Small‐vessel PCI outcomes in men, women, and minorities following platinum chromium everolimus‐eluting stents: Insights from the pooled PLATINUM Diversity and PROMUS Element Plus Post‐Approval studies

Abstract

Objective We evaluated 1‐year outcomes after platinum chromium everolimus‐eluting stents (PtCr‐EES) in small versus non‐small coronary arteries within a large, diverse sample of men, women, and minorities. Background There exists limited outcomes data on the use of second‐generation drug‐eluting stent to treat small diameter coronary arteries. Methods We pooled patients from the PLATINUM Diversity and PROMUS Element Plus stent registries. Small‐vessel percutaneous coronary intervention (SV‐PCI) was defined as ≥1 target lesion with reference vessel diameter (RVD) ≤2.5 mm. Endpoints included major adverse cardiac event (MACE; death, myocardial infarction [MI] or target vessel revascularization [TVR]), target vessel failure (TVF; death related to the target vessel, target vessel MI or TVR) and definite/probable stent thrombosis (ST). Multivariable Cox regression was used to risk‐adjust outcomes. Results We included 4,155/4,182 (99%) patients with available RVD, of which 1,607 (39%) underwent small‐vessel PCI. SV‐PCI was not associated with increased MACE (adjHR 1.02; 95%CI 0.81–1.30) or TVF (adjHR 1.07; 95%CI 0.82–1.39). MI risk was lower in white men compared to women and minorities, both in the setting of SV‐PCI (adjHR 0.41; 95%CI 0.23–0.74 and adjHR 0.39; 95%CI 0.20–0.75, respectively) and for non‐SV‐PCI (adjHR 0.61; 95%CI 0.38–0.99 and adjHR 0.45; 95%CI 0.27–0.74, respectively). There was no significant interaction between RVD and sex or minority status for any endpoint. Conclusion In a large diverse contemporary PCI outcomes database, SV‐PCI with PtCr‐EES was not associated with increased MACE or TVR and did not account for the increased MI risk noted in women and minorities compared to white men.

Small Vessel Coronary Artery Disease: Rationale for Standardized Definition and Critical Appraisal of the Literature

“…Of note, none of these studies used intracoronary imaging to determine vessel size before study inclusion, which might have contributed to the important observed differences between the vessel size-based inclusion criteria and actual reference vessel diameters (Tables 1 [17][18][19][20][21][22][23][24][25][26][27][28][29][30][31][32][33] and 2 [10][11][12][34][35][36][37] ).…”

Long-term safety and efficacy of the Resolute stent: 5-year results from the RESOLUTE China Registry

“…Historically, PCI in small vessels has resulted in an increase in adverse events 17 . However, several recent studies have reported no differences in clinical outcomes or angiographic measurements for small (RVD ≤2.5 mm) compared to non-small vessels after DES implantation, including no association of increased major adverse cardiac events (MACE) or TVR at 1 year 18 , no difference in early or late restenosis at 8 months 19 , and no difference in TLR at 2 years 20 for treatment in small vessels. Notably, favourable short-term outcomes were reported for a subsequent iteration of the R-ZES, the Resolute Onyx™ ZES (Medtronic), for patients with very small (RVD <2.25 mm) lesions: 5.0% TLF and 2.0% TLR at 1 year 21 , suggesting that advances in stent technology may ameliorate the performance of DES in small vessels after PCI.…”

Clinical implication of ticagrelor monotherapy in patients with small vessel coronary artery disease: results from the TICO randomized trial

“…Several definitions have been proposed for small vessel disease, including an angiographic reference vessel diameter of equal to or less than 2.75 mm or 2.5 mm ( 6 , 7 , 10 ). Despite variations in these definitions, small vessel disease has consistently been associated with an increased risk of adverse events, including restenosis and thrombosis ( 1 , 3 , 11 , 12 ).…”

“…For the purpose of this study. small vessel coronary artery disease was defined as a minimal reference diameter ≤2.5 mm ( 6 , 7 ).…”