Strategies for multivessel revascularization in patients with diabetes.

BACKGROUND: In some randomized trials comparing revascularization strategies for patients with diabetes, coronary-artery bypass grafting (CABG) has had a better outcome than percutaneous coronary intervention (PCI). We sought to discover whether aggressive medical therapy and the use of drug-eluting stents could alter the revascularization approach for patients with diabetes and multivessel coronary artery disease. METHODS: In this randomized trial, we assigned patients with diabetes and multivessel coronary artery disease to undergo either PCI with drug-eluting stents or CABG. The patients were followed for a minimum of 2 years (median among survivors, 3.8 years). All patients were prescribed currently recommended medical therapies for the control of low-density lipoprotein cholesterol, systolic blood pressure, and glycated hemoglobin. The primary outcome measure was a composite of death from any cause, nonfatal myocardial infarction, or nonfatal stroke. RESULTS: From 2005 through 2010, we enrolled 1900 patients at 140 international centers. The patients' mean age was 63.1±9.1 years, 29% were women, and 83% had three-vessel disease. The primary outcome occurred more frequently in the PCI group (P=0.005), with 5-year rates of 26.6% in the PCI group and 18.7% in the CABG group. The benefit of CABG was driven by differences in rates of both myocardial infarction (P<0.001) and death from any cause (P=0.049). Stroke was more frequent in the CABG group, with 5-year rates of 2.4% in the PCI group and 5.2% in the CABG group (P=0.03). CONCLUSIONS: For patients with diabetes and advanced coronary artery disease, CABG was superior to PCI in that it significantly reduced rates of death and myocardial infarction, with a higher rate of stroke. (Funded by the National Heart, Lung, and Blood Institute and others; FREEDOM ClinicalTrials.gov number, NCT00086450.).

A Randomized Trial of Creatine-kinase Leak After Rosuvastatin in Elective Percutaneous Coronary Intervention (CLEAR-PCI).

OBJECTIVES: To determine the impact of percutaneous coronary intervention (PCI) performed at the same time of the peak concentration of rosuvastatin to reduce periprocedural myocardial infarction (PMI). BACKGROUND: Prior studies suggest that a high dose of statin before PCI reduce periprocedural myocardial infarction. However, there is no information regarding the elective PCI performed at the time of the peak of statin concentration to reduce PMI. METHODS: From 2001 to 2013, at a single center in Brazil we enrolled 544 patients who underwent elective PCI and after exclusions for baseline biases in clinical and angiographic characteristics, yielding 528 patients, we prospectively randomly assigned them to either a high loading dose of Rosuvastatin before PCI (n = 264) or standard treatment (n = 264). After exclusions for biases in procedural characteristics a total of 487 patients underwent to end points analysis. The primary outcome was the incidence of MB fraction of creatine kinase (CK-MB) greater than three times the upper limit of normal. RESULTS: The primary end point occurred in 7.6% in the rosuvastatin and 4.8% in the control group (P = 0.200). There was a higher incidence in elevation of CK-MB than normal baseline in the rosuvastatin (67.1% vs 59.2%, P = 0.701). There was no difference in major adverse event (0% in the rosuvastatin group vs 0.8% in control).

Clinical, angiographic, and intravascular ultrasound results of the VestSaync II trial.

AIM: We sought to assess the long term efficacy of the novel VESTAsync™ Eluting Stent (VES) combining a Cro-Co platform with a nanothin-microporous hydroxyapatite surface coating impregnated with a polymer-free low-dose of Sirolimus (55 µg). METHODS: The Vestasync II trial was a randomized (2:1), double-blinded, multicenter comparison of the VES to its platform, the Gen X stent, with microporous hydroxyapatite surface coating without sirolimus. Patients were eligible if they presented de novo lesions in native coronary arteries with 3.0-3.5 mm diameter and ≤ 14 mm in length. Primary endpoint was 8-month in-stent late loss and % of stent obstruction. Lifelong aspirin and 6-month clopidogrel were prescribed to all patients. RESULTS: Seventy-five patients were enrolled (VES = 50 pts). Baseline characteristics included mean age of 58 years and 29% of diabetics. Reference vessel diameter and lesion length were 2.8 ± 0.4 mm and 13.0 ± 2.0 mm, respectively. In-stent late loss (0.39 ± 0.20 vs. 0.74 ± 0.52, P = 0.03) and % of neointima hyperplasia (9.3 ± 6.6% vs. 17.6 ± 9.4%, P = 0.0016) were significantly reduced in the VES cohort. Up to 1 year, there was a single case of myocardial infarction and one target lesion revascularization (TLR) (2%) in the VES group while in the control cohort there were one TLR (4%) and one cardiac death (4%). CONCLUSION: The VestSync II trial is a proof-of-concept study and demonstrates the sustained efficacy of this novel polymer-free sirolimus drug-eluting stents. A larger trial, with more complex lesions, clinical endpoints and longer FU period is warranted. © 2013 Wiley Periodicals, Inc.

