Drug-eluting Stent Insertion Research Articles

Long-term outcomes of IVUS-guided and angiography-guided drug-eluting stent implantation for left main coronary artery disease: a retrospective consort study

BackgroundIn patients with unprotected left main coronary artery disease (ULMCAD), this study compared the long-term prognosis of drug-eluting stent insertion guided by intravascular ultrasonography (IVUS) vs. angiography.Patients and methodsThis retrospective consort investigation was performed in December 2021. This analysis included 199 patients who underwent IVUS-guided (IVUS group, n = 81) or angiography-guided (angiography group, n = 118) drug-eluting stent implantation at the Affiliated Hospital of Inner Mongolia Medical University between September 2013 and September 2018. Major adverse cardiac events (MACE) were defined as cardiovascular death, sudden cardiac death, myocardial infarction.ResultsThe IVUS group had considerably lower proportions of MACE within 1 year postoperatively (P = 0.002) and cardiac mortality within 3 years postoperatively (P = 0.018) compared to the angiography group. However, after adjusting for confounding variables, the hazard ratio for 3-year cardiac mortality was similar between the two groups (P = 0.28). In the IVUS group, there was considerably greater minimum lumen diameter (MLD) (P = 0.046), and reduced frequencies of target vessel restenosis (P < 0.050) and myocardial infarction (MI) (P = 0.024) compared to the angiography group. Cox regression analysis for 3-year cardiac mortality found that MSD was independently associated with low cardiac mortality (HR = 0.1, 95% CI: 0.01–14.92, P = 0.030).ConclusionIVUS-guided drug-eluting stent implantation may lead to better long-term prognosis in patients with ULMCAD, and MSD may be a predictor for lower cardiac mortality.

Natural History and Clinical Outcomes After ST-Segment Elevation Myocardial Infarction Without Stent Insertion

After restoration of coronary perfusion in patients presenting with ST-segment elevation myocardial infarction (STEMI), discrete severe stenotic coronary lesions are not always apparent. There remains ambiguity whether drug-eluting stent (DES) insertion or initial medical management is best practice. Assess short-term clinical outcomes in patients presenting with STEMI without initial stent insertion. Patients who underwent percutaneous coronary intervention for STEMI between 2014 and 2020 were prospectively enrolled and assessed for inclusion. Patients presenting with in-stent restenosis or stent thrombosis, or who did not survive to hospital discharge were excluded. Of 13,871 patients presenting, 456 (3.3%) were treated without initial stenting. These patients were older than those treated with DES (66.1 ± 13.6 vs 62.3 ± 12.4years, p <0.001) and had higher rates of diabetes (23.5% vs 16.0%, p <0.001) and previous revascularization with either percutaneous coronary intervention (14.0% vs 7.3%, p <0.001) or coronary artery bypass graft (3.5% vs 1.8%, p = 0.008). Thirty-day mortality rate was elevated in patients treated without stenting compared with the rate in those receiving DES (4.2% vs 0.9%, p <0.001), as were rates of myocardial infarction (1.3% vs 0.5%, p = 0.026) and major adverse cardiac events (10.5% vs 2.4%, p <0.001). After propensity matching, a trend toward increased mortality remained (4.2% vs 2.0%, p = 0.055). In conclusion, a no-stenting initial strategy, compared with DES insertion, is associated with increased 30-day mortality in those presenting with STEMI without severe stenosis. These data suggest when appropriate, current-generation DES insertion should be undertaken.

Early Discontinuation of Aspirin Among Patients with Chronic Kidney Disease Undergoing Percutaneous Coronary Intervention with a Drug-Eluting Stent: A Meta-Analysis.

