Rajiv Jauhar

Bare Metal Stents Versus Drug Eluting Stents: Where Do We Stand in 2015?

Opinion statementThe development of bare metal stent (BMS) was a major advancement over plain old balloon angioplasty (POBA) in the management of symptomatic coronary artery disease. BMS prevented restenosis by attenuating early arterial recoil and contraction; both seen commonly after POBA. However, the rate of clinically indicated target lesion repeat revascularization due to a process of in-stent restenosis (ISR) at 1xa0year remained relatively high (10 to 20xa0%), often due to excessive neointimal growth (Fischman et al. N Engl J Med. 331:496, 1994; Serruys et al. N Engl J Med. 331:489, 1994; Cutlip et al. J Am Coll Cardiol 40:2082, 2002). Stents with drug elution technology (DES) were developed to reduce the relatively high rate of ISR and subsequent repeat revascularization seen with BMS. Clinical trials have confirmed a reduction of as much as 50 to 70xa0% in target lesion revascularization by DES compared to BMS. These findings have led to the preferential use of DES in the majority of percutaneous coronary intervention (PCI). However, as DES require a longer period of dual antiplatelet therapy (DAPT) to prevent stent thrombosis, DES are not appropriate for all patients.

9-Month Clinical and Angiographic Outcomes of the COBRA Polyzene-F NanoCoated Coronary Stent System

OBJECTIVESnThe aim of this study was to assess the safety and effectiveness of the COBRA Polyzene-F NanoCoated Coronary Stent System (CeloNova Biosciences, San Antonio, Texas) for the treatment of de novo coronary artery lesions.nnnBACKGROUNDnPolyzene-F-coated coronary stents have shown reduced thrombogenicity and inflammation in preclinical studies.nnnMETHODSnPatients with de novo coronary artery lesions meeting eligibility criteria were enrolled in a nonrandomized, prospective clinical trial. The primary endpoint was target vessel failure (TVF) (defined as a composite of cardiac death,xa0myocardial infarction, or clinically driven target vessel revascularization) at 9 months. A pre-specified subset was planned for routine repeat angiographic follow-up at 9 months. The powered secondary endpoint was mean late lumenxa0loss (LL). The comparator was a performance goal derived from meta-analysis of historical bare-metal stent trialsxa0of 19.62% for TVF and 1.1 mm for LL. Other secondary endpoints were clinically driven target lesion revascularization and definite or probable stent thrombosis.nnnRESULTSnOf 296 enrolled patients, 287 (97%) completed primary endpoint analysis; 130 were planned for angiographic follow-up and 115 (88%) completed. At 9 months, TVF had occurred in 33 patients (11.5%; upper 95% confidence boundary: 15.07%), including 1 (0.3%) cardiac death, 20 (7.0%) myocardial infarctions (17 periprocedural), and 17 (5.9%) target vessel revascularizations. LL was 0.84 ± 0.48 mm (upper 95% confidence boundary: 0.92). Target lesion revascularization occurred in 13 patients (4.6%). There were no stent thrombosis events.nnnCONCLUSIONSnThe COBRA Polyzene-F stent met performance goals for TVF and LL at 9 months. There was anxa0excellent safety profile, with infrequent late myocardial infarction and no stent thrombosis.

Randomized Comparison of Ridaforolimus-Eluting and Zotarolimus-Eluting Coronary Stents in Patients with Coronary Artery Disease: Primary Results from the BIONICS Trial