One-year results of the INSPIRE trial with the novel MGuard stent: serial analysis with QCA and IVUS.

BACKGROUND: The newly developed balloon-expandable Mguard stent system, a combination of an ultra-thin polymer mesh sleeve attached to the external surface of a BMS, was conceived to provide embolic protection during PCI of SVG and thrombus-containing lesions. Although the acute results (<30 days) have pointed to the efficacy of this novel device, few is known about its long-term performance. METHODS: The present article address the 1-year clinical results of a cohort of 30 patients enrolled in the INSPIRE trial. Inclusion critiria was de novo lesions in SVG or native vessels with angiographic evidence of instability with potential to provoke flow disturbances and/or distal embolization. The primary endpoint (incidence of MACE-composite of cardiac death, nonfatal MI, and TLR) up to 30 days of the procedure has already been published. Secondary endpoints here presented included in-stent late lumen loss (QCA), % of stent obstruction (IVUS) at 6 months and combined MACE at 1 year. QCA and IVUS were performed by independent corelabs. RESULTS: Mean population age was 63 years with 38% of diabetics. Overall, 55% presented with ACS and 57% of lesions were located in SVG. Most lesions had complex morphology including the presence of thrombus (26%) and ulceration (20%). Distal/proximal protection devices were not used. Preprocedural QCA data showed lesion length and reference vessel diameter of 12.0 ± 4.5 mm and 3.0 ± 0.5 mm. The MGuard stent was successfully delivered in all cases and final TIMI-3 was achieved in 100% with no MACE up to 30 days. At 6 months, in-stent late loss and % of stent obstruction were 1.0 ± 0.4 mm and 28.5 ± 15.6%. Up to 1 year there was no case of cardiac death, two MI (one Q-wave and one non-Q-wave) and six cases of ischemia-driven TLR. Of note, there was no case of definite/probable stent thorombosis. CONCLUSIONS: In this series of patients treated with MGuard stent, the novel device showed no midterm efficacy and safety concerns.

Alcohol septal ablation after myomectomy failure solutions for unusual cases.

We report an eight-year-old child presented with classical features of hypertrophic obstructive cardiomyopathy and with New York Heart Association (NYHA) class III symptoms, eight months after myectomy and refractory to medical treatment. Cardiac transplantation was indicated due to the severity of symptoms. But the lymphocyte reaction test showed almost 100% reaction of antibodies, and the surgeons rejected the heart transplantation for fear of hyperacute rejection. Then an alcohol septal ablation (ASA) was proposed, which was successfully performed on August 17, 2005. The post-extrasystolic gradient was reduced from 160 to 60 mm Hg immediately and no other complications were seen. The child is being followed since then and echocardiography changes include a further reduction of septum thickness and gradient (P = 0.001), and important symptoms relieved after 3.5 years of follow up. ASA may be an option to be considered in children with critical hypertrophic obstructive cardiomyopathy in NYHA functional class III/IV, when other methods of treatment failed. © 2010 Wiley-Liss, Inc.

Preliminary results of the INSPIRE trial with the novel MGuard stent system containing a protection net to prevent distal embolization.

OBJECTIVE: To assess the efficacy of the MGuard(TM) stent combining a polymer-mesh sleeve attached to the external surface of a bare-metal stent in preventing distal embolization during percutaneous coronary intervention (PCI). BACKGROUND: Distal embolization of thrombus/platelet aggregates is associated with worse immediate and long-term prognosis after PCI. Treatment of saphenous vein graft (SVG) and PCI in the setting of acute coronary syndromes (ACS) is often related to this complication. Although protection and aspiration devices have been shown to reduce distal embolization, they add time and cost to PCI. METHODS: A total of 30 patients were included. Inclusion criteria were de novo lesions in SVG or native vessels with angiographic evidence of instability with potential to provoke flow disturbances and/or distal embolization. Primary endpoint included the incidence of major adverse cardiac events (MACE) (composite of cardiac death, non-fatal myocardial infarction and TLR) up to 30 days of the procedure and TIMI flow right after the PCI. RESULTS: Mean population age was 60.8 years with 36.7% of diabetes. Overall, 53.3% presented with ACS, and most lesions were located in SVG (16 of 30). The majority of lesions had complex morphology including the presence of thrombus (30%) and ulcer (33.3%). The MGuard stent was successfully deployed in all cases with no angiographic/clinical complications including distal embolization. Final TIMI-3/blush-3 were achieved in all cases with no MACE up to 30 days of the procedure. CONCLUSIONS: In this preliminary evaluation, the MGuard device demonstrated excellent performance in a highly complex lesion subset, including absence of angiographic/procedural complications, and no adverse events up to 30-day FU.

