Upendra Kaul

Paclitaxel-Eluting versus Everolimus-Eluting Coronary Stents in Diabetes

BACKGROUND The choice of drug-eluting stent in the treatment of patients with diabetes mellitus and coronary artery disease who are undergoing percutaneous coronary intervention (PCI) has been debated. Previous studies comparing paclitaxel-eluting stents with stents eluting rapamycin (now called sirolimus) or its analogues (everolimus or zotarolimus) have produced contradictory results, ranging from equivalence between stent types to superiority of everolimus-eluting stents. METHODS We randomly assigned 1830 patients with diabetes mellitus and coronary artery disease who were undergoing PCI to receive either a paclitaxel-eluting stent or an everolimus-eluting stent. We used a noninferiority trial design with a noninferiority margin of 4 percentage points for the upper boundary of the 95% confidence interval of the risk difference. The primary end point was target-vessel failure, which was defined as a composite of cardiac death, target-vessel myocardial infarction, or ischemia-driven target-vessel revascularization at the 1-year follow-up. RESULTS At 1 year, paclitaxel-eluting stents did not meet the criterion for noninferiority to everolimus-eluting stents with respect to the primary end point (rate of target-vessel failure, 5.6% vs. 2.9%; risk difference, 2.7 percentage points [95% confidence interval, 0.8 to 4.5]; relative risk, 1.89 [95% confidence interval, 1.20 to 2.99]; P=0.38 for noninferiority). There was a significantly higher 1-year rate in the paclitaxel-eluting stent group than in the everolimus-eluting stent group of target-vessel failure (P=0.005), spontaneous myocardial infarction (3.2% vs. 1.2%, P=0.004), stent thrombosis (2.1% vs. 0.4%, P=0.002), target-vessel revascularization (3.4% vs. 1.2%, P=0.002), and target-lesion revascularization (3.4% vs. 1.2%, P=0.002). CONCLUSIONS In patients with diabetes mellitus and coronary artery disease undergoing PCI, paclitaxel-eluting stents were not shown to be noninferior to everolimus-eluting stents, and they resulted in higher rates of target-vessel failure, myocardial infarction, stent thrombosis, and target-vessel revascularization at 1 year. (Funded by Boston Scientific; TUXEDO-India Clinical Trials Registry-India number, CTRI/2011/06/001830).

Percutaneous Coronary Intervention in Patients With Insulin-Treated and Non–Insulin-Treated Diabetes Mellitus: Secondary Analysis of the TUXEDO Trial