Conflicting evidence exists to support whether short duration of dual antiplatelet therapy (DAPT) followed by P2Y12 inhibitor monotherapy reduces bleeding complications after coronary artery drug-eluting stent (DES) insertion, compared with standard 12-month DAPT, particularly among patients with CKD who are at increased risk of bleeding. A Medline search identified randomized trials comparing up to 3 months of DAPT followed by P2Y12 inhibitor monotherapy versus twelve months of DAPT after insertion of a DES for any indication. Trials were included if they reported ischemic or bleeding outcomes among patients with CKD. The primary outcome was a composite of all-cause mortality, cardiac or cerebrovascular events, stent thrombosis (MACE), and major or minor bleeding events. Secondary outcomes were the individual components of the primary outcome, and clinically significant bleeding. The relative risk (RR) was estimated using a random-effects model. Seven randomized trials were included for a total of 4,996 patients with CKD (14% of the trial population). Early discontinuation of aspirin was associated with a similar incidence of the primary outcome among patients with CKD compared with twelve-month DAPT (RR 0.97; 95% confidence interval (95% CI) 0.73-1.30). The relative risk of MACE was also similar between the two arms (RR 1.02; 95% CI 0.85-1.23). The risk of clinically significant bleeding was significantly lower with early discontinuation of aspirin (RR 0.60; 95% CI 0.46-0.78). P2Y12 inhibitor monotherapy after a shortened course of DAPT appears to be associated with a similar risk of ischemic events and a lower risk of bleeding events after DES insertion among patients with CKD compared to 12-month DAPT.

Relationship between Metabolic Syndrome and Clinical Outcome in Patients Treated with Drug-Eluting Stenting after Rotational Atherectomy for Complex Calcified Coronary Lesions.

Background and aims: although an association between metabolic syndrome (MS) and cardiovascular disease risk has been documented, the relationship in patients with complex calcified coronary lesions undergoing rotational atherectomy (RA) and drug-eluting stent(DES) insertion remains controversial. Here, the influence of MS on outcomes was assessed. Methods and results: we retrospectively included 398 patients who underwent RA and DES insertion for complex calcified coronary lesions in our institution between June 2015 and January 2019. The modified Adult Treatment Plan III was used to diagnose MS. The endpoint was major adverse cardiovascular events (MACEs), comprising mortality from all causes, myocardial infarction, and target vessel revascularization (TVR). In all, 173 (43.5%) patients had MS. MS was significantly associated with MACE over the 28.32 ± 6.79-month follow-up period (HR 1.783, 95% CI from 1.122 to 2.833) even after adjustment for other possible confounders. Conclusion: MS was frequently observed in patients treated with RA with DES insertion for complex calcified coronary lesions. MS independently predicted MACE in these patients.

Results of drug-eluting stent in significant restenosis of the hemodialysis access: An initial study.

This study aimed to report the 12-month results of drug-eluting stent (DES) for the treatment of significant restenosis of the hemodialysis access. A total of 14 patients (seven men and seven women; median age 70years; range of 50-83years) with significant restenosis of hemodialysis accesses were enrolled from January 2017 to December 2018. A total of 10 arteriovenous graft (AVG) and four arteriovenous fistulae were treated with DES. Study outcomes included primary patency of the target lesion and circuit. Venous anastomosis of the AVG was the most common target lesion for DES insertion (nine hemodialysis accesses). The range of follow-up time was 12-36months. Primary patency rates of target lesion before DES (patency for last conventional balloon angioplasty [CBA]) versus target lesion after DES at 6 and 12months were 29% versus 100% and 7% versus 86% (p<0.001). Primary patency rates of pre-DES circuit (patency for last CBA) versus post-DES circuit at 6 and 12months were 29% versus 64% and 7% versus 29%, respectively (p=0.058). DES might improve the patency rate of target lesion in patients with significant restenosis of the hemodialysis access.

Effect and significance of hyperlipoproteinemia on stent thrombosis in patients with implanted drug-eluting stents: The 5-year follow up study