Cardiovascular Risk Stratification for Patients Treated With Drug-Eluting Stents: Development and Validation of the DESIRE Score.

BACKGROUND: We sought to develop a risk score to estimate the risk of major adverse cardiac event (MACE) occurrence during the in-hospital and long-term follow-up periods after percutaneous coronary intervention (PCI) with drug-eluting stent (DES) implantation. METHODS: This score was developed and validated in a single-center database encompassing all consecutive patients treated with DES between 2007 and 2014 (n = 4061). For the development of the score, we analyzed all patients treated between January 2007 and December 2012 (n = 2863) while the validation was conducted in a cohort treated between January 2013 and December 2014 (n = 1198). MACE was defined as the combination of cardiovascular death, myocardial infarction, and ischemia- driven target-lesion revascularization. Different stratification models were developed for the in-hospital (logistic regression) and late follow-up score (Cox model). RESULTS: In-hospital scores ranged from 0 to 37 points and comprised: (a) age; (b) previous coronary artery bypass grafting (CABG); (c) acute coronary syndrome; (d) peripheral vascular disease; (e) treatment of saphenous vein graft; (f) long lesions; (g) small vessels; (h) multivessel disease; and (i) thrombus. The late scores ranged from 0 to 45 points and comprised: (a) previous CABG; (b) diabetes mellitus; (c) acute coronary syndrome; (d) multivessel disease; (e) small vessels; (f) ejection fraction <40%; and (g) treatment of saphenous vein graft. Patients were stratified into low-risk, moderate-risk, and high-risk groups. Both scores had close to 70% accuracy for predicting MACE. CONCLUSION: The present score was developed and validated based on contemporary models for assessing periprocedural and long-term MACE risk post PCI, throughout the full spectrum of patient risk, and important patient subgroups.

The revascular active percutaneous interventional device for coronary total occlusions study.

BACKGROUND: Despite the well-documented benefit of recanalization of an occluded vessel in some symptomatic patients, attempt is only performed in a minority of them. Percutaneous coronary intervention (PCI) of CTO is associated with high incidence of complications and unsuccessful procedure, mainly due to inability to cross the lesion. We sought to evaluate the efficacy and safety of the novel RVT CTO Guidewire Device (RVT-GDW, ReVascular Therapeutics, Sunnyvale, CA) in this complex scenario. METHODS: The RAPID-CTO study is a non-randomized, single center, first-in-man evaluation of a new guidewire system for treatment of CTO. The RVT-GDW is a new device designed to provide enhanced penetration and positioning control for crossing CTO via: (1) an 0.014 "guidewire with a mechanically active distal end; (2) a handle attached proximally to the guidewire, with an adjustable torquer, and interfaced to (3) a non-disposable, battery-operated, control unit, that provides activation control and audio feedback during the CTO crossing procedure. Per protocol, the RVT-GDW device was only used after at least 5 min (fluoroscopy time) of attempt with commercially available conventional guidewires to cross the target lesion. RESULTS: A total of 16 patients (16 lesions) were treated with the RVT-GDW. Mean age was 56.25 years, 56.2% were men, and 25% diabetics. The average duration of occlusion was 4.7 +/- 2.1 months. The mean vessel reference diameter was 2.76 +/- 0.31 mm and the mean lesion length was 16.64 +/- 7.70 mm (range 4.37-35.0 mm). Thirteen patients (81.2%) had "tapered stump" morphology at the proximal end of the occlusion, and a side branch was involved in 12 (75.0%). All lesions had contralateral circulation; bridging collaterals were seen in three (18.7%). Procedural success was achieved in 10 lesions (62.5%), with an average procedural time of 111.43 +/- 35.76 min. There were no major adverse cardiac events at both in-hospital and 30-day clinical follow-up. CONCLUSIONS: The first-in-man RAPID-CTO study suggests that the novel RVT-GDW device is technically feasible, safe and effective in crossing chronically occluded coronary arteries. Larger studies are warranted.

