Monthly Archives: December 2015

Effect of PCI on Long-Term Survival

From The Journal of Family Practice

Effect of PCI on Long-Term SurvivalOutcomes in patients with stable ischemic HD

December 1, 2015

There was no difference in survival between an initial strategy of PCI plus medical therapy and medical therapy alone after extended 15-year follow-up in patients with stable ischemic heart disease, according to extended survival information for 1,211 patients. Median duration of follow-up for all patients was 6.2 years; the median duration of follow-up for patients at the sites that permitted survival tracking was 11.9 years.

Researchers found:

• 561 deaths occurred; 180 during the follow-up period in the original trial and 381 during the extended follow-up period.

• There were 284 deaths (25%) in the PCI group and 277 (24%) in the medical therapy group (aHR, 1.03).

Citation: Sedlis SP, Hartigan PM, Teo KK, et al. Effect of PCI on long-term survival in patients with stable ischemic heart disease. N Engl J Med.2015;373:1937-1946. doi: 10.1056/NEJMoa1505532.

Commentary: The Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation (COURAGE) trial compared a strategy of optimal medical therapy for advanced coronary artery disease versus optimal medical therapy plus percutaneous coronary intervention (PCI) and found no difference in outcome between these 2  groups. This was a landmark trial and has influenced guidelines and changed the practice of interventional cardiology. The current study follows patients from the original COURAGE cohort for up to 15 years and continues to show no survival advantage in either group. In addition, no high-risk subgroup of patients has been identified that showed a survival benefit from PCI compared with optimal medical therapy alone in the original study or in the extended cohort. This study adds further evidence that PCI can be used for treatment of angina that does not respond to medical treatment but will not offer a survival advantage over optimal medical therapy. —Matthew Sorrentino, MD

Pain Medications for Acute Low Back Pain

  • Opioids and muscle relaxants are often prescribed alongside nonsteroidal anti-inflammatory drugs (NSAIDs) for patients with acute low back pain, although these additional medications are associated with an increased risk of adverse events.
  • In patients with nontraumatic, nonradicular, acute low back pain, there were no significant differences among groups in pain or functional outcomes at 1 week or 3 months comparing the addtion of cyclobenzaprine or oxycodone/acetaminophen or placebo to naproxen.
  • Naproxen alone was also associated with reduced risk of adverse events compared to either naproxen combination therapy.

The American College of Physician and the American Pain Society recommend acetaminophen or nonsteroidal anti-inflammatory drugs (NSAIDs) as first-line medications for patients with low back pain (Ann Intern Med 2007 Oct 2;147(7):478).  However, opioids, NSAIDS, and muscle relaxants alone or in combination are commonly prescribed to patients with low back pain presenting to the emergency department (Spine (Phila Pa 1976) 2010 Nov 15;35(24):E1406).  Some evidence suggests that muscle relaxants and opioid medication may improve pain in patients with acute low back pain, but these medications are also associated with an increased risk of adverse events and, with opioids in particular, there is the potential for abuse and addiction (Ann Intern Med 2007 Oct 2;147(7):478, Cochrane Database Syst Rev 2003;(2):CD004252).  A recent randomized trial compared the addition of one of three regimens (cyclobenzaprine 5 mg or oxycodone 5 mg/acetaminophen 325 mg or placebo) to naproxen 500 mg twice daily in 323 adults 21-64 years old (mean age 39 years) presenting to the emergency department with nontraumatic, nonradicular, acute musculoskeletal low back pain.  Patients were instructed to take 1 tablet of the randomized medication every 8 hours as needed, but they were instructed to take a second tablet if sufficient relief was not achieved within 30 minutes.  All patients also received a 10 minute educational intervention discussing additional therapies to help alleviate pain.

Low back pain was assessed at baseline and during follow-up with the Roland-Morris Disability Questionnaire (RMDQ).  RMDQ scores range from 0-24 with higher scores indicating increasing impairment, and all patients had a baseline RMDQ score ≥ 5 at emergency department discharge (mean score 18.7).  The minimum clinically important difference in RMDQ scores at follow-up was defined as a 5 point improvement on the RMDQ. Comparing the addition of cyclobenzaprine or oxycodone/acetaminophen or placebo to naproxen, there were no significant differences in mean RMDQ score improvement at 1-week follow-up (10.1 points vs. 11.1 points vs. 9.8 points, respectively).  There were also no significant differences at 1-week follow-up in mean RMDQ scores, worst low back pain, frequency of low back pain episodes, use of low back pain medication, the desire for the same medication for subsequent low back pain episodes, and time to return to usual activities.  There were no significant differences among the groups in mean RMDQ score, worst pain, pain frequency, use of mediation, or opioid use at 3 months. Cyclobenzaprine and oxycodone/acetaminophen were each associated with significant increases in the rate of adverse events (sedation and gastrointestinal symptoms) compared to placebo, however.  Adverse events were reported in 33% of patients randomized to cyclobenzaprine (p < 0.05 vs. placebo, NNH 7), 40% of patients randomized to oxycodone plus acetaminophen (p < 0.05 vs. placebo, NNH 5), and 21% of patients randomized to placebo.

While opioids and muscle relaxants are commonly prescribed to patients presenting with acute low back pain, based on this trial naproxen alone is as effective as combination therapy in relieving pain. These results also suggest that the addition of these medications to naproxen may place the patient at an increased risk of harm.  Furthermore, approximately 25% of patients in each group still experienced moderate-to-severe low back pain at the 3-month follow-up, indicating that the initial choice of pain medication may not impact the development of chronic low back pain.

For more information, see the Acute low back pain topic in DynaMed Plus.  DynaMed users click here.