Need For Target Vessel Revascularization Research Articles

Procedural and long-term outcomes of stent post dilatation during primary percutaneous coronary interventions

Abstract Background The role of stent post dilatation (SPD) during primary percutaneous intervention (PPCI) is controversial. Currently there are no clear guidelines or consensus regarding when to perform SPD and it is left to the operator decision. Purpose The aim of this study was to evaluate the procedural and long terms outcomes of SPD during PPCI. Methods We collected retrospectively data of 614 STEMI patients who presented to two tertiary centers during one year period. All patients underwent PPCI. We excluded patients with cardiogenic shock, prior CABG, severe LM disease. Patients were divided into two groups according to SPD procedure. Group 1: who had SPD included 424 patients (69.1%). Group 2: no SPD included 190 patients (30.9%). Both groups were well matched with regard to demographic data and lesion characteristics. Procedural outcomes and clinical outcomes at one year were collected. Results SPD patients had significantly higher incidence of no reflow during the procedure (33.7% in group 1 vs. 21.6% in group 2, P=0.026), but the final TIMI flow was similar between two groups. Also, there was no significant difference between two groups regarding other procedural outcomes as dissection, perforation, or cardiac death. After one year follow up SPD patients had significantly higher incidence of reinfarction (5.6% of group 1 vs. 1.5% in group 2, P=0.03) and significantly more target vessel revascularization (TVR) (16.7% in group 1 vs. 4.7% in group 2 P<0.001). There was no significant difference between the two groups regarding the incidence cerebrovascular stroke (CVS), heart failure or cardiac death. Conclusion Our study shows that SPD during PPCI is associated with an increased risk of procedural no reflow and increased risk of reinfarction as well as need for TVR after 1 year follow up. Finally, SPD did not improve clinical outcomes after 1 year follow up. Nonetheless, large-scale randomized trials are required to establish the role of SPD during PPCI. Funding Acknowledgement Type of funding sources: None.

Distribution and prognostic impact of coronary artery disease and nonischemic cardiomyopathies in patients with electrical storm.

he distribution and prognostic impact of coronary artery disease (CAD) in ES are still under debate. Consecutive ES patients with implantable cardioverter-defibrillator (ICD) were included retrospectively from 2002 to 2016. Three analyses were applied to characterize ES patients: (a) ES patients without CAD (non-CAD), (b) ES patients with CAD (CAD), and (c) diagnostic findings assessed by coronary angiography (CA) at the time of ES (immediate CA). CAD was compared with non-CAD ES patients, and progressive CAD was compared with stable CAD ES patients. The primary endpoint was all-cause mortality at 2.5 years. Secondary endpoints were the composite endpoint of first recurrent ventricular tachyarrhythmias and appropriate ICD therapies, and recurrence of ES (ES-R) at 2.5 years. Within a total of 87 consecutive ES patients. CAD was present in more than two-thirds (67%). However, only 52% patients underwent immediate CA at the time of ES. Here, 84% had CAD, of which 39% revealed progressive CAD with the need of target vessel revascularization (TVR) or cardiac transplantation ( n = 1). At long-term follow-up, neither the presence (or absence) of CAD (41% vs. 34%; log rank P = 0.708) nor of progressive CAD (33% vs. 26%; log rank P = 0.372) was associated with all-cause mortality at 2.5 years, and further secondary endpoints including the composite of recurrent ventricular tachyarrhythmias plus appropriate ICD therapies, or ES-R. In ES patients, CAD was more common than non-CAD-related cardiac diseases, accompanied by an underinvestigated rate of CA despite increasing rates of progressive CAD. CAD had no prognostic impact in ES.

Safety and efficacy of the polymer-free and polymer-coated drug-eluting stents in patients undergoing percutaneous coronary intervention.

The relative safety and efficacy of polymer-free (PF) versus polymer-coated (PC) drug-eluting stents (DES) in patients with angina or acute coronary syndrome (ACS) undergoing percutaneous coronary intervention has received limited study. Digital databases were queried to identify relevant studies. Major adverse cardiovascular events (MACE) and secondary outcomes were compared using a random effect model to calculate unadjusted odds ratios (OR). A total of 28 studies consisting of 23,198 patients were included in the final analysis. On pooled analysis, there was no significant difference in the odds of MACE (OR 0.98, 95% CI 0.91-1.08) and major bleeding (OR 0.87, 95% CI 0.61-1.24) between patients undergoing PF-DES versus PC-DES. Similarly, the odds of myocardial infarction, stroke, stent thrombosis, cardiovascular mortality and need for target vessel revascularization was similar between the two groups. PF-DES was favored due to significantly lower odds of non-cardiac death (OR 0.78, 95% CI 0.68-89) and all-cause mortality (OR 0.87, 95% CI 0.80-0.95), but had a higher need for target lesion revascularization (OR 1.2, 95% CI 1.02-1.42). A subgroup analysis based on follow up duration, clinical presentation, presence of diabetes and class of eluting drugs mirrored the net estimates for all outcomes with a few exceptions. A sensitivity and meta-regression analysis showed no influence of single-study and duration of antiplatelet therapy on pooled outcomes. In patients presenting with angina or ACS, PF-DES might be favored due to lower all-cause mortality and equal risk of ischemic adverse cardiovascular and major bleeding events compared with PC-DES.