Impact of platelet glycoprotein IIb/IIIa receptor inhibitors on outcomes of diabetic patients undergoing percutaneous coronary interventions using sirolimus-eluting stents.

OBJECTIVE: We assessed the outcomes in diabetic patients undergoing percutaneous coronary intervention (PCI) using sirolimus-eluting stents (SES) as a function of treatment with glycoprotein (GP) IIb/IIIa inhibitors. METHODS AND RESULTS: Of 551 diabetic patients treated with a SES in nine trials (RAVEL, SIRIUS, E-SIRIUS, C-SIRIUS, REALITY, SVELTE, DIRECT, SIRIUS 2.25, and SIRIUS 4.0), 187 patients (33.9%) were administered GP IIb/IIIa inhibitors during PCI. GP IIb/IIIa blockade was associated with lower rates of myocardial infarction (MI) at 30 days (1.1% vs. 3.3%, P = 0.12) and at 1 year (1.1% vs. 4.7%, P = 0.04), and composite endpoint of cardiac death/MI at 1 year (2.2% vs. 6.2%, P = 0.05). Benefit from GP IIb/IIIa inhibitors was confined to 128 insulin-treated diabetics who had remarkable reduction in MI (0.0% vs. 6.3%, P = 0.04) and cardiac death/MI at 30 days (0.0% vs. 7.6%, P = 0.05) and at 1-year (0.0% vs. 13.4%, P = 0.01 and 0.0% vs. 15.7%, P = 0.0005, respectively). When treated with GP IIb/IIIa inhibitors, insulin-requiring diabetics had similar rates of 1-year death/MI when compared with the nondiabetic patients (0% vs. 4.7%, P = 0.13, respectively). There were no significant differences in outcomes as a function of GP IIb/IIIa blockade in diabetics not treated with insulin. CONCLUSION: In this analysis, outcomes of insulin requiring diabetic patients undergoing PCI with SES were considerably improved with adjunctive GP IIb/IIIa inhibitors by decreasing the rates of MI and composite endpoint of cardiac death/MI.

Long-term clinical outcomes of the Drug-Eluting Stents in the Real World (DESIRE) Registry.

BACKGROUND: Recently, cardiologists have treated more complex patients and lesions with drug-eluting stents (DES). However, long-term efficacy and safety of the off-label use of these new devices is yet to be demonstrated. METHODS: The Drug-Eluting Stents in the Real World (DESIRE) registry is a prospective, nonrandomized single-center registry with consecutive patients treated solely with DES between May 2002 and May 2007. The primary end-point was long-term occurrence of major adverse cardiac events (MACE). Patients were clinically evaluated at 1, 3, and 6 months and then annually up to 5 years. RESULTS: A total of 2,084 patients (2,864 lesions and 3,120 DES) were included. The mean age was 63.8 +/- 11.5 years. Diabetes was detected in 28.9% and 40.7% presented with acute coronary syndrome. Cyphertrade mark was the predominant DES in this registry (83.5%). Mean follow-up time was 2.6 +/- 1.2 years and was obtained in 96.5% of the eligible patients. Target lesion revascularization (TLR) was performed in 3.3% of the patients. Q wave myocardial infarction (MI) occurred in only 0.7% of these patients and total stent thrombosis rate was 1.6% (n = 33). Independent predictors of thrombosis were PCI in the setting of MI (HR 11.2; 95% CI, 9.6-12.4, P = 0.001), lesion length (HR 4.6; 95% CI, 3.2-5.3, P = 0.031), moderate to severe calcification at lesion site (HR 13.1; 95% CI, 12.1-16.7, P < 0.001), and in-stent residual stenosis (HR 14.5; 95% CI, 10.2-17.6, P < 0.001). CONCLUSION: The use of DES in unselected population is associated with long-term safety and effectiveness with acceptable low rates of adverse clinical events.

Very Long Term Follow-Up After Percutaneous Balloon Mitral Valvuloplasty.