IMPORTANCE Prior studies have shown that patients with insulin-treated diabetes mellitus (ITDM) have a higher risk of cardiovascular events. However, this finding is controversial, as other studies have shown that the increased risk of cardiovascular events disappears after risk adjustment. In addition, the choice of a drug-eluting stent (limus- vs taxol-eluting) in ITDM is controversial, with studies showing worse outcomes with an everolimus-eluting stent compared with a paclitaxel-eluting stent. OBJECTIVES To assess the outcomes of patients with ITDM vs non-ITDM who underwent percutaneous coronary intervention and to assess the efficacy and safety of an everolimus-eluting stent vs a paclitaxel-eluting stent based on insulin use status. DESIGN, SETTING, AND PARTICIPANTS A prespecified analysis was conducted of the Taxus Element vs Xience Prime in a Diabetic Population (TUXEDO) clinical trial, which enrolled 1830 patients with ITDM and non-ITDM from June 23, 2011, to March 12, 2014. Patients were randomized 1:1 to receive either a paclitaxel-eluting stent or an everolimus-eluting stent. MAIN OUTCOMES AND MEASURES The primary end point was target vessel failure, defined as the composite of cardiac death, target vessel myocardial infarction, or ischemia-driven target vessel revascularization at 1 year after the intervention. RESULTS Among the 1830 patients (1377 male) in the TUXEDO trial, 747 patients (40.8%) were receiving insulin (ITDM group). Compared with the 1083 patients with non-ITDM, those with ITDM had a significant increase in target vessel failure (42 [5.6%] vs 36 [3.3%]; P = .02), death or myocardial infarction (43 [5.8%] vs 35 [3.2%]; P = .009), death (26 [3.5%] vs 18 [1.7%]; P = .01), and subacute stent thrombosis (8 [1.1%] vs 3 [0.3%]; P = .03). However, in a propensity score-adjusted analysis to account for baseline differences between the 2 groups, the differences in outcomes were no longer significant. In patients with ITDM, everolimus-eluting stents reduced the rate of target vessel failure (13 of 382 [3.4%] vs 29 of 365 [7.9%]; P = .007), major adverse cardiac events (15 of 382 [3.9%] vs 30 of 365 [8.2%]; P = .01), myocardial infarction (5 of 382 [1.3%] vs 16 of 365 [4.4%]; P = .01), stent thrombosis (2 of 382 [0.5%] vs 11 of 365 [3.0%]; P = .009), target lesion revascularization (4 of 382 [1.0%] vs 19 of 365 [5.2%]; P = .001), and target vessel revascularization (4 of 382 [1.0%] vs 19 of 365 [5.2%]; P = .001) when compared with paclitaxel-eluting stents. The results largely trended in the same direction in patients with non-ITDM (P > .05 for the interaction). CONCLUSIONS AND RELEVANCE Patients with ITDM had a significant increase in the risk of cardiovascular events in unadjusted models that was largely attenuated after propensity score adjustment. Everolimus-eluting stents reduced the rate of cardiovascular events, including stent thrombosis, when compared with paclitaxel-eluting stents in patients with ITDM. TRIAL REGISTRATION ctri.nic.in Identifier: CTRI/2011/06/001830.

Prevalence and control of cardiovascular risk factors in stable coronary artery outpatients in India compared with the rest of the world: An analysis from international CLARIFY registry

Objectives We describe the clinical characteristics, prevalence and control of coronary artery disease (CAD) risk factors of the Indian cohort enrolled in the CLARIFY registry and compare them with data from rest of the world (ROW). Methods CLARIFY is an international, prospective, observational, longitudinal cohort study in stable CAD outpatients. The baseline data of Indian cohort (n = 709) were compared to ROW (n = 31994). Results The CLARIFY India patients were significantly younger than the ROW (59.6 ± 10.9 vs 64.3 ± 10.4). Indian patients were more likely than those in ROW to have diabetes (42.9% vs 28.8%) and angina (27.8% vs 21.9%). Mean heart rate was significantly greater in Indians measured by either palpatory method (76.1 ± 10.4 vs 68.0 ± 10.5) or ECG (74.9 ± 12.9 vs 67.0 ± 11.3). The use of aspirin (85.6% vs 87.8%), β-blockers (69.4% vs 75.4%), and lipid-lowering agents (90% vs 92.4%) was lower in India. A significantly greater proportion of patients in India exhibited low HDL cholesterol (41.6% vs 31.2%), and heart rate ≥70 bpm (82.2% vs 48.5%). The risk factors control was poor in India with heart rate goal of ≤60 bpm achieved in 2.5%; HbA1c <7% in 9.9%; and HbA1c <6.5% in 4.6% patients. Conclusion The CLARIFY registry demonstrates a high prevalence and poor control of cardiovascular risk factors in Indian patients. Systematic efforts to improve risk factor control are required.

Type IV dual left anterior descending coronary artery: A rare anomaly

Type IV dual left anterior descending (LAD) coronary artery is a rare anomaly and was detected incidentally during a routine coronary angiogram. The article discusses the types of dual LAD and their clinical implications.

Choice of drug-eluting stent—evidence-based or empirical

Abstract Percutaneous transluminal coronary angioplasty (PTCA) was developed as a nonsurgical alternative to coronary artery bypass graft surgery (CABG). Its limitations led to the introduction of stents. The introduction of baremetal stents (EMS) virtually eliminated the acute complications of PTCA. Drug-eluting stents (DES) were developed to combat the neo-intimal hyperplasia; and a marked reduction in restenosis rate and target lesion revascularization (TLR) was obtained with their use as compared to BMS.

