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Design and rationale of the North Indian ST-Segment Elevation Myocardial Infarction Registry: A prospective cohort study

Arora, Sameer; Qamar, Arman; Gupta, Puneet; Vaduganathan, Muthiah; Chauhan, Ishit; Tripathi, Ashutosh K; Sharma, Vinamra Y; Bansal, Ankit; Fatima, Amber; Jain, Gagan; Batra, Vishal; Tyagi, Sanjay; Khandelwal, Lokesh; Kaul, Prashant; Rao, Sunil V; Girish, Meenahalli Palleda; Bhatt, Deepak L; Gupta, Mohit D
ST-segment elevation myocardial infarction (STEMI) is associated with increased mortality and morbidity. Although remarkable progress has been made in the management of STEMI in high-income countries, contemporary data to evaluate processes and outcomes of STEMI care in India is limited. The North Indian ST-segment elevation myocardial infarction (NORIN STEMI) registry is a prospective cohort study based at government funded and largely free of cost tertiary medical centers in New Delhi, India. These hospitals serve a large proportion of the patients with lower socioeconomic status presenting from multiple states in India, as many centers in these states lack adequate specialized cardiovascular care. The study has been approved by the Institutional Review Boards of each institution and informed consent has been obtained from study participants. The NORIN STEMI registry aims to provide important insights regarding contemporary risk factors profiles, practice patterns, and prognosis in patients with STEMI in an underserved population in North India. These findings may identify opportunities to improve the outcomes of patients with STEMI in India.
PMCID:6906983
PMID: 31593344
ISSN: 1932-8737
CID: 5222492

Best Practices for the Prevention of Radial Artery Occlusion After Transradial Diagnostic Angiography and Intervention: An International Consensus Paper

Bernat, Ivo; Aminian, Adel; Pancholy, Samir; Mamas, Mamas; Gaudino, Mario; Nolan, James; Gilchrist, Ian C; Saito, Shigeru; Hahalis, George N; Ziakas, Antonio; Louvard, Yves; Montalescot, Gilles; Sgueglia, Gregory A; van Leeuwen, Maarten A H; Babunashvili, Avtandil M; Valgimigli, Marco; Rao, Sunil V; Bertrand, Olivier F
Transradial access (TRA) is increasingly used worldwide for percutaneous interventional procedures and associated with lower bleeding and vascular complications than transfemoral artery access. Radial artery occlusion (RAO) is the most frequent post-procedural complication of TRA, restricting the use of the same radial artery for future procedures and as a conduit for coronary artery bypass graft. The authors review recent advances in the prevention of RAO following percutaneous TRA diagnostic or interventional procedures. Based on the available data, the authors provide easily applicable and effective recommendations to prevent periprocedural RAO and maximize the chances of access in case of repeat catheterization or coronary artery bypass grafting surgery.
PMID: 31753298
ISSN: 1876-7605
CID: 5222562

Clinical and regulatory landscape for cardiogenic shock: A report from the Cardiac Safety Research Consortium ThinkTank on cardiogenic shock

Samsky, Marc; Krucoff, Mitchell; Althouse, Andrew D; Abraham, William T; Adamson, Philip; Aguel, Fernando; Bilazarian, Seth; Dangas, George D; Gilchrist, Ian C; Henry, Timothy D; Hochman, Judith S; Kapur, Navin K; Laschinger, John; Masters, Roy G; Michelson, Eric; Morrow, David A; Morrow, Valarie; Ohman, E Magnus; Pina, Ileana; Proudfoot, Alastair G; Rogers, Joseph; Sapirstein, John; Senatore, Fred; Stockbridge, Norman; Thiele, Holger; Truesdell, Alexander G; Waksman, Ron; Rao, Sunil
PMID: 31707323
ISSN: 1097-6744
CID: 4184732

Stability After Initial Decline in Coronary Revascularization Rates in the United States

