Catheterization and Cardiovascular Interventions 84:565–566 (2014)
Editorial Comment Can We Get Beyond the “Anything But a Prospective Randomized Trial” Comparison in Peripheral Arterial Interventions? Samuel Butman,* MD HVCNA, Verde Valley Medical Center, Cottonwood, Arizona
Did you ever wonder why we have such a clear lack of direction regarding percutaneous interventions in peripheral arterial disease (PAD)? Did you ever think that the technique you use might not be the best for your patient? Did you ever stop and think that “making pathophysiological sense” does not often translate into “clinical efficacy”? Did you ever realize that every new technique we try or routinely use in the periphery comes with a significant price tag? I could go on. In fact, I will. Did you ever wonder why a manufacturer does not double down and go forward with a randomized controlled trial (RCT)? Did you ever feel that you were being schmoozed into trying a new tool, knowing you are too often frustrated or disappointed with current technology? I have. The preceding report is a story of many a trial, all put into a pot, stirred, and NOT meta-analyzed, perhaps out of respect for the limitations of such an endeavor [1]. Alas, few of the studies cited have been prospective, let alone randomized, and few have used comparable comparators, all the while some approaches have come and gone (Cryoballoon), some devices have only a small impact on their own (lasers), and the remainder continue to be heralded as effective, niche products, usually more costly than an admittedly often ineffective, balloon, or Nitinol stent. The authors said it best as, “The increased variation in inclusion criteria, length, and complexity of lesions between studies does not allow direct comparisons between them,” yet we continue to do so. Those real differences in technology are inferred to be clinically relevant at meetings, by sales people, and are now part of our reality. Frankly, I may have read into the superiority of one particular technique after reading the preceding article by over-analyzing the information (Can you determine which?). C 2014 Wiley Periodicals, Inc. V
Even this attempt of being short of a metanalysis has two issues that speak to the dearth of good available comparative clinical research, namely their inclusion of any registry or trial with only 30 patients, and the fact that this was actually not a meta-analysis, but a summary of reports (this probably speaks best to our apparent need.) Short of real multicenter prospective randomized trials of several PAD therapies, better insight may be available by the new, less costly, registry-based randomized trials (a la TASTE Trial) [2]. No question these are not prefect, but may be the wave of the future given some of their pluses [3]. With Accountable Care Organizations, Health Maintenance Organizations, a growing number of mergers to reduce overhead left and right, and government focused on reducing health care costs, knowing which, if any, of our PAD interventions is most cost-effective is more real than ever. This has also meant that the wish to develop new technology is now more than ever also a desire to sell it, and profit before evidence-based trials are performed. Are we patient-centered specialists guilty of embracing these new techniques too quickly, encouraging, or implying their acceptance, thereby making them buying opportunities before comparison research has been done? Okay, enough whining on my part. What additional takeaways are there for us, for me? Well, 5 of 25 trials (20%) of the Nitinol stent studies were RCTs, whereas 5/14 (36%) of the covered stent trials were RCTs and more recently, drug-eluting stent trials and drug-coated balloon trials were RCTs 33% of the time. So, things are looking up, despite the RCTs not being done after too long a time after product release. In the report, it is evident that variation in clinical and angiographic characteristics was quite high with diabetes more common in atherectomy and combination device trials, whereas chronic total occlusions were most common in the covered stents and combination device trials. Average Conflict of interest: Nothing to report. *Correspondence to: Samuel Butman, MD, HVCNA, Verde Valley Medical Center, Cottonwood, Arizona E-mail: [email protected] Received 10 August 2014; Revision accepted 15 August 2014 DOI: 10.1002/ccd.25640 Published online 19 September 2014 in Wiley Online Library (wileyonlinelibrary.com)
566
Butman
lesion length was longest in the covered stent trials and shortest in the Cryo-balloon reports followed by atherectomy and drug-eluting stent trials. Are these clues to our preferences, beliefs, or early evidence of superiority of one approach over another? Given the current lack of cost-effective data, multiple device procedures cost more, and comparisons are sorely needed to justify their use. The authors conclude that, “It is of prime importance to recognize the benefits and shortfalls of each device and choose an appropriate treatment modality.” At first glance this rings true, but on closer inspection we are brought right back to “What is the appropriate treatment modality?” We all have our beliefs but given
a lack of RCTs and the lack of consensus, we actually do not know! REFERENCES 1. Butman SM. Of meta-analyses and men. Cath Cardiovasc Interv 2013;82:108–109. 2. Fr€obert O, Lagerqvist B, Olivecrona GK, Omerovic E, Gudnason T, Maeng M, Aasa M, Angera˚s O, Calais F, Danielewicz M, Erlinge D, Hellsten L, Jensen U, Johansson AC, Ka˚regren A, € Nilsson J, Robertson L, Sandhall L, Sj€ogren I, Ostlund O, Harnek J, James SK. Thrombus aspiration during ST-segment elevation myocardial infarction. N Eng J Med 2013;369:1587–1597. 3. Lauer MS, D’Agostino RB. The randomized registry trial—The next disruptive technology in clinical research?. N Engl J Med 2013;369:1579–1581.
Catheterization and Cardiovascular Interventions DOI 10.1002/ccd. Published on behalf of The Society for Cardiovascular Angiography and Interventions (SCAI).