Elevated blood lipid level, also known as hyperlipoproteinemia (HLP), is the most common metabolic disorder in the general population. According to US National Heart Institute data, about 36% of adults and 10% of children aged 9 to 12 have elevated cholesterol levels. The risk of ischemic heart disease increases by 2-3% with every 1% increase in total cholesterol levels. Therefore, men aged 55-65 with a 10% increase in total cholesterol have about 38% increased ischemic heart disease mortality. The study's main objective is to determine the occurrence of thrombotic complications in patients in whom first-generation drug-eluting stents are implanted and how these events are influenced by the presence of HLP. The study is retrospective, clinical, and non-interventional with a five-year follow-up period for each patient. Initially, 800 patients undergoing index percutaneous coronary angioplasty with sirolimus-eluting and paclitaxel-eluting stent implantation were enrolled. Clinical data collected included cardiac disorders, the presence of diabetes mellitus, hyperlipoproteinemia, and smoking as a risk factor. In the examined group of patients, stent thrombosis was monitored according to Academic Research Consortium (ARC) criteria. The study included 800 patients who underwent percutaneous coronary angioplasty index. At the end of the follow-up period, 701 patients (87.6%) completed the clinical trial and were included in the statistical analysis. Stent thrombosis, determined according to ARC criteria, was reported as 'definitive stent thrombosis' in 22 patients (3.06%), 'probable stent thrombosis' in 1 patient (0.14%), and 'possible stent thrombosis' in 1 patient (0.14%). Of the 404 patients with HLP, 120 patients had a total cholesterol value >300 mg/dL. Twenty patients with definitive stent thrombosis had cholesterol >300 mg/dL. Patients with probable and possible stent thrombosis did not have HLP. A comparison of patients with stent thrombosis, with HLP and without HLP, revealed a statistically significant difference (16.67% vs. 1.35%, p <0.001). Comparing patients with unstable angina pectoris, with cholesterol value >300 mg/dL and without HLP, a statistically significant difference was observed (71.7% vs. 17.2%, p <0.001). We report on the long-term follow up of patients with stent thrombosis after drug-eluting stent insertion with and without HLP. The results suggest that HLP influences the development of coronary disease, with a significant influence on complications following percutaneous coronary intervention.

The Effect of Drug-Eluting Stents on Target Lesion Revascularization in Native Coronary Arteries: Results from the NORSTENT Randomized Study

Background: The NORSTENT trial randomized 9,013 patients to percutaneous coronary intervention (PCI) with a drug-eluting stent (DES) or bare-metal stent (BMS) with 5-year follow-up. No difference was found in the composite primary outcome of death from any cause and nonfatal spontaneous myocardial infarction after a median of 5 years of follow-up. Secondary outcomes included repeat revascularizations, which were reduced by DES. We report the occurrence of target lesion revascularization (TLR) in time and across demographic and clinical subgroups in patients with lesions in native coronary arteries (n = 8,782). Results: Clinically driven TLR was performed on 488 (5.6%) of the 8,782 patients during 5 years of follow-up. Male gender, older age, visible thrombus in the lesion, and larger stent diameter were associated with less TLR; multivessel disease and longer stents were associated with a higher risk of TLR. There was a substantial and highly significant reduction of the risk of any TLR after 5 years in the DES group (hazard ratio [HR] 0.44, 95% confidence interval [CI] 0.36–0.52], p < 0.001). The effect of DES on TLR was limited in time to the first 2 years in the study with no evidence of a later rebound effect. The reduction in TLR after DES insertion was consistent across subgroups defined by gender, age, diabetes status, renal function, and lesion and stent characteristics. The number needed to treat with DES (vs. BMS) to prevent 1 TLR ranged from 4 to 110 across clinically relevant subgroups. Conclusion: DES have a time-limited effect on the rate of TLR, but with a substantial and highly significant reduction in the first 2 years after the procedure. This effect was found to be consistent across all important clinical subgroups.

Aspects of Heart Failure in Patients with Ischemic Heart Disease after Percutaneous Coronary Revascularization with Polymer-coated Drug-Eluting Stents versus Bare-Metal Stents

Percutaneous coronary revascularization (PCR) with polymer-coated drug-eluting stents (DES) or bare-metal stents (BMS) is considered the standard therapy in advanced ischemic heart disease (IHD). Despite revascularisation, many of these patients subsequently develop heart failure with reduced ejection fraction (HFrEF). We analysed 51 patients with IHD, treated by PCR and insertion of DES and/or BMS who later developed HFrEF. Patients with DES where more likely women, of younger age and a higher incidence of diabetes mellitus compared to patients with BMS who were generally men, of older age and had more frequently acute ST-elevation myocardial infarction (STEMI) as indication for PCR. Although patients with DES had more severe IHD, their EF was higher, possibly due to the benefits offered by the DES.

