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Archive for the ‘Perioperative Statins at Noncardiac Surgery’ Category


Perioperative Statins at Noncardiac Surgery: Survival Up, Complications Down

Reporter: Aviva Lev-Ari, PhD, RN

 

UPDATED on 11/26/2018

 

Clinical Trial: Statins Evaluation in Coronary Procedures and Revascularization (SECURE-PCI)

A Cardio-Endo Connection selection

Contribution to Literature:

The Statins Evaluation in Coronary Procedures and Revascularization (SECURE-PCI) trial showed that routine administration of two early doses of high-dose atorvastatin is not superior to placebo in reducing cardiovascular events at 30 days among patients presenting with acute coronary syndrome (ACS) and scheduled to undergo an early invasive approach.

Description:

The goal of the trial was to compare the safety and efficacy of two loading doses of atorvastatin (80 mg) given early among patients presenting with ACS for whom an early invasive approach was planned.

Study Design

Patients presenting with ACS were randomized in a 1:1 fashion to receive either two loading doses of atorvastatin 80 mg before and 24 hours after a planned early invasive approach (n = 2,087) or placebo (n = 2,104). All patients in both groups were to receive 40 mg/d of atorvastatin after the procedure through 30 days.

Interpretation:

The results of this trial indicate that routine administration of two early doses of high-dose atorvastatin is not superior to placebo in reducing cardiovascular events at 30 days among patients presenting with ACS and scheduled to undergo an early invasive approach. Among patients who underwent PCI, there were significant reductions in MACE and non–PCI-related MI. This benefit was maintained irrespective of timing of administration of statin prior to PCI.

Considering that LDL-C levels were similar in both arms (both arms received 40 mg of atorvastatin daily after the initial load), and the benefit in the PCI patients occurred early, the mechanism for benefit in these patients is likely due to the pleiotropic effects of statins. The study also highlights how heterogeneous an ACS population can be, both from a risk and a clinical response perspective.

References:

Lopes RD, et al “Timing of loading dose of atorvastatin in patients undergoing percutaneous coronary intervention for acute coronary syndromes: Insights from the SECURE-PCI Randomized Clinical Trial” JAMA Cardiol 2018; Sep 24 [Epub ahead of print].

Berwanger O, et al on behalf of the SECURE-PCI Investigators “Effect of loading dose of atorvastatin prior to planned percutaneous coronary intervention on major adverse cardiovascular events in acute coronary syndrome: The SECURE-PCI Randomized Clinical Trial” JAMA 2018; 319: 1331-1340.

Editorial: Nicholls SJ, Psaltis PJ “Lipid lowering in acute coronary syndrome: Is treatment early enough?” JAMA 2018; 319: 1325-1326.

Presented by Dr. Otavio Berwanger at the American College of Cardiology Annual Scientific Session (ACC 2018), Orlando, Florida, March 11, 2018.

Primary Source

American College of Cardiology

Source Reference: “Statins evaluation in coronary procedures and revascularization — SECURE-PCI” ACC 2018; Sept 24.

 

Perioperative Statins at Noncardiac Surgery: Survival Up, Complications Down

Conclusions and Relevance  Early perioperative exposure to a statin was associated with a significant reduction in all-cause perioperative mortality and several cardiovascular and noncardiovascular complications. However, the potential for selection biases in these results must be considered.

 

Survival Up, Complications Down With Perioperative Statins at Noncardiac Surgery: Observational Study

Marlene Busko

December 23, 2016

http://www.medscape.com/viewarticle/873626?nlid=111534_3866&src=WNL_mdplsfeat_161227_mscpedit_card&uac=93761AJ&spon=2&impID=1262832&faf=1#vp_1

Original Investigation
December 19, 2016

Association of Perioperative Statin Use With Mortality and Morbidity After Major Noncardiac Surgery

JAMA Intern Med. Published online December 19, 2016. doi:10.1001/jamainternmed.2016.8005

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Editorial

Comment

 

Key Points

Question  Is exposure to a statin in the early perioperative period associated with reduced postoperative complications after noncardiac surgery?

Findings  This observational cohort analysis of veterans linked risk and outcome data from the Veterans Affairs Surgical Quality Improvement Program database to statin prescriptions in 180 478 patients and evaluated the associations of early statin exposure on 30-day mortality. After adjustment for risk, other medications used, and potential selection biases, 30-day mortality was significantly reduced in the statin-exposed group.

Meaning  Perioperative statin use may be beneficial in reducing 30-day mortality, although the effects of selection biases cannot be excluded.

 

Abstract

Importance  The efficacy of statins in reducing perioperative cardiovascular and other organ system complications in patients undergoing noncardiac surgery remains controversial. Owing to a paucity of randomized clinical trials, analyses of large databases may facilitate informed hypothesis generation and more efficient trial design.

Objective  To evaluate associations of early perioperative statin use with outcomes in a national cohort of veterans undergoing noncardiac surgery.

Design, Setting, and Participants  This retrospective, observational cohort analysis included 180 478 veterans undergoing elective or emergent noncardiac surgery (including vascular, general, neurosurgery, orthopedic, thoracic, urologic, and otolaryngologic) who were admitted within 7 days of surgery and sampled by the Veterans Affairs Surgical Quality Improvement Program (VASQIP). Patients were admitted to Department of Veterans Affairs hospitals and underwent 30-day postoperative follow-up. Data were collected from October 1, 2005, to September 30, 2010, and analyzed from November 28, 2013, to October 31, 2016.

Exposure  Statin use on the day of or the day after surgery.

Main Outcomes and Measures  All-cause 30-day mortality (primary outcome) and standardized 30-day cardiovascular and noncardiovascular outcomes captured by VASQIP. Use of statins and other perioperative cardiovascular medications was ascertained from the Veterans Affairs Pharmacy Benefits Management research database.

Results  A total of 180 478 eligible patients (95.6% men and 4.4% women; mean [SD] age, 63.8 [11.6] years) underwent analysis, and 96 486 were included in the propensity score–matched cohort (96.3% men; 3.7% women; mean [SD] age, 65.9 [10.6] years). At the time of hospital admission, 37.8% of patients had an active outpatient prescription for a statin, of whom 80.8% were prescribed simvastatin and 59.5% used moderate-intensity dosing. Exposure to a statin on the day of or the day after surgery based on an inpatient prescription was noted in 31.5% of the cohort. Among 48 243 propensity score–matched pairs of early perioperative statin-exposed and nonexposed patients, 30-day all-cause mortality was significantly reduced in exposed patients (relative risk, 0.82; 95% CI, 0.75-0.89; P < .001; number needed to treat, 244; 95% CI, 170-432). Of the secondary outcomes, a significant association with reduced risk of any complication was noted (relative risk, 0.82; 95% CI, 0.79-0.86; P < .001; number needed to treat, 67; 95% CI, 55-87); all were significant except for the central nervous system and thrombosis categories, with the greatest risk reduction (relative risk, 0.73; 95% CI, 0.64-0.83) for cardiac complications.

Conclusions and Relevance  Early perioperative exposure to a statin was associated with a significant reduction in all-cause perioperative mortality and several cardiovascular and noncardiovascular complications. However, the potential for selection biases in these results must be considered.

SOURCE
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