Association of stent diameter and target vessel revascularization in patients undergoing percutaneous coronary intervention: a secondary retrospective analysis based on a Chinese cohort study

BackgroundIn the treatment of coronary heart disease, target vessel revascularization (TVR) has attracted increasing attention as an efficient means of percutaneous coronary intervention (PCI). The purpose of this study was to explore the association between stent diameter and TVR in patients undergoing PCI.MethodsThis was a secondary retrospective analysis involving patients with PCI with at least one stent implanted. Information was obtained from the Dryad Digital Repository. Multivariable logistic regression models, interaction analyses, subgroup analyses and piecewise linear regression models were used to evaluate the association between stent diameter and TVR.ResultsA total of 2522 patients were eventually enrolled in this study, of which 122 (4.8%) had undergone TVR. Significant positive associations were observed between stent diameter and TVR (continuous: odds ratio [OR] 0.485, 95% confidence interval [CI] 0.305–0.773, P = 0.002; categorical variable: T2 vs. T1, OR 0.541, 95% CI 0.348–0.843; T3 vs. T1, OR 0.520, 95% CI 0.334–0.809; P for trend = 0.005). The association remained stable in the fully adjusted model (continuous: OR 0.526, 95% CI 0.306–0.902, P = 0.020; categorical variable: T2 vs. T1, OR 0.510, 95% CI 0.310–0.839; T3 vs. T1, OR 0.585, 95% CI 0.352–0.973; P for trend = 0.042). Among the subgroups of differing clinical presentations, stent diameter was a powerful protective factor for TVR, especially in the delayed PCI group (P for interaction = 0.002). The association was highly consistent across all the other subgroups studied (all P for interaction > 0.05). In the piecewise linear regression model, the need for TVR decreased with an increase in stent diameter when this ranged between 2.5 and 2.9 mm (OR 0.01, 95% CI: 0.01–0.13, P < 0.001).ConclusionsA large stent diameter is a powerful protective factor for TVR in PCI patients, especially in the delayed PCI group. This “bigger-is-better” protective effect is remarkable in stents with diameter 2.5–2.9 mm.

Diabetes mellitus associated with an increased risk of percutaneous coronary intervention long-term adverse outcomes in Taiwan: A nationwide population-based cohort study

AimsThis study compared the incidence rates of patients with diabetes mellitus (DM) and patients without DM with percutaneous coronary intervention (PCI) in a national population-based cohort to determine if the patients with DM have an increased risk of adverse outcomes. MethodsWe performed a retrospective cohort study among 92,624 patients with and without DM, who underwent PCI for the first time in 2000–2008. The patients were identified from National Health Insurance Program Database through propensity score matching. Endpoints were the occurrence of PCI adverse outcomes, including myocardial infarction (MI), need for target vessel revascularization by either bypass surgery or repeat PCI, all-cause mortality or 2011/12/31. Incidence rate was calculated and hazard ratios of PCI adverse events were estimated using Cox's proportional hazard regression model. ResultsDuring the mean six-year follow up, the rates of MI (incidence rate 20.96 vs. 15.59 per 1000 person-years), bypass surgery (incidence rate 8.15 vs. 5.15 per 1000 person-years), all-cause mortality (incidence rate 6.20 vs. 4.72 per 1000 person-years), and the composite measure of MI, repeat PCI, bypass surgery, all-cause mortality (incidence rate 37.31 vs. 28.14 per 1000 person-years) were higher in patients with DM. The corresponding hazard ratios (HRs) and their 95% confidence intervals (CIs) were 1.34 (95% CI: 1.29, 1.39), 1.46 (1.38, 1.56), 1.34 (1.25, 1.44), and 1.31 (1.27, 1.35). However, the repeat PCI rate (incidence rate 2.65 vs. 2.70 per 1000 person-years); with an adjusted HR of 0.97 (0.88, 1.07) was not statistically different. ConclusionsThis nationwide retrospective cohort study determined a positive correlation between PCI adverse events and DM. As the prevalence of DM and PCI continues to increase, novel treatments and intensified surveillance coronary angiography for high risk patients are needed.