Preoperative Cardiac Evaluation of the Patient Undergoing Noncardiac Surgery

This review summarizes selected recent evidence on cardiovascular evaluation before major noncardiac surgery. Based on recent studies and advancements in coronary stent technology, guidelines now indicate that major noncardiac surgery may be performed sooner (i.e., 3 to 6 months) after drug eluting stent insertion. In addition, contemporary research has emphasized the importance of heart failure, atrial fibrillation, and recent stroke (i.e., prior 9 months) as determinants of perioperative cardiac risk. Biomarkers are taking on increasing importance in preoperative cardiac risk stratification, with the most promising tests being natriuretic peptides and high-sensitivity troponins. These biomarkers may improve the accuracy of risk prediction beyond that based on clinical risk factors alone. Finally, recent data suggest that temporary preoperative discontinuation of chronic aspirin, angiotensin-converting enzyme inhibitor, or angiotensin receptor blocker therapy is preferred in most patients, while bridging therapy is generally not required when antithrombotic therapy is temporarily discontinued before surgery. Evidence pertaining to preoperative cardiac evaluation continues to evolve, with increasing emphasis on risk stratification using biomarkers, and more individualized perioperative management of chronic cardiovascular medications.

Reintervention Is Associated With Improved Survival in Pediatric Patients With Pulmonary Vein Stenosis

ObjectivesThe aim of this study was to evaluate survival following catheter intervention in pediatric patients with pulmonary vein stenosis (PVS). BackgroundDespite aggressive surgical and catheter intervention on PVS in children, recurrence and progression of stenosis can lead to right heart failure and death. Clinicians continue to seek effective treatment options for PVS. MethodsA single-center, retrospective study was performed including all patients <18 years of age who underwent catheter intervention (balloon angioplasty and bare-metal stent and drug-eluting stent insertion) on PVS. Endpoints included death, vein loss, and rate of reintervention. ResultsThirty patients underwent intervention (balloon angioplasty, n = 9; bare-metal stent, n = 5; drug-eluting stent, n = 16) at a median age of 6.4 months (4.3 to 9.9 months). Median follow-up duration was 30.6 months (77 days to 10.5 years). Fourteen patients (47%) died at a median of 2.0 months (0.4 to 3.2 months) following intervention. There was no association between DES placement and survival (p = 0.067). Reintervention (catheter or surgical) was associated with improved survival (p = 0.001), with a 1-year survival rate of 84% compared with 25% for no reintervention. Vein loss occurred in 34 of 58 (59%) veins at a median of 3.3 months (1.0 to 5.0 months). One-year vein survival was higher with DES implantation (p = 0.031) and with reintervention (p < 0.001). ConclusionsDES implantation at first catheter intervention appears to be associated with improved vein survival but may not result in improved patient survival. However, reintervention appears to be associated with improved patient survival and vein patency, suggesting that despite mode of treatment, frequent surveillance is important in the care of these patients.

Case Report - PCOS: A Potential Association with Coronary Vasospasm

A 29-year-old woman with polycystic ovarian syndrome (PCOS) and a past history of a drug-eluting stent insertion to her left anterior descending (LAD) artery presented with an out-of-hospital cardiac arrest (OHCA). Emergent coronary angiography revealed a focal severe stenosis in the right coronary artery (RCA)(Fig. 1a ) and another stenosis adjacent to the previous LAD stent (Fig. 2a ). Her youth and collaborative history of recurrent rest angina despite coronary intervention raised the suspicion of coronary vasospasm. Both RCA and LAD stenosis resolved after administration of intracoronary nitrates (Fig. 1, Fig. 2). Following full neurological recovery, she received a subcutaneous implantable cardiac defibrillator as secondary prevention and commenced long-term on verapamil 240 mg daily and oral nitrates.Fig. 2Stenosis adjacent to LAD stent.View Large Image Figure ViewerDownload Hi-res image Download (PPT) We hereby report the first case of an OHCA secondary to vasospasm in a young woman with PCOS. There are 2 important learning issues: 1) The potential relationship between PCOS and coronary vasospasm due to endothelial dysfunction and impaired platelet responsiveness to nitric oxide (NO); 2) The paramount importance of recognising this phenomenon is to institute optimal medial therapy and avoid coronary intervention where possible. Coronary vasospasm can lead to life-threatening arrhythmia as demonstrated in this scenario, and thus failure to recognise it may lead to potential adverse outcomes.

Clinical impact of routine follow-up coronary angiography after second- or third-generation drug-eluting stent insertion in clinically stable patients.