Background —The safety and efficacy of a novel cobalt alloy-based coronary stent with a durable elastomeric polymer eluting the antiproliferative agent ridaforolimus for treatment of patients with coronary artery disease is undetermined. Methods —A prospective, international 1:1 randomized trial was conducted to evaluate in a noninferiority design the relative safety and efficacy of ridaforolimus-eluting stents (RES) and slow-release zotarolimus-eluting stents (ZES) among 1,919 patients at 76 centers undergoing percutaneous coronary intervention. Inclusion criteria allowed enrollment of patients with recent myocardial infarction (MI), total occlusions, bifurcations lesions and other complex conditions. Results —Baseline clinical and angiographic characteristics were similar between the groups. Overall, mean age was 63.4 years, 32.5% were diabetic and 39.7% presented with acute coronary syndromes. At 12 months, the primary endpoint of target lesion failure (composite of cardiac death, target vessel-related MI and target lesion revascularization) was 5.4% for both devices (upper bound of one-sided 95% confidence interval 1.8%, P noninferiority =0.001). Definite/probable stent thrombosis rates were low in both groups (0.4% RES vs. 0.6% ZES, P=0.75). 13-month angiographic in-stent late lumen loss was 0.22 ± 0.41 mm and 0.23 ± 0.39 mm ( P noninferiority =0.004) for the RES and ZES groups, respectively, and intravascular ultrasound percent neointimal hyperplasia was 8.10 ± 5.81 and 8.85 ± 7.77, respectively ( P noninferiority =0.01). Conclusions —In the present trial which allowed broad inclusion criteria, the novel RES met the prespecified criteria for noninferiority compared with ZES for the primary endpoint of target lesion failure at 12 months, and had similar measures of late lumen loss. These findings support the safety and efficacy of RES in patients representative of clinical practice. Clinical Trial Registration —URL: www.ClinicalTrials.gov nUnique Identifier: NCT01995487Background: The safety and efficacy of a novel cobalt alloy-based coronary stent with a durable elastomeric polymer eluting the antiproliferative agent ridaforolimus for treatment of patients with coronary artery disease is undetermined. Methods: A prospective, international 1:1 randomized trial was conducted to evaluate in a noninferiority design the relative safety and efficacy of ridaforolimus-eluting stents (RESs) and slow-release zotarolimus-eluting stents among 1919 patients undergoing percutaneous coronary intervention at 76 centers. Inclusion criteria allowed enrollment of patients with recent myocardial infarction, total occlusions, bifurcations lesions, and other complex conditions. Results: Baseline clinical and angiographic characteristics were similar between the groups. Overall, mean age was 63.4 years, 32.5% had diabetes mellitus, and 39.7% presented with acute coronary syndromes. At 12 months, the primary end point of target lesion failure (composite of cardiac death, target vessel-related myocardial infarction, and target lesion revascularization) was 5.4% for both devices (upper bound of 1-sided 95% confidence interval 1.8%, Pnoninferiority=0.001). Definite/probable stent thrombosis rates were low in both groups (0.4% RES versus 0.6% zotarolimus-eluting stent, P=0.75); 13-month angiographic in-stent late lumen loss was 0.22±0.41 mm and 0.23±0.39 mm (Pnoninferiority=0.004) for the RES and zotarolimus-eluting stent groups, respectively, and intravascular ultrasound percent neointimal hyperplasia was 8.10±5.81 and 8.85±7.77, respectively (Pnoninferiority=0.01). Conclusions: In the present trial, which allowed broad inclusion criteria, the novel RESs met the prespecified criteria for noninferiority compared with zotarolimus-eluting stents for the primary end point of target lesion failure at 12 months and had similar measures of late lumen loss. These findings support the safety and efficacy of RESs in patients who are representative of clinical practice. Clinical Trial Registration: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01995487.

Gender difference with the use of percutaneous left ventricular assist device in patients undergoing complex high-risk percutaneous coronary intervention: From pVAD Working Group:

Background: The interventional treatment of complex high-risk indicated patients is technically difficult and can result in poor outcomes. Thus, percutaneous left ventricular assist devices are being increasingly used to provide hemodynamic support. No data is available comparing male and female for Complex High-risk Indicated Patients treated with percutaneous left ventricular assist devices. Our goal was to evaluate in-hospital as well as short term outcomes comparing males and females. Methods: There were 160 complex high-risk indicated patients with percutaneous left ventricular assist device use who were not in cardiogenic shock. A total of 132 male and 28 female patients were included. Ejection fraction below 35% with one additional criterion such as use of atherectomy device or treatment on unprotected left main disease or multi-vessel disease were our inclusion criteria. An Impella 2.5 or Impella CP (Abiomed Inc.) device was used as a left ventricular support device. Results: There was no difference in in-hospital mortality between the genders after performing a propensity score matched analysis (8.3% vs. 12.5%, p=0.54). Secondary outcomes of myocardial infarction, cardiogenic shock, congestive heart failure, dysrhythmia, major adverse cardiac events and composite of all complications were higher in males. Furthermore, 30-day survival was similar in males and females (88.9% vs. 87.5%, p=0.31). In addition, worse complications rates and survival were noted in patients with incomplete revascularization compared with those patients with complete revascularization in both gender. Conclusion: This study demonstrated no gender difference in clinical outcomes when using percutaneous left ventricular assist device support for the treatment of complex high-risk indicated patients. Overall, males had higher secondary outcomes compared with females with no difference in in-hospital mortality or 30-day survival rates.

