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Drug Eluting Stents Trump Bare Metal Stents for Chronic Total Blockages

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Use of drug-eluting stents for chronic total occlusions: A systematic review and meta-analysis
-- Catheterization and Cardiovascular Interventions

Bare Metal Stent    

February 9, 2011 -- After reviewing numerous studies that compared the use of drug-eluting stents (DES) to that of bare metal stents (BMS) in the treatment of chronic total occlusions (CTO) in the coronary arteries, a team of Texas cardiologists has concluded that the use of "DES is associated with significant reductions in angiographic and clinical restenosis with similar safety. The consistency and magnitude of treatment effect across both individual trials and the pooled analysis establish DES as the preferred therapy for percutaneous revascularization of CTOs."

This meta-analysis is published in the February issue of Catheterization and Cardiovascular Interventions, the official journal of The Society for Cardiovascular Angiography and Interventions (SCAI) by Emmanouil Brilakis, MD, PhD, FSCAI of VA North Texas Healthcare System and the University of Texas Southwestern Medical Center in Dallas, and colleagues. The researchers performed a systematic review of medical literature published in online databases (PubMed, EMBASE, Cochrane Library) and cardiology societies’ web sites and they found 17 published studies that reported outcomes for sirolimus- or paclitaxel-eluting stents and BMS implantation for coronary occlusions.

Chronic total occlusions historically have been the most difficult blockages to tackle: they routinely have a low rate of procedural success and, even then, there is a high incidence of restenosis or target vessel failure. This difficulty has been present since the beginnings of angioplasty.

As Andreas Gruentzig, the inventor of coronary angioplasty, stated in this 1985 interview, "If we cannot solve the total closure problem, we probably will never really address the question of multivessel disease dilatation." Although this interview was conducted before the introduction of stents, which have made a great advance in this area, and Gruentzig was referring to "dilatation" (balloon angioplasty), the challenges of CTOs remain. Many cardiologists will refer their CTO patients to those interventionalists who specialize in this area, many of whom will be attending the Eighth Annual Chronic Total Occlusion Summit, being held in New York City next week.

    Andreas Gruentzig, MD in 1985

One of the biggest difficulties in performing angioplasty on a total occlusion is the fact that, under angiography, the cardiologist is unable to see the part of the artery beyond the occlusion, since the flow of contrast dye is blocked completely. There have been numerous imaging systems that have attempted to overcome this limitation, often combining CT and angiography, or other modalities, using magnetic fields or ultrasound to guide the wire and catheter through the invisible obstruction -- the danger being that a wrong turn might send the guide wire through the arterial wall, instead of the blockage, causing a dissection. A new technology that may become available in the near future is Forward Looking Intravascular Ultrasound (FLIVUS) that uses the well-known intravascular imaging technique of IVUS to guide and treat the blockage.

But whether the obstruction gets opened successfully is only part of the solution. These chronic blockages have a high incidence of reclosure, so the optimal device for keeping the blockage clear is critically important -- and this study points to drug-eluting stents as the preferred type. In almost all of the studies, DES had better results and, in the four that tracked patients to three years, the incidence of death, MI, and stent thrombosis remained similar between patients with BMS and DES while Target Lesion Revascularization (TLR) and Target Vessel Revascularization (TVR) were significantly lower in the DES group in three of four studies and similar in another. And, although there are still some who are concerned over late stent thrombosis or other adverse effects of DES, mortality was similar among all stents.

Endeavor drug-eluting stent
Endeavor drug-eluting stent
   

Of interest is that the available studies were only able to compare bare metal stents to the first generation drug-eluting stents, namely sirolimus (Cypher) and paclitaxel (Taxus) devices.

As the authors noted, the newer Endeavor and XIENCE/Promus stents may yield even better results, because they are structurally more sophisticated, with thinner struts and more flexible linkages. Currently, four studies are in progress worldwide to measure just how much better these newer stents may perform.

But for the moment, the conclusion of the authors is that:

"Our review demonstrates that in CTO published studies, compared to BMS, DES: (a) consistently reduce angiographic restenosis; (b) reduce target lesion and target vessel revascularization; and (c) appear to be safe with similar rates of death, myocardial infarction and stent thrombosis. A benefit from using DES in CTOs is anticipated, as CTOs are frequently long lesions in diffusely-diseased vessels, requiring implantation of multiple stents, with high restenosis rates if BMS are used. Yet, the consistency of the direction and magnitude of the angiographic and clinical benefit is remarkable across the published studies. The improved outcomes after CTO stenting with DES may in part be responsible for the renewed interest for treating such lesions. Although crossing the CTO remains the main technical challenge of CTO PCI, novel techniques including retrograde PCI are increasing procedural success and in combination with DES implantation could provide excellent results."

Reported by Burt Cohen, February 9, 2011