Background/AimsIn the bare-metal stent era, routine follow-up coronary angiography (RFU CAG) was used to ensure stent patency. With the advent of drug-eluting stents (DESs) with better safety and efficacy profiles, RFU CAG has been performed less often. There are few data on the clinical impact of RFU CAG after second- or third-generation DES implantation in clinically stable patients with coronary artery disease; the aim of this study was to examine this issue.MethodsWe analyzed clinical outcomes retrospectively of 259 patients who were event-free at 12-month after stent implantation and did not undergo RFU CAG (clinical follow-up group) and 364 patients who were event-free prior to RFU CAG (angiographic follow-up group). Baseline characteristics were compared between the groups.ResultsThe Kaplan-Meier estimated total survival and major adverse cardiac event (MACE)-free survival did not differ between the groups (p = 0.100 and p = 0.461, respectively). The cumulative MACE rate was also not different between the groups (hazard ratio, 0.85; 95% confidence interval, 0.35 to 2.02). In the angiographic follow-up group, 8.8% revascularization was seen at RFU CAG.ConclusionsRFU CAG did not affect long-term clinical outcome after second- or third-generation DES implantation in clinically stable patients.

Impact of exercise-based cardiac rehabilitation on de novo coronary lesion in patients with drug eluting stent.

ObjectiveTo compare the rate of progression of de novo lesion between the cardiac rehabilitation (CR) and control groups.MethodsThis is a retrospective observational study. Patients who received drug-eluting stent (DES) due to acute coronary syndrome were included as subjects. The CR group received eight weeks of early CR program, and sustained a self-exercise program in the homes. The control group was instructed to exercise independently. Nine months after the first insertion of DES, we implemented follow-up coronary angiography, and compared the rate of progression of de novo lesion by quantitative angiographic measurement between the two groups.ResultsA total of 81 patients were recruited as subjects to CR group (n=32) or control group (n=49). At nine months, late luminal loss was 0.04±0.23 mm in the CR group and 0.00±0.31 mm in the control group (p=0.54, observed power=0.10). Late loss was -0.90%±9.53% in the CR group and 0.80%±11.15% in the control group (p=0.58, observed power=0.05). No target lesion revascularization procedures were needed in the CR group, while two in the control group (p=0.25). In the CR group, mean VO2max was significantly improved from 24.36±5.00 to 27.68±5.24 mL/kg/min (p<0.001).ConclusionWe could not observe a statistically significant difference in the progression rate of de novo lesion between the CR and control groups. Thus the current amount of nine months exercise-based CR program does not seem to have a distinct impact on the retardation of de novo coronary lesion in patients who received percutaneous coronary intervention with DES.

Pre‐operative medication and proximal femoral fractures

We would like to express some concerns regarding the guidance on antiplatelet therapy in the new AAGBI guidelines on fractured neck of femur [1]. According to the guidelines, ‘aspirin may be withheld during inpatient stay, unless indicated for unstable angina or recent/frequent transient ischaemic attacks’, while ‘clopidogrel is generally not stopped on admission, especially in patients with drug eluting coronary stents’. In our opinion, this advice is contrary to previously published guidance on peri-operative management of antiplatelet therapy. While treatment with aspirin and clopidogrel has been shown to increase transfusion requirements in non-cardiac surgery, there is no evidence that this increases morbidity and mortality [2–4]. In contrast, the risks of stopping antiplatelet medication peri-operatively have been well demonstrated, particularly in those patients with coronary stents, in whom stent thrombosis is frequently a fatal event [5, 6]. Our understanding is that aspirin should be continued throughout the peri-operative period. Clopidogrel should be stopped on admission except in high-risk patients: bare metal stent insertion within 6 months; acute coronary syndrome or stroke within 6 weeks; and drug eluting stent insertion within 6–12 months [3, 4, 7]. In these situations, the decision to stop clopidogrel should be made in conjunction with a cardiologist or the prescribing practitioner. Stopping clopidogrel on admission allows surgery to take place at least 24 hours after the last dose, thereby increasing the effectiveness of any transfused platelets, while still within a 48-hour target. It can be restarted on the morning following surgery, assuming adequate haemostasis [7]. We welcome the statement that antiplatelet therapy should not delay surgery in these patients.

