke assessed at one year. After propensity score analysis, there were no differences in MACCE (21.9% vs. 23.9%; HR 0.91, 95% CI 0.57–1.45, p = 0.681, respectively) nor in secondary endpoints of death, MI, TVR, target lesion revascularization (TLR) and stroke at one year in EPDs PCI group vs. no-EPDs PCI group. Similarly, there were no differences between groups in the study endpoints at 30 days follow-up. Conclusions: There were no clinical benefit for routine use of EPDs during SVG PCI in short and long-term follow-up. Further studies are warranted to explore the effect of individual types of EPDs on clinical outcomes

Resolute zotarolimus‐eluting stent in ST‐elevation myocardial infarction (resolute‐STEMI): A prespecified prospective register from the DAPT‐STEMI trial

To evaluate the safety and efficacy outcomes after primary percutaneous coronary intervention (pPCI) with second‐generation Resolute™ zotarolimus‐eluting stent (R‐ ZES) in patients enrolled in the DAPT‐STEMI Trial (NCT01459627).Background: R‐ ZES is one of the most used drug eluting stents worldwide. To date, the safety and efficacy data of this stent in setting of STEMI is limited.Methods: The Resolute‐STEMI is a prespecified prospective register that reports the safety and efficacy of R‐ZES in setting of ST‐Elevation Myocardial Infarction (STEMI) at 6 months for the following endpoints: a composite endpoint of all‐cause mortality, any myocardial infarction (MI), any (unscheduled) revascularization, stroke and TIMI major bleeding, as well as target lesion failure and stent thrombosis (ST).Results: From a total of 1,100 STEMI patients enrolled in the trial, 998 received a R‐ZES. At 6 months the PE occurred in 42 (4.2%) patients. All‐cause death, MI, revascularization, stroke and TIMI major bleeding was respectively 8 (0.8%), 9 (0.8%), 34 (3.4%), 2 (0.2%), and 4 (0.4%). The rate of target lesion revascularizations involving the culprit lesion was 1.1%. Target lesion failure was 1.5%. The rate of definite ST was 0.5%. The rate of both definite or probable ST was 0.7%.Conclusions: The present analysis is the largest to date reporting short‐ term and mid‐term clinical outcomes with the R‐ZES stent in setting of STEMI. At 30  days and 6‐months R‐ZES has an outstanding safety and efficacy even in this high‐ risk category of patients

Polymer-based or polymer-free stents in patients at high bleeding risk

Background: polymer-free drug-coated stents provide superior clinical outcomes to bare-metal stents in patients at high bleeding risk who undergo percutaneous coronary intervention (PCI) and are treated with 1 month of dual antiplatelet therapy. Data on the use of polymer-based drug-eluting stents, as compared with polymer-free drug-coated stents, in such patients are limited. Methods: in an international, randomized, single-blind trial, we compared polymer-based zotarolimus-eluting stents with polymer-free umirolimus-coated stents in patients at high bleeding risk. After PCI, patients were treated with 1 month of dual antiplatelet therapy, followed by single antiplatelet therapy. The primary outcome was a safety composite of death from cardiac causes, myocardial infarction, or stent thrombosis at 1 year. The principal secondary outcome was target-lesion failure, an effectiveness composite of death from cardiac causes, target-vessel myocardial infarction, or clinically indicated target-lesion revascularization. Both outcomes were powered for noninferiority. Results: a total of 1996 patients at high bleeding risk were randomly assigned in a 1:1 ratio to receive zotarolimus-eluting stents (1003 patients) or polymer-free drug-coated stents (993 patients). At 1 year, the primary outcome was observed in 169 of 988 patients (17.1%) in the zotarolimus-eluting stent group and in 164 of 969 (16.9%) in the polymer-free drug-coated stent group (risk difference, 0.2 percentage points; upper boundary of the one-sided 97.5% confidence interval [CI], 3.5; noninferiority margin, 4.1; P = 0.01 for noninferiority). The principal secondary outcome was observed in 174 patients (17.6%) in the zotarolimus-eluting stent group and in 169 (17.4%) in the polymer-free drug-coated stent group (risk difference, 0.2 percentage points; upper boundary of the one-sided 97.5% CI, 3.5; noninferiority margin, 4.4; P = 0.007 for noninferiority). Conclusions: among patients at high bleeding risk who received 1 month of dual antiplatelet therapy after PCI, use of polymer-based zotarolimus-eluting stents was noninferior to use of polymer-free drug-coated stents with regard to safety and effectiveness composite outcomes. (Funded by Medtronic; ONYX ONE ClinicalTrials.gov number, NCT03344653.)

Impact of renin-angiotensin system inhibitors on mortality during the COVID Pandemic among STEMI patients undergoing mechanical reperfusion : Insight from an international STEMI registry

Background: Concerns have been raised on a potential interaction between renin-angiotensin system inhibitors (RASI) and the susceptibility to coronavirus disease 2019 (COVID-19). No data have been so far reported on the prognostic impact of RASI in patients suffering from ST-elevation myocardial infarction (STEMI) during COVID-19 pandemic, which was the aim of the present study. Methods: STEMI patients treated with primary percutaneous coronary intervention (PPCI) and enrolled in the ISACS-STEMI COVID-19 registry were included in the present sub-analysis and divided according to RASI therapy at admission. Results: Our population is represented by 6095 patients, of whom 3654 admitted in 2019 and 2441 in 2020. No difference in the prevalence of SARSCoV2 infection was observed according to RASI therapy at admission (2.5% vs 2.1%, p = 0.5), which was associated with a significantly lower mortality (adjusted OR [95% CI]=0.68 [0.51 & ndash;0.90], P = 0.006), confirmed in the analysis restricted to 2020 (adjusted OR [95% CI]=0.5[0.33 & ndash;0.74], P = 0.001). Among the 5388 patients in whom data on in-hospital medication were available, in-hospital RASI therapy was associated with a significantly lower mortality (2.1% vs 16.7%, OR [95% CI]=0.11 [0.084 & ndash;0.14], p < 0.0001), confirmed after adjustment in both periods. Among the 62 SARSCoV-2 positive patients, RASI therapy, both at admission or in-hospital, showed no prognostic effect. Conclusions: This is the first study to investigate the impact of RASI therapy on the prognosis and SARSCoV2 infection of STEMI patients undergoing PPCI during the COVID-19 pandemic. Both pre-admission and in-hospital RASI were associated with lower mortality. Among SARSCoV2-positive patients, both chronic and in-hospital RASI therapy showed no impact on survival.Peer reviewe