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The purpose of this randomized study is to determine which treatment option, either paclitaxel-eluting balloon, paclitaxel-eluting stent or plain balloon angioplasty is the most effective in the treatment of restenosis after implantation of "Limus"-eluting stents, (LES).
The use of drug-eluting stents (DES) has led to a drastic reduction of restenosis rates compared to bare metal stents (BMS), but 5% to 10% of patients receiving DES are still in need of revascularization of the treated vessel. Two important families of drugs are used for stent coating: paclitaxel belonging to the taxane family, and the "limus"-family such as sirolimus, everolimus, zotarolimus, biolimus A9 and pimecrolimus.
Data regarding the optimal treatment of in-DES-restenosis is very limited. Implanting a new DES for in-DES-restenosis has been reported to be associated with re-restenosis rates as high as 43%. Several recent well published studies have shown a substantial reduction of restenosis using paclitaxel-eluting balloons (PEB) for de-novo lesions and BMS-restenotic lesions.
The objective of this randomized trial is to assess the hypothesis, that PEB are non-inferior to paclitaxel-eluting-stents (PES) for restenosis in "limus"-eluting-stents (LES), and both, PEB and PES, are superior to plain angioplasty in patients with restenosis after initial LES implantation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Paclitaxel-eluting stent | Experimental | Paclitaxel-eluting stent (Taxus) |
|
| Plain Balloon | Active Comparator | plain balloon angioplasty |
|
| Paclitaxel-eluting balloon | Experimental | SeQuent Please |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Taxus stent | Device | Implantation of paclitaxel-eluting stent |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percent in-segment diameter stenosis at follow-up angiography | 6-8 months |
| Measure | Description | Time Frame |
|---|---|---|
| In-segment minimal luminal diameter | 6-8 months | |
| In-segment binary angiographic restenosis | 6-8 months | |
| Combined incidence of death or myocardial infarction |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Julinda Mehilli, MD | Deutsches Herzzentrum Munich | Principal Investigator |
| Adnan Kastrati, MD | Deutsches Herzzentrum | Study Chair |
| Klaus Tiroch, MD | Deutsches Herzzentrum | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1. Med. Klinik, Klinikum rechts der Isar | Munich | Bavaria | 81675 | Germany | ||
| Herz-Zentrum |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19487593 | Background | Unverdorben M, Vallbracht C, Cremers B, Heuer H, Hengstenberg C, Maikowski C, Werner GS, Antoni D, Kleber FX, Bocksch W, Leschke M, Ackermann H, Boxberger M, Speck U, Degenhardt R, Scheller B. Paclitaxel-coated balloon catheter versus paclitaxel-coated stent for the treatment of coronary in-stent restenosis. Circulation. 2009 Jun 16;119(23):2986-94. doi: 10.1161/CIRCULATIONAHA.108.839282. Epub 2009 Jun 1. | |
| 36807512 |
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| SeQuent Please |
| Device |
Dilation with SeQuent Please (paclitaxel-eluting balloon) |
|
| Conventional Balloon Catheter | Device | Ryuijin, Trek |
|
| 1 and 2 years |
| Incidence of thrombosis | 1 and 2 years |
| Bad Krozingen |
| 79189 |
| Germany |
| Deutsches Herzzentrum | Munich | 80636 | Germany |
| Derived |
| Giacoppo D, Alvarez-Covarrubias HA, Koch T, Cassese S, Xhepa E, Kessler T, Wiebe J, Joner M, Hochholzer W, Laugwitz KL, Schunkert H, Kastrati A, Kufner S. Coronary artery restenosis treatment with plain balloon, drug-coated balloon, or drug-eluting stent: 10-year outcomes of the ISAR-DESIRE 3 trial. Eur Heart J. 2023 Apr 17;44(15):1343-1357. doi: 10.1093/eurheartj/ehad026. |
| 26003022 | Derived | Kufner S, Cassese S, Valeskini M, Neumann FJ, Schulz-Schupke S, Hoppmann P, Fusaro M, Schunkert H, Laugwitz KL, Kastrati A, Byrne RA; ISAR-DESIRE 3 Investigators. Long-Term Efficacy and Safety of Paclitaxel-Eluting Balloon for the Treatment of Drug-Eluting Stent Restenosis: 3-Year Results of a Randomized Controlled Trial. JACC Cardiovasc Interv. 2015 Jun;8(7):877-84. doi: 10.1016/j.jcin.2015.01.031. Epub 2015 May 20. |
| 23206837 | Derived | Byrne RA, Neumann FJ, Mehilli J, Pinieck S, Wolff B, Tiroch K, Schulz S, Fusaro M, Ott I, Ibrahim T, Hausleiter J, Valina C, Pache J, Laugwitz KL, Massberg S, Kastrati A; ISAR-DESIRE 3 investigators. Paclitaxel-eluting balloons, paclitaxel-eluting stents, and balloon angioplasty in patients with restenosis after implantation of a drug-eluting stent (ISAR-DESIRE 3): a randomised, open-label trial. Lancet. 2013 Feb 9;381(9865):461-7. doi: 10.1016/S0140-6736(12)61964-3. Epub 2012 Dec 1. |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D007511 | Ischemia |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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