OBJECTIVES: The aim of this study was to assess very long term outcomes after successful percutaneous balloon mitral valvuloplasty (PBMV). BACKGROUND: PBMV remains the preferred treatment for patients with severe symptomatic rheumatic mitral stenosis and suitable anatomy. METHODS: All consecutive patients who underwent successful PBMV between 1987 and 2010 were included. The primary endpoint was the composite of all-cause mortality, need for mitral surgery, or repeat PBMV up to 23 years. RESULTS: Among all 1,582 consecutive patients undergoing PBMV, acute success was achieved in 90.9% (n = 1,438). Independent predictors of acute success included left atrial size (odds ratio: 0.96; 95% confidence interval [CI]: 0.93 to 0.99; p = 0.045), Wilkins score ≤8 (odds ratio: 1.66; 95% CI: 0.48 to 0.93; p = 0.02) and age (odds ratio: 0.97; 95% CI: 0.96 to 0.99; p = 0.006). Very long term follow-up (median 8.3 years, mean 15.6 years) was obtained in 79.1% of successful cases. The incidence of the primary endpoint was 19.1% (95% CI: 17.0% to 21.1%). The rates of overall mortality, need for mitral valve surgery, or repeat PBMV were 0.6% (95% CI: 0.3% to 1.2%), 8.3% (95% CI: 7.0% to 9.9%), and 10.0% (95% CI: 8.5% to 11.7%), respectively. On multivariate analysis, New York Heart Association functional class III or IV (hazard ratio: 1.62; 95% CI: 1.26 to 2.09; p < 0.001), higher age (hazard ratio: 0.97; 95% CI: 0.96 to 0.98; p = 0.028), and mitral valve area ≤1.75 cm2 after the procedure (hazard ratio: 1.67; 95% CI: 1.28 to 2.11; p = 0.028) were independent predictors of the primary endpoint. CONCLUSIONS: In very long term follow-up, more than 75% of patients exhibited sustained results. Prediction of late favorable results is multifactorial and strongly determined by age, previous symptoms and post-procedural mitral valve area.

Safety of coronary sirolimus-eluting stents in daily clinical practice: one-year follow-up of the e-Cypher registry.

BACKGROUND: The expanding indications for sirolimus-eluting stents (SES) include increasingly complex coronary lesions and populations with clinical profiles markedly different from those of early pivotal controlled studies. The e-Cypher registry monitored the safety and efficacy of SES currently implanted worldwide in daily practice. METHODS AND RESULTS: Between April 2002 and September 2005, data were collected on 15,157 patients who underwent implantation of > or =1 SES at 279 medical centers from 41 countries. An independent endpoint review committee adjudicated all reported major adverse cardiovascular events, stent thromboses, and target-vessel revascularizations. Data were managed and analyzed by independent organizations. Predictors of adverse clinical events were identified by regression analysis. The mean age of the sample was 61.7+/-11.4 years; 77.7% were men, and 28.6% were diabetics. A total of 18,295 lesions were treated (20,503 SES) during the index procedure. The cumulative rates of major adverse cardiovascular events were 1.36% at 30 days, 3.38% at 6 months, and 5.80% at 1 year. The rates of acute, subacute, and late stent thrombosis were 0.13%, 0.56%, and 0.19% of patients, respectively, representing a 12-month actuarial incidence of 0.87%. Insulin-dependent diabetes, acute coronary syndrome at presentation, and advanced age were clinical predictors, whereas TIMI flow grade <3 after the index procedure, treatment of multiple lesions, a prominently calcified or totally occluded target lesion, and multivessel disease were the angiographic or procedural predictors of stent thrombosis at 12 months. CONCLUSIONS: This analysis of 1-year data collected by the e-Cypher registry suggests a high degree of safety of SES, with a rate of stent thrombosis similar to that observed in randomized trials.

A randomized comparison of a sirolimus-eluting stent with a standard stent for coronary revascularization.

BACKGROUND: The need for repeated treatment of restenosis of a treated vessel remains the main limitation of percutaneous coronary revascularization. Because sirolimus (rapamycin) inhibits the proliferation of lymphocytes and smooth-muscle cells, we compared a sirolimus-eluting stent with a standard uncoated stent in patients with angina pectoris. METHODS: We performed a randomized, double-blind trial to compare the two types of stents for revascularization of single, primary lesions in native coronary arteries. The trial included 238 patients at 19 medical centers. The primary end point was in-stent late luminal loss (the difference between the minimal luminal diameter immediately after the procedure and the diameter at six months). Secondary end points included the percentage of in-stent stenosis of the luminal diameter and the rate of restenosis (luminal narrowing of 50 percent or more). We also analyzed a composite clinical end point consisting of death, myocardial infarction, and percutaneous or surgical revascularization at 1, 6, and 12 months. RESULTS: At six months, the degree of neointimal proliferation, manifested as the mean (+/-SD) late luminal loss, was significantly lower in the sirolimus-stent group (-0.01+/-0.33 mm) than in the standard-stent group (0.80+/-0.53 mm, P<0.001). None of the patients in the sirolimus-stent group, as compared with 26.6 percent of those in the standard-stent group, had restenosis of 50 percent or more of the luminal diameter (P<0.001). There were no episodes of stent thrombosis. During a follow-up period of up to one year, the overall rate of major cardiac events was 5.8 percent in the sirolimus-stent group and 28.8 percent in the standard-stent group (P<0.001). The difference was due entirely to a higher rate of revascularization of the target vessel in the standard-stent group. CONCLUSIONS: As compared with a standard coronary stent, a sirolimus-eluting stent shows considerable promise for the prevention of neointimal proliferation, restenosis, and associated clinical events.