Editorial Comment Can We Get Beyond the “Anything But a Prospective Randomized Trial” Comparison in Peripheral Arterial Interventions? Samuel Butman,* MD HVCNA, Verde Valley Medical Center, Cottonwood, Arizona
Did you ever wonder why we have such a clear lack of direction regarding percutaneous interventions in peripheral arterial disease (PAD)? Did you ever think that the technique you use might not be the best for your patient? Did you ever stop and think that “making pathophysiological sense” does not often translate into “clinical efficacy”? Did you ever realize that every new technique we try or routinely use in the periphery comes with a significant price tag? I could go on. In fact, I will. Did you ever wonder why a manufacturer does not double down and go forward with a randomized controlled trial (RCT)? Did you ever feel that you were being schmoozed into trying a new tool, knowing you are too often frustrated or disappointed with current technology? I have. The preceding report is a story of many a trial, all put into a pot, stirred, and NOT meta-analyzed, perhaps out of respect for the limitations of such an endeavor [1]. Alas, few of the studies cited have been prospective, let alone randomized, and few have used comparable comparators, all the while some approaches have come and gone (Cryoballoon), some devices have only a small impact on their own (lasers), and the remainder continue to be heralded as effective, niche products, usually more costly than an admittedly often ineffective, balloon, or Nitinol stent. The authors said it best as, “The increased variation in inclusion criteria, length, and complexity of lesions between studies does not allow direct comparisons between them,” yet we continue to do so. Those real differences in technology are inferred to be clinically relevant at meetings, by sales people, and are now part of our reality. Frankly, I may have read into the superiority of one particular technique after reading the preceding article by over-analyzing the information (Can you determine which?). C 2014 Wiley Periodicals, Inc. V
Even this attempt of being short of a metanalysis has two issues that speak to the dearth of good available comparative clinical research, namely their inclusion of any registry or trial with only 30 patients, and the fact that this was actually not a meta-analysis, but a summary of reports (this probably speaks best to our apparent need.) Short of real multicenter prospective randomized trials of several PAD therapies, better insight may be available by the new, less costly, registry-based randomized trials (a la TASTE Trial) [2]. No question these are not prefect, but may be the wave of the future given some of their pluses [3]. With Accountable Care Organizations, Health Maintenance Organizations, a growing number of mergers to reduce overhead left and right, and government focused on reducing health care costs, knowing which, if any, of our PAD interventions is most cost-effective is more real than ever. This has also meant that the wish to develop new technology is now more than ever also a desire to sell it, and profit before evidence-based trials are performed. Are we patient-centered specialists guilty of embracing these new techniques too quickly, encouraging, or implying their acceptance, thereby making them buying opportunities before comparison research has been done? Okay, enough whining on my part. What additional takeaways are there for us, for me? Well, 5 of 25 trials (20%) of the Nitinol stent studies were RCTs, whereas 5/14 (36%) of the covered stent trials were RCTs and more recently, drug-eluting stent trials and drug-coated balloon trials were RCTs 33% of the time. So, things are looking up, despite the RCTs not being done after too long a time after product release. In the report, it is evident that variation in clinical and angiographic characteristics was quite high with diabetes more common in atherectomy and combination device trials, whereas chronic total occlusions were most common in the covered stents and combination device trials. Average Conflict of interest: Nothing to report. *Correspondence to: Samuel Butman, MD, HVCNA, Verde Valley Medical Center, Cottonwood, Arizona E-mail: [email protected] Received 10 August 2014; Revision accepted 15 August 2014 DOI: 10.1002/ccd.25640 Published online 19 September 2014 in Wiley Online Library (wileyonlinelibrary.com)
566
Butman
lesion length was longest in the covered stent trials and shortest in the Cryo-balloon reports followed by atherectomy and drug-eluting stent trials. Are these clues to our preferences, beliefs, or early evidence of superiority of one approach over another? Given the current lack of cost-effective data, multiple device procedures cost more, and comparisons are sorely needed to justify their use. The authors conclude that, “It is of prime importance to recognize the benefits and shortfalls of each device and choose an appropriate treatment modality.” At first glance this rings true, but on closer inspection we are brought right back to “What is the appropriate treatment modality?” We all have our beliefs but given
a lack of RCTs and the lack of consensus, we actually do not know! REFERENCES 1. Butman SM. Of meta-analyses and men. Cath Cardiovasc Interv 2013;82:108–109. 2. Fr€obert O, Lagerqvist B, Olivecrona GK, Omerovic E, Gudnason T, Maeng M, Aasa M, Angera˚s O, Calais F, Danielewicz M, Erlinge D, Hellsten L, Jensen U, Johansson AC, Ka˚regren A, € Nilsson J, Robertson L, Sandhall L, Sj€ogren I, Ostlund O, Harnek J, James SK. Thrombus aspiration during ST-segment elevation myocardial infarction. N Eng J Med 2013;369:1587–1597. 3. Lauer MS, D’Agostino RB. The randomized registry trial—The next disruptive technology in clinical research?. N Engl J Med 2013;369:1579–1581.
Catheterization and Cardiovascular Interventions DOI 10.1002/ccd. Published on behalf of The Society for Cardiovascular Angiography and Interventions (SCAI).
