Rayyan Hemetsberger1,2, Mohammad Abdelghani3,4, Ralph Toelg5, Hector M Garcia-Garcia6, Serdar Farhan7, Nader Mankerious5, Karim Elbasha5, Abdelhakim Allali5, Stephan Windecker8, Thierry Lefèvre9, Shigeru Saito10, David Kandzari11, Ron Waksman6, Gert Richardt5. 1. Heart Center Bad Segeberg, Segeberger Kliniken GmbH, Am Kurpark 1, 23795, Bad Segeberg, Germany. rayyan.hemetsberger@hotmail.com. 2. Department of Cardiology, Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil Bochum, Bochum, Germany. rayyan.hemetsberger@hotmail.com. 3. Cardiology Department, Al-Azhar University, Cairo, Egypt. 4. Cardiology Department, Amsterdam University Medical Center, University of Amsterdam, Amsterdam, The Netherlands. 5. Heart Center Bad Segeberg, Segeberger Kliniken GmbH, Am Kurpark 1, 23795, Bad Segeberg, Germany. 6. Interventional Cardiology, Medstar Washington Hospital Center, Washington, DC, USA. 7. Icahn School of Medicine at Mount Sinai, The Zena and Michael A. Wiener Cardiovascular Institute, New York, NY, USA. 8. Inselspital (University Hospital), Bern, Switzerland. 9. Hospital Privé Jaques Cartier, Massy, France. 10. Okinawa Tokushukai Shonan Kamakura General Hospital, Kamakura, Japan. 11. Piedmont Heart Institute, Atlanta, GA, USA.
Abstract
BACKGROUND: Patients undergoing complex percutaneous coronary intervention (PCI) are at higher risk of adverse outcomes, but data are scarce in the era of newer-generation coronary stents. AIM: We sought to compare the clinical outcomes after complex PCI with a bioresorbable-polymer sirolimus-eluting stent (BP-SES) versus a durable-polymer everolimus-eluting stent (DP-EES). METHODS: Patients (n = 2350) from BIOFLOW-II, -IV, and -V randomized trials were categorized into non-complex PCI vs. complex PCI. Complex PCI had at least one of the following criteria: multi-vessel PCI, ≥ 3 lesions treated, ≥ 3 stents implanted, total stent length ≥ 60 mm. Endpoints were target lesion failure (TLF: cardiac death, target-vessel myocardial infarction [TV-MI], or target lesion revascularization [TLR]) and probable/definite stent thrombosis (ST) at three years. RESULTS: Patients with complex PCI (n = 348) were older and presented more often with acute coronary syndrome than non-complex PCI patients (n = 2002). Complex PCI lesions were more often type B2/C and bifurcation lesions and required more pre- and post-dilatation. Complex PCI patients had higher rates of TLF (14.6% vs. 8.1%; aHR 1.89, 95% CI [1.31-2.73], p = 0.001), TV-MI (10.2% vs. 4.4%, aHR 2.17, 95% CI [1.40-3.37], p = 0.001), and ST (1.5% vs. 0.4%, p = 0.025) as compared with non-complex PCI. TLF was not lower with BP-SES as compared to DP-EES in complex PCI (12.6% vs 18.2%, p = 0.16). CONCLUSION: Patients undergoing complex PCI with the newer-generation DES still sustain a higher risk of TLF, TV-MI and stent thrombosis as compared with non-complex PCI. This adverse outcome was not significantly modified by the stent platform (BP-SES vs. DP-EES). CLINICAL TRIAL REGISTRATION: Clinicaltrial.gov NCT01356888, NCT01939249, NCT02389946, https://clinicaltrials.gov/show/NCT01356888 ; https://clinicaltrials.gov/show/NCT01939249 ; https://clinicaltrials.gov/show/NCT02389946 .
BACKGROUND: Patients undergoing complex percutaneous coronary intervention (PCI) are at higher risk of adverse outcomes, but data are scarce in the era of newer-generation coronary stents. AIM: We sought to compare the clinical outcomes after complex PCI with a bioresorbable-polymer sirolimus-eluting stent (BP-SES) versus a durable-polymer everolimus-eluting stent (DP-EES). METHODS: Patients (n = 2350) from BIOFLOW-II, -IV, and -V randomized trials were categorized into non-complex PCI vs. complex PCI. Complex PCI had at least one of the following criteria: multi-vessel PCI, ≥ 3 lesions treated, ≥ 3 stents implanted, total stent length ≥ 60 mm. Endpoints were target lesion failure (TLF: cardiac death, target-vessel myocardial infarction [TV-MI], or target lesion revascularization [TLR]) and probable/definite stent thrombosis (ST) at three years. RESULTS: Patients with complex PCI (n = 348) were older and presented more often with acute coronary syndrome than non-complex PCI patients (n = 2002). Complex PCI lesions were more often type B2/C and bifurcation lesions and required more pre- and post-dilatation. Complex PCI patients had higher rates of TLF (14.6% vs. 8.1%; aHR 1.89, 95% CI [1.31-2.73], p = 0.001), TV-MI (10.2% vs. 4.4%, aHR 2.17, 95% CI [1.40-3.37], p = 0.001), and ST (1.5% vs. 0.4%, p = 0.025) as compared with non-complex PCI. TLF was not lower with BP-SES as compared to DP-EES in complex PCI (12.6% vs 18.2%, p = 0.16). CONCLUSION: Patients undergoing complex PCI with the newer-generation DES still sustain a higher risk of TLF, TV-MI and stent thrombosis as compared with non-complex PCI. This adverse outcome was not significantly modified by the stent platform (BP-SES vs. DP-EES). CLINICAL TRIAL REGISTRATION: Clinicaltrial.gov NCT01356888, NCT01939249, NCT02389946, https://clinicaltrials.gov/show/NCT01356888 ; https://clinicaltrials.gov/show/NCT01939249 ; https://clinicaltrials.gov/show/NCT02389946 .
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