Raza, Sajjad; Deo, Salil V; Kalra, Ankur; Zia, Aisha; Altarabsheh, Salah E; Deo, Vaishali S; Mustafa, Rami R; Younes, Ahmad; Rao, Sunil V; Markowitz, Alan H; Park, Soon J; Costa, Marco A; Simon, Daniel I; Bhatt, Deepak L; Sabik, Joseph F
BACKGROUND:It remains uncertain how advances in revascularization techniques, availability of new evidence, and updated guidelines have influenced the annual rates of coronary revascularization in the United States. METHODS:We used the Nationwide Inpatient Sample data from 2005 to 2014 with appropriate weighting to determine national procedural volumes. To present accurately overall percutaneous coronary intervention (PCI) rates, PCI with same-day discharge numbers per year were estimated from the available literature and added to annual PCI procedures performed. RESULTS:Annual PCI rate declined from 353 per 100,000 adults in 2005 to 277 per 100,000 adults in 2009 (P < .001) but remained stable thereafter (P = .50). Annual coronary artery bypass grafting (CABG) rate declined steadily, at a shallower slope than PCI, from 120 per 100,000 in 2005 to 93 per 100,000 in 2009 (P = .02) but remained stable thereafter (P = .60). Similar trends were seen in men and women. Both PCI and CABG rates were lower in women than men over the study period (PCI, 482 to 324/100,000 in men vs 232 to 153/100,000 in women; CABG, 172 to 118/100,000 in men vs 64 to 38/100,000 in women). Annual PCI rates were higher than CABG rates in patients of all age groups including in younger patients (age < 50) and octogenarians. The proportion of coronary revascularization procedures performed per insurance type remained relatively similar across the study period. CONCLUSIONS:Annual rates of coronary revascularization have changed significantly over time, potentially because of advances in revascularization techniques, availability of new evidence, and updated guidelines. Rates of PCI declined more steeply than CABG before plateauing but remained higher than rates of CABG across the study period.
PMID: 31039350
ISSN: 1552-6259
CID: 5222362

A Meta-Analysis of Aspirin for the Primary Prevention of Cardiovascular Diseases in the Context of Contemporary Preventive Strategies

Shah, Rahman; Khan, Babar; Latham, Samuel B; Khan, Sajjad A; Rao, Sunil V
BACKGROUND:The role of aspirin for primary prevention of cardiovascular diseases remains controversial, particularly in the context of contemporary aggressive preventive strategies. METHODS:Relevant randomized clinical trials were included, and risk ratios (RRs) were calculated using random-effects models. Additional moderator analyses were performed to compare the pooled treatment effects from recent trials (those reported after the guidelines of the National Cholesterol Education Program Third Adult Treatment Panel were published in 2001; thus, conducted on the background of contemporary preventive strategies) to the results of older trials. RESULTS:Data from 14 randomized controlled trials involving 164,751 patients were included. Aspirin use decreased myocardial infarction risk by 16% compared with placebo (RR 0.84; 95% confidence interval [CI], 0.75-0.94); however, in the moderator analyses, aspirin was not associated with a decreased risk of myocardial infarction in recent trials, but was in older trials (P-interaction = .02). Overall, aspirin use significantly increased the occurrence of major bleeding (RR 1.49; 95% CI, 1.32-1.69) and hemorrhagic stroke (RR 1.25; 95% CI, 1.01-1.54). In moderator analyses, the risk of major bleeding (P-interaction = .12) or hemorrhagic stroke (P-interaction = .44) with aspirin was not significantly different between the older and new trials. Differences between aspirin and placebo in the risks for all-cause stroke, cardiac death, and all-cause mortality were not found. CONCLUSIONS:In the context of contemporary primary prevention guidelines, the effect of aspirin on myocardial infarction risk was significantly attenuated, whereas its major bleeding and hemorrhagic stroke complications were retained. Therefore, in contemporary practice, routine use of aspirin for the primary prevention of cardiovascular events may have a net harmful effect.
PMID: 31153866
ISSN: 1555-7162
CID: 5222382