Two year efficacy and safety of small versus large ABSORB bioresorbable vascular scaffolds of ≤18 mm device length: A subgroup analysis of the German-Austrian ABSORB RegIstRy (GABI-R)

AimsThe ABSORB bioresorbable vascular scaffold raised safety concerns due to higher rates of scaffold thrombosis (ScT) and adequate scaffold diameter and length for scaffold technology. Smaller scaffold diameter (SScD, 2.5 mm) was an infrequently quoted predictor of major adverse cardiac events (MACE). Therefore, we evaluated the impact of SScD compared to large scaffold diameter (LScD, ≥3 mm) of ≤18 mm device length on 2 year outcome in the all-comer real life GABI-R cohort. Methods and ResultsWe compared patients with implanted LScD (1341 patients) vs. SScD (444 patients) of ≤18 mm device length. Patients with LScD more often presented with ST-elevation myocardial infarction (35.8% vs. 20.6%, p < 0.0001) and single-vessel disease (50.6% vs. 36.5% p < 0.0001). After a 24 months follow-up, there was no difference in regard of MACE (9.66% vs. 12.31%, p = 0.14) or definite/probable ST (2.47% vs. 2.82%, p = 0.71). Despite no difference in target lesion revascularisations (TLR) (5.81% vs. 7.71%, p = 0.18), there was a higher need for target vessel revascularisation (TVR) in the SScD-group (11.57% vs. 7.51%, p < 0.05). ConclusionCompared to LScD, SScD of ≤18 mm device length demonstrated comparable safety in regard to MACE and ScT as well as efficacy in regard to TLR. Resorbable scaffold technology should not be restricted to large vessel diameters. Clinical Trial Registrationhttps://clinicaltrials.gov/ct2/show/NCT02066623.

836 Identification of Risk Factors for Failure of a Deferred Revascularisation Strategy in Patients With Fractional Flow Reserve >0.8

Current practice suggests deferring the revascularisation of stable coronary artery lesions with an fractional flow reserve (FFR) >0.8. However, in an audit of a tertiary Australian hospital database, we found that over an 8 year follow-up period, 12.9% of patients with an FFR >0.8 required target vessel revascularisation (TVR). The purpose of this follow-up was to identify possible risk factors for TVR in patients with an FFR >0.8. From 2008-2015 at a tertiary Australian hospital, 243 patients were audited and 61 patients with stable coronary artery disease and an FFR >0.8 were analysed. Risk factors/comorbidities for accelerated ischemic heart disease were identified: diabetes, hypertension, dyslipidemia, smoking status and obesity. Long term follow-up of the need for TVR was determined with an average follow-up of 65 months. During this 8 year period, there were 8 patients with an FFR >0.8 that required TVR. Analysis was performed on both an individual risk factor basis and the comorbidities which were grouped into either 0 comorbidities, 1 to 2 comorbidities or ≥3 comorbidities. Patients that required TVR within the 5 year follow-up were significantly more likely to have at least 3 comorbidities (75.0% v 24.5 %; p=0.009). When patients with an FFR >0.8 were stratified based on the number of comorbidities, there was a significant trend that demonstrated that a greater number of risk factors predicted failure of a non-revascularisation strategy.

3286Fractional flow reserve-guided treatment strategy for left main coronary artery stenoses. Ten-year clinical outcome

Abstract Background Revascularization decisions regarding left main (LM) coronary stenoses are often very challenging. Non-invasive tests can yield false negative results. On the other hand, some technical aspects of fractional flow reserve (FFR) measurement, as well as the interpretation of their results, are less codified than for other coronary segments. Purpose To investigate the 10-year clinical outcome of patients with isolated angiographically intermediate LM coronary stenosis in whom the treatment strategy was based on Fractional Flow Reserve (FFR) measurements. Methods From 1999 to 2009 we included 96 patients with isolated intermediate LM coronary disease (DS% 30–70%) evaluated with FFR measurement. When FFR was &gt;0.80, patients were deferred to medical therapy (Deferral-group, n=71). When FFR was ≤0.8, surgical revascularization therapy was proposed (Revascularization-group, n=25). Death, the occurrence of myocardial infarction (MI) and the need for target vessel revascularization (TVR) were evaluated in both groups. Results There were no significant differences in clinical characteristics between the 2 groups. Mean DS% was 35% in the Deferral-group and 43% in the Revascularization-group (p&lt;0.01). Average FFR was 0.88 in the Deferral-group and 0.71 in the Revascularization-group (p&lt;0.01). In the latter, the 10-year survival estimate was 72% while it was 77% in the Deferral group (HR [95% CI]: 1.28 [0.53–3.10]; p=NS). No difference was found between the 2 groups in terms of MI (4.5% vs. 1.6%; HR [95% CI]: 3.5 [0.22–56.0]; p=NS) or TVR (9% vs. 12%; HR [95% CI]: 0.94 [0.20–4.43]; p=NS). Conclusions The use of FFR to defer revascularization in patients with non-significant isolated LM stenosis is safe and is associated with favourable clinical outcome at 10 years.