Anatomical and physiologic assessments in patients with small coronary artery disease: final results of the Physiologic and Anatomical Evaluation Prior to and After Stent Implantation in Small Coronary Vessels (PHANTOM) trial.

BACKGROUND: Patients with small coronary arteries are at high risk for complications after percutaneous coronary intervention (PCI). The objective of our study was to investigate the correlation between angiography, intravascular ultrasound (IVUS), and fractional flow reserve (FFR) in patients with moderate stenoses in small (<2.8 mm) coronary arteries. METHODS AND RESULTS: Sixty consecutive patients, of 800 scheduled for PCI during the study period, were prospectively enrolled in the study. The FFR was measured after a 2-minute infusion of adenosine. For the preprocedural assessments, 60 patients underwent an FFR measurement, 56 underwent an IVUS, and 60 underwent an angiography; for the postprocedural assessments, 22 patients underwent an FFR measurement, 18 underwent an IVUS, and 22 underwent an angiography. The jeopardy score for the target vessel was calculated. Data were analyzed by an independent core laboratory. Patients with an FFR >0.75 were deferred from PCI. Patients were stratified in 2 groups according to their FFR values (< or =0.75 vs >0.75) and were followed for 1 year. Significant (FFR < or =0.75) coronary stenosis was observed in only 35% of the patients. The mean preprocedural FFR values were 0.79 +/- 0.13 for the overall population, 0.64 +/- 0.08 for the patients with an FFR < or =0.75, and 0.87 +/- 0.06 for the patients with an FFR >0.75. There was no correlation between angiography, IVUS, and FFR. The jeopardy score was inversely correlated with FFR (R = -0.32). Only a third of the patients with optimal stenting defined by IVUS achieved an FFR >0.90. After 1 year, 24% of the patients with an FFR < or =0.75 required a repeat PCI. There was no occurrence of myocardial infarction or death, and only 2.6% of the patients deferred from PCI required revascularization. CONCLUSION: Anatomical parameters are limited in determining the hemodynamic significance of small coronary disease. Most moderate stenoses in small coronaries could be safely deferred from PCI based on FFR.

Drug-eluting stents vs bare metal stents for the treatment of large coronary vessels.

BACKGROUND: Lately drug-eluting stents (DES) have dramatically reduced restenosis rates and need for repeat revascularization in a wide subset of lesion and patients. However, their benefit for the treatment of large vessels (> 3.0 mm) has yet to be established. OBJECTIVE: We investigated whether DES are superior to bare metal stents (BMS) in terms of clinical outcomes for the treatment of large coronary vessels. METHODS: This study assessed the long-term outcomes (cardiac death, acute myocardial infarction, and need for repeat intervention in the treated vessel) of patients treated with either a DES (Cypher and Taxus) or a BMS of > or = 3.5 mm in diameter. A total of 250 consecutive patients who underwent DES implantation were clinically followed for 1 year and compared to 250 patients who were treated with BMS. Interventions in the setting of acute ST elevation myocardial infarction and treatment of bypass grafts were excluded. RESULTS: Cypher was the DES deployed in 70.8% of cases. Most of the enrolled patients were men (78%) with single vessel disease (65.6%). The left anterior descending artery was the culprit vessel in 34.2% of cases. Bare metal stent and DES cohorts had equivalent interpolated reference vessel diameter (3.19 +/- 0.3 mm for BMS vs 3.18 +/- 0.2 for DES; P = .1). Lesion was significantly longer in the group treated with DES (13.4 +/- 5.1 mm for BMS group vs 14.3 +/- 3.5 for DES; P = .0018). After 1 year of clinical follow-up, 95.2% of patients treated with DES and 91.2% of the patients who received BMS were free of major events (P = .2). A trend toward higher target-lesion revascularization was noticed in the group treated with BMS (4.8% vs 1.6%; P = .07). CONCLUSION: Percutaneous treatment of large coronary vessels carries a low risk of clinical events irrespective of the type of stent used.