Complete Revascularization with Multivessel PCI for Myocardial Infarction

Mehta, Shamir R; Wood, David A; Storey, Robert F; Mehran, Roxana; Bainey, Kevin R; Nguyen, Helen; Meeks, Brandi; Di Pasquale, Giuseppe; López-Sendón, Jose; Faxon, David P; Mauri, Laura; Rao, Sunil V; Feldman, Laurent; Steg, P Gabriel; Avezum, Álvaro; Sheth, Tej; Pinilla-Echeverri, Natalia; Moreno, Raul; Campo, Gianluca; Wrigley, Benjamin; Kedev, Sasko; Sutton, Andrew; Oliver, Richard; Rodés-Cabau, Josep; Stanković, Goran; Welsh, Robert; Lavi, Shahar; Cantor, Warren J; Wang, Jia; Nakamya, Juliet; Bangdiwala, Shrikant I; Cairns, John A
BACKGROUND:In patients with ST-segment elevation myocardial infarction (STEMI), percutaneous coronary intervention (PCI) of the culprit lesion reduces the risk of cardiovascular death or myocardial infarction. Whether PCI of nonculprit lesions further reduces the risk of such events is unclear. METHODS:We randomly assigned patients with STEMI and multivessel coronary artery disease who had undergone successful culprit-lesion PCI to a strategy of either complete revascularization with PCI of angiographically significant nonculprit lesions or no further revascularization. Randomization was stratified according to the intended timing of nonculprit-lesion PCI (either during or after the index hospitalization). The first coprimary outcome was the composite of cardiovascular death or myocardial infarction; the second coprimary outcome was the composite of cardiovascular death, myocardial infarction, or ischemia-driven revascularization. RESULTS:At a median follow-up of 3 years, the first coprimary outcome had occurred in 158 of the 2016 patients (7.8%) in the complete-revascularization group as compared with 213 of the 2025 patients (10.5%) in the culprit-lesion-only PCI group (hazard ratio, 0.74; 95% confidence interval [CI], 0.60 to 0.91; P = 0.004). The second coprimary outcome had occurred in 179 patients (8.9%) in the complete-revascularization group as compared with 339 patients (16.7%) in the culprit-lesion-only PCI group (hazard ratio, 0.51; 95% CI, 0.43 to 0.61; P<0.001). For both coprimary outcomes, the benefit of complete revascularization was consistently observed regardless of the intended timing of nonculprit-lesion PCI (P = 0.62 and P = 0.27 for interaction for the first and second coprimary outcomes, respectively). CONCLUSIONS:Among patients with STEMI and multivessel coronary artery disease, complete revascularization was superior to culprit-lesion-only PCI in reducing the risk of cardiovascular death or myocardial infarction, as well as the risk of cardiovascular death, myocardial infarction, or ischemia-driven revascularization. (Funded by the Canadian Institutes of Health Research and others; COMPLETE ClinicalTrials.gov number, NCT01740479.).
PMID: 31475795
ISSN: 1533-4406
CID: 4066962

Incident anaemia in older adults with heart failure: rate, aetiology, and association with outcomes

Ambrosy, Andrew P; Gurwitz, Jerry H; Tabada, Grace H; Artz, Andrew; Schrier, Stanley; Rao, Sunil V; Barnhart, Huiman X; Reynolds, Kristi; Smith, David H; Peterson, Pamela N; Sung, Sue Hee; Cohen, Harvey Jay; Go, Alan S
AIMS:Limited data exist on the epidemiology, evaluation, and prognosis of otherwise unexplained anaemia of the elderly in heart failure (HF). Thus, we aimed to determine the incidence of anaemia, to characterize diagnostic testing patterns for potentially reversible causes of anaemia, and to evaluate the independent association between incident anaemia and long-term morbidity and mortality. METHODS AND RESULTS:Within the Cardiovascular Research Network (CVRN), we identified adults age ≥65 years with diagnosed HF between 2005 and 2012 and no anaemia at entry. Incident anaemia was defined using World Health Organization (WHO) haemoglobin thresholds (<13.0 g/dL in men; <12.0 g/dL in women). All-cause death and hospitalizations for HF and any cause were identified from electronic health records. Among 38 826 older HF patients, 22 163 (57.1%) developed incident anaemia over a median (interquartile range) follow-up of 2.9 (1.2-5.6) years. The crude rate [95% confidence interval (CI)] per 100 person-years of incident anaemia was 26.4 (95% CI 26.0-26.7) and was higher for preserved ejection fraction (EF) [29.2 (95% CI 28.6-29.8)] compared with borderline EF [26.5 (95% CI 25.4-27.7)] or reduced EF [26.6 (95% CI 25.8-27.4)]. Iron indices, vitamin B12 level, and thyroid testing were performed in 20.9%, 14.9%, and 40.2% of patients, respectively. Reduced iron stores, vitamin B12 deficiency, and/or hypothyroidism were present in 29.7%, 3.2%, and 18.6% of tested patients, respectively. In multivariable analyses, incident anaemia was associated with excess mortality [hazard ratio (HR) 2.14, 95% CI 2.07-2.22] as well as hospitalization for HF (HR 1.80, 95% CI 1.72-1.88) and any cause (HR 1.77, 95% CI 1.72-1.83). CONCLUSION:Among older adults with HF, incident anaemia is common and independently associated with substantially increased risks of morbidity and mortality. Additional research is necessary to clarify the value of routine evaluation and treatment of potentially reversible causes of anaemia.
PMCID:6775859
PMID: 30847487
ISSN: 2058-1742
CID: 5222312