Long-term clinical outcome and graft patency of radial artery and saphenous vein grafts in multiple arterial revascularization

ObjectiveThe long-term benefits of multiple arterial revascularization (MAR) in coronary artery bypass grafting remain uncertain. The aim of this study was to investigate the clinical outcome, graft patency, and need for subsequent target revascularization of radial artery (RA) versus saphenous vein graft in patients undergoing MAR in both patient- and graft-specific analyses. MethodsBetween 2001 and 2016, we followed 1654 patients over a median of 7.4 years in a prospective, longitudinal study. Major adverse cardiac and cerebrovascular events, graft patency, and need for revascularization were assessed through clinical manifestation, coronary angiography, or coronary computed tomography and analyzed with propensity score–adjusted Cox regression, general estimating equation, and competing risk models. ResultsBilateral internal thoracic artery (BITA) grafting was performed in 910 patients (55.0%), and 744 patients (45.0%) received a left internal thoracic artery graft together with at least 1 RA graft. Patients receiving BITA, of whom 187 received an additional RA, showed improved survival (hazard ratio, 0.57; 95% confidence interval [CI], 0.38-0.86; P = .009), major adverse cardiac and cerebrovascular event–free survival (hazard ratio, 0.33; 95% CI, 0.23-0.46; P < .001), and lower need for repeat revascularization (subhzhard ratio, 0.59; 95% CI, 0.39-0.90; P = .015). In a subgroup of 512 patients, comparing 419 RA with 487 saphenous vein grafts, RA grafting showed a lower risk for graft occlusion (odds ratio, 0.59; 95% CI, 0.47-0.73; P < .001) and target revascularization (subhazard ratio, 0.58; 95% CI, 0.43-0.78; P < .001). ConclusionsMAR with BITA and RA grafting revealed to be the recommended strategy in coronary artery bypass grafting to achieve long-term beneficial results. The use of saphenous vein graft showed less favorable outcomes regarding patency and the need for target-vessel revascularization.

Prognostic Value of Chronic Kidney Disease in Acute Coronary Syndrome Patients Treated with Percutaneous Coronary Intervention

&lt;p&gt;&lt;strong&gt;Objective:&lt;/strong&gt;Impact of renal impairment (RI) on short&amp;amp;long term outcome of percutaneous coronary intervention (PCI) in patients with ACS.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods:&lt;/strong&gt; 427 patients with ACS, treated with PCI .They were classified into 4 groups (normal , mild, moderate and severe renal impairment) based on creatinine clearance (eCrCl).MACE including death, new myocardial infarction (MI) and target vessel revascularization (TVR) were recorded during early (30 days) and late for average 49months.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results:&lt;/strong&gt;Patients with severe RI had higher number of vessels affected (p 0.023), lower grade of TIMI flow(p0.029), lower percent dilatation of culprit lesion( p&amp;lt;0.001), less frequent use of GPIIb/IIIa inhibitors(p0.002) and more frequent need for TVR(p0.03). eCrCl had positive correlation with EF and percent dilatation of stenotic lesion (p,0.001)and negative correlation with number of vessels &amp;amp; late MACE(p0.001).Patients with severe RI had increase in frequency of lateMACE compared to other groups(p0.001).TypeC lesions were more common in patients with advanced RI(p0.03).MACE free survival showed significant decline matching the decline in eCrCl among study groups.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusion:&lt;/strong&gt; PCI outcome in patients with severe RI was suboptimal.They had increased riskof TVR within one month and increased riskof MI,death and total MACE on the long term.&lt;/p&gt;

Everolimus-Eluting Stents in Patients With Bare-Metal and Drug-Eluting In-Stent Restenosis: Results From a Patient-Level Pooled Analysis of the RIBS IV and V Trials.

