Cutting or not Cutting: More than 10 Years Later the Cutting Balloon is Around and Still Looking for “The” Indication! <br />

It failed to be approved for the “plain” indication when the Cutting Balloon Global Randomized Trial shows no benefit over the plain balloon in pre-stenting era. In this multicenter, randomized clinical trial, cutting balloon angioplasty (CBA) did not reduce rates of angiographic restenosis but did reduce the rate of target vessel revascularization and appeared to be useful in the treatment of specific lesion subsets, such as LAD artery location.1 The CB demonstrated excellent acute procedural results; however, it is an example of another new coronary angioplasty device that despite its novel mechanism of plaque displacement, resulted in the expected proportional response to injury previously seen with conventional angioplasty (BA), atherectomy, and stenting. It is unlikely that different mechanical solutions will alter the arterial response to injury enough to prevent restenosis. New interventions that address the biology of restenosis, such as the promising pharmaceutical-coated stents, will reduce the injury response.2 Nevertheless, CBA is a safe alternative to BA. The CB was approved by the FDA for the treatment of resistant lesions, which still remains a challenge in modern angioplasty. Classical approaches to dilate these lesions include high-pressure or prolonged inflations and balloon oversizing. Other alternatives include the buddy-wire technique with 1 or 2 guidewires passed alongside a conventional balloon catheter. Once inflated, the guidewire exerts a focused force onto the resistant plaque. Another approach, the hugging balloon technique, involves simultaneous inflations of 2 balloon catheters at the critical stenosis level. New technologies like rotablation, atherectomy or laser angioplasty have also been proposed in case of failed angioplasty or for lesions, which seem unsuitable for BA. We have reported our initial experience using the CB catheter in 6 resistant lesions recruited from 3,090 coronary angioplasties performed over 19 months.3 The lesions were resistant to BA at a balloon/artery ratio (BAR) over 1.1, a mean of 20 atm of pressure and more than 10 minute inflation time. CBA was performed to dilate these lesions 8 ATM using a 0.99 BAR and 3-minute total inflation time. Additional BA and successful stenting completed the CB intervention without complication. Thus, CBA found its “niche” and became a special application for the treatment of resistant coronary lesions. Despite dramatic decrease in the need for repeat intervention following stenting as compared with BA, in-stent restenosis (ISR) remains a significant clinical problem. In contrast to restenosis after catheter-based techniques, ISR results almost exclusively from neointima formation that protrudes through stent struts and may create significant lumen obstruction. Intravascular ultrasound (IVUS) studies have demonstrated that, despite optimal angiographic result a significant number of stents are not perfectly deployed.4 Several IVUS criteria have been proposed to evaluate stent expansion.5 Although it has been demonstrated that stent under-deployment (SU) is associated with ISR, little data have been reported to estimate the true incidence of SU in patients presenting with ISR.6 Also, the effect of repeat angioplasty on stent deployment has not been well characterized.7 Among patients presenting with clinical restenosis and referred for brachytherapy standard IVUS criteria has permitted to recognize 20–40% of under deployed stents. IVUS-guided repeat PTCA may improve further deployment, irrespective of SU criteria. The exact role of improved stent expansion on further restenosis after vascular brachytherapy remains, however, to be defined.8 The usefulness of CBA for ISR seems to reside in 2 items: first the "anchorage" by the blades preventing the “soap effect” of the balloon so frequent in in-stent restenotic lesions and second the combination of the blades on a non-compliant balloon, permitting a focalization of the “force” on the resistant part of the lesion or re-expansion of the stent. This is well demonstrated in the actual study where CB used trend to have larger size in comparison to the plain balloon with a bigger balloon/artery ratio (p = 0.07) and a lower inflation pressure 8 vs. 15 ATM (p = 0.01) to balance for the size.9 The "focalization" of the re restenosis after CBA for ISR is "well taken" but not understood. Despite this present positive registry, the RESCUT trial, the only randomized trial, in this indication was unable to demonstrate an advantage over "plain" BA.10 The RENO registry (Registry Europe Novoste) has shown the feasibility and safety of the strategy of combining CBA followed by beta vascular brachytherapy, moreover follow-up data trend to demonstrate that this combined intervention further reduces restenosis rates beyond those obtained with brachytherapy only.11 Five randomized, placebo-controlled trials have established that beta- and gamma-based intravascular brachytherapy reduces the incidence of restenosis and clinical event rates following PCI for the treatment of ISR. In these randomized studies the treatment effect of any kind of radiation was over 30% for any analyzed parameter with a similar benefit for both beta (Sr-90, P-32) and gamma emitters (Ir-192).12–18 The small series of drug-eluting stents for ISR do not seem to be promising with controversial results and increased MACE.19,20 The plus and minus of CBA reside in a non-slippery device which can “focus” the force, non-compliant, without any “Dog Bone” effect, minimizing distal dissection, but at a price of larger profile and stiffness, necessitating shorter length for adequate progression, where "predilation" may be necessary. CB “to be” indicated for ISR: slightly oversized with the risk of larger profile (4 blades over 3.0 mm in diameter), at nominal pressure for more than 30 seconds with repetitive inflations if necessary and followed by vascular brachytherapy!

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