Gennaro Sardella1, Pieter Stella2, Mauro Chiarito3, Antonio M Leone4, Vruyr Balian5, Franco Prosperi6, Giovanni Sorropago7, Massimo Mancone1, Simone Calcagno1, Carlo Briguori8, Giulio G Stefanini3. 1. Department of Cardiovascular, Respiratory, Nephrologic, Anesthesiologic and Geriatric Sciences, Policlinico Umberto I, "Sapienza" University of Rome, Rome, Italy. 2. University Medical Centre Utrecht, Utrecht, Netherlands. 3. Department of Biomedical Sciences, Humanitas University, Rozzano, Milan, Italy. 4. Policlinico Universitario Agostino Gemelli, Rome, Italy. 5. Ospedale di Circolo di Busto Arsizio, Busto Arsizio, Italy. 6. Ospedale Civile G.Mazzini Cardiologia 2, Teramo, Italy. 7. Policlinico di Monza, Monza, Italy. 8. Casa di Cura Mediterranea, Napoli, Italy.
Abstract
BACKGROUND: Patients with diabetes mellitus (DM) remain at higher risk of restenosis after percutaneous coronary intervention despite the use of contemporary drug-eluting stents. The Cre8 amphilimus-eluting stent (AES) has shown promising results in DM patients. Whether this holds true irrespective of patient's clinical and angiographic complexity is unknown. METHODS: Five hundred and ninety five consecutive patients (738 lesions) undergoing AES implantation were included in the INVESTIG8 multicenter registry. Patients were stratified according to DM status and further stratified according to patients' complexity. The prespecified primary endpoint was target lesion failure (TLF)-defined as the composite of cardiac death, target-vessel myocardial infarction, and target lesion revascularization (TLR). RESULTS: DM patients were more often complex as compared to non-DM patients (70% vs. 61%, P = 0.015). At 18-month follow-up, there was a trend to a higher TLF rate in DM than in non-DM patients (6.9% vs. 3.5%, P = 0.063). This was largely driven by a markedly higher risk of TLF among complex DM patients as compared to simple DM patients (8.9% vs. 2.4%, P = 0.053). A multivariate analysis identified complexity (HR 6.11, 95% CI: 1.42-26.2) but not DM (HR 1.59; 95% CI 0.71-3.56) as an independent predictor of TLF. Of note, TLR rates were similar between DM and non-DM patients (3.3% vs. 1.9%, P = 0.228). CONCLUSIONS: In this real-world, multicenter registry the Cre8 AES showed favorable clinical outcomes in DM patients. Increased risk of TLF appears to be driven by patients' complexity rather than DM status. These findings will need to be confirmed in a large-scale randomized trial.
BACKGROUND:Patients with diabetes mellitus (DM) remain at higher risk of restenosis after percutaneous coronary intervention despite the use of contemporary drug-eluting stents. The Cre8 amphilimus-eluting stent (AES) has shown promising results in DMpatients. Whether this holds true irrespective of patient's clinical and angiographic complexity is unknown. METHODS: Five hundred and ninety five consecutive patients (738 lesions) undergoing AES implantation were included in the INVESTIG8 multicenter registry. Patients were stratified according to DM status and further stratified according to patients' complexity. The prespecified primary endpoint was target lesion failure (TLF)-defined as the composite of cardiac death, target-vessel myocardial infarction, and target lesion revascularization (TLR). RESULTS:DMpatients were more often complex as compared to non-DMpatients (70% vs. 61%, P = 0.015). At 18-month follow-up, there was a trend to a higher TLF rate in DM than in non-DMpatients (6.9% vs. 3.5%, P = 0.063). This was largely driven by a markedly higher risk of TLF among complex DMpatients as compared to simple DMpatients (8.9% vs. 2.4%, P = 0.053). A multivariate analysis identified complexity (HR 6.11, 95% CI: 1.42-26.2) but not DM (HR 1.59; 95% CI 0.71-3.56) as an independent predictor of TLF. Of note, TLR rates were similar between DM and non-DMpatients (3.3% vs. 1.9%, P = 0.228). CONCLUSIONS: In this real-world, multicenter registry the Cre8 AES showed favorable clinical outcomes in DMpatients. Increased risk of TLF appears to be driven by patients' complexity rather than DM status. These findings will need to be confirmed in a large-scale randomized trial.
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