Treatment of patients with drug-eluting stent (DES) in-stent restenosis (ISR) is more challenging than that of patients with bare-metal stent ISR. However, the results of everolimus-eluting stents (EES) in these distinct scenarios remain unsettled. A pooled analysis of the RIBS IV (Restenosis Intra-Stent of Drug-Eluting Stents: Paclitaxel-Eluting Balloon vs Everolimus-Eluting Stent) and RIBS V (Restenosis Intra-Stent of Bare Metal Stents: Paclitaxel-Eluting Balloon vs Everolimus-Eluting Stent) randomized trials was performed using patient-level data to compare the efficacy of EES in bare-metal stent ISR and DES-ISR. Inclusion and exclusion criteria were identical in both trials. Results of 94 patients treated with EES for bare-metal stent ISR were compared with those of 155 patients treated with EES for DES-ISR. Baseline characteristics were more adverse in patients with DES-ISR, although they presented later and more frequently with a focal pattern. After intervention, minimal lumen diameter (2.22±0.5 versus 2.38±0.5 mm, P=0.01) was smaller in the DES-ISR group. Late angiographic findings (89.3% of eligible patients), including minimal lumen diameter (2.03±0.7 versus 2.36±0.6 mm, P<0.001) and diameter stenosis (23±22 versus 13±17%, P<0.001) were poorer in patients with DES-ISR. Results were consistent in the in-segment and in-lesion analyses. On multiple linear regression analysis, minimal lumen diameter at follow-up remained significantly smaller in patients with DES-ISR. Finally, at 1-year clinical follow-up (100% of patients), mortality (2.6 versus 0%, P<0.01) and need for target vessel revascularization (8 versus 2%, P=0.03) were higher in the DES-ISR group. This patient-level pooled analysis of the RIBS IV and RIBS V randomized clinical trials suggests that EES provide favorable outcomes in patients with ISR. However, the results of EES are less satisfactory in patients with DES-ISR than in those with bare-metal stent ISR. URL: http://www.clinicaltrials.gov. Unique identifiers: NCT01239953 and NCT01239940.

Comparison of the Efficacy of Everolimus-Eluting Stents Versus Drug-Eluting Balloons in Patients With In-Stent Restenosis (from the RIBS IV and V Randomized Clinical Trials)

Treatment of patients with in-stent restenosis (ISR) remains a challenge. This study sought to compare the efficacy of everolimus-eluting stents (EESs) and drug-eluting balloons (DEBs) with paclitaxel in patients with ISR. A pooled analysis of the Restenosis Intra-Stent of Drug-Eluting Stents: Drug-Eluting Balloon vs Everolimus-Eluting Stent (RIBS IV) and Restenosis Intra-Stent of Bare-Metal Stents: Drug-Eluting Balloon vs Everolimus-Eluting Stent (RIBS V) randomized trials was performed using patient-level data. In both trials, EESs were compared with DEBs in patients with ISR (RIBS V included 189 patients with bare-metal ISR; RIBS IV included 309 patients with drug-eluting ISR). Inclusion and exclusion criteria were identical in both trials. A total of 249 patients were allocated to EES and 249 to DEB. Clinical follow-up at 1 year was obtained in all (100%) patients and late angiography (median 249 days) in 91% of eligible patients. Compared with patients treated with DEBs, patients treated with EESs obtained better short-term results (postprocedural minimal lumen diameter 2.28 ± 0.5 vs 2.12 ± 0.4 mm, p <0.0001). At follow-up, patients treated with EESs had larger in-segment minimal lumen diameter (primary end point 2.16 ± 0.7 vs 1.88 ± 0.6 mm, p <0.0001; absolute mean difference 0.28 mm; 95% confidence interval [CI] 0.16 to 0.40) and net lumen gain (1.33 ± 0.6 vs 1.00 ± 0.7 mm, p <0.0001) and had lower %diameter stenosis (19 ± 21% vs 28 ± 22%, p <0.0001) and binary restenosis rate (8.7% vs 15.7%, p = 0.02). Consistent results were observed in the in-lesion analysis. No interactions were found between the underlying stent type and treatment effects. At 1-year clinical follow-up, the composite of cardiac death, myocardial infarction, and target vessel revascularization was significantly reduced in the EES arm (8.8% vs 14.5%, p = 0.03; hazard ratio 0.59, 95% CI 0.31 to 0.94) mainly driven by a lower need for target vessel revascularization (6% vs 12.4%, p = 0.01, hazard ratio 0.46, 95% CI 0.25 to 0.86). This pooled analysis of the RIBS IV and RIBS V randomized trials demonstrates the superiority of EES over DEB in the treatment of patients with ISR.

Abstract 11774: Beyond Restenosis - Patients’ Preferences for Drug Eluting versus Bare Metal Stents

Introduction: Drug eluting stents (DES) reduce the need for target vessel revascularization, and are used in ~80% of percutaneous coronary interventions (PCI) in the US. However, DES also necessitate the use of prolonged dual anti-platelet therapy (DAPT), which is associated with increased bleeding/bruises, can complicate future surgeries and can increase patients’ medication costs (DAPT drawbacks). Patients’ preferences regarding the benefits of DES and DAPT drawbacks have not previously been studied or reported. Methods: In a prospective, observational cohort study, consecutive patients undergoing PCI at 2 Kansas City hospitals completed a survey assessing the importance of the following factors related to the decision to receive DES: need for repeat PCI and DAPT drawbacks. Each factor was rated from 1 (not important) to 10 (extremely important). The most important factor, or group of factors, to each patient was then identified. Results: Among 317 PCI patients (66% male, 71% white, 45% DM, 80% HTN, 43% with prior PCI), 21% did not consider the need for repeat PCI as the most important factor (Figure). Only 14% considered the need for repeat PCI the single most important factor and 65% considered at least one DAPT drawback as important as repeat PCI. A third (32.8%) ranked minor bleeding/bruising as the most important factor (alone (5.5%) or with other domains (27.3%)). Conclusions: While the need for repeat PCI is an important factor to patients considering stent options, 85% of PCI patients regard other factors to be at least as important. Eliciting patients’ preferences is important to better tailor stent choices to the goals and values of individual patients undergoing PCI.