Surgical treatment of giant left ventricular apical thrombus diagnosed with contrast echocardiography in patient with previous anterior myocardial infarction

Abstract Introduction We report a case of a 66-year-old man with previous anterior ST-elevated myocardial infarction, treated with primary percutaneous coronary intervention and insertion of drug eluting stent on the left anterior descending coronary artery, and left ventricular (LV) apical aneurysm due to no-reflow. After 2 months follow-up contrast echocardiography allowed to detect giant apical LV thrombosis and to exclude impending LV wall rupture. Anticoagulant oral therapy failed to dissolve the thrombus. Aneurismectomy with left ventricular remodeling and excision of the thrombus was performed successfully and the patient was discharged in good condition. Conclusions Contrast echocardiography was fundamental in diagnosis of LV thrombus excluding an impending LV wall rupture and to guide treatment.

Recent trends in Australian percutaneous coronary intervention practice: insights from the Melbourne Interventional Group registry

To evaluate percutaneous coronary intervention (PCI) practice trends and 12-month outcomes in Australia in the era of drug-eluting stents (DES). Prospective study of consecutive patients undergoing 9204PCIs between 1April 2004and 31March 2008at seven Victorian public hospitals. Temporal trends in baseline characteristics and in-hospital and 12-month clinical outcomes including death, myocardial infarction (MI), target vessel revascularisation (TVR) and composite major adverse cardiac events (MACE), from year to year. Between 2004-2005and 2007-2008, the mean age of patients undergoing PCI was stable (65± 12years), and comorbidities such as hypertension, hyperlipidaemia, peripheral arterial disease and stroke increased (P<0.05). There were fewer elective and more urgent PCIs, especially for MI <24hours (17.6% in 2004-2005to 27.2% in 2007-2008, P<0.01). Overall stent use remained high (mean, 94.6%), but use of DES declined steadily (53.9% in 2004-2005to 32.0% in 2007-2008, P<0.01), despite increases in complex lesions. Planned clopidogrel therapy of ≥12months after insertion of DES increased from 54.7% in 2004-2005to 98.0% in 2007-2008(P<0.01). The overall procedural success rate was high (mean, 95.9%), and 12-month rates of mortality (3.8%), MI (4.8%), TVR (6.8%) and stent thrombosis (1.8%) remained low. Selective use of DES was an independent predictor of freedom from MACE at 12months (odds ratio, 0.68; 95% CI, 0.56-0.81). Use of DES declined steadily from 2004-2005to 2007-2008, despite increasing patient risk profile and lesion complexity. Procedural success remained high and 12-month adverse outcomes remained low, with increasing use of prolonged dual antiplatelet therapy.

