Briefly describe a specific question, or set of related questions, about a health care test or treatment that this program should consider.

Is transradial access comparable to transfemoral access with respect to efficacy and superior with respect of safety in primary percutaneous coronary intervention in ST-elevation myocardial infarction patients?

Does your question include a comparison of different health care approaches? (If no, your topic will still be considered.)

yes

If yes, explain the specific technologies, devices, drugs, or interventions you would like to see compared:

Comparison of transradial versus transfemoral access with respect to door-to balloon times as well as post-procedural bleeding, other vascular complications, as well as major adverse clinical outcomes such as death, MI and target lesion revascularization.

What patients or group(s) of patients does your question apply to? (Please include specific details such as age range, gender, coexisting diagnoses, and indications for therapy.)

Anyone 18 years of age or older who presents with ST-elevation myocardial infarction for whom primary percutaneous coronary intervention is the preferred reperfusion treatment

Are there subgroups of patients that your question might apply to? (For example, an ethnic group, stage or severity of a disease.)

No

Describe the health-related benefits you are interested in. (For example, improvements in patient symptoms or problems from treatment or diagnosis.)

We are interested in improved clinical outcomes including reductions in bleeding as well as related vascular complications which will lead to improved patient care as well as reduced hospitalization times and subsequent costs.

Describe any health-related risks, side effects, or harms that you are concerned about.

One of the biggest concerns with regards to primary angioplasty for ST-elevation MIs is bleeding, particularly in this era of aggressive anti-coagulation. Such bleeding in this setting leads to increased morbidity and mortality as well as prolonged hospitalizations and increased cost. We believe the transradial approach will significantly minimize bleeding compared to the traditional transfemoral approach. However, there has been resistance to accepting the transradial approach for ST-elevation MI therapy because of technical concerns regarding door-to-balloon times. We believe that, in the hands of experienced operators, this time difference between the transradial and transfemoral approaches is minimal.

Appropriateness for EHC Program

Does your question include a health care drug, intervention, device, or technology available (or likely to be available) in the U.S.?

yes

Which priority area(s) and population(s) does this topic apply to? (check all that apply)

EHC Priority Conditions (updated in 2008)

• Cardiovascular disease, including stroke and hypertension
• Diabetes mellitus
• Obesity

AHRQ Priority Populations

• Low income groups
• Minority groups
• Women
• Elderly

Federal Health Care Program

• Medicaid
• Medicare

Importance

Describe why this topic is important.

We believe this topic is important as it will attempt to establish an approach that is comparable to the traditional (transfemoral) approach but with significantly increased safety which will translate into reduced complications, hospital stays, recovery times,patient outcomes and costs.

What specifically motivated you to ask this question? (For example, you are developing a clinical guideline, working with a policy with large uncertainty about the appropriate approach, costly intervention, new research you have read, items in the media you may have seen, a clinical practice dilemma you know of, etc.)

With the use of more and more aggressive anti-coagulation for which there is significant date with regard to improved cardiac morbidity and mortality, we, as practicing interventional cardiologists, were left dealing with the consequential bleeding complications from coronary angioplasty procedures. Subsequently, we began to seek an alternative access route which would minimize this complication but still allow us to be aggressive with the medical therapies proven to improve cardiac outcomes.

Does your question represent uncertainty for clinicians and/or policy-makers? (For example, variations in clinical care, controversy in what constitutes appropriate clinical care, or a policy decision.)

yes

If yes, please explain:

Several cohort studies have shown that there is no difference between the transradial and transfemoral approaches with respect to efficacy and that the transradial approach does is fact lead to significantly less bleeding and vascular complications. However, cohort studies are limited by bias and confounding. Secondarily, we propose a large, multicenter randomized study to adequately address these issues.

Potential Impact

How will an answer to your research question be used or help inform decisions for you or your group?

If we do in fact establish that the transradial approach is comparable to the transfemoral approach with respect to door-to-balloon times and superior with respect to bleeding complications, these results will likely influence change of practice throughout the entire interventional cardiology community.

Describe the timeframe in which an answer to your question is needed.

We would, of course, like this question to be resolved as soon as reasonably possible, but with sufficient time to reliably and credibly study the comparative outcomes of each approach.

Describe any health disparities, inequities, or impact on vulnerable populations your question applies to.

N/A

Nominator Information

Other Information About You: (optional)

Please choose a description that best describes your role or perspective: (you may select more than one category if appropriate)

If we do in fact establish that the transradial approach is comparable to the transfemoral approach with respect to door-to-balloon times and superior with respect to bleeding complications, these results will likely influence change of practice throughout the entire interventional cardiology community.

Are you making a suggestion as an individual or on behalf of an organization?

Organization

Please tell us how you heard about the Effective Health Care Program