A Prospective Randomized Trial of Drug-Eluting Balloons Versus Everolimus-Eluting Stents in Patients With In-Stent Restenosis of Drug-Eluting Stents: The RIBS IV Randomized Clinical Trial

BackgroundTreatment of patients with drug-eluting stent (DES) in-stent restenosis (ISR) remains a major challenge. ObjectivesThis study evaluated the comparative efficacy of drug-eluting balloons (DEB) and everolimus-eluting stents (EES) in patients presenting with DES-ISR. MethodsThe study design of this multicenter randomized clinical trial assumed superiority of EES for the primary endpoint, in-segment minimal lumen diameter at the 6- to 9-month angiographic follow-up. ResultsA total of 309 patients with DES-ISR from 23 Spanish university hospitals were randomly allocated to DEB (n = 154) or EES (n = 155). At late angiography (median 247 days; 90% of eligible patients), patients in the EES arm had a significantly larger minimal lumen diameter (2.03 ± 0.7 mm vs. 1.80 ± 0.6 mm; p < 0.01) (absolute mean difference: 0.23 mm; 95% CI: 0.07 to 0.38), net lumen gain (1.28 ± 0.7 mm vs. 1.01 ± 0.7 mm; p < 0.01), and lower percent diameter stenosis (23 ± 22% vs. 30 ± 22%; p < 0.01) and binary restenosis rate (11% vs. 19%; p = 0.06), compared with patients in the DEB arm. Consistent results were observed in the in-lesion analysis. At the 1-year clinical follow-up (100% of patients), the main clinical outcome measure (composite of cardiac death, myocardial infarction, and target vessel revascularization) was significantly reduced in the EES arm (10% vs. 18%; p = 0.04; hazard ratio: 0.58; 95% CI: 0.35 to 0.98), mainly driven by a lower need for target vessel revascularization (8% vs. 16%; p = 0.035). ConclusionsIn patients with DES-ISR, EES provided superior long-term clinical and angiographic results compared with DEB. (Restenosis Intra-Stent of Drug-Eluting Stents: Drug-Eluting Balloon vs Everolimus-Eluting Stent [RIBS IV]; NCT01239940)

Prevalence, etiology, and characteristics of patients with type-2 acute myocardial infarction

BackgroundIn clinical practice, type-1 (coronary thrombosis) and type-2 (imbalance between oxygen demand and supply) acute myocardial infarction (AMI) are not clearly differentiated. The aim of this study was to evaluate the prevalence and etiology of type-2 AMI and compare its profile with that of type-1 AMI. MethodsPatients admitted with ST-segment elevation AMI (STEMI)<12hours of symptom onset, and referred for coronary angiography, from 2009 to 2013, were analyzed. ResultsThere were 1,960 patients included; 1,817 were analyzed, of whom 1,786 (98.3%) had type-1 AMI, and 31 (1.7%), type-2. All patients with type-2 AMI showed no significant coronary lesions, and 36% of the cases had apical dyskinesia. Type-2 AMI patients had, in general, a clinical and laboratory profile that was similar to those with type-1, except for the younger age, lower levels of myocardial necrosis markers, higher probability of having pre-TIMI 3 flow and higher left ventricular ejection fraction. At 30 days, mortality (3.2 vs. 9.0%; p=0.23) and the occurrence of death, reinfarction, or need for target-vessel revascularization (3.2 vs. 13.0%; p=0.09) were numerically lower in type-2 AMI. ConclusionsFew patients with STEMI were classified as type-2; they had structural abnormalities, isolated or associated with the absence of significant lesions; showed little difference regarding the clinical and laboratory profile, and similar clinical outcomes at 30 days, when compared to patients with type-1 AMI.

The everolimus-eluting Xience stent in small vessel disease: bench, clinical, and pathology view.

