Comparison of bioresorbable vs durable polymer drug-eluting stents in unprotected left main (from the RAIN-CARDIOGROUP VII Study)

Mario Iannaccone, Umberto Barbero, Michele De Benedictis, Yoichi Imori, Giorgio Quadri, Daniela Trabattoni, Nicola Ryan, Giuseppe Venuti, Andrea Montabone, Wojciech Wojakowski, Andrea Rognoni, Gerard Helft, Radoslaw Parma, Leonardo De Luca, Michele Autelli, Giacomo Boccuzzi, Alessio Mattesini, Christian Templin, Enrico Cerrato, Wojciech Wańha, Grzegorz Smolka, Zenon Huczek, Francesco Tomassini, Bernardo Cortese, Davide Capodanno, Alaide Chieffo, Ivan Nuñez-Gil, Sebastiano Gili, Antonia Bassignana, Carlo di Mario, Baldassarre Doronzo, Pierluigi Omedè, Maurizio D'Amico, Delio Tedeschi, Ferdinando Varbella, Thomas Luscher, Imad Sheiban, Javier Escaned, Mauro Rinaldi, Fabrizio D'Ascenzo, Mario Iannaccone, Umberto Barbero, Michele De Benedictis, Yoichi Imori, Giorgio Quadri, Daniela Trabattoni, Nicola Ryan, Giuseppe Venuti, Andrea Montabone, Wojciech Wojakowski, Andrea Rognoni, Gerard Helft, Radoslaw Parma, Leonardo De Luca, Michele Autelli, Giacomo Boccuzzi, Alessio Mattesini, Christian Templin, Enrico Cerrato, Wojciech Wańha, Grzegorz Smolka, Zenon Huczek, Francesco Tomassini, Bernardo Cortese, Davide Capodanno, Alaide Chieffo, Ivan Nuñez-Gil, Sebastiano Gili, Antonia Bassignana, Carlo di Mario, Baldassarre Doronzo, Pierluigi Omedè, Maurizio D'Amico, Delio Tedeschi, Ferdinando Varbella, Thomas Luscher, Imad Sheiban, Javier Escaned, Mauro Rinaldi, Fabrizio D'Ascenzo

Abstract

Background: There are limited data regarding the impact of bioresorbable polymer drug eluting stent (BP-DES) compared to durable polymer drug eluting stent (DP-DES) in patients treated with percutaneous coronary intervention using ultrathin stents in left main or bifurcations.

Methods: In the RAIN registry (ClinicalTrials NCT03544294, june 2018 retrospectively registered) patients with a ULM or bifurcation stenosis treated with PCI using ultrathin stents (struts thinner than 81 μm) were enrolled. The primary endpoint was the rate of target lesion revascularization (TLR); major adverse cardiovascular events (MACE, a composite of all-cause death, myocardial infarction, TLR and stent thrombosis) and its components, along with target vessel revascularization (TVR) were the secondary ones. A propensity score with matching analysis to compare patients treated with BP-DES versus DP-DES was also assessed.

Results: From 3001 enrolled patients, after propensity score analysis 1400 patients (700 for each group) were selected. Among them, 352 had ULM disease and 1048 had non-LM bifurcations. At 16 months (12-22), rates of TLR (3.7% vs 2.9%, p = 0.22) and MACE were similar (12.3% vs. 11.6%, p = 0.74) as well as for the other endpoints. Sensitivity analysis of outcomes after a two-stents strategy, showed better outcome in term of MACE (20.4% vs 10%, p = 0.03) and TVR (12% vs 4.6%, p = 0.05) and a trend towards lower TLR in patients treated with BP-DES.

Conclusion: In patients with bifurcations or ULM treated with ultrathin stents BP-DES seems to perform similarly to DP-DES: the trends toward improved clinical outcomes in patients treated with the BP-DES might potentially be of value for speculating the stent choice in selected high-risk subgroups of patients at increased risk of ischemic events.

Trial registration: ClinicalTrials.gov Identifier: NCT03544294. Retrospectively registered June 1, 2018.

Keywords: Coronary bifurcation; Drug eluting stents; Left main; Percutaneous coronary intervention; Struts thickness.

Conflict of interest statement

Fabrizio D’ascenzo is member of the editorial board (Section Editor) of this journal. All the other authors have no competing interests.

Figures

Fig. 1
Fig. 1
design of the study
Fig. 2
Fig. 2
outcomes at follow-up. Blue columns represent the percentage of events among patients receiving a DP-DES, red columns represent the percentage of events among patients receiving a BP-DES
Fig. 3
Fig. 3
outcomes at follow-up in the subgroup of patients in whom a coronary bifurcation was treated with a 2-stent technique. Blue columns represent the percentage of events among patients receiving a DP-DES, red columns represent the percentage of events among patients receiving a BP-DES

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