Percutaneous coronary revascularization using a trilayer metal phosphorylcholine-coated zotarolimus-eluting stent.

The ZoMaxx Coronary Stent System elutes the antiproliferative agent zotarolimus via a biocompatible phosphorylcholine polymer loaded onto a novel, thin, stainless steel stent platform containing an 0.0007-inch inner layer of tantalum that enhances fluoroscopic radiopacity. The objective of this single-arm prospective clinical trial was to assess the safety and performance of the ZoMaxx stent for the treatment of coronary artery stenosis. Forty consecutive patients with ischemic coronary occlusive disease due to single de novo obstructive lesions of native coronary arteries were treated with 3 x 18 mm ZoMaxx stents at the Dante Pazzanese de Cardiologie in Saõ Paulo, Brazil, between April and July 2005. Independent core laboratories analyzed quantitative coronary angiography and intravascular ultrasound results immediately after stent implantation, and after 4 months. The lesion, procedure, and device-deployment success rates were all 100% (40 of 40). There were no major adverse cardiac events during the study. Follow-up quantitative coronary angiography at 4 months revealed in-stent and in-segment late lumen losses of 0.20 +/- 0.35 and 0.17 +/- 0.35 mm, respectively. Follow-up intravascular ultrasound at 4 months revealed 6.5 +/- 6.2% neointimal volume obstruction. There were no instances of late acquired stent incomplete apposition or stent thrombosis. In conclusion, the ZoMaxx Coronary Stent can be safely implanted for the treatment of de novo coronary artery stenosis. The inhibition of neointima formation as measured by follow-up angiography and IVUS after 4 months suggests therapeutic potential for the reduction of restenosis.

Impact of PCI Appropriateness in the Long-Term Outcomes of Consecutive Patients Treated With Second-Generation Drug-Eluting Stents.

BACKGROUND: Appropriate use criteria (AUC) for coronary revascularization were developed to deliver high-quality care; however, the prognostic impact of these criteria remains unclear. We sought to assess the outcomes of patients treated with second-generation drug-eluting stent (DES) classified according to the updated American College of Cardiology Foundation/American Heart Association/Society for Cardiac Angiography and Intervention AUC for percutaneous coronary intervention (PCI). METHODS: Between January 2012 and December 2013, a total of 1108 consecutive patients treated only with second-generation DES were categorized according to the AUC in three groups, using the new proposed terminology: appropriate ("A"); uncertain ("U"); and inappropriate ("I"). Major adverse cardiac event (MACE, defined as cardiac death, non-fatal myocardial infarction, and ischemia-driven target-lesion revascularization) and stent thrombosis up to 3 years were compared. RESULTS: PCI was categorized as A in 33.8%, U in 46.8%, and I in 19.4% of all cases. PCI-A patients had a higher prevalence of acute coronary syndromes, while PCI-I involved the treatment of more diabetics and patients with stable coronary disease. There were no differences in procedural complications among the three groups, with comparable rates of in-hospital MACE (9.3% for A vs 9.0% for U vs 7.0% for I; P=.70) and 2-year MACE (13.9% for A vs 9.0% for U vs 8.6% for I; P=.40). In the multivariable analysis, AUC classification was not associated with adverse outcomes. CONCLUSIONS: In this contemporary cohort of patients treated with second-generation DES implantation, AUC did not impact 3-year clinical follow-up.

Progression and Prognosis of Paravalvular Regurgitation After Transcatheter Aortic Valve Implantation.