Coronary artery disease (CAD) is the leading cause of morbidity and mortality worldwide. The pathogenesis of CAD relates to the presence of atherosclerotic plaques in the coronary arteries, which are most frequently treated today by percutaneous coronary intervention. Small vessel disease treatment represents one-third of all percutaneous coronary interventions with higher rates of restenosis and major adverse cardiac events. Initially, drug-eluting stents (DES) were developed to reduce in-stent restenosis, improving clinical outcomes and reducing the need for target vessel revascularization. However, late and very late stent thrombosis emerged as a new problem compromising DES’s long-term results. The cobalt–chromium everolimus-eluting stent (CoCr-EES) represents the results of an evolutionary process in DES technology aimed at improving the shortcomings of first-generation DES. Small vessel CAD has historically been an obstacle to long-term patency following implantation of DES. Antirestenotic efficacy has been shown to be of high relevance in small vessels. Therefore, stent selection may play an important role in determining outcomes in this subgroup of patients. This article will review the performance of CoCr-EES in the treatment of small vessel CAD from preclinical, clinical, and pathology perspectives, and it will highlight the most important findings in this regard.

Coronary Stent Evolution – From Pathology to Clinic

Coronary artery disease (CAD) is the leading cause of morbidity and mortality worldwide. The pathogenesis of CAD relates to the presence of atherosclerotic plaques in coronary arteries, which are today most frequently treated by percutaneous coronary intervention. Initially, plain old balloon angioplasty demonstrated feasibility of dilating atherosclerotic coronary lesions; however, the high rate of acute-vessel recoil, restenosis, and dissection resulted in high acute closure rates and restenosis, which lead to the introduction of coronary stents, improving clinical outcome. However, in-stent restenosis (ISR) became the Achilles heel of bare metal stents owing to sustained neointimal (NI) growth. Drug-eluting stents (DES) were developed to reduce ISR, improving clinical outcomes and reducing the need for target vessel revascularisation. However, late and very late stent thrombosis emerged as a new problem compromising long-term results of DES, along with late catch-up of NI growth. Better materials, especially more biocompatible polymers, contributed to the refinement of DES technology, which substantially reduced stent thrombosis rates in second-generation DES. The idea of eliminating the foreign material after temporary scaffolding using fully bioresorbable scaffolds may hold great potential to revisit the interventional approach of treating CAD. This article will review the evolution of coronary artery intervention from clinical application to pathology, and will discuss current status and potential future directions of the newer therapeutic approaches.

Recurrent restenosis in saphenous vein graft. What is the next step?

The long-term outcome after percutaneous treatment of saphenous vein graft (SVG) is worse than of native coronaries. We present a patient with degenerated SVG, which had been treated with several interventions. Despite this, there was multiple recurrence of SVG-restenosis. A 76-year-old patient after implantation of a cardiac pacemaker, with arterial hypertension, atrial fibrillation, and chronic kidney disease, underwent coronary artery bypass grafting in 1993. Left internal mammary artery to left anterior descending artery, jump-SVG to marginal (Marg) and diagonal branches and SVG to right coronary artery (RCA) were inserted. Control angiography carried out 18 years later revealed occluded native coronary arteries and occluded SVG segment to Marg. Additionally, there was tight stenosis in RCA-SVG (Fig. 1A). Immediate intravascular ultrasound-guided percutaneous coronary intervention (PCI) of RCA-SVG was done with a 2.5 × 12 mm paclitaxel-eluting stent implantation and postdilatation. Seven months later, tight in-stent restenosis was diagnosed (Fig. 1B). After predilatation, a 2.5 × 18 mm zotarolimus-eluting stent was implanted. Subsequent two in-stent restenoses a few months later were treated twice with 3.0 × 25 mm paclitaxel-eluting balloons (Figs. 1C, D). The last in-stent restenosis (Fig. 1E) was treated with a 3.0 × 15 mm everolimus-eluting stent. There is no convincing proof of better long-term outcomes after SVG-PCI with drug-eluting stents (DES) compared to bare metal stents (BMS). DES significantly reduces the target vessel revascularisation (TVR) in SVG. However, there is no clear benefit on mortality and myocardial infarction. Histological examination of SVG-lesions shows a different pattern of restenosis compared to native coronaries, with enhanced inflammatory and thrombotic response. A Japanese restenosis registry in native coronaries indicated that if the original restenosis developed in a sirolimus-eluting stent (SES), it would more likely occur again after the next in-stent SES implantation. However, the need for TVR for second restenosis was rarer, if the original restenosis developed in BMS (and not in SES) and was subsequently treated with in-BMS SES implantation. Both first and second generation DES failed in our case. There have been no direct comparisons from randomised trials of different DES types for SVG. Chatani et al. (J Interv Cadiol, 2009; 22: 354–361) suggested that the only independent predictive factor of re-restenosis after SES-in-SES implantation in native coronaries was the reference diameter. In our case, we implanted two second generation DESs into a first generation DES. Additionally, two PCIs with drug-eluting balloons, postponed further metal jacket insertion. After careful lesion preparation, implantation of the last (third) DES with larger diameter than the previous stents was possible. DESs have the advantage over BMSs in terms of SVG-TVR reduction, but in rare cases both DESs of first and second generation and drug-eluting balloon fail to prevent it. If a sixth restenosis were to occur, implantation of bioabsorbable vessel scaffolding or rotablation might be the treatment option.