Clinical outcomes of atherectomy prior to percutaneous coronary intervention: A comparison of outcomes following rotational versus orbital atherectomy (COAP-PCI study)

BACKGROUNDnBecause of the challenges in treating calcified coronary artery disease (CAD), lesion preparation has become increasingly important prior to percutaneous coronary intervention (PCI). Despite growing data for both rotational atherectomy (RA) and orbital atherectomy (OA), there have been no multicenter studies comparing the safety and efficacy of both. We sought to examine the clinical outcomes of patients with calcified CAD who underwent atherectomy.nnnMETHODSnA total of 39u2009870 patients from five tertiary care hospitals who had PCI from January 2011 to January 2017 were identified. 907 patients who had RA or OA were included. This multicenter, prospectively collected observational analysis compared OA and RA. The primary end-point was myocardial infarction and safety outcomes including significant dissection, perforation, cardiac tamponade, and vascular complications. Propensity score matching (1:1) was performed to reduce selection bias.nnnRESULTSnAfter matching, 546 patients were included in the final analysis. The primary endpoint, myocardial infarction occurred less frequently with OA compared to RA (6.7% vs 13.8%, Pu2009≤u20090.01) in propensity score matched cohorts. Procedural safety outcomes were comparable between the groups. The secondary outcome of death on discharge occurred less in the OA group as compared with RA (0% vs 2.2%, Pu2009=u20090.01). Fluoroscopy time was less in patients who were treated with OA (21.9 vs 25.6u2009min, Pu2009≤u20090.01). Additional secondary outcomes were comparable between groups.nnnCONCLUSIONnIn this non-randomized, multicenter comparison of contemporary atherectomy devices, OA was associated with significantly decreased in-hospital myocardial infarction and mortality after propensity score matching with decreased fluoroscopy time.

Comparison of drug eluting stents (DESs) and bare metal stents (BMSs) with STEMI: who received BMS in the era of 2nd generation DES?

Highlights:Drug Eluting Stent (DES) stent should be the standard of care.Bare Metal Stent (BMS) was used in certain high‐risk procedures and in patients with multiple comorbidity in the era of 2nd generation of DES.Disparities in the use of stent should not be based on race, gender, household income or age group but should be based on each individual patients risk factor and characteristics.Further research is needed to see whether these differences in stent selection reflect physician decisions regarding appropriateness of treatment of ST segment elevated myocardial infarction. Background: The aim of this study was to analyze the indications for using bare metal stents (BMSs) in hospitalizations with ST segment elevation myocardial infarction (STEMI) undergoing percutaneous coronary intervention (PCI). Methods: The study cohorts were identified from the National Inpatient Sample database from 2010–2014 using appropriate, International Classification of Diseases, 9th Revision, Clinical Modification, diagnostic and procedural codes. Results: A total of 123,487 hospitalizations were identified for this study. Drug eluting stent (DES) use demonstrated lower in‐hospital mortality (5.8% vs. 3.3%, P = < 0.01) and other in‐hospital outcomes, thus resulting in lower hospitalization stay. Higher age, black race, greater comorbidity burden, inferior wall myocardial infarction, and the use of mechanical circulatory devices were all associated with BMS use. Conclusion: DES was the preferred standard of care in the era of 2nd generation DES; however, BMSs were used in hospitalizations with high‐risk procedures and multiple risk factors.

