Late lumen enlargement after treatment of de-novo lesions with drug coated balloon catheters – Glagov effect or plaque regression?

Abstract

Percutaneous transluminal angioplasty [ [1] Gruntzig A. Transluminal dilatation of coronary-artery stenosis. Lancet. 1978; 1: 263 Abstract PubMed Scopus (1043) Google Scholar ] and stent implantation [ [2] Sigwart U. Puel J. Mirkovitch V. Joffre F. Kappenberger L. Intravascular stents to prevent occlusion and restenosis after transluminal angioplasty. N. Engl. J. Med. 1987; 316: 701-706 Crossref PubMed Scopus (1468) Google Scholar ] became the standard of care in the majority of treatments of stenotic and occluded arteries. In addition to an improved pharmacological concomitant therapy in the form of dual platelet inhibition [ [3] Colombo A. Hall P. Nakamura S. et al. Intracoronary stenting without anticoagulation accomplished with intravascular ultrasound guidance. Circulation. 1995; 91: 1676-1688 Crossref PubMed Scopus (1350) Google Scholar ], local drug delivery by stents (drug eluting stents, DES) [ [4] Morice M.C. Serruys P.W. Sousa J.E. et al. A randomized comparison of a sirolimus-eluting stent with a standard stent for coronary revascularization. N. Engl. J. Med. 2002; 346: 1773-1780 Crossref PubMed Scopus (3806) Google Scholar ] and later also balloons (drug coated balloons, DCB) [ [5] Scheller B. Speck U. Abramjuk C. Bernhardt U. Bohm M. Nickenig G. Paclitaxel balloon coating, a novel method for prevention and therapy of restenosis. Circulation. 2004; 110: 810-814 Crossref PubMed Scopus (384) Google Scholar , [6] Scheller B. Hehrlein C. Bocksch W. et al. Treatment of coronary in-stent restenosis with a paclitaxel-coated balloon catheter. N. Engl. J. Med. 2006; 355: 2113-2124 Crossref PubMed Scopus (621) Google Scholar ] led to a significant improvement in long-term outcomes. The DCB concept was described by our group in 2004 [ [5] Scheller B. Speck U. Abramjuk C. Bernhardt U. Bohm M. Nickenig G. Paclitaxel balloon coating, a novel method for prevention and therapy of restenosis. Circulation. 2004; 110: 810-814 Crossref PubMed Scopus (384) Google Scholar ] defining its basic principles: paclitaxel or similar drugs as the biologically active component, an additive such as contrast medium [ [5] Scheller B. Speck U. Abramjuk C. Bernhardt U. Bohm M. Nickenig G. Paclitaxel balloon coating, a novel method for prevention and therapy of restenosis. Circulation. 2004; 110: 810-814 Crossref PubMed Scopus (384) Google Scholar , [7] Cremers B. Milewski K. Clever Y.P. et al. Long-term effects on vascular healing of bare metal stents delivered via paclitaxel-coated balloons in the porcine model of restenosis. Catheterizat. Cardiovasc. Intervent. 2012; 80: 603-610 Crossref PubMed Scopus (18) Google Scholar ] or other excipients like urea [ [8] Kelsch B. Scheller B. Biedermann M. et al. Dose response to Paclitaxel-coated balloon catheters in the porcine coronary overstretch and stent implantation model. Investig. Radiol. 2011; 46: 255-263 Crossref PubMed Scopus (93) Google Scholar , [9] Speck U. Cremers B. Kelsch B. et al. Do pharmacokinetics explain persistent restenosis inhibition by a single dose of paclitaxel?. Circulation. 2012; 5: 392-400 PubMed Google Scholar ], resveratrol [ [10] Speck U. Häckel A. Schellenberger E. et al. Drug distribution and basic pharmacology of paclitaxel/resveratrol-coated balloon catheters. Cardiovasc. Intervent. Radiol. 2018; 41: 1599-1610 Crossref PubMed Scopus (11) Google Scholar ], or magnesium stearate [ [11] Jia X. Zhang J. Zhuang B. et al. Acotec drug-coated balloon catheter: randomized, multicenter, controlled clinical study in femoropopliteal arteries: evidence from the AcoArt I trial. JACC Cardiovasc. Intervent. 2016; 9: 1941-1949 Crossref PubMed Scopus (72) Google Scholar ], a suitable dose range, a dry predominantly crystalline coating in case of paclitaxel [ [5] Scheller B. Speck U. Abramjuk C. Bernhardt U. Bohm M. Nickenig G. Paclitaxel balloon coating, a novel method for prevention and therapy of restenosis. Circulation. 2004; 110: 810-814 Crossref PubMed Scopus (384) Google Scholar ] or highly crystalline in case of sirolimus or its related macrolides [ [12] Clever Y.P. Peters D. Calisse J. et al. Novel sirolimus-coated balloon catheter in vivo evaluation in a porcine coronary model. Circulation. 2016; 9 PubMed Google Scholar ], coating on a balloon without the need for a protective sheath to prevent premature release of the slightly soluble drugs, handling similar to the use of plain angioplasty balloons, and an inflation time between 30 s (coronary) and a few minutes (peripheral) [ [5] Scheller B. Speck U. Abramjuk C. Bernhardt U. Bohm M. Nickenig G. Paclitaxel balloon coating, a novel method for prevention and therapy of restenosis. Circulation. 2004; 110: 810-814 Crossref PubMed Scopus (384) Google Scholar ].