Proposed Framework for the Optimal Measurement of Quality Assessment in Percutaneous Coronary Intervention

Klein, Lloyd W; Anderson, H Vernon; Rao, Sunil V
PMID: 31509176
ISSN: 2380-6591
CID: 5222482

Ad hoc percutaneous coronary intervention in patients with stable coronary artery disease: A report from the National Cardiovascular Data Registry CathPCI Registry

Faridi, Kamil F; Rymer, Jennifer A; Rao, Sunil V; Dai, David; Wojdyla, Daniel; Yeh, Robert W; Wang, Tracy Y
Percutaneous coronary intervention (PCI) may be performed in the same procedure as diagnostic coronary angiography (ad hoc PCI). This study aimed to evaluate current rates of ad hoc PCI use and associated risks of adverse outcomes in patients with stable coronary artery disease (CAD).
PMID: 31401443
ISSN: 1097-6744
CID: 5222422

The OPTIMIZE randomized trial to assess safety and efficacy of the Svelte IDS and RX Sirolimus-eluting coronary stent Systems for the Treatment of atherosclerotic lesions: Trial design and rationale

Mauri, Laura; Doros, Gheorghe; Rao, Sunil V; Cohen, David J; Yakubov, Steven; Lasala, John; Wong, S Chiu; Zidar, James; Kereiakes, Dean J
Coronary stenting without angioplasty pretreatment (direct stenting) may simplify procedures in appropriate lesions. Direct stenting is facilitated by smaller profile coronary stent platforms. The present study was designed for regulatory approval of a novel drug-eluting coronary stent and incorporates both randomized comparison for non-inferiority to an approved predicate device as well as a nested evaluation of subjects eligible for direct stenting. STUDY DESIGN AND OBJECTIVES: Prospective, single-blind, randomized, active-control, multi-center study designed to assess the safety and efficacy of the novel Svelte sirolimus-eluting stent (SES) systems. A total of 1630 subjects with up to 3 target lesions will be randomized 1:1 to the Svelte SES versus either the Xience or Promus everolimus-eluting stents (control). Randomization will be stratified by whether or not a direct stenting strategy is planned by the investigator. The primary endpoint is target lesion failure (TLF) at 12 months post index procedure, defined as cardiac death, target vessel myocardial infarction, or clinically driven target lesion revascularization, and the primary analysis is a non-inferiority test with a non-inferiority margin of 3.58%. Secondary clinical endpoints include individual components of TLF, stent thrombosis and measures of procedural resource utilization including contrast administration, fluoroscopy exposure and procedural resource utilization as well as costs. CONCLUSION: The OPTMIZE Trial will evaluate the safety, efficacy and clinical value of the novel Svelte SES in subjects with up to 3 lesions, and will provide a comparison of direct stenting between randomized devices.
PMID: 31415994
ISSN: 1097-6744
CID: 5222432