BACKGROUND: The impact of paravalvular regurgitation (PVR) following transcatheter aortic valve implantation (TAVI) remains uncertain. OBJECTIVE: To evaluate the impact of PVR on mortality and hospital readmission one year after TAVI. METHODS: Between January 2009 and June 2015, a total of 251 patients underwent TAVI with three different prostheses at two cardiology centers. Patients were assessed according to PVR severity after the procedure. RESULTS: PVR was classified as absent/trace or mild in 92.0% (n = 242) and moderate/severe in 7.1% (n = 18). The moderate/severe PVR group showed higher levels of aortic calcification (22% vs. 6%, p = 0.03), higher serum creatinine (1.5 ± 0.7 vs. 1.2 ± 0.4 mg/dL, p = 0.014), lower aortic valve area (0.6 ± 0.1 vs. 0.7 ± 0.2 cm2, p = 0.05), and lower left ventricular ejection fraction (49.2 ± 14.8% vs. 58.8 ± 12.1%, p = 0.009). Patients with moderate/severe PVR had more need for post-dilatation (p = 0.025) and use of larger-diameter balloons (p = 0.043). At one year, all-cause mortality was similar in both groups (16.7% vs. 12%, p = 0.08), as well as rehospitalization (11.1% vs. 7.3%, p = 0.915). PVR grade significantly reduced throughout the first year after the procedure (p < 0.01). The presence of moderate/severe PVR was not associated with higher one-year mortality rates (HR: 0.76, 95% CI: 0.27-2.13, p = 0.864), rehospitalization (HR: 1.08, 95% CI: 0.25-4.69, p=0.915), or composite outcome (HR: 0.77, 95% CI: 0.28-2.13, p = 0.613). CONCLUSION: In this sample, moderate/severe PVR was not a predictor of long-term mortality or rehospitalization. (Arq Bras Cardiol. 2017; [online].ahead print, PP.0-0).

Four-year angiographic and intravascular ultrasound follow-up of patients treated with sirolimus-eluting stents.

BACKGROUND: Despite the proven superiority of sirolimus-eluting stents (SESs) compared with bare stents in the first year after implantation, long-term outcomes of patients treated with these novel devices remain unknown. Our goal was to evaluate the clinical, angiographic, and intravascular ultrasound (IVUS) outcomes of patients treated with SESs 4 years after implantation. METHODS AND RESULTS: The study included 30 patients treated with sirolimus-eluting Bx Velocity stenting (slow release [SR; n=15] and fast release [FR; n=15]). Twenty-six patients underwent 4-year angiographic and IVUS follow-up and had matched assessments at all time points (index and 4-, 12-, 24-, and 48-month follow-up). One death occurred during the study period in a patient with a patent SES. There were no target-vessel revascularizations or thromboses between 2- and 4-year follow-up examinations. There was no stent thrombosis, target-lesion revascularization, death, or myocardial infarction in the SR group up to 4 years. Cumulative event-free survival rate was 87% for the total population (80% in the FR group and 93% in the SR group). In-stent late loss was slightly greater in the FR group (0.41+/-0.49 mm) than the SR group (0.09+/-0.23) after 4 years. One patient in the FR group had a 52% in-stent restenosis lesion. Percent neointimal hyperplasia volume, as detected by IVUS, remained minimal after 4 years (FR=9.1% and SR=5.7%). CONCLUSIONS: This study confirms the longevity of the optimal outcomes observed in patients treated with sirolimus-eluting Bx Velocity stents 4 years after implantation. In-stent lumen dimensions remained essentially unchanged at 4-year follow-up, particularly in the population treated with the currently available SES (SR formulation).

Maintenance of long-term clinical benefit with sirolimus-eluting coronary stents: three-year results of the RAVEL trial.

BACKGROUND: The use of sirolimus-eluting coronary stents has been associated with a nearly complete elimination of restenosis at 6 months and with a very low 1-year incidence of major adverse cardiac events (MACE). This analysis examined whether these beneficial effects persist over the longer term. METHODS AND RESULTS: This multicenter trial randomly assigned 238 patients to revascularization of single, de novo, native coronary artery lesions with sirolimus-eluting versus conventional bare-metal stents. Survival free from target lesion revascularization (TLR), target vessel failure (TVF), and MACE up to 3 years of follow-up was compared between the 2 treatment groups. Complete data sets were available in 94.2% of patients treated with sirolimus-eluting stents and in 94.1% of patients randomized to the control group. The cumulative 1-, 2-, and 3-year event-free survival rates were 99.2%, 96.5%, and 93.7% for TLR and 95.8%, 92.3%, and 87.9% for TVF, respectively, in the sirolimus-eluting stent group, versus 75.9%, 75.9%, and 75.0% for TLR and 71.2%, 69.4%, and 67.3% for TVF in the control group (P<0.001 for both comparisons at 3 years). Rates of MACE at 3 years were 15.8% in patients randomly assigned to sirolimus-eluting stents versus 33.1% in patients assigned to bare-metal stents (P=0.002). One patient treated with a sirolimus-eluting stent died of a cardiac cause between 12 and 36 months. CONCLUSIONS: Treatment of de novo coronary stenosis with sirolimus-eluting stents was associated with a sustained clinical benefit and very low rates of TLR and of other MACE up to 3 years after device implantation.