TCT-457 Paclitaxel - eluting stents vs Everolimus - eluting Coronary Stents in a Diabetic population: 2 Years Follow-up of TUXEDO-India Trial

TCT-457 Paclitaxel eluting stents vs Everolimus eluting Coronary Stents in a Diabetic population: 2 Years Follow-up of TUXEDO-India Trial Upendra Kaul, Dr. Rajpal K. Abhaichand, Tejas Patel, Darshan Banker, Atul Abhyankar, Ajit Mullasari, Sanjay Shah, Rajneesh Jain, premchand rajendra kumar, C.G. Bahuleyan, Priyadarshini Arambam, Sripal Bangalore Fortis Escorts Hospital, New Delhi, India; GKNM Hospital, Coimbatore, India; APEX Heart Institute, Ahmedabad, Gujarat, India; Bankers Heart Institute, Vadodara, Gujarat, India; Sahajanand Medical, Surat, Gujarat, India; Madras Medical Mission Hospital, Chennai, India; Unknown, Ahmedabad, India; Sri Gangaram Hospital, Delhi, India; KIIMS Hyderabad, Hyderabad, India; Ananthapuri Hospitals and Research Institute,, Trivandrum, Kerala, India; Fortis Healthcare Limited, New Delhi, India; New York University School of Medicine, New York, New York, United States

TCT-450 Bare Metal Stent, Durable Polymer Drug Eluting Stent, or Biodegradable Polymer Drug Eluting Stent in Patients with Diabetes Mellitus - A Mixed Treatment Comparison Analysis of 63,940 Patient-Years of Follow-up from Randomized Trials

TCT-449 Abluminal Groove-Filled Biodegradable Polymer Sirolimus-Eluting Stent versus Cobalt-Chromium Everolimus-Eluting Stent in De Novo Native Coronary Lesions: The Final 5-Year Results of the TARGET I Randomized Controlled Trial Bo Xu, Changdong Guan, Yuejin Yang, Yaling Han, Shao-Liang Chen, Alexandra Lansky, Martin Leon, Runlin Gao Fu Wai Hospital, Beijing, Beijing, China; Fu Wai Hospital, National Center for Cardiovascular Diseases, Beijing, Beijing, China; Cardiovascular Institute and Fu Wai Hospital, Beijing, Beijing, China; Shenyang, Liaoning, China; Nanjing First Hospital of Nanjing Medical Center, Nanjing, China; Yale School of Medicine, New Haven, Connecticut, United States; NewYork-Presbyterian Hospital/Columbia University Medical Center, New York, New York, United States; Fu Wai Hospital, Beijing, Beijing, China

Effectiveness of Ventricular Intrinsic Preference (VIP™) and Ventricular AutoCapture (VAC) algorithms in pacemaker patients: Results of the validate study.

Several past clinical studies have demonstrated that frequent and unnecessary right ventricular pacing in patients with sick sinus syndrome and compromised atrio‐ventricular conduction (AVC) produces long‐term adverse effects. The safety and efficacy of two pacemaker algorithms, Ventricular Intrinsic Preference™ (VIP) and Ventricular AutoCapture (VAC), were evaluated in a multi‐center study in pacemaker patients.

Primary Angioplasty Using a Renal Stent in a Severly Ectactic and Occluded Left Anterior Descending Coronary Artery

Revascularization of ectatic coronary arteries in the setting of acute myocardial infarction pos- es great challenges for the operator. We report a case, where a peripheral renal stent was used successfully to treat the clinical situation.

Adenosine induced coronary spasm – A rare presentation

Adenosine is commonly used as a pharmacological agent in myocardial perfusion imaging, as an antiarrhythmic agent, and in Cath Lab. during PCI for treating no reflow phenomenon. Coronary spasm has been reported following adenosine injection during stress imaging. We report a rare complication with ST segment elevation, following adenosine injection, given for treatment of supraventricular tachycardia.