A Randomized Comparison of Drug-Eluting Balloon Versus Everolimus-Eluting Stent in Patients With Bare-Metal Stent–In-Stent Restenosis: The RIBS V Clinical Trial (Restenosis Intra-stent of Bare Metal Stents: Paclitaxel-eluting Balloon vs. Everolimus-eluting Stent)

This study sought to compare the efficacy of drug-eluting balloons (DEB) with that of everolimus-eluting stents (EES) in patients with bare-metal stents (BMS) in-stent restenosis (ISR). Treatment of patients with ISR remains a challenge. This was a prospective, multicenter, randomized trial comparing DEB with EES in patients with bare-metal stents (BMS) in-stent restenosis (ISR). The primary endpoint was the minimal lumen diameter at 9 months' follow-up. A total of 189 patients with BMS-ISR from 25 Spanish sites were included (95 were allocated to DEB and 94 to EES). Procedural success was achieved in all patients. At late angiography (median 249 days; 92% of eligible patients), patients in the EES arm had a significantly larger minimal lumen diameter (2.36 ± 0.6 mm vs. 2.01 ± 0.6 mm, p < 0.001; absolute mean difference: 0.35 mm; 95% confidence interval [CI]: 0.16 to 0.53) and a lower percent of diameter stenosis (13 ± 17% vs. 25 ± 20%, p < 0.001). However, late loss (0.04 ± 0.5 mm vs. 0.14 ± 0.5 mm, p = 0.14) and binary restenosis rate (4.7% vs. 9.5%, p = 0.22) were very low and similar in both groups. Clinical follow-up (median 365 days) was obtained in all (100%) patients. Occurrences of the combined clinical outcome measure (cardiac death, myocardial infarction, and target vessel revascularization; 6% vs. 8%; hazard ratio [HR]: 0.76; 95% CI: 0.26 to 2.18, p = 0.6) and the need for target vessel revascularization (2% vs. 6%; HR: 0.32: 95% CI: 0.07 to 1.59, p = 0.17) were similar in the 2 groups. In patients with BMS-ISR, both DEB and EES provided excellent clinical results with a very low rate of clinical and angiographic recurrences. However, compared with DEB, EES provide superior late angiographic findings. (Restenosis Intra-stent of Bare Metal Stents: Paclitaxel-eluting Balloon vs. Everolimus-eluting Stent [RIBS V]; NCT01239953).

Left Main Coronary Artery Stenosis: A Meta-Analysis of Drug-Eluting Stents Versus Coronary Artery Bypass Grafting

The goal of this study was to provide a systematic review comparing the long-term outcomes of percutaneous coronary intervention (PCI) with drug-eluting stents (DES) versus coronary artery bypass graft surgery (CABG) for unprotected left main coronary artery (UPLM) stenosis. One-year outcomes from randomized controlled trials, observational studies, and pooled analyses have demonstrated the safety and efficacy of PCI of the UPLM when compared with CABG. However, there remain concerns over the sustainability of PCI with DES at longer follow-up. Studies published between January 2000 and December 2012 of PCI versus CABG for UPLM stenosis were identified using an electronic search and reviewed using meta-analytical techniques. Twenty-four studies comprising 14,203 patients were included in the analysis. There was no significant difference for all-cause mortality between PCI or CABG at 1 year (odds ratio [OR]: 0.792, 95% confidence interval [CI]: 0.53 to 1.19), 2 years (OR: 0.920, 95% CI: 0.67 to 1.26), 3 years (OR: 0.94, 95% CI: 0.60 to 1.48), 4 years (OR: 0.84, 95% CI: 0.53 to 1.33), and 5 years (OR: 0.79, 95% CI: 0.57 to 1.08). The need for target vessel revascularization (TVR) was significantly higher in patients undergoing PCI at all time points. The occurrence of stroke, however, was significantly less frequent in patients treated with PCI. The occurrence of nonfatal myocardial infarction showed a statistically significant trend towards a lower incidence in CABG patients at 1 year (OR: 1.62, 95% CI: 1.05 to 2.50), 2 years (OR: 1.60, 95% CI: 1.09 to 2.35), and 3 years (OR: 2.06, 95% CI: 1.36 to 3.1). There was no significant difference in combined major adverse cardiovascular and cerebrovascular events between the 2 groups. Our findings suggest that PCI with DES is a safe and durable alternative to CABG for the revascularization of UPLM stenosis in select patients at long-term follow-up.