Clinical Trials Update AHA Congress 2010

The clinical trials described in this article were presented at the Late Breaking Trials and the Clinical Science: Clinical Reports sessions of the American Heart Association Congress held in November 2010 in Chicago. The sessions and topics chosen for this article reflect the scope of interest of Cardiovascular Drugs and Therapy. The presentations should be considered preliminary, as further analyses may be done, which could alter the final publication of the results of these studies. PROTECT (ProBNP Outpatient Tailored Chronic Heart Failure Therapy) was designed to test the hypothesis that adjustment of intensity of chronic heart failure (HF) therapy on the basis of NT-proBNP plasma level monitoring would improve outcomes. The results provided some support of this concept, but needs further evaluation in larger, blinded trials. REVEAL (Reduction of Infarct Expansion and Ventricular Remodeling with erythropoietin after large myocardial infarctions) evaluated in the clinical setting of ischemia-reperfusion following STEMI that erythropoietin could salvage ischemic myocardium. The results did not show a reduction in infarct size, but, in contrast, an increase in adverse event rates in the erythropoietin group. GRAVITAS (Gauging Responsiveness with a VerifyNow assay-Impact on Thrombosis and Safety trial) investigated the effect of a standard vs. high maintenance clopidogrel dose in patients with stable myocardial ischemia or NSTEMI and drug-eluting stent insertion. Patients with high PRU values as determined by VerfyNow assay were randomized to 75 mg or 150 mg clopidogrel daily. The study did not show a significant difference in primary event rate between both groups. The Cholesterol Treatment Trialists' Collaboration Studies group evaluated the concept proposed in the JUPITER study that HDL levels on statin treatment may not provide useful prognostic information. The CTTC in a large sample size of statin-treated patients observed, on the contrary, a significantly increased risk of CV events, even in patients with low LDL cholesterol levels. DEFINE (Determining the Efficacy and Tolerability of CETP inhibition with Anacetrapib) evaluated possible safety aspects with the CETP inhibitor anacetrapib (increase in blood pressure). The study did not show adverse safety aspects, but significantly reduced LDL cholesterol and increased HDL cholesterol levels. ASSERT, a phase 2 dose-ranging study, investigated whether RVX-208 would increase Apo-A1 production. Apo-A1 may induce cholesterol efflux from macrophages and facilitate atherosclerosis regression. The study did not meet its primary endpoint, but significant prominent effects on lipids were found. ASCEND-HF was a large trial of nesiritide in >7000 patients with acute heart failure. The study did not show convincing symptom benefit, but on the other hand did not show harmful effects of nesiritide. EMPHASIS-HF evaluated the long term effects of eplerenone in patients with mild (NYHA class II) heart failure and systolic dysfunction. The study was prematurely ended because of highly significant beneficial effects. CUPID (Calcium Up-regulation by Percutaneous administration of gene therapy In cardiac Disease) is the first human study with gene transfer of SERCA2a (AVV1/SERCA2a: Mydicar). In a small placebo-controlled dose-ranging study in advanced heart failure patients a multiple endpoint analysis provided positive effects of the highest dose on symptomatic, functional and structural efficacy endpoints without adverse effects.

Intraoperative drug-eluting stent thrombosis in a patient undergoing robotic prostatectomy

Insertion of drug-eluting stents is one of the strategies for treating patients with coronary artery disease. These patients can be a perioperative challenge in management as they need to be maintained on antiplatelet therapy to prevent stent thrombosis, which puts them at an increased risk for surgical bleeding. Recently revised guidelines on elective surgery following insertion of a drug-eluting stent recommend dual antiplatelet therapy for a period of twelve months. The management of a patient who presented for surgery more than two years after the insertion of a drug-eluting stent, and who developed in-stent thrombosis intraoperatively, is presented.

Minimal withdrawal of dual antiplatelet agents under the guidance of a point-of-care platelet activity assay early after drug-eluting stent implantation for surgical removal of renal cell carcinoma

A 58-year-old man presented with unstable angina, for whom drug-eluting stent (DES) was successfully implanted in mid portion of left anterior descending artery and diagonal branch bifurcation. During hospitalization, renal cell carcinoma was incidentally found. Right radical nephrectomy was planned 5 weeks after the DES insertion to minimize thrombotic risk following discontinuation of antiplatelet agents. Seven days and 5 days prior to the operation, clopidogrel and aspirin were withdrawn respectively while platelet activity was serially monitored using VerifyNow Aspirin/P2Y12® assay. According to the results of the assay, the infusion of tirofiban was started from the third day after stopping dual antiplatelet therapy and maintained till 8 h prior to the nephrectomy. With the help of this bridge therapy, the surgery was successfully performed and histology confirmed a renal cell carcinoma. Clopidogrel and aspirin were resumed the next day after the operation. Eight days after his nephrectomy, the patient was discharged without stent thrombosis or bleeding complication.

Drug-eluting Stents

Percutaneous coronary intervention (PCI) has a special role in the treatment of coronary heart disease. The insertion of drug-eluting stents (DES) requires dual anti-platelet therapy for at least 1 year which makes planned and emergency surgery difficult. There is a dilemma between high risk of stent thrombosis and perioperative bleeding. There is no evidence-based, bridging therapy option available perioperatively. This complex of problems should be considered whenever PCI is performed. An interdisciplinary approach is obligatory in these imminent conditions to proceed with either interventional or surgical revascularization. Co-existing malignancies and disorders which must be treated surgically should be excluded before PCI. Furthermore, DES and dual anti-platelet therapy produce unanswered forensic questions. On legal grounds it is not possible to proceed with surgery in cases of medication with anti-platelet therapy. Therefore, it is mandatory to discuss the possible answers to this problem with health care lawyers. The patient must be informed about this complex of problems.