Safety of orbital atherectomy in patients with left ventricular systolic dysfunction

OBJECTIVESnWe evaluated the angiographic and clinical outcomes in patients with severely calcified lesions and systolic dysfunction who underwent orbital atherectomy (OA). We hypothesized that OA would provide similar outcomes in patients with systolic dysfunction compared with patients with preserved systolic function.nnnBACKGROUNDnSystolic dysfunction is associated with an increased risk of adverse clinical events after percutaneous coronary intervention (PCI). The effects of OA in patients with systolic dysfunction are unknown.nnnMETHODSnOur analysis retrospectively analyzed 438 patients (nu2009=u200969 with EFu2009≤u200940%) who underwent OA. The primary endpoint was the rate of major adverse cardiac and cerebrovascular events (MACCE) at 30 days.nnnRESULTSnThere were no significant differences between patients with preserved versus reduced systolic function in terms of dissections (0.9% vs. 1.6%, Pu2009=u20090.51), perforation (0.3% vs. 3.2%, Pu2009=u20090.07), or no reflow (0.3% vs. 3.2%, Pu2009=u20090.07). Patients with systolic dysfunction had higher rates of the composite of 30-day MACCE (1.1% vs. 8.7%, Pu2009=u20090.002) and the individual end points of death (0.3% vs. 7.2%, Pu2009<u20090.001), and myocardial infarction (0.5% vs. 4.3%, Pu2009=u20090.03). The rates of target vessel revascularization (0% vs. 0%, Pu2009=u20091), stroke (0.3% vs. 0%, Pu2009>u20090.9), and stent thrombosis (0.8% vs. 1.4%, Pu2009=u20090.5) were low in both groups and did not differ.nnnCONCLUSIONnPlaque modification with OA was safe and well tolerated in patients with systolic dysfunction. In this high-risk cohort, adverse clinical outcomes occurred more frequently than in a lower risk population.

Comparison of the Diameters of the Major Epicardial Coronary Arteries by Angiogram in Asian-Indians Versus European Americans <40 Years of Age Undergoing Percutaneous Coronary Artery Intervention

Coronary artery disease (CAD) rates are higher in Asian-Indians than in Caucasians. CAD occurs at an earlier age in this group, with about a quarter of all myocardial infarctions occurring under the age of 40. Previous reports have suggested smaller coronary artery size in Asian-Indians as a major cause for increased CAD in this population. This study sought to evaluate the size of normal atheroma-free segments of the epicardial coronary arteries in Asian-Indians and Caucasians aged ≤40 years undergoing coronary artery intervention in other diseased segments. A total of 69 consecutive patients (41 whites, 28 Asian-Indians) aged ≤40 years were evaluated. Angiograms were analyzed using standard quality control analysis software with digital acquisition. The arteries measured were the left main, left anterior descending, left circumflex, and the right coronary artery. Conventional risk factors, including hypertension, smoking, and diabetes, that could influence coronary size were also assessed. The coronary arteries of Asian-Indian patients showed significantly smaller values in the mean diameters of the left main (2.96u2009mm vs 4.04u2009mm, pu2009=u20090.0004), left anterior descending (2.48u2009mm vs 3.24u2009mm, pu2009=u20090.0005), left circumflex (2.52u2009mm vs 3.06u2009mm, pu2009=u20090.00002), and right coronary artery (2.71u2009mm vs 3.65u2009mm, pu2009=u20090.0008) as compared with Caucasians. Even after correction for body surface area, a statistically significant difference remained in coronary artery diameters. In conclusion, statistically significant difference in the mean diameter size even after correction for body surface area in Asian-Indians has implications for predisposition to atherosclerosis, and more challenging performance of procedures such as coronary artery bypass grafting, stent implantation, or atherectomy.

INCIDENCE OF TEMPORARY TRANSVENOUS PACEMAKER PLACEMENT WITH CORONARY ORBITAL ATHERECTOMY COMPARED TO ROTATIONAL ATHERECTOMY

Transvenous temporary pacing (TVP) is often used during percutaneous coronary intervention (PCI) in patients undergoing rotational atherectomy (RA) and is recommended for prophylactic use in all cases involving the RCA. The placement of transvenous pacing has cost implications, but more importantly

INCIDENCE, PREDICTORS AND OUTCOMES OF ACUTE KIDNEY INJURY FOLLOWING TRANSCATHETER AORTIC VALVE REPLACEMENT

Acute kidney injury (AKI) after Transcatheter aortic valve replacement (TAVR) is associated with poor prognosis. However, there is limited data on the incidence and impact of AKI following TAVR defined using the VARC-2 criteria.nn90 consecutive TAVR procedures performed in 2 large hospitals in our