Residual Dissection After DCB Treatment for De Novo CAD Generally Resolves

Patients who have residual dissection after being treated with second-generation drug-coated balloons (DCBs) in native coronary lesions still have acceptable outcomes, according to observational data published online November 25, 2015, ahead of print in JACC: Cardiovascular Interventions.

The findings were previously presented at TCT 2015 in San Francisco, CA.

Bernardo Cortese, MD, of A.O. Fatebenefratelli (Milan, Italy), and colleagues prospectively studied 156 patients who received either the Restore (Cardionovum; n = 87) or Elutax SV (Aachen Resonance; n = 69) paclitaxel-coated balloon at 2 Italian centers between July 2012 and July 2014. The indication was stable stable angina in 52.6%, unstable angina in 19.9%, and NSTEMI in 27.6%.

In all, 52 patients had a final dissection—4 received another device (2 BMS, 1 DES, and 1 bioresorbable scaffold) and 48 were left untreated. All dissections were type A-C and non-flow limiting.

Complete vessel healing was seen in 45 patients (93.8%) on angiographic follow-up at a median of 201 days. Three patients each had persistent but uncomplicated dissection. Binary restenosis was observed in 3 patients (6.2%), and mean late lumen loss was 0.14 mm. There were no cases of thrombosis/vessel occlusion.

By 9-month clinical follow-up, 7.2% of patients in the overall cohort and 8.1% of dissection patients had experienced MACE (STEMI, TVR, TLR, or death; P = .48), with TLR rates of 5.3% and 6.2%, respectively (P = .37).

“Our results confirm that leaving a not flow-limiting dissection untreated after DCB-PCI is safe and not associated with an increase in myocardial infarction and TLR, despite the short-term (1 month) dual antiplatelet treatment” in those who did not go on to receive an additional device, the investigators conclude.

They advise that a “strategy of bailout stenting should be reserved to more severe, flow-limiting dissections.”

Hard to Compete With Stents

In an accompanying editorial, Robert A. Byrne, MB BCh, PhD, of Deutsches Herzzentrum München (Munich, Germany), and Michael Joner, MD, of CVPath Institute (Gaithesburg, MD), delve into why balloon angioplasty has been regarded as a “vain undertaking” while stenting has grown in prominence.

“Firstly, angioplasty alone results in varying degrees of vessel wall injury ranging from intimal tears to frank medial dissection,” they observe. “Secondly, vessel recoil and constrictive remodeling are dominant causes of restenosis after angioplasty. Routine stenting [especially with the advent of DES] addresses both issues and results in greater acute gain and lower risk of subsequent restenosis compared with angioplasty alone. … Thirdly, the proliferation of high performance ‘me too’ DES devices has driven the cost of stent technology downwards to the point where unit cost in certain countries already approaches the $100 mark.”

Overall, there is a “perceived lack of clinical equipoise” between balloon angioplasty and stenting, the editorialists note. But they suggest that DCBs, as compared to their uncoated counterparts, may still show potential in treating de novo stenosis.

“The observations of Cortese et al [with DCBs] are important and reinforce the impression from trials of plain balloon angioplasty that mild-moderate dissection is associated with a benign clinical course,” Byrne and Joner write, though they offer a number of caveats including that angiography is a “blunt tool for assessing dissection” and the study lacks the statistical power for examining clinical outcomes.

While the results should inspire further research, “in exploring the late benefits of stentless technologies in clinical practice, we must not surrender the predictable acute results and the excellent mid-term outcomes that we and our patients have come to expect with current generation DES devices,” they stress.

Thus, studies must be rigorously designed, the editorialists conclude. “In the absence of such trials it is difficult to envisage that the call ‘the balloon is back!’ will gain widespread support in the contemporary era of percutaneous intervention.”

Sources: 
1. Cortese B, Orrego PS, Agostini P, et al. Effect of drug-coated balloons in native coronary artery disease left with a dissection. J Am Coll Cardiol Intv. 2015;Epub ahead of print. 
2. Byrne RA, Joner M. Drug-coated balloon angioplasty for de novo stenosis the balloon is back...reloaded [editorial]! J Am Coll Cardiol Intv. 2015;Epub ahead of print.

Disclosures:

• Cortese reports no relevant conflicts of interest.
• Byrne reports receiving lecture fees from B. Braun Melsungen AG, Biotronik and Boston Scientific.
• Joner reports receiving grants and personal fees from Abbott Vascular, Biotronik, Boston Scientific, and Orbus Neich as well as grants from BioSensors International, CeloNova, Medtronic, Microport, SinoMedical, Terumo, and WL Gore.

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